HEAVEN PHARMACY
HEAVEN PHARMACY
Heaven
Pharmacy Practice - II
h
Dispensing and Community
Pharmacy for Pharm D
Graduates
“It is easy to get a thousand prescriptions, but hard to get one single remedy.”
M Ameer Haroon
i
ii
iii
Heaven
Pharmacy Practice- II
notes
DISPENSING AND
COMMUNITY
PHARMACY
For Pharm.D
Graduates
iv
DISCLAIMER
Care has been taken to confirm the accuracy of the information
present and to describe generally accepted practices. However,
the authors, editors, and publisher are not responsible for errors
or omissions or for any consequences from application of the
information in this book and make no warranty, expressed or
implied, with respect to the currency, completeness, or accuracy
of the contents of the publication. Application of this information
in a particular situation remains the professional responsibility of
the practitioner; the clinical treatments described and
recommended may not be considered absolute and universal
recommendations.
I DO NOT own the rights of the pictures and
some context. All rights reserved to their
copyright owner, those context and pictures
are just used as a reference in this book.
The authors, editors, and publisher have exerted every effort to
ensure that drug selection and dosage set forth in this text are in
accordance with the current recommendations and practice at the
time of publication.
v
Compiled By:
Muhammad Ameer Haroon
(School of Pharmaceutical Sciences, JIPS)
Dedicated To:
My beloved Parents,
Teachers and friend (M Noman).
Contributors:
Muhammad Adeel
And all other class
fellows.
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Dispensing and Community Pharmacy for Pharm D
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Contents
Contents
PART A
Dispensing Pharmacy
Chapter 1 Basic Principles of Compounding and Dispensing .................... 3
Dispensing ................................................................................................................................ 5
Prescription: ............................................................................................................................. 5
Containers & Closures............................................................................................................... 7
Labelling ................................................................................................................................. 14
Weights and measures: .......................................................................................................... 17
Chapter 2 Extemporaneous dispensing ................................................. 23
Pharmaceutical powders ........................................................................................................ 25
1. Bulk powders for external uses: ............................................................................................................ 25
2. Bulk oral powders: ................................................................................................................................. 26
3. Individual unit dose powders: ............................................................................................................... 27
4. Unit dose capsules: ................................................................................................................................ 29
Dispensing of solutions ........................................................................................................... 32
Definition: .................................................................................................................................................. 32
General principles of solution preparation ............................................................................................... 34
General methods of Preparation of Solution ............................................................................................ 34
Discard date: .............................................................................................................................................. 39
Labelling:.................................................................................................................................................... 40
Dispensing of Pharmaceutical Emulsions ................................................................................. 41
Definition: .................................................................................................................................................. 41
General method of preparation of an emulsion using the dry gum method:........................................... 47
Packaging: .................................................................................................................................................. 50
Discard dates: ............................................................................................................................................ 50
Labeling: .................................................................................................................................................... 51
Dispensing of Pharmaceutical suspensions .............................................................................. 52
Introduction: .............................................................................................................................................. 52
Definition: .................................................................................................................................................. 52
General principles of suspension preparation .......................................................................................... 53
Packaging: .................................................................................................................................................. 56
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Dispensing and Community Pharmacy for Pharm D
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Discard date: .............................................................................................................................................. 56
Labelling:.................................................................................................................................................... 57
Dispensing of pharmaceutical ointments ................................................................................ 58
Ointment bases: ........................................................................................................................................ 58
General method for ointment preparation ............................................................................................... 59
Dispensing of Pharmaceutical Creams ..................................................................................... 61
Definition: .................................................................................................................................................. 61
General principles of cream preparation: ................................................................................................. 61
Packaging: .................................................................................................................................................. 63
Discard date: .............................................................................................................................................. 63
Labelling:.................................................................................................................................................... 64
Dispensing of Pharmaceutical Paste and Gels .......................................................................... 65
Pastes:........................................................................................................................................................ 65
Gels: ........................................................................................................................................................... 65
Packaging: .................................................................................................................................................. 68
Discard date: .............................................................................................................................................. 69
Labeling: .................................................................................................................................................... 69
Dispensing of pharmaceutical suppositories and Pessaries ...................................................... 70
Suppositories: ............................................................................................................................................ 70
Pessaries: ................................................................................................................................................... 70
General principles of suppository and pessary preparation...................................................................... 71
General method of suppository preparation: ........................................................................................... 72
Packaging: .................................................................................................................................................. 73
Discard dates: ............................................................................................................................................ 73
Labelling:.................................................................................................................................................... 73
Dispensing of Classical Dosage Form ....................................................................................... 74
Classical dosage form ................................................................................................................................ 74
Chapter 3 Pharmaceutical Incompatibilities .......................................... 81
Pharmaceutical Incompatibilities ............................................................................................ 83
Classification of incompatibilities: ........................................................................................... 83
1. Therapeutic incompatibilities: ............................................................................................................... 83
2. Physical incompatibilities: ..................................................................................................................... 85
3. Chemical incompatibilities: ................................................................................................................... 87
Chapter 4 I.V Admixtures .............................Error! Bookmark not defined.
IV Admixtures ................................................................................ Error! Bookmark not defined.
Preparation of IV Admixtures......................................................... Error! Bookmark not defined.
ix
Contents
Aseptic Dispensing Technique .................................................................... Error! Bookmark not defined.
IV solutions ................................................................................... Error! Bookmark not defined.
Labelling of an IV admixture: ......................................................... Error! Bookmark not defined.
Chapter 5 Radio-Pharmacy Techniques & Applications Error! Bookmark not
defined.
Radio-Pharmacy ............................................................................ Error! Bookmark not defined.
Radiopharmaceuticals: .................................................................. Error! Bookmark not defined.
Preparation of Radiopharmaceuticals ............................................ Error! Bookmark not defined.
Applications of Radiopharmaceuticals ........................................... Error! Bookmark not defined.
PART B:
Community social and administrative Pharmacy
Chapter 6 INTRODUCTION TO COMMUNITY PHARMACY ...................... 95
Community Pharmacy ............................................................................................................ 97
Role of community pharmacist ............................................................................................... 98
Chapter 7 Pharmacy layout and Design ............................................... 101
Pharmacy layout design ........................................................................................................ 103
Design of pharmacy: ................................................................................................................................ 105
Pharmacy layout:.................................................................................................................. 106
Objective of layout Design....................................................................................................................... 106
Types of community pharmacy: .............................................................................................................. 107
Layout of community pharmacy:............................................................................................................. 107
Types of Layout Design: ........................................................................................................................... 109
Styles of layout Design: ........................................................................................................................... 110
Minimum requirement for pharmacy: .................................................................................................... 110
Chapter 8 Patient education and council............................................. 113
Patient Education & Counselling ........................................................................................... 115
Patient Education .................................................................................................................................... 115
Patient counseling ................................................................................................................................... 120
Chapter 9 Medical Complications of Drug Taking ................................ 123
Medical Complications of Drug Taking .................................................................................. 125
Introduction ............................................................................................................................................. 125
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Complications of Medicine ...................................................................................................................... 125
Health outcomes ..................................................................................................................................... 125
Specific Health outcomes ........................................................................................................................ 126
(Medical Conditions Arising from Drug use) ........................................................................................... 126
Social sequelae ........................................................................................................................................ 128
Other forms of drug misuse .................................................................................................................... 128
Chapter 10 Drug Abuse and Misuse .................................................... 129
DRUG ABUSE AND MISUSE ................................................................................................... 131
Terminologies .......................................................................................................................................... 131
DRUG ABUSE............................................................................................................................................ 132
Symptoms of drug abuse ......................................................................................................................... 132
Harms related to drug abuse ................................................................................................................... 133
Strategies to control drug abuse ............................................................................................................. 133
Major classes of drugs causing addiction, Their withdrawal and treatment .......................................... 135
DRUG MISUSE .......................................................................................................................................... 137
Chapter 11 PUBLIC HEALTH AND COMMUNITY PHARMACY ................ 141
EPIDEMIOLOGY .................................................................................................................... 143
EPIDEMIOLOGICAL STUDY DESIGN ........................................................................................ 146
Classification of Epidemiological study design ........................................................................................ 146
PHARMACOEPIDEMIOLOGY .................................................................................................. 148
Drug utilization evaluation/ Drug Utilization Review (DUE\DUR) ........................................................... 149
PHYSICAL HEALTH ................................................................................................................. 152
HEALTH POLICY..................................................................................................................... 153
FAMILY PLANNING ............................................................................................................... 156
Methods of contraception....................................................................................................................... 156
Chapter 12 PHARMACOECONOMICS ................................................... 165
PHARMACOECONOMICS ....................................................................................................... 167
Introduction ............................................................................................................................................. 167
Costs ........................................................................................................................................................ 167
Consequences (Outcomes) ...................................................................................................................... 168
Pharmacoeconomic Methodologies........................................................................................................ 168
Applications of Pharmacoeconomics ...................................................................................................... 173
Chapter 13 Alternative Therapies ....................................................... 175
Alternative Therapies: .......................................................................................................... 177
Introduction ............................................................................................................................................. 177
Herbal medicine ...................................................................................................................................... 177
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Contents
Homoeopathy .......................................................................................................................................... 178
Acupuncture ............................................................................................................................................ 179
Acupressure ............................................................................................................................................. 180
Reflexology .............................................................................................................................................. 182
Aromatherapy ......................................................................................................................................... 183
Bach flower remedies .............................................................................................................................. 184
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Dispensing and Community Pharmacy for Pharm D Graduates
PART A
Dispensing Pharmacy
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Dispensing and Community Pharmacy for Pharm D Graduates
2
Basic Principles of Compounding and Dispensing
Chapter 1 BASIC PRINCIPLES OF
COMPOUNDING AND DISPENSING
Chapter Outline
1.
Prescription and Prescription handling
Prescription, Parts of prescription, Prescription
Handling, Filling, Interpretation and Pricing.
2.
Containers and closures for Dispensed
products,
3.
Labelling of Dispensed Medication.
4.
Fundamental operations in compounding,
5.
Weights and measures,
6.
Calculations for compounding and dispensing,
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Dispensing and Community Pharmacy for Pharm D Graduates
4
Basic Principles of Compounding and Dispensing
Dispensing
The branch of pharmacy which is concerned with the distribution of medicaments especially the
filling of prescriptions. This is concerned with receiving, handling, compounding and dispensing
pharmaceutical products in conformity with the expressed wishes of a licensed practitioner.
Compounding:
Compounding is the mixing of drugs by a compounding pharmacist to fit the unique needs of a
patient.
Prescription:
It is an order for the medication issued by physician, dentist or other properly licensed medical
practitioner.
It is may be written or may be verbal or oral.
Parts of prescription
Parts of prescription are as follows;
1. Prescriber’s office information:
The prescription must contain the information about prescriber’s office. That includes address,
telephone no. It is essential because sometimes for the confirmation of dosage or medication or for
the correction of any sort discrepancy in prescription.
2. Date:
Date must be properly mentioned on the prescription as it tells about the day of prescription. It is
necessary for the narcotic medicine. It is also necessary to check on refill status.
3. Patient’s information:
Patient’s information must be asked and it should be written on the prescription as well. It includes
name, gender, age, address of the patient.
4. Superscription:
Some say this is a Latin word, “Recipe” meaning ‘Take thou (you take)’ and some people says that it
is the sign of Jupiter.
5. Inscription:
It is called the ‘Heart of prescription.’ It contains the name and exact quantity of the prescribed
medicine (medication prescribed). It may be an official formula or trade name, generic name, special
formula or non-proprietary name.
6. Subscription:
It includes the directions to the pharmacist (dispensing directions), sometimes dispenses it in doses,
or compounding may be done (compounding prescription).
✓ How to make.
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Dispensing and Community Pharmacy for Pharm D Graduates
✓ What to make.
✓ The type of dosage form to be compound.
7. Signatura / sign:
It includes the instructions to the patient. This all information should clearly be mentioned on the
label for the convenience of patient.
Example:
✓
✓
✓
✓
✓
Dose of the medicine
At what time the medication should be taken.
Either the preparation is for external or internal use.
If an external topical medication then where to apply, and how to apply.
If an internal preparation then with what vehicle medicine should be take, which shouldn’t
be taken before and after medicine.
✓ Discard date of the preparation
✓ In case of ophthalmic preparations, instructions about how to instill, how much to instill,
and either in one eye or both.
✓ In case of emulsion or suspension, both should be shaken before use.
8. Refill information:
Dispensing on old prescription or again refilling of prescription.
Example:
✓ No refill is mentioned on the prescription for narcotic drugs.
✓ Refill is mentioned for diseases like tuberculosis.
9. Prescriber’s signature:
At the end of prescription, the practitioner must confirm it either by the official sign no stamp.
Signature can be replaced by License no., narcotic registry sign, or license no. of any sort of by the
country.
In case of verbal prescription then the pharmacist should first write it then take the signature.
Prescription handling
Prescription handling includes;
▪
▪
▪
Filling or Refusal of prescription
Compounding of formulation
Pricing
Filling or Refusal of prescription:
The pharmacist has the right to refuse the filling of prescription if it is not legal, legible and
complete.
Filling of any prescription is carried out after the confirmation of all parts of prescription. The
prescription is refused on following bases;
6
Basic Principles of Compounding and Dispensing
✓
✓
✓
✓
✓
✓
✓
If either the ingredients are not present in the stock or they are not readily available.
If the essential information is missing or doubtful.
If the safety of the prescription is doubtful.
If the prescription does not confirm to the legal requirements.
If the parts of prescriptions are missing or not mentioned.
If the prescription is not legible and confusing.
If any forgery or illegal alteration is suspected.
Compounding:
If the prescription is of standard and complete from all aspects then it is accepted and compounding
is performed. During the compounding of preparation, one must keep following things in mind;
▪
▪
Compound one product at a time.
Compounding should be performed at one place so that there will be less chances of
mistakes.
Compounding includes;
▪ Choosing container
▪ Label preparation
▪ Filling the product
▪ Rechecking of the product
▪ Prizing of prescription
▪ Filling of prescription.
Pricing:
Pricing should be done by keeping all the aspects in the mind. Following prizes must be added with
proper proportion to the price of final product formulation;
▪
▪
▪
▪
▪
Cost of ingredients
Cost of container
Cost of time required for compounding and dispensing.
Cost of professional services (knowledge, professional skill, time required, duties and
services indirectly related to compounding and dispensing).
Cost of overhead expenses (electricity, tax, rent, heat, refrigeration and insurance,
depreciation in equipment, deterioration and obsolescence of drugs, advertising and other
miscellaneous expenses of the operation)
Containers & Closures
The choice of containers for the raw material or for dispensing is very much important.
Desired features for a container & closure:
1. The containers must be rigid enough to prevent damage to contents. For example; crushing
of capsule, fracture of tablet.
2. The material of the container must be inert i.e. it should not react with the contents present
in it.
3. The closure must prevent;
▪ Access of moisture.
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Dispensing and Community Pharmacy for Pharm D Graduates
▪
▪
▪
4.
5.
6.
7.
8.
9.
Loss of moisture in case of creams lotions etc.
Unintentional loss of contents.
Entry of dirt or other contaminants. For example, odors or vapors.
The closure must be easily removed and replaced.
It must not be difficult to abstract the contents or to empty the container completely.
For many products protection from light must be given.
The BPC defines; A light resistant container as one that doesn’t transmit more than 10%
of incident radiation at any wavelength between 290 nm – 450 nm.
The European Pharmacopoeia specifies uncolored glass for containers of injectable
preparations unless they are extremely light sensitive.
Medicaments or adjuncts must not be absorbed neither by container materials nor must
diffuse through the walls be possible.
It must be easy to label the container easily.
It must be elegant in appearance pharmaceutically.
Classification of Containers
Based on utility containers can be classified into following groups;
1. Airtight containers
These containers prevent the contents from dust, moisture, and air. These are also called
hermetic containers. Airtight containers have air-tight sealing or closing, which prevents moisture
entry in the packaging. These types are commonly used for materials that are prone to degradation in
contact with air or moisture.
2. Light resistant containers
Some materials are light sensitive. They lose their characteristics on exposure to sunlight.
Such types of materials are kept in light-resistant containers. They protect the contents from direct
exposure to light. Many medicines are photosensitive and are stored in light-sensitive containers.
3. Multi-dose containers
These types of containers are used to allow the withdrawal of multiple doses from the same
container without affecting the quality, purity, or strength of the pharmaceutical dosage. Such types
of containers often contain multiple doses of the product. These are generally used for injectables.
4. Single-dose containers
These are special types of containers that are used for storing a single dose of the product.
Parenteral products are generally stored in these types of containers. E.g., ampoules.
5. Well closed containers
These are the common types of containers used generally in the markets to hold the products
easily and in a well-closed environment. They protect the contents from loss during transportation,
storage, handling, and sale.
6. Aerosol containers
Aerosol containers are used to store aerosols. They are made up of suitable materials to
withstand the pressure required to contain aerosols.
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Basic Principles of Compounding and Dispensing
7. Child-proof containers
These types of containers are used to protect the children from hampering the contents.
Sometimes, the products are harmful to the children and can cause a hazardous effect. To protect
such products, they are fitted with closures that protect the package from the children.
Liquid preparations:
Liquid preparations are of three types;
i.
ii.
iii.
Intended to be swallowed
Not to be swallowed
Other liquid preparations
i. Intended to be swallowed (oral):
Colorless cheaper glass bottles are used. Which are flat from one side and ovoid from the other.
The flat side is for the label.
Screw caps made up of white propylene are available. They are of different sizes 50ml, 100ml,
500ml or 1000ml.
ii. Not to be swallowed:
Ribbed or fluted bottle is used with pourable mouth shape. It is used to differentiate between oral
and external preparation.
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Dispensing and Community Pharmacy for Pharm D Graduates
iii. Other liquid preparations:
Application in skin:
Colored or fluted bottle is used for packaging. Some preparations need an applicator. For
example; brush for paints and such preparations have wide mouths.
Lotions and liniments and others without applicator must be packed in plastic collapsible
bottle with narrow tips.
Cavities; colored fluted bottle are used. Caps must have nozzle that assist administration or
instillation.
For inhalation:
Colored or fluted bottle are used for its packing.
Vitrellae inhalation: it is just like an ampule. It must be packed in boxes for better protection.
Semi solid dosage form:
The packaging material must have these following properties;
✓
✓
✓
✓
It is capable of preventing moisture or evaporation.
It should be inert and shouldn’t liberate toxic chemicals.
It must provide adequate mechanical strength and provide an effective seal.
It should not liberate irritating or sensitizing substances.
Packing material Used for Solid dosage Form
The packaging material which is used for semisolid dosage forms are;
10
Basic Principles of Compounding and Dispensing
Collapsible metal or plastic tube
They prevent contamination. One should not touch the tip of the tube to the infected area while
application to prevent contamination of the product.
•
•
•
•
•
•
They are acceptable due to few reasons;
They possess narrow orifice.
They prevent serious contamination.
The wastage of the dosage form is reduced.
For their better use, nozzle type applicators can be attached.
Not replaced by air.
Glass or plastic pot
Plastic is preferred for packing as the metal is reactive to many chemicals. Similarly, is it cheap as
compared to the metal bottles and easily available.
Solid unit dosage form:
Solid dosage forms can be:
1. Oral: Intended to be swallowed, chewed and sucked like cachets, lozenges, pills, capsules,
tablets etc.
2. Rectal: Intended to be used in body cavities, like; suppositories.
3. Powders (oral powders & external powders)
1. Oral solid dosage forms:
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Dispensing and Community Pharmacy for Pharm D Graduates
They are packed in;
Paper board
Glass
Plastic
Aluminum
General features; robust, strong, unbreakable containers. So that;
✓ They prevent unintentional release of content.
✓ They prevent deformation in use which normally leads to the difficulty in closing.
✓ They are protective against moisture, oxygen and light.
i.
Paper boards:
They are either collapsible cartons, rigid boxes or drums. They are foiled or blister packed actually.
ii.
Glass:
It is an oval or rectangular bottle with plastic or metal screw caps. They are may be colorless.
Normally amber or opaque color glass is used.
iii.
Plastic:
For plastic packing the following materials are used; Poly vinyl chloride PVC, Polystyrene, Poly
propylene.
iv.
Aluminum:
Lined with paper or internally lacquered. It is robust and unbreakable. It is lighter in weight. They
require less storage space. Its mechanical filling is simple. Label can be oriented simply. It provides
protection against light.
2. Rectal and Vaginal solid dosage forms:
They are packed in shallow partitioned paper boxes. They are also wrapped in aluminum foils
individually and then placed in glass bottles.
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Basic Principles of Compounding and Dispensing
3. Powders:
Powders are of two types;
(i)
(ii)
i.
Powders for oral use
Powders for external use
Powders for oral uses:
a. Bulk powders: They are packaged in wide mouth bottles made up of glass or plastic.
b. Unit dose powders: They are individually packed in sashes. Then these sashes are packed
in hard boxes.
ii.
Powders for external use, in body cavities:
They are packed in plastic containers with perforated lids for their easy application.
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Dispensing and Community Pharmacy for Pharm D Graduates
Labelling
After the transfer of the final formulation to the container, a neat, clean label according to the size
of container is pasted on the container.
Features of a good Label
It should have following information;
1. Pharmacy address and phone no.
In case of any query, patient can go back and confirm it or if he is unable to go to get refill,
the person going instead can have the address.
2. Patient’s information
It includes patient name, age, gender and address. It will assist the patient to locate his
medicine, and will restrict others to use someone else’s medicine.
3. Name and strength of the prescribed product
Some people favor while some others opposes the idea to mention name and strength of the
product.
The supporters are of the view;
▪ In case of toxicity one can know the strength to treat.
▪ It should be mentioned to manage the dose.
▪ If new therapy or treatment is given, dosage form must be mentioned. It will assist
the patient in its application or etc.
▪ It will help the health care professional to know the history of previous medication.
The non-supporters are of the view that;
▪ Sometime dispensed medicine is available with changed container.
▪ The brand f the same medicine can be changed
▪ The patient may start self-medication.
4. Directions for use:
These must be clearly mentioned on the label. They must be confusion free so that patient
can easily understand.
Example:
▪ ‘2’ 5ml spoonful three times a day. So, one must write alphabetical ‘two’ instead of
writing in digits.
▪ Write ‘0’ before the decimal. E.g. 0.5ml
5. Prescription reference no. / date
6. Signature of the compounding pharmacist
In case of any adverse reaction to patient due to mistake in compounding one can caught the
actual culprit.
7. Dispensed date
It indicates that when the product is dispensed.
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Basic Principles of Compounding and Dispensing
8. Discard date
Discard date must be mentioned on label, as it helps the patient to abstain from using the
medication after the expiry and save himself from toxicity or adverse effects.
Additional labels
They must be pasted for the patient compliance. Additional labels are pasted basically for two
reasons;
1. Labels which are required by Law
2. Labels which are necessary for pharmaceutical reasons
1. Labels required by Law:
The labels which are required by Law are as fallows;
➢ For external use only: It is only mentioned on liquid preparations which are used
externally. For example, Liniment.
➢ Not to be taken: It is mentioned on products which are packed in greater quantity more
than 3 liters. They are antiseptic of disinfectant solutions.
2. The labels necessary for pharmaceutical reasons:
The labels necessary for pharmaceutical reasons are as follows;
➢ For external use only: it must be on all preparations which are intended to be used
externally not to be taken orally.
Special labels:
Some Special labels are also mentioned on the preparations. These help the patients by making it
more understandable and legible.
There are some reasons for special labels which are discussed below;
1. To restrict on use
Special labels are pasted to indicate the restrictions on use of preparations.
Example:
✓ For pediatric patients only.
✓ For adults only.
✓ Not to apply.
✓ Not to be taken.
2. To assist on use:
Special label also assists in the use of medication to a specific site in the body.
Example:
✓ For nasal use only for nasal drops.
✓ For rectal use only for rectal suppositories.
✓ For otic use only for ear drops.
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Dispensing and Community Pharmacy for Pharm D Graduates
3. To give special instructions:
Special labels are also pasted to give specific instructions to the patient regarding to the
formulation. They play dominant role in understanding the method of use of the
formulation.
Example:
✓ For Poultice it is mentioned to apply with suitable dressing.
✓ For dusting powder, it is mentioned that not to apply on open wounds.
✓ For Lotion it is mentioned that apply without rubbing.
✓ For liniment it is mentioned apply with rubbing.
4. To specify storage conditions
Special labels are applied to specify the storage conditions for the formulation.
Example:
✓ Keep away from naked flame.
✓ Store below 150 C or store at cool place.
✓ Protect is from light.
5. For safety
Special labels are applied for the safety and protection of children.
Example:
Keep out of reach of children.
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Basic Principles of Compounding and Dispensing
Fundamental operations in compounding
The fundamental operations of compounding include;
Weights and measures
Size reduction
Size separation
Filtration
Solubility of solution
Mixing
Weights and measures:
Accuracy: It is the measure of capability of a balance to approach a true or absolute
value.
Precision: It is the relative degree of repeatability i.e. how closely the values within a
series of replicate measurements agree.
Tolerance: Tolerance or limits of permissible error is the extreme value of an error
permitted by specification for a measuring instrument.
Sensitivity: it is the smallest weight to which the balance responds when loaded to
capacity.
Error: it is the excess of deficiency at full load.
Weighing System
The system of weighing are as follows;
1. The Apothecaries system:
The weigh was calculated by comparing it with barley grains. The units were grains, scruples,
Drachms and apothecary’s ounce.
Grains (barley)
480
60
20
Scruples
24
3
1
Drachms
8
1
Apothecaries ounce
1
2. The Imperial system:
➢ Weighing units:
Grains
437.5
7000
Avoirdupois ounces
1
16
➢ Measuring units:
Minims
Fluid drachms
9600
160
Fluid ounces
20
17
Avoirdupois pounds
1
Pints
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Dispensing and Community Pharmacy for Pharm D Graduates
3. Decimal system
In 17th century another system was introduced known as Decimal system of units. It was also called
as CGS system or Centimeter Gram Second system.
4. Metric system
The USP adopted the metric system in 1890. The system was introduced by the French when US
adopted it, they changed the spellings. Its latest form is SI system.
According to this system the units of weights are;
• Kilogram
Kg
• Gram
g
• Milligram
mg
• Microgram
µg
• Nanogram
ng
According to this system units of volume are;
• Liter
l
• Milliliter
ml
• Microliter
µl
According to SI system of units there are seven basic units:
Parameter
Current
Mass
Length
Intensity of Light
Quantity of matter
Time
Temperature
Units
Ampere
Kilogram
Meter
Candela
Mole
Second
Kelvin
Symbol
A
Kg
m
Cad
mol
s
K
In case of Latin, the prefixes are placed after the word gram while in case of Greek, prefixes are
placed before the unit.
Weighing apparatus:
The local weighing apparatus is used. It is less sensitive. It consists of two pans. In one pan the weight
is placed and in the other pan the drug is weighed in comparison to the weight. The drug is placed
with the help of forceps. The measured weight is placed at right side of the weighing apparatus.
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Basic Principles of Compounding and Dispensing
Digital weighing apparatus:
It is the modern way of weighing the drug. It is a sensitive
apparatus. It consists of a digital apparatus. First the watch glass is
placed and the weight of watch glass is turned autozero then the
drug is placed onto it with forceps and weighed accurately.
Measuring of liquids:
For the measuring of liquids; conical flasks, measuring cylinders are
used. While for the measuring the little quantity, syringes are used.
Always use that measuring apparatus which is near to the measuring
quantity. Observe the meniscus carefully at eye level.
Size reduction
The second operation is the size reduction for their better handling. The most common methods of
size reduction used are;
1. Trituration
2. Levigation
Mechanism:
Mechanism consist of following steps;
✓ Cutting (knife)
✓ Compression (pressure, when both surfaces are stationary)
✓ Impact (pressure, when one surface is stationary and other is movable)
✓ Attrition (pressure, when both surfaces are movable)
19
Dispensing and Community Pharmacy for Pharm D Graduates
Equipment:
The commonly used equipment includes;
•
•
•
Mortar and pestle
Spatula & tile
Small grinder
Size separation
For the size separation, sieving method used. It is a useful
method to separate the specific type of particle size by
choosing a specific sieve.
Sieve: no. of openings per linear inch.
Filtration
It is a technique used for the purification. It is normally used to separate the solid particles or
impurities from the liquid. It can also be used for the Clarification of liquid (separation of liquid
from liquid).
Filtration process
As studied previously:
It can be performed by either of the following apparatus;
Filter medium:
Different filter mediums are used according to the nature of the liquid under filtration.
Filter paper
▪ Cone filter paper
20
Basic Principles of Compounding and Dispensing
▪
Fluted filter paper
Crucible
▪ Gooch crucible
▪ Sintered glass crucible
Some other filtration aids are also used. For example; for pressure filtration suction flask
with vacuum pump is employed for faster and better filtration.
Solubility of solutions
Solutions are homogenous mixtures. Before compounding the solubility of the ingredients in
checked in the different solvent.
✓
✓
✓
✓
If the solute is completely soluble then simply mix them.
The solute is sparingly soluble then dissolve it separately in additional solvent.
To enhance the solubility sometimes co-solvents are employed.
Volatile oils and volatile substances are added at the end.
Equipment:
Commonly a Glass stirrer of Magnetic stirrer apparatus is used for the
uniform mixing of the sample in the solvent.
Mixing
Mixing is a process in which different components are come closer to each other. Mixing is done is
case of;
Emulsions
Suspensions
Semisolid formulation
21
Dispensing and Community Pharmacy for Pharm D Graduates
22
Extemporaneous dispensing
Chapter 2 EXTEMPORANEOUS
DISPENSING
Chapter Outline
This chapter includes extemporaneous dispensing of:
1. Powders and Granules
2. Solutions
3. Suspensions
4. Emulsions
5. Ointments
6. Creams
7. Pastes and gels
8. Suppositories and pessaries
9. Oral unit dosage form
10.Classical Dosage form
23
Dispensing and Community Pharmacy for Pharm D Graduates
24
Extemporaneous dispensing
Pharmaceutical powder
“A dosage form composed of a solid or a mixture of a solids reduced to a finely divided state
and intended for internal or external use is known as Pharmaceutical powder.”
Pharmaceutical powders are solid dosage forms of medicament in which one or more drugs are
dispensed in finely divided state with or without excipients. They are available in crystalline or
amorphous form.
The following types of preparation considered for Powders:
1.
2.
3.
4.
Bulk powders for external use – termed dusting powders
Bulk oral powders
Individual unit dose powders
Unit dose capsules
1. Bulk powders for external uses:
These are dry, free-flowing preparations consisting of one or a mixture of finely powdered
substances and intended for external application.
Advantages:
✓ They are easy to apply.
✓ They are pleasant to use.
✓ They absorb skin moisture, which leads to reduced friction between skin surfaces,
discourages bacterial growth and has a cooling effect.
Disadvantages:
✓ They may block pores, causing irritation, or if applied to parietal surfaces, granulomas,
fibrosis or adhesions.
✓ Starch, although an excellent dusting powder, is organic and can support microbial growth.
✓ Talc, despite being an inert compound, can be contaminated with microorganisms and must
therefore always be sterilized prior to incorporation into a dusting powder.
✓ Light fluffy powders may be inhaled by infants, causing breathing difficulties.
✓ They are not suitable for application to broken skin.
Dusting powders:
Dusting powders are applied to the skin for a surface effect such as drying or lubrication. Some
dusting powders incorporate medicaments, giving them antibacterial or antifungal action. Examples
include:
Example:
1. Talc Dusting Powder BP – Used as a lubricant to prevent chafing.
2. Chlorhexidine Dusting Powder BP – Used for its antibacterial effect.
3. Tinaderm Powder – A proprietary product used for the treatment of fungal infections (e.g.
Tinea infections such as athlete’s foot)
25
Dispensing and Community Pharmacy for Pharm D Graduates
4. Zinc, Starch and Talc Dusting Powder BPC 100 g (British Pharmaceutical Codex 1973,
page 664):
• Zinc Oxide BP
• Starch BP
• Purified Talc BP
25 g
25 g
50 g
Use:
-
It is used as lubricant.
