DRUG LABELS: Complexity Plagues Doctors and Patients
The complexity of drug labels has stopped many patients and doctors from reading them, which critics say has led to inappropriate prescribing by doctors, illness and even death, USA Today reports. Instead of being printed on labels, warnings are now included in "tiny typeface" on "tightly folded" package inserts that patients either don't see or find very confusing. "Less than 1% of physicians have seen a label in the last year," Dr. Robert Califf, director of Duke University's Clinical Research Center, said. Critics hold the FDA responsible, arguing that instead of "withholding approval of potentially dangerous drugs ... the agency sends them to market with inserts jam-packed with warnings." Thomas Moore of George Washington University and others point to the recent removal of Rezulin, Posicor and Duract and the anticipated removal of Propulsid. Each of the drugs' warning labels underwent multiple revisions as new safety concerns surfaced. Rachel Behrman of the FDA's medical policy office admits that package inserts "are far from perfect," but stresses the agency's efforts to make them "more user-friendly, more informative [and] more consistent." She said that until recently, "comprehensiveness superseded clarity." Raymond Woosley, chair of pharmacology at Georgetown University, said that current teaching methods also add to the problem. He argues that many prescribing errors would be eliminated if doctors looked up information rather than relied on their memory, which they are taught to do in medical school. "We've got to start by changing the way we teach people," he said (Rubin, 5/3).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.