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.

Background

Over-the-counter (OTC) medicines play an important role in global healthcare by supporting the management of minor ailments and potentially improving health system efficiency when used appropriately (Mizranita et al., 2024; Tesfamariam et al., 2019). Self-medication is considered one component of broader self-care practices that can support health and well-being when used appropriately (WHO, 2021). Over the past decade, several countries implementing liberalised or risk-stratified regulatory reforms have permitted OTC medicines to be sold beyond in non-pharmacy settings. Even with the facilitative role of health literacy and digital access, the expansion stems primarily from explicit regulatory policy decisions, not from market-driven demand alone (Akande-Sholabi & Akinyemi, 2023; Noone & Blanchette, 2018). Several countries, including Sweden, South Korea, and the United Kingdom, have implemented deregulation policies that allow selected OTC medicines to be sold through non-pharmacy outlets in an effort to improve access and reduce pressure on healthcare systems (Chun et al., 2017; López Vila et al., 2023). However, regulatory practices vary considerably, as some European countries, such as Sweden, the United Kingdom (UK), and Portugal, permit OTC sales in retail stores with limitations on drug type, quantity, or purchaser age, while others like Germany maintain pharmacy-only systems (Darracq & Thornton, 2022; Głowacka & Wiela-Hojeńska, 2021). In comparison, Germany maintains pharmacy monopoly, as other countries with certain restrictions allow distribution in convenience, gas stations, or drug stores (Eickhoff et al., 2021; Heinsohn & Flessa, 2013). Asian regulatory models vary considerably, from Japan's risk-based OTC classification system and South Korea's selective non-pharmacy sales model to stricter pharmacy-based distribution and oversight models in other Asian countries (Chun et al., 2017; Leelavanich et al., 2020).

The present findings align with evidence from international studies indicating that increased access to over-the-counter (OTC) medicines may facilitate self-medication practices across a wide range of healthcare contexts. Similar observations have been reported in both developed and developing countries, including the United States (Noone & Blanchette, 2018), Nigeria (Akande-Sholabi & Akinyemi, 2023), and several countries in the Middle East (Wazaify et al., 2017).

The expansion of access to OTC medicines through non-pharmacy channels is associated with potential risks. Although these medicines are generally considered safe when used as directed, inappropriate self-medication may result in adverse drug reactions, drug interactions, contraindications, overdose, and misuse of certain active ingredients such as paracetamol, ibuprofen, dextromethorphan, pseudoephedrine, and diphenhydramine (López Vila et al., 2023; Wazaify et al., 2017). To balance accessibility and patient safety, several countries have adopted risk-based regulatory controls for OTC medicines. In the United Kingdom, medicines available for sale outside pharmacies are subject to specific conditions of sale, including pack-size restrictions, reduced strengths, clear warning labels, and recommendations to seek professional advice if symptoms persist or worsen. Some products are also approved only for limited indications, treatment durations, or specific population groups. For example, pack-size restrictions for paracetamol-containing products are intended to reduce the risk of overdose. In addition, medicines containing pseudoephedrine are subject to stricter controls because of their misuse and diversion potential. In the United Kingdom, sales are limited to a maximum of 720 mg pseudoephedrine per transaction and remain under pharmacy supervision, whereas in the United States pseudoephedrine-containing products are dispensed behind the counter (BTC) and are subject to purchaser identification and purchase-limit requirements (Center for Drug Evaluation and Research, 2026; López Vila et al., 2023).

The majority of existing studies on OTC medicine access are limited to specific jurisdictions or categories, creating a global knowledge gap in understanding regulatory variations and implementation practices. Furthermore, results are inconsistent and often centred on pharmacy settings, providing limited information on policies governing OTC sales in non-pharmacy environments such as drugstores, minimarkets, supermarkets, and convenience stores (Oleszkiewicz et al., 2021).

