The World Health Organization defines self-medication as the selection and use of medicinal products by individuals to treat self-recognized disorders or symptoms, including the intermittent or continued use of a medication prescribed by a physician for chronic or recurring disease [1]. The use of over-the-counter (OTC) medications is increasingly prevalent in India, with individuals frequently self-medicating for a wide range of health issues. A systematic review and meta-analysis reported a pooled self-medication prevalence of 53.57% in India, with non-steroidal anti-inflammatory drugs (analgesics) being the most commonly self-medicated drug class (45.90%) [2]. A study among engineering students in Chennai similarly reported that 34.7% used analgesics and 22.61% used antibiotics for self-medication [3]. While OTC drugs are beneficial for managing minor ailments, inappropriate use can result in significant health risks.
In India, local pharmacists and digital/social media platforms are frequently reported as primary sources of information for self-medication decisions; one recent study among urban adults found pharmacies (42.18%) and digital platforms (18.00%) to be the leading information sources [4-7]. Given limited time for healthcare access and reliance on such informal information sources, outpatients remain susceptible to self-medication behaviours. Assessing these parameters is essential for identifying misconceptions, risky behaviours, and areas requiring targeted educational interventions. The findings from this study will contribute to the development of informed public health strategies aimed at promoting the rational use of medications among out patients attending healthcare facilities.
Objective:
To assess the knowledge, attitudes, and practices regarding the use of over – the - counter (OTC) medications among out patients of tertiary healthcare hospital.
METHODOLOGY:
This cross-sectional, observational study was conducted among outpatients attending the clinical departments of Nandha Medical College and Hospital to evaluate the prevalence, consumer purchasing behaviours, and adverse drug reaction (ADR) profiles associated with over-the-counter (OTC) self-medication practices. The sample size was calculated using the formula n = Z²pq/d², where Z = 1.96 (95% confidence level), p = 53.57% (pooled prevalence of self-medication practice in India, based on a systematic review and meta-analysis [2]), q = (1–p) = 46.43%, and d = 5% (margin of error). This gives a minimum calculated sample size of 384; accounting for an anticipated 10% non-response/incomplete-response rate, the final target sample size will be approximately 420. The study participants were adult outpatients aged 21 years and above was selected using a convenient sampling technique. Ethical clearance was formally obtained from the Institutional Ethics Committee (IEC) prior to study initiation, and written informed consent was secured from each participant before administration of the survey. Outpatients who were unwilling to participate, critically ill, or unable to communicate effectively were excluded from the study.
Data collection was executed using a structured, pre-tested, validated questionnaire comprising three main sections: socio-demographic characteristics, self-medication prevalence, underlying motivations, and drug procurement sources, and knowledge, safety attitudes, and reported adverse events. Quantitative data were processed and analyzed using Python statistical libraries (statsmodels and scipy.stats). Descriptive statistics, including frequencies, percentages, and means with standard deviations ("Mean"±"SD" ), were calculated to summarize demographic and behavioral variables. Inferential statistical evaluations were performed using Pearson’s Chi-square (χ^2) tests for univariable cross-tabulations, followed by multivariable binary logistic regression analysis to adjust for confounding variables and determine independent predictors of adverse drug events, expressed as Adjusted Odds Ratios (aOR) with 95% Confidence Intervals (CI) at a statistical significance threshold of p<0.05.
RESULTS:
The overall study population comprised 420 outpatients attending Nandha Medical College and Hospital. The mean age of the participants was 45.09±13.80 years (range: 21–85 years), with a balanced distribution between males (50.24%, n=211) and females (49.76%, n=209). Urban residents accounted for 56.67% (n=238) of the cohort, while 43.33% (n=182) resided in rural areas. In terms of education, secondary schooling was the most commonly reported attainment level (32.62%, n=137), followed by tertiary education (26.67%, n=112) and primary education (26.19%, n=110). Homemakers (18.57%, n=78) and private sector employees (18.33%, n=77) represented the largest occupational groups within the cohort. The socio-demographic features of the study population are summarized in Table 1.
