Taking the Package Insert into the Electronic Age
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
F’rinted in the USA. All rights reserved.
TAKING THE PACKAGE INSERT INTO THE ELECTRONIC AGE* NEILV. SMITH,PHARMD,MBA Regulatory Associate, Intercontinental Regulatory Affairs
KATHRYNE. RAMSEYER,PHARMD Regulatory Research Scientist, US Regulatory Affairs Eli Lilly and Company, Indianapolis, Indiana
The United States Package Insert, often referred to as the package insert (PI), contains information critical to appropriate prescribing of pharmaceutical products. This printed document evolves throughout the life cycle of a product, and under current regulated dissemination methods, having the PI physically accompany the product may not provide information to prescribers, pharmacists, and other health care providers as efficiently as proposed enhanced dissemination methods. To overcome this and other inherent problems of present PIS, the Pharmaceutical Research and Manufacturers of America established a task force. This task force published a white paper detailing the idea of a realtime electronic version of the package insert (ePI). However, opposition to this transition abounds from multiple sources. To better assess the opposition to and the impact of the ePI on pharmacists and pharmacy practice, information was collected through a survey at the 2000 American Society of Health-Systems Pharmacists Midyear Clinical Meeting in Las Vegas, Nevada. Results of this survey demonstrate that 65% of the individuals questioned claim they have never heard of the idea of an ePI, 57.5% reported printing out a PIfrom a company Webpage, and 77.5%of those surveyed thought that dissemination of the PI should change to an electronic format. pharmacists are well positioned to be integral in the successful transition to an ePI. Key Words: Package insert; Paperless; Electronic; Pharmacist; Labeling
INTRODUCTION THE UNITED STATES PACKAGE Insert physically accompanies the drug product either on or in the carton or bottle. The origin of the PI stems from the Federal Food, Drug and Cosmetic Act, hereafter referred to as “the act,” sections 502 (f) and (n) (1). The
Reprint address: Neil V. Smith, PharmD, MBA, Lilly Research Laboratories, L d y Corporate Center, Indianapolis, Indiana 46285. *This paper was presented in part at the American Society of Health-System Pharmacists Midyear Clinical Meeting, Las Vegas, Nevada, December 5, 2000.
act requires the product to have adequate labeling for use, and specifies that labeling for prescription drugs must contain information relating to side effects, contraindications, and effectiveness. The act does not require labeling to be physically attached to the product. As part of its duty, the Food and Drug Administration (FDA) promulgates regulations whereby it can enforce the act. As such, the Code of Federal Regulations indicates that labeling is required to be “on or within the package from which the drug is dispensed” (2). This regulation complies with the act, and adds specific instructions and
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