[TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING o ● OUTLINE I II III EXTEMPORANEOUS COMPOUNDING A. Standards of extemporaneous compounding B. Label Preparation C. Pharmaceutical Packing D. Dispensing Procedure On Receipt Of A Prescription For Extemporaneous Preparations E. Ingredient consideration in compounding MEDICATION DISPOSAL A. Types of pharmaceutical waste B. Disposal of medication waste C. General guidelines for the disposal of medication waste D. Minimization of pharmaceutical waste SUITABLE RECORD KEEPING Employ personal handwashing techniques to ensure personal hygiene. Personal Hygiene is extremely important because mediations are being prepared for patients who may already be ill. PERSONAL PROTECTIVE EQUIPMENT ● ● ● ● ● A clean white coat should be worn Safety glasses should always be worn Additional safety equipment (e.g. facemasks, gloves) may also be required. Long hair should be tied back and hands washed, ensuring any open cuts are covered. To protect the compounder from the product and, conversely, the product from contamination from the compounder. CLEAN WORK AREA AND EQUIPMENT IV EQUIPMENT A. Standard balances B. Conical measures C. Mixing and grinding D. Methods of comminution in small scale E. Other equipment’s for compounding ● ● Before starting to compound a product, the work area and equipment should be cleaned with a suitable solution (e.g. industrial methylated spirits (IMS), which must be allowed to dry fully.” The risk of contaminating the final product with either dirt or microorganisms from the surroundings, or from ingredients from a previous preparation, can be considerable if attention is not paid to the cleanliness of the work area and equipment. EXTEMPORANEOUS COMPOUNDING ● ● ● It is important that the compounder adheres to strict procedures to ensure the safety of the patient. Compounder experience and expertise are significant factors in the production of safe and effective extemporaneous formulations. Because of the diversity of the types and number of preparations that can be formulated extemporaneously APPROPRIATE WORK AREA ● ● ● COMPOUNDING (EXTEMPORANEOUS DISPENSING) ● ● A small-scale manufacture of medicines from basic ingredients in the community or in hospital pharmacy (vs. medicines manufactured by the pharmaceutical industry) Extemporaneous dispensing should only be used when medicines are not available commercially in the market: o Low demand o Requires an individual dose (pediatric) o Requires an individual formulation for a patient PREMISES’ STANDARDS ● ● ● ● STANDARDS OF EXTEMPORANEOUS COMPOUNDING ● ● The products produced in the pharmacy must be suitable for use, accurately prepared, and prepared in such a way as to ensure the products meet the required standard for quality assurance. Patients are entitled to expect the standards within a pharmacy to be comparable to those of a licensed manufacturing unit. PERSONAL HYGIENE ● Hygiene standards in a pharmaceutical environment should be as high as, if not higher than, those found in food kitchens Ensure that the work area is suitable for its intended purpose Lighting and ventilation need to be adequate o To prevent mix ups Some pharmaceutical ingredients are highly volatile and if the ventilation within the work area is inadequate this could cause problems for the compounding staff. ● Premises’ decoration should be of a good basic standard. The floor should be covered but in such a manner as to be easily cleaned, surfaces should be smooth, impervious to dirt and moisture, and should be clean and uncluttered. Sinks should be clean and have a supply of hot and cold water. There should be a functioning, clean refrigerator. o Food of staff and medications should not be kept in 1 refrigerator. o Refrigerators used in pharmacies must be capable of storing medicines between 2oC and 8oC and must be equipped with a maximum/minimum thermometer. There should be a supply of mains (potable) water o For cleaning AVOIDANCE OF CONTAMINATION ● ● ● ● Ensure all equipment is clean and dry prior to use. Keep the dispensing area clear of unnecessary items. Do not leave lids off stock bottles: always replace immediately after use. Do not return material to stock containers once removed. PROTACIO, EUCASION, JUQUIANA | 2E-PH 1 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● ● o Do not leave weighed and measured items unlabeled on the work surface. Do not allow raw materials or the final product to come in contact with the hands (if necessary, wear gloves). ● LABEL PREPARATION ● ● The functions of a label are to indicate clearly: o The contents of the container o How and when the medicinal product should be taken or used o How the product should be stored and for how long o Any warning or cautions that the patient needs to be made aware of. Label must be prepared before starting the compounding procedure to: o Enable the product to be labelled as soon as it has been manufactured and packaged o Eliminate the possibility that an unlabeled product will be left on the bench. o Reduce the possibility of the product being mislabeled and given to the wrong patient ▪ If compounded product, you have to write the dosage of the drug and how did you prepare it. ● ● Products for external use o If the product being made is official the official title should be used o If the product is an unofficial one the label title may reflect the type of external product e.g. the nose drops, the mouthwash, etc. o In the case of the product for external use, the quantitative particulars are expressed as the complete formula ● ● Labels must also include an expiry date Warning labels should be required. These may be pharmaceutical or pharmacological warnings. o Enemas: rectal use only o Gargles and mouthwashes: not to be taken o Inhalations: not to be taken o Nasal drops: not to be taken o Pessaries: vaginal use only o Suppositories: rectal use only GENERAL PRINCIPLES OF LABELLING FUNCTIONS OF A LABEL ARE TO INDICATE CLEARLY CONTENTS OF THE CONTAINER ● ● ● The date, name, and address of the pharmacy are also legally required o The words “keep out of the reach of the children” are also legally required All labels must state the name of the product dispensed, the strength where appropriate, and the quantity dispensed Products for internal use o The tile of an extemporaneous preparation if it is an official product o Unofficial products must state the full quantitative particulars on the label o For preparations intended for internal use this is expressed as the amount of ingredient per unit dose How and when the medicinal product should be taken or used How the product should be stored and for how long Any warning or cautions that the patient needs to be made aware of APPEARANCE POSITIONING ● ● ● Medicine bottles: the label should be on the front of a medicine bottle about third of the way down the container Cartons: the label should be placed on the large side of the carton Ointment jars: The label should be placed on the side of the jar CLEANLINESS ● ● ● Ensure the container is clean before packing the products Clean the outside of the container before affixing the label Never pour any liquids into a pre labelled container to avoid the risk of spoiling the label with drips of the medication ● Make sure that the label is secure before dispensing the product to the patient ● The information on the label should be: o Legible o Concise o Adequate o Intelligible o Accurate SECURITY INFORMATION DISPENSED TYPE LABELS (C/O LABELLING) ● All the labels for dispensed medicine must have the name of the