Prescription-to-OTC Switch: A Systematic Review of Opportunities and Challenges in Self-Care

The shift of prescription medications to over-the-counter (OTC) status, commonly referred to as Rx-to-OTC switch, represents a significant evolution in healthcare delivery, enabling greater patient autonomy in self-care while simultaneously introducing new challenges in safety, regulation, and public health [1]. This transition has been driven by the growing emphasis on self-medication as a means to reduce healthcare costs, improve accessibility, and empower patients to manage minor ailments without direct physician oversight [2]. Historically, Rx-to-OTC switches have included medications for allergies, pain relief, gastrointestinal disorders, and more recently, treatments for chronic conditions such as statins and antihypertensives [3]. The expansion of OTC availability has been facilitated by regulatory agencies in various regions, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which have established frameworks to evaluate the suitability of drugs for non-prescription use [4].

The concept of self-care has gained prominence in recent decades, particularly in response to rising healthcare expenditures and the increasing burden on primary care systems [5]. OTC medications play a pivotal role in this paradigm, allowing individuals to address common health concerns without professional intervention. However, the benefits of self-medication must be balanced against potential risks, including misdiagnosis, inappropriate use, and delayed treatment of serious conditions [6]. Studies have shown that while many consumers are capable of safely self-medicating, others may lack the necessary health literacy to make informed decisions, leading to adverse outcomes [7]. Moreover, the absence of continuous medical supervision for OTC drugs raises concerns about long-term safety, particularly for medications that were previously restricted to prescription-only status [8].

Extensive research has been conducted into Rx-to-OTC switches but there are still some gaps in the literature. The most appropriate criteria for deciding which drugs are good candidates for OTC transition are not universally agreed upon. Regulatory authorities apply different standards in different jurisdictions [9]. Second, the socioeconomic impacts of reduced access and affordability are often neglected, in the face of commonly documented economic benefits like lower healthcare costs [10]. It is recognized that pharmacists play a significant role in supporting self-medication without risk. However, their education and involvement in OTC decision-making processes remain inconsistent [11]. Moreover, consumer behaviour studies are mainly concerned with short-term usages and do not look at longitudinal studies of how availability impacts health [12]. Resolving these issues is a must for evidence-based policies to harness the benefits of Rx-to-OTC switches and mitigate risks.

This systematic review has been initiated to review the existing evidence regarding the Rx-to-OTC transitions and various opportunities and challenges. This review, by examining safety, economics, regulation, and consumer behaviour, provides a better understanding of how self-care may be optimally enhanced in an increasingly non-prescribed environment. The results will hopefully give some insight to a policy maker who wants to enhance the regulatory frameworks, healthcare providers who want to guide their suitable patients towards safe self-medication and researchers who may be able to use them to identify future directions.

The rest of this document is organized as follows: Section 2 deals with the methodology used for the systematic literature review that consists of the search strategy, inclusions, the analysis of the results. Presented in the analysis are the results arranged under sub-sections where trends in research, a brief on Rx to OTC switches, safety monitoring, self-medication practices, economic impact, pharmacists, regulations, and marketing are discussed. Section 4 synthesizes the main findings, noting their key themes and gaps. In conclusion, Section 5 will outline guidelines for future research.

2. Methodology

2.1 Review Protocol

This systematic review was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines [13]. A literature search was performed of 6 major databases and search engines based on relevance to the pharmaceutical and public health domains. For biomedical literature coverage PubMed was chosen and Scopus was taken for its help for interdisciplinary picking up as well as solid charges of citation. The peer-reviewed articles published on ScienceDirect and SpringerLink in pharmacology and health policy are of high quality. A wider coverage of journals was provided by Web of Science with journals in medicine and social sciences. Google Scholar was used to further assist in capturing grey literature, which may not yet be indexed.

Utilizing specific keywords, the search strategy was customized to retrieve studies focusing on Rx-to-OTC switches, self-care plus, and challenges with opportunities. In PubMed, the combination of terms “.Switch prescription OTC” and “self-care” was done using Boolean operators appropriately to exclude reviews and metanalyses. Other databases were modified similarly to facilitate its use, keeping the platform-specific syntax in mind. Scopus used the TITLE-ABS-KEY field, for example, while ScienceDirect employed filters to restrict results to research articles. The strings were thus chosen to strike a balance between high sensitivity and high specificity.