Based on the description above, this scoping review aims to address the knowledge gap by systematically mapping OTC access policies across multiple countries. The analysis focuses on three key areas, namely (1) regulation and supervision, (2) self-medication and consumer behaviour, and (3) oversight mechanisms. Despite the growth of OTC availability in non-pharmacy retail settings and the increasing consumer demand for convenience, the existing literature does not provide a comprehensive understanding of how countries regulate, supervise, or mitigate the risks associated with expanded access. The lack of related existing literature shows the need for a clearer synthesis to inform policies responses, particularly as deregulation can influence both accessibility and medication safety. Therefore, this scoping review compiles and synthesises international results on OTC access policies in non-pharmacy settings, offering an integrated foundation for regulators and policymakers to balance accessibility, patient protection, and public health outcomes.

Methods

A scoping review was conducted to map policies governing the distribution of OTC medicine in non-pharmacy settings across countries. This scoping review was conducted following the methodological framework proposed by Arksey and O'Malley, which includes identifying the research question, identifying relevant studies, selecting eligible studies, charting the data, and collating, summarising, and reporting the findings. This review aimed to synthesise existing literature on regulatory methods, an area that had not been investigated extensively.

Search strategy

Searches were conducted across PubMed/MEDLINE, Scopus, and ScienceDirect to identify publications relevant to policies governing access to OTC medicines in non-pharmacy settings. The search strategy was developed using three conceptual domains: non-pharmacy retail settings, OTC medicine distribution and access, and regulatory and policy framework. Keywords and MeSH terms within each domain were combined using the Boolean operator OR, while the three domains were linked using AND to generate a comprehensive search strategy. Additional citation searching was undertaken to identify relevant studies not captured through database searches. The non-pharmacy retail settings domain included terms such as ‘supermarket,’ ‘grocery stores,’ ‘drug outlet,’ ‘non-pharmacy,’ ‘general store,’ ‘convenience store,’ ‘drug shop,’ ‘drug store,’ ‘retail drug sellers,’ and ‘non-pharmacy outlets.’ The OTC medicine distribution and access domain included terms related to medicine supply and access, such as ‘distribution,’ ‘over-the-counter,’ ‘OTC,’ ‘medicine distribution,’ ‘drug distribution,’ ‘pharmaceutical distribution,’ and ‘restriction.’ The regulatory and policy domain incorporated the MeSH terms ‘Government Regulation’ and ‘Health Policy,’ together with keywords including ‘policy,’ ‘regulation,’ ‘framework,’ ‘government policy,’ ‘policy analysis,’ ‘regulatory framework,’ and ‘legislation.’ Boolean operators (AND, OR, and NOT) were applied as appropriate to refine the search strategy.

Study selection and extraction

All records retrieved from PubMed/MEDLINE, Scopus, and ScienceDirect were imported into Covidence for study management and screening. Duplicate records were identified and removed prior to the screening process. Study selection was conducted in three sequential stages. First, titles were screened against the predefined inclusion and exclusion criteria. Second, abstracts of potentially relevant studies were reviewed to determine eligibility. Third, full-text articles were assessed for final inclusion in the review. Additional studies identified through citation searching were subjected to the same screening procedure. The study selection process was documented using the PRISMA-ScR flow diagram.

Following study selection, all included studies were organised using EndNote. A standardised data extraction template was developed and used by five reviewers. Data extracted from each study included publication characteristics (study title, study type, and year of publication), study objectives, study design, data sources, focus of the study, inclusion criteria, results, and key findings. The characteristics and main findings of the included studies are summarised in Table 1.

Table 1.

. Characteristics and Main Findings of Included Studies on OTC Medicine Access and Policies in Non-Pharmacy Retail Settings

