 prepared by: |
Volume 5, Issue 2
February 2, 2006 |
Sponsored by |
|
|
If you'd like to respond to one of our
columns or to add yourself to our | |
|
According to the rule, PIs for all new or recently approved prescription drugs must include: • a highlights selection of the prescribing information• a table of contents • reordering and minor content changes • minimum graphical requirements FDA is also building an electronic infrastructure for drug makers to access such data. According to the agency, DailyMed is an interagency online health information clearinghouse intended to provide free up-to-date medication information on the Internet to healthcare professionals, healthcare information providers, and consumers. The DailyMed is in line with the paperless labeling initiative by The Pharmaceutical Research and Manufacturers of America (PhRMA). If linked, vendor companies could access labels from the DailyMed repository for delivery to dispensing pharmacies, says Alan Goldhammer, associate vice president, regulatory affairs, PhRMA. A field test last year of the program with 250 pharmacies used labeling information from member companies. “We believe that this is the way to move forward, and right now we are working on a business plan to do just that. We have continued to brief FDA throughout the process, and they are very encouraged by it.” Goldhammer says the test was well received by the pharmacists. “The only major concern expressed was that we didn’t have labels for all the drugs.”
Insert revisions and the DailyMed program should make it easier for time-strapped, overworked professionals, such as pharmacists, to quickly grasp drug data and pass it along. But will the revisions really result in better-informed patients? It may depend on how detailed the pharmacy-generated patient information is and whether drug manufacturers play an active role in determining what information patients carry home. It may also depend on FDA’s future plans for the container label intended for patients. The agency proposed several changes in 2000, such as including references to PIs, detailing storage and handling requirements, limiting artwork that may interfere with comprehension, listing inactive ingredients, and other changes. The agency has long been aware of the need to improve patient labeling. FDA chose to delay such decisions, unfortunately—patients could sure benefit from more detailed drug information on the actual packages themselves. Perhaps FDA needs time to figure out how such information could possibly be included on the labeling of the traditional pharmacy package—the amber vial. FDA’s revisions to package inserts and its efforts to backup such print with electronic data will surely arm doctors and pharmacists with better information. But these professionals can’t be expected to cover every base when it comes to patient education. They simply are stretched too thin in terms of scheduling and staff shortages. Instead, FDA needs to include patient-directed labeling in its plans. Such labeling needs to be increased, improved, and enhanced. |
|
Daphne Allen, Editor Senior Editor David Vaczek contributed to this article. For information on subscribing to Pharmaceutical & Medical Packaging
News, please click here.
Pharmaceutical &
Medical Packaging News |
|
