Drug Naming
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Drug Names, Labels, and Packaging 11/01/1999 Introduced |
AMCP encourages drug manufacturers and the FDA to work with pharmacists, physicians, other health care professionals and professional organizations to design and adopt drug names, labeling, and packaging that will avoid confusion and help prevent medication errors.
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Prescription to Over the Counter "Rx-to-OTC" Switches Policy 0108 03/01/2001 Introduced |
AMCP supports the Food and Drug Administration’s regulatory process that allows the marketing of over-the-counter (OTC) drug products which were previously available by prescription only. In the process of determining whether a drug product should be classified as prescription only or available as OTC, AMCP encourages that: (1) a range of stakeholders such as health care providers and managed care organizations be included in the evaluation process; (2) procedures to initiate petitions to switch drugs from one status to another be available to stakeholders; and (3) stakeholders take an active role in the FDA's scientific and clinical evaluation of drugs potentially eligible for OTC status. |
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OTC Brand Name Confusion 04/07/2015 Reapproved |
AMCP is concerned that a distinct brand name on an OTC product does not always refer to the same active ingredient(s). This inconsistent relationship between brand name and ingredients may be confusing to some patients and may lead to medication errors and adverse events. AMCP believes that the naming approach should be changed to avoid this confusion. In conjunction with pharmacists, physicians, and other health care professionals, product names and packaging should be adopted and designed to minimize confusion and prevent adverse outcomes. |
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