patient, preferrable the full name PROTACIO, EUCASION, JUQUIANA | 2E-PH 2 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● ● ● ● All directions on labels should use active rather than passive verbs (e.g. Take two) not “two to be taken” Where possible adjacent numbers should be separated by the formulation name eg “take two tablets three times a day” Liquid preparations for internal use usually have their dose expressed as a certain number of 5mL doses e.g. 5mL spoon = 10mL tds Simple language should be used o Never use the word “take: on a preparation that is not intended for the oral route of administration o Use “give” as a dosage instruction on product for children, as a responsible adult should administer them o Only use numerals when quoting number of milliliters to be given or taken. All the other dosage instructions should use words in the preference to numerals o Always be prepared to give the patient a verbal explanation of the label PHARMACEUTICAL PACKAGING ● ● All dispensed medicinal products will need to be dispensed to the patient in a suitable product container. The function of a container for a medicinal product is to maintain the quality, safety and stability of its contents TO TARE A CONTAINER ● ● ● ● ● ● Measure a volume of water equal to that of the product being prepared. This must be measured accurately using a conical measure Pour the water into the container and mark the meniscus using a small adhesive label Remove the water from the bottle and drain the bottle Transfer the prepared mixture into the calibrated bottle. rinse the measure or mortar used in the preparations of the product with more vehicle and add this to the bottle Add any liquid ingredient and make the mixture up to the volume using the vehicle Remove the meniscus marker before dispensing preparation to the patient CARTON ● ● ● They tend to be rectangular in shape and the label is placed on the larger side of the box They are used to package blister strips of the tablets or capsules, powder papers Additional care must be exercised in the storage of pharmaceutical products in cardboard cartons as they do not come with child resistant closures. IDEAL CONTAINER SHOULD BE ● ● ● ● ● Robust enough to protect the contents against crushing during handling and transport Convenient to use in order to promote good patient compliance Easy to open and close, if required, especially if the medication is for an elderly or arthritic patient Constructed of material that do not react with the medicine, so the materials of constructions should be inert Sufficiently transparent to allow inspection of the content in the case of liquid preparations OINTMENT JAR ● ● ● Can be made of either colorless glass or amber glass Amber ointment jars ae used for preparations that are sensitive to light and to package ointments, creams and individually wrapped suppositories Additional care must be exercised in the storage of ointment jars as they do not come with child resistant closures. DISPENSING PROCEDURE ON RECEIPT OF A PRESCRIPTION FOR EXTEMPORANEOUS PREPARATIONS TABLET BOTTLES ● ● ● ● They come in variety of shapes and sizes They are usually made of either glass or plastic They are usually colored amber to reduce the likelihood of the contents reacting with light They are used for solid single dose preparations that are intended for oral use MEDICINE BOTTLES PLAIN AMBER MEDICINE BOTTLES ● ● ● Can be used to package all internal liquid preparations Two different sides: curved and flat Plain amber medicine bottle com in a variety of sizes FLUTED AMBER MEDICINE BOTTLES ● ● ● They have flat plain side Side is curved and contains a number of ridges or grooves running form the top of the bottle down to the bottom These types of containers are often referred to as external medicine bottles CALIBRATED CONTAINERS FOR LIQUID PREPARATIONS ● A tared bottle is normally only employed when, because of the viscosity of the final product, the transference loss from the measure to the container would be unacceptable PROTACIO, EUCASION, JUQUIANA | 2E-PH 3 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING GUIDE TO AUXILIARY LABELS AND DISCARD DATES FOR EXTEMPORANEOUS PREPARATIONS INGREDIENT CONSIDERATION IN COMPOUNDING SOURCES OF INGREDIENTS ● ● ● A USP, NF or FCC substance is the recommended source of ingredients for compounding all drug preparations. Alternative high-quality source such as analytical reagent (AR) or certified American Chemical Society (ACS) grade may be considered applying professional judgement. Only manufactured drug products from containers labeled with a batch control number and a future expiration date are acceptable as potential source of active ingredients. PROTACIO, EUCASION, JUQUIANA | 2E-PH 4 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● When compounding with manufactured drug products, all ingredients present in the drug product must be considered relative to the intended use of the compounded preparation. ● ● SELECTION OF INGREDIENTS ● ● ● ● ● Variety of forms Examples: o Light Kaolin: Used in suspensions o Heavy Kaolin: Used in preparation of kaolin poultice Synonyms Examples: o Wool fat – Anhydrous lanolin o Hydrous wool fat - Lanolin Concentrated waters o All concentrated waters have the same dilution factor, i.e. 1 part of concentrate plus 39 parts of water yields 40 parts of flavoured water. COMPOUNDING INFORMATION SOURCES COMPOUNDING DATABASES ● Characteristics of inorganic salts, like particle size, tendency to absorb or give off water and pH, affect their physical and chemical properties. Solubility properties of the compound should be considered. EXAMPLES ● ● Acid salts corresponding to an insoluble salt will be more water soluble than the original salt. Sulfides are water-insoluble, except for their alkali metal salts. COMPOUNDING WITH ORGANIC SALTS ● ● ● Many drugs are “salts”, and the dose may be based on the “total salt” form or just the “base” form of the drug. Because many drugs are either weak acids or weak bases and have limited water solubility, they are often used as their “salts” to increase their aqueous solubility. Salt forms may also be used to enhance the stability and change other attributes of the drug to aid handling during compounding www.CompoundingToday.com EXAMPLES REFERENCES ● ● ● ● ● ● ● ● ● ● ● ● The Art, Science and Technology of Pharmaceutical Compounding Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems Handbook of Extemporaneous Preparation Pharmaceutical Compounding and Dispensing Merck Index Remington: The Science and Practice of Pharmacy Applied Pharmaceutics in Contemporary Compounding A Practical Guide to Contemporary Pharmacy Practice Trissel’s Stability of Compounded Formulations Handbook of Injectable Drugs USP/NF SPECIAL CONSIDERATIONS ● ● ● ● ● ● ● ● Compounding with hydrates and solvates Compounding with inorganic salts Compounding with organic salts Compounding with esters Compounding with aliquots, dilutions & concentrates Compounding with “potency-designated” ingredients Compounding with complex organic molecules Compounding with commercial products COMPOUNDING WITH HYDRATES AND SOLVATES ● The more molecules of water present in the molecule, the more of the chemical should be weighed to obtain the actual active drug. ● COMPOUNDING WITH ESTERS ● ● ● ● ● ● ● Dexamethasone contains less than 0.5% of its weight in water. Dexamethasone acetate has one molecule of water of hydration and contains between 3.5 and 4.5% water; the anhydrous form contains less than 0.4% water. Dexamethasone sodium phosphate contains a sum of water and