Abstract

THE CORNERSTONE OF PHARMACOVIGILANCE: DRUG SAFETY AND ADVERSE EVENT

*Revati I. Dapurkar, Sampada S. Jadhav, Nikita V. Mahalle and Harigopal S. Sawarkar

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Abstract

Pharmacovigilance, or Drug Safety, encompasses the science and activities aimed at detecting, assessing, and preventing adverse drug reactions (ADRs) to enhance patient safety and treatment outcomes. ADRs can vary from mild side effects to severe, life-threatening conditions. Effective monitoring and reporting are essential for improving drug safety. ADRs are classified into six types: Type-A (Augmented), Type-B (Bizarre), Type-C (Continuous), Type-D (Delayed), Type-E (End-of-dose), and Type-F (Failure of Therapy). The field emerged in response to the Thalidomide tragedy of the late 1950s, prompting stringent drug safety regulations, including the Kefauver-Harris Amendment and the WHO Programme for International Drug Monitoring. Current PV systems include the Spontaneous Reporting System (SRS), which relies on voluntary reports; Cohort Event Monitoring (CEM), which actively investigates specific medications; and Targeted Spontaneous Reporting (TSR), focusing on specific patient groups. Additionally, the use of proton pump inhibitors (PPIs), widely prescribed for acid-related conditions, has been linked to adverse effects such as gastrointestinal issues, nutrient malabsorption, kidney problems, and potential gastric cancer. These findings underscore the critical need for ongoing monitoring and cautious prescribing practices in pharmacotherapy. Proton pump inhibitors (PPIs) are commonly used to treat gastrointestinal conditions, but long-term use may lead to adverse reactions. This case report describes a patient who developed thrombocytopenia after initiating PPI therapy, which resolved upon discontinuation. This highlights the importance of considering PPIs as a potential cause of idiopathic thrombocytopenia.

Keywords: Pharmacovilance, Adverse Drug Reaction, Spontaneous Reporting, Cohort Event monitoring, Targeted Spontaneous Reporting.