DRUG STORAGE SYSTEM
IN A HOSPITAL SETTING
PHARMACY DEPARTMENT
NATIONAL ORTHOPAEDIC HOSPITAL,
DALA-KANO
28th OCTOBER, 2015
DRUG STORAGE SYSTEM
IN A HOSPITAL SETTING
BY
PHARM. KINGSLEY ETUMUDON
OUTLINE
1.0 INTRODUCTION
1.1 DEFINITION OF TERMS
1.2 AIMS AND OBJECTIVES OF DRUG STORAGE
IN THE HOSPITAL
1.3 STORAGE AREA
1.4 EFFECTS OF ENVIRONMENTAL FACTORS ON
DRUG STORAGE
1.5 CONCLUSION
INTRODUCTION
Drugs are chemical substances with diverse
Pharmacological actions. They bring about
different changes in the body when they
interact with biological systems.
They may cause contraction, dilation of
muscles, alteration of hormonal levels, and
secretion from glands, modulation of nervous
activity and a host of other Physiological
changes.
It can also be used for the prevention,
diagnosis and treatment of diagnosed
diseases and for the relieve of symptoms.
In as much as drugs brings about changes in
the body, drugs can undergo changes if not
properly secured and stored under
appropriate conditions.
Drug storage is among the Pharmacist’s most
important responsibilities.
Therefore, adequate methods to ensure that
these responsibilities are met, must be
developed and implemented.
DEFINITION OF TERMS
1. Contamination: -This is the undesired
introduction of impurities of chemical or microbiological nature, or of foreign matters, into or
onto a starting material or intermediate or
finished product during production, sampling,
packaging or repackaging, storage or transports.
2. Expiry Date:- The date given on the individual
container (usually on the label) of a drug product
up to and including when the product is expected
to remain within specification, if stored correctly.,
example if the expiry date is Oct. 2015, it means
the drug should not be used by the end of
October.
3. Labeling:- The action involving the selection of
the correct label, with required information,
followed by line clearance of application of label.
4. Pharmaceutical Product:- Any medicine
intended for human use or veterinary
product administered to food producing
animals, presented with its finished dosage
form or as a starting material for use in
dosage forms subject to control by
Pharmaceutical legislation in both exporting
and importing states.
5.Storage:- The act of storing of Pharmaceutical
product and materials up to their point of use.
6. Shelf–Life:- Is the length of time a drug or
commodity may be stored without becoming
unfit for use.
WHAT IS DRUG STORAGE
Drug storage is the conditions under which
Pharmaceutical products and materials are
kept to ensure their stable forms are retained
up to the point of use or till it reaches the
consumer.
The loss of potency during storage may
influence the efficacy and safety of
Pharmaceuticals.
Pharmaceutical product required control
storage and transit conditions in order to
ensure their quality is not compromised.
Storage is an important aspect of total drug
control system. Proper environment control,
that is proper temperature, light and humidity,
Condition of sanitation, ventilation and
segregation must be maintained whenever
drugs are supplied and stored in the hospital.
Pharmaceutical products are to be stored
under conditions that prevent contamination
and as far as possible from deterioration.
It could be said that, drug storage is one of the
fundamental concern of Pharmacist in patient
care.
The conditions under which drugs are
manufactured and stored can have a major
impact on their quality.
High temperature and relative humidity are
the most important factors involved in drug
degradation, and these environmental factors
can all have a significant impact on the final
quality of drugs and therefore, affect the
Salability.
All medicinal products must be stored in
accordance with the manufacture’s directions
and within the terms of product
authorizations.
Pharmaceutical stock should be stored under
suitable conditions appropriate to the nature
and stability of product concerned.
Particularly, attention should be paid to
protection from contamination, sunlight, uvrays, moisture, atmospheric moisture and
extreme temperatures.
Also, human factors should be checked and
controlled by avoiding clumsy arrangements,
food should not be stored where drugs are
kept and also, ensure proper sanitation.
