Inclusion of non-prescription medicines in essential lists: a cross-sectional study

Over and behind-the-counter medicines are among the most used medicines globally, but their availability differs across countries. While they offer convenient access and fill critical gaps in healthcare, their misuse or improper administration poses risks. This study aimed to assess the inclusion patterns of over-the-counter (OTC) and behind-the-counter (BTC) medicines on essential medicines lists worldwide and examine their effect on public health in terms of accessibility and affordability, as well as the common medical conditions they are intended to address. Additionally, the study examines the regulatory frameworks governing these medicines to understand how healthcare systems balance accessibility with safety. Findings are intended to inform policy decisions aimed at optimizing medicine availability while minimizing potential harms.

This cross-sectional study involved a comparative analysis of essential medicines lists from 158 countries with publicly accessible lists. Main outcomes included the proportion of essential medicines classified as OTC or BTC, variations in their availability across countries, and a comparison with the World Health Organization's model list.

Findings suggest significant variability in the availability of both prescription and non-prescription medicines across countries. While some nations prioritize accessibility by classifying a larger proportion of essential medicines as OTC, others implement stricter regulations to mitigate risks of misuse.

This study highlights the critical role of regulatory frameworks in shaping access to medicines and ensuring their safe use. Understanding global patterns in over or behind-the-counter medicine availability and their inclusion in essential medicines lists can inform policy decisions to optimize healthcare delivery.