Pharmacovigilance and Quality Assurance in Adverse Drug Reaction Monitoring: A Cross-Sectional Assessment of Reporting Practices, Signal Detection Compliance, and Data Quality Indicators in Tertiary Care Hospitals of Karnataka

Abstract

Pharmacovigilance — the science and activities relating to the detection,assessment, understanding, and prevention of adverse effects and any otherdrug-related problems — is the cornerstone of post-marketing drug safetysurveillance and a fundamental component of a healthcare system's qualityassurance architecture. India's Pharmacovigilance Programme of India(PvPI), launched in 2010 and co-ordinated by the Indian PharmacopoeiaCommission under the Central Drugs Standard Control Organisation,mandates Adverse Drug Reaction (ADR) monitoring and reporting byhealthcare institutions as part of the national drug safety surveillanceinfrastructure. Despite this regulatory framework, ADR underreporting andinadequate data quality in submitted reports remain significant challengesthat compromise signal detection efficacy and ultimately patient safety.Quality assurance frameworks for pharmacovigilance — encompassingstandardised reporting procedures, mandatory completeness criteria, causality assessment requirements, timeliness standards, and signal detection protocols — are the systemic interventions most directly capable of improving the fidelity and value of pharmacovigilance data. This cross-sectional study assessed pharmacovigilance quality assurance compliance across eight tertiary care hospitals in Karnataka: four with formal, structured pharmacovigilance quality assurance (PV-QA) programmes and four without. A total of 480 ADR reports from the 12-month study period were reviewed against five quality assurance criteria — completeness, causality assessment completion, timeliness of serious ADR reporting, signal detection protocol compliance, and follow-up report filing — and 248 healthcare professionalswere surveyed on pharmacovigilance knowledge, attitudes, and reportingpractices. Hospitals with formal PV-QA programmes showed significantlybetter compliance across all five quality metrics compared with non-QAhospitals: ADR report completeness 82.4% vs 48.6% (p < 0.001), causalityassessment completion 76.8% vs 38.4% (p < 0.001), serious ADR reportingwithin 24 hours 84.6% vs 52.2% (p < 0.001), signal detection compliance68.4% vs 28.6% (p < 0.001), and follow-up report filing 72.6% vs 34.8% (p < 0.001). Healthcare professional knowledge scores were significantly higher in PV-QA hospitals (72.4 vs 48.6 out of 100, p < 0.001). These findings provide evidence that structured pharmacovigilance quality assurance programmes substantially improve ADR reporting quality and signal detection capability in Indian tertiary care settings, and support universal adoption of formal PV-QA frameworks as a regulatory and institutional quality standard. KEYWORDS: Pharmacovigilance, Quality assurance, Adverse drug reactionreporting, ADR monitoring, PvPI, Signal detection, Drug safety, Causalityassessment, Karnataka, Tertiary care hospital.