It is used as antiseptic.
Precaution: Don't apply on open wounds.
General method for preparing dusting powders:
The method for mixing powders in the formulation of a dusting powder is the standard ‘doublingup’ technique.
1. Weigh the powder present in the smallest volume (powder A) and place in the mortar.
2. Weigh the powder present in the next largest volume (powder B) and place on labelled
weighing paper.
3. Add approximately the same amount of powder B as powder A in the mortar.
4. Mix well with pestle.
5. Continue adding an amount of powder B that is approximately the same as that in the mortar
and mix with the pestle, i.e. doubling the amount of powder in the mortar at each addition.
6. If further powders are to be added, add these in increasing order of volume as in parts 3, 4
and 5 above.
2. Bulk oral powders:
Powders are dispensed in bulk when accuracy of dosage is not important. They are supplied in wide
mouthed container with spoon. Bulk oral powders resemble dusting powders with the exception that
they are intended for oral administration. The dose to be taken is measured with a 5 mL spoon, stirred
into a quantity of water and then swallowed.
Preparations in this group are formulated on the basis of dose-weights, whereas the dose is actually
measured by volume. The measure of volume used is a heaped 5 mL spoonful, which is considered
to be the equivalent to 5g of powder.
It is obvious that both the accuracy and precision of the dosage will be significantly influenced by a
large number of varying factors. These include;
The density of the powders used
The interpretation of ‘heaped’ 5 mL spoon by the patient
Consequently, this formulation is restricted to use in preparations consisting of relatively non-potent
medicaments such as Kaolin BP and Magnesium Trisilicate BP.
Bulk powders may be a single powder (e.g. Magnesium Trisilicate Powder BP) or a mix of several
powders (e.g. Calcium Carbonate Compound Powder BPC 1973).
26
Extemporaneous dispensing
Example:
Compound Rhubarb powders B.P.C (Gregory's powder)
•
•
•
•
Rhubarb powder
Light magnesium carbonate
Heavy magnesium carbonate
Ginger in powder
250 g
325 g
325 g
100 g
Direction: 0.5g to 5g to be taken twice a day.
Advantages:
✓ Dry powders may be more stable than their liquid equivalent
✓ Large doses of bulky powders may be administered with relative ease (e.g. indigestion
powders)
✓ Absorption from the gastrointestinal tract will be quicker than with capsules or tablets.
Disadvantages:
✓ The accuracy of dosage is not guaranteed; therefore, it is not a suitable dosage form for
potent medication
✓ The large size container means that they may be inconvenient to carry
✓ It is difficult to mask any unpleasant taste.
3. Individual unit dose powders:
Definition:
“Single-dose powders usually consist of one or more powdered active medicaments, together
with an inert diluent, and wrapped as single doses in white demy paper, folded to a uniform
shape and size.”
The sole difference between individual unit dose powders and bulk oral powders is that the dosage
problem is overcome by providing the patient with a set of separate doses, each of which has been
individually wrapped.
The weight of each powder should be 200 mg, our recommended weight, for ease of handling by the
patient. This weight is chosen because;
200 mg can be weighed on a Class II balance (or electronic equivalent) (i.e. 200 mg is
greater than the minimum weighable quantity of the balance)
200 mg is an easy figure to use in pharmaceutical calculations (it is easy to undertake
calculations using multiples or divisions of 200)
200 mg is the amount of powder that will fit into a size 3 capsule and, for ease, it would
make sense to use the same calculations for both powders and capsules
The diluent used is normally Lactose BP as it is colorless, soluble and harmless and therefore shows
the ideal properties of an inert diluent. Starch BP is an alternative diluent if the patient is lactose
intolerant.
Advantages:
✓ They show greater stability than liquid dosage forms as the rate of reaction between drugs in
a dosage form in atmospheric conditions is slower than the rate of reaction in a liquid medium.
27
Dispensing and Community Pharmacy for Pharm D Graduates
✓ Accurate dosage is possible.
✓ They are easy to administer. Powders are relatively easy to swallow and may be mixed with
food or drink in order to assist administration.
✓ The small particle size leads to more rapid absorption from the gastrointestinal tract compared
with tablets. This in turn leads to reduced local irritation of the gastrointestinal tract which
may be caused by local concentration of a drug, as encountered when taking an equivalent
tablet.
✓ They are well accepted by patients, attractive to patients and convenient to carry.
Disadvantages:
✓ They may be difficult to swallow.
✓ Unpleasant flavors, bitter or nauseous, are difficult to mask when in powder form.
Calculations for powders
There are two main calculations for powders, the choice being dependent on the quantity of active
ingredient to be incorporated into each powder and the total number of unit doses (or excess) to be
made. The two different calculations are termed single dilution and double dilution (or serial
dilution).
Single dilution:
Write out the formula for one powder based on a final weighing of 200 mg. Then write out the
formula for the total number of powders. Remember to always make an excess.
Example:
If the prescription is for five Furosemide 25 mg powders, including a suitable excess, calculate for
10 powders:
For
one powder
for 10 powders
Furosemide BP
25 mg
250 mg
Lactose BP
to 200 mg (i.e. 175 mg)
to 2000 mg (i.e.
1750mg)
So long as the final quantities to be weighed are above the minimum weighable quantity of the
balance single dilution can be used. In this case, 250 mg is the smallest amount to be weighed. This
is greater than the minimum weighable quantity of the balance and so single dilution will be suitable.
If, however, the amount of active ingredient to be weighed is below the minimum weighable quantity
of the balance, double dilution must be used.
Double dilution (serial dilution)
When dosages of very potent drugs are required, the active ingredient will be present in very low
concentrations. By simply multiplying the quantities of the ingredients up to weighable quantities,
owing to the small amount of active ingredient that would be present, it would be difficult to ensure
that a uniform mix of active ingredient and diluent would be obtained.
This might result in ‘clumping’ of the active ingredient, which could have potentially fatal
consequences for the patient. The dosage at which serial, rather than single, dilution would be
required is to a certain extent arbitrary and really a matter of professional judgment.
28
Extemporaneous dispensing
Our suggested limit is that concentrations of active ingredient below 15 mg require serial dilution.
This limit is based on an initial mix (including an excess) for 10 powders. If each powder contains
15 mg of active ingredient, the total for 10 powders will be 150 mg of active ingredient (10x15 = 150).
This (150 mg) is equal to the accepted usual minimum weighable quantity of a Class II balance. Any
smaller quantity would be less than the minimum weighable quantity of the balance and therefore
require double dilution.
General method for producing unit dose powders:
1. Remember, for ease of handling, the minimum weight of powder in a unit dose paper is 200
2.
3.
4.
5.
6.
7.
8.
9.
10.
mg.
Calculate to make an excess of the number of powders requested.
Determine whether a single or double dilution of the active ingredient is required.
Mix the active ingredient and the diluent (Lactose BP unless there is a reason not to use
Lactose BP, for example if the patient is intolerant to lactose, or due to instability of the
ingredients) in a mortar using the ‘doubling-up’ technique
Work on a clean dry glass tile, select a suitable size of paper (e.g. 10 cm X 10 cm), and turn
in one edge and fold down approximately half an inch (1 cm). Repeat for the required number
of powders.
Place the papers on the glass tile, with the folded edge away from the compounder, and each
slightly overlapping, next to the balance pan to be used for weighing.
Weigh out the individual powder from the bulk powder, and transfer to the center of the paper
(if placed too near the fold, the powder will fall out during opening).
Fold the bottom of the powder paper up to, and underneath, the flap folded originally.
Fold down the top of the paper until it covers about two-thirds of the width of the paper. This
top edge of this fold should help to hold the contents in the center of the paper.
Fold the two ends under, so that the loose ends slightly overlap, and then tuck one flap inside
the other.
4. Unit dose capsules:
Capsules are a further development from unit dose powders in that each dose of powder is enclosed in
an edible container, which is swallowed whole with a draught of water (about 30–60 mL). The powder
is not released from its container until it is in the stomach. This type of presentation is more convenient
for the patient, and is particularly useful for medicaments which have an unpleasant taste.
Advantages:
✓ They are stable. Powders show greater stability than liquid dosage forms as the rate of
✓
✓
✓
✓
✓
✓
reaction between drugs in a dosage form in atmospheric conditions is slower than the rate of
reaction in a liquid medium.
Accurate dosage is possible.
They are easy to administer – capsules are relatively easy to swallow (suitable shape and
slippery when moistened).
Unpleasant tastes can be easily masked.
The release characteristics of the drugs can be controlled.
They can be made light resistant using opaque capsules.
The smaller particle size of powdered drugs leads to more rapid absorption from the
29
Dispensing and Community Pharmacy for Pharm D Graduates
gastrointestinal tract compared to tablets. This in turn leads to reduced local irritation of the
gastrointestinal tract which may be caused by local concentration of a drug as encountered
when taking an equivalent tablet.
✓ They are well accepted by patients, attractive to patients and convenient to carry.
Disadvantages:
✓ They may be difficult to swallow.
✓ Capsules are unsuitable for very small children.
✓ Patients with strict religious beliefs and vegetarians may object to the use of animal gelatin
(although non-animal gelatin capsules may be available).
General method of preparation of capsules;
The method is given below;
1. Choose an appropriate size capsule for the powder bulk. Normally a size 3 capsule would
be chosen and so work on the basis of filling each capsule with 200 mg of powder
2. Calculate quantities required and make an excess, as with the manufacture of individual unit
dose powders.
3. Mix using the ‘doubling-up’ technique.
4. Handle the capsules as little as possible as powder fill weights will be inaccurate as a result
of contamination with grease, moisture, etc., and also for reasons of hygiene. Fill powder into
the longer half of the capsule.
Methods of capsule filling
There are at least three methods of filling capsules manually. Always work on a clean tile: remember
these capsules are to be swallowed by a patient.
i.
ii.
iii.
Place some powder onto a piece of weighing paper. Hold the capsule with one hand and
lift the paper with the other and scoop the powder into the capsule.
Place some powder onto a piece of weighing paper and fill the capsule using a chemical
spatula.
Weigh approximately 200 mg of powder onto a piece of weighing paper, which has
been folded in half. Use the weighing paper to pour the powder into the capsule.
Ensure capsule outer surface is powder free. Check weight of the filled capsule. Remember to tare
with an empty capsule of the same size so you are only weighing the contents of the capsule (and not
including the weight of the capsule itself).
Packaging:
Bulk powders for external use
Bulk powders for external use are either packaged as for bulk oral powders or in a powder shaker
with a sifter top.
Bulk oral powders
Bulk oral powders are usually packaged in an airtight glass or plastic jar. It is important that the
preparation is not exposed to moisture as this will result in clumping of the product and may
encourage microbial growth.
Individual unit dose powders
30
Extemporaneous dispensing
Once made, individual unit dose powders are placed flap to flap and secured together by a rubber
band. The whole set of powders is then placed in a rigid cardboard container and the label is placed
on the container before the preparation is dispensed to the patient. Preparations containing
effervescent or deliquescent ingredients need to be packed in a sealed container (e.g. an ointment
jar).
Unit dose capsules
Unit dose capsules are dispensed in a glass or plastic tablet bottle with a child-resistant closure.
Discard date:
Proprietary powders and capsules are manufactured in special environments and usually attract a
long shelf life. When dealing with extemporaneously prepared preparations, the compounder must
take a number of considerations into mind when deciding the length of expiry to give a product, such
as;
The stability of the ingredients within the preparation.
The susceptibility of the preparation to microbial contamination.
As a general rule, an expiry of up to three months may be given to any of the preparations although
consideration must be given to each individual formulation.
Labelling:
In addition to the standard requirements for the labelling of extemporaneous preparations of powders,
the following points need to be taken into consideration;
❖ Bulk oral powders, individual unit dose powders and bulk powders for external use are all
susceptible to moisture. For this reason, it is necessary to include the caution ‘Store in a dry
place’ on the label of any of these preparations.
❖ Dusting powders will also attract the caution ‘Not to be applied to open wounds or raw
weeping surfaces.’
❖ In addition, any preparation intended for external use (i.e. bulk powders for external use)
would attract the additional caution ‘For external use only.’
31
Dispensing and Community Pharmacy for Pharm D Graduates
Dispensing of solutions
Mixtures
When two or more things are mixed together without any fix ratio of mass, a mixture is formed.
Types of Mixtures:
1. Homogenous e.g. True solutions
2. Heterogeneous e.g. coarse and colloidal dispersions Homogeneity means something evenly
distributed
Heterogeneity means something not distributed evenly in space; a clump or cluster (not a single
phase as in case of colloidal and coarse dispersion).
Definition:
“Liquid preparations that contain one or more chemical substances dissolved in a suitable
solvent or mixture of mutually miscible solvents is known as solvent” (Ansel’s)
Essentially a solution is a homogeneous liquid preparation that contains one or more dissolved
medicaments. Since, by definition, active ingredients are dissolved within the vehicle, uniform doses
by volume may be obtained without any need to shake the formulation. This is an advantage over some
other formulation types, e.g. suspensions.
A solution is a homogeneous mixture of two or more substances
A solution is a homogenous mixture of solute and solvent.
A solution is a homogenous mixture of two substances but consisting of one phase.
In the British Pharmacopoeia (BP), oral solutions are defined as ‘Oral Liquids containing one or
more active ingredients dissolved in a suitable vehicle’.
Generally, water is chosen as the vehicle in which medicaments are dissolved, since it is non-toxic,
non- irritant, tasteless, and relatively cheap and many drugs are water-soluble. Problems may be
encountered where active drugs are not particularly water-soluble or suffer from hydrolysis in
aqueous solution. In these cases, it is often possible to formulate a vehicle containing water mixed
with a variety of other solvents.
Advantages:
Drug available immediately for absorption:
When solid dosage forms are taken orally, the drug needs to dissolve before absorption into the body
can take place. By providing the drug in a solution, the dissolution phase of the absorption process
can be bypassed, providing quicker absorption.
Flexible dosing:
The active ingredient within the solution will be present in a certain concentration per unit volume.
If alterations to the quantity of active ingredient to be administered are required, a simple alteration
to the quantity of solution to be taken is all that is required.
32
Extemporaneous dispensing
Designed for any route of absorption:
Although when discussing solutions, the oral route of administration is often considered, solutions
can be administered via a number of other routes. Parenteral preparations (injections), enemas for
rectal use, topical (for use on the skin) preparations and ophthalmic preparations can all be solutions.
No need to shake the container:
Unlike some liquid preparations (e.g. suspensions), as the active ingredient is dissolved within the
vehicle there is no need to shake the container to ensure a uniform dose is measured.
Facilitate swallowing in difficult cases:
Some patients may find it hard to swallow traditional solid dosage forms (e.g. infants or the elderly).
In these situations, it may be easier for the patient to take a liquid dosage form.
Disadvantages:
Drug stability often reduced in solution by solvolysis, hydrolysis or
oxidation:
The stability of the active ingredient needs to be taken into consideration when formulating a
solution. For this reason, it is common for solutions to attract a shorter expiry date than equivalent
solid dosage forms.
Difficult to mask unpleasant tastes:
Although liquid dosage forms may be ideal for small children who are unable to swallow solid dosage
forms, many drugs taste unpleasant when formulated into a solution. It is possible to attempt to mask
any unpleasant tastes by the addition of a flavoring, but this will not always be successful.
They are bulky, difficult to transport and prone to breakages:
A major disadvantage of all liquid dosage forms is that they are always much larger and bulkier than
their comparable solid formulation. This makes them heavier and more difficult to transport. Coupled
with this is the fact that, traditionally, pharmaceutical liquids are packed in glass bottles. These are
obviously prone to breakage which can be hazardous and cause the loss of the preparation.
Technical accuracy is needed to measure the dose:
Although the dose can be titrated without the need to produce additional preparations (see point 2
from the advantages above), patient accuracy in measuring a dose is required. It is accepted that
patients’ abilities to measure an accurate dose can vary considerably and this needs to be taken into
consideration when preparing a liquid preparation. This is especially important when the volume of
liquid to be administered is very small, where small changes in the volume administered may result
in large increases or decreases in dose.
Some drugs are poorly soluble:
The solubility of a drug needs to be taken into consideration when preparing a solution to ensure that
the final volume produced is not excessive. In some cases, it may be necessary to alter the vehicle or
drug form (for example the free alkaloid or its salt) in order to be able to formulate a convenient
33
Dispensing and Community Pharmacy for Pharm D Graduates
preparation.
A measuring device is needed for administration:
Although not a major disadvantage, it must be borne in mind that a measuring device will need to be
supplied to the patient in order for them to be able to measure an accurate dose (this will have cost
implications), and in addition the patient will need counseling on the use of the measuring device.
General principles of solution preparation
The two key characteristics that need to be considered when compounding solutions are solubility
and stability.
Solubility
The following points relating to the solubility of the drug element(s) of the formulation need to be
taken into consideration:
•
•
•
•
•
Will the drug(s) dissolve in the solvent or a component of the solvent system?
What quantity of drug will dissolve?
How long will dissolution take?
Will the drug(s) remain in solution and for how long?
What is the pH of solvent required for dissolution?
During compounding, is worth remembering that dissolution rates generally increase with;
•
•
•
•
Smaller particle sizes
Effective stirring
Lower viscosities
Increased temperature.
Stability:
In addition to the solubility of the drug element(s) of the formulation, other considerations regarding
the physical stability of the preparation will need to be taken into consideration (e.g. temperature
variation, photosensitivity, etc.), as will the chemical stability and time period, and the
microbiological stability and need for a preservative.
General methods of Preparation of Solution
The following general method should be used in the preparation of a solution:
1. Write out the formula either from the prescription (unofficial) or from an official text
(official).
2. Calculate the quantities required for each ingredient in the formula to produce the required
final volume. Remember, it is not usual to calculate for an overage of product in the case of
solutions as it is relatively easy to transfer the entire final contents of the conical measure.
Additionally, as far as is practically possible, the product will be assembled in the final
measure, thus reducing any transference losses.
3. Complete all sections of the product worksheet.
4. Prepare a suitable label.
34
Extemporaneous dispensing
5. Weigh all solids.
6. Identify the soluble solids and calculate the quantity of vehicle required to dissolve the solids
7.
8.
9.
10.
11.
12.
13.
14.
fully. If more than one solid is to be dissolved, they are dissolved one by one, in order of
solubility (i.e. the least soluble first). In almost all cases, dissolution will take place in a glass
(or occasionally plastic) beaker, not a conical measure. Remember that the solubility of the
soluble solids will be dependent on the vehicle used.
Transfer the appropriate amount of vehicle to a glass beaker.
If necessary, transfer the solid to a glass mortar and use the glass pestle to reduce particle size
to aid dissolution.
Transfer the solid to the beaker and stir to aid dissolution. If a mortar and pestle have been
used to reduce particle size, ensure that the mortar is rinsed with a little vehicle to ensure
complete transfer of the powders.
When all the solid(s) has/have dissolved, transfer the solution to the conical measure that will
be used to hold the final solution.
Rinse out the beaker in which the solution was made with a portion of the vehicle and transfer
the rinsing to the conical measure.
Add any remaining liquid ingredients to the conical measure and stir.
Make up to final volume with remaining vehicle.
Transfer to a suitable container, label and dispense to the patient.
Key points from the method: During the dissolution phase, solutions should be stirred gently
and uniformly to avoid air entrapment, which may result in foaming of the solution. If available,
automatic stirring devices may be useful in assisting the production of a uniform product and can be
time saving. If stirring devices are used to assist dissolution (e.g. rod, magnetic stirrers), remember
to remove them before adjusting to final volume.
Further considerations: To aid dissolution, high-viscosity liquid components should be added to
those of lower viscosity. Completely dissolve salts in a small amount of water prior to the addition
of other solvent elements.
In complex solutions, organic components should be dissolved in alcoholic solvents and watersoluble components dissolved in aqueous solvents. Aqueous solutions should be added to alcoholic
solutions with stirring to maintain the alcohol concentration as high as possible – the reverse may
result in separation of any dissolved components.
Oral solutions
Elixir
“Clear sweetened hydroalcoholic solutions intended for oral use and are usually flavored to
enhance their palatability are known as Elixirs”
An elixir preparation usually contains either potent or unpleasant-tasting drugs. The formulation is
clear and generally contains a high proportion of sugar or other sweetening agent, included to mask
offensive or nauseating tastes. Pediatric elixirs are usually formulated with a fruit syrup as a base
flavoring agent.
In general, non-aqueous solvents (alcohol, glycerin or propylene glycol) form a significant
proportion of the vehicle used in elixirs, or alternatively solubilizing agents are included.
35
Dispensing and Community Pharmacy for Pharm D Graduates
Example:
1. Chloral Elixir Pediatric BPC (Elixir Chloralis pro Infantibus) (BPC 1973)
•
•
•
•
Ingredients
Quantities
Chloral Hydrate BP
Water
Blackcurrant Syrup BP
Syrup BP to
40 g
20 mL
200 mL
1000 mL
Dose: Child up to 1 year – 5mL.
Use: Short-term treatment of insomnia.
2. Paracetamol Elixir Pediatric BPC (Elixir Paracetamolis pro Infantibus) (BPC
1973) Ingredients
•
•
•
•
•
•
•
•
Paracetamol BP
Amaranth Solution BP
Chloroform Spirit BP
Concentrated Raspberry Juice BP
Alcohol (95%) BP
Propylene Glycol BP
Invert Syrup BP
Glycerol BP to
Quantities
24 g
2 mL
20 mL
25 mL
100 mL
100 mL
275 mL
1000 mL
Dose: Child up to 1 year – 5mL; 1–5 years – 10 ml.
Precaution: The elixir should not be diluted.
Use: Analgesia and antipyretic.
Syrups:
Concentrated aqueous preparations of a sugar or sugar substitute with or without flavoring
agent and medicinal substances are known as Syrups
OR
A syrup is a concentrated, viscous solution containing one or more sugar components, chiefly
sucrose.
Linctures:
A linctus is a liquid oral preparation that is chiefly used for a demulcent, expectorant or sedative
purpose, principally in the treatment of cough. As such, a linctus is intended to be sipped slowly and
allowed to trickle down the throat in an undiluted form. Consequently, linctures are formulated as
viscous solutions which contain sugars.
36
Extemporaneous dispensing
Example:
1. Simple Linctus BPC (Linctus Simplex) (BPC 1973, page 724)
•
•
•
•
•
Ingredients
Quantities
Citric Acid BP
Concentrated Anise Water BP
Amaranth Solution BP
Chloroform Spirit BP
Syrup BP to
25 g
10 mL
15 mL
60 mL
1000 mL
Dose: 5 ml.
This product would be Recently Prepared and therefore would attract a four-week discard date.
Use: Demulcent cough mixture.
2. Codeine Linctus BPC (Linctus Codeinae) (BPC 1973, page 722)
•
•
•
•
•
•
•
Ingredients
Quantities
Codeine Phosphate BP
Compound Tartrazine Solution BP
Benzoic Acid Solution BP
Chloroform Spirit BP
Water
Lemon Syrup BP
Syrup BP to
3g
10 mL
20 mL
20 mL
20 mL
200 mL
1000 mL
Dose: 5 ml.
Use: Cough suppressant.
Draughts:
A draught is an older term used to describe a liquid preparation formulated as a single dose, in a
volume which is larger than generally utilized in traditional mixture formulations. Each draught was
usually supplied in a 50 mL unit dose container.
Spirits:
Alcoholic or hydroalcoholic solutions of volatile substances are known as spirits.
Spirits are solutions containing one or more active medicaments dissolved in either absolute or dilute
ethanol having alcoholic concentration usually more than 60%.
Pediatric drops:
These are an oral liquid formulation of potent drugs usually in solution, intended for administration
to pediatric patients, though they may be useful in other patients with swallowing difficulties. The
formulation is designed to have very small dose volumes which must be administered with a
calibrated dropper.
Gargles and mouthwashes:
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Dispensing and Community Pharmacy for Pharm D Graduates
Gargles and mouthwashes are aqueous solutions that are intended for treatment of the throat (gargles)
and mouth (mouthwashes) and are generally formulated in a concentrated form. These preparations
must be diluted before use and care should be taken to ensure that appropriate instructions are
included on the label and that the container used will be easily distinguishable from those containing
preparations intended to be swallowed.
Example:
1. Compound Sodium Chloride Mouthwash BP (BP 1988)
Ingredients
•
•
•
•
•
Quantities
Sodium Chloride BP
Sodium Bicarbonate BP
Concentrated Peppermint Emulsion BP
Double Strength Chloroform Water BP
Water to
15 g
10 g
25 mL
500 mL
1000 mL
Dose: Use approximately 15 mL diluted with an equal volume of water each morning and night.
Use: Used to cleanse and freshen the mouth.
Enemas and douches:
These liquid preparations are often formulated as solutions (though they may be presented as an
emulsion or suspension) and are intended for instillation into the rectum (enema) or other orifice,
such as the vagina or nasal cavity (douche). The volumes of these preparations may vary from 5 mL
to much larger volumes. When the larger volumes are used it is important that the liquid is warmed
to body temperature before administration.
External solutions
Lotions
Lotions are solutions, but may also be suspensions or emulsions, that are intended to be applied to
the skin without friction on a carrier fabric such as lint and covered with a waterproof dressing. In
some cases, lotions are applied to the scalp, where the vehicle for the medication is alcohol based,
allowing for rapid drying of the hair and thus making the product more acceptable to the patient (e.g.
Salicylic Acid Lotion 2% BPC). In these cases, problems of flammability are addressed by suitable
labelling.
Example:
1. Calamine Lotion Oily BP (Lotio Calamine Oleosa) (BP 1980)
Ingredients
•
•
•
•
•
Calamine BP
Wool Fat BP
Arachis Oil BP
Oleic Acid BP
Calcium Hydroxide Solution BP to
Quantities
50 g
10 g
500 mL
5 mL
1000 mL
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Extemporaneous dispensing
Use: Calamine Lotion Oily was used as a mild astringent to soothe irritating rashes such as prickly
heat or chickenpox.
Liniments:
Alcoholic or oleaginous solutions or Emulsions of various medicinal substances intended to be
rubbed on skin are known as liniments.
A liniment is a liquid preparation intended to be rubbed with friction and massaged onto the skin to
obtain analgesic, rubefacient or generally stimulating effects. Liniments should not be used on broken
skin. They are usually solutions of oils, alcohols or soaps, but may be formulated as emulsions.
Example:
1. White Liniment BPC (Linimentum Album) (BPC 1973, page 726)
•
•
•
•
•
Ingredients
Quantities
Ammonium Chloride BP
Turpentine Oil BP
Oleic Acid BP
Dilute Ammonia Solution BP
Water
12.5 g
250 mL
85 mL
45 mL
625 mL
Use: Lin Alb was also known as White Embrocation. The turpentine acts as a rubefacient and
liniments such as this were used for rheumatic pains and stiffness.
Collodions:
Liquid preparations composed of Pyroxylin dissolved in a solvent mixture usually composed of
alcohol and ether with or without added medicinal substances are known as Collodions.
These are principally solutions of pyroxylin in a vehicle of ether and alcohol that are intended to be
painted onto the skin and left to dry. When dry, the collodion leaves a flexible film of cellulose on
the skin which may be used to seal minor injuries or retain a dissolved drug in contact with the skin
for an extended period. Collodions are highly volatile and highly flammable and care should be taken
to label any preparation appropriately.
Packaging of solutions:
When selecting packaging for extemporaneously prepared solutions, consideration should be given to
the route or method of administration. Liquid preparations that are intended for the oral route should
be packed in plain (smooth) amber bottles. External preparations and preparations that are not
intended to be taken internally (e.g. mouthwashes) should be packaged in fluted amber bottles (i.e.
amber bottles with vertical ridges or grooves). This will enable simple identification, by both sight
and touch, of preparations that are not to be taken via the oral route.
Discard date:
Extemporaneously compounded solutions are often relatively unstable for physical, chemical
(hydrolysis) and microbiological reasons. The exact impact of such processes on a compounded
solution will depend largely upon the storage conditions, the formulation and its intended purpose.
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Dispensing and Community Pharmacy for Pharm D Graduates
Commercially available manufactured products generally have long shelf-lives because of strictly
controlled manufacturing environments supported by rigorous quality assurance testing. Because of
the lack of complete control of conditions and inability to perform retrospective stability tests on
extemporaneously compounded solutions, much shorter shelf-lives must be attributed.
✓ ‘Freshly Prepared’ refers to a preparation that has been compounded less than 24 hours prior
to issue for use. In practical terms it is suggested that an expiry date two weeks is applied to
oral solutions that need to be Freshly Prepared or that contain an infusion or other vegetable
matter.
✓ ‘Recently Prepared’ should be applied to compounded items that are likely to deteriorate if
stored for a period greater than four weeks when maintained at 15–25 C. In practical terms it
is suggested that four-week expiry should be applied oral solutions that require to be Recently
Prepared.
Remember that because patients frequently misunderstand the term ‘expiry’ it is suggested that a
preferred method of indicating shelf-life on the label of extemporaneously compounded products is
to apply the term ‘Discard after’ or ‘Do not use after’ followed by a definite date and/or time.
As a general rule in case of unofficial products, an expiry of 7–14 days would be given to any of the
following preparations;
•
•
A solution that does not contain a preservative.
A solution where there are no stability data available.
Labelling:
In addition to the standard requirements for the labelling of extemporaneous preparations, the
following points need to be taken into consideration;
‘Not to be taken’ and ‘Do not swallow in large amounts’ – This warning must be added
to gargles and mouthwashes.
‘Not to be taken’ – This warning should be added to inhalations and nasal drops.
‘For rectal use only’ and ‘Warm to body temperature before administration’ – These
warnings should be added to large-volume enemas.
‘For external use only’ – This warning must be added to the label of any other
preparation that is not intended for administration via the oral route.
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Extemporaneous dispensing
Dispensing of Pharmaceutical Emulsions
The pharmaceutical term ‘emulsion’ is solely used to describe preparations intended for internal use
(i.e. via the oral route of administration). Emulsion formulation for external use are always given a
different title that reflects their use (e.g. application, lotion, cream, etc.).
An emulsion is essentially a liquid preparation containing a mixture of oil and water that is rendered
homogeneous by the addition of an emulsifying agent.
•
•
The emulsifying agent ensures that the oil phase is finely dispersed throughout the water as
minute globules (Figure 1). This type of emulsion is termed an ‘oil-in-water’ emulsion. The
oily phase (disperse phase) is dispersed through the aqueous phase (continuous phase).
Generally, all oral dose emulsions tend to be ‘oil in water’, as the oily phase is usually less
pleasant to take and more difficult to flavor.
‘Water-in-oil’ emulsions can be formed, but these tend to be those with external uses.
Definition:
“A thermodynamically unstable system containing at least two immiscible liquid phases one of
which is dispersed as globules in the other phase, stabilized by the presence of an emulsifying
agent is called Emulsion.”
OR
A dispersion in which the dispersed phase is composed of small globules of a liquid distributed
throughout a vehicle in which it is immiscible is known as Emulsion
OR
According to the British Pharmacopoeia (BP):
Oral Emulsions are Oral Liquids containing one or more active ingredients. They are stabilized oilin-water dispersions, either or both phases of which may contain dissolved solids. Solids may also be
suspended in Oral Emulsions. When issued for use, Oral Emulsions should be supplied in widemouthed bottles.
41
Dispensing and Community Pharmacy for Pharm D Graduates
Extemporaneous preparation:
In Oral Emulsions prepared according to the formula and directions given for Extemporaneous
preparation, the quantity of emulsifying agent specified in individual monographs may be reduced to
yield a preparation of suitable consistency provided that by so doing the stability of the preparation
is not adversely affected.
Advantages and disadvantages of emulsions:
The advantages and disadvantages of emulsions are discussed below;
Advantages:
✓ A dose of an unpalatable drug may be in a palatable liquid form (e.g. cod liver oil
emulsion).
✓ An oil-soluble drug can be dissolved in the disperse phase and be successfully administered
to a patient in a palatable form.