2.2 Analytical Framework

Seven research dimensions are based on themes that keep coming up in the literature review. Examining Prescription-to-OTC Switches: Criteria and Process for Drug Reclassification Safety and monitoring activities related to OTC medicines include mechanisms for pharmacovigilance and adverse event reporting. Self-medication practices deal with patients’ behaviour and health literacy. The evaluation of economic impact cost savings and burden on healthcare system. The role of the pharmacist and the training gaps. The regulatory considerations look at the international approval frameworks, while the marketing and consumer behaviour discuss demand drivers and perceptions. The given dimensions give a complete picture of Rx-to-OTC movement.

2.3 Inclusion and Exclusion Criteria

Only English-language studies reporting on effects of Rx-to-OTC switches, self-care or related subtopic (e.g., safety, economics) were considered. There are no time constraints to generate historical trends and changing policies. Articles, case studies and analyses were followed who have peer reviewed. Non-English publications, opinion pieces and studies lacking primary data (eg, editorials). We excluded reports lacking sufficient methodological detail or that had an irrelevant focus (e.g., veterinary drugs).

2.4 Study selection process

After the elimination of duplicates, 499 records remained from an initial 606. A total of 281 studies were excluded for irrelevance after title and abstract screening. The full-text examination of 105 articles resulted in the exclusion of 23 ineligible reports. Thus, 82 studies were available for final synthesis. (Figure 1). The assessment of quality included verifying the study design, sample size, and methodology, with special emphasis placed on the research dimensions.

Figure 1. PRISMA flowchart of study selection

3. Results

3.1 Research Trends

Figure 2. Research trends in prescription-to-OTC switch literature

Rx-to-OTC switch research displays clear time and theme concentrations, as revealed by publication patterns analysis. A considerable number of studies, a total of 42 publications, existed before 2016. The publishing frequency dropped sharply, as seen between the years 2017 and 2021, when a meager 19 studies appeared. In 2022, a revival happened as seven of them were published with no output afterwards. The bimodal distribution indicates Rx-to-OTC transitions have remained a constant research focus but the attention of scholars has ebbed and flowed according to regulatory events and public health needs.

Research dimensions’ uneven thematic coverage was discerned. According to a 2016 review, self-medication practices and anything related to pharmacists accounted for 21 papers before 2016. Conversely, safety monitoring is a more recent development, with six studies emerging since 2020 that highlight growing concerns over post-switch pharmacovigilance. Research on economic impact is quite rare, with five papers noted and all prior to 2016. There is a need for cost-benefit analysis. Regulatory considerations and marketing studies have been published intermittently, which implies that they are often examined and published in response to specific policy changes, rather than being the subject of continuous research.

3.2 Dispensing medicine switch From Regulatory and Economic Perspectives

The movement of prescription drugs to over-the-counter status is a complicated regulatory process that has serious economic implications. This section will look at regulatory, economic, and public health literature on Rx-to-OTC switches in 16 studies.

3.2.1 Rule frameworks and decision making

According to [14], the FDA follows a rigorous evaluation procedure for Rx-to-OTC switches, which includes assessment of the safety profile, potential for abuse, and ability of the consumer to self-diagnose. Historical analyses show that from 2002 to 2022, the FDA authorized 78 switches, with allergy drugs (e.g., loratadine) and analgesics dominating.  However, international comparisons show considerable differences in regulatory approaches. Germany undertakes a process of reclassification in a stakeholder consultation that is different from the FDA’s committee (16). The challenges of global pharmaceutical companies seeking simultaneous switches in various markets are created by these disparities.

3.3 Effects on the Economy and Healthcare Use

The healthcare systems that implement Rx-to-OTC switches save a lot of costs by avoiding doctor visits and claims for prescriptions. In the U.S., after the switch of second-generation antihistamines, the expenditures on prescriptions fell by 23%. Moreover, health insurers redirected $1.2 billion annually on other services [17]. According to European studies, a theoretical triptan switch in six EU countries could yield similar results; this would save about €380 million in healthcare costs through lower hospitalization rates for those with migraines [18]. However, when insurers exclude OTC products from coverage [19], high spending comes from the consumers instead, which offsets these savings.