alcohol that may be up to 16.0%. COMPOUNDING WITH INORGANIC SALTS Esters are prepared for solubility and stability purposes, to enhance resistance to degradation after administration and for use as prodrugs. Some drugs may cause pain at the site of injection, especially if they precipitate and damage the surrounding tissue. This may be overcome by preparing a drug with increased solubility. Since some drugs may occur in salt forms, ester forms, and/or salt-ester forms, it is important to document what form is used and whether it is a salt, ester, or combination. Some drugs are very soluble but tend to degrade easily when in solution. To increase stability, esters that are poorly soluble are prepared. “suspension” dosage form in place of a “solution” dosage form. A drug in suspension degrades at much slower rate than in solution. After oral administration, the ester is cleaved, and the active drug moiety released for absorption. EXAMPLES ● ● ● Erythromycin estolate is a salt. Erythromycin ethylsuccinate is an ester. Erythromycin stearate is a salt. COMPOUNDING WITH ALIQUOTS, DILUTIONS & CONCENTRATES EXAMPLES ● Albuterol Sulfate Tablets, USP, are based on the “albuterol” content (present as sulfate form). Diphenhydramine Hydrochloride Capsules, USP, are based on the total molecule. ● ● Reasons for preparing aliquots, dilutions and concentrates: o Quantities required for dosing or compounding are too small for accurate weighing. o Some items (e.g nitroglycerin) are explosive and must be diluted for safe handling. o Many substances, such as acids & bases, are commercially available in percentage strengths that vary from one acid to another. Diluted acids are aqueous solutions 10% w/v, but diluted acetic acid is 6% w/v. Concentrations of official undiluted PROTACIO, EUCASION, JUQUIANA | 2E-PH 5 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING acids are expressed as percentages weight in weight (w/w), but the strengths of official diluted acids are expressed as percentages weight in volume (w/v). Therefore, it is necessary to consider the specific gravities of the concentrated acids, when calculating the volume required to make a given quantity of diluted acid. COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS ● ● ● Some antibiotics, endocrine products, biotechnologyderived products, and biologics, have potencies that are based on “activity” and are expressed in terms of “units of activity”. There is no relationship between the units of potency of one drug with another different drug. Determinations of potency are done on the “dried or anhydrous” basis o ● ● ● According to the USP, for substances that cannot be fully characterized by chemical and physical means, it may be necessary to express quantities of activity in biological units of potency, each defined by an authoritative, designated reference standard. The potency of antibiotics is commonly expressed as “mcg of activity per mg of substance”. In some drugs, the actual dose may be expressed in units, instead of mg. o Example: heparin and insulin Each container must be labeled with the actual potency, and this information is to be used in calculations involving dosing prior to compounding. COMPOUNDING WITH COMPLEX ORGANIC MOLECULES ● ● ● ● Most complex molecules and biotechnology products are proteins. Proteins are inherently unstable molecules and require special handling, and their degradation profiles can be quite complex. The pharmacist must be knowledgeable on their stabilization, formulation and delivery to the site of action. Protein drugs are very potent and are used in quite low concentrations. The bulk of compounded preparations may be the excipients, including the vehicle, buffers and stabilizers. ● In general, compounding with complex organic molecules require special formulation, compounding and packaging considerations, thus appropriate skill and care should be applied. COMPOUNDING WITH COMMERCIAL PRODUCTS ● ● ● ● ● ● ● ● ● pH is key to formulating a stable preparation. o Physiologic buffers may be used to obtain optimal pH range. o An increase in buffer concentration means an increase in pain on injection Chelating agents are added to bind trace metals, like copper, iron, calcium and manganese, and minimize rates of degradation. o Example: EDTA (0.01-0.05%) Antioxidants are incorporated to prevent protein degradation due to oxidation. o Examples: ascorbic acid, sodium disulfide, tocopherol (0.05-0.1%) Preservatives may be required, especially if multiple dose vials are prepared o Examples: phenol, chlorobutanol and benzyl alcohol Oral tablets and capsules are commonly used to prepare oral liquids (solutions and suspensions) for pediatric use, and injectable drugs to prepare intravenous admixtures. Use of commercial products as source of API usually result in higher prescription cost. Uncertainties in compounding involve the presence of excipients and actual assay potency. The presence of buffers in the commercial drug product may influence and dictate the pH of the final compounded preparation. Modified-release dosage forms, including extendedrelease, delayed-release, repeat-action and targeted release, should not be used in compounding unless it has been indicated or documented that they can be used. When using commercial products in compounding, it is important to list the manufacturer, lot number, and expiration date of the product used. MEDICATION DISPOSAL ● ● The most appropriate method for medication disposal is based on government regulations, environmental impact, type, volume and toxicity of medication being disposed, setting and risk of diversion. Optimal method of medication disposal is by incineration. TYPES OF PHARMACEUTICAL WASTE HAZARDOUS WASTE ● ● ● ● FACTORS TO BE CONSIDERED ● Addition of stabilizers (e.g. polyols at 1-10%) and tonicityadjusting agents (e.g. sodium chloride and dextrose). I. II. III. IV. V. VI. VII. Ignitable o aqueous drug formulations containing >24% alcohol by volume, oxidizers or materials that readily supply oxygen to a reaction in the absence of air (e.g. AgNO3 applicators), and flammable aerosol propellants. Corrosive o agents with pH<2 or >12.5 and include glacial acetic acid, NaOH Reactive Toxic o include heavy metals like barium, selenium and thimerosal ASHP list of dangerous pharmaceutical waste: P (acutely hazardous) or U list (toxic) drugs (discarded commercial chemical products that are acutely hazardous or toxic) Chemotherapy agents Drugs with LD50 of <50 mg/kg Endocrine disruptors Immunosuppresants Drugs meeting NIOSH or OSHA criteria Drugs with potential toxicity due to chromium, selenium or cadmium REGULATED MEDICAL WASTE ● ● biohazardous waste or infectious medical waste waste contaminated by blood, body fluids, or other potentially infectious and sharp materials PROTACIO, EUCASION, JUQUIANA | 2E-PH 6 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● UNIVERSAL WASTE ● commonly generated hazardous waste like batteries, pesticides, mercury-containing products and bulbs/lamps. CONTROLLED SUBSTANCE WASTE NON-HAZARDOUS MEDICAL WASTE DISPOSAL OF MEDICATION WASTE ● ● ● ● ● ● ASHP recommends that healthcare facilities have a multidisciplinary waste management team. Hazardous waste must be incinerated at an EPA-approved facility. Nonhazardous pharmaceutical waste should be disposed of in a medical waste or municipal incinerator. Disposal by sink or toilet has resulted in increased levels of pharmaceuticals in rivers, streams and drinking water supplies. Medications thrown in the trash with prescription labels still on them contain personal