✓ The aqueous phase can be easily flavored.
✓ The texture/consistency of the product is improved as the ‘oily’ sensation in the mouth is
successfully masked by the emulsification process.
✓ Emulsification increases the absorption of fats through the intestinal wall. Consider the
process of fat digestion, whereby fats are emulsified in the duodenum by bile salts. The
efficient absorption of the oil is increased by a process of homogenization which reduces the
size of the oil globules.
✓ Liquid dosage forms of incompatible ingredients may be formulated by dissolving or
suspending each ingredient in one of the phases of an emulsion system.
Disadvantages:
✓ They must be shaken well prior to measuring a dose, and even after efficient shaking the
accuracy of the dose is likely to be less than with equivalent
✓ A measuring device is needed for administration. Although not a major disadvantage, it must
be borne in mind that a measuring device will need to be supplied to the patient in order for
them to be able to measure an accurate dose (this will have cost implications), and in addition
the patient will need counselling on the use of the measuring device.
✓ Some degree of technical accuracy is needed to measure a dose.
✓ Conditions of storage may adversely affect the disperse system, leading to creaming or
cracking of the emulsion.
✓ Like all liquid dosage forms, they are much bulkier than their comparable solid formulation.
This makes emulsions heavier and more difficult to transport than solid dosage forms.
Coupled with this is the fact that, traditionally, pharmaceutical liquids are packed in glass
bottles. These are obviously prone to breakage which can be hazardous and cause the loss of
the preparation.
✓ They are liable to microbial contamination which can lead to cracking.
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Extemporaneous dispensing
Methods of preparation
Continental & Dry gum method:
1. Extemporaneously prepared emulsions for oral administration are usually made by the
Continental or the dry gum method, where the emulsion is formed by mixing the emulsifying
gum (usually Acacia BP) with the oil, which is then mixed with the aqueous phase. The only
difference between the Continental and dry gum methods is the proportions of constituents
within the primary emulsion (for example, fixed oil emulsions made by the Continental
method would use a ratio of 4:3:2 rather than 4:2:1 with the dry gum method).
2. Internal emulsions prepared by the dry gum method should contain, in addition to the oil to
be emulsified, the following ingredients:
i.
A vehicle – freshly boiled and cooled purified water is normally used because of the
increased risk from microbial contamination.
ii.
A preservative (usually added to the product as Double Strength Chloroform Water
BP at 50% of the volume of the vehicle). If freshly boiled and cooled purified water
is used as the vehicle, it would be appropriate to manufacture the Double Strength
Chloroform Water BP using freshly boiled and cooled purified water rather than
potable water
iii.
An emulsifying agent (or emulgent). The quantity of emulsifying agent added is
determined by the type of oil to be emulsified and the quantity of emulsion to be
prepared.
iv.
Additional flavoring if required.
v.
Additional coloring if required.
Occasionally, finely divided solids have been used to form emulsions. The solid must possess a
balance of hydrophilic and hydrophobic properties. Colloidal clays such as bentonite, magnesium
hydroxide, aluminium hydroxide, magnesium oxide and silica gel are some of the insoluble substances
that have been used as emulsifying agents.
If the chosen powder is easily wetted by water then an oil-in-water emulsion is formed, whereas
those that are preferentially wetted by the oil phase produce water-in-oil emulsions. The colloidal
clays are mainly used as emulsion stabilizers for external lotions or creams. Whereas, aluminum
and magnesium hydroxide have both been used as emulsifying agents for preparations intended for
internal use.
All emulsifying agents will exhibit certain physical and chemical characteristics that will determine
how effective they are under various conditions of use.
Emulsifying agent:
All emulsifying agents will contain a water attracting or hydrophilic part and an oil-attracting or
lipophilic part.
•
If an emulsifying agent was too hydrophilic it would dissolve completely in the aqueous
phase.
• If it was too lipophilic it would totally dissolve in the oily phase.
The ideal emulsifying agent must concentrate predominantly at the interface between oil and aqueous
phases, where it is positioned such that the hydrophilic portion is in the aqueous phase and the
lipophilic portion is in the oily phase. When an emulsifying agent displays these properties, it is said
43
Dispensing and Community Pharmacy for Pharm D Graduates
to have the proper hydrophilic–lipophilic balance. If an emulsifying agent is predominantly
hydrophilic an oil-in-water emulsion is formed. Conversely, if it is predominantly lipophilic it will
favor the production of a water-in- oil emulsion.
The hydrophilic–lipophilic balance (HLB) of surface-active agents has been categorized into the HLB
system of numbering.
•
•
High HLB numbers indicate hydrophilic properties
Low HLB numbers indicate lipophilic properties (Table 1)
The HLB system was developed by W. C. Griffin in 1949, originally for non-ionic surface-active
agents, but has been expanded to include cationic and anionic surface-active agents. Each
emulsifying agent is allocated an HLB number (see Table 2). When several oils or fats are included
in a preparation a blend of emulsifying agents is sometimes employed to produce the best product.
HLB range
Application
3-6
W/O Emulsifying agent
7-9
Wetting agent
8-18
O/W Emulsifying agent
13-15
Detergents
15-16
Solubilizes
Table 1: Different hydrophilic–lipophilic balance HLB) ranges and their applications
Emulsifying agent
HLB VALUE
Acacia
8.0
Polysorbate 20
16.7
Polysorbate 60
14.9
Polysirbate 80
15.0
Sodium lauryl sulphate
40.0
Sorbitan Monolaurate
8.6
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Extemporaneous dispensing
Sorbitan Monostearate
4.7
Sodium oleate
18.0
Tragacanth
13.2
Triethanolamine oleate
12.0
Table 2. Hydrophilic–lipophilic balance (HLB) value of a number of common emulsifying
agents.
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Dispensing and Community Pharmacy for Pharm D Graduates
Calculation of the amount of emulsifying agent to be used in the preparation of an emulsion
using the dry gum method:
The amount of emulsifying agent used is dependent on the amount and type of oil to be emulsified.
Oils can be divided into three categories, fixed oils, mineral oils and aromatic (volatile) oils.
Fixed oils:
Oil
Aqueous phase
Gum
Mineral oils:
4 parts by volume
2 parts by volume
1 part by weight
Oil
Aqueous phase
Gum
3 parts by volume
2 parts by volume
1 part by weight
Aromatic (volatile) oils:
Oil
Aqueous phase
Gum
2 parts by volume
2 parts by volume
1 part by weight
These proportions are important when making the primary emulsion, to prevent the emulsion
breaking down on dilution or storage.
The quantities for primary emulsions (in parts) are summarized in Table 3.
Accurate weighing and measuring of the components in the primary emulsion are important when
making the primary emulsion to prevent the emulsion breaking down on storage or dilution.
Table 3: Ratio of oily phase to aqueous phase to gum in a primary emulsion.
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Extemporaneous dispensing
Wet gum method:
1. The proportions of oil, water and emulsifying agent for the preparation of the primary
2.
3.
4.
5.
emulsion are the same as those used in the dry gum method.
The difference is in the method of preparation. Using this method, the acacia powder would
be added to the mortar and then triturated with the water until the gum was dissolved and a
mucilage formed (thick gluey substance).
The oil would then be added to the mucilage drop by drop while triturating continuously.
When nearly all the oil has been added, the resulting mixture in the mortar may appear a little
poor with some of the oil appearing to be absorbed or mixture become too thick. This can be
rectified by the addition of slightly more water.
The trituration continues until all the oil has been added, adding extra small amounts of water
when necessary.
When all the oil has been added, the mixture is triturated until a smooth primary emulsion is
obtained. In the main this method has fallen out of favor as it takes much longer than the dry
gum method.
General method of preparation of an emulsion using
the dry gum method:
It is relatively easy for an emulsion to crack, resulting in a failed product. Remember the following
points are critical when preparing emulsions:
1) Clean, dry equipment – All equipment should be thoroughly cleaned, rinsed with water and
dried carefully before use, particularly measures, mortars and pestles.
2) Accurate quantities – Accurate quantities are essential. Check weighing/measuring technique
and minimize transference losses (e.g. allow oil to drain from measure).
3) Have all ingredients ready – Correct rate of addition is important. Ingredients for the
primary emulsion should all be weighed and measured before starting to make the product.
The preparation of an emulsion has two main components:
Preparation of a concentrate called the ‘primary emulsion’.
Dilution of the concentrate.
Preparation of primary emulsion:
Measure the oil accurately in a dry measure. Transfer the oil into a large dry porcelain
mortar, allowing all the oil to drain out.
Measure the quantity of aqueous vehicle required for the primary emulsion. Place this
within easy reach.
Weigh the emulsifying agent and place on the oil in the mortar. Mix lightly with the
pestle, just sufficient to disperse any lumps. Caution – over mixing generates heat, which
may denature the emulsifying agent and result in a poor product.
Add all of the required aqueous vehicle in one addition. Then mix vigorously, using the
pestle with a shearing action in one direction.
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Dispensing and Community Pharmacy for Pharm D Graduates
When the product becomes white and produces a ‘clicking’ sound the primary emulsion
has been formed. The product should be a thick white cream. Increased degree of
whiteness indicates a better-quality product. Oil globules/slicks should not be apparent.
Dilution of the primary emulsion:
Dilute the primary emulsion drop by drop with very small volumes of the remaining
aqueous vehicle. Mix carefully with the pestle in one direction.
Transfer emulsion to a measure, with rinsing’s. Add other liquid ingredients if necessary
and make up to the final volume.
Stability of emulsion:
Emulsions can break down through cracking, creaming or phase inversion;
1. Cracking
This is the term applied when the disperse phase coalesces and forms a separate layer. Re-dispersion
cannot be achieved by shaking and the preparation is no longer an emulsion. Cracking can occur if
the oil turns rancid during storage. The acid formed denatures the emulsifying agent, causing the two
phases to separate.
2. Creaming:
In creaming, the oil separates out, forming a layer on top of the emulsion, but it usually remains in
globules so that it can be re-dispersed on shaking (e.g. the cream on the top of a pint of milk). This
is undesirable as the product appearance is poor and if the product is not adequately shaken there is a
risk of the patient obtaining an incorrect dose. Creaming is less likely to occur if the viscosity of the
continuous phase is increased.
3. Phase inversion
This is the process when an oil-in-water emulsion changes to a water-in-oil emulsion or vice versa.
For stability of an emulsion, the optimum range of concentration of dispersed phase is 30–60% of
the total volume. If the disperse phase exceeds this the stability of the emulsion is questionable. As
the concentration of the disperse phase approaches a theoretical maximum of 74% of the total volume,
phase inversion is more likely to occur.
Emulsions for external use:
Emulsions for external use are designed for application to the skin and may be liquid or semi-liquid
in consistency. The formulation of external emulsions differs from that of conventional emulsions in
that no primary emulsion is formed. As with internal emulsions, both oil-in-water and water-in-oil
emulsions can be produced and applied to the surface of the skin and mucous membranes.
The consistency of the formed emulsion determines whether it is a lotion or a much thicker cream
product. The advantage of an emulsion as an external application is that it is easily spread over the
skin and usually easily removed by washing.
Water miscible vehicles:
48
Extemporaneous dispensing
Water – Usually freshly boiled and cooled purified water to reduce the
chances of any
microbial contamination.
Alcohol – Industrial methylated spirit (IMS) is the normal alcoholic constituent of products
for external use as it is exempt from excise duty and therefore cheaper than ethanol. Alcohol
is sometimes added to increase the cooling effect of the product, owing to the evaporation of
the alcohol from the skin’s surface.
Oily vehicles
Mineral oils – e.g. Light Liquid Paraffin BP, Liquid Paraffin BP.
Vegetable oils – e.g. Arachis Oil BP, Coconut Oi BP, Olive Oil BP. The problem with
these oils is that they tend to go rancid.
Synthetic oils – e.g. Dimethicone (Dimeticone) BP.
Preservative:
The preservatives commonly used in emulsions for external use are the same as those commonly
employed in the extemporaneous formulation and production of creams namely;
Benzoic Acid BP 0.1%
Chlorocresol BP 0.1%
Cetrimide BP 0.002–0.01%
Emulsifying agents used in the preparation of external emulsions
Water in oil emulsifiers:
•
Beeswax – Occasionally used and is a traditional water-in-oil emulsifier; it is not a very
good emulsifier and nowadays tends to be used as an emulsion stabilizer.
•
•
•
•
Calcium soaps – Made in situ by mixing a fat acid and calcium hydroxide solution (lime
water).
Wool alcohol – Preferable to wool fat as it is purer but still has the problem of creating
unpleasant odors in warm weather.
Wool fat – Similar to human sebum and can cause sensitization problems in some patients.
Mainly used as an emulsion stabilizer.
Synthetic surfactants – Synthetic surface-active agents with low HLB values.
Oil in water emulsifiers:
Emulsifying waxes:
– Anionic – Emulsifying wax BP
– Cationic – Cetrimide Emulsifying Wax BP
– Non-ionic – Cetomacrogol Emulsifying Wax BP.
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Dispensing and Community Pharmacy for Pharm D Graduates
Soaps:
– Soft soap – sticky green material that produces an oil-in-water emulsion (e.g. Turpentine
Liniment BP)
– Ammonium soaps formed during the preparation of products when the oleic acid and
ammonium compounds react to produce ammonium oleate, an oil-in-water emulsifying
agent.
Synthetic surface-active agents with a high HLB value.
The emulsifying agents used for emulsions for internal use, namely tragacanth and acacia, would not
be suitable for an emulsion for external use as they are too sticky. Other than creams that are thick
emulsions, applications, lotions and liniments are often liquid emulsions.
Packaging:
With pharmaceutical emulsions intended for internal use, a suitable container would be a flat amber
medical bottle.
External emulsions (e.g. creams, liniments, lotions, etc.) would be packaged in suitable containers.
For example; a fluted amber bottle for liniments and lotions and a collapsible tube for a cream.
Pharmaceutical bottles come in a variety of different sizes and it is important to choose a suitably
sized container to match the volume of preparation to be dispensed. Obviously, it is important not to
use a size of container that is too large for the volume of preparation to be dispensed, for both cost and
appearance reasons. Consideration should be given to selecting a bottle that will leave sufficient
space to allow the product to be shaken adequately before a dose is measured.
Discard dates:
Discard dates for pharmaceutical emulsions typically mirror those for pharmaceutical solutions. The
discard date of official preparations will be advised via the relative official texts. As with solutions
and suspensions, for official preparations the BP employs two definitions that are useful when
extemporaneously compounding emulsions:
•
•
‘Freshly Prepared’ refers to a preparation that has been compounded less than 24 hours
prior to issue for use.
‘Recently Prepared’ should be applied to compounded items that are likely to deteriorate
if stored for a period greater than four weeks when maintained at 15–25 C.
Traditionally it was suggested that an expiry date of four weeks be applied to oral emulsions in the
absence of any official guidance. Although emulsions usually contain a preservative (Double
Strength Chloroform Water BP at 50% v/v), they are liable to microbial contamination. For this
reason, consideration should be given to shortening the expiry date to 7–14 days.
Remember that because patients frequently misunderstand the term ‘expiry’ it is suggested that a
preferred method of indicating shelf-life on the label of extemporaneously compounded products is
to apply the term ‘Discard after’ or ‘Do not use after’ followed by a definite date and/or time.
50
Extemporaneous dispensing
Labeling:
In addition to the standard requirements for the labelling of extemporaneous preparations, the
following points need to be taken into consideration:
▪
▪
‘Shake the bottle’ – All emulsions will require this additional label.
‘For external use only’ – This warning must be added to the label of any external
emulsion.
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Dispensing and Community Pharmacy for Pharm D Graduates
Dispensing of Pharmaceutical suspensions
Introduction:
Suspensions are an important pharmaceutical dosage form that are still widely in use. Owing to
their versatility they are often used in situations where an ‘emergency’ formulation is required.
Common pharmaceutical products that are suspensions Include;
•
•
•
•
•
Ear drops
Enemas
Inhalations
Lotions
Mixtures for oral use.
Definition:
A pharmaceutical suspension is defined as a preparation where at least one of the active ingredients
is suspended throughout the vehicle. In contrast to solutions, in a suspension at least one of the
ingredients is not dissolved in the vehicle and so the preparation will require shaking before a dose
is administered.
The British Pharmacopoeia (BP) defines oral suspensions as, ‘Oral Liquids containing one or more
active ingredients suspended in a suitable vehicle. Suspended solids may slowly separate on
standing but are easily re-dispersed.’
Advantages:
The advantages of suspension are as fallows;
✓ Insoluble derivatives of certain drugs may be more palatable than their soluble equivalent.
✓ Insoluble derivatives of drugs may be more stable in the aqueous vehicle than the
✓
✓
✓
✓
equivalent soluble salt.
Suspended insoluble powders are easy to swallow.
Bulky insoluble powders such as Kaolin BP and Chalk BP can be administered in suspension
and can act as adsorbents of toxins in the gastrointestinal tract.
Suspended drugs will be more rapidly absorbed from the gastrointestinal tract than the
equivalent solid dosage form (although absorption will be slower than from the equivalent
solution).
Lotions that are suspensions leave a thin layer of medicament on the skin. The liquid part of
the suspension evaporates, giving a cooling effect to the skin and leaving the thin layer of
powder behind (for example Calamine Lotion BP).
Disadvantages:
✓ They must be well shaken prior to measuring a dose.
✓ The accuracy of the dose is likely to be less than with the equivalent solution.
52
Extemporaneous dispensing
✓ Conditions of storage may adversely affect the disperse system and in the case of in diffusible
solids clumping may occur, leading to potential dosing inaccuracy.
✓ Like all liquid dosage forms, they are always much larger and bulkier than their comparable
solid formulations. This makes them heavy and difficult to transport. Coupled with this is the
fact that, traditionally, pharmaceutical liquids are packed in glass bottles. These are obviously
prone to breakage which can be hazardous and cause the loss of the preparation.
General principles of suspension preparation
Although similar to pharmaceutical solutions in a number of ways, pharmaceutical suspensions
differ in that one or more of the solid ingredients are suspended throughout the vehicle rather than
dissolved within it. Different pharmaceutical solids have differing abilities to suspend throughout a
vehicle. This results in two types of pharmaceutical suspension: diffusible suspensions and in
diffusible suspensions.
Diffusible solids:
These are suspensions containing light powders that are insoluble, or only very slightly soluble, in
the vehicle but which on shaking disperse evenly throughout the vehicle for long enough to allow
an accurate dose to be poured.
Examples of diffusible powders commonly incorporated into pharmaceutical suspensions include;
•
Light Kaolin BP – insoluble in water
•
Light Magnesium Carbonate BP – very slightly soluble in water
•
Magnesium Trisilicate BP – insoluble in water.
In diffusible solids:
These are suspensions containing heavy powders that are insoluble in the vehicle and which on
shaking do not disperse evenly throughout the vehicle long enough to allow an accurate dose to be
poured.
Examples of in diffusible powders commonly incorporated into pharmaceutical suspensions
include;
•
•
Aspirin BP
Calamine BP
In the preparation of in diffusible suspensions, the main difference from diffusible suspensions is
that the vehicle must be thickened to slow down the rate at which the powder settles. This is
achieved by the addition of a suspending agent.
Formulation of suspensions:
The non-soluble ingredients of a suspension are dispersed in the vehicle and, as with
pharmaceutical solutions, water is normally the vehicle of choice. The density of the aqueous
vehicle can be altered slightly by the addition of sucrose or glycerol and the viscosity can be
changed by the addition of thickening agents. The increase in the viscosity means that the rate of
sedimentation of the insoluble solid will be slower.
53
Dispensing and Community Pharmacy for Pharm D Graduates
Suspension as emergency formulation:
In addition to established formulae, compounders may be required to produce a suitable liquid
preparation for patients who are unable to swallow tablets or capsules. Occasionally, the
medicament required may only be available commercially as a solid dosage form. If a liquid
preparation is unavailable, the compounder may be expected to prepare a liquid product from the
commercially available solid dosage form. This normally involves crushing of tablets or opening of
capsules to provide powdered drug to prepare a suspension.
When preparing a suspension from solid dosage forms, it must always be remembered that tablets
and capsules will contain unknown excipients as well as the nominal quantity of drug. The
bioavailability of the drug is likely to be unknown, and if possible, a pure sample of powdered drug
should be obtained in order to produce a suspension without extraneous components. However, in
cases where the solid dosage form is the only source of the drug, Tragacanth Powder BP or
Compound Tragacanth Powder BP are usually suitable suspending agents.
Oral diffusible suspensions
General method preparation:
The steps involved in the preparation of diffusible suspension are written below;
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Check the solubility, in the vehicle, of all solids in the mixture.
Calculate the quantities of vehicle required to dissolve any soluble solids.
Prepare any Double Strength Chloroform Water BP required.
Weigh all solids on a Class II or electronic balance.
Dissolve all soluble solids in the vehicle in a small glass beaker using the same procedures
as outlined in the chapter on solutions.
Mix any insoluble diffusible powders in a porcelain mortar using the ‘doubling-up’
technique to ensure complete mixing
Add a small quantity of the vehicle (which may or may not be a solution of the soluble
ingredients) to the solids in the mortar and mix using a pestle to form a smooth paste.
Add further vehicle in small quantities, and continue mixing until the mixture in the mortar
is of a pourable consistency.
Transfer the contents of the mortar to a conical measure of suitable size.
Rinse out the mortar with more vehicle and add any rinsings to the conical measure.
Add remaining liquid ingredients to the mixture in the conical measure. (These are added now,
as some may be volatile and therefore exposure during mixing needs to be reduced to prevent
loss of the ingredient by evaporation.)
Make up to final volume with vehicle.
Stir gently, transfer to a suitable container, ensuring that all the solid is transferred from the
conical measure to the bottle, and label ready to be dispensed to the patient.
Point of clarity – method; alternatively, the contents of the mortar could be transferred directly
to a pre-prepared tarred container. Rinsing from the mortar and other liquid ingredients could then be
added to the bottle before being made up to final volume. This would prevent any possible
transference loss caused by powders sedimentations in the conical measure
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Extemporaneous dispensing
Oral in diffusible suspension
Oral in diffusible suspensions are prepared using the same basic principles as for oral diffusible
suspensions. The main difference is that the preparation will require the addition of a suspending
agent. The suspending agent of choice will normally be combined with the in diffusible solid using
the ‘doubling- up’ technique before incorporation into the product.
General method of preparation:
The steps involved in the preparation of in diffusible suspension are written below;
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Check the solubility in the vehicle of all solids in the mixture.
Calculate the quantities of vehicle required to dissolve any soluble solids.
Prepare any Double Strength Chloroform Water BP required.
Weigh all solids on a Class II or electronic balance.
Dissolve all soluble solids in the vehicle in a small glass beaker.
Mix any insoluble in diffusible powders and the suspending agent in a porcelain mortar
using the doubling-up’ technique to ensure complete mixing
Add a small quantity of the vehicle (which may or may not be a solution of the soluble
ingredients) to the solids in the mortar and mix using a pestle to form a smooth paste.
Add further vehicle in small quantities, and continue mixing until the mixture in the mortar
is a pourable consistency.
Transfer the contents of the mortar to a conical measure of suitable size.
Rinse out the mortar with more vehicle and add any rinsing’s to the conical measure.
Add remaining liquid ingredients to the mixture in the conical measure. (These are added now,
as some may be volatile and therefore exposure during mixing needs to be reduced to prevent
loss of the ingredient by evaporation.)
Make up to final volume with vehicle.
Stir gently, transfer to a suitable container, ensuring that all the solid is transferred from the
conical measure to the bottle, and label ready to be dispensed to the patient.
Point of clarity – method; alternatively, the contents of the mortar could be transferred directly
to a pre-prepared tared container. Rinsing from the mortar and other liquid ingredients could then
be added to the bottle before being made up to final volume. This would prevent any possible
transference loss caused by powders sedimenting in the conical measure.
Suspensions for external use:
Suspensions intended for external use can be compounded using the same basic principles as those
intended for internal use. There may be differences in the choice of suspending agent used.
Inhalations:
Inhalations are liquid products that contain volatile ingredients intended to be released and brought
into contact with the respiratory lining. Suspensions are a particularly useful way of effecting this
transfer as the volatile ingredient can be adsorbed onto a carrier powder (a diffusible solid) and
formulated as a suspension which can then provide an accurate dose to be added to hot (about 65 C)
but not boiling water, so that the volatile ingredient is released and inhaled by the patient. Alcoholic
55
Dispensing and Community Pharmacy for Pharm D Graduates
solutions are also suitable to use as a ‘hot’ inhalation. If ingredients are volatile at room temperature
they may be inhaled directly from a handkerchief or absorbent pad.
Lotions:
Lotions can be suspensions, although they may also be solutions or emulsions. They are intended to
be applied to the skin, without friction, on a carrier fabric such as lint and covered with a waterproof
dressing. In some cases, such as Calamine Lotion BP, they may be dabbed onto the skin surface and
allowed to dry.
Packaging:
The packaging for suspensions is based on the same principles as for solutions, as both preparation
types are based on liquid administration. When selecting packaging for extemporaneously prepared
suspensions, consideration should be given to the route or method of administration.
•
Liquid preparations that are intended for the oral route should be packed in plain amber
bottles.
•
External preparations should be packaged in fluted amber bottles.
This will enable simple identification, by both sight and touch, of preparations that are not to be taken
via the oral route.
Pharmaceutical bottles come in a variety of different sizes and it is important to choose a suitably
sized container to match the volume of preparation to be dispensed. Obviously, it is important not to
use a size of container that is too large for the volume of preparation to be dispensed, for both cost and
appearance issues. Consideration should be given to selecting a bottle that will leave sufficient space
to allow the product to be shaken adequately before a dose is measured
Discard date:
Discard dates for pharmaceutical suspensions typically mirror those for pharmaceutical solutions.
The discard date of official preparations will be advised via the relative official texts. As with
solutions, for official preparations the British Pharmacopoeia employs two definitions that are
useful when extemporaneously compounding suspensions:
▪
▪
‘Freshly Prepared’ refers to a preparation that has been compounded less than 24 hours
prior to issue for use.
‘Recently Prepared’ should be applied to compounded items that are likely to deteriorate
if stored for a period greater than four weeks when maintained at 15–25 C.
In practical terms it is suggested that an expiry date of two weeks is applied to oral suspensions
that need to be Freshly Prepared or that contain an infusion or other vegetable matter. A four-week
expiry should be applied to oral suspensions that need to be Recently Prepared.
Remember that because patients frequently misunderstand the term ‘expiry’ it is suggested that a
preferred method of indicating shelf-life on the label of extemporaneously compounded products is
to apply the term ‘Discard after’ or ‘Do not use after’ followed by a definite date and/or time.
When dealing with unofficial preparations, the compounder must consider the following. As a
general rule, an expiry of 7–14 days would be given to any of the following preparations;
56
Extemporaneous dispensing
✓ A suspension that does not contain a preservative
✓ A suspension where there are no stability data available
✓ A new suspension or ad hoc preparation.
Labelling:
In addition to the standard requirements for the labelling of extemporaneous preparations, the
following points need to be taken into consideration;
▪
▪
▪
‘Shake the bottle’ – All suspensions will require this additional label.
‘Not to be taken’ – This warning must be added to the label of any inhalations.
‘For external use only’ – This warning must be added to the label of any other suspension
not intended for administration via the oral route.
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Dispensing and Community Pharmacy for Pharm D Graduates
Dispensing of pharmaceutical ointments
Ointments
Ointments are preparations for external application but differ from creams in that they have greasy
bases. The base is usually anhydrous and immiscible with skin secretions. Ointments usually contain
a medicament or a mixture of medicaments dissolved or dispersed in the base.
According to the British Pharmacopoeia (BP) Ointments are formulated to provide preparation that
are immiscible, miscible or emulsifiable with the skin secretion. Hydrophobic ointments and wateremulsifying ointments are intended to be applied to the skin or certain mucous membranes for
emollient, protective, therapeutic or prophylactic purposes where a degree of occlusion is desired.
Hydrophilic ointments are miscible with the skin secretion and are less emollient as a consequence.
Ointment bases:
The base of a traditional ointment consists of a mixture of waxes, fats and oils:
▪
▪
▪
Waxes – solid and hard at room temperature
Fats – semi-solid, soft at room temperature
Oils – liquid at room temperature.
A change in temperature can affect the physical state of a base (e.g. coconut oil is solid in winter but
is more likely to be liquid in summer).
The addition of a wax to an ointment makes the preparation smoother and lighter in consistency.
Altering the proportions of oil, fat and wax in the ointment may vary the consistency. For example,
extra wax will make the ointment stiffer; extra oil will make the ointment less viscous. The
proportions used may vary depending on storage or the climatic conditions.
Example: whether the product is intended for use in the Tropics or in the Arctic.
1. Hydrocarbon bases:
These bases are immiscible with water and are not absorbed by the skin. They usually consist of soft
paraffin or mixtures of soft paraffin with hard paraffin or liquid paraffin. The paraffins form a greasy
waterproof film on the skin. This inhibits water loss from the skin, thereby improving the hydration
of the skin, which is particularly important in the treatment of dry scaly conditions
2. Absorption bases:
Absorption bases are good emollients and are less occlusive and easier to apply than hydrocarbon
bases. Absorption bases can be divided into non-emulsified bases and water-in-oil emulsions;
Non-emulsified – These bases absorb water to form water-in-oil emulsions. Generally they
consist of a hydrocarbon base combined with a water-in-oil emulsifier such as Wool Alcohols
BP (Wool alcohol ointment BP) or Wool Fat BP (Simple ointment BP).
Water-in-oil emulsions – These are similar to non-emulsified bases but are capable of
absorbing more water. The constituents of emulsified bases include Hydrous Wool Fat BP
(lanolin) and Oily Cream BP (Hydrous Ointment BP).
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Extemporaneous dispensing
3.Water miscible/ emulsifying bases:
These are anhydrous bases that contain oil-in-water emulsifying agents, which make them miscible
with water and therefore washable and easily removed after use. The following three emulsifying
ointments are used as water-miscible bases:
▪ Emulsifying Ointment BP (anionic)
▪ Cetrimide Emulsifying Ointment BP (cationic)
▪ Cetomacrogol Emulsifying Ointment BPC (non-ionic).
As the bases mix readily with the aqueous secretions of the skin and therefore wash out easily, they
are particularly suitable for use on the scalp
4. Hydrophilic bases:
These have been developed from polyethylene glycols (macrogols). They are non-occlusive, mix
readily with skin secretions and are easily removed by washing (e.g. Macrogol Ointment BP).
Macrogol bases are commonly used with local anesthetics such as Lidocaine BP.
General method for ointment preparation
Fusion
This involves melting together the bases over a water bath before incorporating any other ingredients.
The ointment base may include a mixture of waxes, fats and oils, of which some are solid at room
temperature and others are liquid:
▪
▪
▪
Hard – Paraffin BP, Beeswax BP, Cetostearyl Alcohol BP
Soft – Yellow and White Soft Paraffin BP, Wool Fat BP
Liquid – Liquid Paraffin BP and vegetable oils.
Method:
1. Always make excess as transference losses will always occur.
2. Determine the melting points of the fatty bases and then melt together. Starting with the base
with the highest melting point, each base should be melted at the lowest possible temperature
as the mixture progressively cools.
3. Add the ingredients to an evaporating basin over a water bath to avoid overheating – use a
thermometer to check the temperature regularly.
4. As the first base cools add the ingredients with decreasing melting points at the respective
temperatures, stirring continuously to ensure a homogeneous mix before leaving to set. It is
important to stir gently to avoid incorporating excess air, which could result in localized
cooling and a lumpy product.
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Dispensing and Community Pharmacy for Pharm D Graduates
General method for incorporating powders into an ointment base
Soluble solids
Soluble solids should be added to the molten fatty bases at the lowest possible temperature and the
mixture stirred until cold. Alternatively, if using a pre-prepared base, soluble solids may be
incorporated using the method employed for insoluble solids.
Insoluble solids
Insoluble solids should be incorporated using an ointment tile and spatula. If there is more than one
powder to be added these should be mixed in a mortar using the ‘doubling-up’ method.
