Risks and Regulations of Online Pharmacies

The demand for online pharmacies (e-pharmacies) and product access has grown significantly between 2014 to 2023 worldwide, with a reported 98 billion dollars in sales.^{1, 2}  Online pharmacies have existed for years, but the expansion of access has grown substantially since the COVID-19 pandemic. Alongside the growth of access comes an increase in the risks and need for strong regulations of online pharmacies.

Tainted drugs

Policing the internet is a massive challenge. In March and April of 2022, the US Food and Drug Administration (FDA) issued warnings to e-pharmacies. After multiple FDA risk assessments, failure to comply with good manufacturing processes (GMPs) was found.³  Warnings were sent to the generic drug-making company and the online pharmacies selling their products. The risk assessments uncovered cross-contamination risks and the creation of tainted drugs and impurities.³ 

When dealing with raw materials like active pharmaceutical ingredients (APIs), safety and standardized operational procedures for handling and manufacturing is essential. While challenging to prevent all forms of impurities, quality pharmaceutical companies anticipate and mitigate impurity risk by adhering to strict guidelines on drug processing.⁴ E-pharmacies are hard to police and can more easily bypass regulations that can put customers at risk as drug impurities have the potential to become toxic.⁴

Undeclared drug components 

The FDA also warned Amazon and Walmart about distributing non-steroidal anti-inflammatory (NSAID) products with undeclared drug ingredients like diclofenac and dexamethasone.³

The dangers of combining prescription and non-prescription drugs, or polydrug use (taking multiple drugs), can have profound health implications, especially if all ingredients are not listed. Polydrug use can cancel out the intended effect of another drug or decrease the required dosing time of the pharmaceutical.⁴ However, studies have also identified adverse effects of polydrug use with NSAIDs, such as gastrointestinal bleeding, platelet function impairment, and increased cardiac risk.⁴ 

Online pharmacy safety is a public health issue

Although online pharmacies have helped lower costs and increase accessibility to patients, the enforcement of rules and regulations must be followed up on. In addition, the responsibility of delivering safe and effective pharmaceutical drugs through rigorous monitoring and maintenance to e-pharmacies is the responsibility of all stakeholders involved.

References

1. Zhao, H., Muthupandi, S., & Kumara, S. (2020). Managing illicit online pharmacies: Web analytics and predictive models study. Journal of Medical Internet Research, 22(8). https://doi.org/10.2196/17239 
2.  Soboleva MS, Loskutova EE, Kosova IV. Problems of purchasing pharmacy products through online orders. J Adv Pharm Technol Res [serial online] 2022;13:286-90. Available from: https://www.japtr.org/text.asp?2022/13/4/286/358219 
3. Mezher, M. (n.d.). FDA sends warning letters to Lupin, Amazon and Walmart. Regulatory Affairs Professionals Society (RAPS). Retrieved February 5, 2023, from https://www.raps.org/news-and-articles/news-articles/2022/11/fda-sends-warning-letters-to-lupin-amazon-and-walm   
4. Cascorbi, I. (2017). Drug interactions. Deutsches Ärzteblatt International. https://doi.org/10.3238/arztebl.2012.0546