Medication Error Update
ISMP, FDA launch labeling, education programs
The nonprofit Institute for Safe Medication Practices (ISMP) in Warminster, PA, and the FDA have unveiled new medication programs aimed at brand name labeling, patient education, and post-market surveillance. Backed by internal research showing that 25% of all medication errors result from "confusing or misleading naming, labeling, and packaging," says ISMP President Michael Cohen, MS, FASHP, the organization has developed a software program that can analyze and predict potential problems when new brand names come to market. The ISMP is offering this confidential service to pharmaceutical companies during marketing development. The ISMP is launching the program as a corporate subsidiary named the Medical Error Recognition and Revision Strategies (MED-ERRS) program. The computer program evaluates similarities between word pairs of proposed and existing brand names. In addition, software can be installed into hospital pharmacy systems that can flag similar drug names.
Cohen has consistently faulted drug makers for lacking the initiative to undertake this type of review on their own, and hopes the confidentiality of the MED-ERRS offer will prompt pharmaceutical companies to get involved. One spokesman for a large drug manufacturer responds, "Money is always a factor for our industry, and budgeting for these kinds of systematic or exhaustive reviews has always fallen off the books. If this program can be used efficiently and if it’s coming from a nonprofit and can be confidential, I don’t see why the industry can’t take a look at it." A new FDA regulation taking effect June 1 demands the attention of drug makers on the issue of patient education.
The agency’s MedGuide rule requires that patient information leaflets be supplied to dispensing pharmacists, and that pharmacists include them in prescription packaging. The FDA is defining which classes of drugs must be covered by the regulation, which will largely effect new drugs coming to market. Overall, the regulation will affect drugs carrying potentially serious adverse effects and when "serious risk-to-benefit ratios" are present. The ruling also affects new and refill prescriptions. The agency will approve the content of the leaflets, and will allow manufacturers to supply the information to unit dose or bulk containers, which pharmacies must then adapt to individual patients.
The FDA has also announced the formation of a new regulatory Office of Post Marketing Drug Risk Assessment. The office will concentrate on designing post market approval studies, assessing the risks of new drugs, overseeing manufacturers’ observational studies, and dealing with post-marketing errors.
For more information, contact ISMP at (301) 497-2375, and the FDA’s Office of Drug Standards at (301) 594-5443.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content