General method for incorporating liquids into an ointment base
Non-volatile, miscible liquids
Non-volatile, miscible liquids may be mixed with the molten fat in the evaporating basin.
Alternatively, if a pre-prepared base is used, then incorporate as for volatile or immiscible liquids.
Volatile or immiscible liquids
Volatile or immiscible liquids (e.g. coal tar solutions) should be triturated with the ointment on the
ointment tile.
A very small amount of the ointment should be placed on the tile and a ‘well’ made in the center.
Traditionally, small quantities of liquid should be gently folded in to avoid splashing.
An alternative method is to spread a small amount of the ointment on the tile and then ‘score’ it with
a spatula. Then add small quantities of the liquid and fold into the base gently. If using coal tar or
other volatile ingredients, these should not be weighed until immediately before use and the beaker
in which it has been weighed should be covered with a watch glass to prevent evaporation.
60
Extemporaneous dispensing
Dispensing of Pharmaceutical Creams
In pharmacy the term ‘cream’ is reserved for external preparations. Creams are viscous semi-solid
emulsions for external use. Medicaments can be dissolved or suspended in creams.
A cream may be ‘water-in-oil’ or ‘oil-in-water’ depending on the emulsifying agent used. A cream is
always miscible with its continuous phase.
Definition:
Creams are formulated to provide preparations that are essentially miscible with the skin secretion.
They are intended to be applied to the skin or certain mucous membranes for protective, therapeutic
or prophylactic purposes, especially where an occlusive effect is not necessary.
Water-in-oil creams (oily creams) as bases – These are produced by the emulsifying agents
of natural origin (e.g. beeswax, wool alcohols or wool fat). These bases have good emollient
properties. They are creamy, white or translucent and rather stiff.
Oil-in-water creams (aqueous creams) as bases these are produced by the synthetic waxes
(e.g. macrogol and cetomacrogol). They are the best bases to use for rapid absorption and
penetration of drugs. They are thin, white and smooth in consistency.
Terminologies:
Terminology used in the preparation of creams, ointments, pastes and gels;
Trituration
This is the term applied to the incorporation, into the base, of finely divided insoluble powders or
liquids. The powders are placed on the tile and the base is incorporated using the ‘doubling-up’
technique. Liquids are usually incorporated by placing a small amount of ointment base on a tile and
making a ‘well’ in the center. Small quantities of liquid are then added and mixed in. Take care not
to form air pockets that contain liquid, which if squeezed when using an inappropriate mixing action
will spray fluid on the compounder and surrounding area.
Trituration can be successfully achieved using a mortar but this method is usually reserved for large
quantities.
Levigation:
This is the term applied to the incorporation into the base of insoluble coarse powders. It is often
termed ‘wet grinding’.
It is the process where the powder is rubbed down with either the molten base or a semisolid base. A
considerable shearing force is applied to avoid a gritty product.
General principles of cream preparation:
The preparation of a cream from first principles;
▪
As with other types of emulsion, hygiene is extremely important and all surfaces, spatulas
and other equipment must be thoroughly cleaned with industrial methylated spirits (IMS).
61
Dispensing and Community Pharmacy for Pharm D Graduates
▪
▪
▪
▪
▪
▪
▪
IMS is better than freshly boiled and cooled purified water as it will quickly evaporate,
leaving no residue.
Always make an excess as it is never possible to transfer the entire cream into the final
container.
Determine which of the ingredients are soluble in/ miscible with the aqueous phase and which
with the oily phase. Dissolve the water-soluble ingredients in the aqueous phase.
Melt the fatty bases in an evaporating dish over a water bath at the lowest possible
temperature. Start with the base having the highest melting point. These should then be cooled
to 60 C (overheating can denature the emulsifying agent and the stability of the product can
be lost).
Substances that are soluble/miscible with the oily phase should then be stirred into the melt.
The temperature of the aqueous phase should then be adjusted to 60 C.
The disperse phase should then be added to the continuous phase at the same temperature.
Hence, – for an oil-in-water (o/w) product add oil to water – for a water-in-oil (w/o) product
add water to oil.
Stir the resulting emulsion without incorporating air, until the product sets. Do not hasten
cooling as this produces a poor product.
Incorporation of ingredients into cream base:
In addition to the preparation of a cream from first principles, it is common to incorporate either liquid
or solid ingredients into a cream base.
Incorporation of solids into a cream base
If the cream base has been prepared from first principles, the solid can be incorporated into the cream
62
Extemporaneous dispensing
as it cools. Alternatively, if using a pre-prepared base, soluble and insoluble solids may be
incorporated using the method employed for insoluble solids.
✓ Soluble solids should be added to the molten cream at the lowest possible temperature and
the mixture stirred until cold.
✓ Insoluble solids should be incorporated using an ointment tile and spatula. If there is more
than one powder to be added these should be triturated together in a mortar using the
‘doubling-up’ technique prior to transfer to an ointment tile.
– To the evaporating basin with the remaining cream and stirred until cold or the
remaining cream in the evaporating basin may be allowed to cool and triturated with
the powder/cream mixture on the tile.
✓ Fine powders may be triturated into the otherwise finished cream on an ointment tile. Small
amounts of powder should be added to an equal amount of cream (i.e. using the ‘doubling
up’ technique). These should be well triturated.
Incorporation of liquid into cream base:
✓ Non-volatile, miscible liquids may be mixed with the molten cream in the evaporating basin.
Alternatively, if a pre-prepared base is used, the incorporate as for volatile or immiscible
liquids.
✓ Volatile or immiscible liquids (e.g. coal tar solutions) should be triturated with the cream on
the ointment tile. A very small amount of the cream should be placed on the tile and a ‘well’
made in the center.
Traditionally, small quantities of liquid should be gently folded in to avoid splashing. An
alternative method is to spread a small amount of the cream on the tile and then ‘score’ it
with a spatula. Then add small quantities of the liquid and fold into the base gently.
If using coal tar or other volatile ingredients, these should not be weighed until immediately
before use and the beaker in which it has been weighed should be covered with a watch glass
to prevent evaporation.
Packaging:
As all pharmaceutical creams are intended for external use, a suitable container would be either an
amber wide-necked ointment jar or a metal collapsible tube.
1. Pharmaceutical ointment jars come in a variety of different sizes and it is important
to choose a suitably sized container to match the volume of preparation to be dispensed. This
is best done by eye. Obviously, it is important not to use a size of container that is too large for
the volume of preparation to be dispensed, for both cost and appearance reasons.
2. Amber glass jars are preferable to clear glass jars as they protect the preparation from
degradation by light. More recently, plastic ointment jars have become available and,
although cheaper than glass jars, are less preferable because of an increased likelihood of the
products reacting with the container (e.g. as can occur with preparations containing coal tar).
When packaging a cream into an ointment jar, ensure that the cream is packed well and that no air
pockets are visible. This will produce a product with a professional appearance.
Discard date:
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Dispensing and Community Pharmacy for Pharm D Graduates
Some official texts may give a suggested discard date for certain extemporaneously prepared creams.
In the absence of any guide, it is suggested that creams are given a four-week discard date. This is
significantly shorter than the suggested discard date for extemporaneously prepared ointments (which
is three months) because of the susceptibility of creams to microbial contamination.
Diluted creams would normally be given a two-week discard date. Remember that as patients
frequently misunderstand the term ‘expiry’ it is suggested that a preferred method of indicating shelflife on the label of extemporaneously compounded products is to apply the term ‘Discard after’ or
‘Do not use after’ followed by a definite date and/or time.
Labelling:
In addition to the standard requirements for the labelling of extemporaneous preparations, the
following points need to be taken into consideration;
✓ ‘For external use only’ – This warning must be added to the label of all extemporaneously
prepared creams as all creams are for external use only.
64
Extemporaneous dispensing
Dispensing of Pharmaceutical Paste and Gels
Pastes:
Pastes are semi-solid preparations for external use. They consist of finely powdered medicaments
combined with White Soft Paraffin BP or Liquid Paraffin BP or with a non-greasy base made from
glycerol, mucilages or soaps.
Pastes contain a high proportion of powdered ingredients and therefore are normally very stiff.
Because pastes are stiff, they do not spread easily and therefore this localizes drug delivery. This is
particularly important if the ingredient to be applied to the skin is corrosive, such as dithranol, coal tar
or salicylic acid.
Advantages:
✓ It is easier to apply a paste to a discrete skin area such as a particular lesion or plaque, and
thereby not compromising the integrity of healthy skin.
✓ Pastes are also useful for absorbing harmful chemicals, such as the ammonia that is released
by bacterial action on urine, and so are often used in nappy products.
✓ Also because of their high powder content, they are often used to absorb wound exudates.
✓ Because pastes are so thick, they can form an unbroken layer over the skin which is opaque
and can act as a sun filter. This makes them suitable for use by skiers as they prevent excessive
dehydration of the skin (wind burn) in addition to sun blocking.
✓ The principal use of pastes traditionally was as an antiseptic, protective or soothing dressing.
Often before application the paste was applied to lint and applied as a dressing.
Gels:
Pharmaceutical gels are often simple-phase, transparent semi-solid systems that are being
increasingly used as pharmaceutical topical formulations. The liquid phase of the gel may be retained
within a three-dimensional polymer matrix. Drugs can be suspended in the matrix or dissolved in the
liquid phase.
The advantages of gels are that;
✓ They are stable over long periods of time
✓ They have a good appearance
✓ They are suitable vehicles for applying medicaments to skin and mucous membranes,
giving high rates of release of the medicament and rapid absorption.
Gels are usually translucent or transparent and have a number of uses:
▪
▪
▪
▪
Anaesthetic gels
Coal tar gels for use in treatment of psoriasis or eczema
Lubricant gels
Spermicidal gels.
Gelating agent:
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Dispensing and Community Pharmacy for Pharm D Graduates
The consistency of gels can vary widely depending on the gelling agent used in their preparation.
Common gelling agents used in aqueous gels are discussed below. Generally, the medication in a gel
is released quite freely provided the medicament does not bind with the polymer or clay used in its
formation.
Tragacanth
The Concentrations of 2–5% of tragacanth are used to produce different viscosities. Tragacanth is a
natural product and is therefore liable to microbial contamination.
The gum tends to form lumps when added to water and therefore most formulae will include a wetting
agent such as ethanol, glycerol or propylene glycol. By pre-wetting the tragacanth, the problems of
a lumpy product should be minimized, and should lumps develop they will disperse easily on
standing.
Example: A typical tragacanth gel formula;
Formula:
▪ Tragacanth BP
▪ Glycerol BP
▪ Alcohol BP
▪ Methylparahydroxybenzoate BP
▪ Water to
3% w/w
20% w/w
2.5% w/w
0.2% w/w
100%
Method:
Mix together the Tragacanth BP and the Methylparahydroxybenzoate BP (the preservative) in a
mortar.
1. Place the Alcohol BP and a small amount of Glycerol BP in a beaker.
2. Add the powder slowly.
3. Stir to form a smooth-flowing liquid.
4. Add any remaining glycerol.
5. Add all the water in one addition and stir (not too rapidly to avoid incorporation of air
bubbles).
As a general rule, any powdered ingredients to be added to a gel, such as the crystalline
Methylparahydroxybenzoate BP, should be admixed with the Tragacanth BP powder prior to
wetting.
Alginates:
The viscosity of alginate gels is more standardized than that of tragacanth. Alginate concentrations
of 1.5% produce fluid gels.
Alginate concentrations of 5–10% produce dermatological grade gels suitable for topical
application. Wetting agents (such as glycerol) need to be employed to prevent production of a
lumpy product.
Example: A typical alginate gel;
▪
▪
▪
▪
Sodium Alginate BP
Glycerol BP
Methylparahydroxybenzoate BP
Water to
7% w/w
7% w/w
0.2% w/w
100%
Method:
66
Extemporaneous dispensing
1. Mix together the Sodium Alginate BP and the Methylparahydroxybenzoate BP (the
2.
3.
4.
5.
preservative) in a mortar.
Place the Glycerol BP in a beaker.
Add the powder slowly.
Stir to form a smooth-flowing liquid.
Add all the water in one addition and stir (not too rapidly to avoid incorporation of air
bubbles).
Pectin:
* Pectin is suitable for acid products.
* It is prone to microbial contamination.
It is prone to water loss and therefore necessitates the addition of a humectant (e.g. glycerol,
propylene glycol or sorbitol).
Gelatin
Gelatin is rarely used as the sole gelling agent in dermatological preparations. It is usually combined
with other ingredients such as pectin or carmellose sodium.
Cellulose derivatives:
Cellulose derivatives are widely used and form neutral, stable gels. They exhibit good resistance to
microbial attack. They form clear gels with good film strength when dried on the skin.
Methylcellulose 450 is used in strengths of 3–5% to produce gels. Carmellose sodium (sodium
carboxymethylcellulose) is used in concentrations of 1.5–5% to make lubricating gels. In higher
concentrations it is used to make dermatological gels.
Carbomers:
Carbomer is useful in production of clear gels (provided too much air is not incorporated in the gel
production). In concentrations of 0.3–1%, carbomer acts as a lubricant.
Carbomer is used in dermatological preparations in concentrations of 0.5–5%.
Polyvinyl alcohol
Polyvinyl alcohol is useful for preparing quick drying gels. It leaves a residual film that is strong and
plastic. It provides gels that have good skin contact and therefore ensures the medicament has good
skin contact.
Differing viscosities are achieved depending on the concentration of polyvinyl alcohol used
(normally 10– 20%) and the grade of polyvinyl alcohol employed.
Clays:
Bentonite is used in concentrations of 7–20% to formulate dermatological bases. The resultant gel
is opalescent, therefore less attractive to the patient.
On drying, the gel leaves a powdery residue on the skin.
Other additives of Gels:
Among the other additives it contains various preservatives and humectants.
Humectants
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Dispensing and Community Pharmacy for Pharm D Graduates
Loss of water from a gel results in a skin forming. The addition of a humectant can minimize this.
Examples of additives that may be added to help retain water include;
▪ Glycerol in concentrations of up to 30%
▪ Propylene glycol in concentrations of approximately 15%
▪ Sorbitol in concentrations of 3–15%.
Preservatives
Gels have a higher water content than either ointments or pastes and this makes them susceptible to
microbial contamination. Choice of preservative is determined by the gelling agent employed
Table 1. Choice of preservative to be used in a gel
Packaging:
Ointments, pastes and gels are intended for external use, a suitable container would be either an
amber wide-necked ointment jar or metal collapsible tube.
Pharmaceutical ointment jars come in a variety of different sizes and it is important to choose a
suitably sized container to match the volume of preparation to be dispensed. Obviously, it is
important not to use a size of container that is too large for the volume of preparation to be dispensed
for both cost and appearance issues.
▪
Amber glass jars are preferable to clear glass jars as they protect the preparation from
degradation by light. More recently, plastic ointment jars have become available and although
cheaper than glass jars, are less preferable because of an increased likelihood of the products
reacting with the container (e.g. as can occur in preparations containing coal tar).
When packaging a pharmaceutical product into an ointment jar, ensure that the product is packed
well and that no air pockets are visible. This will produce a final product with a professional
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Extemporaneous dispensing
appearance.
Discard date:
Some official texts may give a suggested discard date for extemporaneously prepared ointments,
pastes and gels. In the absence of any guide, it is suggested that ointments and pastes are given a
three-month discard date.
This is significantly longer than the suggested discard date for extemporaneously prepared creams
(which is four weeks) owing to the fact that ointments are less susceptible to microbial contamination.
Diluted ointments would normally be given a two-week discard date.
Gels, which have a higher water content, will attract a shorter discard date. In the absence of any
official guidance, it is suggested that gels are given a four-week expiry date.
Remember, that as patients frequently misunderstand the term ‘expiry’ it is suggested that a preferred
method of indicating shelf-life on the label of extemporaneously compounded products is to apply
the term ‘Discard after’ or ‘Do not use after’ followed by a definite date and/or time.
Labeling:
In addition to the standard requirements for the labelling of extemporaneous preparations, the
following points need to be taken into consideration:
✓ ‘For external use only’ – This warning must be added to the label of all extemporaneously
prepared ointments pastes and gels as all are for external use only.
✓ ‘Store below 15C’ – Depending on the temperature of the environment, it may be advisable
to place a storage temperature warning on the label. This would not normally be necessary in
the UK (depending on the ingredients within the preparation) but may be advisable if the
patient is travelling to a location with a warmer climate.
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Dispensing and Community Pharmacy for Pharm D Graduates
Dispensing of pharmaceutical suppositories and
Pessaries
Suppositories:
Suppositories are solid unit dosage forms suitably shaped for insertion into the rectum. The bases
used either melt when warmed to body temperature or dissolve or disperse when in contact with
mucous secretions.
Suppositories may contain medicaments, dissolved or dispersed in the base, which are intended to
exert a systemic effect. Alternatively, the medicaments or the base itself may be intended to exert a
local action. Suppositories are prepared extemporaneously b incorporating the medicaments into
the base and the molten mass is then poured at a suitable temperature into moulds and allowed to
cool until set.
The British Pharmacopoeia (BP) definition is as follows;
Suppositories are solid, single-dose preparations. The shape, volume and consistency of
suppositories are suitable for rectal administration.
They contain one or more active substances dispersed or dissolved in a suitable basis which may be
soluble or dispersible in water or may melt at body temperature.
Excipients such as diluents, adsorbents, surface-active agents, lubricants, antimicrobial
preservatives and coloring matter, authorized by the competent authority, may be added if
necessary.
Advanatages:
✓ They can be used to exert a local effect on the rectal mucosa (e.g. anaesthetic, etc.)
✓ They can be used to promote evacuation of the bowel
✓ if a particular drug causes irritation of the gastrointestinal tract this can be avoided by rectal
administration
✓ They can be used for patients who are unconscious, fitting or vomiting, etc.
✓ Systemic absorption can be achieved by rectal delivery and has the added advantage of
avoiding first-pass metabolism by the liver.
Disadvantages:
✓ They may be unacceptable to certain patients/ cultures
✓ They may be difficult to self-administer by arthritic or physically compromised patients
✓ They have unpredictable and variable absorption in vivo.
Pessaries:
Pessaries are a type of suppository intended for vaginal use. The larger size moulds are usually
used in the preparation of pessaries, such as 4 g and 8 g moulds.
Pessaries are used almost exclusively for local medication, the exception being prostaglandin
pessaries that do exert a systemic effect.
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Extemporaneous dispensing
Common ingredients for inclusion in pessaries for local action include;
▪
▪
▪
▪
▪
Antiseptics
Contraceptive agents
Local an-aesthetics
Various therapeutic agents to treat trichomonal, bacterial and monilial infections.
The British Pharmacopoeia (BP) definition is as follows:
Pessaries are solid, single-dose preparations they have various shapes, usually ovoid, with a volume
and
consistency suitable for insertion into the vagina. They contain one ormore active substances
dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at
body temperature. Excipients such as diluents, adsorbents, surface-active agents, lubricants,
antimicrobial preservatives and colouring matter authorised by the competent authority may be
added, if necessary.
General principles of suppository and pessary
preparation
The methods used in the preparation of pessaries are the same as those for suppositories.
The preparation of suppositories invariably involves some wastage and therefore it is recommended
that calculations are made for excess.
Example: if you are required to dispense six suppositories, to include a suitable excess calculate
for 10.
Suppository mould calibration:
Suppository moulds are calibrated in terms of the weight of Theobroma Oil BP each will contain.
Typical sizes are 1 g, 2 g or 4 g. Because the moulds are filled volumetrically, use of a base other
than Theobroma Oil BP will require recalibration of the moulds. Many synthetic fats have been
formulated to match the specific gravity of Theobroma Oil BP and therefore the mould sizing will
be the same and not require recalibration. However, this is not the case for all synthetic bases. To
recalibrate a suppository mould, the compounder needs to prepare a number (e.g. five) of (perfectly
formed) suppositories containing only the base. These can then be weighed and the total weight
divided by the number of suppositories present to find the mould calibration value.
Calibrate 1g of mould with a synthetic base:
1. The synthetic base is melted in an evaporating basin over a water bath until around two2.
3.
4.
5.
6.
7.
thirds of the base has melted.
The evaporating basin is then removed from the heat and stirred, using the
Residual heat to melt the remaining synthetic base.
When the base has cooled to close to its melting point, it is poured into the mould and
allowed to overfill slightly.
After around 5 minutes, trim the tops and then leave the suppositories to set completely.
Weigh all the perfect suppositories (i.e. avoiding any chipped suppositories) and divide the
total weight by the number of suppositories weighed.
This will give the value that should be used for this particular mould with this base.
Displacement value:
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Dispensing and Community Pharmacy for Pharm D Graduates
Problems also arise when medicaments are added to the base, where the density of the medicament
differs from that of the base and a specific quantity of ingredient is required to be incorporated into
each suppository. The amount of base displaced will depend on the densities of the ingredients and
the base. For ease of calculation this is expressed in terms of a series of displacement values, where
the displacement value of an ingredient is defined as the number of parts by weight of the
ingredient that displaces one part of Theobroma Oil BP (or other fatty base, e.g. Hard Fat BP).
Definition: The displacement value is defined as the quantity of medicament that displaces one
part of the base. For example, Hydrocortisone BP has a displacement value of 1.5.
This means that 1.5 g Hydrocortisone BP displaces 1 g of the suppository base (Theobroma Oil BP
or Hard Fat BP).
Calculations using displacement values:
If the active ingredient in a suppository is expressed in terms of weight then a calculation based on
displacement values will need to be made in order to determine the amount of Hard Fat BP
required.
Formulae requiring percentage calculations:
If the active ingredient in a suppository is expressed in terms of a % w/w then a calculation based
on displacement value will not be required. The drug is present in the suppository as a proportion.
Therefore, simply subtract the total weight of the medicament from the total weight of the fat to
determine the amount of fat required.
General method of suppository preparation:
The steps involved in the preparation of suppository are mentioned below;
1. Most moulds prepare six suppositories, but it is necessary to calculate to include an excess
2.
3.
4.
5.
6.
7.
8.
(usually a multiple of 10).
Choose a suppository mould to provide the suppositories of the required size (usually a 1 g
size). Check that the two halves of the mould are matched (numbers are etched on the
sides).
Check that the mould is clean and assemble the mould but do not over-tighten the screw.
For some suppository bases it is necessary to lubricate the mould (e.g. use Liquid Paraffin BP),
but this is not required when using Hard Fat BP.
If the suppository is to contain insoluble, coarse powders these must be ground down in a
glass mortar before incorporation.
It is important not to overheat the base, which may change its physical characteristics. Find
the melting point of the base and heat it to about 5– 10 C less than the melting point. (There
should still be some solid base present.) Hold the evaporating basin in the palm of your hand
and stir (do not use the thermometer to stir) to complete the melting process.
Immiscible liquids and insoluble solids should be incorporated into the fatty base by
Levigation (wet grinding). The substance should be rubbed into the minimum quantity of
molten base on a tile using a spatula. The ‘shearing’ effect will not be obtained if too much
base is used, resulting in a gritty product.
The paste obtained in step above should be returned to the evaporating basin with the
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Extemporaneous dispensing
9.
10.
11.
12.
13.
14.
remainder of the base, stirring constantly.
The molten mass should be poured into the mould when it is just about to solidify. (This is
usually judged by experience. Look for a slight sheen on the surface of the mass, similar to a
skin forming on custard as it cools.)
Pour the mass into the mould uniformly in one movement.
Allow the mixture to overfill slightly but not to run down the sides of the mould (if this
happens, it is likely to be due to the mixture still being too hot).
When the suppositories have contracted, but before they have set completely, trim off the
excess Hard Fat BP. This can easily be achieved by rubbing the flat blade of the spatula over
the top of the mould.
After further cooling, when the suppositories have set, loosen the screw and tap once sharply
on the bench. Remove the suppositories carefully (avoid over handling or damaging the
suppositories with your nails).
Pack the required number of suppositories individually in foil and place in an amber wide
necked jar.
Packaging:
Suppositories and pessaries that have been manufactured in metal moulds should be removed from
the mould carefully and individually wrapped in suitably sized pieces of aluminium foil. Once
wrapped, the suppositories can be placed in an ointment jar or cardboard carton and labelled.
Suppositories that have been manufactured in a disposable mould are often dispensed to the patient
in the mould. It is important to ensure that the patient will be able to release each suppository from
the mould and that the label is placed on a suitable part of the mould. Sometimes, it will be
necessary to remove the suppositories from the disposable mould and wrap and package as for
those prepared in metal moulds.
Discard dates:
In practical terms it is suggested that an expiry date of three months is given to suppositories and
pessaries in the absence of any official guidance
Remember that because patients frequently misunderstand the term ‘expiry’ it is suggested that a
preferred method of indicating shelf-life on the label of extemporaneously compounded products is
to apply the term ‘Discard after’ or ‘Do not use after’ followed by a definite date and/or time.
Labelling:
In addition to the standard requirements for the labelling of extemporaneous preparations, the
following points need to be taken into consideration:
▪
▪
▪
‘For rectal use only’ – This warning must be added to the label of any suppositories.
‘For vaginal use only’ – This warning must be added to the label of any pessaries.
‘Store below 15 C’ – This warning must be added to the label of all suppositories and
pessaries.
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Dispensing and Community Pharmacy for Pharm D Graduates
Dispensing of Classical Dosage Form
Classical dosage form
The following sections are devoted to descriptions of the nature, preparation, equipment and
technology associated with the compounding of some traditional drug forms, compounds and
formulations, most of which have become defunct during the 20th century.
They are presented here in part to satisfy historical interest and partly as a repository of methods and
skills that would otherwise be lost completely to the general pharmaceutical world.
Galenicals:
Galen was the first scientist who device solutions of active constituents of plants. Therefore, presently
they are referred to as Galenicals.
Galenicals are defined as the pharmaceutical preparations which are prepared by macerating or
percolating the active constituents of the plant by alcohol or suitable solvent leaving the undesired
solid (marc) behind.
Example: True galenicals are extracts, decoctions, tinctures, vinegars and oxymels etc.
Bougies:
Bougies are solid dosage form which is designed to be inserted into the urethra, nose or ear in order
to exert their local or systemic action in a similar manner to the modern suppository.
Bougies are available in long thin pencil shapes. The weight is 2g for females and 4g for males.
They are formulated in Glycerogelatin base, Glyceriyl monosterate and polyoxyl ethylene.
Example: Furacin urethral inserts.
Cachets:
Cachets are classical dosage form. Cachets are the solid unit dosage form of medicaments in which
the drug is enclosed or encapsulated in bread and jam.
Advantages:
✓
✓
✓
✓
They are good in masking the taste of bitter drugs.
They are easy to prepare because no complicated machinery is required.
Drugs can be extemporaneously and quickly dispensed in cachets.
They quickly disintegrate in stomach.
Collodions:
It is a classical dosage form. Collodions are a clear or slightly opalescent, viscous liquid prepared
by dissolving pyroxylin (4% w/v) in a three to one 3:1 mixture of ether and alcohol.
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Extemporaneous dispensing
The resulting solution is highly volatile and flammable and should be preserved in a tight container
remote from fire at a temperature not exceeding 300C.
Uses:
It gives protective films useful in holding the edges of incised wound together.
Disadvantage:
The presence is uncomfortable because it is of inflexible nature. Therefore, there is flexible
collodions.
Flexible Collodions:
If we add 2% camphor with 3% castor oil to the simple collodion the resulting mixture is referred
to as flexible collodion.
Camphor make the film water proof while the castor oil makes the film more flexible and
comfortable.
Uses:
▪
▪
Its use is comfortable over skin areas that are normally movers, such as fingers and toes.
Its coating is applied on stitched incisions to make them water proof and to protect them
from external stress.
Salicylic acid collodion:
It is prepared by mixing 10% solution of salicylic acid in flexible collodion.
Uses:
Apply one drop at a time on corms or warts. Line the adjacent healthy skin with white petrolatum
prior to application of product.
Confections:
Confections are thick, sweet, soft, solid preparations into which one or more drug substances are
incorporated.
Example: Confection of Senna BP.
Advantages:
✓ They offer a convenient method of preservation.
✓ They help in making the bitter taste of drugs.
Decoctions:
In this process, the crude drug is boiled in a specified volume of water for a defined time (10
minutes) it is then cooled and strained or filtered.
This procedure is suitable for extracting water-soluble, heat-stable constituents and drugs of hard
and woody nature. This process is typically used in preparation of Ayurvedic extracts called quath
or kawath.
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Dispensing and Community Pharmacy for Pharm D Graduates
Decoctions are aqueous products thus they are very susceptible to decomposition and therefore
they are freshly prepared.
Example: Decoction of Chondrus.
Extracts:
Extracts are produced by the action of various solvents (alcoholic, aqueous, ethereal) by variety of
processes (maceration, decoction, percolation, expression) which may be followed by evaporation
with or without the vacuum assistance to produce, liquid, semi-solid or solid extract.
Example: Extract of cannabis.
Eye discs:
They are also known as Lamellae. Lamellae are small discs of glycol-gelatin base that are intended
to be placed onto the cornea of the eye, where they would be allowed to dissolove in lachrymal
secretions to produced their local effect.
Often, the active ingredient is an alkaloid that would be released for a local effect.
Juices:
Juices are prepared by expression and evaporation, form the fresh natural products. Such extracts are
frequently termed as succi spissati.
Example: belladonna, henbane, hemlock, broom etc.
Lozenges:
Lozenges are solid dosage form of medicaments which are designed to dissolve slowly and
disintegrate in the mouth. They are used principally for drugs exerting a local action in the mouth
and throat.
Example: Strepsils, it is used for sore throat.
Infusions:
Infusions are dilute solutions containing the readily soluble constituents of crude drugs.
Process:
It is a process of steeping or drenching a drug in water so as to extract the active principles.
It involves pouring water over the drugs and then allowing it to keep in contact with water for the
stated period (15 min) with occasional stirring and finally filtering off the liquid. Fresh infusion is
prepared by macerating the drug for a short period of time with cold or hot (boiling) water.
Concentrated infusions are prepared by a modified percolation or maceration process.
Infusion pot:
It consists of covered jar (made of earthenware, stainless-steel, ceramic, glass, porcelain) to which is
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Extemporaneous dispensing
fitted at certain height a perforated tray upon which the crude drug may be allowed to rest in water
being poured over it.
The drug may be enclosed loosely in a small muslin bag and suspended in the jar at a height where
it will be just covered by the liquid. The perforated tray or muslin bag confers two advantages:
1. Complete extraction because when the menstruum (solvent) surrounding the drug becomes
saturated, it will sink to the bottom due to its increased density and another amount of fresh
menstruum displace it leading to circulatory diffusion
2. At the end of infusion time, the drug can be lifted out, leaving clear liquid which can be
strained quickly.
Fresh (Dilute) Infusion
A fresh infusion is an aqueous solution of active constituents of a vegetable drug prepared by the
process of infusion. Water is used as menstruum. Fresh infusion should be used within 12 hours after
its preparation because it gets spoiled due to bacterial and fungal growth e.g. Fresh infusion of
Quassia.
Concentrated (stock) infusion
Prepared by double or triple maceration 8 times stronger than fresh infusion. Alcohol in the
concentration of 20-25% is used as menstruum. Avoid rapid decomposition to which the fresh
(dilute) infusions are subjected. The dilution of 1 volume of concentrated infusion with 7 volumes
of water resembles corresponding fresh infusion in potency e.g. Concentrated infusion of Quassia.
Mucilages:
Mucilages are thick, viscous, concentrated aqueous solutions or extractions of gums.
Example: Mucilage of Acacia, Mucilage of Tragacanth. Both are used as thickening agents in
medications for internal use.
Glycerins:
They are produced by dissolving or incorporating substances in glycerin. The principal use of glycerin
is to provide simple and rapid method of producing aqueous solution of drug that was not otherwise
readily soluble.
Many of the glycerin’s are made in concentrated form that could easily diluted with water or alcohol
without precipitation.
Example: Glycerite of Tar.