Study title	Study type	Year’s	Aims/Objectives	Study design	Data	Focused study	Inclusion	Results	Key results
(Morthorst et al., 2018)	Original Study–Quantitative	2018	To assess the implementation of OTC paracetamol pack-size restrictions and availability in non-pharmacy outlets	Cross-sectional survey	Poison Information Center (PIC) data through EAPCCT	Pack-size rules, non-pharmacy availability, poisoning enquiry rates	Countries with functional PICs	Two-thirds had pack-size limits; 43% allowed non-pharmacy sales	Higher poisoning enquiry rates in countries allowing non-pharmacy sales show misuse risks
(López Vila et al., 2023)	Original Study: Quantitative Policies Analysis	2021	Classify OTC regulatory system (dispensing, distribution, ownership, and pricing)	Policies review and cluster analysis	National regulations, EU directives, and WHO/OECD reports	Regulatory variation, non-pharmacy permissions, and restrictions	European countries with available regulatory data	Seven regulatory clusters identified; 16 countries allow non-pharmacy sales	Wide variation; liberal systems expand access but often lack supervision
(Nomura et al., 2016)	Descriptive Policies Review	2016	To describe the reclassification and regulatory systems for safe OTC use	Desk-based policies review	MHLW reports, PMDA guidelines, and law revisions	Rx-to-OTC reclassification; risk-based categories	National regulatory documents	Japan uses a three-tier OTC classification	Risk levels determine the retail setting and qualifications; low-risk OTC can be sold outside pharmacy settings
(Lind et al., 2016)	Comparative Policies Analysis	2016	To compare the regulatory systems for general-sale OTC medicines	Qualitative policies review	Pharmacy Acts, MPA/MHRA Guidelines, and Government Reports	Legal framework and supervision systems	Official national documents	Both countries allow general-sale OTC medicines	Key differences in supervision affect compliance and safety outcomes
(Chun et al., 2017)	Original Study–Policies Evaluation	2017	To evaluate the effects of deregulation on outpatient visits	Interrupted Time Series (ITS)	Korean National Health Insurance Cohort (2009–2013)	Impact of Deregulation on Access and Healthcare Use	Outpatient claims	Deregulation increased accessibility	Improved access requires stronger labelling and patient education to prevent misuse
(Håkonsen et al., 2016)	Original Study – Cross-sectional Survey	2016	To investigate preferences for OTC medicine retailers and the factors influencing the choice between pharmacy and non-pharmacy outlets.	Web-based survey (LORE panel)	Adult panel participants	Consumer decision factors after deregulation	Adults ≥20 years enrolled in LORE	90% purchased OTC in the past 6 months	Consumers value the convenience of non-pharmacy stores but prefer pharmacies for professional guidance
(Molloy et al., 2016)	Original Research–Mystery Shopper	2016	To evaluate compliance with the MHRA pack-size rules for paracetamol/aspirin	Mystery shopper design	Observations from 62 retail stores	Compliance with legal and safety limits	General-sale retail outlets	Over half exceeded the pack-size limits; 98% sold multiple packs	Poor compliance indicates significant safety concerns in deregulated settings.
(Dulęba et al., 2021).	Original Research – Cross-sectional Survey	2021	To assess patient awareness of risks in buying OTC from non-pharmacy outlets	Questionnaire (paper + online)	Adult respondents ≥18 years	Risk perception under the deregulated OTC system	Adults ≥18 years	47% purchased OTC in non-pharmacy outlets	High access but low safety literacy; limited oversight increases the risk

Abbreviations: OTC, over-the-counter; Rx, prescription medicine; PIC, Poison Information Center; EAPCCT, European Association of Poisons Centres and Clinical Toxicologists; WHO, World Health Organization; OECD, Organisation for Economic Co-operation and Development; MHLW, Ministry of Health, Labour and Welfare (Japan); PMDA, Pharmaceuticals and Medical Devices Agency (Japan); MPA, Medical Products Agency (Sweden); MHRA, Medicines and Healthcare products Regulatory Agency (United Kingdom); ITS, interrupted time series.

Eligibility criteria

The inclusion criteria were studies that discussed policies, regulations, or governance of OTC drug access, and focused on non-pharmacy facilities, such as supermarkets, minimarkets, convenience stores, drug shops, retail stores, and petrol stations. Furthermore, peer-reviewed studies that were original, policies review, and analyses, or grey literature comprising official regulatory documents, government reports, and WHO documents were included. Others were publications between January 2015 and August 2025, as well as studies conducted using English or another language that could be translated. The exclusion criteria were studies that only focused on pharmacy-based OTC access, addressed clinical/pharmacological topics unrelated to access policies, or lacked full-text availability.

