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Regulations and Legislation
Dr Ozawa pointed out that regulating illegitimate online pharmacies can be challenging because they cross international borders, and countries have varying laws, regulations, policies, and surveillance practices that should be coordinated to increase effective policing.
Dr Mackey said manufacturers, regulators, and law enforcement should cooperate in more active monitoring of illegal online drug sources. In addition, social media platforms, search engines, and e-commerce sites should take more severe measures against these illegal sites.
Dr Mackey did note, however, that the “US drug supply chain is generally resilient against counterfeit drugs, and the implementation of the Drug Supply Chain Security Act should, in principle, enhance this resilience.”11
The Drug Supply Chain Security Act “outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States,” according to the FDA. The goal is to improve the FDA’s ability to protect patients from “counterfeit, stolen, contaminated, or otherwise harmful” drugs.
Another piece of legislation that might prevent patients from buying counterfeit cancer drugs online is the Inflation Reduction Act of 2022.12 The act requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare, beginning in 2026. These negotiations could potentially make some cancer drugs more affordable and result in fewer patients seeking to buy treatments online.
Dr Mackey and Dr Ozawa both agree that the primary need is to make cancer drugs more accessible and affordable so patients won’t feel compelled to buy drugs from illegitimate sources.
“Clinicians should work with pharmacy teams and social workers to assist patients with enrolling in manufacturer or health system medication assistance programs or patient assistance programs to reduce their costs,” Dr Ozawa said.
“People need cancer medications for long periods of time and should not be facing financial hardship to pay for them,” she added.
Resources for Clinicians and Patients
To help steer patients away from dubious sources of cancer drugs, Dr Ozawa recommends that clinicians ask patients where they are buying their medications and educate them about the prevalence and risks of illegitimate online pharmacies.
“It is deceiving how well some illegitimate websites mimic the legitimate ones, and it is difficult to distinguish between them,” she said.
Patients can confirm the legitimacy of online pharmacies through sites such as LegitScript, Verify Before You Buy, and Safe.Pharmacy.
The FDA also provides resources for educating consumers on how to safely purchase medications online, as well as an up-to-date list of websites that have received FDA warning letters for illegally selling prescription drugs online.13
As part of this ongoing work, the FDA recently updated its advice to consumers on how to spot illegitimate sellers.1 The update also details the hazards of purchasing medications from unlicensed online pharmacies, including receiving drugs with unknown active ingredients or drugs that have not been stored properly. The FDA’s BeSafeRx campaign provides additional resources as well as tools for reporting the illegitimate sale of medications.14
Disclosures: Dr Ozawa has no relevant disclosures. Dr Mackey is the CEO and co-founder of S-3 Research, a company funded by the US government to develop technology to detect illegal online sales of drugs.
References
1. How to buy medicines safely from an online pharmacy. US Food and Drug Administration. Updated November 16, 2022. Accessed February 1, 2023.
2. The internet pharmacy market in 2016: Trends, challenges, and opportunities. LegitScript. Published January 2016. Accessed February 1, 2023.
3. Fincham JE. Negative consequences of the widespread and inappropriate easy access to purchasing prescription medications on the internet. Am Health Drug Benefits. 2021;14(1):22-28.
4. Forster V. COVID-19 is still causing drug shortages that impact cancer care. Cancer Therapy Advisor. Published August 19, 2022. Accessed February 1, 2023.
5. McBride A, Hudson-DiSalle S, Pilz J, et al. National survey on the effect of oncology drug shortages in clinical practice: A Hematology Oncology Pharmacy Association survey. JCO Oncol Pract. 2022;18(8):e1289-e1296. doi:10.1200/OP.21.00883
6. Fittler A, Vida RG, Rádics V, Botz L. A challenge for healthcare but just another opportunity for illegitimate online sellers: Dubious market of shortage oncology drugs. PLoS One. 2018;13(8):e0203185. doi:10.1371/journal.pone.0203185
7. Sun Y, Hendrix A, Muluneh B, Ozawa S. Online pharmacy accessibility of imatinib, an oral chemotherapy medication. J Natl Compr Canc Netw. 2022;20(7):808-814. doi:10.6004/jnccn.2022.7007
8. Mackey TK, Cuomo R, Guerra C, Liang BA. After counterfeit Avastin®—what have we learned and what can be done? Nat Rev Clin Oncol. 2015;12(5):302-308. doi:10.1038/nrclinonc.2015.35
9. Warning letter: IceRx. US Food and Drug Administration. Updated October 23, 2018. Accessed February 1, 2023.
10. Medical Product Alert N°2/2019: Falsified ICLUSIG traded globally. World Health Organization. Published February 1, 2019. Accessed February 1, 2023.
11. Drug Supply Chain Security Act (DSCSA). US Food and Drug Administration. Updated November 2, 2022. Accessed February 1, 2023.
12. Inflation Reduction Act of 2022. HR 5376, 117th Cong (2021-2022). Pub L No. 117-69. Accessed February 1, 2023.
13. Internet pharmacy warning letters. US Food and Drug Administration. Updated October 26, 2022. Accessed February 1, 2023.
14. BeSafeRx: Your source for online pharmacy information. US Food and Drug Administration. Updated September 21, 2020. Accessed February 1, 2023.
This article originally appeared on Cancer Therapy Advisor