information which can promote identity theft. Disposal of medications in the trash can lead to accidental exposure of children, pets and wildlife, and can also lead to pharmaceutical drug diversion. the completion of the record will be another safety check for the patient and is an essential part of any standard operating procedure for extemporaneous dispensing. ● Other records (e.g. fridge temperatures) should be routinely recorded. ● The notes section is added to allow for any special instructions with regard to method of preparation. ● Extemporaneous record sheets should be kept for a minimum of two years, although ideally five years would be advisable. Extemporaneous Dispensing Record: o As much as possible, have someone to double check calculations. GENERAL GUIDELINES FOR THE DISPOSAL OF MEDICATION WASTE ● ● ● ● ● ● ● ● ● Utilize medication collection programs whenever possible. Do not flush away medications. When disposal programs are not available, throw away unwanted medications in the trash using appropriate safeguards Utilize medication collection programs whenever possible. Do not flush away medications. When disposal programs are not available, throw away unwanted medications in the trash using appropriate safeguards Place mixed contents in a sealable bag, empty canister or other container to prevent the medication from leaking or breaking out of a garbage bag. Throw the container away in household trash. Remove any personal information prior to throwing the containers away in the garbage. MINIMIZATION OF PHARMACEUTICAL WASTE ● ● ● ● ● ● ● ● Controlling inventory levels Using just-in-time dispensing and compounding practices Dispensing smaller quantities Reconsidering 3-month supplies or automatic refills Using available tools to prevent ADRs and interactions Improving compliance Minimizing prescription drug therapies, when appropriate Pharmacists should play a significant role in minimizing pharmaceutical waste and educating consumers about appropriate disposal of medications. ● Suitable record keeping is a vital part of good extemporaneous preparation because poor record keeping can lead to dispensing errors which could result in the patient receiving a product other than that intended by the prescriber.” EQUIPMENT ● ● ● A wide variety of equipment is used in extemporaneous dispensing, depending on the product type to be prepared The selection of complete equipment or ‘tool’ for the job is essential The equipment must be used in the correct way EQUIPMENT REQUIREMENTS SUITABLE RECORD KEEPING WEIGHING AND MEASURING PROCEDURE PROTACIO, EUCASION, JUQUIANA | 2E-PH 7 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● ● o o o It is preferable to incorporate a weighed or measured ingredient into a product as soon as possible to prevent any accidental switching. When weighing or measuring more than one ingredient, place each on a piece of labelled paper as soon as it has been weighed or measured. Used to weigh amounts below 150 mg. It has an accuracy of ±1mg. Minimum amounts that are weighed on these balances are 50 mg for non potent substances, increasing to 100 mg for potent substances. WEIGHING ● ● When weighing pharmaceutical substances, the Systeme International d’Unites (SI) based around the gram (g), is the system that is used. For weights less than 1 mg, the units of the weight are usually written in full to avoid confusion could then result in dosing errors of one thousand times plus. BALANCES FOR WEIGHTS GREATER THAN 50 G ● STANDARD BALANCES ● ● The balance most commonly found in the pharmacies will be either a traditional ‘Class II’ dispensing beam balance or a modern electronic equivalent. Class II balances are similar to older Class B balances and use the same weighing techniques. BALANCES (traditional) o Different types of balance are designed to weigh within different ranges to differing degree of accuracy. o Balances used in pharmaceutical environmental: ▪ Class II balance or electronic equivalent. ▪ Sensitive electronic balances ▪ Balances for weights greater than 50. o Balances have different accuracies, precision and tolerance. o Classes of balances with their weighing capabilities ANALYTICAL BALANCE MEASURING ● ● ● ● TYPE MINIMUM WEIGHT NORMAL MAXIMUM WEIGHT CLASS A 50 mg 1 mg 1g CLASS B 100 mg 10 mg 50 g CLASS C 1g 100 mg 2 kg Ex. Pptabs – class A, Activated charcoal – class C INCREMENT ● ● Class I, Class II, Class III, and Class IV Class B balance – most commonly used balance in dispensing Class II balance is its nearest equivalent CLASS II BALANCES ● ● ● ● A traditional Class II dispensing beam balance is marked with a maximum weighable quantity of 25 g and a minimum weighable quantity of 100mg. ELECTRONIC PHARMACY BALANCES ● ● In general conical rather than cylindrical are used in pharmacy practice because: o They are easier to fill without spilling liquid on the sides above the required level. o They are easier to clean after use. Compared to cylinders, with conical measures, it is harder to read the meniscus accurately and it is difficult to estimate volume between graduations. In measuring large volumes, this is used because it is more accurate than syringes REMINDERS WHEN MEASURING LIQUIDS ● ● ● ● Liquids are universally measured in liters For volumes less than 1 mL, the units of the weight are usually written in full. It is also best practice when referring to volumes in multiples of liters to write the word “liter” or “liters” in full. Two main types of vessel used within pharmacy for measuring liquids: o Conical measures o Syringes Graduated cylinders and beakers can also be used CONICAL MEASURES NEW CATEGORIES OF BALANCES ● ● These balances are designed to weigh weights over the maximum weighable weight (i.e. 25 g) of a class II balance or electronic equivalent. The scale pan is made of metal than glass. Solids are weighed into a watch glass, greasy solids on a greaseproof paper and liquids into a small pot. Tare the balance with the container beforehand to ensure that only the weight of the ingredient will register on the display. Sensitive Electronic Balances ● ● ● The bottom of the meniscus should be in line with the desired graduation mark. When reading, ensure that the eye is in line with the meniscus to avoid parallax error. The measure should be on a flat surface. When measuring dark or colored liquids, place a piece of white or colored card or paper behind the measure. Avoid spilling of any liquid down the side of the measure to prevent adding incorrect amount of a substance in the preparation. PROTACIO, EUCASION, JUQUIANA | 2E-PH 8 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING MEASURING LIQUIDS CORRECT USE OF A MORTAR AND PESTLE ● ● MIXING AND GRINDING MORTAR AND PESTLE ● ● ● ● Mortars and pestles are used to: o reduce the particle size of powders o grind crystals into powder form o mix powders o mix powders and liquids o make emulsions ▪ It should be noted that the mortar is the bowl and pestle is the pounding/shearing/grinding implement, so compounders mix in a mortar with a pestle. Mortar (bowl) and pestle (pounding device) Used to reduce the size of powders, mix powders, mix powders and liquids, and make emulsions. Two types, each in varying size are used ● ● ● ● Size reduction using a mortar and pestle o Selection of the correct type of mortar is vital o A flat-bottomed mortar and pestle with a flat end should be chosen o A flat-ended pestle in a mortar with a round bottom, or vice versa, will mean a lot of wasted effort Using a mortar and pestle for mixing powders o Overfilling of the mortar