Exercise 8 Key Terms Labeling - means all labels and other written, printed or graphic matter (1) upon

any article or any of its containers or wrappers (2) accompanying such articles Outer label means the label on or affixed to the outside package of an article. Example carton label KeyTerms Principal display panel means the part of the label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale Cosmetics means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering appearance Key Terms Auxiliary labels are placed on drug product containers to give the patient, healthcare provider important information needed for using the product Label means a display of written, printed or graphic matter upon any article or any of its container or wrappers or attached to or accompanying such article Inner label means the label on or affixed to an immediate container Key Terms Packaging materials means all items used or attached to blind, enclose or contain the preparation in the final form for market presentation of the product Packaging the activity of designing and producing the container or wrapper for a product Devices instrument, apparatus, or contrivance, including their components, parts, and accessories, intended for use in diagnosis, treatment, cure, prevention, mitigation of disease in man and animal 1. Differences between Inpatient and outpatient label Outpatient name and address of pharmacy name of patient name of prescriber direction for use date dispensed

cautionary statements, if any serial number of prescription name or initial of dispensing pharmacist quantity dispensed expiration number of refills, etc. Inpatient Label of single unit packages should include name of the drug route of administration, unless oral strength, if applicable, volume of the product, expressed when possible in the metric system control number and expiration date if repackaged, identification of the repackager special storage conditions, if needed Multiple dose identification of the dispensing pharmacy patients name date of dispensing name of the drug strength Auxiliary labels Shake well Keep in the refrigerator, Do not Freeze Do not use after Refrigerate, Shake well, Discard After External Use Only May cause drowsiness; Alcohol and Operating Car or Machine Warning Do not Drink Alcohol Avoid Sun Exposure Take with food Take on an Empty Stomach Finish all this medication Do not take Aspirin Keep Out of the Reach of Children This prescription May be Refilled _____________ Times Cancer Chemotherapy, Dispose of Properly Terms generally employed in storage labeling Cold 20 C to 80 C 2. Cool 80 C to 150 C 3. Room temperature 200 C to 250 C

4. Warm 300 C to 400 C Excessive heat above 400 C Protection from freezing Exercise 9 Drug Labels and Packaging Key Terms Component means any ingredient intended for use in the manufacturing of drugs including those that not appear in the finished product Lot means batch or any portion of a batch of a drug produced by a continuous process, an amount of drug produced in a unit of time or quantity in a manner that assures its uniformity and in either case which is identified by a distinctive lot number and has uniform character and quality within specified limits KEY TERMS Active Ingredient means any substance of a drug which is intended to furnish pharmacologic activity Strength means concentration of known active drug substance in formulation Brand name refers to the proprietary, trade name assigned to the product by the drug establishment Pharmacologic category refers to the classification of the product based on its therapeutic action as specified in the product registration Indication refers to the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form Warning - refers to the instruction and special care required in the use of product to avoid undesired effects and to ensure the safe and effective use of the drug Contraindications refers to statements regarding the conditions wherein the use of the product may cause harm to the patient Expirations refers to the date after which the product is not expected to retain its claimed safety, efficacy and quality or potency or after which it is not permissible to sell, distribute or use said product Net Content refers to the total amount/quantity/number of the dosage form in a certain container of a product expressed in metric system

Batch means a specific homogeneous quantity of a drug or in a case of drug produced according to single manufacturing order during the same cycle of manufacture Lot number means any distinctive combination of letters or numbers, or both, by which the complete history of the manufacture, control, packaging and distribution of a batch or lot of a drug is determined Materials approved unit means an organizational element having the authority and responsibility to approve or reject raw materials, in process materials, packaging components, and final product Generic name refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredient as determined by the BFAD of DOH KEY TERMS Inactive ingredient means any substance other than active ingredient present in a drug Formulation refers to the name/s and amount/s of active medicinal ingredients per dosage unit expressed in the metric system Dosage forms means the pharmaceutical form of the preparation based on official pharmacopeia Mode of administration refers to the site and manner the product is to be introduced into or applied on the body Precautions refers to the instructions and special care required in the use of product to avoid undesired effects and to ensure the safe and effective use of the drug Storage conditions refers to the prevailing specified range of temperature, humidity, and other environmental factors within optimal stability of the product is ensured based on laboratory data Date of manufacture for products other than biological products means the date (month and year) during which the processing of the product, from which the goods are to be filled, is completed Storage conditions refers to the prevailing specified range of temperature, humidity, and other environmental

factors within optimal stability of the product is ensured based on laboratory data Date of manufacture for products other than biological products means the date (month and year) during which the processing of the product, from which the goods are to be filled, is completed POWDERS for external use are usually described as dusting powders, usually contain starch, talc, and zinc stearate DRESSINGS external applications resembling ointment usually used as a covering or protection. CREAMS viscous liquid or semi-solid emulsions of either the oil in water or water in oil type Exercise 9 Key Terms Component means any ingredient intended for use in the manufacturing of drugs including those that not appear in the finished product Lot means batch or any portion of a batch of a drug produced by a continuous process, an amount of drug produced in a unit of time or quantity in a manner that assures its uniformity and in either case which is identified by a distinctive lot number and has uniform character and quality within specified limits Active Ingredient means any substance of a drug which is intended to furnish pharmacologic activity Strength means concentration of known active drug substance in formulation Brand name refers to the proprietary, trade name assigned to the product by the drug establishment Pharmacologic category refers to the classification of the product based on its therapeutic action as specified in the product registration Indication refers to the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form Key Terms Warning - refers to the instruction and special care required in the use of product to avoid undesired effects and to ensure the safe and effective use of the drug

