Proactive Warning Is Crucial in Preventing OTC Drug Abuse

To alleviate the rising trend of OTC drug abuse, it is crucial for pharmacists and other providers to communicate proactive warnings about potential effects of these products, according to authors of a study published in Exploratory Research in Clinical and Social Pharmacy.¹

“The safety profile of OTC medicines is reassuring; however, these medicines are not harmless, and the abuse of OTC medicines, which means using them for nonclinical purposes, can lead to severe complications, such as addiction and even death,” wrote authors of a study published in Hospital Pharmacy.² “Additionally, misuse of OTC medicines, which occurs when these medicines are used for medical purposes and with honest intentions but in the wrong manner, can induce adverse clinical outcomes.”

US patients have a unique relationship with both prescription and OTC drugs. Prescription drugs have historically been prescribed via a certified recommendation from a primary care physician. For OTC drugs, however, these products are available to mostly all US patients at any pharmacy or grocery store in the country.

READ MORE: Tracking OTC Sales Can Significantly Improve Disease Monitoring

Although there are continuous concerns regarding substance use disorder for patients and their prescription medications, OTC drug misuse and abuse are on the rise among young people in particular. A 2023 survey showed that 10.9% of eighth graders, 19.8% of 10th graders, and 31.2% of 12th graders had illicitly used some type of drug in the past year.³

The same survey showed a decline in rising trends related to OTC misuse between the years 2021 and 2023. However, for 8th graders specifically, their OTC misuse peaked at an all-time high of 4.6% in 2020. Data like these show that the COVID-19 pandemic may have had an unprecedented effect on patients’ OTC drug use.

“With the substantial increase in the prevalence of self-medication of OTC medicines during the pandemic, the patterns of abuse and misuse of these medicines could be increased,” continued authors of the Hospital Pharmacy study.² “Maintaining people’s mental health, patient education about medication use and adverse events, minimizing misinformation and rumors, and improving access to health care in a pandemic are recommended to be implemented in a multifactorial strategy for the prevention of abuse and misuse of OTC medicines in a pandemic.”

With OTC drug misuse being one of the many health care occurrences exacerbated by the COVID-19 pandemic, researchers of the current study wanted to update their current understanding of OTC drug misuse, the drugs that patients are misusing the most, and the future approaches necessary for alleviating these issues.¹

In Japan, where the current study was conducted, all pharmaceutical products with potential for misuse are designated by the Ministry of Health, Labor, and Welfare (MHLW). Furthermore, any business or pharmacist attempting to distribute these products to patients must provide information regarding proper use.

However, there are many OTC products not designated by the MHLW susceptible to misuse, leading researchers to get to the bottom of current OTC misuse trends.

“In this study, we focused on OTC drugs, which are often abused, set survey items regarding warnings at the time of the sale of these drugs, and aimed to investigate the actual situation based on whether these drugs contain the ministry-designated ingredients,” wrote the study authors.¹

Among 17 randomly selected pharmacies and drugstores in Japan, they explored a total of 25 OTC drugs. In their field research, study investigators purchased 1 product at a time at each location, with the survey period spanning from August 7, 2024, to May 13, 2025. Across the 25 products selected, 13 were designated by the MHLW for potential misuse, while the remaining 12 were not designated but sometimes abused.

Researchers then presented their findings on field research exploring distributors’ warnings about OTC drug misuse. They found that 44% of the time a qualified individual provided proper warning explanations and 36% of the time distributors provided point-of-purchase warning displays. When comparing designated OTC drugs with non-designated products, warnings were much more significant among the OTC drugs designated for potential misuse.

Despite OTC distributors often providing the proper warning information for their products, the pharmacies surveyed in this study did not show positive results across the board. With a health care sector dedicated to avoiding adverse events and medication misuse, pharmacist expertise should be utilized much more significantly to minimize these concerns in the future.

“In order to proactively intervene with targets to prevent the abuse of OTC drugs, in addition to issuing warnings at the time of sale about OTC drugs that contain designated ingredients, it is necessary to also proactively warn about OTC drugs that do not contain designated ingredients but are abused,” the authors concluded.¹

READ MORE: OTC Resource Center

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REFERENCES

1. Nagashima K, Nasu H, Sekine Y. Field survey on warnings to prevent drug abuse when selling over-the-counter drugs at drugstores. Explor Res Clin Soc Pharm. December 3, 2025:100690. https://doi.org/10.1016/j.rcsop.2025.100690

2. Al Meslamani AZ, Abdel-Qader DH. The abuse and misuse of over-the-counter medicines during COVID-19. Hosp Pharm. 2023 Oct;58(5):437-440. doi: 10.1177/00185787231158777. Epub 2023 Mar 5.

3. Low rates of OTC medicine abuse continue in 2023. Stop Medicine Abuse. January 18, 2024. Accessed December 4, 2025. https://stopmedicineabuse.org/resource/2023-monitoring-the-future-results-low-rates-of-otc-medicine-misuse-continue/