In January 2024, Florida became the only state to allow the importation of medications for public use.
The pharmaceutical industry serves a critical role in providing safe and effective medications to patients globally. The industry faces persistent challenges, notably proliferation of counterfeit medications and, now, drug importation challenges.1 In fact, counterfeiting and trafficking medications has become one of the fastest-growing criminal enterprises globally, with an estimated $431 billion generated by criminals worldwide.2 In developing countries, a study done by the World Health Organization found that counterfeit medications are now a major cause of death in children.3
Recently, the FDA reported that counterfeit semaglutide (Ozempic; Novo Nordisk) was found in the legitimate US drug supply chain; the FDA seized thousands of units of product as a result.4 Similarly, Gilead Sciences issued a statement on efforts the company is taking to halt distribution of counterfeit HIV medications.5 These examples indicate that despite current regulatory measures in the US, counterfeit products are still making their way into the supply chain, potentially containing dangerous substances.6
Securing the Drug Channel Within the US
To improve security of the supply chain of pharmaceuticals within the US and protect consumers from counterfeit medications, the Drug Supply Chain and Security Act (DSCSA) was passed in 2013, accompanied by phased implementation requirements unfolding over subsequent years. For 2023 and beyond, enhanced product tracing at the individual package level is required. However, the FDA announced a 1-year delay (from November 27, 2023, to November 27, 2024) in implementing the new electronic prescription tracking and tracing system in the DSCSA.7-9 These administrative rules are intended to allow the use of serialized electronic tracing mechanisms to track prescription drugs as they move throughout the supply chain.10 Eventually, this should help improve the removal of dangerous counterfeit drugs.
DSCSA Implementation
DSCSA required phased implementation and the following changes8:
- Phase 1: Wholesale distributors, repackagers, dispensers, and other third-party logistics providers are required to implement interoperable and electronic tracing of prescription products at the individual package level. Also, supply chain partners are expected to accept saleable returns that are unable to comply with new regulations.
- Phase 2: Products are to be handled and traced by using serialization of all pharmaceutical products, converting product information into alphanumeric sequences.
- Phase 3: Wholesale distributors and third-party logistics providers are to send annual licensed reports to the FDA, as well as reports of suspicious products. This can be done through the FDA’s Center for Drug Evaluation and Research NextGen portal.
The implementation delay for DSCSA was a result of the supply chain not being completely ready for implementation. Many distributors questioned exactly what and how much tracing information needed to be supplied to state and federal authorities and how many resources were needed to comply. They also questioned what to do with nonserialized products in the supply chain.8,10
Novel Use of Blockchain Technology in Supply Chain
Tracking The FDA launched the DSCSA Pilot Project Program in 2019 to assess the blockchain technology utility in implementation of security standards set forth by DSCSA. This program evaluated the ability of selected supply chain members to connect disparate systems utilizing blockchain technology in satisfying enhanced drug distribution security requirements. The results demonstrated the utility of blockchain in connecting supply chain members to provide a secure drug channel.11
Policy Changes on Drug Importation
In January 2024, Florida became the first state in the country to begin allowing importation of medications into the US for public use.12,13 This policy was opposed by over 70 pharmacy and health or ganizations, citing additional risks to the health and safety of American patients.14 Additionally, this policy change raised concerns among individual pharmacists, with 58% of pharmacists surveyed noting concern about the safety and monitoring of imported medications from Canada.12-14
Ultimately, the importation of medications from other countries will forgo the secure channel established by DSCSA, potentially putting patients at risk. Further, the lack of regulatory standards in relation to the importation of medications into Florida raises questions about the origin of the medications, storage conditions, and contamination.1
Conclusion
The integrity of the US drug supply chain is critical in protecting the health and safety of the American patient. The implementation of the DSCSA within the US represents a significant step toward fortifying the supply chain. Pharmacists continue to plan and work toward complying with the final requirements of the DSCSA as the stabilization period proceeds. The stabilization period will allow organizations to ensure efficient processes and transactions, and it should also help ensure patients get medications when and where they need them without unnecessary delays or supply chain disruptions.