Oxymels:
The term is applied to purified honey to which acetic acid is added. There are many examples of
oxymels formulated with active ingredients.
Example: Oxymel BPC, Squill Oxymel BPC.
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Dispensing and Community Pharmacy for Pharm D Graduates
Poultices or Cataplasm:
These are preparations of thick semisolid base which are often heated and applied to body part or
area on a cloth in order to draw infection or infectious material.
They are intended to localize infectious material in the body or to act as counter irritant. The
material intended to be absorptive which together with heat accounts for their popular use.
These should be supplied in a suitable container which minimize absorption, diffusion or
evaporation of ingredients.
Direction of use: They are either dabbed on the skin or applied on a suitable dressing and
covered with a water proof dressing to reduce evaporation.
Example: None is now official in USP. Though the last official preparation left is Kaolin poultice
NF.
Uses:
These are used for the treatment of boils and other inflammatory skin conditions.
Pills:
Pills are small solid oral dosage form of ovoid or lenticular shape.
Resins:
Resins are solid preparations consisting of the resinous constituents of vegetable matter. They are
soluble in alcohol and in most organic solvents but insoluble in water.
Preparation:
They are prepared by extraction of vegetable matter using 90% alcohol. In order to isolate the
resinous matter the alcoholic extract is concentrated and poured into water. The resinous matter
precipitates out, which can be subsequently washed with water.
Snuffs:
Snuffs are finely divided solid dosage form of medicaments which are inhaled into nostrils for their
antiseptic, decongestion or bronchodilators action. Snuffs should be dispensed in flat metal boxes.
Aromatic water:
They are defined as aqueous solutions of volatile substances. The volatile substance can be solid,
liquid or gaseous. Concentrated aromatic waters also contain alcohol from 52 – 56 % v/v.
▪ These are to be free from smoke like odor and other odors.
▪ They must have odor and taste similar to those oil or drugs from which they are prepared.
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Extemporaneous dispensing
Uses:
Now days they are not frequently used but they can be used as; Perfuming, flavoring and for
special use i.e. camphor water is used as vehicle in eye preparations. It gives refreshing and
stimulating action.
Hamamelis (witch hazel) water is employed in rule a perfuming and astringent in cosmetics
(after shave)
Chloroform water is used as sedative in cough, asthma & colic mixtures. Also, as vehicle for
administering other ingredients.
Vinegars:
Medicated vinegars can be defined as, “solutions of drugs in dilute acetic acid, which is a good solvent
and possess antiseptic properties.
The use of vinegars has now declined but they are worthy of mention as their use as a menstruum for
medicinal preparations dates back to ancient times. Vinegar was itself used as an antiseptic.
Example: Squill vinegar BPC.
Tinctures:
Tinctures are alcoholic solutions of drugs.
A product is called tincture when it contains 45% v/v or more alcohol. Tincture ipecacanha is an
exception containing about 23% v/v of alcohol.
Generally, a tincture contains alcohol ranging 20% - 90% v/v alcohol. Four parts by of volumes
product represents one part by weight of the drug. (Strong ginger is an exception having 2 parts to 1
part of the drug.)
Preparation:
They can be prepared by;
Simple solution method
Maceration
Percolation
Example: Tincture of benzoin, Tincture of iodine.
Wines:
Wines closely resemble with tinctures with the only difference being menstruum. The presence of
alcohol in medicated wines makes them more stable than decoctions and infusions.
Wines can be;
Medicated wines – Vinum Xericum
Un medicated wines – sherry
Plasters:
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Dispensing and Community Pharmacy for Pharm D Graduates
Plasters is a solid or semisolid mass supplied on a backing material and intended to provide
prolonged contact with skin.
The adhesive material is a rubber base or a synthetic resin.
Types of Plaster:
Plasters are classified into two major categories;
Unmedicated plasters:
Unmedicated plasters are those plasters that provide protection or medicinal support at the
site of application.
Example: Adhesive tape.
Medicated plasters:
Medicated plasters are those plasters which provide therapeutic effects.
Syrups:
Syrups are concentrated solutions of sugar (such as sucrose) in water or other aqueous liquids with
or without added flavoring agents and medicinal substances.
Types of syrups
Syrups are classified into three main categories;
1. Non- medicated syrup
2. Medicated syrup
3. Flavored syrup
1. Non- medicated syrup:
Non- medicated syrup is also known as simple syrup. It is the concentrated solution of
sucrose in purified water alone.
2. Medicated syrup:
It is aqueous solution of sucrose; it also contains ingredients giving them therapeutic value.
Polyols (glycerol or sorbitol) are sometimes added to retard the crystallization of sucrose.
Example: Ipecac Syrup - emetic
3. Flavored syrup:
It contains various aromatic and pleasantly flavored substances and is intended as a vehicle or
flavor or diluent for the preparations of other syrups.
Example: Orange Syrup, Glycyrrhiza Syrup, Raspberry Syrup.
80
Pharmaceutical Incompatibilities
Chapter 3 PHARMACEUTICAL
INCOMPATIBILITIES
Chapter Outline
This Chapter includes:
1.
Pharmaceutical Incompatibilities
2.
Types of incompatibilities
Therapeutic Incompatibility, Physical Incompatibility, and
Chemical Incompatibility,
The manifestation, Correction Prevention with reference to
typical examples of types of Incompatibilities
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Dispensing and Community Pharmacy for Pharm D Graduates
82
Pharmaceutical Incompatibilities
Pharmaceutical Incompatibilities
“The unusual result of mixing two or more antagonistic substances which is detected by
changes in physical, chemical or therapeutic qualities that may affect the safety, efficacy or
appearance of a medicine is known as Incompatibility.”
A prescription is considered to possess an incompatibility when the combination of its ingredients
adversely effects the appearance, elegance, safety or therapeutic efficacy.
A problem arises during the pharmaceutical compounding of two or more substances because of their
therapeutic, physical or chemical properties the substances are said to be incompatible. In general, we
can say there are two types of incompatibilities;
✓ Minor incompatibilities (which do not harm or which can be easily avoided)
✓ Major incompatibilities (which should not be dispensed)
Classification of incompatibilities:
Incompatibilities can be classified into three classes;
1. Physical incompatibilities
2. Chemical incompatibilities
3. Therapeutic incompatibilities
1. Therapeutic incompatibilities:
“The type of incompatibility in which an undesirable pharmacological interaction between
two or more ingredients leads to Potentiation of therapeutic effect, Destruction of
effectiveness or Occurrence of toxic manifestations within the patient is known as
Therapeutic incompatibility.”
Causes
Therapeutic incompatibility arises when a drug error, dosage error or a dosage form error is made
either by the physician in prescribing or by pharmacist in counselling, prescription handling or
compounding.
Drug error:
Drug error can be made either by the physician or by the pharmacist. It can be due to;
•
•
Writing or speaking error by the physician in the verbal or non-verbal prescription
Reading or hearing error by the pharmacist in prescription handling
Example:
Such problems tend to arise with, incorrect drug due to trademark or nomenclature error.
▪
▪
▪
Alphaden – Mineral supplement
Alphalin – Vitamin A product
Alphyllin – A diuretic
Contraindicated drugs:
Pharmacist should take history before dispensing the drug to the patient. So that;
83
Dispensing and Community Pharmacy for Pharm D Graduates
•
•
•
•
•
He must be aware of any sort drug – drug interaction
He avoids dispensing a drug which undergo renal clearance, to a patient with renal
insufficiency.
He avoids dispensing a drug which mainly undergo hepatic metabolism, to a patient with
liver dysfunction.
He avoids dispensing morphine to an asthmatic patient.
He avoids dispensing vasoconstrictor to a hypersensitive patient.
Dosage form error:
These are the errors which occurs due to;
•
•
•
•
If topical products are swallowed by the patient.
If skin dosages are instilled into eyes, nose or ears.
If auxiliary label is not mentioned on the final compounded product.
If the doctor has asked to compound topical product and pharmacist compounded an oral
product.
Dosage error:
If there is an error in dosage requirement, i.e. how to take? When to take? How much to take? How
long to take?
•
Over dosage; Excessive single dosage because of decimal errors. It occurs if the doctor
wrote it wrong or pharmacist read it in a wrong way.
•
Excessive daily dose; suppose doctor has to write ‘after every 4 hours’ but mistakenly he
wrote ‘after every 1 hour’ then by this error the patient will receive over dosage of the
medicament.
•
Addictive or synergistic combination; Two drugs may have such relation that when
they are administered together, leads to more intense effect.
Example: morphine with barbiturates produce intense CNS depressant action.
•
Antagonistic combination; Two drugs may have such relation leads to under dosage to
the patients.
Example: The reduction of the anticoagulant effect of warfarin when an agent that
accelerates its hepatic metabolism, such as phenobarbital.
In case of emulsion or suspension if patient forget to shaken the preparation before usage,
leads to unequal dosage to user.
Methods of calculating dose
𝑌𝑜𝑢𝑛𝑔′𝑠 𝑟𝑢𝑙𝑒 =
𝑎𝑔𝑒 (𝑦𝑒𝑎𝑟𝑠)
× 𝐴𝑑𝑢𝑙𝑡 𝑑𝑜𝑠𝑒 = 𝑐ℎ𝑖𝑙𝑑 ′ 𝑠 𝑑𝑜𝑠𝑒
𝑎𝑔𝑒 (𝑦𝑒𝑎𝑟𝑠) + 12
𝑎𝑔𝑒 (𝑦𝑒𝑎𝑟𝑠)
𝐶𝑜𝑤𝑙𝑖𝑛𝑔′ 𝑠 𝑟𝑢𝑙𝑒 =
× 𝐴𝑑𝑢𝑙𝑡 𝑑𝑜𝑠𝑒 = 𝑐ℎ𝑖𝑙𝑑′ 𝑠 𝑑𝑜𝑠𝑒
24
𝑎𝑔𝑒
(𝑀𝑜𝑛𝑡ℎ𝑠)
𝐹𝑟𝑖𝑒𝑑 ′ 𝑠 𝑟𝑢𝑙𝑒 =
× 𝐴𝑑𝑢𝑙𝑡 𝑑𝑜𝑠𝑒 = 𝑐ℎ𝑖𝑙𝑑 ′ 𝑠 𝑑𝑜𝑠𝑒
150
𝐶𝑙𝑎𝑟𝑘 ′ 𝑠 𝑟𝑢𝑙𝑒 =
𝑊𝑒𝑖𝑔ℎ𝑡 (𝑙𝑏𝑠)
× 𝐴𝑑𝑢𝑙𝑡 𝑑𝑜𝑠𝑒 = 𝑐ℎ𝑖𝑙𝑑 ′ 𝑠𝑑𝑜𝑠𝑒
150
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Pharmaceutical Incompatibilities
2. Physical incompatibilities:
The type of incompatibilities in which the physical properties of ingredients produce a
mixture unacceptable in appearance or in accuracy of dosage is known as Physical
incompatibilities.
Physical incompatibilities can arise due to following reasons;
▪ Insolubility
▪ Liquefaction
▪ Immiscibility
▪ Precipitation
i. Insolubility:
When a certain amount of solute is not dissolved in a given amount of solvent it is called
Insolubility.
It usually occurs between solid and liquid ingredients.
Causes
Incompatibility can be occurred due to:
•
•
•
•
•
•
•
In complete solution;
✓ Wrong (agents) solvents e.g. gum-alcohol, silicon-water)
✓ Amount of solvent is insufficient
In liquid preparations containing indiffusible solids such as; chalk, aromatic chalk, powder
succinyl sulphathiazole and sulphadimidine (in mixture) and calamine and Zinc oxide (in
lotion), a thickening agent is necessary to obtain an elegant product from which uniform dose
can be removed.
Insoluble powders e.g. sulphur, certain corticosteroids and antibiotics are difficult to wet
with water, wetting agent are used.
Example:
✓ Saponins for sulphur continuing lotions.
✓ Polysorbates for parenteral suspensions of corticosteroids and antibiotics.
The deflocculating action of excess surface-active agent may be cause claying. This may be
controlled by reducing the surfactant concentration.
Potent insoluble drugs are converted into salt form (Salt formation).
Example:
✓ An alkaloidal salt for an alkaloid.
✓ Sodium salt of barbiturates for the corresponding free compound.
Constituents of alcoholic vegetable extract may precipitate.
When a resinous tincture is added to the water. The water-insoluble resin agglomerates
forming indiffusible clots.
ii. Liquefaction:
At certain low melting point solids are powdered together, a liquid or soft mass is produced due to
lowering of melting point of the mixture to below room temperature.
Example:
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Dispensing and Community Pharmacy for Pharm D Graduates
Among the medicaments exhibiting this behavior are any pair of the following;
✓ Camphor, menthol, phenol, thymol, and chloral hydrate.
✓ Sodium salicylate or aspirin with phenazone.
iii. Immiscibility:
Immiscibility occurs between two liquids ingredients.
• Oil (fixed oil) in water emulsion (emulsification or solubilization)
• Concentrated hydrophilic solutions of volatile oils such as spirits and concentrated water used
as adjuncts. (For example, flavoring agents) in aqueous preparations, are either gradually
diluted with the vehicle before admixture with the remaining ingredients or poured slowly
into vehicle with constant stirring.
• Addition of high concentration of electrolytes to mixtures in which vehicle is a saturated
aqueous solution of a volatile oil causes the oil to separate and collect as an unsightly
surface layer.
Example: Potassium citrate mixture BPC, in which the large quantity of soluble solid, salts
out the lemon oil and to disperse this evenly quillaia tincture is added as a suspending agent or
emulsifying agents.
iv. Precipitation:
Solubilize substances may precipitate from its solution, if a non-solvent for the substances is added
to the solution.
Examples:
(a) Resins are insoluble in water. Thus, Alcoholic solutions of resins and water results in
precipitated resins.
(b) Aqueous dispersions of hydrophilic colloids (polysaccharide mucilage + high concentration
of alcohol and salt) results into precipitated colloids.
(c) High concentration of electrolytes causes cracking of soap emulsion by salting out the
emulsifying agents.
(d) Vehicles (one or more organic liquids) used to dissolve medicaments of low solubility.
Water soluble adjuncts/adjuvants particularly inorganic salts may be precipitated in such
vehicle.
(e) When tinctures containing resinous matter are added in water, resins agglomerates, forming
insoluble precipitates. This can be prevented by slowly adding the undiluted tincture with
vigorous shaking to suspension or by adding some suitable thickening agent.
Example of Prescription
Lotion of compound tincture of benzoin
➢ Tincture benzoin compound --- 5g
➢ Glycerin --- 10ml
➢ Rose water --- up to 100ml
Result:
Tincture benzoin compound contains resins. The solvent system results in an
unavoidable precipitates.
Remedy:
Addition of tincture with rapid stirring yields a fine colloidal dispersion so there is
no need of any suspending agent.
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Pharmaceutical Incompatibilities
3. Chemical incompatibilities:
“The type of incompatibilities in which reaction between two or more substances leads to
change in chemical properties of pharmaceutical dosage form is known as Chemical
Incompatibility”
Chemical incompatibilities occur as a result of chemical reaction;
✓ Effervescence
✓ Precipitation
✓ Color changes
It can be immediate or it can be delayed. Following are the types of reaction that occurs;
▪
▪
▪
▪
▪
▪
▪
▪
Oxidation
Hydrolysis
Polymerization
Combustion reactions
Isomerization
Decarboxylation
Formation of insoluble complexes
Absorption of CO2
i. Oxidation:
In general oxidation refers to the addition of oxygen. The factors which leads to oxidation are
mentioned below;
Factors lead to Oxidation
•
Pressure of oxygen: Increased pressure of oxygen will lead to oxidation of the
ingredients.
•
Light: Presence of light may cause photochemical oxidation reactions.
•
Temperature: Elevated temperature leads to oxidation of ingredients.
•
pH: Every drug has its optimum pH for stability. Therefore, change in the pH may affect
the stability of the drug and may cause its oxidation.
•
Pharmaceutical dosage form: Choice of dosage form is very important. Oxidation
reactions occurs in solutions faster than in solid dosage forms.
•
Presence of pre-oxidants: Presence of pre-oxidants leads to the oxidation of ingredients.
For example; metals, peroxides.
•
Type of solvents/ vehicle used: Oxidation occurs faster in aqueous solvent / vehicles
than others.
•
Presence of unsaturated bonds: Presence of unsaturation (double or triple bond) leads
to easier oxidation than saturated bonds.
Preventive Measures
Certain preventive measures are taken to prevent oxidation reactions during compounding;
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Dispensing and Community Pharmacy for Pharm D Graduates
•
Addition of antioxidants: To avoid oxidation antioxidants are used.
For example; Vitamin E, Vitamin C and inorganic sulfur compounds e.g. polysulfide and
thiosulfate.
•
Protection form pre-oxidants: Addition of chemicals which forms complexes with
metals. For example; EDTA, Benzalkonium chloride.
•
Protection from light: The drug ingredients must be protected from light by using dark
containers for packing, storage of formulation in dark places, or by packaging with substances
which absorbs light.
For example; oxybenzene.
•
Choice dosage form: Suitable dosage form must be selected which reduces the possibility
of oxidation.
For example; solids dosage forms are better over solutions.
•
Maintenance of pH: Buffers must be used to maintain the pH for the stability of the drug
ingredients.
•
Choice of suitable solvent/ vehicle: Hydroalcoholic or alcoholic vehicles are used
instead of aqueous vehicle to overcome oxidation.
•
Maintenance of temperature: Storage at low temperature prevent oxidation.
•
Protection from air: Oxidation can be avoided by packing the formulation in well closed
container or by the replacement of oxygen by nitrogen inside the container.
Chemical groups undergo oxidation:
These are some drugs which undergo oxidation;
✓
✓
✓
✓
✓
Phenolic compounds – Phenylephrine
Catechol derivatives – Adrenaline, Nor-adrenaline
Antibiotics – Tetracycline
Oils – Fixed oils and Volatile oils
Vitamins – Lipid soluble vitamins and Water-soluble vitamins
ii. Hydrolysis
Chemical reaction in which water is used to breakdown a compound. This is achieved by breaking
a covalent bond in the compound by inserting a water molecule across the bond.
Hydrolysis is of two types;
1. Ionic hydrolysis: The breakdown of ionic compound into its positive and negative ions.
Example: codeine phosphate reversibly broken down to codeine and phosphate.
2. Molecular hydrolysis: It is defined as the breakdown of whole molecule into its
components.
Example: Acetyl salicylic acid irreversibly broken down into salicylic acid and acetic
acid.
Factors lead to Hydrolysis
The factors which leads to hydrolysis are mentioned below;
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Pharmaceutical Incompatibilities
•
•
Presence of water: Presence of water leads to hydrolysis of formulation ingredients.
Use of water for vehicle: Using of water as vehicle for formulation may cause
hydrolysis.
• pH: Every drug has its optimum pH for stability. Therefore, change in the pH may affect
the stability of the drug and may cause its hydrolysis.
For example; optimum pH for Atropine is 3.1 – 4.5
• Temperature: High temperature during autoclaving may leads to hydrolysis of the
formulation.
Preventive Measures
Certain preventive measures are taken to prevent hydrolysis during compounding;
•
Protection from moisture: it can be done by packing with such substances which are
impermeable to water.
•
•
•
•
•
•
Addition of dehydration agents: hydrolysis can also be avoided by the addition of
substances that absorb water.
For example; Silica gel, Calcium carbonate.
Use of vehicle: Hydrolysis can be prevented by using vehicles other than water. For
example; alcohol.
Maintenance of pH: Buffers must be used to maintain the pH for the stability of the drug
ingredients.
Using of surfactants: Surfactants must be used which cause miscall formation.
Reducing the solubility: By reducing the solubility of substances drugs can be protected
against hydrolysis.
For example; suspensions.
Complex formation: Formation of complexes must be done which protect the drug from
effects of water.
Chemical groups undergo hydrolysis:
These are some drugs which undergo hydrolysis;
✓ Esters – Benzocaine, Procaine
✓ Amides – Chloramphenicol, Sulphonamides, Procainamide
✓ Nitriles – drugs containing NO2, NO3, N2O
iii. Polymerization:
Polymerization can be defined as; the process in which small repeating units called monomers are
bonded to form a long chain polymer.
Example:
✓ Formaldehyde convert into para formaldehyde which appears in the form of precipitate. So,
to avoid, formaldehyde must be stored at suitable temperature.
✓ Ampicillin at high temperature form polymers which causes allergy.
Factors Lead to Polymerization
The following factors induces polymerization;
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Dispensing and Community Pharmacy for Pharm D Graduates
•
Light: light may cause polymerization in the formulation or individual ingredients.
• Solvent/ vehicle: certain solvents induce polymerization.
• pH: Every drug has its optimum pH for stability. Therefore, change in the pH may affect
the stability of the drug and may cause its polymerization of monomers.
•
Temperature: High temperature causes polymerization of ingredients.
Preventive Measures
Certain preventive measures are taken to prevent Polymerization reactions during compounding;
•
Protection from light: The drug ingredients must be protected from light by using dark
containers for packing, storage of ingredients in dark places, or by packaging with substances
which absorbs light.
For example; oxybenzene.
•
Use of vehicle: Polymerization can be prevented by using suitable vehicles.
• Maintenance of pH: Buffers must be used to maintain the pH for the stability of the drug
ingredients.
•
Maintenance of temperature: Storage at suitable low temperature prevent
polymerization.
iv. Combustion reaction:
Such reactions take place when the pharmaceutical dosage form contain substances with different
charges.
Example:
Surfactant with +ve and –ve charges.
v. Isomerization:
Conversion of drug to its isomer is called isomerization. While, isomers have same molecular
formula and different structural formula (arrangement of atoms).
There are two types of isomerism;
1. Optical isomerism: these are expressed by dextro rotatory and levo rotatory.
Example:
✓ L-adrenaline is converted into d-adrenaline by change in pH and temperature.
✓ D-tubocurarine is more active than its L form.
2. Geometrical isomerism: these are expressed by Cis and Trans. Most of the times the Cis
form is more active than trans form.
Example:
✓ Cis form of Vitamin A is more active.
Factors lead to Isomerization
The following factors induces isomerization;
•
Solvent/ vehicle: certain solvents induce isomerization of ingredients.
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Pharmaceutical Incompatibilities
•
pH: Every drug has its optimum pH for stability. Therefore, change in the pH may affect
the stability of the drug and may cause its isomerization.
•
Temperature: Variation in temperature causes isomerization of ingredients.
•
Impurities: certain impurities lead to isomerization of ingredients.
Preventive Measures
Certain preventive measures are taken to prevent isomerization of ingredients during compounding;
•
Use of vehicle: isomerization can be prevented by using suitable vehicles.
•
Maintenance of pH: Buffers must be used to maintain the pH for the stability of the drug
ingredients.
•
Maintenance of temperature: Storage at suitable temperature prevent isomerization of
drug ingredients.
•
Protection from Impurities: Drugs can be protected against impurities by filtering them
out.
vi. Decarboxylation reaction:
In general, it can be understood by; evolution of Carbon dioxide during the formulation.
✓ Carbon dioxide is evolved if a carbonate or bicarbonate is dispensed in a liquid medicine
containing an acid of an acidic drug. To prevent leakage or explosion the reaction must be
completed before the preparation is bottled.
✓ In some instances, the reaction is slow and should be hastened by using a hot vehicle.
✓ All drugs containing bicarbonate are not sterilized at high temperature.
Factors lead to decarboxylation
The following factors induces decarboxylation
•
Solvent/ vehicle: certain solvents induce decarboxylation of ingredients. For example;
acidic solvents
•
pH: Every drug has its optimum pH for stability. Therefore, change in the pH may affect
the stability of the drug and may cause its decarboxylation reaction.
For example; if the pH changes o slightly acidic the decarboxylation will occur.
•
Temperature: Variation in temperature causes de-carboxylation of ingredients.
Preventive Measures
Certain preventive measures are taken to prevent decarboxylation of ingredients during
compounding;
•
Use of vehicle: Decarboxylation can be prevented by using suitable non-acidic vehicles.
• Maintenance of pH: Buffers must be used to maintain the pH for the stability of the drug
ingredients.
•
Maintenance of temperature: Storage at suitable temperature prevent de-carboxylation
of drug ingredients.
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Dispensing and Community Pharmacy for Pharm D Graduates
vii. Formation of insoluble complexes:
Complexes are formed either due to drug or due to adjuncts used in formulation.
✓ Drugs: tetracycline form complex with heavy metals removed with EDTA molecules.
✓ Adjuncts: Many molecular adjuncts used which medicaments and preservations are bound
to the macromolecules or trapped within miscall. The behavior is most common in nonionic macromolecules.
Therapeutic activity or adjunct efficacy may be seriously impaired by complex formation
particularly emulgents (macrogol esters and ethers) and solubilizes (polysorbates) exhibit this
phenomenon.
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Heaven Pharmacy Practice - II
PART B
Community Pharmacy
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Heaven Pharmacy Practice - II
94
Introduction to Community Pharmacy
Chapter 4 INTRODUCTION TO
COMMUNITY PHARMACY
Chapter Outline
This Chapter include:
1.
Community Pharmacy
2.
Future Community Pharmacist
3.
Responsibilities of Community Pharmacist
4.
Services Given at Community Pharmacy
5.
Competencies of a Pharmacist
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Dispensing and Community Pharmacy for Pharm D Graduates
96
Introduction to Community Pharmacy
Community Pharmacy
A retail setup in a community where patient is provided with complete information and assistance
regarding his/her medication and health under the personal supervision of a skilled, trained a
competent Pharmacist.
Community
The people with common interests living in a particular area
.
Pharmacy
A place where drugs are compounded or dispensed.
Community Pharmacist
A person licensed to prepare, compound, and dispense drugs upon written order (PRESCRIPTION)
from a licensed practitioner such as a physician, dentist, or advanced practice nurse. A pharmacist
is a health care professional who cooperates with consults with, and sometimes advises the
licensed practitioner concerning drugs
Five Star Pharmacists
Every competent pharmacist is called as a five-star pharmacist. A five-star pharmacist must have
following properties.
1. A good Care provider
2. Excellent communicator
3. Excellent community minder
4. Top decision maker
5. Manager / leader (community leader)
Difference between Pharmacy & Medical Store
A pharmacy is a place where medicines are not only sold but could be dispensed as well in presence
of a qualified person (pharmacist). A medical store could not dispense medicine because don't have
pharmacist.
Pharmacy
Use the title of "Pharmacy"
✔
Sale of controlled medicines
✔
Use "Rx" logo
✔
With duty pharmacist in the shop
✔
Dispensing of prescription only drugs
✔
Sell common drugs, such as cold and
flu medicines
✔
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Medical Store
✖
✖
✖
✖
✖
✔
Dispensing and Community Pharmacy for Pharm D Graduates
Role of community pharmacist
Community Pharmacist
A Community Pharmacist is the professional who would be in direct access to the public and whose
duties are widely sought after by the public and patients. He dispenses medicines with a
prescription and
in certain cases, without a prescription where applicable (OTC drugs). As he is the person who will
be in
direct contact with the public, he has to play an important role in decreasing the mortality and
morbidity
in the public.
Competencies of a Pharmacist
1. Evaluate prescriptions accurately and safely, compound drugs in appropriate dosage forms,
and package and dispense dosage forms.
2. Manage systems for storage, preparation, and dispensing of medicines, and supervise
technical personnel who may be involved in such processes.
3. Apply computer skills and technological advancements to practice.
4. Communicate with health care professionals and patients regarding rational drug therapy,
wellness and health promotion
5. Design, implement, monitor, evaluate, and modify or recommend modifications in drug
therapy to ensure effective, safe and economical patient care.
6. Identify, assess, and solve medication-related problems, and provide clinical judgment as to
the continuing effectiveness of individualized therapeutic plans and intended therapeutic
outcomes.
7. Evaluate patients and order medications and/or laboratory tests in accordance with
established standards of practice.
8. Monitor and Counsel patients regarding the purposes, uses, and effects of their medications
and related therapy
9. Understand relevant diet, nutrition, and nondrug therapies.
10. Recommend, counsel and monitor patient use of non-prescription drugs.
11. Provide emergency first care.
12. Retrieve, evaluate, and manage professional information and literature.
13. Use clinical data to optimize therapeutic drug regimens.
14. Collaborate with other healthcare professionals,
15. Evaluate and document interventions and pharmaceutical care outcomes.
Services Given at Community Pharmacy
1)
2)
3)
4)
5)
Quality medicines
Counselling
Disease information (HTN, Diabetes etc....)
Community awareness (HIV/AIDS, STDs etc...)
Health and Hygiene Promotion
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Introduction to Community Pharmacy
6)
7)
8)
9)
Patient Care
Information on Seasonal Ailments (Asthma)
Guidance for Mother and Child Health
Guidance for Family Planning
Responsibilities of Community Pharmacist
i. A community pharmacist works according to legal and ethical guidelines to ensure the
correct and safe supply of medical products to the general public. They are involved in
maintaining and improving people's health by providing advice and information
ii. Dispensing prescription medicines to the public
iii. Ensuring that different treatments are compatible:
iv. Checking dosage and ensuring that medicines are correctly and safely supplied and labelled.
v. Keeping a register of controlled drugs for legal and stock control purposes
vi. Liaising with doctors about prescriptions;
vii. Communicate with Prescribers and their agents to obtain refill authorization.
viii. Selling over-the-counter medicines,
ix. Counselling and advising the public on the treatment of minor ailments,
x. Advising patients of any adverse side-effects of medicines or potential interactions with
other medicines/treatments.
xi. Undertaking Medicine Use Reviews (MUR), an advanced service to help patients understand
how their medicines work and why they have to take them;
xii. Providing a prescription intervention service.
xiii. Dispensing emergency hormonal contraception
xiv. Monitoring blood pressure and cholesterol levels;
xv. Offering a diabetes screening service.
xvi. Providing pregnancy testing.
xvii. Budgeting and financial management.
xviii. Promoting sales and developing the business.
xix. Keeping up to date with current pharmacy practice. new drugs and their uses.
Future Community Pharmacist
The future Community Pharmacists will have seven principal roles to play:
a. Care giver
b. Decision-maker
c. Communicator
d. Leader
e. Manager
f. Lifelong learner
g. Role model
The Community Pharmacist with the above skills and attitudes should make himself an
indispensable partner in health care system .
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Dispensing and Community Pharmacy for Pharm D Graduates
100
Pharmacy layout and Design
Chapter 5 PHARMACY LAYOUT AND
DESIGN
Chapter Outline
This Chapter include:
1.
Objectives of Layout Design,
2.
Types of Community
3.
Pharmacies
(Pharmaceutical Centre, Prescription-oriented Pharmacies,
Traditional Pharmacies and The Super Drug Store),
4.
Consumer goods and purchases,
5.
Classes of Layout designs,
6.
Principles and characteristics of Layout Design
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102
Pharmacy layout and Design
Pharmacy layout design
“A layout primarily refers to the floor plan and the arrangement of fixtures in your front
end, which reflects how you want to flow your space and present your merchandise”.
Your pharmacy layout influences your customer experience, for better or for worse
What is pharmacy?
A pharmacy (also called "drugstore" in American English or "community pharmacy" or
"chemist's" in Common wealth English) is a retail shop which provides prescription drugs,
among other products.
At the pharmacy, a pharmacist oversees the fulfilment of medical prescriptions and is available to
give advice on their offerings of over-the-counter drugs. A typical pharmacy would be in the
commercial area of a community.
Characteristics of a good pharmacy:
The American Association of Colleges of Pharmacy recommends that consumers choose a pharmacy
at which they can have a consulting relationship with the pharmacist.
Anyone using drugs benefits when they have easier access to a pharmacist.
Being timely includes both processing the request quickly and having drug stock available to fill the
prescription.
Some consumers need drugs delivered to their home, perhaps by mail, and may select a pharmacy
which offers that service.
Different pharmacies may charge different prices for the same drugs, so shopping for lower prices
may identify a pharmacy offering better value.
In addition to fulfilling prescriptions, a pharmacy might offer preventive healthcare services like
vaccinations.
Up-to-date technology at a pharmacy can assist a patient with prescription reminders and alerts about
potential negative drug interactions, thereby reducing medical errors.
