Counterfeit medicines: Threat to patient health and safety

Abstract

Counterfeit medicines are, first and foremost, a matter of patient health and safety. Counterfeit medicines pose a threat to patients because of the conditions under which they are manufactured, in unlicensed, unregulated, uninspected and often unsanitary sites. The “medicines” themselves pose a threat to patient health and safety because their contents are not regulated and they may not contain the correct active pharmaceutical ingredient (API) to deliver the therapeutic benefit for which they were prescribed, or even ingredients that are themselves harmful such as heavy metals or pesticides. To mitigate that threat, and ensure that their patients receive safe and effective medicines, pharmaceutical companies have incorporated anti-counterfeiting technologies into their packaging and implemented campaigns to detect and disrupt those counterfeiters who place greed above patient safety. Although counterfeiting presents a global threat from which no company, therapeutic area, region or country is immune; gauging the true scope of the problem has remained a challenge. There are hopeful signs, however, as we have seen improved reporting and greater transparency by enforcement and regulatory agencies.