Contraindications refers to statements regarding the conditions wherein the use of the product may cause harm to the patient Expirations refers to the date after which the product is not expected to retain its claimed safety, efficacy and quality or potency or after which it is not permissible to sell, distribute or use said product Net Content refers to the total amount/quantity/number of the dosage form in a certain container of a product expressed in metric system Batch means a specific homogeneous quantity of a drug or in a case of drug produced according to single manufacturing order during the same cycle of manufacture Lot number means any distinctive combination of letters or numbers, or both, by which the complete history of the manufacture, control, packaging and distribution of a batch or lot of a drug is determined Inactive ingredient means any substance other than active ingredient present in a drug Materials approved unit means an organizational element having the authority and responsibility to approve or reject raw materials, in process materials, packaging components, and final product Generic name refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredient as determined by the BFAD of DOH Formulation refers to the name/s and amount/s of active medicinal ingredients per dosage unit expressed in the metric system Key Terms Dosage forms means the pharmaceutical form of the preparation based on official pharmacopeia Mode of administration refers to the site and manner the product is to be introduced into or applied on the body Precautions refers to the instructions and special care required in the use of product to avoid undesired effects and to ensure the safe and effective use of the drug Unit Dose Individually wrapped and labeled drugs

Multiple Dose Large stock containers of drugs Ampule Glass container holding a single dose. Container must be broken to reach the drug. Any portion not used must be discarded. Vial Glass or plastic container with a sealed top that allows medication to be kept sterile Topical Drug applied to skin or mucous membranes to achieve a local effect. May be absorbed into the circulation and cause a systemic effect. Parenteral Drug given by injection include SC, IM, IV, etc. Trade name Brand or proprietary name of manufacturer. Identified by symbol Generic name Official name of a drug as listed in the USP Prefilled Liquid sterile medication ready to administer Reconstituted Powder or crystals diluted according to specific directions. Date and time of preparation must be written on the label and expiration date noted. Importance of the following Lot Number - indicates the batch of drug from which this stock came Expiry date the drug cannot be used after the last day of the month indicated EXERCISE 10 : Pricing Procedures and Credit Terms KEY TERMS Marginal Cost The Pharmacist needs to determine the marginal cost of selling one additional unit and the net change in total revenue, i.e. the marginal revenue, that results from the sale. Target Pricing Also known as Target Return On Investment. It is determined by adding a desired rate of return on investment (or sales) to total cost. Cost-Plus approach means that the selling price for an item is equal to the cost plus a desired profit. Price ceiling Most products or items are brought on the basis of perceived value in the minds of the buyer and not on the basis of what it costs the pharmacy.

Marginal Revenue Is the addition to the total revenue by the sale of an additional unit. Example article at 10 each, the revenue is Rs 100 sale of additional 11th units at the same price of Rs 10 - raises the total revenue to Rs 110. Price Elasticity is also known as Elasticity of Demand Mark-Up is an addition to the cost of a product to reach a selling price. Example; if a pharmacy buys a drug for P5 and sells it for P10, the mark up is P5. Markdowns are reductions in the original price set on a product. Example:, if a pharmacy sells some aspirin for P2.49 instead of P2.99, the markdown percentage is figured as follows: Markdown % = markdown/net sales price = P.50/P2.49 = 20.1% Third party program means any organization (third party payers) that will affect the pricing of pharmaceutical products. Examples: Philhealth, SSS, Medicare or Health Insurance Markup is an addition to the cost of a product to reach a selling price. It can be computed as percentage of sales or cost Selling price cost P10 P5 = = 50% markup on selling price Selling price P 10 Percentage of Cost Selling price cost P 10 P5 = = 100% markup cost Cost P5 Markdowns are reductions in the original price set on a product (See above example) Exercise 11 Key Terms Generic Names is the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official generic names Chemical Names is the description of the chemical structure of the drug or

medicine and serves as the complete identification of a compound. Drug Establishment is any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines Essential Drug List is a list of drugs prepared and periodically updated by the DOH on the basis of health conditions obtained in the Philippines, as well as on internationally accepted criteria Complementary List is a list of alternative drugs used when there is no response to the core essential drug or when there is a hypersensitivity reactions to the core essential drug or when, for one reason or another, the core essential drug cannot be given Active Ingredient is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product. Drug Product is the finished product form that contains the active ingredients, generally but not necessarily in association with inactive ingredients. Drug outlets means drugstores, pharmacies, and any other business establishments which sell drugs or medicines Core list is a list of drugs that meet the health care needs of the majority of the population Brand Name is the proprietary name given by the manufacturer to distinguish its production from those of competitors

