Paperless Labeling Task Force Launched
ASHP is assisting in a new public-private initiative to ensure medication package inserts are as up-to-date, readable, and accurate as possible.The PhRMA Paperless Labeling Task Force, initially comprised of representatives from members of the Pharmaceutical Research and Manufacturers of America, is working to eliminate paper inserts by studying electronic ways to handle label changes. The Food and Drug Administration Center for Drug Evaluation and Research (CDER) is testing an initiative whereby 8 1/2" by 11" versions of approved labeling for medications are available on the agency's Intranet for all CDER reviewers. Building on this initiative, the task force is recommending that the companies also produce the approved labeling as a portable document file, or PDF, immediately upon approval or labeling change. This process would allow all pharmacies and other dispensing sites free access to this critical information. Representing ASHP on the task force is Gary C. Stein, Ph.D., director of federal and regulatory affairs.