should be avoided o Pestle should be rotated in both right and left directions to ensure thorough mixing o Undue pressure should not be used to prevent impaction of the powder on the bottom of the mortar When using a mortar and pestle to reduce substances to fine particles: o The powder is placed in the mortar and the pestle is used to rub down in a lateral shearing manner on the powder o The pestle is given a circular motion accompanied by downward pressure ▪ Not too much pressure as the powder can become compacted on the bottom of the mortar The most effective way to use the pestle is to start in the center of the mortar and make a circular motion on the powder, gradually increasing the diameter of the circle with each revolution until the sides of the mortar are touched, then reverse the process, making the circles smaller with each revolution until the center is reached again. The pestle therefore follows a spiral track around the mortar Mortars and pestles need to be matched <3 o Flat bottomed mortar will need a flat headed pestle o Round bottomed mortar will need a round headed pestle METHODS OF COMMINUTION IN SMALL SCALE ● TWO MAIN TYPES OF MORTAR AND PESTLE ● ● Glass o Not usually used for the production of large quantity products as they are usually fairly small o Surfaces of a glass mortar and its pestle are very smooth, making them less suitable for size reduction of powders o Efficient when grinding crystals into powder form o Useful when dissolving small amounts of medicament or when incorporating substances that are absorbed by and stain porcelain mortars o For mixing of substances such as dyes which are absorbed by and stain composition or porcelain mortars Porcelain o These lend themselves to larger scale production o Are ideal for the size reduction of powders, for mixing powders with other powders, for mixing powders with liquids, and for the preparation of emulsions ● ● Trituration - is the process of grinding a powder in a mortar and pestle to reduce its particle size. Pulverization by Intervention - is the reduction of particle size with the aid of a second agent which can be readily removed from the pulverized product o Example: Applies to camphor where it is readily triturated when a few drops of alcohol or other volatile solvent is added. The pulverized camphor is readily recovered as the solvent evaporates. Levigation - is the process of reducing particle size by first forming a paste of the solid with a minimum amount of a levigating agent and then triturating the paste in a mortar or on slab with a spatula. TILES ● ● ● Ointment tile or slab is used to prepare ointments by means of trituration or levigation Tiles are usually made of glazed porcelain or glass Tiles should be large enough for the quantity of ointment to be prepared STIRRING RODS PROTACIO, EUCASION, JUQUIANA | 2E-PH 9 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● ● ● Are used to agitate liquids to speed up the process of dissolution of solids Usually made of glass Care must be taken not to stir too vigorously as this may cause the stirring rod to break BURNER PIPETTES ● ● When measuring small volumes a syringe is used but syringes are less accurate than pipettes and so traditionally small volumes have been measured using graduated pipettes Two types of pipette are employed, either ‘drainage’ or ‘blow out’ NOTE: Syringes have a high degree of accuracy and are readily available in most pharmacies Bunsen burner WATER BATHS ● ● ● SUPPOSITORY MOULDS ● ● ● Used to clarify liquids Coarse filtration or straining – carried out by pouring the liquid through muslin. Filter paper or sintered glass filters – used when finer degree of filtration is required. o Disadvantage: can introduce fibers into the filtrate and may also absorb significant amounts of active ingredients. SINTERED GLASS FILTERS MANIPULATIVE TECHNIQUES ● MIXING o Goal: To ensure that even distribution of all the ingredients has occurred. o If a sample is removed from any part of the final preparation it should be identical to a sample taken from any other part of the container. ● Simple stirring or shaking is usually all that is required to mix two or more liquids. Degree of mixing will depend on the viscosities of the liquid. o Liquids of low viscosities – minimal stirring o 2 Liquids with high viscosity – vigorous agitation MIXING OF LIQUIDS ● MIXING SOLIDS WITH LIQUIDS ● FILTERS A heat supply is needed for the production of suppositories, pessaries, ointments and creams. The item to be melted is placed in an evaporating basin over a water bath containing hot water and allowed to melt. Heat sources: Bunsen burner or Hot plate. NOTE: As most products only need to be melted gently, there is no necessity for the water in the bath to be boiling rapidly. ● Suppositories and pessaries are made using the same mould. ● The traditional moulds are made of metal with two or three sections held together with a screw fixing. ● Metal moulds allow the suppositories to set quickly because of their efficient heat transfer. NOTE: When no weight is specified a 1g mould is used for suppositories and the larger 4 g and 8 g moulds are used for pessaries. o This is an advantage when making suppositories that contain an insoluble medicament, because it does not allow time for the suspended solids to settle by sedimentation. ● After removal from the mould, the suppositories used to be dispensed in partitioned boxes of paper board, metal or plastic and lined with waxed paper. ● Nowadays, in small scale production the use of aluminum foil is recommended for wrapping. Tirril burner Factors to consider: o Solubility of solids o Particle size reduction NOTE: These factors may either speed up the dissolution process or improve the uniform distribution of the solid throughout the liquid. MIXING SOLIDS WITH SOLIDS ● Stages of mixing: o The ingredient with the smallest bulk is placed in the mortar. o A quantity of the second ingredient, approximately equal in volume to the first is added and carefully mixed, using the pestle. o A further quantity of the second ingredient, approx. equal in volume to the mixture in the mortar, is now added. o This process, known as “doubling-up”, is continued until all the powder has been added. MIXING SEMI-SOLIDS PROTACIO, EUCASION, JUQUIANA | 2E-PH 10 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● ● Occurs in the preparation of ointments where two or more ointment bases may be mixed together. METHODS OF MIXING: o Rubbing them down on an ointment slab, using spatula. o Fusion method ▪ Do not add any solid active ingredients to the basin before the bases have set. Addition of any further ingredients is best done by rubbing down on an ointment slab. Tablet Counting Tray FrymaKoruma MaxxD is a modular system for the manufacture of emulsions and suspensions in a wide viscosity range COUNTING DEVICES MANUAL METHOD CAPSULE COUNTERS o This consist of pouring the product onto a piece of clean white demy paper which overlaps another piece. o The product are then counted off in 10’s using a spatula, onto the second piece of paper. o This is formed into a small funnel and the tablets/capsules poured into the appropriate container NOTE: Problems with this method are that demy paper is becoming increasingly difficult to obtain ● ● PERFORATED COUNTING TRAYS ● ● ● COUNTING TRIANGLES AND CAPSULE COUNTERS COUNTING TRIANGLES ● ● ● ● ● ● ● ● Fast, accurate and simple way to count tablets Based on Pascal’s Triangle Made either of metal or plastic The capsule counter was designed to allow easy counting of capsules in rows of 