Results

The search identified 295 studies (PubMed: 127; ScienceDirect: 16; Scopus: 150; citation searching: 2). After removing 15 duplicates, 280 studies remained, followed by screening of titles and abstracts that excluded 267, leaving 13 full texts for evaluation. After assessment, eight studies met all the eligibility criteria and were included in the final scoping review, with the selection process shown in Figure 1.

Figure 1.

PRISMA 2020 flow diagram of study selection process.

Characteristics of the studies included

This scoping review identified eight studies using varied methodological designs, including five empirical investigations (cross-sectional surveys, observational audits, and policies impact evaluations), two comparative regulatory analyses, and one national policies review (Chun et al., 2017; Dulęba et al., 2021; Håkonsen et al., 2016; Lind et al., 2016; López Vila et al., 2023; Molloy et al., 2016; Morthorst et al., 2018; Nomura et al., 2016). A multi-country analysis involving 21 European countries, including Sweden and Poland, highlighted substantial variation in OTC distribution models and regulatory approaches across Europe (Oleszkiewicz et al., 2021), a UK mystery shopper audit assessing compliance with analgesic sales regulations (Molloy et al., 2016), and an interrupted time-series analysis evaluating the effects of OTC deregulation in South Korea (Chun et al., 2017). Meanwhile, a multi-country cross-sectional survey examined paracetamol pack-size limits and poisoning enquiries across 21 European countries.

The comparative analyses mapped regulatory variations in OTC dispensing permissions, pack-size restrictions, staff qualification requirements, and authorisation for non-pharmacy outlets across Europe (López Vila et al., 2023; Morthorst et al., 2018). Another study evaluated Japan uses a risk-based reclassification system that categorises OTC medicines into Type 1, Type 2, and Type 3 products, with evaluations suggesting that reclassification has expanded consumer access while maintaining pharmacist oversight for higher-risk medicines (Nomura et al., 2016).

Geographically, six studies were conducted in Europe, while Japan and South Korea contributed two, focusing on risk-based governance and deregulation outcomes. Data sources included national policies documents, Poisons Information Centre surveillance systems, health insurance claims databases, and validated consumer or patient survey instruments.

The thematic mapping of the included studies is summarised in Table 2. The studies were categorised according to three overarching themes identified through the thematic analysis: regulation and supervision, self-medication and consumer behaviour, and deregulation and service system changes. Each theme was further organised into relevant subthemes to facilitate comparison of regulatory approaches and their implications across countries.

Table 2.

Thematic mapping of included studies on OTC medicine access and policies in non-pharmacy retail settings.

