“The Hidden Risks Of Using Counterfeit Drugs”

Steven Mandel, MD and Joseph A. Hirsch, PhD, PsyD

Health Crisis – A known but underappreciated health crisis is the glut of counterfeit drugs sold on the world market. According to the World Health Organization (WHO), counterfeit drugs are those that are “deliberately and fraudulently mislabeled with respect to identity, composition or source.” The Drug Enforcement Agency (DEA) characterizes that counterfeit drugs are fake medications that are made to appear like legitimate drugs but differ in that they may not have the actual active ingredient, a substitution with another drug, or if they do have the active ingredient, the dosage is incorrect.
(https://www.dea.gov/documents/2021/2021-09/2021-09-27/counterfeit-pills-factsheet).

The WHO proposed the definition of “substandard” drugs for all those products that are authorized on a local basis but fail to meet quality standards for or specification (Sansone et al, 2021). Drug counterfeiting has been around since at least the 17th century when fake anti-malarial drugs were sold (Sansone et al, 2021). The Pharmaceutical Security Institute (PSI), a not-for-profit, membership organization has made it its mandate to identify and help combat fake, fraudulently packaged, or stolen or illegally diverted pharmaceuticals (https://www.psi-inc.org). The PSI states that counterfeit products include drugs with no active ingredients to those with dangerous impurities. They can be copies of branded drugs, generic drugs, or over-the-counter drugs. They can be stolen (diverted) from legitimate sources or tampered with. The exact magnitude of counterfeit drug sale is unknown because of imprecise or, in some countries, non-existent tracking procedures. The DEA rather explicitly states “Criminal drug networks are mass-producing fake pills and falsely marketing them as legitimate prescription pills to deceive the American public.”

Steven Mandel, MD and Joseph A. Hirsch, PhD, PsyD have looked at the evidence based literature, and from public resources. Read their in-depth comprehensive review!