How can you improve your pharmacy layout? /
Characteristics & Principles of layout design
While no single layout will suit every pharmacy, there are certain layout and design concepts that
should apply to most retail pharmacies. Here are ten tips for improving your pharmacy layout and
design:
1. Layout and Design. These two functions are often misinterpreted as one in the same. Not true.
Layout relates to the arrangement and placement of everything within the space; Design relates to
aesthetics such as colour and visual effects. Your customers and staff are influenced by the layout
but do not see it while the design is much more obvious. Layout is much more essential than design
and should never be sacrificed in order to create a unique appearance.
2. Use a grid layout style. Displays and counters positioned in straight, parallel lines will maximise
the use of space. Angled island displays and curved counters can waste up to one third of the space
without making any contributions while the higher cost is never justified.
3. Modular cabinetry combined with custom casework. Adjustments are inevitable as the
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Dispensing and Community Pharmacy for Pharm D Graduates
pharmacy grows and trends change; modular fixtures make changes a lot easier and less costly. Each
layout should provide versatility so that changes can be made with minimal interruption.
4. Use metal shelves in most areas. Metal shelving has many advantages over wood and glass.
Metal shelves are more adjustable, easier to maintain, cost less and look better much longer. Further,
they have built-in label channels for price tags and scanner labels while others do not. Again, wood
shelving that is used to make your pharmacy look different is a waste of money.
5. Adjust lighting levels in the pharmacy. The prescription department generally requires more
lighting than the sales area. A valance separating the work area from the customer area makes the
ceiling and lighting configuration less noticeable. A misconception is that you need less lighting
during daylight than at night.
6. Choose colours wisely. Most non-selling areas such as the walls and floors should be a neutral
colour; darker colours may be used for accents, service counters, vertical panels, and signage that can
emanate individual personality. Lighter colours make the pharmacy appear more spacious, and the
colourful merchandise becomes the attention getter. Avoid Retail Pharmacy Layout Designs on the
floor covering that cause the space to look smaller and attract attention.
7. Dispensing area. The dispensing department should have adequate work counter space and
shelving. Again, modular counters and shelving make adjustments and expansions much simpler.
The area should not be crowded so that personnel can move about with ease. Work flow is a major
component in the dispensing area.
8. Display similar categories together. For customer convenience, place similar merchandise and
service departments adjacent to each other. That may also lead to an additional purchase.
9. Differentiate your business. Provide departments and services not offered by your competition.
Compounding, MTM, and custom patient services are examples. It is much more significant to be
unique than to look unique. Some pharmacy designers like to use lots of custom applications that
draw more attention to the décor than to the merchandise.
10. Security. Place departments that are more susceptible to pilferage in view of personnel and
service counters. Have as much of the sales area viewable at personnel stations as possible. Having
one entrance rather than two or more improves security. Installation of cameras and other security
measures will discourage criminals from targeting your pharmacy.
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Pharmacy layout and Design
Design of pharmacy:
a. Exterior Design:
The uniqueness of the store front and the creative use of entrance display windows and distinctive
outdoor signs can help create favourable pharmacy image.
b. Interior Design:
Interior elements that serve as attention attractors include
• Fixtures
• Lightning
• Flooring
• Colours
• Scents and
sounds
• Temperature
• Width of aisles
• Cleanliness
• Modernisation
• Merchandise
assortment
• Display of
prices, and
personnel
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Dispensing and Community Pharmacy for Pharm D Graduates
Pharmacy layout:
It Involves:
•
•
•
Planning the internal arrangement of departments
Allocating the amount of space for each department
Arrangement of drugs in each department
Before a pharmacist under takes to design a layout or modernise the pharmacy
He should consider the,
▪ Objectives of the various designs
▪ The type of community pharmacy
▪ Types of layout design
▪ Style of layout design
Objective of layout Design
The major objective in the design of exterior of pharmacy is,
❖ To attract more patrons into the pharmacy.
❖ To increase the amount of the total purchases of each person who enters the pharmacy.
❖ To enhance the general appearance of the pharmacy and to project a professional image.
❖ To control payroll expenses through convenience and efficiency of the layout.
❖ To improve patron’s satisfaction and convenience.
❖ To maximise the utilisation of space.
❖ To disperse and control the traffic pattern within the pharmacy.
❖ To provide surveillance and reduce pilferage.
❖ To minimise the movement of customers within the premises of drug store.
Community pharmacy:
A retail pharmacy practices that services prescription directly to the public and over the counter
products (OTC).
OR
Community pharmacy can be defined as an area or place under the supervision of pharmacist where
pharmacy practice occur and prescription are compounded and dispensed other than limited service
pharmacy. It is unique hybrid of business and professionalism.
Success of community pharmacy:
The factors on which the success of community pharmacy depends are:
• Location
• Physical environment
• Sufficient Finance
• Staff experience, sincerity and behaviour
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Pharmacy layout and Design
Types of community pharmacy:
Community pharmacy has four major types that must be consider to choose the type of retail to
adopted
1. Pharmaceutical Centre:
Pharmaceutical centre sell medicine, surgical and orthopaedic appliances and convenience articles.
No product of any kind is displayed and the décor and the organised floor space are its hallmarks.
2. Prescription oriented pharmacy:
Prescription oriented pharmacies occupy a space of 1000 to 2000 sq. feet. They have comfortable
waiting area for the customers so that they can wait while the prescription is being processed Drugs
health related items and prescription accessories are displayed in its vicinity while a separate room is
used to keep surgical and orthopaedic appliances.
3. Traditional pharmacy:
Traditional pharmacy also known as conventional pharmacy occupies a space of 2000 to 5000 sq.,
feet. The entire pharmacy is expose to the customer. It must have pleasing appearance and
environment for both the customers and the employees and have capabilities of giving maximum sale
with minimum expenses.
4. The Super Drug Store:
The super drug store occupies a space of 5000 to 10000 sq. feet. The entire super drug store is
exposed to the customers where they can handle and select articles by themselves which self-service
pattern except for the prescription department.
Layout of community pharmacy:
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Dispensing and Community Pharmacy for Pharm D Graduates
The first step involved in layout design of community pharmacy is
Selection of Location:
Following factors must be considered for the selection of location:
• Sufficient finance must be available
• Such area shall be selected that has dense population and need medicines
• Pharmacy site shall be such that it is centre of population and is accessible and convenient to
the customers.
• Pharmacy site shall have proper parking area.
• Surrounding area of pharmacy site shall have hospital and doctors around it.
• Other drugs stores around the pharmacy site.
• Flow of traffic,
• Located at needy town city.
• Select suitable site that provide easy access to majority of customers
• Should be equipped with free parking facilities
Legal Requirements for Drug Store:
Minimum Qualification:
•
•
A person who is interested to start a retail sale drug store must be registered pharmacist with
State Pharmacy Council.
A person without diploma or degree can also start pharmacy but he/she shall a employ
registered pharmacist because license will be granted to the registered pharmacist employed
for the purpose.
Minimum space:
The space for the premises of a pharmacy shall not be less than 140 sq. feet with minimum breath of
8 feet in the front and height of 8feet.In case of medical store 96 sq. ft. with minimum breadth of
08ft.in front and height of 08ft.
Display of Sign Board:
The pharmacy and medical store shall display a sign board of minimum length of 5feet and 2.5 width
on the outside wall with displaying word ‘pharmacy’ in white writing on a green coloured signboard
in case of pharmacy while the word ‘Medical Store’ in white on a blue coloured signboard in case of
medical store.
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Pharmacy layout and Design
Facility Requirements:
The premises have proper and adequate facility for storage of drugs and for their protection from
direct sunlight, dust or dirt, including refrigeration facility.
Application for the grant of License:
A person who is interested in starting a pharmacy must submit application for the grant of licence to
the licensing authority.
Physical Environment:
Physical environment is yet another factor along with the location, sufficient capital and management
that plays an important role in success of pharmacy. Physical environment and its characteristics help
to develop and maintain the image of pharmacy along with drawing customers.
Physical facilities:
❖
❖
❖
❖
❖
❖
❖
❖
Administration section
Storage for bulk items
Impatient department
Outpatient department in case of hospital pharmacy
Emergency medicine storage
Medicine information resource centre
Narcotics and another dangerous drug locker
Manufacturing and repacking
Types of Layout Design:
1. Clerkship or personal services:
The clerk service layout is the old traditional design that is still in most pharmacies. It consists
entirely of complete assistant service except a small part of the products exposed for customers to
handle. This is one of the compulsions for prescription products where there is no selection of the
customers at retail level. There is no self-service or self-selection in this setup. The pharmacy staff
supplies drugs to the customers it enables maximum interchange between staff and customers.
2. Self-selection:
Self-selection provides personal service in a more efficient manner and as a result more competitive
with larger super drug stores. Many independent pharmacies are now trying to use the self-selection
layout design. In this type of layout design clerk service is maintained at all service-oriented sections
such as cosmetics, photo supplies, prescription and selected non-prescription drugs, surgical and
orthopaedic appliances and supplies, and veterinary sections. However, other products are displayed
so that the customers can see, handle and select themselves but prescription item have no possibility
of self-selection.
3. Self-service:
Self service is restricted for layout utilising a minimum of clerk service and exposes the maximum of
customers to handle.
• It is not possible to have 100% self-service in pharmacy because of the prescription drugs and
item.
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Dispensing and Community Pharmacy for Pharm D Graduates
•
This type of layout is most often used in super drug store but for the non-drug items and
commodities such as cosmetics and nutritional supplements.
Styles of layout Design:
1. Grid layout
Here the products are displayed in parallel lines.
Advantage
➢
➢
➢
➢
More product exposure
Increase self-service possibility
Maximise the use of available space
Familiarity with products that can be needed in future.
2. Free flow layout
Here the fixtures are arranged in irregular shaped circles or triangles.
Advantages:
❖ Flexibility and visual appeal
❖ Maximise impulse purchases
Disadvantage:
❖ Costly
❖ Waste of floor space
Minimum requirement for pharmacy:
Premises:
•
•
The word pharmacy shall be displaced on green colour sign board in white writing with
minimum of 5feet length and 2.5feet width.
The premises shall be well, ventilated and built dry and shall be suitably arranged and have
sufficient dimensions to allow goods such as drugs and poisons to be kept visible.
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Pharmacy layout and Design
•
•
•
•
•
The area for dispensing department shall not be less than 6sq.meter for each additional
person.
Height shall be at least 2.5 sq. Meter.
Floor shall be smooth and washable
Walls shall be oil painted, titled and plastered to avoid cracks, holes, and, maintain smooth,
washable surface.
Separation shall be made in dispensing department to avoid public entry.
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112
Patient education and council
Chapter 6 PATIENT EDUCATION AND
COUNCIL
Chapter Outline
This Chapter include:
1.
Patient education rationale
2.
Patient education
Introduction, the effective educator, steps of patient education
3.
Patient counselling
Introduction, steps during patient counselling,
4.
Conclusion
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Patient education and council
Patient Education & Counselling
Patient education is the process by which health professionals impart information to patients and
their caregivers that will alter their health behaviours or improve their health status.
Also known as Health education” a tool that include both general preventive education or health
promotion and disease or condition specific education.”
Professional guidance of the individual by utilizing psychological methods especially in collecting
case history data, using various techniques of the personal interview, and testing interests and
aptitudes is known as counselling.
Patient Education Rationale
Patient Education
Introduction
Skill Building and Responsibility – Patients need to know when, how, and why they need to make a
lifestyle change
Increased adherence – Effective communication and patient education increases patient motivation to
comply
Patient Outcomes – Patients more likely to respond well to their treatment plan – fewer
complications
Informed Consent – Patients feel you’ve provided the information they need
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Dispensing and Community Pharmacy for Pharm D Graduates
Utilization – More effective use of medical services – fewer unnecessary phone calls and visits.
Satisfaction and referrals – Patients more likely to stay with your practice and refer other patients
The Effective Educator
Effective Patient Educator skills include:
• Determining patient concerns
• Avoiding Assumptions
• Explaining things clearly
Question the educator must ask:
➢ How do I determine patients’ needs and concerns?
➢ How do I treat patients equally and as individuals?
➢ How do I know when I’ve explained things clearly?
Steps
Assess – Define patient and family needs and concerns; observe readiness to learn.
Plan – Set objectives with your patient; select materials.
Implement – Put the plan in motion; help patients along the way to reach the objectives you’ve set
together.
Document – Create a written history and keep records.
Evaluate - Evaluation is critical and should be continuous through all four steps! This will help you
stay on track and spot problems quickly.
Step 1 – Assessment
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
Assessment provides you with essential information about your patient
Patient education success depends on the assessment of needs, concerns, and preferences
Assessment should be ongoing – make it a part of every encounter with your patient.
Avoiding Assumptions – Never assume! Incorrect assumptions can be counterproductive.
Gather as much information on the patient’s situation as you can early on.
Getting to Know Your Patient –
o Review the patient’s chart first
o Introduce yourself by name and clearly explain your role
Ask basic, introductory questions
o Support – is there family or a friend who can assist with care?
o Limitations – address known physical or mental problems early
o Cultural History – Note language barriers and cultural preferences.
Understanding Cultural Issues
o Treat all patients without judgment
o Show respect, gain patient trust, when in doubt – ask questions!
Establishing Rapport –
o The patient must feel comfortable with you
o When meeting a patient: Try to be empathetic, Avoid focusing on a chart, Make Eye
Contact, Communicate nonverbally if there are language barriers
Learning the Patient’s Perspective –
o Fears, worries, misconceptions – get everything out in the open early!
o Ask: “When you think of (this condition), what do you think of?
o Patient concern should be primary focus in your education plan.
Answers should uncover core beliefs – Ask specific questions - ask to discover what
motivates your patient:
o “What are you afraid might happen?”
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Patient education and council
o “What barriers get in your way?”
o “When you tried this before, what problems did you have”
Closed
Are you upset?
Are you in pain?
Is this hard for you to deal with?
Are you taking your medicine every day?
▪
▪
Open
What’s bothering you?
How would you describe your pain?
What are some problems this is causing?
How and when do you take your
medicine?
Determining readiness to learn – Your patient will present challenges if resistant to
education
o Motivation – Patients are motivated when they learn how their lives could improve.
Focus on the benefits of education.
o Attitude – Denial, Fear, Anger, Anxiety – all could be barriers to education. Patient
must know that he or she will make gains by learning new skills.
o Outlook – A patient’s beliefs about their situation could effect education. Let them
know that learning new skills can help them feel better or slow disease progression.
Assessing Patient Skills – Request a demonstration of what he or she has learned in the past.
Step 2 – Planning
➢
➢
➢
➢
Once you know your patient’s needs, planning begins.
You both should set some mutually agreeable goals.
Gather the materials you need to meet these goals
When building your plan, make building patient skills and addressing concerns the top
priority!
▪ Thinking Realistically
o Goals should focus on what is necessary / critical to patient survival first.
o Pay attention to patient concerns – they could stand in the way of progress
o Respect stated limits – if a patient has refused to do something, try to work around the
problem and incorporate something new as best you can.
▪ Helping a Patient Make Life Changes
If your patient needs to make lifestyle changes, make sure he or she:
o Understands the need for changing behavior
o Has the confidence to complete the required tasks
o Successfully begins to change behavior.
Below are some simple examples of ways in which someone might decide to bridge the gap between
needs and concerns.
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Dispensing and Community Pharmacy for Pharm D Graduates
▪
Finding Resources
o Printed Materials, Video or Audio CDs/DVDs, Electronic content
o Look for inconsistencies between your goals and those of the materials.
o Make sure the resources are up-to-date
o Patient Education publishers provide information on patient education techniques and
practices.
o Premade plans may be available from pharmaceutical companies or other
organizations. Be careful they are not biased!!
o Clinical pathways that your facility already uses can work as effective plans.
o Disease-specific or voluntary organizations may provide materials.
o Experienced colleagues can be useful resources in helping you come up with a plan.
Step 3 – Implementing
▪
▪
▪
▪
Implementing your plan begins with reassessment
o Surprises can arise that will cause you to adjust the plan.
Assess continually
o Reassess the patient during each contact
o The success of your plan depends on the quality of your assessment and the patient’s
ability to meet goals.
Providing a Good Learning Environment
o Tone of voice, eye contact, and touch vary for all cultural backgrounds
✓ Use the knowledge you gained during assessment
o Environment
✓ Good lighting
✓ Comfortable temperature
✓ Low noise
✓ Room to spread out
o Privacy
✓ If possible, seek out a place you can work privately with the patient and his or
her support person
Alerting Patients to What’s Ahead
o Develop time frames for you patients
o Provide a number to call in case conditions change – make them feel self-directed and
in control.
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Patient education and council
o Let patients know what to accept – avoiding surprises and promoting patient
acceptance
o Emphasize on quality-of-life changes over cures
▪ Thinking Small
o Small steps are better than none – take small steps toward achieving a goal
o Avoid overloading the patient with information
o Accept whatever number of steps the patient is willing to accept, and always offer the
opportunity to learn more at a later time.
▪ Keep content simple
o Speak with all patients using simple language
o Focus on one goal or behavior change per visit
o Highlight key concepts and provide printed materials
o Stay interactive – let the patient show you what he/she learned
▪ Use visuals
o Drawings, visuals, illustrations can reinforce key concepts
o Some people learn visually
o Illustrations boost comprehension
▪ Mixing Education Media
o You will never have all the time you would like so supply your patients with
educational material
o Give your patients printed material, or even video or audio material - go over what
they should focus on.
o Different patients respond to different material – the more options, the better
o Document what you’ve coached on – so your team knows what’s been covered
o Ask your patient to demonstrate what he or she has learned.
Breaking Through Barriers – Here are some examples of barriers you may encounter, along with
some ways to work through them:
Barrier
Behavior
Implementation
Denial, anger,
anxiety, or
depression
Patient is distracted,
disinterested, hostile, or
doesn’t believe there’s a
problem.
Tell your patient that these feelings are
normal, that anyone would be concerned.
Use the opportunity to reassess for new
concerns.
Physical Pain
Patient is unable to
concentrate
Focus on managing your patient's pain before
implementing the plan.
Acute Illness
All patient’s energy is
focused on coping with the
illness. Patient finds it
difficult to learn
Address patient’s fear, pain or anxiety first,
and then focus on developing new skills.
Learning disability
Patient finds it difficult to
comprehend educational
materials presented
Try to give a wide variety of materials.
Including demonstrations.
Step 4 – Documenting
▪
Patient records inform colleagues what you’ve done.
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Dispensing and Community Pharmacy for Pharm D Graduates
▪
▪
Properly documented patient education can help you meet Meaningful Use Requirements for
reimbursement
A record of patient education provides future health care providers a starting point should
your patient need assistance in the future
Patient counseling
Patient counseling is defined as providing medication information orally or in written form to
the patients or their representatives on directions of use, advice on side effects, precautions,
storage, diet and life style modifications.
Who and When to counsel?
➢ The amount and type of information provided to the patient will vary based on the patient’s
needs, and practice setting.
➢ Ideally, the pharmacist counsels’ patients on all new and refill prescriptions.
➢ If the pharmacist cannot counsel to this extent, it should be defined which patient types, or
which medications pharmacists will routinely counsel patients.
➢ Patients receiving more than a specified number of medications
➢ Patients known to have visual, hearing or literacy problems
➢ Pediatric patients
➢ Patients on anticoagulants
Patients who should always be counseled
➢
➢
➢
➢
➢
➢
➢
Confused patients, and their caregivers
Patients who are sight or hearing impaired
Patients with poor literacy
Patients whose profile shows a change in medications or dosing
New patients, or those receiving a medication for the first time (transfer prescription)
Children, and parents receiving medication
Patients receiving medication with special storage requirements, complicated directions
Patients who should be counseled at certain intervals
•
•
•
•
•
•
•
•
•
Asthmatic patients
Diabetic patients
Patients taking 4 or more prescribed medications
Patients who are mentally ill
Patients using appliances
Epileptic patients
Patients with skin complaints
Patients misusing drugs
Patients who are terminally ill
Communication skills for effective counseling
The counselling process uses verbal and non-verbal communication skills.
▪ Verbal communication skills are: o Language
o Tone
o Volume
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Patient education and council
▪
o Speed
Non-verbal communication skills are: o Proximity
o Facial expression
Steps during patient counseling
•
•
•
•
•
Counseling is a two-way communication process and interaction between the patient and the
pharmacist is essential for counselling to be effective.
Preparing for the session
Opening the session
The counseling content (how to take the medication, - expected duration of treatment,
expected benefits of treatment, - possible adverse effects, possible medication or dietary
interaction, - advice on correct storage, minimum time duration required to show therapeutic
benefit etc)
Ensuring and ending the session
Conclusion
A good physician treats the disease & the pharmacists treat the patient that has the disease.
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122
Medical Complications of Drug Taking
Chapter 7 MEDICAL COMPLICATIONS OF
DRUG TAKING
Chapter Outline
This Chapter include:
1.
Introduction
2.
Complication of medicine
3.
Health outcomes
4.
Medical condition arising from drug use
5.
Social squalene
6.
Other forms of drug misuse
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Medical Complications of Drug Taking
Medical Complications of Drug Taking
Introduction
What is a Drug?
A drug is any substance other than food which changes the way the body or mind functions.
For example
Stimulants (uppers) – Speed up the brain and central nervous system. E.g. caffeine (coffee,
tea) nicotine (cigarettes), amphetamines, speed, cocaine and diet pills.
Depressants (downers) – Slow down the brain and central nervous system. E.g. alcohol,
beer, wine, vodka, gin etc. and heroin, tranquilizers, sleeping pills.
Hallucinogens – These drugs alter the user’s state of consciousness. (Distort auditory and
visual sensations) e.g. LSD, ecstasy, magic mushrooms, marijuana.
Why Do People Use Drugs?
➢
➢
➢
➢
➢
➢
➢
Media
Boredom
Curiosity
Emotional pressure
Celebrations
Peer pressure
Dependence
Complications of Medicine
Illicit drug use is associated with a multitude of serious adverse health, social and economic
consequences.
They can be categorized as:
A. Health outcomes
B. Specific health outcomes
C. Social sequelae.
Health outcomes
Mortality rate
Studies revealed that MR among injecting drug users is about 13 times greater than same age sex of
non-users. Once HIV enters drug injecting population, HIV related complication dominates &
mortality rate increases.
Morbidity;
Injecting drug use is also associated with considerable morbidity, most of which indirectly related to
drug injecting. This is because drug use
i.
Is accompanied by hazardous consumption of legal & illegal drugs (alcohol, BDZ, cocaine,
cannabis, amphetamine etc.)
ii.
Is associated with low socio-economic status, inadequate & irregular diet, limited education,
unemployment etc.
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Dispensing and Community Pharmacy for Pharm D Graduates
iii.
Poorer outcome be of limited access to medical care.
Morbidity is more difficult to measure; hospital bed occupancy is main accepted marker for
measuring morbidity.
Specific Health outcomes
(Medical Conditions Arising from Drug use)
Overdose;
It is the major cause of death in injecting drug users, and second to AIDS in HIV prevalent countries.
Types
1. Intentional as to no way out or mainly
2. Unintentional due to low margin of safety & poly pharmacy of CNS drugs)
Examples
Heroin + other depressants (alcohol, BDZ) most common overdose.
▪ Loss of tolerance to Opioid & relapse to heroin injecting is very risky.
▪ Typical symptoms of opiate overdose include pinpoint pupil un reactive to light, shallow
respiration, low pulse rate, hypotension, unconsciousness.
▪ Naloxone, a parenteral short acting Opioid antagonist is very effective for overdose.
Causes of overdose
Drug interactions
Psychoactive drugs, such as opiates and stimulants, have a number of drug interactions.
These drugs may interact in a number of ways, for example CNS depressants (e.g. alcohol,
benzodiazepines and TCAs) may increase sedation in those on opiates and decrease
respiration, increasing the risk of overdose.
Poly-drug use
Many injecting drug users will be using more than one drug. There may be additional
complications associated with the combined adverse effects of using the drugs.
Hepatitis & AIDS
Hepatitis B & C can be occurred due to stick injury while AIDS and hepatitis B can also by sexual
contact.
Drug user have 9-fold greater risk of hepatitis A, it spread through feaco-oral & common in drug
users because of poor standards of hygiene).
Sexually transmissible infections and Gynae problems;
AIDS, gonorrhea, others, pelvic inflammatory disease, menstrual irregularities are common among
drug users. Opioid users frequently suffer from loss of libido.
Other infections;
Tetanus, botulism is common in drug user who inject SC with non-sterile equipment, where
microbes find anaerobic environment.
i.
Distal bacterial infection can result in; septicemia, endocarditis, lung, brain and joint
abscesses.
ii.
Fungal infections; A endophthalmitis is linked with lemon juice containers used to acidify
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Medical Complications of Drug Taking
iii.
iv.
v.
vi.
vii.
viii.
heroin.
Tuberculosis; common in HIV infected injecting drug users.
Parasitic infections; malarial outbreaks are linked with sharing of needles.
Cardiovascular complications; tachycardia, vasoconstriction, rise in BP observed in users
of CNS stimulants & in CNS depressant withdrawal
Respiratory complications; all CNS drugs cause respiratory depression which in overdoses
life threatening, cough suppressant
Dental Problems; Accelerated dental decay is common among drug injectors. This is
because of poor oral hygiene, decreased salivary flow by Opioids.
Mental illness; Anti- social personality disorder and affective disorder are extremely
common among drug users. visual disturbances, impairment of cognition & psychomotor
function, interference with short term memory that is necessary for work performance
Amphetamine and cocaine used is linked with acute paranoid psychosis.
Medical hazards of injecting
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
Abscess (sterile or cold abscess; when vein is missed and infected or hot abscess from using
non sterile techniques)
Thrombophlebitis (because of some irritant excipient, veins of arms, legs are commonly
used; jugular vein & dorsal vein of penis also used)
Gangrene (if barbiturates are injected into femoral artery, amputation)
Septicemia (serious illness occurs in drug user who inject using non- sterile techniques)
Collapsed veins because of repeated use of same vein, inappropriate injecting techniques.
Deep vein thrombosis by injecting in femoral vein.
Emboli because of unfiltered particles being injected.
Cellulitis bacterial infection of skin and soft tissue at injecting site is very common which
may develop to necrotic ulcers.
Effect on immunity. (humoral immunity is stimulated in heroin user)
Vitamin & other nutritional deficiencies (most common among drug users)
Risks associated with non-injecting route of administration
i.
ii.
iii.
iv.
Intranasal: Nose bleeds, ulceration, rhinitis, septal perforation, risk of transmission of
hepatitis C if equipment is shared
Inhalation: Asphyxiation, aspiration, peri-oral dermatitis
Smoking: Respiratory infection, cough, cancer, accidental, burns, chronic lung disease
Oral. Gastric irritation
Health problems associated with opiates
i.
ii.
iii.
iv.
Respiratory: Opiates suppress the cough reflex, leading to increased risk of aspiration and
bacterial infection. They also depress the respiratory center which is the main cause of death.
Gastrointestinal: Nausea, vomiting and constipation are all side effects of opiate use.
Cardiac: Right sided infection—tricuspid endocarditis—has been linked to injection of
opiate (and other) drugs.
Others Methadone suppresses saliva production. This coupled with lifestyle factors such as
poor diet can lead to dental problems.
Health problems associated with stimulants (cocaine and amphetamine)
i.
Cardiac: Stimulants activate sympathetic autonomic activity resulting in increased BP &
force of myocardial contraction (and vasoconstriction with cocaine) so demand on the heart is
increased, these drugs may also cause arrhythmias, and may precipitate tachycardia and MI.
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Dispensing and Community Pharmacy for Pharm D Graduates
ii.
iii.
Neurological: Due to raised blood pressure, headaches, strokes and cerebral bleeds may
occur. Amphetamine can also induce a psychotic state in some users.
Respiratory: Cough, airway burns, problems with nasal septum, sinus infections, shortness
of breath possible worsening of asthma.
Social sequelae
Harms related to drug use and dependence includes:
❖ Crimes (Drug Possession, Drug Use, Drug Trafficking, Drug Manufacturing, Theft, Break
and Enter, Robbery, Homelessness)
❖ Poorly Defined Rules / Inconsistent Application of Rules
❖ Early antisocial behavior (e.g., aggression, hyperactivity)
❖ Parental drug use and a positive attitude toward use
❖ Absence of healthy recreational or leisure interests
❖ Academic Failure (low and failing grades)
❖ Negative Communication Patterns
❖ Family management problems
❖ Little commitment to school
❖ Poor living conditions.
❖ Excessive Discipline
❖ Lack of Monitoring
❖ Bad Social Circle
❖ Unemployment,
❖ Accidents and
❖ Violence etc.
Other forms of drug misuse
➢
➢
➢
➢
➢
➢
➢
No drug needs
Wrong drug
Ineffective drug unsafe drug
Under use of available effective drugs
Under use of ORS in diarrhea of children
Incorrect use of drugs
Unlicensed drug prescribing
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Drug Abuse and Misuse
Chapter 8 DRUG ABUSE AND MISUSE
Chapter Outline
This Chapter include:
1.
Terminologies
2.
Drug abuse
Symptoms of drug abuse, harms related to drug abuse,
strategies to control drug abuse, major classes of drug causing
drug addition and their withdrawal therapy
3.
Drug misuse
Definition, types of drug misuse, adverse impact of drug
misuse, factors underlying drug misuse, improving the drug
use
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Dispensing and Community Pharmacy for Pharm D Graduates
130
Drug Abuse and Misuse
DRUG ABUSE AND MISUSE
Terminologies
Drug:
A substance other than food that changes the structure or function of the body or mind.
Prescription:
A doctor’s written permission or order for a specific medication.
Drug use:
Taking the drug as order by a physician.
Drug misuse:
Improper use of a drug.
Drug abuse:
Intension improper use of a drug.
Illegal Drugs:
Drugs that can’t be legally sold, purchased or used.
Addiction
The word addiction is derived from Latin word ‘‘addicere’’ which refers to the process of binding to
things.
WHO definition of addiction 1964
"Addiction is a state of periodic or chronic intoxication detrimental to individual and society which
is characterized by an overwhelming desire to continue taking the drug and obtaining it by any
means."
Psychic dependence
A state in which there is a feeling of satisfaction and psychic drive that requires periodic or
continuous administration of the drug to produce pleasure or to avoid discomfort
Physical dependence
It is a state of adaptation is manifested by specific withdrawal syndrome that can be produced by
abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of
an antagonist.
Cross dependence
When one drug maintains the physical dependence produced by another drug it is called cross
Dependence.
Tolerance
A condition in which a person’s body becomes used to the effect of a medicine and needs
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Dispensing and Community Pharmacy for Pharm D Graduates
greater and greater amounts of it in order for it to be effective.
After repeated administration of drug, a larger dose is required to produce the same effect.
When a physician prescribes a medicine that must be taken for a long period of time, a tolerance may
develop.
Pseudo addiction
It is a term which has been used to describe patient behaviors that may occur when pain is
Undertreated. Patients with unrelieved pain may become focused on obtaining medications, may
"clock watch, and may otherwise seem inappropriately "drug seeking even such behaviors as Illicit
drug use and deception can occur in the patient's efforts to obtain relief. Pseudo addiction Can be
distinguished from true addiction in that the behaviors resolve when pain is effectively treated
Drug habituation
Drug habituation (habit) is a condition resulting from the repeated consumption of a drug.
Its Characteristics include
• A desire (but not a compulsion) to continue taking the drug for the sense of Improved wellbeing
• Little or no tendency to increase the dose. Some degree of psychic dependence on the effect
of the drug, but absence of physical dependence and hence of abstinence syndrome
(withdrawal).
• Detrimental effects, if any, primarily on the individual.
Difference between abuse and addiction
Substance abuse is considered maladaptation leading to recurrent ADR’s consequences or
impairment While true addiction or substance dependence involves the continued use despite or
problems known to the user. It includes following features:
1. Tolerance
The need for increased amount of drug or diminished effect of same amount of drug.