Author	Nation	Regulation and supervision			Self-medication and consumer behaviour		Deregulation and service system changes
		T1-S1 dispensing restrictions	T1-S2 Non-Pharmacy Facilities	T1-S3 Oversight systems/mechanical systems	T2-S1 Consumer behaviour and preferences	T2-S2 Impact of Self-Medication on Patient Safety	T3-S1 OTC Access and Distribution after Deregulation	T3-S2 Impact of Deregulation
(Morthorst et al., 2018).	Denmark, Norway, Ireland, United Kingdom, Czech Republic, Poland, Russian.	Pack-size limits for paracetamol ranged from 8–30 g per transaction; 14 of 21 countries implemented quantitative restrictions to mitigate overdose risk.	Supermarkets and general retail are allowed in 43% of 21 countries.	Enforcement inconsistent; PICs used for monitoring.	Quick, convenience-driven purchasing	Higher poisoning enquiries in countries allowing non-pharmacy sales	The article shows that 43% of countries allow the sale of paracetamol in non-pharmacy outlets	Increased toxicology burden and competitive retail market growth
(López Vila et al., 2023)	30 European Countries	Restrictions on strength, pack size, age, and display	Supermarkets, minimarkets, and retail chains	Staff training, minimum and periodic health inspections.			16/30 countries allow non-pharmacy OTC sales → access expansion	Potential market oligopoly: shifts in ownership and pricing structure
(Nomura et al., 2016).	Japan	Japan implements a tiered risk-based OTC system in which Category 2 and Category 3 medicines may be sold in licensed non-pharmacy outlets, subject to seller qualification requirements.	Convenience stores, Supermarkets, Super drugstores/retail health chains.	Seller certification, regulatory inspection, and national post-marketing monitoring under MHLW.	-	Risks include delayed diagnosis and under-recognized ADRs	The deregulation of 2009 and 2014 allowed OTC sales by registered sellers, including online sales, to expand access	Market growth is slower than expected; limited cost reduction
(Lind et al., 2016).	Sweden and United Kingdom (UK)	Pack-size restrictions for analgesics	Supermarkets, convenience stores, and retail chains may sell only low-risk OTC medications.	National regulatory authorities (MHRA; MPA in Sweden). Main mechanisms: mandatory labelling, routine inspections, and distribution compliance audits	Consumers tend to buy analgesics and mild cold medicines without consultation.	Overuse risk; packaging controls are effective in reducing overdoses	Consumers have faster and cheaper access, specifically in urban areas	Online/non-pharmacy growth reshapes market access.
(Chun et al., 2017).	South Korea	Sales do not require a specific age, but a warning leaflet must be included.	Convenience stores and supermarkets	Routine Inspections and Labelling Rules	Consumers increasingly choose large retail pharmacy chains, such as consumer value store (CVS), for extended operating hours and convenience.	Overuse risk, packaging controls are effective in reducing overdoses
(Håkonsen et al., 2016)	Sweden	Low-risk OTC allowed outside pharmacy	Supermarkets, petrol stations, and minimarkets	Consumers prefer retail outlets with easy access, extended hours, and competitive prices	Consumers in Sweden tend to choose retailers with easy access		Deregulation increased the number of OTC sales outlets and expanded access, particularly through large retail chains	Non-pharmacy retailers gained a larger share of the OTC market
(Molloy et al., 2016).	United Kingdom	Pack-size limits (16 tablets), often violated	OTC analgesics may be sold in supermarkets, general retail outlets.	National regulations exist, but oversight at the retail level is weak	Selections driven by cost, not safety.	High overdose rates are related to poor compliance.	Wider retail availability	Loss of the pharmacist role; retail chains gain OTC market share
(Dulęba et al., 2021).	Poland		Supermarkets, convenience stores, and gas stations	Not explained in regulatory terms, but the study underlines the lack of supervision of trained personnel	Consumers are unaware of risks; poor leaflet reading	ADRs and drug interactions are under-recognized	Broad, rapid access, specifically for analgesics	Growing market but rising clinical burden (polypharmacy risks)

Abbreviations: ADRs, Adverse Drug Reactions; MHRA, Medicines and Healthcare products Regulatory Agency; MHLW, Ministry of Health, Labour and Welfare; MPA, Medical Products Agency; OTC, Over-the-Counter; PICs, Poisons Information Centres; UK, United Kingdom.

Themes: T1, Regulation and Supervision; T2, Self-Medication and Consumer Behaviour; T3, Deregulation and Service System Changes.

Theme 1: regulation and supervision

The literature search included three sub-themes, namely dispensing restrictions (dosage/packaging) (Håkonsen et al., 2016; Lind et al., 2016; Morthorst et al., 2018; Nomura et al., 2016), non-pharmacy outlet type (Chun et al., 2017; Lind et al., 2016; López Vila et al., 2023; Molloy et al., 2016; Morthorst et al., 2018; Nomura et al., 2016), and regulatory oversight in non-pharmacy settings (Lasota et al., 2022; López Vila et al., 2023; Nomura et al., 2016). The sub-theme grouping results are as follows.

Subtheme: dispensing restrictions, dosage, and packaging

A total of five studies reported that across Europe, dispensing controls for OTC medicines, particularly paracetamol, were primarily implemented through pack-size limits, typically restricting sales to 16–20 tablets per transaction to reduce overdose risk (Håkonsen et al., 2016; Lind et al., 2016; Morthorst et al., 2018; Nomura et al., 2016).

