Taking the Package Insert into the Electronic Age *

Abstract

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 PI from a company Web page, 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.

Keywords

Package insert Paperless Electronic Pharmacist Labeling

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References

21 U.S.C. 352 (f) and (n).

21 C.F.R. § 201.100(c)(1).

21 C.F.R. § 201.50–57.

Food and Drug Administration Modernization Act of 1997. US Public Law 105–115 (1997 Nov 21); 21 USC 355a; 111 Stat 2296.

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