Critical Analysis of Quality Adverse Drug Reaction Related Published Reports in Indian Biomedical Journal

摘要

To critically analyze the quality of medical contents of published ADR reports in Indian biomedical Journals. The current descriptive observational study evaluated case reports of last 2 years published in two standard Indian journals from the field of pharmacology and Pharmacotherapeutics with PV as scope. The international society of epidemiology (ISPE) and the international society of pharmacovigilance (ISoP) joint recommendations for submitting ADR's for publication were used. Out of 96 ADE's 86.45% were ADRs, 10.41% drug interactions & 3.13% medication errors. 22.91% were new drugs and 78.12% were due to old drugs. 66.67% & 25.00% of ADRs were rare and unusual respectively. 14.58% of the cases was seriousness/life threatening and 4.17% of cases were fatal. 14.5% & 19.7% cases were type A & B reactions respectively. 98.95% of the reports provided information about drug dosage, duration, route and formulation. Naranjo and WHO scale were not used in 21.88% and 56.25% of cases respectively. Severity scale and preventability scale were not applied in 90.63% and 94.79% of cases. Temporal relationship was not clear in 4.21% cases while medical contents were inadequate in 42.71% of cases. In 83.33% dose response relationship was not seen. Pictorial evidence was lacking in 48.9% & drug estimation in 92.71% cases. Other offending drug or pathology was present in 53.13% cases. In 19.79% of cases investigations were present but inadequate.The quality & Medical contents of published ADR reports in Indian journals are inadequate in various aspects which need improvisation.