A counterfeit-dealing Chicago pharmacist has been sentenced to prison and will forfeit his pharmacy after pleading guilty last year to counterfeit drug charges (see here). Michael Markiewicz admitted to illegally purchasing counterfeit versions of Viagra and Cialis from China and selling them to his pharmacy customers without a prescription (see my previous post here).
This case, and others like it, highlight the Achilles’ heel of the DSCSA. Corrupt pharmacists and pharmacy owners engaged in drug diversion and counterfeiting crimes are not going to comply with the DSCSA’s pivotal verification requirements. Without increased regulatory oversight over certain high-risk pharmacies, vulnerable patients will continue to be exposed to illegitimate products of unknown safety and origin. If only the good guys comply with the DSCSA’s verification requirements, the law’s ability to protect our nation’s pharmaceutical distribution supply chain will be greatly diminished. Identifying common attributes of pharmacies most susceptible to diversion and counterfeiting activities has therefore become a crucial endeavor that must be pursued by state and federal regulatory authorities without delay. Doing so will facilitate the sort of risk-based compliance and enforcement efforts over such pharmacies on supply chain security issues that are long overdue and urgently needed in an environment of increasing threats to patient safety.