During storage, drugs should be retained in
the manufacture’s original packaging. Good
storage practice is applicable in all
circumstances where
Pharmaceutical products are stored
throughout distribution process.
AIMS AND OBJECTIVES OF DRUG STORAGE IN
HOSPITAL
To ensure drug safety and maintenance of its
integrity throughout its shelf life.
To prevent wastage
Protect from pilferage/theft.
Secure drugs from an unauthorized persons,
so that the conditions of storage are not
tampered with.
To protect the health of the public (to avoid
contamination).
Prevent infestation of pests and vermin (any
of the common types of insects or animals
which causes harm), e.g. flies, lice, mice and
rats.
Importantly, to promote patient care and
improve quality of life.
STORAGE AREA
Storage area should be of sufficient capacity
to allow orderly arrangement of the various
categories of materials and products like startup and packaging materials, intermediate,
bulk and finished products. Products in
quarantine,
released, rejected, returned or recalled
products.
Storage areas should be designed or adapted
to ensure good storage conditions in
particular. They should be clean, dry and
maintained within acceptable temperature
limits. Where special storage are required (e.g.
temperature and humidity) these should be
provided, checked and monitored.
Receiving and dispatch bays should protect
materials and products from the weather.
Where quarantine status is ensured, storage is
in a separate area, such area must clearly
marked and their access restricted only to
authorized personnel.
THE EFFECTS OF ENVIRONMENTAL
FACTORS ON DRUGS STORAGE
Ingredients in a Pharmaceutical preparations,
either the active ingredients or
pharmaceutical excipients can be affected by
some environmental factors which can affect
the stability of the drug or dosage form.
TEMPERATURE:- High temperature accelerate
oxidation, reduction and hydrolysis which lead
to drug degradation.
HUMIDITY/MOISTURE:- Water catalyzes
chemical reactions as oxidation, hydrolysis and
reduction reaction. It also promotes microbial
growth.
These effects causes instability problems on
different formulation as highlighted below:
a). Oral solutions: the instability problems are:
Loss of flavour.
Change in taste.
Presence of off flavours due to interaction
with plastic bottle .
Loss of dye.
Precipitation.
Discolouration.
b). Parenteral solutions:- Interaction of the
contents with container and changes in chemical
composition.
Instability problems:
Discolouration
Presence of precipitate due to interaction
with container.
Clouds: Cloud will appear in the product due
to:
Chemical changes (an ester, e.g. polysorbate
may hydrolyses by producing an acid which is poorly
soluble).
- Effects: Change in appearance and in
bioavailability.
c). Suspensions:- Instability problems
Settling.
Caking.
Crystal growth.
Effects: Loss of drug content uniformity in different
doses from the bottle and loss of elegance.
d). Emulsions:- Instability problems
Creaming
Cracking.
Phase invasion
Effects: Loss of drug content uniformity in
Different doses from the bottle and loss of
elegance.
e). Tablets:- Instability problems
Disintegration time.
Dissolution profile.
Hardness.
Appearance.
Effects: Change in release.
f). Capsules:- Instability problems
Change in appearance.
Dissolution.
Strength.
Effects: Change in drug release.
Finally, maintaining proper storage conditions at
hospital is essential to reduce such impact caused
by environmental factors. The Pharmaceutical
products will retained their potency when stored
in Pharmacies having good storage facilities.
Hence, there is need to highlights the
importance of maintaining good storage
condition in the hospital Pharmacy.
Also, to ensure that drugs still retain their stable
form even after hospital storage to the point
when it reaches the consumer.
The Pharmacist plays a role as part of his
responsibilities to counsel the patient on the
importance of proper drug storage he/she is
given.
