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Dr. Nelson T.


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

Key Terms
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

Key Terms
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

Key Terms
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

Key Terms
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

Drug Packaging
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. D J G I A C H B E F


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.

Key Terms
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.

Key Terms
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

1. Why is pricing one of the most critical and complex decisions a pharmacy manager has to make? Price is a key element in operations because it relates directly to the generation of total revenue and affects the pharmacys profits. The pricing objectives can be classified into profitability, volume, meeting- the- competition, and image objectives

2.How are markups and markdowns calculated?

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

= Selling price Percentage of Cost Selling price cost = Cost P 10

P10 P5
= 50% markup on selling price

P 10 P5 = 100% markup cost P5

Markdowns are reductions in the original price set on a product

(See above example)