Japan’s OTC system employs a tiered, risk-based classification. Category 1 medicines require mandatory pharmacist counselling, while lower-risk Category 2 and Category 3 products can be sold in licensed outlets by either pharmacists or registered sellers. Category 2 typically includes systemic cold remedies, analgesics, and gastrointestinal agents, whereas Category 3 comprises lower-risk items like vitamins and digestive aids, which may be sold in authorised retail settings under standard labelling requirements (Chun et al., 2017; Nomura et al., 2016). Similarly, South Korea permits selected low-risk OTC medicines to be sold in convenience stores under regulatory oversight, while higher-risk products remain pharmacy-only (Chun et al., 2017).

The effectiveness of such risk-based regulatory frameworks depends not only on classification design but also on implementation quality. Evidence from the UK indicates instances of non-adherence to pack-size restrictions, while studies in Poland report low consumer risk awareness despite regulatory safeguards. These findings suggest that classification alone may be insufficient without consistent compliance and consumer literacy support.

Subtheme: non-pharmacy retail outlets

Countries that permit non-pharmacy OTC sales distribute medicine through supermarkets, convenience stores, and retail chains (Chun et al., 2017; López Vila et al., 2023; Nomura et al., 2016). Although consumers often prefer these outlets for convenience, many still select pharmacy reassurance is needed, particularly product-use clarification, or risk assessment (Lind et al., 2016; Molloy et al., 2016; Morthorst et al., 2018). Variability in retail compliance and staff knowledge contributes to inconsistent implementation of safety measures across countries (Dulęba et al., 2021; Håkonsen et al., 2016).

Subtheme: regulatory oversight

Oversight mechanisms include mandatory labelling, inspections, controlled display locations, and licensing of registered sellers. However, enforcement varies significantly and is often considered insufficient in system with broad non-pharmacy access (Lasota et al., 2022; López Vila et al., 2023; Nomura et al., 2016).

Theme 2: self-Medication and consumer behavior

Most of the studies identified in the literature search emphasised aspects of self-medication and consumer behaviour (Chun et al., 2017; Håkonsen et al., 2016; Hedenrud & Håkonsen, 2017; Hedenrud et al., 2019; Lasota et al., 2022; López Vila et al., 2023; Morthorst et al., 2018; Nomura et al., 2016). Therefore, this theme was elaborated into several sub-themes, namely consumer behaviour and preferences (Lasota et al., 2022; López Vila et al., 2023; Nomura et al., 2016) and the impact of self-medication on patient safety (Chun et al., 2017; Håkonsen et al., 2016; Hedenrud & Håkonsen, 2017; Hedenrud et al., 2019; Lasota et al., 2022; López Vila et al., 2023; Morthorst et al., 2018; Nomura et al., 2016). The method allows for a more comprehensive analysis of how each country balances expanding public access to self-medication drugs and protecting patient safety.

Subtheme: consumer behavior and preferences

Consumers commonly purchase analgesics and cold medicine from non-pharmacy outlets due to greater accessibility, lower prices, and extended operating hours, leading to increasingly self-directed self-medication practices (Chun et al., 2017; Håkonsen et al., 2016; Nomura et al., 2016). However, pharmacy remains preferred in situations of uncertainty or perceived risk (Chun et al., 2017; Nomura et al., 2016). Convenience-oriented behaviour often outpaces consumer understanding of medication safety, thereby increasing the tendency for misuse and adverse events (Dulęba et al., 2021; Molloy et al., 2016; Morthorst et al., 2018).

Subtheme: impact of self-Medication

Expanded access through non-pharmacy retailers introduces safety concerns, particularly for paracetamol and other analgesics. These include unintentional overdose, delayed care-seeking, and drug interactions in patients with chronic conditions (Chun et al., 2017; Dulęba et al., 2021; Lind et al., 2016; López Vila et al., 2023; Molloy et al., 2016; Morthorst et al., 2018). Although pack-size restrictions serve as preventive measures, the associated impact depends on enforcement and consumer risk-awareness, which remain suboptimal in many regions (Dulęba et al., 2021; Håkonsen et al., 2016; Molloy et al., 2016; Morthorst et al., 2018).