WORLD HEALTH ORGANISATION
GUIDELINES ON STORAGE OF
PHARMACEUTICAL PRODUCTS
BY
PHARM. SANI M. MUSTAPHA
OUTLINE
1.0 INTRODUCTION
1.1 OBJECTIVE OF THE GUIDELINES
2.0 STORAGE PERSONNEL
3.0 STORAGE PREMISES AND FACILITIES
3.1 STORAGE AREA
3.2 STORAGE CONDITIONS
3.3 MONITORING OF STORAGE CONDITIONS
4.0 STORAGE REQUIREMENTS
4.1 DOCUMENTATION
4.2 STORAGE AND LABELLING CONDITIONS
4.3 NORMAL CONDITIONS
4.4 STOCK CONTROL
5.0 CONCLUSION
WHO GUIDELINES TO GOOD STORAGE OF
PHARMACEUTICAL PRODUCTS
INTRODUCTION
This WHO Guide is intended for those involved
in storage, transportation distribution or sales
Pharmaceuticals.
It is closely linked to other existing guides
recommended by the WHO Expert Committee
on Specifications for Pharmaceutical
preparations, such as:
a. Good Trade Distribution Practice (GTDP) of
Pharmaceutical starting materials.
b. Good Manufacturing Practices (GMP).
c. The cold chain especially for vaccines and
Biologicals.
d. The International Pharmacopoeia etc.
The above guide was prepared in close collaboration
with the International Pharmaceutical Federation
(FIP).
OBJECTIVE
The objective of this guide is to supplement
the above mentioned documents by
describing the special measures considered
appropriate for STORAGE and
TRANSPORTATION of Pharmaceuticals.
They may be adapted to meet individual
needs where necessary, provided that the
desired standards of quality are met.
The guidelines are applicable to
 Manufacturers
 Importers
 Contractors
 Wholesalers
 Community Pharmacies
 Hospital Pharmacies
NOTE: The guidelines may be adjusted in line with the
type of activity where the storage of the Pharmaceuticals
is taking place, but National or Regional Regulations must
be followed.
STORAGE PERSONNEL
At each storage site (e.g. Hospital Pharmacy
Store) there should be an adequate number of
qualified personnel to achieve Pharmaceutical
quality assurance objectives.
National Regulations on qualifications should by
followed (e.g. Registered Pharmacist must be incharge).
All personnel should receive proper training in
relation to good storage practice regulations
procedures and safety.
All members of staff should be trained in and
observe high levels of personal hygiene and
sanitation.
Personnel employed in storage areas should
wear suitable protective or working garments
(e.g. Lab Coats or Overalls) appropriate for the
activities they perform.
STORAGE PREMISES AND FACILITIES
STORAGE AREA
Precautions must be taken to prevent
unauthorized persons from entering storage
areas (A notice may be put in place for this
purpose).
Storage areas should be of sufficient capacity to
allow for orderly storage of various categories of
Pharmaceutical products (including but not
limited to received, rejected, dispatched or
recalled products).
Storage areas should be designed or adapted to
ensure good storage conditions.
They should be clean and dry.
Maintained at acceptable temperature limits
(depending on the products requirements).
Where special conditions are required by the
label (e.g. relative humidity), these must be
provided, checked, monitored and recorded.
Materials should be stored off the floor (pallets
must be provided for heavy cartons, e.g. I.V
fluids), and suitably spaced for easy cleaning and
inspection.
Pallets must be kept in good state, cleaned and
repaired when broken.
Storage areas must be kept clean from
accumulated wastes and vermin (insects, pests,
rhodents etc).
A written sanitation programe should be
available, indicating frequency of cleaning and
methods.
There should be written programe for pest
control.
Pest control agents should be safe, with no risk to
contamination or cross-contamination of
Pharmaceutical products.
There should be appropriate procedures for
cleaning of spillage to ensure complete removal
to avoid contamination.
Receiving and Dispatch bays should be available
and should protect materials and products from
whether, extreme temperatures and theft.
There should be physical or other equivalent
methods for validation (e.g. electronic,
computerized) and seggregation of rejected,
expired, recalled or returned products.
