Expanding OTC medicine access in non-pharmacy settings for self-medication: a scoping review.

Abstract

Introduction: In recent years, OTC distribution has expanded into non-pharmacy retail settings, with 19 of 30 European countries permitting non-pharmacy OTC sales. This may increase accessibility and promote self-medication, but it also creates risks of misuse, overdose, and greater retail market concentration. Therefore, countries have adopted various regulatory mechanisms to balance accessibility with patient safety. This scoping review aimed to examine the global regulatory models governing OTC dispensing and distribution at non-pharmacy retail settings, with particular emphasis on regulatory mechanisms influencing availability and accessibility.

Methods: A scoping review was conducted following the PCC framework and reported in accordance with PRISMA-ScR and JBI guidance. Literature published between January 2015 and August 2025 was identified through PubMed/MEDLINE, Scopus, ScienceDirect, and citation searching. Eligible studies were selected through systematic screening and synthesised using thematic analysis.

Results: The search identified 295 studies, followed by the removal of 15 duplicates. After screening 280 unique studies, 8 met the inclusion criteria. Data from empirical studies and regulatory documents were synthesised. Three major themes were identified; the first was regulation and supervision, including medication classification, dispensing, pack-size limits, age restrictions, and oversight mechanisms. The second was self-medication and consumer behaviour, showing convenience-driven purchasing and limited risk awareness. The third was deregulation and service system changes, indicating expanded access through supermarkets, convenience stores, and online platforms, alongside concerns about safety and shifting market dynamics.

Conclusion: This scoping review indicates that deregulation, particularly in regions with limited healthcare access, enhances availability of medications and facilitates self-medication. Risk-based governance relies on safety-based classification, which establishes dispensing restrictions and determines where and how products may be accessed. These safeguards are further supported by controls such as pack-size limitations, mandated personnel qualifications, regulatory oversight, and consumer education to promote safe usage.