3.3.1 Trade-offs of Public Health

While switches to over-the-counter medications may overcome access difficulties, they may also transfer the responsibility for ensuring appropriate use from the clinician to the consumer. Following the switch, usage of vaginal antifungal products increased by 40% but associated studies showed an increase in misdiagnosis [19]. Likewise, the switch to loratadine enhanced access to allergy treatment, but decreased physician oversight for possible drug interactions [20]. The necessity for strong consumer education programs in addition to regulatory approvals of the findings.

Table 1. Key Studies on Rx-to-OTC Switch Outcomes

Two studies ([21], [22]) provided general overviews of switch mechanisms but did not present original data. Meanwhile, [23] utilized data from Libyan pharmacies to give localized insights. The other literature identifies three tensions: accessibility versus safety, cost-savings versus equitable access, and consumer empowerment versus health literacy. All the jurisdictions surveyed appear to hard press a balance between self-care benefits and public health protections.

3.3.2 Safety of OTC medicines and their monitoring

The conversion of prescription medicines to OTC class should have strong safety monitoring systems in place to prevent self-medication risks. It looks at safety issues and surveillance challenges highlighted in the literature. It specifically mentions vulnerable population pharmacist intervention and misuse patterns.

An important finding of the analysis is the inappropriate use and misuse of OTC medications due to varied patient expectations, and limited follow-up opportunities.  [6] Studies show that high-risk OTC medications, especially those containing codeine or other psychoactive substances, pose monitoring challenges due to their potential for abuse 24 25 26 27 28. The issue of antibiotic resistance adds to this scenario, with self-medication with antibiotics (as the experience of some regions with Rx-to-OTC-switch suggests) adding to global antimicrobial resistance [29].

Vulnerable populations and older patients are particularly at risk from labeling and consumer education issues related to OTC analgesics [30]. Pharmacists are ideally positioned to tackle these issues, but their use of pharmacists to address silent drug therapy issues and enhance community pharmacovigilance is underutilized. [31], [32]

Table 2. Taxonomy of Safety Concerns and Monitoring Challenges in OTC Medicines

According to this classification, which can be found in Table 2, the safety concerns of OTC products can be classified into three categories, specifically inappropriate use and misuse, vulnerable populations and pharmacists’ role. According to studies on high-risk OTC medications ([24]-[28]), there is a critical need for improved surveillance systems to detect and prevent abuse. At the same time, [31] highlights the frequently neglected complications in drug therapy that occur when patients unintentionally suffer from adverse effects or interactions when taking non-prescription medications that go unnoticed in the clinic.

The lack of structured pharmacovigilance systems for OTC drugs adds to the current situation as spontaneous reporting of adverse events is low amongst consumers (32). Community pharmacists who sell OTC products can counsel patients and document drug-related problems effectively to address the issues related to the use of OTC. Although guidance counselors could fulfill these roles, barriers including time constraints, lack of training, and limited integration with health systems prevent this.

3.4 Self-Medication Habits Social Implications, Risks and Patterns

The self-medication practices are increasingly common in developed and developing nations alike owing to increased access to health services, low-cost options, and patient empowerment. This subsection combines results of 28 studies on the socio-demographic, behavioural and health impacts of self-medication, particularly with regard to use of an over the counter (OTC) medication.

3.4.1 Differences in Demographics and Geography

The self-medication practices depend on the age and regions. Adolescents and young adults have been found to have a relatively high rate of use of over-the-counter (OTC) medications. Prevalence studies report that university students often take OTC medication for pain and allergy. The prevalence of OTC medication use among university students has been found to be 62–78% [33], [34], [35]. On the contrary, older adults are less likely to self medicate and have a greater risk due to polypharmacy and age-related alteration in pharmacokinetics.  [36]  Across the globe, developing nations are more reliant on self-medication as an alternative to formal medical care. This is mainly attributed to lack of resources or access to health care services [37], [38], [39]. For example, it has been reported that communities in rural areas of sub-Saharan Africa and South Asia often without prescription antibiotics and analgesics as first line against acute conditions [40], [38].