10. For both, the tablets or capsules are placed on the counter and any excess removed using a spatula. Two rows of figures are printed or etched along the edge. Top row of figures – number of rows Numbers below – number of tablets contained in that number of row. Metal rows consisting of 10 rows of grooves. Efficient method of counting capsules ● Made of clear perspex Consist of rectangular box with a sliding lid, on top of which is placed in perforated tray An experienced operator can count quite quickly using this type of counter, but the novice can find it quite frustrating. Disadvantage: necessity to change the trays for different products ELECTRONIC COUNTERS ● ● Electronic Balance o Between 5 and 20 of the dosage form is put on a balance pan. o From the weight of this, a microprocessor within the device calculated the total number of dosage forms, as they are added. o Disadvantages: ▪ For accurate counting, it requires consistent uniformity of the weights of capsules/tablets. ▪ More problematic when dealing with very small tablets or sugar-coated tablets ▪ Balance needs to be recalibrated for each type and size of dosage form counted ▪ It is very sensitive to vibration and air movement. Photoelectric Cell Counters o Products to be counted is poured through a hopper on the top of the machine. o The tablets/capsules are then channeled into straight line and counted as they are interrupted by a beam of light to the photoelectric cell. o Accurate PROTACIO, EUCASION, JUQUIANA | 2E-PH 11 [TRANS] UNIT 9: EXTEMPORANEOUS COMPOUNDING AND DISPENSING ● Disadvantages: o They do not discriminate between whole or broken or fragments of tablets o Cannot count clear or transparent capsules o The speed of pouring must be controlled, if not the system will not cope. o Difficult to clean REFERENCES Notes from the discussion by Assoc. Prof. Nelson Tubon, Ph.D. University of Santo Tomas powerpoint presentation: Extemporaneous Compounding and Dispensing PROTACIO, EUCASION, JUQUIANA | 2E-PH 12 [TRANS 11]: PROCESSING THE PRESCRIPTION I II III OUTLINE Steps In Processing The Prescriptions Magistral Pharmacy How Is A Prescription Processed A Receiving the Rx B Reading and Checking the Rx C Numbering and Dating the Rx D Labeling the Rx i Standard Requirements for Labeling Dispensed Medicines E Preparing the Rx F Packaging i Types of Containers Generally Used G Rechecking H Delivering the Prescription i Provide Patient Counseling I Recording J Pricing K Filing 9. Patient receives script, pharmacy assistant must offer counseling to the patient. Then script is rung on cash register, and insurance log signed 10. Pharmacist provides counseling on the medication prescribed and all medically related questions. ● ● ● STEPS IN PROCESSING THE PRESCRIPTIONS • • • • • • • • • MAGISTRAL PHARMACY Most important division of true pharmaceutical practice. Preparation or compounding & dispensing of prescriptions extemporaneously or as the occasion or physician’s needs may require. o Any medicinal product prepared in pharmacy (in accordance w/ medical prescription or prescription for an individual patient) o Official preparation means any medicinal product which is prepared in pharmacy in accordance w/ prescriptions of pharmacopeia and is intended to be The extemporaneous compounding of prescription is an activity for which pharmacists are qualified by virtue of their education, training and experience. HOW IS A PRESCRIPTION PROCESSED Receiving the Prescription Reading and Checking the Prescription Numbering and Dating Prepare the Label Compound and Package the Drug Product Recheck the Label of the Product vs the Rx Check the Price of the Product and Inform the Patient Delivering the Product and Provide Patient Counseling Recording and File the Rx STEPS IN PROCESSING Rx ORDER Pharmacy Assistant should: o Give the price of the product o Get the payment for the product (from the patient) ▪ The pharmacist/pharmacy assistant will prepare the medicine o Deliver the drug product 1. 2. 3. 4. 5. 6. 7. 8. Prescription written by authorized prescriber (in other countries) Patient presents prescription to the pharmacy Prescription is checked for completeness; prescriber info, drug name, strength, dose and directions Correct patient info is entered into computer system (by person at the counter) Prescription is interpreted and confirmed by pharmacy system. Third party is billed online (optional) Pharmacy label is generated. Make sure all the legal items are identified Prescription is prepared. Correct amount of med prescribed is measured and placed into container Prescription is prepared by pharmacy technician and final check done by pharmacist. ● ● 1. RECEIVING THE Rx Enhance the pharmacist patient relationship Patient may be asked for a brief health and medication history PHARMACIST should: o Estimate length of time required to fill the Rx o To price the Rx if requested by the patient For drugs with interactions (food-drug interaction, drug-drug interaction and drug-lifestyle interaction), pharmacist must consider alternative drugs and consult the physician to determine the best therapeutic alternative for the patient o Need to check the therapeutic classification of the drug and ask yourself ‘is the prescription right for him/her’ o Ensure dosage is both safe and appropriate based on age and weight EUCASION, PROTACIO, TANSIONGCO | 2E-PH 1 TRANS [11]: PROCESSING THE PRESCRIPTION o o o If something is illegible or if it appears that an error has been made, pharmacist should consult another pharmacist or the prescriber o When a pharmacist receives a prescription, they must check is the prescription is valid and prescriber has prescribed w/ their permit o Remember that upon receiving a prescription, evaluate if it has prescriber details/physician info, patient details (like age, weight, medical conditions, allergies), confirm medication items to be dispensed, confirm indication, preference details and prescription meets legal requirements (including date, drug, strength, instructions and signature) ● ● ● ● Read the Rx in the privacy of the prescription department There should be no doubt as to the ingredient or quantities prescribed o Prescription is usually written on a pre-printed pad w/ doctor’s name, address and phone number o Found on the top or bottom of prescription is the special identification numbers such as S2-license of physician, if that will be dangerous drug, regulated/prohibited drug or controlled substances o There is space for your name and address, age, date, place for doctor’s signature and blank area for doctor to write following directions: name, dose, how often to take, when to take and how to take the medication If something is illegible or if it appears that an error has been made. Pharmacist should consult another pharmacist (copharmacist) or the prescriber. Should verify omission or failure to specify desired strength of medication or its dosage form, should be corrected o Always consult the prescriber DOSE BE Age Weight and condition of patient Possible influence of other drugs being taken Frequency of administration (if drug is taken twice a day, thrice a day, every 6 hours or once a day) PHARMACIST ● ● Should consult the prescriber Familiar with available strengths and dosage forms of prefabricated drug products, to detect such omission and provide the physician with necessary information ● It is a universal practice to number the Rx order and to place the same number on the label. To identify the bottle or package & to connect it with the original medication order (reference) Numbering