ADAP Advocacy and the Partnership for Safe Medicines (PSM) have issued a joint statement warning pharmacists that all 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 obtained this way must be quarantined and verified before dispensing, as patients living with HIV/AIDS are potentially being put at risk.
PSM's Executive Director, Shabbir Imber Safdar, highlighted the risks: "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 help pharmacies manage inventory but pose risks of suspicious sales. Dispensers must quarantine and investigate suspect products and report illegitimate products to the FDA and partners within 24 hours. The warning is particularly significant for independent pharmacies, which may also trade stock in less formal settings such as WhatsApp or Telegram. Brandon M. Macsata, CEO of ADAP Advocacy, cautioned: "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."
The implications for the healthcare industry are substantial. Pharmacies that purchase from these platforms not only violate FDA guidelines but also risk distributing adulterated or counterfeit medications, potentially leading to patient harm, legal liability, and regulatory action. For patients living with HIV/AIDS, any disruption in the integrity of their medication regimen can have serious health consequences, including drug resistance and disease progression. The warning underscores the need for strict adherence to supply chain security protocols to ensure patient safety.
The full warning issued by ADAP Advocacy and PSM is available online at https://www.safemedicines.org/diverted-hiv-meds-on-p2p-platforms. Pharmacists are advised to review the FDA's risk criteria for suspect product and to implement robust verification processes when acquiring medications from secondary sources.