The overall prevalence of self-medication practice among outpatients was 54.05% (n=227; 95%" CI: " 49.26%-58.84%). Among those practicing self-medication (n=227), 40.53% (n=92) reported doing so occasionally, while 25.11% (n=57) practiced it frequently. Retail pharmacies/chemists served as the primary procurement source (37.89%, n=86), followed by leftover medicines kept at home (25.55%, n=58). Analgesics/painkillers were the most commonly consumed drug class (49.34%, n=112), followed by cough and cold remedies (39.65%, n=90) and antibiotics (25.99%, n=59). The primary driver for self-medication was previous experience with a similar illness (59.91%, n=136), followed by the perception of the illness being minor (47.14%, n=107). These purchasing behaviors and motivations are detailed in Table 2.
Assessment of knowledge and safety parameters revealed that 60.95% (n=256) of respondents read package inserts, while 52.38% (n=220) reported awareness regarding potential drug side effects. Overall, 44.52% (n=187) believed self-medication to be safe for minor conditions. A total of 54 participants (12.86%) experienced adverse drug reactions (ADRs), with mild stomach upset (18.52%, n=10), nausea (18.52%, n=10), drowsiness (18.52%, n=10), and diarrhoea (18.52%, n=10) being the most frequent symptoms. Despite these practices, 70.95% (n=298) expressed willingness to consult healthcare providers if accessible consultation services were available. Stricter regulatory control over OTC sales (22.62%, n=95) and public awareness campaigns (21.67%, n=91) were recommended as key strategies to curb unsafe practices, as presented in Table 3.
Univariable analysis demonstrated no statistically significant association between self-medication practice and demographic factors, including gender (χ^2=0.082,p=0.775), residence (χ^2=1.029,p=0.310), education (χ^2=0.863,p=0.834), or age group (χ^2=0.725,p=0.867). However, self-medication was strongly associated with an increased incidence of adverse drug reactions (χ^2=17.532,p<0.001). In multivariable binary logistic regression, self-medication practice was confirmed as an independent risk factor for adverse events ("aOR"=4.631, 95%" CI: " 2.244-9.559, p<0.001). Conversely, habitually reading the package insert or leaflet functioned as a significant protective factor, reducing adverse event odds by 54.8% ("aOR"=0.452, 95%" CI: " 0.249-0.820, p=0.009). These statistical evaluations are presented in Table 4.
Table 1: Socio-Demographic Profile of Study Outpatients (N=420)
Table 2: Self-Medication Practices, Sourcing, and Motivations (N=227)
Table 3: Knowledge, Attitudes, Adverse Effects, and Suggestions (N=420)
Table 4: Univariable and Multivariable Predictors of Adverse Drug Reactions (N=420)
DISCUSSION:
The present study offers a comprehensive evaluation of self-medication practices, consumer purchasing behaviours, and associated adverse drug events (ADEs) among outpatients attending a tertiary care facility in Tamil Nadu. In our study population (N=420), the overall prevalence of self-medication was found to be 54.05% (n=227; 95% CI: 49.26%–58.84%). This finding aligns closely with national epidemiological estimates; a comprehensive meta-analysis evaluating self-medication across 10,248 Indian participants reported a pooled nationwide prevalence of 53.57% (95% CI: 49.2%–58.0%). Furthermore, our results mirror regional findings from hospital outpatients in South India, where community-level reliance on non-prescribed pharmaceuticals typically ranges between 50% and 65%.
Previous personal illness experience (59.91%), the belief that the ailment was minor (47.14%), and easy over-the-counter (OTC) access at pharmacies (42.29%) emerged as the primary motivations driving self-medication in our cohort. These observations closely reflect patterns documented by Chakravarthy & Maiya (2021) [2] in suburban Chennai, where prior prescription awareness and time convenience were cited as the predominant motivators among community respondents. In terms of drug categories, analgesics/painkillers were the most frequently self-medicated drug class (49.34%), followed by cough/cold formulations (39.65%) and antibiotics (25.99%). The high rate of non-prescribed antibiotic consumption (25.99%) is of major clinical concern. This corresponds with broader findings across Tamil Nadu tertiary care settings, where loose dispensing of Schedule H and H1 drugs at retail pharmacies continues despite national regulatory mandates under the Drugs and Cosmetics Rules.