What are the penalties for violating the rules and regulations of Generic Dispensing? First conviction shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the Professional Regulation Commission (PRC) Second conviction fine of NLT P2,000.00 but NMT P5,000.00 Third conviction fine NLT P5,000.00 but NMT P10,000.00 and suspension of license to practice his profession Fourth and subsequent convictions fine NLT P10,000.00 and suspension of his license How can you detect whether a certain prescription is violative, erroneous, impossible, or not? Violative prescription where generic name is not written where the generic name is not legible and a brand name which is legible is written where the brand name is indicated and instructions added (such as the phrase no substitution) which tend to obstruct, hinder or prevent proper generic dispensing Erroneous prescription where the brand name precedes the generic name

where the generic name is the one in parenthesis where the brand name is not in parenthesis where more than one drug product is prescribed on one prescription form Impossible prescription when only the generic is written but it is not legible when the generic name does not correspond to the brand name when both the generic and the brand name are not legible when the drug product prescribed is not registered with the BFAD For violative prescription Violative prescription shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH Office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription For erroneous prescription Erroneous prescriptions shall be filled. Such prescription shall also be kept and reported by the pharmacist of the drug outlet or any interested party to the nearest DOH Office for appropriate action For impossible prescription Prescriptions mentioned shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH Office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the patient to get the proper prescr Exercise 12 Information Basic To Dispensing Drugs KEY TERMS Generic name is the official name given a drug. Dosage and Route this refers to how much drug is given and how the drug is to be given. Indications information gives the reasons for using the drug. This information aids in observing for expected effects and therapeutic response, as well as indicating what side and adverse effects might occur.

Contraindications and Precautions These refers to condition in which a drug should be given with caution or not given at all. Classification The drug class is a quick reference to the therapeutic action, use, and adverse effect of a drug. KEY TERMS Action Information explains how the drug is known or believed to act to produce a therapeutic effect. This knowledge aids in understanding whether a drug should be taken with food or between meals, with other drugs or alone, orally or parenterally. Side and adverse effects Side effects are nontherapeutic reactions to a drug that are transient. Adverse effects are nontherapeutic effects that may be harmful to the patient and that require lowering the dosage or discontinuing the drug. Kinds of information the pharmacist need to know to give drugs safely. Generic name/trade name Action of the drug Use of the drug Side/adverse effects of the drug Contraindications/Precautions Interactions/Incompatibilities Nursing implications Evaluation effectiveness Patient counseling B. Pregnancy categories used to identify the safety of drugs No risk to fetus No adverse effects in animals, but no human studies Animals show adverse effects, calculated risk to fetus Fetal risk exists Absolute fetal abnormality Positive actions to avoid liability 1. Know policies and practices of the establishment 2. Research unfamiliar drugs 3. Do not leave medicines at the bedside 4. Chart carefully

5. Listen to the patients complaints 6. Check yourself (read labels carefully) 7. Label anything you reconstituted/diluted 8. Keep up to date D. Ethical principles in the drug therapy 1. Autonomy : freedom to decide based on knowledge with no constraint 2. Truthfulness: truth telling that can create a dilemma. It is absolute or is there a beneficient deceit? 3. Beneficence: obligation to help others 4. Nonmaleficence: do no harm 5. Confidentiality: keep secrets 6. Justice: rights of an individual 7. Fidelity: keep promises 1. The primary reason patients should have individual eye medication is to To prevent cross contamination 2. How should each of the following be applied to a patients skin? A. Powders Sprinkle on gloved hands and apply; use sparingly to prevent caking B. Lotions Pat on lightly with gloved hand or gauze pad C. Creams Rub into skin while wearing gloves D. Ointments Use gloved hand to apply an even coat and cover with dressing 3. How should a vaginal applicator be inserted? Back and up 5. How should the skin be prepared for an injection? Rub the skin with alcohol pad in a circular motion from the center of site out 6. List three reasons for administering medication by injection a. The drug would be destroyed orally b. A rapid effect is desired c. The patient is unable to take the drug orally 7. What is the difference between administering ear drops to an adult and a 2 year-old-child?

In the adult, pull the ear back and up. In a 2 year old child full the ear back and down. 4. Identify administration procedures as clean or sterile. A. SC injection sterile B. Nitroglycerin ointment clean C. SL tablet clean D. Urethral suppository sterile E. Vaginal suppository clean F. Nasogastric route clean G. Nose drops clean H. Intradermal sterile I. IM injection sterile J. Rectal suppository clean