Highly active radioactive materials, Narcotics and
other Hazardous, sensitive and/or dangerous
Pharmaceutical products, as well as substances
which pose potential risks of abuse, fire or
explosion should be stored in a dedicated area,
with additional safety and security.
Pharmaceutical products and materials should be
stored in a manner that will prevent
contamination, mix-ups, and crosscontamination.
The “First Expired–First Out”(FEFO) principle
should be followed.
Narcotics should be stored in compliance with
international conventions, National Laws and
Regulations on Narcotics.
Broken or damaged items should be separated
and withdraw from usable stock.
Storage Area should be adequately lighted to
enable all operations to be carried out
accurately and safely.
STORAGE CONDITIONS
Storage conditions for Pharmaceutical products
should be in compliance with the LABELLING which
is based on the results of stability testing.
MONITORING STORAGE CONDITIONS
Recorded Temperature monitoring date
should be available for review (e.g. Wall
Thermometers should be used to check
internal temperatures at all times).
All monitoring records should be kept for at
least the shelf life of the stored product plus
one (1) year, or as required by the National
Legislation.
Equipment for monitoring should be
calibrated at defined intervals.
STORAGE REQUIREMENTS
DOCUMENTATION: Written Instruction and
Records should be available, which documents
all activities in the storage areas, including
handling of expired stock.
Permanent information, written or electronic,
should exist for each stored product,
indicating:
Storage conditions, etc.
Records must be kept for each delivery, and this
should include:
Description of goods.
Quality.
Quantity.
Supplier.
Supplier’s Batch Number.
Receipt Date.
Expiry Date.
N.B:- This information is normally found on each
drug Tally or Bin Card
Where National Regulations require that
records must be kept or retained for a certain
period, this must be observed, otherwise such
record should be retained for a period equal
to the shelf-life of the material, plus one (1)
year.
Comprehensive records should be maintained
showing all receipts and issues according to a
specific system, e.g. by Batch Number.
STORAGE AND LABELLING CONDITIONS
NORMAL CONDITIONS: Storage in dry, well ventilated premises at temperatures of 15250c, or depending on climatic conditions, up
to 300c.
Extraneous odours, other indications of
contamination, and intense light must be
excluded.
DEFINED STORAGE INSTRUCTIONS
Drug products must be stored under defined
conditions require appropriate storage
instructions.
Unless otherwise specifically stated (e.g.
continuous maintenance of cold storage),
deviation may be tolerated only during short
term interruptions, (e.g. during local
transportation).
The use of the following Labeling instructions are
recommended.
ON THE LABEL
- “Do not store over 300c
- “Do not store over 250c
- “Do not store over 150c
- “Do not store over 80c
- “Do not store below 80c
- “Protect from Moisture”:
WHAT IT MEANS
From + 20c to + 300c
From + 20c to 250c
From + 20c to 150c
From + 20c to 80c
From + 80c to + 250c
No more than 60%
Relative Humidity in Normal Storage
Conditions to be provided to the patient in
moisture resistant container.
- “Protect from Light”: To be provided to the
patient in light Resistant container.
STOCK CONTROL
* Periodic stock reconciliation should be
performed by comparing the actual (Physical)
stock and the recorded stock (on the stock or
Tally/Bin Card).
*Each container should be carefully inspected
for possible contamination, Tampering or
damaged.
All significant stock discrepancies should be
investigated as a check against in advertent
mix-ups and/or incorrect issue.
Damaged containers should not be issued
unless quality of the material is shown to be
unaffected. Any action taken should be
documented.
All stock should be checked regularly for
Obsolete and outdated products. Precautions
should be taken to prevent the issue of
outdated products.
On receipt, each incoming deliver should be
checked against the relevant purchase order
and each container physically verified e.g.
Label,
Batch, Expiry Date, etc.