3.4.2 Motivating Factors and Health Literacy.

Using medication without prescription is influenced by convenience, severity of minor illness, and previous experience of the same illness. Research reveals that 54 to 67 percent of consumers choose their over-the-counter (OTC) medications based on earlier prescriptions or on recommendations from non-health-care sources (e.g. family and internet) [41], [42], [43] Nonetheless, gaps in health literacy experience in 29–41% of the users who cannot identify the active ingredients or contra-indications of common OTC [44], [45]. The rise of digital platforms has made matters worse. In another study, 22% of adolescents reported using unverified sources to diagnose conditions and choose treatments [41].

Table 3. Taxonomy of Self-Medication Practices and Associated Risks

3.4.3 Health impacts and effects on systems

The practice of self medication has both positive and negative public health implications. Self-medication eases the burden on the formal healthcare system. However, improper use leads to antibiotic resistance, misdiagnosis and delay in treatment for serious conditions. Up to 27% of self-medication episodes are estimated to lead to inappropriate treatment; mainly for respiratory/gastrointestinal symptoms [47], [43]. The economic impact is similarly dual; OTC medications reduce direct costs but may increase indirect costs through productivity losses due to untreated or aggravated conditions [48].

The above theory is formulated by [49] that values the unsubstantiated self-medication. The regional snapshots presented in the other excluded studies [50], [51], [52] echo the broad trends outlined above.

According to the synthesis, three essential tensions in self-medication practices have been discovered. These are: autonomy contrary to safety; easy access contrary to appropriate use; and, convenient access contrary to long-term health outcomes.

These tensions highlight the need for targeted interventions in the form of increased pharmacist counselling and digital health literacy programs, to prevent risks yet reap benefits of self-care.

3.5 The Economic Impact of the Rx-to-OTC Switch Variation in Costs and usage

The economic implications of prescription-to-OTC switches are an essential factor in the overall assessment. This subsection synthesizes evidence from five distinctive studies on the impact of Rx-to-OTC switches on the distribution of costs in health care, the drug being used, and payers’ policies in different health care systems.

The U.S. switch of loratadine from prescription to OTC provides a paradigmatic case of how such switches change health care spending patterns. The switch was estimated to lower yearly prescription costs by $1.3 billion and grow OTC sales by $800 million, thus saving the healthcare system money [20]. Notably, the researchers found that 34% of patients who had insurance coverage for loratadine prescriptions were faced with higher out-of-pocket costs following the switch that took place, showing the cost-shifting nature of the switch. A similar study on second-generation antihistamines indicated that payer policies moderated cost impact. As observed by [17], insurers introducing OTC exclusion clauses experience 22% lower cost reductions than those with OOP and OTC clause policies.

European research shows contrasting views through the use of hypothetical modelling approaches. According to research, author estimated the expected impact of a broad Rx-to-OTC switch in Spain could yield annual savings of €290 million in public health expenditure. This impact is largely accounted for by a drop in visits to and processing of doctors’ prescriptions. Nonetheless, this model was for ideal consumer behaviour and did not include the misuse related cost. A more focused analysis of triptans in six EU countries by [18] estimated savings of €380 million from avoided hospitalizations for migraine, but noted that the benefits would be distributed unevenly across healthcare systems with varying reimbursement.

T

able 4. Comparative Economic Outcomes of Rx-to-OTC Switches

The vaginal antifungal study by [19] provides additional insights on service use impacts as the use of the product rises by 40% while the cost of doctor consultation drops by 75 million dollars. Yet, this research lacked measurement of the costs related to misdiagnosed cases that follow-up studies suggest might ‘eat up’ 15–20% of the savings on paper.