2. Withdrawal
Withdrawal symptoms for specific substance occurred.
3. Compulsive
An increasing amount of time spent in substance related activities such as obtaining using and
recovering from its effects.
DRUG ABUSE
Definition
“It refers to inappropriate, excessive self administration of a drug for non-medical purposes.”
Symptoms of drug abuse
✓
✓
✓
✓
Abrupt change in behavior
Diminished drive, ambition and moodiness.
deteriorating judgment and loss of short-term memory.
Isolation from family members.
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Drug Abuse and Misuse
✓
✓
✓
✓
✓
✓
✓
Use of odd words
Over reaction to even mild criticism.
Carelessness regarding appearances.
rapid weight loss and loss of appetite.
Articles missing from home.
inability to plan, inability to solve problem.
Loss of motor coordination.
Most experts acknowledge that biological factors play an essential role in drug abuse. These factors
are
Likely to determine how the brain responds to these drugs and why such substances prove addictive.
By
Knowing these factors, we can find out the prevention and treatment.
Harms related to drug abuse
A. Social problems
•
•
•
•
damage to family relations
social deprivation
exclusion from society
violence and aggression
B. Drug use and crimes
Well known correlation exists between drug use and crime. For example, burglary to obtain
money for drugs
C. Drug use and accidents
Driving following use of alcohol or sedatives and hypnotics leads to road accidents
D. Legal issues
Drug use is legally prohibited, drug users violate the law,
E. Medical problems
Injurious to health e.g. CVS disorders.
Strategies to control drug abuse
1.
2.
3.
4.
5.
6.
Primary prevention
Secondary prevention
Drug education
Social support
Detoxification
Rehabilitation
1. Primary prevention
It is concerned with preventing people from starting to use the drug
Basic aim
Warning people about possible harms of drug use
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It includes:
•
•
•
Educational campaigns
Promotional campaigns
legislation
2. Secondary prevention
Basic aim
Secondary prevention is aimed at people who use.
It includes
Giving advice to users to prevent further problem.
Example
Use of CNS depressants by stimulant user to assist with "come down following CNS stimulation
3. Drug education
It is a tool used in primary and secondary prevention campaigns.
Basic aim
•
•
To provide education to general public
People who are dependent on drug may also benefit from drug education as they may not be
fully Informed on the drugs, they use e.g. long-term risks or overdose prevention. It is also
key part of harm reduction giving people information to assist them in minimizing risks from
drug taking e.g. Safer injecting
It includes
•
•
•
•
Leaflets
Booklets
Videos
Posters
Provision of drug education
Drug education may be given by:
• Teacher
• Youth workers
• Health promotion workers
• Medical and nursing staff
• Pharmacists
• . Police officers
4. Social support
Social support refers loosely to non-medical pharmacological interventions that can be made,
It involves
•
Practical advices and assistance
▪ Seeking housing
▪ Benefits
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•
▪ Advice
▪ Provision of hostel accommodation
Psychological tools
An important psychological tool is " motivational interviewing". It aims to assist people in
examining their drug use and the impact it has on their lives and on society
5. Detoxification
It refers to provision of treatment in order to help someone who is dependent on a drug to stop using
it
Examples
Drug of abuse
Treatment
Heroin, morphine, oxycodone
Methadone, Buprenorphine
Narcotics, alcohol, nicotine
Ibogaine
6. Rehabilitation
It is an umbrella term for process of medical and/or psychotherapeutic treatment, for dependency on
psychoactive substance.
It involves
•
•
•
Detoxification
Social support
psychotherapy
Purpose
•
•
To enable patient to cease substance abuse
To avoid psychological, legal, financial, social and physical consequences that can be caused
Types of treatments available at rehab-centers
•
•
•
•
•
Residential treatment (in-patient]
Out patient
Local support groups
Extended care centers
Recovery houses
Major classes of drugs causing addiction, Their
withdrawal and treatment
Drugs causing addiction
According to the definition of the American society of addiction medicine, drugs known to cause
addiction include illegal drugs as well as prescription and OTC drugs. Addictive drugs also include a
large number of substrates that are currently considered have no medical value and are not Available
over the counter or by prescription.
A. Stimulants
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➢
➢
➢
➢
Amphetamine and methamphetamine
Caffeine.
Cocaine.
Nicotine.
Medical withdrawal therapy
For severe symptoms
For severe symptoms e.g. agitation, seizures and high blood pressure give i/v antihypertensive
agents and
Benzodiazepines.
For mild symptoms
Antidepressants are given.
Life style and diet modifications
•
•
•
Drink lots of fluids
Exercise
Three meals a day
Behavioral therapy
Programs based on:
• Incentives
• Reward systems
B. Sedatives and hypnotics
➢
➢
➢
➢
Alcohol
Barbiturates
Benzodiazepines particularly flunitrazepam, triazolam, temazepam, and nimetazepam.
methaqualone and the related quinazolinone sedative-hypnotics.
Medical withdrawal therapy
Detoxification with sedatives and hypnotics require careful medical considerations,
Medical withdrawal therapy
For high dose intoxication
• Treatment takes four weeks
• Reassurance required
For low dose intoxication
• Treatment takes up to 8 weeks.
• Symptoms are reduced not more than 10% per week
C. Opiate and opioid analgesics
Naturally occurring opiates
•
•
•
•
•
•
•
Morphine
codeine.
Semi-synthetic
Heroin(diacetylmorphine)
Oxycodone
Hydrocodone
Hydromorphone
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Fully synthetic
•
•
•
Fentanyl and its analogs
Meperidine
methadone
Medical withdrawal therapy
•
•
Using methadone, codeine, buprenorphine
Neuroleptics, beta blockers, sedatives
DRUG MISUSE
Definition
"the rational use of drug requires that patient receive medication appropriate to his own
individual
Requirements for an adequate period of time and at lowest cost to them and their community.”
(WHO1985)
More than 50% of all medications are prescribed, dispensed or sold inappropriately and not in
accordance
With the standard principles. (whio 1992)
Types of drug misuse
1. No drug need
For example, minor upper respiratory viral infections of children are treated with Antibiotics
2. Wrong drug
Many children with streptococcal pharyngitis are not properly treated with narrow Spectrum
penicillin instead tetracycline (broad spectrum) is used.
3. Ineffective drug
Use of anti-motility agents in acute diarrhea.
4. Unsafe drug
Anabolic steroids for growth and appetite stimulation of children and athletes.
5. Incorrect use of drug
One- or two-days’ supply of antibiotic rather than the full course of therapy.
6. Unnecessary use
Unnecessary use of a 3rd generation broad spectrum antibiotics when a 1st line narrow Spectrum is
needed.
7. Unlicensed drug prescribing
It includes unregistered unsafe drugs.
Adverse impact of misuse of drugs
➢ increased likelihood of ADR’s.
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➢
➢
➢
➢
➢
➢
➢
➢
➢
➢
➢
➢
➢
rapid emergence of resistance strains to chemotherapeutic agents.
non sterile injections are increasing the transmission of hepatitis and other blood disorders.
Poor patient outcomes.
patient's inappropriate reliance on drugs.
impact of cost.
Over use of drugs even essential ones, causes spending of pharmaceuticals and Wastes of
financial resources both by patient and health care system.
Expenditure on non-essential pharmaceuticals like multi vitamins products, cough mixtures
inappropriate under dose of a drug at early stage of disease may produce excess cost by
increasing the probability of prolonged disease.
Psychological impact
The concept that there is a pill of every pill is harmful. Patient comes to rely on Drugs and
this reliance increase the demand for them. Patient may demand Unnecessary injections
because they have to accustomed to them.
Edema
fatty liver.
Cholesterolemia.
.
Factors underlying misuse of drugs
1. Health system related
•
•
•
•
•
unreliable supply.
drug shortages.
Availability of inappropriate drug: such influences results in lack of confidence of Prescriber
in system and also of the patient.
expired drugs.
The patient demands treatment and the prescriber feels obliged to provide what Is available
even if the drug is not correct to treat the condition
2. Prescriber related
•
•
•
•
Inadequate training
Outdated prescribing practices due to lack of continuing education.
Lack of objective drug information and the drug information provided by the Medical
representations may be unreliable.
Profit may affect a prescriber's choice; if the prescriber's income is dependent on the drug
sale.
3. Dispensor related
•
•
•
•
•
•
•
Substitution of the prescribed drug with substandard drugs.
Dispensing of drugs without individualized labels.
Dispensing without counseling
Improper storage of drugs.
Drug regulation
availability of non-essential drugs.
lack of regulation enforcement
4. Patient and community related
The individual's adherence to treatment depends upon:
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•
•
•
•
•
•
Cultural believes
Communication skills
attitude of prescriber and dispensers
limited time available for counseling
the shortage of printed material
community's belief about efficacy of certain drugs and routes of administration
5. Industry related
pharmaceutical industries often make misleading claims about their product me promotional
activities by the medical representatives also serve as seed for it Prescribing and also, the companies
succeed to change the habits al doctors because they understand what influences their habits.
Improving the drug use
1. Educational aspects
Patient education
It is necessary for using various dosage forms:
• printed materials (leaflets, labels).
• mass media
• counseling
• drug use aids
Prescriber education
• prescribing from EDL.
• Follow standard treatment guidelines.
• use unbiased information for drug use.
• monitor patients for ADR's.
2. Managerial aspects
•
•
•
•
•
Define and practice EDL/ formulary system
Prepare and follow standard treatment guideline.
Perform dur.
Follow GSP and good dispensing practices,
create public awareness about patient's rights
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•
.
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Chapter 9 PUBLIC HEALTH AND
COMMUNITY PHARMACY
Chapter Outline
This Chapter include:
1.
Epidemiology
Introduction, Types of epidemiology, observational epidemiology,
Epidemiological approaches, basic features of epidemiology, levels of
disease prevention, disease status based on trend, dynamics of disease
transmission,
2.
Epidemiological study design
Introduction and classification
3.
Pharmacoepidemiology
Introduction, potential contribution and importance of
pharmacoepidemiology, Responsible use of medicine.
Drug utilization and evaluation
4.
Physical health
5.
Health policy
6.
Family planning
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EPIDEMIOLOGY
Epidemiology is a Greek word derived from “Epi means Among”, “demos means People” and “logy
means Study”
Epidemiology is the branch of Science which deals with the study of all aspects of disease(s)
except
for PRACTICALLY TREATING the disease(s).
OR
The branch of medical science which treats epidemics.
OR
Epidemiology is the study of "epidemics and their prevention.
OR
The study of the occurrence of illness
OR
The study of the distribution of a disease or a physiological condition in human populations and of
the factors that influence distribution
OR
The study of the distribution and determinants of health-related states and events in populations
and the application of this study to control of health problems"
Types of epidemiology
There are two broad types of epidemiology:
1. Observational epidemiology
2. Experimental epidemiology
Types of Observational Epidemiology
Descriptive Epidemiology:
Examining the distribution of a disease in a population, and observing the basic features of its
distribution in terms of time, place, and person.
Analytic Epidemiology:
Testing a specific hypothesis about the relationship of a disease to a putative cause, by conducting
an epidemiologic study that relates the exposure of interest to the disease of interest.
Epidemiologic approaches
Descriptive: (Health and disease in the community)
It consists of following approaches:
✓ What are the health problems of the community?
✓ What are the attributes of these illnesses?
✓ How many people are affected?
✓ What are the attributes of affected persons?
✓ Over what period of time?
✓ Where do the affected people live, work or spend leisure time?
Analytic: (Etiology, prognosis and program evaluation)
It consists of following approaches:
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✓ What are the causal agents?
✓ By what mechanism do they operate?
Basic Features of Epidemiology
1.
2.
3.
4.
5.
Studies are conducted on human population
It examines patterns of events in people
Can establish cause-effect relationship without the knowledge of biological mechanism
It covers a wide range of conditions
It is an advancing science
Levels of Disease Prevention
Three major levels of disease prevention are:
Primary prevention
Targeted at healthy people (Objectives are Promotion of health, Prevention of exposure and
Prevention of disease).
Secondary prevention
Targeted at sick individuals (Objective is to stop or slow the progression of disease and to prevent
or limit permanent damage through early detection & treatment).
Tertiary prevention
Targeted at people with chronic diseases & disabilities that can’t be cured (Objective is to prevent
further disability or death and to limit impacts of disability through rehabilitation).
Comparison Between Clinical Medicine and Epidemiology
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Disease status based on trend
Endemic:
Disease occurring at normally expected frequency (habitually present).
Epidemic:
Sudden rise in disease frequency.
Pandemic:
A global epidemic. An outbreak of a disease affecting large geographic area usually many
countries.
Sporadic:
Off and on, un related cases.
Exotic:
Imported disease (Rabies in UK).
Dynamic of Diseases Transmission
The following are the three dynamics of transmission of disease:
1. Reservoir
It covers following aspects:
✓ Case,
✓ Carrier,
✓ Animals,
✓ Reservoir of non- living Things – Soil etc.
2. Mode of Diseases Transmission
The disease can be transmitted directly or indirectly from reservoir.
3. Susceptible Host
The following are the susceptible hosts to the disease:
✓ low immunity person,
✓ high risk person like HIV patients
Diseases Prevention and Control
➢ Prevention of source or reservoir
❖ Early diagnosis
❖ Notification
❖ Epidemiological Investigation
❖ Isolation
❖ Treatment
❖ Quarantine
➢ Interruption of the disease transmission
➢ Prevention of susceptible host
❖ Immunization
❖ Health education.
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EPIDEMIOLOGICAL STUDY DESIGN
The science of epidemiology has matured significantly from the times of Hippocrates and John snow
that the techniques for analyzing data vary depending on the type of diseases being monitored.
Classification of Epidemiological study design
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On the basis of researcher, the epidemiological design study can be:
A. Observational
B. Interventional/ Experimental
A. OBSERVATIONAL STUDIES
It can be:
▪ Descriptive
▪ Analytical
1. Descriptive studies
Cross-sectional:
It consists of Snap-shot/Prevalence studies
Case series:
It consists of Detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of
an individual patient.
Case report
It tracks patients with a known exposure given similar treatment or examines their medical
records for exposure and outcome-small number of cases
Ecological:
It is the studies of risk-modifying factors on health or other outcomes based on populations defined
either geographically or temporally.
2. Analytical studies
It may be:
➢ Case Control
➢ Cohort study
COHORT STUDY
A study design where one or more samples (called cohorts) are followed prospectively and
subsequent status evaluations with respect to a disease or outcome are conducted to determine
which initial participants exposure characteristics (risk factors) are associated with it. As the study
is conducted, outcome from participants in each cohort is measured and relationships with specific
characteristics determined.
Advantages
▪
▪
▪
Subjects in cohorts can be matched, which limits the influence of confounding variables
Standardization of criteria/outcome is possible
Easier and cheaper than a randomized controlled trial (RCT)
Disadvantages
▪
▪
▪
▪
Cohorts can be difficult to identify due to confounding variables
No randomization, which means that imbalances in patient characteristics could exist
Blinding/masking is difficult
Outcome of interest could take time to occur.
.
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EXPERIMENTAL OR INTERVENTIONAL STUDIES
➢ Randomized controlled trials
➢ Field trials
➢ Community trails
➢ Descriptive Studies
PHARMACOEPIDEMIOLOGY
Introduction
The study of the use of and the effects of medicines in large numbers of people is known as
Pharmacoepidemiology.
OR
The study of the use (drug-use) & effects/side-effects of drug in large number of people with the
purpose of supporting the rational & cost-effective use of drugs in the population thereby
improving health outcomes
Pharmacoepidemiology is the New applied field bridging between clinical pharmacology and
epidemiology which applies epidemiological methods to studies of the ethical use of drugs in
population & the application of this study to control health problems.
Pharmacoepidemiology started with increasingly frequent accusations about adverse drug reactions,
often arising out of spontaneous reporting system, followed by formal studies proving or disproving
those associations.
Potential Contributions of Pharmacoepidemiology
1. Discovery of previously undetected adverse and beneficial effects, uncommon effects,
delayed effects
2. Patterns of drug utilization
3. The effects of drug overdoses
4. The economic implications of drug use
Importance of Pharmacoepidemiology
❖ One of the most pressing problems facing public health providers and administrators in many
countries is ensuring the rational use of drugs.
❖ In recent years, the term rational itself has gone through drastic changes:
❖ Rational use…………. Quality use…………. Responsible us
❖ In practice, success of treatment largely depends on the ability of a physician to diagnose,
prescribe, foresee probable adverse reactions and prevent unnecessary or dangerous
duplication therapy.
❖ Further success depends on performance of the pharmacy and nursing departments in
preparing and administering drugs.
❖ However, the existence of a rationally derived list of drugs approved for procurement and
health care consultant’s performance does not ensure that they are prescribed and used
correctly.
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❖ THUS, to ensure the rational use of drugs and correct prescribing we study
Pharmacoepidemiology.
One mechanism to ensure correct prescribing and use is the drug utilization evaluation (DUE)/ Drug
Utilization Review (DUR).
Responsible Use of Medicines
The term ‘responsible use of medicines (RUM)’ implies that the activities, capabilities, and existing
resources of health system stakeholders are aligned to ensure patients receive the right medicines at
the right time, use them appropriately, and benefit from them.
•
•
•
The concept of RUM incorporates the importance of stakeholder responsibility and
recognizes the challenge of finite resources.
RUM is essential to avoid or reduce avoidable adverse events, worse quality of life, and
inferior health outcomes.
RUM is essential to contain the escalating pharmaceutical expenditure.
Drug utilization evaluation/ Drug Utilization Review
(DUE\DUR)
Introduction
DUE is an ongoing, systematic process designed to maintain the appropriate and effective
use of medicines.
DUE is defined as an authorized, structured, ongoing review of practitioner prescribing,
pharmacist dispensing, and patient use of medications.
Aims of DUE\DUR
➢ The purpose of a DUE is to ensure that drugs are used appropriately, safely, and effectively to
improve patient health status.
➢ It involves a comprehensive review of patients' prescription and medication data before,
during, and after dispensing in order to assure appropriate therapeutic decision making and
positive patient outcomes.
➢ Pharmacists participating in DUE programs can directly improve the quality of care for
patients, individually and as populations, by preventing the use of unnecessary or
inappropriate drug therapy and by preventing adverse drug reactions.
➢ The process of DUE goes by many names. In certain settings, it may be referred to as drug
utilization review (DUR). At one time, a distinction was drawn between DUE and DUR
based on the notion that the former was prospective and the latter retrospective. However,
most experts agree that there is little difference between the two and favor use of the term
DUE.
Classification of DUE\DUR
DUE is typically classified in three different categories:
▪
Prospective,
▪
Concurrent, and
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▪
Retrospective
1. Prospective DUE/DUR
Prospective review involves evaluating a patient's planned drug therapy before a medication is
dispensed.
This process allows the pharmacist to identify and resolve problems before the patient has received
the medication.
Pharmacists routinely perform prospective reviews in their daily practice by assessing a
prescription medication's dosage and directions and reviewing patient information for possible
drug interactions or duplicate therapy.
Issues Commonly Addressed by Prospective DUE
•
•
•
•
•
•
•
Drug-disease contraindications
Therapeutic interchange
Generic substitution
Incorrect drug dosage
Inappropriate duration of drug treatment
Drug-allergy interactions
Clinical abuse/misuse
2. Concurrent DUE
Concurrent review is performed during the course of treatment and involves the ongoing
monitoring of drug therapy to ensure positive patient outcomes.
Some refer to this as case management or health management. It presents pharmacists with the
opportunity to alert prescribers to potential problems and to intervene in areas such as drug-drug
interactions, duplicate therapy, over or underutilization, and excessive or insufficient dosing.
This type of review allows therapy for a patient to be altered if necessary.
Issues Commonly Addressed by Concurrent DUE
•
•
•
•
•
•
•
•
Drug-drug interactions
Excessive doses (High or low dosages)
Duplicate therapy
Drug-disease interactions
Over and underutilization
Drug-age precautions
Drug-gender precautions
Drug-pregnancy precautions
3. Retrospective DUE
A retrospective DUE is the simplest to perform since drug therapy is reviewed after the patient has
received the medication.
A retrospective review may detect patterns in prescribing, dispensing, or administering drugs to
prevent recurrence of inappropriate use or abuse and serves as a means for developing prospective
standards and target interventions.
In retrospective DUE, patient medical charts or computerized records are screened to determine
whether the drug therapy met approved criteria and aids prescribers in improving care for their
patients, individually and within groups of patients, such as those with diabetes, asthma, or high
blood pressure.
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Issues Commonly Addressed by Retrospective DUE
•
•
•
•
•
•
•
•
Therapeutic appropriateness
Over and underutilization (Appropriate generic use)
Therapeutic duplication
Drug-disease contraindications
Drug-drug interactions
Incorrect drug dosage
Inappropriate duration of treatment
Clinical abuse/misuse
Steps in Conducting A Drug Use Evaluation
Identify or Determine Optimal Use –
Criteria are defined to allow for comparisons of optimal use with actual use. Criteria should focus
on relevant outcomes. For example, if the use of a drug prescribed to treat a patient with diabetes
is being evaluated, then set standards should be determined to evaluate its effectiveness, such as a
decrease in blood glucose or HbA1c (glycosylated hemoglobin) levels.
Measure Actual Use –
This step is where data is gathered to measure the actual use of medications. This data can be
obtained from medical and prescription records or electronic claim forms.
Compare –
This involves the comparison between optimal or appropriate and actual use. During this process,
the evaluator determines whether findings are expected and causes for any discrepancies. In this
process, patterns or aberrations can be interpreted.
Intervene –
This is the step where corrective action is implemented. Action should be targeted to areas of
concern such as prescribing patterns, medication misadventures, the quality of drug therapy, or
economic consideration.
Evaluate the DUE Program –
The last step is to assess the effectiveness of the DUE program. Efforts should be made to
evaluate the outcomes and document reasons for positive and negative results. Implementing
appropriate changes to the DUE program and continued observation should be undertaken.
Importance of DUE Programs
❖ DUE programs play a key role in helping a health organization to understand, interpret, and
improve the prescribing, administration, and use of medications. This is often accomplished
by using DUE programs to provide physicians with feedback on their performance and
prescribing behaviors as compared to pre-set criteria or treatment protocols.
❖ DUE information also allows physicians to compare their approach to treating certain
diseases with their peers. The "peer pressure" generated by these comparisons is useful in
stimulating physicians to change their prescribing habits in an effort to improve care.
❖ DUE information also assists health policy makers in designing educational programs that
improve rational prescribing, formulary compliance, and patient compliance.
❖ Using DUE information, pharmacists can identify prescribing trends in patient populations
and initiate corrective action to improve drug therapy for groups of patients, as well as
individuals.
❖ As the variety of health care professionals (pharmacists, physicians, nurses, optometrists)
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involved in the medication use process expands, DUE will require a more multidisciplinary
approach to improving patient care.
❖ This will lead to the next logical step, the evolution of DUE into a more comprehensive
"healthcare utilization evaluation."
PHYSICAL HEALTH
Physical health deals with the body’s ability to function.
Physical health has many components including: exercise, nutrition, sleep, alcohol & drugs, and
weight management.
Exercise
Exercise is the act of using your muscles to stay physically fit.
Exercise helps to give you more energy, maintain weight, increase confidence & self esteem, and
helps to battle chronic diseases.
Nutrition
Proper balanced meals are essential in leading a healthy life.
Nutritious meals create a balance between what we eat and the way our body uses the food for
energy and growth.
Sleep
It is recommended that the average person get at least 8 hours of sleep.
The human body likes regularity, so try to go to bed and wake up at the same time daily.
Alcohol & Drugs
Alcohol and other drugs interfere with messages to the brain and alters perception.
Use of such substances puts you at risk for accidental injuries, car crashes, trouble with the law,
unwanted pregnancies, and fights.
Weight Management
Maintaining a healthy weight decreases your risk of certain diseases such as heart disease and
diabetes.
Exercise and proper nutrition help to maintain healthy weight levels.
Mental Health
Mental health deals with how we think, feel and cope with daily life.
Mental health encompasses learning, stress management, and mental illnesses or disorders.
Learning
Learning is the development of skills, behaviors, and knowledge.
Learning increases self-confidence, awareness, and self-perception. It also teaches one coping
skills.
Stress Management
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Stress deals with the way our bodies and minds deal with life changes.
It is important to learn healthy ways to deal with stress or you could be at risk for anxiety or
depression.
Mental Disorders
Stress and problems with school, friends, and family can cause mental illnesses.
Mental illnesses include: depression, bipolar disorder, schizophrenia, and phobias.
Social Health
Social Health deals with the way react with people within our environment.
This includes: public health, family relationships, and peer relationships.
Public Health
Public health includes disease prevention and promoting health through good decision making.
Keeping yourself safe and healthy benefits your community as a whole.
Family Relationships
A healthy family relationship is one that is supportive, loving, responsible, and balanced.
Families should work together to eliminate stress and negativity in the home. Promoting a safe and
enjoyable environment.
Peer Relationships
Strong and supportive friendships increase happiness, self-esteem, and reduces stress.
Friends are there to help celebrate your accomplishments and there to offer
support in times of need.
The Health Triangle Review
There are 3 major areas of the health triangle: physical, mental and social.
Good decision making and healthy choices reduce the risk of disease and
increase health overall.
HEALTH POLICY
Policy
Principles that govern action directed towards given ends. (Titmus, 1974)
OR
Consciously chosen course of action (or inaction) directed toward some end (Kalisch and
Kalisch, 1982)
OR
Plan, direction or goal for action; authoritative decision making. (Stimpson ands Hanley, 1991)
Health policy
Also referred Public health policy & Health care policy is:
“An authoritative statement of intent adopted by government on behalf of the public with the aim
of improving the health and welfare of the populations (centrally determined basis for action)”
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Potential Role of Government in Health Care
➢
➢
➢
➢
➢
➢
A regulator of health care agencies
A stimulator of research
A protector of deprived and disadvantaged groups
A financier of health and health care programs
A purchaser of health care services
A direct provider of services
“A Social Problem Is Not A Social Problem Unless Those in
Power Decides That the Issue Is Worthy of Attention”
Public vs. Private Policymaking
Public Policy
Policy that is established by the federal, state, and local levels of government.
Private Policy
Policy that is established by private organizations.
For example, WHO.
Forms of Health Policies
There are five main forms of health policies
1. Laws
2. Rules/Regulations
3. Operational Decisions
4. Judicial Decisions
5. Macro Policies
1. Laws
A rule of conduct or action prescribed or formally recognized as binding or enforced by a
controlling authority.
➢ It Enacted by any level of government
➢ It Can also be referred to as a program
➢ For example, the Medicare program
2. Rules/Regulations
Designed to guide the implementation of laws.
➢ It Can be made in the executive branch by the organizations and agencies responsible for
implementing laws
3. Operational Decisions
Operational decisions are made by the executive branch of the government as a part of the
implementation of a law
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➢ Normally these decisions consist of protocols and procedures that follow the
implementation of a new law
➢ These decisions tend to be less permanent than rules or regulations
4. Judicial Decisions
These are policies that are created as a result of a decision made in the court system
➢ For example, an opinion listed in 1992 by a DHHS administrative law judge stated that a
hospital was in violation of the Rehabilitation Act Amendments of 1974
5. Macro Policies
Macro policies are broad and expansive and help shape a society’s pursuit of health in
fundamental ways.
➢ Example: FDA regulation of pharmaceuticals
Categories of Public Health Policies
Public health policies are grouped into two categories:
Allocative:
Designed to provide net benefits to some distinct group of class of individuals or organizations, at
the expense of others, in order to ensure that public objectives are met. In general, allocative policies
come in the form of subsidies.
Regulatory:
Policies designed to influence the actions, behaviors, and decisions of others to ensure that public
objectives are met. E.g. Social regulations, quality controls on the provision of health services, rate
or price-setting controls on health service providers etc.
PUBLIC HEALTH POLICIES AND REGULATIONS
Social Regulations
These regulations are established in order to achieve socially desirable outcomes and to reduce
socially undesirable outcomes
Examples
▪
▪
▪
Environmental protection
Childhood immunization requirements
No smoking
Quality Controls
These regulations are intended to ensure that health services providers adhere to acceptable levels of
quality in the services they provide and that producers of health-related products meet safety and
efficacy standards
Example
▪
FDA regulation of pharmaceuticals
Market-entry Restrictions
These regulations focus on licensing of practitioners and organizations
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Example
▪
Certificate of Need programs, Pharmacists credentialing
Rate or Price-setting Controls
These regulations are designed to control the growth of prices.
Example
▪
The federal government’s control of the rates of reimbursement to hospitals that participate in
the insurance program
FAMILY PLANNING
Family
It refers two or more individuals who depend on one other for
emotional, physical, and financial support.
Family Planning
Family planning is done to regulate the number and spacing of
children in a family through the practice of contraception or other
methods of birth control.
Definition
A way of thinking and living that is adopted voluntarily upon the basis of knowledge, attitudes and
responsible decisions by Individuals and couples, in order to promote the health and welfare of the
family group and thus contribute effectively to the social development of a country.
Purposes
➢ Raising a child requires significant amounts of resources: time, social, financial and
environmental.
➢ Planning can help assure that resources are available.
➢ To improve the health of the mother and child.
➢ Helping to prevent HIV/aids.
Criteria for ideal contraceptive
❖
❖
❖
❖
❖
It should be safe for use means free from any kind of side effects.
It should be reliable.
It should be easy to administer and convenient.
It should be cost effective.
It should be culturally feasible and acceptable.
Methods of contraception
The following are common methods of contraception.
1. Spacing methods:
i.
Natural methods
ii. Barrier methods: -
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a. Physical barrier methods
b. Chemical barrier methods
c. Intra- uterine devices
d. Hormonal methods
e. Post conceptional methods
2. Terminal methods:
i.
Vasectomy
ii. Tubectomy
1. SPACING METHODS
❖
❖
❖
❖
These methods help in prevention of pregnancy as long as they are used.
These methods can help in timing and spacing of pregnancies, preventing unwanted children.
These methods are temporary methods.
The spacing methods can be:
i. Natural methods
Natural methods do not involve the use of any of the man-made devices.
These methods are useful for timing and spacing of pregnancies.
a. Coitus interruptus / withdrawal
Method
In this method the penis is withdrawn from the vagina before ejaculation. In this way semen is
prevented from entering the uterine cavity and pregnancy does not take place. Since the penis is
withdrawn and ejaculation takes place outside the vagina, this method is called coitus interruptus
or withdrawal methods.
Merits: ▪ involves no cost
▪ it does not require any other device.
▪ with self-control and discipline, it can be fairly effective.
Demerits: ▪ require a great deal of self-control.
▪ failure rate is very high.
▪ slightest delay in withdrawal can lead to pregnancy.
b. Safe period
It is Based upon the process of ovulation and menstrual cycle which helps in determination of the
safe period when coitus can be done and unsafe period when coitus can be avoided to prevent
pregnancy.
Merits:
▪ it does not require any man-made device.
Demerits: ▪ require self-control by the partners during the highly unsafe period.
▪ not suitable for the women who does not have regular periods.
▪ failure rate is high.
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▪
require great deal of will power and motivation.
c. Abstinence
This involves complete avoidance of sexual cohabit.
ii. Barrier Methods
Barrier methods are those methods which prevent meeting of sperms with the ovum. There are
many major types of barrier methods.
a.
Physical Barrier Methods
Condom: It is a thin rubber sheath which is use by men. It is rolled over the erect penis before having sex.
This rubber sheath prevents the entry of semen into the vagina. The condom must be held
carefully when taking out the penis from the vagina to prevent spilling of semen into the vagina.
It is available free of cost from urban or rural family welfare centers.
TYES:
1) dry Condom
2) deluxe Condom
3) super deluxe Condom
Merits: ▪ It is most simple and effective methods
▪ Easy to use
▪ Disposable
▪ No medical supervision is required
▪ Protects from sexually transmitted disease
Demerits: ▪ If not used correctly it may slip or get tear of and the semen gets spilled into vagina.
▪ In some rare cases the person may have allergic to rubber.
▪ Some people may not enjoy sex because of interference with the sensation.