Theme 3: deregulation and service system changes

Subtheme: OTC access and distribution after deregulation

Deregulation has broadened OTC access through multiple retail channels, such as supermarkets, convenience stores, modern retail chains, and online platforms, making self-medication more convenient (Håkonsen et al., 2016; Lind et al., 2016; López Vila et al., 2023; Morthorst et al., 2018). Regulatory intensity varies across countries, as liberal models in the UK, Sweden, and South Korea allow widespread non-pharmacy access. Meanwhile, restricted models in Germany, Belgium, and Italy confine most OTC sales to pharmacy (Chun et al., 2017; Lind et al., 2016; López Vila et al., 2023; Morthorst et al., 2018). Japan and South Korea represent risk-stratified systems that balance accessibility with vendor qualifications and consumer education (Chun et al., 2017; Nomura et al., 2016).

Subtheme: impact on non-pharmacy outlets and the market structure

The availability of analgesics like paracetamol in non-pharmacy settings introduces safety risks, including unintentional overdose and drug interactions (Chun et al., 2017; Lind et al., 2016; López Vila et al., 2023; Molloy et al., 2016; Morthorst et al., 2018a). However, the effectiveness of preventive pack-size restrictions is undermined by inconsistent enforcement and limited consumer risk-awareness across many regions (Chun et al., 2017; Dulęba et al., 2021; Håkonsen et al., 2016; Lind et al., 2016).

Discussion

A shared commitment to balancing access with risk control underpins OTC drug classification systems in both Europe and Asia. In Europe, this is achieved through three distinct access models: pharmacy-only, non-pharmacy, and limited non-pharmacy trade. Specifically, limited non-pharmacy functions as a compromise that expands availability and restricts higher-risk products to pharmacy (López Vila et al., 2023; Oleszkiewicz et al., 2021). Under this model, low-risk OTC medicine may be sold in supermarkets, convenience stores, and licensed outlets, while medium- and high-risk products remain under the supervision of pharmacy. Regulatory tools include pack-size limits, labelling requirements, and authorisation or licensing mechanisms for non-pharmacy outlets. This method has been implemented by various countries such as Germany (freiverkäuflich), Switzerland (categories D/E), Portugal (Infarmed oversight) (López Vila et al., 2023; Molloy et al., 2016; Oleszkiewicz et al., 2021).

A parallel risk-based structure is found in East and Southeast Asia. Japan uses a tiered system that classifies OTC medicine into three categories, allocating greater responsibilities to pharmacists and registered sellers for higher-risk drugs (Kizaki et al., 2021; Nomura et al., 2016). South Korea has allowed low-risk OTC medicine to be sold in convenience stores since 2012 under Ministry of Food and Drug Safety (MFDS) oversight, although weaknesses in routine monitoring have been identified (Håkonsen et al., 2016; Lasota et al., 2022). Across regions, these frameworks show an adaptive strategy using risk stratification, outlet licensing, and vendor competency requirements to protect patient safety, e while enabling controlled expansion of self-medication access (López Vila et al., 2023; Oleszkiewicz et al., 2021).

Reclassification policies in Japan and South Korea show risk governance principles. This enables certain prescription drugs to become OTC with controls such as mandatory counselling, sales record-keeping, or limits on the type of outlet permitted for dispensing (Catlin & Brass, 2018; Shankar et al., 2016). These policies are similar to European trends, focusing on enhancing self-care while maintaining adequate safeguards Westerlund et al. (2017).

Deregulation has increased access to analgesics, cough medicines, and other self-care products in multiple jurisdictions (Chun et al., 2017; Nomura et al., 2016; Oleszkiewicz et al., 2021). However, the rising misuse of medicine such as dextromethorphan and high-dose paracetamol shows a gap in oversight and the need for stricter control mechanisms (Purser et al., 2025).

