PhRMA introduces e-label initiative

The Pharmaceutical Research and Manufacturers of America, the Washington-based pharmaceutical industry lobbying organization, has formed a Paperless Labeling Task Force to look into the use of new technologies as a means to assure timely distribution of full prescribing information to pharmacists.

"New information technologies have enabled the world to electronically share vast amounts of information," said task force Chairman Irwin Martin, in announcing the initiative. "In contrast, prescription drug professional information, or full prescribing information, is still required to physically accompany prescription drug containers in the United States as a package insert."

This information may not be current by the time it reaches the pharmacy, especially in the case of products with frequent labeling changes. The most up-to-date labeling is often found on company Web sites. "The most practical method of dissemination of full prescribing information is by electronic means," said PhRMA Senior Vice President for Scientific and Regulatory Affairs Bert Spilker.

Members of the task force include representatives from PhRMA member companies as well as pharmacy, nursing and medical professional organizations. The function of the task force is to facilitate the provision of the latest full prescribing information to pharmacists to help them optimize patient use of pharmaceuticals. The ultimate goal of the task force is to add the option for an electronic package insert rather than the current FDA requirement to provide a paper package insert for the dispensing pharmacist.

The Paperless Labeling Task Force has produced two documents, a white paper and "User Requirements for Paperless Labeling," both of which are posted on PhRMA's Web site at www.phrma.org.

The task force has noted that the FDA Center for Drug Evaluation and Research is currently moving ahead with making downloadable versions of approved professional labeling available on their Intranet for all CDER reviewers. Drug industry representatives are currently working with the CDER to facilitate this process. The Paperless Labeling Task Force proposes that this initiative be expanded to a system that allows a manufacturer the option to use electronic full prescribing information in lieu of paper for all purposes. PR