Electronic Labeling: A Paperless Future?
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0092-86 15/98 Copyright 0 1998 Drug Informalion Association Inc.
ELECTRONIC LABELING: A PAPERLESS FUTURE? IRWING. MARTIN,PHD Vice-President, FDA Liaison, Worldwide Regulatory Affairs. Parke-Davis Pharmaceutical Research Division, Warner-Lambert Company, Ann Arbor, Michigan
The United States pharmaceutical industry and the Food and Drug Administration are both moving rapidly to make professional labeling f o r prescription products available to a wide audience via electronic means. Technology available today could allow every physician and pharmacist to easily obtain the most recent prescribing information electronically via the Internet. It is suggested that the package insert, that is, the printed professional labeling which accompanies the actual product, is an obsolete method for information dissemination. Elimination of the paper package insert would save money and time to market launch. Access to electronic professional labeling would assure that the customer and prescribing physician have the most recent version of the labeling available for their use. Key Words: Prescribing information; Professional labeling; Package Insert; Internet; Food and Drug Administration
INTRODUCTION INFORMATION TECHNOLOGY HAS enabled the world to share vast amounts of information quickly and electronically. The easy access to the Internet gives businesses, individuals, and professionals up to date information on a wide range of topics. In contrast, professional labeling, or prescribing information, is still required to physically accompany prescription drug containers in the United States as a “package insert.” This information is often not the most recent by the time it reaches the pharmacy, especially in the case of products with rapidly evolving labeling. Often, the professional (physician, pharmacist, nurse, or other health care pro-
Presented at the DIA Workshop “Information Technology Initiatives in Drug Registration Submissions,” January 12-14, 1998. Washington, District of Columbia. Reprint address: Irwin Martin, PhD, Worldwide Regulatory Affairs, Parke-Davis Pharmaceutical Research, 2800 Plymouth Road, Ann Arbor, MI 48105.
vider) seeks information on prescription drugs via a third-party compilation of labeling published on a periodic basis or via advertising or promotional materials produced by a pharmaceuticalcompany. Third-party publications could be as much as a year out of date for new products. Company-produced materials are more current, but also may contain prescribing information that had been changed since the printing of these materials. It is proposed that the most practical method of information dissemination is electronically via the Internet.
CURRENT LAW, REGULATION, AND PRACTICES The Food, Drug, and Cosmetic Act, as amended, states in Section 502 that a drug or device shall be deemed to be misbranded unless its labeling bears adequate directions for use. The law does not specify that these adequate directions must physically accompany the drug product. The Code of Federal
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