A critical insight from our multivariable logistic regression analysis involves the strong association between unguided self-medication and negative clinical outcomes. Outpatients practicing self-medication exhibited a 4.63-fold increase in the odds of experiencing an adverse drug reaction ("aOR"=4.631, 95% CI: 2.244–9.559, p<0.001). This finding corroborates observational data from Tejasvi & Magendran et al. (2020) [8] study done at a Medical College Hospital in Chennai, where 28% of urban self-medictors reported adverse effects, primarily gastrointestinal distress and allergic skin reactions. Crucially, our study identified reading the package insert or leaflet as an independent protective factor against adverse events. Outpatients who habitually verified package inserts demonstrated a 54.8% reduction in the odds of experiencing an ADE ("aOR"=0.452, 95% CI: 0.249–0.820, p=0.009). Regional survey in Coimbatore by Vinotha et al. (2025) [9] highlights that less than 50% of consumers routinely review dosing instructions or expiry dates prior to consumption, underscoring patient package insert verification as a key target for consumer safety interventions.
Although 44.52% of respondents initially perceived self-medication as safe for minor ailments, 70.95% expressed willingness to consult healthcare professionals if accessible clinical services were provided. Furthermore, participants identified strict enforcement of OTC regulations at retail pharmacies (22.62%) and public health awareness campaigns (21.67%) as the most necessary regulatory solutions. Strengthening point-of-sale pharmacist counselling and strictly enforcing antimicrobial stewardship regulations remain essential steps toward mitigating self-medication risks and combatting antimicrobial resistance (AMR) in Tamil Nadu.
Study Limitations:
This study was a single-centre study with cross-sectional design and reliance on convenience sampling of outpatients, which restricts the generalizability of the findings to broader populations. Additionally, data on self-medication frequency and adverse reactions relied on self-reported questionnaire responses, introducing potential recall and social desirability biases.
Conflict of Interest: Nil
CONCLUSION:
In conclusion, while over-the-counter self-medication is practiced by more than half of the outpatient population, it significantly increases the risk of adverse drug reactions by over fourfold ("aOR"=4.631,p<0.001). Enforcing stricter retail pharmacy regulations on non-prescription drug sales and promoting routine package insert verification are essential public health interventions to mitigate adverse drug events and prevent irrational drug use.
REFERENCES
- World Health Organization. Guidelines for the regulatory assessment of medicinal products for use in self-medication. Geneva: WHO; 2000. Available from: https://apps.who.int/iris/bitstream/handle/10665/66154/WHO_EDM_QSM_00.1_eng.pdf?sequence=1&isAllowed=y. [Accessed 25 Sep 2022]
- Rashid M, Chhabra M, Kashyap A, Undela K, Gudi SK. Prevalence and predictors of self-medication practices in India: a systematic literature review and meta-analysis. Curr Clin Pharmacol 2020; 15(2):90–101
- Chakravarthy SA, Maiya GR. Prevalence of self-medication and its associated factors among students of an engineering college in Chennai. J Fam Med Prim Care 2021 Mar; 10(3):1204–8
- Ray I, Bardhan M, Hasan MM, Sahito AM, Khan E, Patel S, et al. Over the counter drugs and self-medication: a worldwide paranoia and a troublesome situation in India during the COVID-19 pandemic. Ann Med Surg 2022 Jun 1; 78:103797.
- Shastri A, Chavhan MK, Chavhan GK, Chavan BK. Navigating health information online: self-medication practices and digital platform use among urban adults in Central India: a mixed method study. Int J Innov Res Technol 2026; 12(9):3828–3836.
- Jain S, Thakur A, Peepre K, Kaushal S, Kasar P. Prevalence of self-medication practices among the residents of urban slums located near govt. medical college, Jabalpur. Int J Community Med Public Health 2018 Jan 24; 5:811.
- Nakakande J, Taremwa IM, Nanyingi M, Mugambe S. The utility of internet-enabled antibiotic self-medication and its associated factors among patients attending private clinics in Kawempe division in Kampala capital city, Uganda: community-based cross-sectional study. Drug Healthc Patient Saf 2023 Apr; Volume 15:85–91.
- Tejasvi, P. K., & Magendran, J. (2020). A study of over-the-counter (OTC) drug usage pattern among the patients attending a medical college hospital. Medico-Legal Update, 20(3), 211–216. https://doi.org/10.37506/mlu.v20i3.1398
- Vinotha ATS, Bhuvaneshwari S, Vijayamathy A, Umamageswari MS, Jeevithan S, Monisha A, Prakash S. (2025) Knowledge, Attitude, and Practice on Over-the-Counter Drugs among Undergraduate Medical Students. J Pharm Res. 2025;24(1):22–27. doi:10.18579/jopcr/v24.i1.122
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