Through the analysis of these examples, three main findings emerge. First, Rx-to-OTC switches generally decrease system-level spending, but often lead to cost-shifting to the consumer. Second, the level of savings largely depends on payer policies and what is already in place. Thirdly, most economic evaluations miss likely secondary effects, such as expenses related to misuse or health outcomes over the longer term. There is a growing awareness of the high costs of responding to an influenza outbreak that is being overlooked or hidden. The constant methodological differences from retrospective claims analysis to hypothetical modeling further exemplifies the lack of standard metrics for evaluating Rx-to-OTC switch economics in different circumstances.

3.6 Pharmacist Role in Over-the-Counter Medication Management

The change of prescription drugs to over the counter (OTC) has significantly impacted the role of pharmacists. They are now key players, helping guarantee safe and effective self-medication. In this subsection, we will focus on the changing roles, challenges and educational needs of pharmacists in the context of Rx-to-OTC switches based on 15 studies. This review mainly highlights the collaborative role of pharmacists in self-care.

Pharmacists are frontline healthcare professionals who connect expert practice advice with self-care management by patients. These professionals counsel patients on medication usage, flag inappropriate TDH uses and preferred options. Research underscores how often pharmacists meet patients with insufficient health literacy to make informed decisions on OTC medicines, which calls for more tailored counselling [54]. Work function and time pressure restrict the interactions between experts and operators in fast retail [55].

The growing complexity of OTC drugs, including for chronic conditions (e.g., GERD and allergy), is increasing the need for pharmacist involvement. Omeprazole (Prilosec OTC) changed from prescription (Rx) to over-the-counter (OTC). This required intervention of pharmacists to inform patients about the use, dose and drug interactions. Thus, the availability of tamsulosin for BPH symptoms in the UK raised concern about patient assessment and follow-up [56] . Various instances are a reminder to the pharmacists that there are two sides of a coin, that is, the availability and safety of a drug.

Table 5. Taxonomy of Pharmacist Roles and Challenges in OTC Medication Management

The proper training and education for pharmacists will play an essential role in proper OTC medicine management. Although some schools of pharmacy have incorporated strong self-care curricula, others have not adequately prepared students to counsel on OTC things [58], [59]. According to [60], a study shows that students’ confidence in answering OTC-related questions was significantly improved as a result of advanced community pharmacy rotations. Continuing education on newly switched medications would not readily be available to practicing pharmacists which may hamper their ability to advise patients [60].

Regulatory changes further complicate the role of the pharmacist with drug re-classification which takes place without development support. Australian pharmacists expressed fears of lacking the capability to manage long term conditions with OTC medicines and insufficient infrastructure for continued monitoring of patients [57], [61]. The same uncertainty was reported by UK pharmacists regarding responsibilities for OTC tamsulosin. In particular, differentiating BPH symptoms from more serious conditions which required physician referral [56].

The authors of [62] and [63] provide insights into pharmacists’ decision-making as well but were not included in Table 5. The study by [62] examined attitudes toward recommendations for herbal medicine. Pharmacists try to strike a balance between evidence, which could include real-world evidence and medical-scientific evidence, and consumer wishes for herbal and alternative therapies. The study by [63] on product selection for undiagnosed skin problems illustrated the difficulty that pharmacists encounter when people present with symptoms requiring a professional diagnosis.

The synthesis of the studies provides insights into pharmacists’ OTC-related roles. It reveals three tensions pharmacists experience in practice: between patient autonomy and professional safeguards; between expanding access and protecting consumers; and between ideal counselling and practical constraints. To solve the problem, we need to implement a various range of solutions that involve a facilitation of counseling through workflow redesigns, more training programs, and better clarified regulations on pharmacists’ duties in the OTC sphere. The changing nature of Rx-to-OTC switches indicates that the challenges will only be more profound going forward, as more medicines get switched to non-prescription status. This highlights the need for more solution-oriented pharmacist support for self-care.

3.7 Regulatory Considerations in the Switch to Over-The-Counter

The regulations on prescription-to-OTC (Rx-to-OTC) switches involve safety assessments, market realities and public health objectives.  Across six studies, this subsection summarises the several regulatory considerations highlighted in these studies. The regulatory considerations note policy choices, stakeholder perspectives, implementation challenges and more.

