Report 2 of the Council on Scientific Affairs (I-99)
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Labeling of Prescription Drug Containers for Generic-Substituted Drugs

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Resolution 514, introduced at the 1998 Interim Meeting by the Michigan Delegation and referred to the Board of Trustees by the House of Delegates, asks:

That the American Medical Association (AMA) reaffirm existing policy calling for complete explanatory information on prescription labels; and

That the AMA request the Food and Drug Administration (FDA) to require a pharmacy, when it changes between trademark drugs and generics or when it changes generic manufacturers for prescription refills, to note that fact on the prescription label so the patient can so inform the physician in case problems arise.

Background

When a physician prescribes a brand name drug product, but authorizes the pharmacist to substitute a generically equivalent product (generic substitution), the potential exists for confusion in labeling. Whereas the name of the drug product in the medical record and on the physician's prescription will be that of the brand name prescribed, the name of the drug product on the label affixed to the patient's container will be that of the generic name (or, in some instances, a brand name of a generic substitute ["branded" generic name]) dispensed. Two examples to illustrate this potential confusion are Lopressor^R, 100 mg, prescribed and metoprolol, 100 mg, dispensed, or Ery-Tab^R, 333 mg, prescribed and E-Mycin^R, 333 mg, dispensed.

Additional confusion for patients, especially those on chronic therapy, can occur when the pharmacist refills a generic prescription with a product from a different generic manufacturer. For example, metoprolol tablets, 100 mg, from Mylan are round in shape and light blue in color whereas metoprolol tablets, 100 mg, from Geneva are oblong in shape and white in color. (Note: Lopressor^R tablets, 100 mg, are oblong in shape and medium blue in color.) Although the FDA requires all solid oral dosage forms (e.g., tablets and capsules) to be uniquely identifiable by means of a "code imprint," it is highly unlikely that patients or their physicians will know these codes in the absence of help from a pharmacist.

At the 1995 Annual Meeting, Board of Trustees Report 1 entitled, "Prescription Labeling," addressed many of the issues that are again being raised in referred Resolution 514. Board Report 1 recommended mechanisms to prevent or minimize the potential for confusion among patients when generic substitution occurs. The recommendations of that report were adopted as AMA policy (see below). This Council on Scientific Affairs (CSA) report briefly reviews the subject and recommends modifications to current policy to further diminish the potential for confusion.

AMA Policy

AMA Policy H-115.974 (AMA Policy Compendium) recommends: (1) That when a physician desires to prescribe a brand name drug product, they do so by writing the brand name drug product and the phrase "Do Not Substitute" (or comparable phrase or designation, as required by state law or regulation) on the prescription; and when a physician desires to prescribe a generic drug product, they do so by writing the USAN-assigned generic name of the drug on the prescription whenever possible. (2) That, except where the prescribing physician has indicated otherwise, the pharmacist include the following information on the label affixed to the container in which a prescription drug is dispensed: In the absence of product substitution, a) the brand or generic name of the drug dispensed; b) the strength, if more than one strength of drug is marketed; c) the quantity dispensed; and d) the name of the manufacturer or distributor. When generic substitution occurs: a) the generic name (or, when applicable, the brand name of the generic substitute ["branded" generic name]) of the drug dispensed; b) the strength, if more than one strength of drug is marketed; c) the quantity dispensed; d) the manufacturer or distributor; and e) either the phrase "generic for [brand name prescribed]" or the phrase "substituted for [brand name prescribed]."

Discussion

The CSA believes that AMA Policy H-115.974 adequately addresses the labeling of prescription drug containers when a generic drug is substituted for a brand name drug. Specifically, including the name of the generic drug dispensed and its manufacturer or distributor as well as the phrase "generic for [brand name prescribed]" (or, alternatively, "substituted for [brand name prescribed]") should provide patients (and their physicians) with sufficient information to know that a generic drug product from a specific manufacturer or distributor was substituted for the brand name product written on the original prescription. For example, if Mylan s metoprolol, 100 mg, was substituted for Lopressor^R, 100 mg, the prescription drug container would contain the following:

Metoprolol tablets, 100 mg (Mylan)
(generic for Lopressor^R)

Current AMA policy does not adequately address the situation when a pharmacist refills a generic prescription with a product from a different generic manufacturer or distributor. When possible, switching of generic drug manufacturers should be avoided to prevent potential confusion for the patient. If changing the generic manufacturer or distributor cannot be avoided, the pharmacist has an obligation to ensure that the patient clearly understands that a switch in manufacturer (or distributor) has occurred, but that the medication is the same. This can best be accomplished if the pharmacist orally explains to the patient that the generic drug product being dispensed is from a different manufacturer or distributor and, if possible (e.g., for solid oral dosage forms), visually shows the product being dispensed to the patient. At the same time, the pharmacist should show the patient that the label affixed to the prescription container has the same generic drug name, but a different manufacturer or distributor name. Taking the earlier example, if the prescription is being refilled with Geneva's metoprolol, 100 mg, instead of the Mylan product, the prescription drug container label would contain the following:

Metoprolol tablets, 100 mg (Geneva)
(generic for Lopressor^R)

Finally, the pharmacist should affix to the primary label on the container an auxiliary (sticker) label that states:

This is the same medication you have been getting. Color, size, or shape may appear different.

