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Guidelines for Pharmacists Performing Product Selection
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• Dispensing Decisions APhA's Bioequivalency Working Group recommends that pharmacists consider the following factors when selecting drug products to be dispensed to their patients. Not all of these factors will apply to each situation nor are they of equal weight. We believe if pharmacists consider these points as part of the professional judgment process when making drug product selections, it is likely that the best interests of the patients will be served. It is the responsibility of the pharmacist to use professional judgment in selecting the product.
• State Rules and Regulations. All states have legal requirements that address the issue of drug product selection. Pharmacists should be cognizant of these requirements and how they may impact their role in drug product selection. State regulations also might provide information and guidance in drug product selection through positive or negative formularies. • Bioequivalency Information/Orange Book Ratings. Only products with proven bioequivalency should be selected to be dispensed in lieu of the innovator product. Products being dispensed in response to a prescription drug order that is written generically should be expected to produce a therapeutic benefit for the patient at a reasonable cost. Products that are listed in the FDA's Approved Drug Products and Therapeutic Evaluation 1 (the Orange Book) as "}t rated should be selected when such products are available. For pre-1938 drugs, the selection should be based on data obtained from the literature, because bioequivalency testing is not required by the FDA for these drug products. FDA's review of the applicant's bioequivalency study is available under Freedom of Information (FOI). 2
original product dispensed a generic product? If so, preference should be given to continuing to dispense the same generic product from the same source.
• Patient Status. The pharmacist should consider how well controlled the patient is and how susceptible that patient might be to small changes in drug absorption. If a patient has labile control or has experienced great difficulty in achieving control, the pharmacist should continue therapy with a product from a single source throughout therapy. • Diseases. The seriousness of the disease and its potential impact on the patient may influence the pharmacist's willingness to change products. • Drug Class or Category. Drugs with narrow therapeutic ranges and with known clinically significant bioavailability problems should be substituted with care and/or after discussion with the prescriber. • Cost. The cost of the product, while an important consideration, should be a secondary consideration in selecting among products judged by the pharmacist to be bioequivalent. • Patient Opinion. An informed patient, cooperating with a physician and pharmacist in his or her drug therapy, is an important element in ensuring the best possible therapeutic outcomes. The pharmacist should take into account the patient's needs when selecting from multi source drug products and inform the patient of any potential consequences associated with alternate product selections.
• Dosage Form. The type of dosage form should be considered whenever one drug product is selected from among multisource drug products. This is especially true with extended or delayed release medications. The Orange Book does not rate any different dosage forms as therapeutically equivalent.
• Purchase Decisions
• Previous Drug Use. Two questions should be considered regarding previous drug product usage. First, is the prescribed drug a continuation of already successful therapy? If it is, only a bioequivalent product should be selected, and the impact of any change in source of the medication should be considered. The pharmacist should also know which product the patient was using previously, including any medications in the hospital if the patient was recently discharged. Second, was the
• Current State Laws and Regulations. States have legal requirements that address the issue of drug product selection. Some states have positive or negative formulary systems that place regulatory restrictions on the products considered therapeutically equivalent. The state formulary may not always be in agreement with classifications listed in the FDA's Orange Book. Therefore, pharmacists should be familiar with both. Some states also have regulations that define the role of the
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APhA's Bioequivalency Working Group recommends that pharmacists consider the following factors when purchasing products from multi source vendors. Not all of these factors are of equal importance in each purchasing decision, but all are worthy of consideration.
American Pharmacy, Vol. NS30, No.7 July 1990/408
pharmacist, physician, and patient in the drug product selection process.
