ADAP Advocacy and the Partnership for Safe Medicines (PSM) have issued a joint statement warning pharmacists that discounted HIV products purchased from online pharmacy-to-pharmacy (P2P) marketplaces meet the definition of suspect product under U.S. Food and Drug Administration (FDA) guidelines and the Drug Supply Chain Security Act. The organizations urge pharmacies not to buy from these platforms, stating that any HIV medicines acquired through these channels should be considered suspect, requiring quarantine and verification before dispensing. Patients living with HIV/AIDS are potentially being put at risk.
Shabbir Imber Safdar, Executive Director of PSM, emphasized the dangers: "A deeply discounted HIV product bought off the internet from an unknown seller who won't provide a pedigree qualifies as suspect even before the purchasing pharmacy receives it because the listing alone meets many of the U.S. Food and Drug Administration's risk criteria for illegitimacy: deep discounts, an established pattern of fraud in the HIV drug supply chain over the last six years, unknown sellers, and incomplete transaction histories. Once received, the often-observed damage to the packaging confirms that this product will need to be quarantined and investigated."
Online P2P marketplaces are designed to help pharmacies manage inventory, but they also pose risks of suspicious sales. Dispensers are required to quarantine and investigate suspect products and report illegitimate products to the FDA and supply chain partners within 24 hours. The warning issued to pharmacists is available online at https://www.safemedicines.org/diverted-hiv-meds-on-p2p-platforms.
Brandon M. Macsata, CEO of ADAP Advocacy, highlighted additional concerns: "Independent pharmacies have also been known to trade stock in less formal settings such as WhatsApp or Telegram. Those transactions are, if anything, more vulnerable and never advisable. We're strongly urging pharmacists to heed our warning and avoid exposing patients to unnecessary risks."
This joint statement underscores the ongoing threat of counterfeit and diverted medications entering the legitimate supply chain, particularly for high-cost HIV treatments. The organizations call for heightened vigilance among pharmacists to protect patient safety and maintain the integrity of the drug supply.