of Rx: o Consecutive numbers may be assigned by the use of a numbering machine. Dating of the prescription: o On the date filled/compounded to establish identity & should never be omitted ▪ Must date every prescription w/ date you gave to the patient ● ● ● 3. NUMBERING AND DATING THE Rx ▪ ▪ Prescription number is prescription being an abbreviation for prescription. This number identifies your prescription Numbers are assigned in the order filled at the pharmacy When calling for a refill, providing this number for easy identification by pharmacy staff WHAT IS THE PURPOSE OF NUMBERING AND DATING THE PRESCRIPTION? ● ● ● ● 2. READING AND CHECKING THE Rx THE SIZE AND FREQUENCY OF CAREFULLY NOTED AND CHECKED: ● ● ● ● ▪ Ensure medication is compatible w/ current medical conditions and allergies Ensure medication is compatible w/ other medication being taken Ensure prescription is appropriate for the condition being treated ● ● ● ● The same number of the original prescription should appear at the label of the filled prescription – to avoid error in dispensing The date of the prescription is not the same date that should be placed on the filled prescription – for identification purposes 4. LABELING THE Rx Prescription label - prepared by pharmacist, an assistant may be employed for this purpose Rx labels should be computerized or typewritten to make them neat, attractive and legible o Preparing label is one of the most important aspect of dispensing a prescription o The label must comply w/ FDA regulations and should correctly and clearly convey all necessary information regarding dosage, mode of administration, and proper storage of the product o The quality of labeling is extremely important to patient’s perception of the quality of the product and may have profound implications for his/her safe use of medication and compliance w/ prescribed regimen o Labeling of medication encompasses the provision of information and instructions to ensure safe and effective use of product by patients o The label of dispensed medication represent one of the most important sources of information available to patient A prescription should have an aesthetic and professional appearing label The size of the label should be in conformance with the size of the prescription container Name, address and telephone number of the pharmacy are generally imprinted in the label The pharmacist should give clear directions to the patient and complete as possible LABEL OF COMPOUNDED RX SHOULD INCLUDE: ● ● ● ● ● ● ● ● ● ● Name and address of the pharmacy Date of filling/dispensing Prescription number Prescriber’s name Patient’s name Name and strength of the medication Directions for administration/use Manufacturer’s lot number and expiration date Auxiliary and cautionary labels Name and initials of the dispensing pharmacists LABEL OF UNIT DOSE RX SHOULD INCLUDE: ● ● ● ● ● ● ● Prescription number Name of patient Generic name of drug Brand name Manufacturer Dosage strength Expiry date EUCASION, PROTACIO, TANSIONGCO | 2E-PH 2 TRANS [11]: PROCESSING THE PRESCRIPTION ● ● Directions for use Name of pharmacist ● NOTE: Labels may come w/ more information including adverse effects, warnings, auxiliary information including specific alerts that help the patient take the medication safely as intended. The auxiliary label can include the route of administration or medication, what to avoid, how to take it. ● AUXILIARY LABELS – emphasize a number of important aspects of the dispensing medication including: o Proper use o Handling o Storage o Refill status o Necessary warning and precautions ▪ Example: “Shake well”, “POISON”, “Should Not Be Swallowed”, “Keep Out of Reach of Children” ▪ Other examples: “Take medication with full glass of water”, “Refrigerate and shake well”, “Take with food” “For the nose”, “Do not drink alcoholic beverages while taking this medication may cause dizziness”, “Take with nitrates” or “Take medication on an empty stomach” Pharmacist may supplement the instruction or direction of the prescriber to clarify and expand the instruction o Eg. If to be taken with water, with or without food, activities to avoid when taking the medication (like exercise) Patient product information must be provided with the dispensing of certain drugs o Helps pharmacist to reinforce effort during counseling o Pharmacist should assist patient to interpret the information contained in the product information STANDARD REQUIREMENTS DISPENSED MEDICINES ● ● ● FOR LABELING Name of the preparation, strength and form o The name which appears on the label must be the same as the one which appears on the prescription Quantity o The quantity which appears on the label will be the quantity which has been prescribed Instruction for use o No patient should leave a pharmacy without knowing: ▪ How much ▪ How often ▪ How to use 5. PREPARING THE Rx Pharmacist should organize the method to be used Information Necessary: ● Compatibility of the ingredient o Chemical compatibility measures how stable a substance is when mixed w/ another substance o If two substances can mix together and undergo a chemical reaction, they are considered incompatible o Chemical compatibility is important when choosing materials for chemical storage/reactions that vessel and other apparatus will not be damaged by its contents o For purposes of chemical storage, chemicals that are incompatible should not be stored together so that any leak will not cause even more dangerous situation by reacting after leaking o Chemical compatibility refers to the container of material being acceptable to store the chemical or for an object that comes in contact w/ chemical to not degrade ● ● ● ● ● Adjuvant used o Adjuvants is an ingredient (in prescription or solution) that modifies the action of the principal ingredient o This is a drug or method that enhances the effectiveness of medical treatment Order of mixing o Step by step order that needs to be followed Amount of each ingredients o Weigh accurately each ingredient Capsule size o If you will be preparing capsule Type and size of container Name and product identification number of manufacturer. In partial filling of the prescription, the following should be written on the face of the prescription: o Date of partial filling ▪ Should be placed on the face of prescription o Quantity served and balance unserved ▪ Should be specified, some are doing it by placing a circle o Name and address of the drugstore ▪ There is a rubberstamp for you to place the name and address of the drugstore ▪ Sometimes the initial of the pharmacy is stated ● ● ● ● ● • • ● ● Partially filled Rx should be returned to the buyer after recording the partial filling in the Rx book o Whoever who will be dispensing the remaining quantity should be the one to file the prescription Partial filling of prohibited or List A drugs shall not be allowed. o Especially the dangerous drugs or regulated/prohibited drugs 6. PACKAGING Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale and use. It also refers to the process designing, evaluating and producing packages. It protects, preserves, transports, informs and sells. The primary purpose of packaging is to protect its contents from any damage that could happen in transport, handling, and storage. Retains the product intact throughout its logistics chain from manufacture to the end user. It protects product from humidity, light, heat and other external factors Pharmacist should consider the size, shape, mouth opening, color and composition in packaging o Packaging selection is based primarily on the type and quantity of medication to be dispensed. 