Evolving Regulatory Criteria Fuel Rx-to-OTC Rejections

A variety of regulatory concerns—including safety, diagnosis, and behavioral issues, among others—significantly contribute to the rejection of prescription drug to over-the-counter (Rx-to-OTC) product development, according to a study in Clinical Therapeutics.¹ With regulatory criteria for Rx-to-OTC switches rapidly evolving, researchers explained the opportunities for improving the framework of this process through pharmacist involvement and novel risk mitigation strategies.

“The self-care movement has become fundamental to modern health care, as individuals are more proactive in managing their own health, supported by technologies like telemedicine, online pharmacies, and health apps, which empower patients to make informed health decisions,” wrote authors of the study. "The COVID-19 pandemic has highlighted the importance of self-care interventions in maintaining essential health services, especially during national health crises.”

Regarding so many of the groundbreaking developments pharmacy has experienced in recent history, COVID-19 has played a major factor. Because of the pandemic, as well as an evolving digital landscape within health care, more and more patients are placing their personal health journeys in their own hands rather than the hands of health care providers.

READ MORE: COVID-19: Most-Read Stories of 2025

Self-care approaches across various patient populations have indeed risen since the pandemic, with reports claiming that up to 80% of Americans conduct some sort of self-care management since the onset of the pandemic’s restrictions.² However, whether patients are caring for themselves or not, the pandemic has had an immense impact on chronic disease and mental health outcomes, to name a few.

“Measures imposed to mitigate the spread of COVID-19 did have an impact on people with chronic conditions and their self-care capabilities, resulting in the decline in physical activity and self-monitoring of signs and symptoms, increase in unhealthy food consumption, and difficulties in medication adherence,” according to the authors in JMIR Human Factors.³ Furthermore, a study from PEC Innovation reported that adults with chronic conditions reported significant amounts of COVID-related stress during the pandemic, which significantly impacted self-care management behaviors.⁴

However, with pandemic-related restrictions in the past, researchers are now revisiting self-care methods across patient populations and how they relate to OTC use.

Examining Rejected Rx-to-OTC Switches to Improve Self-Care

“OTC drugs, purchased without a prescription, can offer many advantages when used appropriately, such as decreased need for doctor visits, improved patient access to effective treatments, and lower treatment costs for self-manageable conditions,” continued the authors of the current study.¹ “This study explored the challenges of Rx-to-OTC switches and potential policy changes to improve patient access to medications. The goal was to assess reasons for the rejection of switch applications for selected International Nonproprietary Names (INNs) across various countries.”

Researchers conducted a qualitative analysis of 19 INNs to better understand why Rx-to-OTC switches are rejected across 8 distinct countries. By uncovering the key reasons that lead to these rejections, researchers hoped to provide specific approaches to improving self-care among patients in the community.

Using data on rejection and withdrawal of these switches, as well as the reasons behind them, researchers grouped countries’ INNs in 10 therapeutic areas. In the context of this study, the INNs included were a collection of 19 different drugs examined for Rx-to-OTC switches, grouped within 1 of the 10 therapeutic areas.

The main findings regarding why rejections occurred were attributed to safety concerns, diagnosis and self-management concerns, and behavioral and misuse concerns.¹

READ MORE: Pharmacists Guide Patients as Prescription Drugs Move Over the Counter

“This study highlights the complexity and inconsistencies of the Rx-to-OTC switch process, emphasizing variability in evaluation outcomes and approval rates across countries,” they wrote. “It notes recurring reasons for rejections and inconsistencies in decision-making, reflecting the challenges in balancing safety, accessibility, and self-care.”

Amid the sheer variability across countries in the Rx-to-OTC process, these high-level findings allowed researchers to propose a detailed path forward for better patient outcomes stemming from this process. Researchers discussed global standardization methods, contributions from pharmacists, real-world evidence on consumer behaviors, utilizing AI, and creating industry incentives to further drive these approaches.

However, despite the study’s findings, researchers implored all providers and regulators to understand that these processes are constantly evolving. By keeping a close eye on developments and offering a collaborative effort, the Rx-to-OTC process and its impacts on self-care can certainly be improved in the future.

“The analysis of Rx-to-OTC switch rejections reveals that regulatory decisions focus on key criteria: safety, efficacy, low potential for misuse, self-diagnosis capability, suitability for self-treatment, and clear usage directions,” the authors concluded.¹ “By recognizing that the traditional switch criteria exist within an evolving context of health care consumer capabilities and technological support, regulators can develop more flexible pathways that expand access to effective treatments while preserving appropriate safeguards.”

READ MORE: OTC Resource Center

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REFERENCES

1. Uliana T, Lassoued Z, Restrepo SM, et al. Analyzing prescription drug to over-the-counter drug switch rejections: understanding regulatory concerns, a global overview. Clin Ther. January 22, 2026. https://doi.org/10.1016/j.clinthera.2025.12.012

2. Gramigna J. 80% of Americans intend to regularly practice self-care after COVID-19 pandemic. Healio. June 12, 2020. Accessed January 30, 2026. https://www.healio.com/news/psychiatry/20200612/80-of-americans-intend-to-regularly-practice-selfcare-after-covid19-pandemic

3. Sakur F, Ward K, Khatri NN, et al. Self-care behaviors and technology used during COVID-19: systematic review. JMIR Hum Factors. 2022 Jun 21;9(2):e35173. doi: 10.2196/35173.

4. Russell A, Filec S, Serper M, et al. Impact of COVID-19 on the capacity to self-manage health and chronic conditions. PEC Innov. 2023;2:100163. https://doi.org/10.1016/j.pecinn.2023.100163