The Pharmacist's Role in the Changing World of Drug Recalls and Market Withdrawals

Earlier this spring, an unprecedented event occurred in the United States. Two drugs were withdrawn from the market within 24 hours. On March 29th, the Food and Drug Administration (FDA) announced that pergolide, a dopamine agonist approved approximately 20 years ago for the management of Parkinson disease, was withdrawn from the market. This action was based, in part, on two postmarketing studies, which demonstrated an increased rate of cardiac valvulopathy associated with the use of the drug in Parkinson patients when compared with placebo. ¹ Less than 24 hours later, the FDA announced the withdrawal of tegaserod, an agent initially approved for the treatment of constipation-predominant irritable bowel syndrome in women. In this case, an FDA analysis of safety data pooled from 29 clinical trials enrolling more than 18,000 patients demonstrated an increased rate of serious cardiovascular adverse events (eg, angina, heart attacks, stroke) associated with tegaserod when compared with placebo. ² Tegaserod was initially approved in July 2002.

The management of drug recalls and withdrawals has always been a part of the pharmacist's role in health care systems, oftentimes requiring not only the identification of the drug location within a hospital or health care setting (eg, clinic, nursing home), but also the identification of patients currently taking the drug. Additional actions include the notification of other health professionals with more detailed information regarding the recall or market withdrawal and recommended alternative therapies, if needed. Typically, pharmacists and other health care professionals have been notified of recalls and market withdrawals via Dear Health Professional letters from the manufacturer, notifications from drug wholesalers, or in various professional publications. It is also possible to keep current of a list of recalls or drug withdrawals at the FDA Web site: http://www.fda.gov/opacom/7alerts.html.

Within the last few years, the incidence of drug safety alerts and market actions related to recalls has increased, signaling a more responsive role of the FDA in postmarketing surveillance. However, this increase has also required additional coordination by pharmacists. As many health care systems are merging and growing, the effective coordination of recall policy and procedures that manage different levels of care is needed. A review of the literature reveals very little information regarding the development, implementation, or documentation of drug recall procedures both in the acute care or ambulatory health care settings. Hospital Pharmacy is interested in pharmacists sharing innovative plans in developing effective management of drug recalls and withdrawals.