3 types of packaging: primary, secondary and tertiary Use appropriate containers: o Low viscosity: ordinary Rx bottles o High viscosity: tablets in bulk, wide-mouth o Semi-solids: tubes, ointment jar o Powder: papelitos (or paper tablets) o Ophthalmic solutions: dropper bottle/applicator bottle Size of bottle should be enough to hold the content o Emulsion: space allotted for shaking ▪ Remember you are going to place “Shake well” label as part of auxiliary label If not sensitive: colorless If active ingredient is sensitive: amber colored (avoids photo degradation) PLASTIC CONTAINERS ● Advantages: o Lightness of weight, resistance to breakage, versatile design EUCASION, PROTACIO, TANSIONGCO | 2E-PH 3 TRANS [11]: PROCESSING THE PRESCRIPTION ● Disadvantages: o Permeable to atmospheric gases & moisture vapor o Subject to leaching – component of the container mixes with the active ingredient o Deformed with extreme temperature • • TYPES OF CONTAINERS GENERALLY USED • • • • • • • • • Round Vials – for solid dosage forms as capsules and tablets Prescription Bottles – for dispensing liquids of low viscosity Wide Mouth Bottle – used for bulk powders, large quantities of tablets or capsule and viscous liquid Dropper bottle – for ophthalmic, nasal, otic, or oral liquids to be administered by drop Application bottle – used for applying liquid medication to a wound or skin surface Ointment jars and collapsible tube – ointment and creams Sifter-Top Container – for powders applied by sprinkling Hinger lid or Slide Boxes – for suppositories and powder packet Aerosol Container – pharmaceutical aerosol product PHARMACIST SHOULD CHECK FOR • • • • • Permeability of containers to atmospheric gases and to moisture vapor o Permeability is the quality or state of being permeable, able to be penetrated or pass through especially by a liquid or gas Leaching of constituents of the container to internal content o Leaching is the removal of a solute from a porous solid using a liquid solvent or when liquid substances are used to remove porous solid this is the process used Absorption of drugs from content container o The chemical composition of the drug and environment to which a drug is placed work together to determine the rate and extent of drug absorption Transmission of light through the container o Light transmission – when light travels through a medium (glass) without being reflected, absorbed or scattered. When this happens the light energy is not lost and considered 100% transmitted Alteration of the container on storage, particularly at extremes in temperature (specific pharmaceutical product) CHILD RESISTANT CONTAINERS • • ● • • • • To prevent accidental poisoning resulted from ingestion of medication and other household chemicals by children. With safety closures A child resistant container is designed to be difficult for a child to open. It is developed to prevent children getting access to contents of medicine packaging. They are tested to ensure young children cannot open them Exempted: o Oral Contraceptive o Cardiac Drugs o Products for childless person, arthritic and debilitated patient o Products used in institutionalized setting Reasons for Exemption o The container is not appropriate, feasible or practical o Quick access to medication 7. RECHECKING The importance of this step should not be overemphasized Every Rx should be rechecked by the Pharmacist (ingredients and amounts used) • • • All details of the label should be rechecked against the Rx order to verify directions, patient’s name, Rx number, date and prescriber’s name Rechecking should be done at least 3 to 4 times o Before getting from the shelf o While preparing the product o When returning the containing o Before dispensing the medication 8. DELIVERING THE PRESCRIPTION The pharmacist personally presents the prescription medication to the patient unless it is to be delivered to the patient`s home or office Gives assurance that the patient understands how to use the medication properly Make certain (if personal delivery is not possible) appropriate instructions are provided and encourage the patient to call should there be any questions PROVIDE PATIENT COUNSELING The pharmacist must offer to discuss the following: ● Information on the drug ● Dosage form (like tablets, capsules, suspensions) ● Route of administration ● Special directions for use ● Common side effects or interactions ● Therapeutic contraindications ● Technique for self-monitoring drug therapy ● Proper storage ● Prescription refill information ● Action to be taken in cases of missed dose NOTE: Written information may supplement but not replace oral counseling requirement. Pharmacist may also obtain, record and maintain profiles on patient’s disease state, known allergies, drug sensitivities, medication history and comments relevant to the drug therapy. As well as the name, address, telephone no, Birth date, age and gender of the patient. 9. RECORDING • Any record relating to the supply of a prescription medicine must be kept for the required duration and produced for inspection when requested (example Food Drug Administration (FDA) officials • Pharmacist should considere any other rules and regulation regarding with recording of dangerous drug, ordinary prescription and poison substances if any • A record of the prescriptions dispensed should be maintained in addition to the prescription files • This would permit rapid location of prescription orders • Different RECORDS used: (for hospital and community setting) o Prescription Book = 2 years o Poison Book (very rare) = 5 years o Dangerous Drug Record Book = 1 year and reported twice a year in the Dangerous Drug Board, on January 1-15 and July 1-15 o Referral Book (the latest and is stated in RA 10198) = 2 years NOTE: These record books shall be available when FDA will visit your drugstore, present them in case if they are going to ask. INFORMATION TO BE PRESCRIPTION BOOK • • • RECORDED IN THE Name of physician Name of the drug (being dispensed) Quantity EUCASION, PROTACIO, TANSIONGCO | 2E-PH 4 TRANS [11]: PROCESSING THE PRESCRIPTION • • • Date when dispensed Balance (quantity if any) Pharmacist signature, etc. • The dispensed price or prescription cost refers to cost when patient has to pay to get medicine and treatments which are written as direction on prescription by prescribers The prescription price is a regular healthcare price for sick and may mean economic hardship for underprivilege Code in Pricing – traditional code in which letters selected should have 10 letters with no duplicate letters. Example: • • • 10. PRICING THE Rx o o • • • SMIT (code) = 67.89 Today, it is already modern such as cash registry and price tag 11. FILING To be kept for 2 years Prescription File Types: o Metal or cardboard unit o Partitioned drawers FILING: o Prescription Book = 2 years o Poison Book = 5 years o Dangerous Drug Record Book = 1 year o Referral Book = 2 years METHODS OF PRESERVING PRESCRIPTIONS • • • • • • Filing on string or wire Pasting on scrap book (old method) Writing a copy in a blank book and returning the original Wrapping the Rx in packages of 100 and packing ten consecutive hundreds in wooden box (old method) Pasting the Rx to a card which is then filed in a cabinet (old method but some are still using) Computer filing of prescription is most recommended (latest filing of prescription) REFERENCES Notes from the discussion by Nelson T. Tubon University of Santo Tomas Processing the Prescription powerpoint presentation: EUCASION, PROTACIO, TANSIONGCO | 2E-PH 5