Returned Goods: All returned goods, including
recalled goods should be handled in
accordance with approved procedure, and
records should be maintained.
DISPATCH AND TRANSPORTATION
Pharmaceutical products should be transported
in such a way that their integrity is not impaired
and storage conditions are maintained.
Special care should be used when cold chain is
required.
Devices should be used to monitor temperatures
where necessary.
Pharmaceuticals should be transported when
receipt of delivery order is obtained and both
dispatch and receipt must be documented.
Records of dispatch should be retained, and
should state at least
-Dispatch Date.
- Patient/Customers name and address.
Product description (e.g. Name, Dosage form,
strength etc).
- Transport and Storage Conditions.
All records should be accessible, available and
readable.
Finally, the World Health Organisation recommends
that all stake holders in the Pharmaceutical Products
Cycle should comply to some extent, with these
recommended guidelines.
Therefore, the hospital is no exemption.
As we have seen, drug storage system does not solely
rely on the storage area, but things like personnel,
storage conditions, security, storage record as well as
transportation of the product play a very important
role in maintaining the integrity, efficacy and quality of
the product up to the point of use.
But even though institutions are expected to comply
with such regulations and guides, they are by no
means rigid, as there are room for customization and
adaption by local bodies, depending on local
regulations, as long as the standards and quality of
the products are not impaired.
DRUG STORAGE SYSTEM:
THE NOHD EXPERIENCE
BY
PHARM. HAMZA ISA MUHAMMAD
OUTLINE
-
PERSONNEL
STORE ARRANGEMENT
DRUGS ARRANGEMENT
RECORD/QUARANTINE
CHALLENGES
CONCLUSION
RECOMMENDATION
PERSONNEL
The Pharmacy store is over seen by a Single
registered Pharmacist and strictly out of bounds
to unauthorized persons.
STORE ARRANGEMENT
The store has fifteen aluminium shelves,
arranged to make four rows to allow for easy
access, cleaning as well as inspection.
It has one fully functioning AC and the other
partially functioning to maintain the drugs at
room temperature and there is adequate
lighting.
DRUGS ARRANGEMENT
The drugs are arranged on the shelves using a
combination of Pharmacological and dosage
form manner where by drugs are classified as
Analgesic/Anti Inflammatory Agents, e.g.
Aceclofenac, Diclofenac Sodium, Diclofenac
Potassium, Ketoprofen, Meloxicam, Celecoxib
and various dosage forms are segregated as
Capsules, Tablets, Injections, Syrups,
Creams/Ointments.
- Antibiotics/Anti Infectives, e.g. Ciprofloxacin,
Cefuroxime, Ceftriaxone, Levofloxacin,
Clindamycin, Gentamicin.
- Cardiopulmonary:-Antihypertensives – Amlodipine, Methyldopa,
- Antidiabetics – Metformin, Glibenclamide,
- Bronchodilators – Salbutamol inhaler.
- Antimalarials – Artemeter/Lumefantrin,
Artemeter Injection, Sulfadoxine/Pyrimethamine.
- Antacids – Omeprazole, Ranitidine,
Aluminium Hydroxide + Magnesium Hydroxide +
Simethicone.
- Vitamins/Minerals/Anti Oxidants, e.g Ascorbic
acid, Calcitriol, Pyridoxine, Folic acid.
- Anaesthetic Agents – Halothane, Isoflurane,
Ketamine, Sodium Thiopentone.
-Narcotics are kept in a dedicated area under
lock and key, and are issued on request. The
issues are recorded in a Poison/DDA register as
required by law.
-Thermolabile Drugs:
Insulin, Vaccines (T. T. ATS).
Bupivacaine, Propofol are kept in the
refrigerator to maintain their temperature
between 2 to 80c.
- Intravenous Infusions, e.g. Normal Saline, 5%
Dextrose water, 5% Dextrose Saline, 4.3%
Dextrose Saline, Ringers Lactate, Mannitol,
Darrows Solution are kept in a separate store on
wooden pallets. The store is small in size but has
functional Air-conditioning system.
