Roles for pharmacy in combatting counterfeit drugs.

OBJECTIVES: To describe (1) the international scope of counterfeit drugs, (2) international and U.S. anticounterfeiting initiatives, and (3) the enhanced roles and challenges facing pharmaceutical organizations and individual pharmacists to thwart counterfeit drugs. DATA SOURCES: PubMed and Ovid from 1970 to 2008 using the search terms counterfeit drugs, counterfeit pharmaceuticals, and counterfeit medicines, with English as the limiting term. Nonprimary literature sources included the U.S. Food and Drug Administration (FDA) Web site (www.fda.gov) from 1990 to 2008 using the search term counterfeit drugs, presentations from meetings or workshops attended or accessed via the Internet, and Web sites of professional organizations. Additional resources were identified from personal bibliographies collected by the author and bibliographies of gathered articles. DATA SYNTHESIS: Counterfeit drugs--defined as those containing no active ingredient, an incorrect amount of active ingredients, incorrect ingredient, and/or unapproved labeling and packaging--represent an unquantified problem of international proportions. The existing situation has been facilitated by inconsistent national regulatory oversight, disparate unlinked databases, lack of unified anticounterfeiting actions, and inability to track the distribution of domestically produced or imported drug products between, among, and within nations. In the United States, several important anticounterfeiting initiatives announced by FDA in 2004 have been implemented but the benefits of others, such as electronic tracking of a drug's movement through the U.S. distribution chain to a dispensing pharmacy, will not be realized in the near future. The role of pharmacists as patient educators, prudent purchasers, and detectors of counterfeit drugs can typically be accomplished with minimal added expense or work; however, the impact of electronic tracking on pharmacies' expenses and workflow is unknown. Pharmacists need to be included in efforts to thwart receipt of counterfeit drugs by patients, but this must be accomplished with minimal negative impact on pharmacy practices.
CONCLUSION: Although consistent detection of counterfeit drugs is difficult, pharmacists can take several reasonable measures to lessen the chances they are dispensing counterfeit drugs. However, the increased role of pharmacists is accompanied by several important challenges involving increased expense and altered business practices.