Referred Resolution 514 asks the AMA to request that the FDA require pharmacies to include this information on labels affixed to prescription containers when generic substitution has occurred. However, the FDA does not regulate the practice of pharmacy. The practice of pharmacy is regulated by the individual states, and labeling requirements for prescription drug containers are included in state Pharmacy Practice Acts and/or Board of Pharmacy regulations.

The National Association of Boards of Pharmacy (NABP) is a voluntary organization whose membership consists of the state boards of pharmacy in the United States, the District of Columbia, Puerto Rico, the Virgin Islands, eight provinces of Canada, Western Australia and Victoria, Australia. The NABP publishes the NABP Model State Pharmacy Practice Act and Rules (Model Act) to assist state boards of pharmacy in developing legislation to regulate the practice of pharmacy. In 1995, the AMA sent Board Report 1 to the NABP for consideration.

In preparing this report, the CSA contacted the NABP to determine what its Model Act recommends regarding information on the label affixed to prescription drug containers in ambulatory or outpatient settings. The NABP Model Act (in the section entitled, "Model Rules for Pharmaceutical Care") recommends including: the name and address of the pharmacy dispensing the drug; the name of the patient for whom the drug is prescribed; the name of the prescribing practitioner; such directions as may be stated on the prescription drug order; the date of dispensing; any cautions which may be required by federal or state law; the serial number of the prescription drug order; the name or initials of the dispensing pharmacist; the proprietary [brand] or generic name of the drug dispensed and its strength, if more than one strength of the drug is marketed; the name of the manufacturer or distributor of the drug; and the beyond-use date.

To the specific question of what the NABP Model Act recommends for labeling on prescription drug containers when a generic drug product is substituted for a brand name drug product, the NABP Model Act states the following for single-entity, multiple-source drugs:

When dispensing an equivalent drug product, the word "INTERCHANGE" or letters "IC" must appear on the label affixed to the container in which such drug is dispensed, followed by the generic name and manufacturer, or reasonable abbreviation, and/or distributor of the chosen product.

The above language was incorporated into the NABP s Model Act as the result of AMA Board Report 1 (A-95). The CSA asked the NABP why it did not adopt the AMA's recommendation for labeling (AMA Policy H-115.974[2]) verbatim. The NABP responded that its Committee on Law Enforcement/Regulation, while recognizing the merit of AMA's recommendation, was concerned that there may be "legal constraints (i.e., trademark ownership, implied or express warranty issues) that prevent the placement of a trade name on a container that does not contain the product." Thus, the NABP s committee recommended the use of the word "INTERCHANGE" or the letters "IC" to denote that generic substitution had occurred.

The CSA believes that many patients will not understand the meaning of the word "INTERCHANGE" or the letters "IC" at the present time. Thus, the CSA believes the AMA's current policy is preferable to the NABP's recommendation from a clinical perspective because patients are less likely to be confused. Furthermore, it should be noted that the CSA obtained information regarding prescription drug container labeling from the NABP s database of state pharmacy laws and regulations. Currently, 10 states require or recommend either the phrase "generic for [brand name prescribed]" or "substituted for [brand name prescribed]" be placed on the label when generic substitution occurs. In contrast, it appears that only one or two states have adopted the NABP's recommendation to use the word "INTERCHANGE" or the letters "IC."

RECOMMENDATIONS

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA policy at the 1999 AMA Interim Meeting.

1. Policy H-115.974 is amended to read as follows: The AMA recommends: (a) That when a physician desires to prescribe a brand name drug product, he or she do so by designating the brand name drug product and the phrase "Do Not Substitute" (or comparable phrase or designation, as required by state law or regulation) on the prescription; and when a physician desires to prescribe a generic drug product, he or she do so by designating the USAN-assigned generic name of the drug on the prescription. (b) That, except where the prescribing physician has indicated otherwise, the pharmacist include the following information on the label affixed to the container in which a prescription drug is dispensed: In the absence of product substitution, i) the brand or generic name of the drug dispensed; ii) the strength, if more than one strength of drug is marketed; iii) the quantity dispensed; and iv) the name of the manufacturer or distributor. When generic substitution occurs: i) the generic name (or, when applicable, the brand name of the generic substitute ["branded" generic name]) of the drug dispensed; ii) the strength, if more than one strength of drug is marketed; iii) the quantity dispensed; iv) the manufacturer or distributor; and v) either the phrase "generic for [brand name prescribed]" or the phrase "substituted for [brand name prescribed]." (c) When a prescription for a generic drug product is refilled (e.g., for a patient with a chronic disease), changing the manufacturer or distributor should be discouraged to avoid confusion for the patient; when this is not possible, the dispensing pharmacist should satisfy the following conditions: i) orally explain to the patient that the generic drug product being dispensed is from a different manufacturer or distributor and, if possible (e.g., for solid oral dosage forms), visually show the product being dispensed to the patient; ii) replace the name of the prior generic drug manufacturer or distributor on the label affixed to the prescription drug container with the name of the new generic drug manufacturer or distributor and, show this to the patient; iii) affix to the primary label an auxiliary (sticker) label that states, "This medication contains the same active ingredient you have been getting. Color, size, or shape may appear different;" and iv) place a notation on the prescription record that contains the name of the new generic drug manufacturer or distributor and the date the product was dispensed.  
2. The AMA will send this report, as expeditiously as possible, to the National Association of Boards of Pharmacy.