Diaphragm
The diaphragm is used by women in her vagina to form a barrier in front of the cervix. The
diaphragm is dome shaped and is like a shallow cap.
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It is made of soft synthetic rubber or plastic with a stiff but flexible rim around the edge. It is also
known as Dutch cap.
Diaphragm is available in different ranging from 5-10cm.
It is held in position partly because of the tension created by the spring and partly because of the
muscle tone of vagina. It is very important to observe the vaginal muscle tone otherwise the
diaphragm may not remain in position.
Merits: ▪ A diaphragm along with spermicidal is very effective.
▪ Failure rate is low.
▪ There is no risk or any kind of contraindication.
Demerits: ▪ It requires the assistance of doctor and any other health personnel.
▪ It requires privacy and time to place it in the vagina.
▪ It requires periodical check up
▪ It requires facilities for its proper care and storage.
Vaginal Sponge
It is small polyurethane foam sponge, diffused with spermicide.
The sponge is shaped in a way that it can be filled on to the cervix
and has a loop on its outer surface which can be to pull out the
sponge after use.
▪ It Should be inserted before the coitus.
▪ Provides protection for 24 hours.
▪ It should remain be there for at least 6 hours after coitus.
▪ Sperms are trapped on in the sponge and are destroyed.
▪ It is better than not to use any method.
b.
Chemical Barrier Methods
These methods usually kill the sperms and this way chemical contraceptives help in
preventing the pregnancy. The chemical contraceptives which are in use are: ▪ Form of tablets arosols
▪ Cream jelly
▪ Suppositories
Merits: ▪ They are easy to administer
▪ Available free in health centers
▪ Not very expansive
Demerits: ▪ Most be inserted deep down and in all such points where
sperms are likely to reach.
▪ Must be applied each time before sex.
▪ May cause irritation and burning.
C.
Intra Uterine Devices
These are the devices which are placed in the uterine cavity.
Earlier these devices were made up of silk worm gut, silk and
gold. Three different types of IUD’S generations are:
✓ First Generation IUD’S
✓ Second Generation IUD’S
✓ Third Generation IUD’S
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First Generation IUD’S
These devices were made of polyethylene and are non-medicated. These are available in different
sizes and shapes such as coils, spirals, loops. The lippes loop is the most popular and commonly
used devices.
It is made of polyethylene and contains barium sulphate which makes it possible to be located
when required by x-ray. The loop is double ‘S’ shaped and has an attached made of Fine Nylon
Threads.
Second Generation IUD’S
These are also made of polyethylene but copper is added into these. The copper enhances the
contraceptive effect. Variety of copper devices are: o Copper-7 and copper t-200
o Variants of T devices: TCU: 220C and TCU: 380A
o Multi load devices: ML-CU: 250, ML:375
o Nova T: TCU- 380
All cu devices are more effective and less chances of side effects i.e. pain and bleeding.
Third Generation IUD’S
These contains hormones which is released slowly in the uterus. The hormone affects the lining
of the uterus and cervical mucus. It may affect the sperm.
There are two types of hormone IUD’S:▪ Progestaserl
▪ Levonorgestrel device
Merits:
▪
▪
▪
▪
▪
▪
Can be used for longer period
Can be easily removed when couple wants
to have child
Do not interfere with coitus
Inexpensive
Very effective and failure rate if less
Do not require hospitalization
Demerits
▪
d.
Bleeding, pain, perforation of uterus, expulsion.
Hormonal method
I. Oral Pills
There are variety of oral contraceptive pills.
i. Combined pills: - The pills are composed of two Hormones i.e. synthetic oestrogen and
progesteogen in very small doses.
✓ Its action is to inhibit ovulation of ovum by blocking the secretion of gonadotropin
from pituitary gland. progestogen also
thickens the mucosa of the cervix which
prevents the entry of sperm into the genital
canal.
✓ There are two types of pills available with the
name of MALA-D , MALA-N.
✓ MALA -D: D-Norgestrol – 1.0mg
✓ Ethynil estradiol – 0.03mg
✓ MALA-N: Norethisterone – 0.50mg Ethynil
Estadiol- 0.04mg
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Merits: It is 100% effective if taken regularly.
Easy to use and does not interfere with coitus.
Reduce the risk of anemia because menstrual bleeding is lass.
Reduce the risk of pelvic inflammatory disease, cyst and uterine cancer.
Demerits: Failure rate increase if take irregularly.
Minor side effects like dizziness, nausea, vomiting, headache, weight gain etc.
Increases the risk of heart problems if women is already at risk.
May increases the risk of gall bladder disease and cervical cancer.
ii. Progesterone only pill: - The pill is also known as mini pill. It contains only progestogen
and it thickens the cervical mucus cavity mini pills are taken throughout the menstrual cycle
and these are not used widely because of its high failure rate.
iii. Once –A MONTH PILL: - it is modified combined pill. It contains long acting oestrogen
and short acting progestogen. These pills are not in use because experimental results
revealed high pregnancy rate and irregularity in the menstrual cycle.
II. Depot Formulations
These are long acting hormonal contraceptive contains only synthetic progestogen. These are
available in three forms:
✓ Injectable
✓ Subdermal implants
✓ Vaginal ring
1. Injectable Contraceptives
It is again of two: a. Progestogen Only Injectable: There are two preparations which are available:
▪
DMPA (Depot medroxy progestrone
acetete)
▪ NET-EN (Norethiseterone anante) Both
of these contain synthetic progestogen.
Progestogen prevents ovulation
Merits: It is easy to administer, highly effective and irreversible, do not interfere with
lactation and does not cause any effect on infant.
Contraindication: Abnormal uterine bleeding any malignancy of the genital tract,
suspected malignant growth and caner breast.
b. Combined Injectable Contraceptives: These contains progestogen and oestrogen contraceptive action is similar to that of
progestogen only injectable.
The injection is given once in a month three days early or three days late.
It is contraindicated in pregnancy, women, having any other problem like diabetes
with complications, vascular disorder, suspected malignancy.
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2. Subdermal Implants
There are two varieties. The earlier one is known as
Norplant and latest one is Norplant R-2 the Norplant has
six small silicon rubber tubes. each of these tubes contains
30mg of progestogen. The norplant-R-2 has two small rods.
Both of these devices are placed under the skin of the arm.
The tubes or the rods allow steady diffusion of steroids into
the blood stream for period of five years to give effective
contraceptive effects.
3. Vaginal Rings
This method is not much in use. It consists of ring which
contains small amount of progestogen. The ring is fitted
into the vagina for three weeks of menstruation cycle,
after which it is removed for a week and then reborn
after menstruation cycle. The steroid is directly
absorbed by the mucus lining of the vagina.
e.
Post Conceptional Methods
These are the methods which are used after the missed period and pregnancy may or may not have
occurred. This method is used in regulating and inducing the menstruation and terminating the
pregnancy or aborting the fetus.
These methods are: -
I. Menstrual Regulation
It is done within 14 days of missed period when pregnancy is doubted but it is not confirmed. In
this the uterine contents are evacuated. The procedure is very safe. There is no legal restriction.
Complication which can occur are: - local injury, perforation of uterus, infection.
Other complications may include: Infertility, menstruation disorders, ectopic pregnancy,
II. Menstrual induction
This is done with in few days of missed period. It is done by application of prostaglandin F2
under sedation. This induces continuous contraction of uterus lasting for 7 min. it is followed by
cyclic contraction which continues for next 3-4 hours. This initiates bleeding which lasts for a
week or so.
III. Abortion
Abortion refers to the termination of pregnancy
before the fetus become viable i.e. before it is able
to live outside the womb. This period is fixed at 28
weeks when the fetus weights 1000 grams,
abortion are either spontaneous or induced.
2. TERMINATION METHODS
Sterilization is only method which gives permanent
protection from conception from conception. Either
husband and wife can undergo sterilization by a
simple surgical operation i.e. vasectomy or tubectomy.
i. Vasectomy
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Vasectomy is sterilization of male. It is very simple and minor operation which takes hardly 15-20
min.
The operation involves a small cut on both sides of scrotum then a small portion of vasdeferens
(about 1cm) on either side of the scrotum is cut and ligated, folded back and sutured. The operation
is done not affect the sexual characteristics and sex life in any form. The sperms are produces but
not ejaculated along with semen.
ii. Tubectomy
It is sterilization of female. This is done by resecting a small part of fallopian tubes and ligate the
sected ends. The closing of tubes can also be done by using other methods like closing the tubes
the tubes with bands clips and electrocautery.
The operation can be done through abdominal or vaginal approach. The most common abdominal
procedure is laparoscopy and mini-laprotomy.
The tubectomy can be done after delivery, between delivery and after abortion.
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Pharmacoeconomics
Chapter 10 PHARMACOECONOMICS
Chapter Outline
This Chapter include:
1.
Introduction
2.
Costs and its types
3.
Consequences
4.
Pharmacoeconomic methodologies and modelling
5.
Importance of Pharmacoeconomics
6.
Applications of Pharmacoeconomics
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Pharmacoeconomics
PHARMACOECONOMICS
Introduction
Economics
Economics is the Study of allocation of limited or scarce resources or inputs among alternatives to
satisfy the wants of output.
Health economics
Health economics is the science of assessing cost and benefits of healthcare.
Pharmacoeconomics
“Pharmacoeconomics is a branch of health economics which compares the value of one drug or a
drug therapy to another.”
Pharmacoeconomic Analysis
Pharmacoeconomic analysis involves…
✓ Choosing a perspective
✓ Identifying and measuring costs
✓ Identifying and measuring consequences
Perspectives of Evaluation
➢
➢
➢
➢
➢
Common perspectives include:
Patient perspective – Portion of cost not covered by Insurance.
Provider perspective – e.g. Hospitals- Direct costs
Payer perspective – e.g. Insurance companies, employers, or the government.
Society perspective - All direct and indirect costs.
Costs
The value of the resources consumed by a program or drug therapy, is defined as Cost.
Types of costs
Healthcare costs are categorized as…
Direct Medical Costs –
It is the cost of medical service. E.g. Drugs, medical supplies, and equipment, laboratory and
diagnostic tests, hospitalizations, and physician visits.
Direct Nonmedical Costs –
Transportation to and from healthcare facilities, extra trips to the emergency department, child or
family care expenses, special diets, and various other out-of-pocket expenses.
Indirect Nonmedical Costs –
Morbidity cost – Loss of productivity. Mortality – Loss of years of service due to premature death.
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Intangible Costs –
Nonfinancial outcomes of disease and medical care such as pain, suffering, inconvenience, and
grief.
Opportunity Costs –
Value (economic benefit) of the alternative therapy that was forgone.
Incremental Costs –
The extra costs required to purchase an additional unit of effect.
Direct Costs = Direct Medical Costs + Direct non-medical costs
Indirect Costs = Morbidity costs + Mortality costs
Total costs
= Direct costs + Indirect costs + Intangible costs
Consequences (Outcomes)
Consequence is defined as the effects, outputs, or outcomes of the program or drug therapy.
Consequences are categorized as…
Economic outcomes –
Comparing direct, indirect, and intangible costs with the consequences of medical treatment
alternatives.
Clinical outcomes –
Medical events that occur as a result of disease or treatment (e.g., safety and efficacy end points).
Humanistic outcomes –
Consequences of disease or treatment on patient functional status such as physical function, social
function, general health and well-being, and life satisfaction.
Positive outcomes –
Desired effect of a drug
Negative outcomes –
ADR or toxicity of a drug
Intermediate outcome –
Can serve as a proxy for more relevant final outcomes
Final outcome –
To get final outcome of reduced MI rate, lipid lowering agents are being used to decrease LDL
levels which is an intermediate outcome.
Pharmacoeconomic Methodologies
Economic evaluations
➢ Partial economic evaluations include:
✓ Cost consequence analysis (CCA) or Cost outcome analysis (COA)
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✓ Cost-of-illness (COI) evaluation
➢ Full economic evaluations
✓ Cost Minimization Analysis (CMA)
✓ Cost Benefit Analysis (CBA)
✓ Cost Effectiveness Analysis (CEA) o
✓ Cost Utility Analysis (CUA)
Humanistic evaluation
➢ Health Regulated Quality of Life (HRQOL)
➢ Patient preferences
➢ Patient satisfaction
ECONOMIC EVALUATION
Cost-Consequence Analysis (CCA)
➢ Partial economic evaluations can o Include simple descriptive tabulations of outcomes or
resources consumed
➢ Require a minimum of time and effort.
➢ A cost-outcome or cost-consequence analysis (CCA) o describes the costs and consequences
of an alternative o does not provide a comparison with other treatment
➢ options
Cost of Illness (COI) evaluation
➢ COI identifies and estimates the overall cost of a particular disease for a defined population.
➢ COI evaluation method is also known as burden of illness.
➢ It involves measuring the direct and indirect costs attributable to a specific disease such as
diabetes, mental disorders, or cancer.
➢ COI evaluation is not used to compare competing treatment alternatives but to provide an
estimation of the financial burden of a disease.
Cost Minimization Analysis (CMA)
When two or more interventions are evaluated and demonstrated or assumed to be equivalent
in terms of a given outcome or consequence, costs associated with each intervention may be
evaluated and compared.
➢ Cost-minimization analysis is the most basic technique.
➢ Costs are measured, outcomes are not
➢ Costs are measured in monetary terms and outcomes are assumed to be equivalent
➢ The objective of this method is to select the least costly among multiple equivalent
interventions.
➢ This method is frequently used to compare brands with generics, different routes of
administration and different settings of administration, etc.
➢ An example of this type of investigation regarding drug therapy may be the evaluation of two
generically equivalent drugs in which the outcome has been proven to be equal.
➢ CMA involves the determination of the least costly alternative.
➢ For example, if drugs A and B are antiulcer agents equivalent in efficacy and adverse drug
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reactions (ADRs), then the costs of using these drugs could be compared using CMA.
➢ Another example would be prescribing a generic preparation instead of the brand leader.
➢ Advantage: simple since outcomes need not to be measured
➢ Disadvantage: used only when outcomes are identical
Cost Benefit Analysis (CBA)
➢
➢
➢
➢
➢
➢
➢
➢
A cost-benefit analysis compares the costs and outcomes of alternative therapies and the
outcome is then expressed in monetary terms.
It measures costs and benefits in monetary terms.
Cost-benefit analysis allows researchers to make comparisons across a wide variety of
alternatives.
Estimates the strengths and weaknesses of alternatives.
Both the costs and the benefits are measured and converted into equivalent dollars (Rupee in
Pakistan) in the year in which they will occur.
The costs and benefits are expressed as a ratio (a benefit-to-cost (B:C) ratio).
Many CBAs measure and quantify direct costs and direct benefits only due to difficulties in
measuring indirect and intangible benefits.
This approach is not widely used in health economics.
For example, the benefits of improved patient quality of life, patient satisfaction with the
healthcare system, and working conditions for the physician are not only difficult to measure,
but are extremely difficult to assign a value to.
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Cost Effectiveness Analysis (CEA)
“Cost-effectiveness analysis is defined as a series of analytical and mathematical procedures
that aid in the selection of a course of action from various alternative approaches.”
➢ It is the most commonly employed method is cost-effectiveness analysis.
➢ Measures effectiveness (health benefit) in natural units (e.g. years of life saved, ulcers healed)
and the costs in money.
➢ Cost-effectiveness analysis is used to compare two or more treatment options for a specific
condition.
➢ It also compares therapies with qualitatively similar outcomes in a particular therapeutic area.
For instance, in severe reflux esophagitis, using a proton pump inhibitor compared to using
H2 blockers.
➢ CEA does not allow comparisons to be made between two totally different areas of medicine
with different outcomes.
➢ The results of CEA are expressed as a ratio either as an average cost-effectiveness ratio
(ACER) or as an incremental cost effectiveness ratio (ICER).
➢ An ACER represents the total cost of a program or treatment alternative divided by its
clinical outcome to yield a ratio representing the dollar cost per specific clinical outcome
gained, independent of comparators.
Average cost effectiveness (ACER) = Net Cost / Net Health Benefit
➢ The key measure of CEA is the incremental cost effectiveness ratio (ICER).
Incremental Cost Effectiveness Ratio = (Cost of drug A - Cost
of drug B) / (Benefits of drug A - Benefits of drug B)
ICER = Difference in costs (A-B) / Difference in benefits (A-B)
➢ CEA is being used to set public policies regarding the use of pharmaceutical products
(national formularies) in countries such as Australia, New Zealand, and Canada.
Cost Utility Analysis (CUA)
Cost-utility analysis (CUA) is a method for comparing treatment alternatives that integrates
patient preferences and Health Regulated Quality of Life (HRQOL).
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➢ HRQOL measure is an utility, having value between 1.0 (perfect health) and 0.0 (death).
➢ Quality-adjusted life years (QALYs) are then derived by multiplying the time in a health state
by the appropriate utility score.
➢ In CUA, Cost is measured in dollars, and therapeutic outcome is measured in patient
weighted utilities rather than in physical units.
➢ This method is well suited to the evaluation of chronic diseases that have deleterious effects
on HRQOL.
➢ Differences between treatments are expressed as the incremental cost per QALY gained.
➢ CUA can compare cost, quality, and the quantity of patient-years.
➢ Results of CUA are expressed in a ratio, a cost-utility ratio (C:U ratio).
➢ CUA is complex, and thus CUA can be limited in scope of application from a hospital or
MCO perspective.
➢ CUA is employed less frequently than other economic evaluation methods because of a lack
of agreement on measuring utilities, difficulty comparing QALYs across patients and
populations, and difficulty quantifying patient preferences.
➢ In CEA, the costs are measured in money and there is a defined outcome. But in CUA, the
outcome is a unit of utility (e.g. a QALY).
➢ Example:
▪ Evaluating arthritis treatment
▪
Chemotherapy that increases survival but decreases patient well-being.
Extra
2. HUMANISTIC EVALUATION METHODS
➢ Methods for evaluating the impact of disease and treatment of disease on a patient’s HRQOL,
patient preferences, and patient satisfaction are all growing in popularity and application to
pharmacotherapy decisions.
➢ HRQOL has been defined as the assessment of the functional effects of illness and its
consequent therapy as perceived by the patient.
➢ These effects often are displayed as physical, emotional, and social effects on the patient.
➢ Measurement of HRQOL usually is achieved through the use of patient-completed
questionnaires.
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Pharmacoeconomics
Importance of Pharmacoeconomics
❖
❖
❖
❖
Pharmacoeconomic analysis helps to achieve maximum benefit in limited cost.
Clinicians want their patients to receive best care and outcome available.
The payers want to manage rising costs.
Pharmacoeconomics combines the objectives of both clinician and payers by estimating the
value of patient outcomes for the expenditure spent on medications and other healthcare
services.
❖ In today’s healthcare settings, pharmacoeconomic methods can be applied for effective
formulary management, individual patient treatment, medication policy determination, and
resource allocation.
Applications of Pharmacoeconomics
✓ Healthcare practitioners can benefit from applying the principles and methods of
Pharmacoeconomics to their daily practice settings.
✓ Pharmacoeconomics aid clinical and policy decision making.
✓ Complete pharmacotherapy decisions should contain assessments of three basic outcome
areas whenever appropriate: economic, clinical, and humanistic outcomes (ECHO).
✓ Traditionally, most drug therapy decisions were based solely on the clinical outcomes (e.g.,
safety and efficacy) associated with a treatment alternative.
✓ Over the past 15 to 20 years, assessment of the economic outcomes associated with a
treatment alternative become popular.
✓ The current trend is to incorporate the humanistic outcomes associated with a treatment
alternative, that is, to bring the patient back into this decision-making equation.
✓ In today’s healthcare environment, it is no longer appropriate to make drug-selection
decisions based solely on acquisition costs.
✓ Pharmacoeconomic data can be a powerful tool to support various clinical decisions,
including effective formulary management, individual patient treatment, medication policy,
and resource allocation.
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✓
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Alternative Therapies
Chapter 11 ALTERNATIVE THERAPIES
Chapter Outline
This Chapter include:
1.
Introduction to Alternative Therapies
2.
Herbal Medicines
3.
Homoeopathy
4.
Acupuncture
5.
Acupressure
6.
Reflexology
7.
Aromatherapy
8.
Bach Flower remedies
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Alternative Therapies
Alternative Therapies:
Introduction
Alternative medicine are interventions that differ from the traditional or conventional
biomedical treatment of disease.
OR
The therapies other than allopathy which are widely used for the treatment of
diseases in very natural way are known alternative therapies.
The modern allopathic system has been globally acclaimed as the principal system of
medicine, and so all the other systems prevalent and practiced in various parts of the world
are supposed to be alternative systems.
The philosophy and the basic principles of these alternative systems might differ
significantly from each other, but the fact cannot be denied that these systems have served
the humanity for the treatment and management of diseases and also for maintenance of good
health.
It is an intervention that is used instead of conventional medicine.
Alternative medicine is called alternative because they may not always be effective or not
proved 100% successful.
About 80 percent of the world population still rely and use the medicines of these alternative
systems.
The systems of medicine which were once practiced only in the respective areas or
subcontinents of the world, are now popularly practiced all over the world are:
✓ Herbal medicine
✓ Homoeopathy
✓ Acupuncture
✓ Acupressure
✓ Reflexology
✓ Aromatherapy
✓ Bach Flower Remedies
Herbal medicine
Herbal medicine (also Herbalism) is the study of pharmacognosy and the use of medicinal
plants.
Plants have been the basis for medical treatments through most of human history, and such
traditional medicine is still widely practiced today.
Principle
Herbal medicine is also called phytomedicine or phototherapy consists of alternative and
pseudoscientific practices of using unrefined plant or animal extracts as unproven medicines
or health-promoting agents.
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Advantage
✓ Herbal medicines can treat minor conditions like scrapes, rashes and burns.
✓ They can also be used to treat migraines, arthritis and depression (University of New
Hampshire) at a very low cost.
✓ The cost of herbal medicines is very low compared to pharmaceutical drugs because
they can be found in local supermarkets or grown at home.
✓ Herbal medicine can also be found in everyday foods such as ginger, garlic and
rhubarb.
Disadvantage
✓ Herbal medicines take a longer time to work compared to pharmaceutical drugs. If an
individual decides to take the herbal alternative to pharmaceuticals, he or she must be
very patient.
✓ Herbal medicines are often self-administered. As a result, there is no dosage or
warnings specified.
✓ When Herbal medicines are consumed with pharmaceutical drugs, the two can interact
with each other resulting in injuries to health.
✓ It is also important to know that plants used as a herbal medicine may poison rather
than cure someone. It may be the case where a certain part of a plant may be edible
and another part may be poisonous.
✓ An individual may not be able to identify a poisonous plant. This would put the
individual at the risk of poisoning themselves or others.
Homoeopathy
Main aim:
✓ Revitalize the injured vital force
✓ No side effects of the medicine in human organism
Principle
It works on the Principle “Like cure like” that is: a substance that causes symptoms of a
disease in a healthy person can cure similar symptoms in a sick person.
So, the drug whose symptoms matches to the patient's symptoms is given in the very diluted
form which eventually and slowly cures the Patient.
Other principles are:
➢ Principle of Simplex Similimum Minimum
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Alternative Therapies
➢ Principle of Individualization
➢ Principle of Potentization
Example
Apis melifica (made from Honey bee) is given to
the patient having symptoms like: swelling,
edema, stinging pain, soreness and inflammation
etc.
Advantage
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
Complete Science
Aims at removing the Cause
Avoid surgery
Holistic Methodology
No Side Effects
Improves Immunity
Safest Medicine
Preventive capacity
Can be use in Epidemic diseases
Anti-allergic, anti-viral, anti-septic
Inexpensive remedies
Disadvantage
✓ It isn't easy to find the proper remedy from among the thousands available.
✓ It takes great skill and much time in complicated cases for the physician to properly
prescribe for and treat each patient.
✓ It generally isn't possible for him to command fees commensurate with the time
involved, and homeopathy thus hasn't become popular.
✓ In chronic disorders, considerable time is necessary to effect a proper cure.
✓ Ineffective in treating some conditions which cry out for simple nutrition and lifestyle
changes.
Acupuncture
The term "acupuncture" describes a procedure involving the stimulation of anatomical points
on the body using a variety of techniques.
The acupuncture technique involves penetrating the skin with thin, solid, metallic needles
that are manipulated by the hands or by electrical stimulation.
Principle
Through the use of extremely fine needles, there is an energy flows (Qi flow) through the
body in channels called acupuncture meridians which influences an organ. There are
different meridians for the heart, liver, lung, large intestine, stomach, kidney, urinary bladder
etc.
Procedure
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Acupuncture involves the insertion of needles about as slender as a human hair into the skin
on specific locations of the body. The acupuncturist may simply leave the needles in for a
period of time, or may manipulate them with his hands or via electrical stimulation. Different
people experience acupuncture in different ways. Many reports no discomfort whatsoever
during needle insertion, while others report pain. Some people feel a burst of energy
following the treatment, while others become relaxed. Follow-up treatments typically occur
over a time span of several weeks or months.
Advantage
✓ Noninvasive treatment, with
✓ Little to no side effects or recovery time.
✓ Reduce dependence on medications as well as the need for unpleasant medical
procedures.
✓ Suitable for almost all people, regardless of physical condition, with the possible
exception of those suffering from bleeding disorders or taking blood thinners.
✓ The practice takes a holistic approach in attempting to eliminate the root cause of the
malady, rather than simply mitigating the symptoms.
Disadvantage
✓ Minor soreness for a period of time immediately following treatment.
✓ Cannot possibly cure the physical ailment, as in the case of broken bones
✓ Involves regularly scheduled follow-up treatments, which may prove a hassle for
some patients.
✓ Treatments can be costly.,
✓ Unqualified practitioners can deliver substandard care, resulting in pain from
improper needle placement
✓ Infections from unsterilized needles.
Acupressure
Acupressure is a natural science, philosophy and a rational method of therapy based
on an inbuilt mechanism provided in the human body by the Nature.
Acupressure refers to a therapy wherein pressure is applied at specified locations of
therapeutic value in the human body (acu points) to heal diseases.
Principle
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Alternative Therapies
Acupressure seeks to cure diseases by restoring the imbalance of energy flow in the human
body.
Procedure
A number of points known as acu points are located along the meridians and control the flow
of energy on these pathways, just the way electrical switches/regulators control the flow of
current in a circuit.
Stimulation of these acu points with pressure using specific techniques corrects the energy
imbalance along a meridian and the disease gets cured. Pressure may be applied by hand, by
elbow, or with various devices.
Advantage
✓
✓
✓
✓
✓
✓
✓
Relieving pain
Balances the body
Maintains good health.
The healing touch of acupressure reduces
Tension, increases circulation, and enables the
Body to relax deeply
By relieving stress, acupressure strengthens resistance to disease and promotes
wellness.
Disadvantages
✓ After an acupressure session, some people may feel soreness or bruising at
acupressure points.
✓ Treatments can be costly and often aren’t covered by health insurance providers, and
results aren’t guaranteed
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✓ Some diseases can be cured for a short period of time but may occur again.
✓ It cannot possibly cure the physical ailment, as in the case of broken bones.
✓ Putting pressure on the wrong points does not beneficial for the problem and
sometimes it can cause many other problems.
✓ Getting acupressure therapy in pregnancy can cause miscarriage and if pressure is put
on the wrong point, both mother and child may be at risk.
✓ If the disease is too old, acupressure therapy can cause harm to the advantages and the
disease can be even more serious.
Reflexology
Reflexology, or zone therapy, is the practice of massaging, squeezing, or pushing on
parts of the feet, or sometimes the hands and ears, with the goal of encouraging a
beneficial effect on other parts of the body, or to improve general health.
There is no consensus on how reflexology does or could work in practice; a unifying theme
is the idea that areas on the foot correspond to areas of the body, and that by manipulating
these, one can improve health through one.
Principle
Reflexology is based on the principle that certain parts of the body reflect the whole. Reflex
points, which relate to all parts of the body, can be found in the feet, hands, face and ears.
These points respond to pressure, stimulating the body's own natural healing process.
Advantages
✓ Creates relaxation
✓ Reduces pain:
✓ Improves blood flow: Separate studies show that reflexology work increases blood
flow to the feet, brain, kidneys and intestines.
✓ Aids post-operative recovery
✓ Positive impact on physiological measures e. g. blood pressure and cholesterol;
✓ Enhances medical care phantom limb pain sufferers, neuropathy patients, and
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Alternative Therapies
hemodialysis patients to name a few.
✓ Benefits mental health - reflexology can reduce depression
✓ Complements cancer care - Pain, nausea, vomiting, and/or anxiety eased for
chemotherapy
✓ Eases pregnancy, delivery and post-partum effects - Women who received reflexology
experienced shorter labor times and used less analgesia
Disadvantages
Reflexology cannot heal or may be harmful in following cases: Applying pressure at wrong
pressure point will not give relief to the problem. But it may lead to rise of some other
problem.
Aromatherapy
The word aromatherapy means treatment using scents.
It refers to the use of essential oils in Holistic healing to improve health and emotional wellbeing, and in restoring balance to the body.
Essential oils are aromatic essences extracted from plants, flowers, trees, fruit, bark, grasses
and seeds.
Principle
All essential oils have unique healing and valuable antiseptic properties. Some oils are
antiviral, anti-inflammatory, pain relieving, antidepressant, stimulating, relaxing,
expectorating, support digestion and have diuretic properties too.
Essential oils get absorbed into our body and exert an influence on it. The residue gets
dispersed from the body naturally.
Mode of action of aroma oil:
The aroma enters our nose and connects with cilia, the fine hair inside the nose lining. The
receptors in the cilia are linked to the olfactory lobe which is at the end of the smell tract.
The end of the tract is in turn connected to the brain itself.
Smells are converted by cilia into electrical impulses that are transmitted to the brain through
olfactory system.
All the impulses reach the limbic system. Limbic system is that part of the brain, which is
associated with our moods, emotions, memory and learning. All the smell that reaches the
limbic system has a direct chemical effect on our moods.
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Advantages
✓ Essential oils take few seconds to enter the skin, and within four hours, the toxins get
out of the body through urine, perspiration and excreta.
✓ Aromatherapy works like magic for:
▪ stress-related problems,
▪ psychosomatic disorders,
▪ skin infections,
▪ hair loss,
▪ inflammations and pains arising from muscular or skeletal disorders.
✓ Essential oils are safe to use
✓ Aromatherapy is a relatively simple therapeutic procedure, with readily available
products, and requires no professional supervision.
✓ There are readily available and affordable products to fit almost any budget.
Disadvantage
✓ Allergy or Photosensitivity - There is a caution being that the essential oils should
never be used directly because some oils may irritate sensitive skin or cause
photosensitivity.
✓ Essential oils are Flammable thus they should be used with caution.
✓ Aromatherapy has Lack of Medical Research
✓ Anyone with hypertension should avoid stimulating essential oils such as rosemary,
spike lavender and cinnamon. These oils are used to stimulate blood flow and energy.
Bach flower remedies
Bach flower remedies are dilutions of flower material developed by a renowned pathologist,
bacteriologist, physician and homeopath Edward Bach in 1930s
The remedies contain very small amount of flower material in a 50:50 solution of water and
brandy having no any taste or characteristic scent of the plant as they are completely diluted.
The remedies are mainly intended for spiritual and emotional conditions, including but not
limited to insomnia, anxiety, depression as well as stress.
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Alternative Therapies
Principle
Dew found on flower petals retains healing properties of that plant. The remedies contain
very small amount of flower material.
There are various kinds of psychological problems which can be resolved by them. They help
to balance state and are often recommended by practitioners for pain and psychological
problems.
Along with these things, they are also useful for various physical problems and also used as
nutritional supplements
Advantages
✓
✓
✓
✓
✓
Completely safe.
No adverse effect
Self-prescription can do no harm
Hey can be taken with food or any other substance and be effective
Non-addictive.
Disadvantages
There may be harmful for your body if you take these kinds of medicines without taking any
advice from medical consultants. You must be aware of these things if you are going to buy
Bach Flower Remedies products.
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Pharm. D (UOS)
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