OTC Medication Risk Literacy, Confidence, and Safety Behaviours Among Romanian Adults: A Cross-Sectional Scenario-Based Assessment.

Background: The widespread availability of over-the-counter (OTC) medicines supports self-care but also requires users to recognize medication-related risks and make safe decisions without direct professional supervision. Existing studies have often examined medication literacy, self-medication, or pharmacovigilance separately. To address this gap, we developed a questionnaire within the conceptual framework of OTC medication risk literacy to explore scenario-based OTC medicine risk recognition, self-assessed confidence, self-reported safety behaviours, information-seeking practices, and pharmacovigilance awareness among respondents recruited through an online survey in Romania. Methods: A cross-sectional observational study was conducted using an anonymous Google Forms questionnaire. Data were collected between June-July 2026. The questionnaire included scenario-based items addressing common OTC medicine risks, self-assessed confidence in medication-related decision-making, self-reported safety behaviours, information sources, chronic disease and medicine use, adverse effect experience, reporting behaviour, and pharmacovigilance awareness. Associations were evaluated using chi-square tests, effect-size measures, and multivariable regression analyses. Results: A total of 423 respondents completed the survey. Recognition of major medication-safety risks was high for persistent symptoms requiring medical evaluation (96.5%), severe allergic reactions (95.7%), severe cutaneous adverse effects (96.2%), OTC medicine use during pregnancy (95.7%), antibiotic misuse (89.8%), and contraindications associated with chronic disease or anticoagulant therapy (91.7-92.7%). In contrast, recognition was lower for the antihistamine-alcohol interaction scenario, for which only 53.9% selected the safest response. Confidence was highest for understanding information provided on medicine packaging and patient information leaflets, whereas lower confidence was reported for recognising unsafe medicine combinations and contraindications. Most respondents reported reading medicine packaging and following recommended dosage instructions. Doctors (69.0%), pharmacists (61.2%), and patient information leaflets (56.3%) were the most used information sources. Pharmacovigilance awareness was limited, although 45.1% of respondents agreed that they knew how to report a suspected adverse effect, 35.0% disagreed and 52.3% of eligible respondents reported having previously submitted a suspected adverse effect report. Healthcare background remained independently associated with higher recognition and confidence scores after adjustment. Conclusions: In this online convenience sample, respondents generally recognized major OTC medicine safety risks in structured scenarios and reported several safe-use behaviours, but practical gaps remained in interaction recognition, complex risk assessment, and pharmacovigilance awareness. The findings should be interpreted as exploratory and not as representative national estimates. Scenario-based assessment may help identify educational priorities, while pharmacist counselling, clearer information, and pharmacovigilance education remain plausible strategies that require further evaluation.