• Bioequivalency Information/Orange Book. Products shown to be bioequivalent through reference to the Orange Book or other reliable source of bioequivalency information are preferred. Purchase decisions for drugs marketed prior to 1938 should be based on data obtained from the literature or the manufacturer, because bioequi valency testing may not be required by the FDA for these drug products. • Drug Category. Greater attention should be given to purchasing strategies for drug products used for serious or life-threatening diseases and in situations where therapeutic activity of the product is confined to a narrow range of biologic fluid concentration. • Availability. A continuous supply from the same manufa·cturer is essential even in the event that the distributor has changed to ensure that refills of pre scriptions will contain the same product as originally dispensed. However, in those instances when the manufacturer of a generic drug product has to be changed, care should be exercised to ensure that the new drug product is equivalent to the formerly stocked drug product. • Supplier's Reputation. The reputation of the manufacturer in terms of its ability to adhere to good man-
ufacturing practices (GMP) that ensure that each dosage form is manufactured correctly and in a consistent manner is an important consideration. When purchasing a product from a distributor rather than directly from the manufacturer, the procedure used by that supplier in selecting manufacturers for multi source products is also an important consideration. Establishment Inspection Reports and recall reports 3 are available from FDA through a Freedom of Information (FOI) request. These are valuable tools in this decision. • Cost. Cost of the product is an important consideration for both the patient and the pharmacy. ®
References 1. A subscription to the Orange Book, which includes the
1990 Basic Manual and monthly supplements, is available for $91 from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9372. A subscription to the USP-DI, Approved Drug Products and Legal Requirements, Volume III, includes one book and monthly updates. It is available for $59 from the U.S. Pharmacopeial Convention, Inc., Order Processing Department, 12601 Twinbrook Parkway, Rockville, MD 20852 2. Freedom of Information Staff, HFW-35, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; (301) 433-6310. 3. RecalllRegulatory Analysis, P.O. Box 6353, Silver Spring, MD 20906; (301) 460-8821.
What the Codes Mean: The Orange Book Two-Letter Coding System AA Bioequivalent products in conventional dosage forms AB Products therapeutically equivalent to other AB products under that heading AN Solutions and powders for aerosolization AO Injectable oil solutions AP Injectable aqueous solutions AT Topical products considered therapeutically equivalent Be Extended-release tablets, capsules, and injectables BD Active ingredients and dosage forms with documented bioequivalence problems BE . Delayed-release oral dosage forms BN Products in aerosol-nebulizer drug delivery systems BP Active ingredients and dosage forms with potential bioequivalence problems BR Suppositories or enemas that deliver drugs for systemic absorption BS Products having drug standard deficiencies BT Topical products with bioequivalence uncertainties BX Insufficient data
American Pharmacy, Vol. NS30, No.7 July 1990/409
41
I
Ii
r
r
• Dispensing Decisions APhA's Bioequivalency Working Group recommends that pharmacists consider the following factors when selecting drug products to be dispensed to their patients. Not all of these factors will apply to each situation nor are they of equal weight. We believe if pharmacists consider these points as part of the professional judgment process when making drug product selections, it is likely that the best interests of the patients will be served. It is the responsibility of the pharmacist to use professional judgment in selecting the product.
• State Rules and Regulations. All states have legal requirements that address the issue of drug product selection. Pharmacists should be cognizant of these requirements and how they may impact their role in drug product selection. State regulations also might provide information and guidance in drug product selection through positive or negative formularies. • Bioequivalency Information/Orange Book Ratings. Only products with proven bioequivalency should be selected to be dispensed in lieu of the innovator product. Products being dispensed in response to a prescription drug order that is written generically should be expected to produce a therapeutic benefit for the patient at a reasonable cost. Products that are listed in the FDA's Approved Drug Products and Therapeutic Evaluation 1 (the Orange Book) as "}t rated should be selected when such products are available. For pre-1938 drugs, the selection should be based on data obtained from the literature, because bioequivalency testing is not required by the FDA for these drug products. FDA's review of the applicant's bioequivalency study is available under Freedom of Information (FOI). 2
original product dispensed a generic product? If so, preference should be given to continuing to dispense the same generic product from the same source.
• Patient Status. The pharmacist should consider how well controlled the patient is and how susceptible that patient might be to small changes in drug absorption. If a patient has labile control or has experienced great difficulty in achieving control, the pharmacist should continue therapy with a product from a single source throughout therapy. • Diseases. The seriousness of the disease and its potential impact on the patient may influence the pharmacist's willingness to change products. • Drug Class or Category. Drugs with narrow therapeutic ranges and with known clinically significant bioavailability problems should be substituted with care and/or after discussion with the prescriber. • Cost. The cost of the product, while an important consideration, should be a secondary consideration in selecting among products judged by the pharmacist to be bioequivalent. • Patient Opinion. An informed patient, cooperating with a physician and pharmacist in his or her drug therapy, is an important element in ensuring the best possible therapeutic outcomes. The pharmacist should take into account the patient's needs when selecting from multi source drug products and inform the patient of any potential consequences associated with alternate product selections.