As the availability of nonprescription drugs expands, regulatory agencies are developing more nuanced approaches toward the evaluation of Rx-to-OTC switches. Regulatory expansion should strike a balance between increasing access and implementing safety monitoring systems by ensuring medications do not mask serious conditions. According to the study the regulator, industry, insurers, and healthcare providers should work collaboratively to enhance the switching process. The case of H2-receptor antagonists reveals these tensions. Their conversion to OTC at first raised concerns on delayed diagnosis of gastric malignancies. It also empowered patients to self-manage mild GI symptoms [65].

Different countries that have similar products have various policies and act differently on them.  Some nations allow patients autonomy when it comes to taking care of themselves, while some places only allow access to OTC under strict regulations. According to [66], increasing access that removes the prescription requirement for OTC drugs has its benefits and demerits. One significant advantage is its potential to lessen health-care costs. However, this might lead to inappropriate use in the absence of any safeguards.  Considering the Managed Care Perspective, the insurers weigh the improved access against potential overutilization and challenges to their coverage [67]. The absence of a global consensus on ideal OTC regulatory standards is evident in these views.

Table 6. Regulatory Dimensions in Rx-to-OTC Switches

Labelling practices have emerged as a major implementation challenge in markets migrating from pharmacy-centered to patient-centered OTC. The article [68] examines the Indian context and likely highlights how evolving labeling standards are addressing low health literacy without compromising on any essential safety information. As per the study, FDA approval of nicotine patch switches set important precedents for meat-friendly labeling. However, cultural and educational differences pose challenges to global standardization efforts.

Strategies employed for developing markets also affects how a regulatory authority approaches the situation. For instance, Turkey has been trying to grow its OTC sector with the support of regulations and self-care initiatives [69]. The findings of our study suggest that regulation helps shape behavior and market development rather than simply responding to them. The successful Rx-to-OTC switch needs the alignment of policy, industry and healthcare system. The alignment is done in various countries since, it is not same globally.

The findings of these studies present three recurring regulatory dilemmas, namely the problem of uniformity versus local specificity, the problem of market development versus safety monitoring, and the problem of professionalism versus consumer choice. The implication of these challenges is that any future regulation and innovative approaches for Rx-to-OTC switches may require a more flexible and risk proportionate approach while strengthening systems for post-market surveillance and consumer education. Self-care frameworks are constantly evolving. Therefore, regulatory issues will remain a dynamic and contested terrain in pharmaceutical policy.

3.8 Marketing and Consumer Behaviour Influencing the Adoption of OTC Medications

The transition from prescription to over-the-counter (OTC) drug status changes the way drug makers market their products and how consumers engage with them. This literature section is about the adaptation of the strategies of the pharmaceutical companies for OTC products. It also elucidates the rationale behind consuming self-medication which is in the form of psychological and behavioural aspect of consumers.

The transition of a product from prescription to an OTC status changes pharmaceutical marketing. Businesses need to enhance their competencies in DTC advertising while managing their scientific credibility. According to the research, striking a balance between educational messaging and promotional messaging is a challenge especially for drugs previous unavailable except doctors. In the same way,  [71] discusses post-patent marketing strategies and mention that once a drug will be available as a generic product, it will be rather the brand loyalty and the perceived efficacy that will be the relevant differentiators in OTC products. This means that in order for Rx-to-OTC switches to be a success, rebranding must take place on a large scale and on functional benefit and emotional consumer need level.

The various influences on consumers’ decision-making for OTC medicines are a mix of digital, experiential, and social. According to [72], there are three main factors that affect OTC buying behavior. These factors include digital marketing, brand experience as well as reference group opinion. The research indicates that 62% of consumers surveyed for the study confirm to look for information online before buying an OTC product. Also, 41% say user reviews are their most trusted source of information. The mediation of the digital platform offers opportunity and challenges for pharmaceutical marketers; with the use of the online platform, word-of-mouth effect can easily be amplified but on the same side, it can also go contrary due to misinformation. The consumers tend to show surprisingly sophisticated self-knowledge about medication despite the fact that it varies significantly with age and education level according to [73].

Table 7. Consumer Behavior Determinants in OTC Medication Purchases