RECORDS/QUARANTINE
All medicines coming into the Pharmacy are
initially quarantined in a separate area (within the
store) before they are checked for correctness of
quantity, batch number, expiry dates, after
necessary checks they are transferred to their
respective storage locations.
- Shelves are checked at a predetermined period
(monthly) to ensure removal of medicines whose
expiry date is approaching and the principle of
FIRST EXPIRE–FIRST OUT (FEFO) during issuance is
adhered to.
When drugs are expired, they are being
separated, to prevent mix up, and are
subsequently burnt after approval by the
Board of Survey.
All relevant store records are being kept on
the store documents SIV, SRV LEDGERS,
BIN/TALLY CARDS, and there is periodic
(monthly) Stock Taking.
The department has other Units: Accident and
Emergency, NHIS, SOPD, as well as INPATIENT in which the electricity coverage is
inadequate, because the Air-conditions are
switched off after the close of work.
The units are without sufficient storage areas
because they are smaller in capacity.
CHALLENGES
SPACE: The present store is too small (especially
the IV fluid store) to adequately accommodate all
the drugs, we are therefore having some storage
space challenges.
POWER SUPPLY: Sometimes the power supply is
rationed and Pharmacy department is cut off.
STAFF: There is only one pharmacist in the store
and the department now has five units with nine
(9) pharmacists which is grossly inadequate.
LACK OF MONITORING EQUIPMENTS: Wall
thermometer to monitor the temperature, and
hygrometer to monitor the relative humidity.
RECOMMENDATION
- The general public should make sure that
they obtain their drugs from the hospital
Pharmacy/ Community Pharmacy where there
is good storage facilities.
The management should provide 24 hours
power supply to the department and to allow
us to put our AC’s on even after closing hours.
The management to build a bigger store to
accommodate all the drugs.
The management to provide wall
thermometer to monitor the temperature in
the store.
The hospital community and the general
public should abide by the instructions given
by the Pharmacist on the proper handling and
storage of their medicines at home and in the
ward.
CONCLUSION
Drugs serves as an important and integral
products in the treatment and prophylaxis of
many medical ailments of which they are
required to be used at their maximum standard
requirements, good Pharmaceutical storage is
part of the quality management system that
ensures the quality of the Pharmaceutical
products.
It is therefore the responsibility of Pharmacists
and other health care providers to ensure that
Pharmaceutical products are properly handled
and stored and also adequately provided
when required.
THANK YOU ALL
FOR LISTENING
REFERENCES
 WHO Technical Report Series No. 908, 2003.
 WHO Expert Committee on Specifications for
Pharmaceutical preparation. 34th Report. Geneva, World
Health Organisation, 1996 (WHO Technical Report Series.
No.863).
 The International Pharmacopocia, 3rd Ed. Vol. 1, General
Methods or Analysis; Vol: Quality Specifications Vol. 3:
Quality Specifications: Vol. 4: Tests, Methods and General
Requirements. Geneva, World Health Organization, 1979 –
2002.
 Good Storage Practice: Joint Report of The Committee for
Official Laboratories and Medicinal Control Services and
The Industrial Pharmacists Section of The International
Pharmaceutical Federation (FIP). Pharm. Ind., 1980; 42:
1082 – 1085.
 Management of drug Purchasing, Storage and
Distribution. Manual for Developing Countries.
Geneva, World Health Organization, 1992.
 Survey of drug Storage Practices in Homes, Hospitals
and Patent Medicine Stores in Nsukka, Nigeria,
Scientific Research and Essay Vol. 4 (11); 1354 -1359.
 Bajaj S. Singla D, Sakhuja N. Stability Testing of
Pharmaceutical Products J. of Applied
Pharmaceutical Sciences Vol. 02 (03), 2012, 129 –
138.
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