Oversight of OTC access outside pharmacy generally depends on medicine classification systems, dose restrictions, packaging size, storage location, and consumers age as strategies to reduce the risk of misuse (Bertsche et al., 2023; Gilson et al., 2025; Molloy et al., 2016; Oleszkiewicz et al., 2021). Reports from European countries show that pack-size limits for paracetamol significantly reduce fatal overdose rates (Alhammad et al., 2024; Casati et al., 2012; Stosic et al., 2011). However, overly lax deregulation can promote market dominance by large retail chains, as observed in Norway and Iceland, showing the need to balance consumer access with safeguards against oligopolistic market structures (Algarni et al., 2021; Bertsche et al., 2023; Molloy et al., 2016).

Although deregulation increases access, particularly in urban regions, the impact varies and may reinforce market concentration (Jo et al., 2022). OTC reclassification is often intended to reduce healthcare burden and promote self-care; however, long-term evidence regarding safety and economic outcomes remains limited (Cohen et al., 2013; Otto et al., 2018). To support safe self-medication, efforts must focus on both improving public health literacy and strengthening regulatory safeguards. Informed consumers are better equipped to dose correctly, recognise adverse effects, and seek timely care-key competencies that mitigate the risks of expanded access, such as misuse or delayed diagnosis. Accordingly, the findings of this review suggest that effective OTC governance requires a combination of risk-based classification systems (López Vila et al., 2023; Nomura et al., 2016), enforceable age and pack-size restrictions (Hawton et al., 2013; Morthorst et al., 2018), supervision by trained and qualified sales personnel (Nomura et al., 2016), and regulatory oversight measures, including routine inspections, licensing requirements, sales documentation, and controls on the placement of higher-risk medicines (López Vila et al., 2023; Tavares, 2025). In addition, consumer education through medicine labelling, warning information, and access to reliable medicine information may support safer self-medication practices (Morthorst et al., 2018; Sánchez-Sánchez et al., 2021). Together, these measures may help balance improved access to OTC medicines with the need to protect patient safety and promote responsible self-medication.

Evidence from other regions similar challenges and opportunities associated with expanded OTC access. In the United States, OTC medicines play a substantial role in self-care and healthcare cost reduction, although concerns remain regarding inappropriate use and consumer understanding of product information (Noone & Blanchette, 2018). In Africa, studies from Nigeria have reported widespread self-medication practices driven by the accessibility of OTC medicines and limited access to health care services (Akande-Sholabi & Akinyemi, 2023). Similarly, evidence from the Middle East indicates that convenience and ease of access contribute to OTC medicine use, while highlighting the need for stronger consumer education and regulatory oversight to promote safe self-medication (Wazaify et al., 2017).

Conclusion

In conclusion, OTC medicine regulations vary globally but share the common goal of balancing access with safety. Most countries employ risk-based regulatory approaches supported by a range of control measures, including pack-size limits for analgesics such as paracetamol, age restrictions for selected medicines, limits on product strength and treatment duration, display restrictions, and requirements for pharmacist or trained-seller supervision. Additional controls are often applied to medicines with a higher potential for misuse or diversion, such as quantity restrictions and pharmacy-supervised supply arrangements. Evidence from Europe and Asia indicates that deregulation can improve access to OTC medicines but may also increase the risks of misuse, overdose, and inappropriate self-treatment when adequate safeguards are lacking. Strengthening governance therefore requires clearer risk stratification, enforceable restrictions, qualified oversight, consistent monitoring, and consumer education to ensure safe and responsible medicine use.

Funding Statement

This scoping review was funded by the Indonesian Endowment Fund for Education (LPDP) on behalf of the Indonesian Ministry of Higher Education, Science and Technology, and managed under the EQUITY Programme (Contract No. 4302/B3/DT.03.08/2025 and 573/PKS/R/UI/2025).

Disclosure statement

No potential conflict of interest was reported by the author(s).

Availability of data and materials

All data used in this scoping review are available in the manuscript and as additional appendices.

Ethics approval and consent to participate

This scoping review did not directly include human or animal subjects and required no ethics approval.