However, Florida’s new policy that allows for the international importation of prescription drugs poses concerns for public health safety. Regardless, health care professionals and patients should remain vigilant and report adverse events to the FDA MedWatch safety information and adverse event reporting program. Suspected counterfeit products should also be reported to the FDA. The goal is to ensure a safe supply chain.
References
1. Massaro L. FDA approval makes Florida first state to import drugs from Canada. Drug Topics®. January 5, 2024. Accessed January 25, 2024. https://www.drugtopics.com/view/fda-approval-makes-florida-first-state-to-import-drugs-from-canada
2. Gurney B, Amundson G, Boumediene SL. Ways to battle the $431 billion fake pharmaceutical industry. Rev Financ Stud. 2017;8(1):33-40.
3. Reed B. 10% of drugs in poor countries are fake, says WHO. The Guardian. November 28, 2017. Accessed January 25, 2024. https://theguardian.com/global-development/2017/nov/28/10-of-drugs-in-poor-countries-are-fake-says-who
4. FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain. December 21, 2023. Accessed January 21, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain
5. Gilead continues efforts to halt the distribution of counterfeit HIV medications and protect patient safety. News release. Gilead Sciences. September 28, 2022. Accessed January 21, 2024. https://www.gilead.com/news-and-press/companystatements/gilead-continues-efforts-to-halt-the-distribution-of-counterfeit-hiv-medications-and-protect-patient-safety
6. Saraceno N. The importance of drug supply chain security. Pharmaceutical Commerce. January 17, 2024. Accessed January 24, 2024. https://www.pharmaceuticalcommerce.com/view/the-importance-of-drug-supply-chain-security
7. Hunter E. FDA announces delayed enforcement of DSCSA to 2024. Pharmacy Times. August 28, 2023. Accessed January 22, 2024. https://www.pharmacytimes.com/view/fda-announces-delayed-enforcement-of-dscsa-to-2024
8. DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems. FDA. Updated August 30, 2023. Accessed January 22, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/dscsa-compliance-policies-establish-1-year-stabilization-period-implementing-electronic-systems
9. Corrigan-Curray J, Furman J. FDA protects patients from harmful drugs through the Drug Supply Chain Security Act. FDA. Updated November 27, 2023. Accessed January 23, 2024. https://www.fda.gov/news-events/fda-voices/fda-protectspatients-harmful-drugs-through-drug-supply-chain-security-act
10. Meara K. How pharmacists can successfully navigate the FDA’s new DSCSA stabilization policy. Drug Topics. January 9, 2024. Accessed January 24, 2024. https://www.drugtopics.com/view/how-pharmacists-can-successfully-navigate-the-fda-s-newdscsa-stabilization-policy
11. DSCSA Pilot Project Program. FDA. Accessed January 24, 2024. https://www.fda.gov/drugs/drug-supply-chain-securityact-dscsa/dscsa-pilot-project-program
12. Hertig JB, Jochem JM, Long AM. Pharmacists’ perceptions and attitudes toward drug importation into the state of Florida. J Pharm Policy Pract. 2021;14(1):101. doi:10.1186/s40545-021-00381-0
13. FDA authorizes Florida’s drug importation program. News release. FDA. January 5, 2024. Accessed January 24, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program
14. Pharmacy organizations raise concerns about Florida’s drug importation program. News release. American Society of Health-System Pharmacists. January 17, 2024. https://www.ashp.org/-/media/assets/advocacy-issues/docs/Joint-pharmacydrug-importation-letter-1-17-24
By Craig Kimble, PharmD, MBA, MS, BCACP and Thomas Pile, PharmD, CDCES, Pharmacy Times
Tags: Blockchain Counterfeit Distributors DSCSA New Drug Trends Semaglutide Supply Chain
