The Patient Labeling Program at Bristol-Myers Squibb
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Information Journal, Vol. 33, pp. 64-54, Printed in the USA. All rights reserved.
0092-8615/99
1999
Copyright 0 1999 Drug Information Association Inc.
THE PATIENT LABELING PROGRAM AT BRISTOL-MYERS SQUIBB CATHLEEN A. O’CONNELL,RPH, MS, PHD Director, U.S. and Export Labeling, Bristol-Myers Squibb Company, Princeton, New Jersey
REBECCASKINNER Senior U.S.Labeling Associate, Bristol-Myers Squibb Company, Wallingford, Connecticut
Among the goals of the Department of Health and Human Services and the Food and Drug Administration (FDA) is to improve written communication to patients about their prescription medicines. Bristol-Myers Squibb Company recognizes the need for patients to receive high-quality information regarding their therapeutic options. The company has initiated a program to prepare patient-oriented labeling for certain prescription products for which such material is appropriate, using the FDA’s proposed Medication Guide as a basis for content and format. Key Words: Food and Drug Administration; Patient labeling; Consumer labeling; Patient package insert; Medication Guide, Healthy People 2000. Action Plan for the Provision of Useful Prescription Medicine Information
INTRODUCTION THE CONCEPT OF patient-oriented labeling for prescription drugs in the United States is not a new one, nor is the idea that such labeling be subject to regulatory oversight. Since 1968 the Food and Drug Administration has required that patient information be distributed with certain prescription products when such a measure would enhance the safe use of the drug or alert the patient to particular safety issues. This information is written and produced by the sponsor and reviewed by the FDA. The first class of drugs to be subject to a mandatory requirement for patient labeling was the isoproterenol inhalation products (l), followed by oral contraceptives (2), estrogens (3), and progestational drugs (4). FDA has also imposed the requirement for patient-oriented labeling on certain
Reprint address: Lh.C. O’Connell, Bristol-Myers Squibb Company, PO Box 4000, Princeton, NJ 08543-4000.
individual products as a condition for approval or postapproval when there was a concern for safe use either generally or in a specific population. At present, FDA requires that more than 40 prescription medicines be accompanied by consumer-oriented written information ( 5 ) . In addition, approximately 70 drugs have patient labeling of some type that has been submitted voluntarily by the manufacturer to FDA for review. In 1979 FDA issued a proposed rule to set a requirement for “patient package inserts” (PPIs) for all prescription products, based on its research into the utility of such written information for consumers (6). This rule was finalized the following year, with FDA declaring that there was “ample evidence that PPIs can significantly improve the quality of health care obtainable from using prescription drugs” (7). FDA then issued draft guidelines for patient labeling for 10 drugs or drug classes (ampicillin, benzodiazepines, cimetidine,
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