Pharmacovigilance and Over Counter Drugs Ensuring Safety

Pharmacovigilance is critical for monitoring the safety and efficacy of all pharmaceutical products, including over-the-counter (OTC) drugs like paracetamol (acetaminophen) and ibuprofen, which are commonly used for pain relief and fever reduction. Although these medications are available without a prescription, their widespread use presents potential risks due to improper dosing, drug interactions, and the lack of professional oversight. This review examines the role of pharmacovigilance in ensuring the safety of OTC drugs, specifically focusing on paracetamol and ibuprofen, two of the most frequently used analgesics globally. Paracetamol, widely regarded as a safe option when used appropriately, can cause severe liver toxicity in cases of overdose, often due to consumer misjudgment or lack of awareness regarding safe dosage limits. Conversely, ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), poses risks related to gastrointestinal bleeding, renal impairment, and cardiovascular events, especially when used long-term or in higher-than-recommended doses. Pharmacovigilance systems, such as spontaneous reporting of adverse drug reactions (ADRs) and post-market surveillance, are essential for detecting and addressing safety concerns associated with these OTC drugs. This review also highlights the challenges faced by regulatory bodies and healthcare providers in tracking ADRs for OTC drugs. The relatively low rate of reporting ADRs by consumers, coupled with limited healthcare interventions for OTC drug users, complicates the ability to detect potential safety signals. Additionally, the risk of polypharmacy and drug interactions is higher in self-medication practices, further emphasizing the need for increased pharmacovigilance. To improve safety outcomes, the review suggests several strategies, including the enhancement of public education regarding safe use, the development of digital tools for ADR reporting, and the expansion of integrated surveillance systems that track the safety profiles of commonly used OTC medications. By strengthening pharmacovigilance efforts and fostering a more informed public, the risks associated with paracetamol, ibuprofen, and other OTC drugs can be minimized, ensuring safer use and better health outcomes for consumers.