• Dosage Form. The type of dosage form should be considered whenever one drug product is selected from among multisource drug products. This is especially true with extended or delayed release medications. The Orange Book does not rate any different dosage forms as therapeutically equivalent.
• Purchase Decisions
• Previous Drug Use. Two questions should be considered regarding previous drug product usage. First, is the prescribed drug a continuation of already successful therapy? If it is, only a bioequivalent product should be selected, and the impact of any change in source of the medication should be considered. The pharmacist should also know which product the patient was using previously, including any medications in the hospital if the patient was recently discharged. Second, was the
• Current State Laws and Regulations. States have legal requirements that address the issue of drug product selection. Some states have positive or negative formulary systems that place regulatory restrictions on the products considered therapeutically equivalent. The state formulary may not always be in agreement with classifications listed in the FDA's Orange Book. Therefore, pharmacists should be familiar with both. Some states also have regulations that define the role of the
40
APhA's Bioequivalency Working Group recommends that pharmacists consider the following factors when purchasing products from multi source vendors. Not all of these factors are of equal importance in each purchasing decision, but all are worthy of consideration.
American Pharmacy, Vol. NS30, No.7 July 1990/408
pharmacist, physician, and patient in the drug product selection process.
• Bioequivalency Information/Orange Book. Products shown to be bioequivalent through reference to the Orange Book or other reliable source of bioequivalency information are preferred. Purchase decisions for drugs marketed prior to 1938 should be based on data obtained from the literature or the manufacturer, because bioequi valency testing may not be required by the FDA for these drug products. • Drug Category. Greater attention should be given to purchasing strategies for drug products used for serious or life-threatening diseases and in situations where therapeutic activity of the product is confined to a narrow range of biologic fluid concentration. • Availability. A continuous supply from the same manufa·cturer is essential even in the event that the distributor has changed to ensure that refills of pre scriptions will contain the same product as originally dispensed. However, in those instances when the manufacturer of a generic drug product has to be changed, care should be exercised to ensure that the new drug product is equivalent to the formerly stocked drug product. • Supplier's Reputation. The reputation of the manufacturer in terms of its ability to adhere to good man-
ufacturing practices (GMP) that ensure that each dosage form is manufactured correctly and in a consistent manner is an important consideration. When purchasing a product from a distributor rather than directly from the manufacturer, the procedure used by that supplier in selecting manufacturers for multi source products is also an important consideration. Establishment Inspection Reports and recall reports 3 are available from FDA through a Freedom of Information (FOI) request. These are valuable tools in this decision. • Cost. Cost of the product is an important consideration for both the patient and the pharmacy. ®
References 1. A subscription to the Orange Book, which includes the
1990 Basic Manual and monthly supplements, is available for $91 from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9372. A subscription to the USP-DI, Approved Drug Products and Legal Requirements, Volume III, includes one book and monthly updates. It is available for $59 from the U.S. Pharmacopeial Convention, Inc., Order Processing Department, 12601 Twinbrook Parkway, Rockville, MD 20852 2. Freedom of Information Staff, HFW-35, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; (301) 433-6310. 3. RecalllRegulatory Analysis, P.O. Box 6353, Silver Spring, MD 20906; (301) 460-8821.
What the Codes Mean: The Orange Book Two-Letter Coding System AA Bioequivalent products in conventional dosage forms AB Products therapeutically equivalent to other AB products under that heading AN Solutions and powders for aerosolization AO Injectable oil solutions AP Injectable aqueous solutions AT Topical products considered therapeutically equivalent Be Extended-release tablets, capsules, and injectables BD Active ingredients and dosage forms with documented bioequivalence problems BE . Delayed-release oral dosage forms BN Products in aerosol-nebulizer drug delivery systems BP Active ingredients and dosage forms with potential bioequivalence problems BR Suppositories or enemas that deliver drugs for systemic absorption BS Products having drug standard deficiencies BT Topical products with bioequivalence uncertainties BX Insufficient data
American Pharmacy, Vol. NS30, No.7 July 1990/409
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