CRITICAL APPRAISAL OF DRUG PACKAGE INSERTS: A STUDY AMONG MEDICAL STUDENTS
Main Article Content
Keywords
Package Inserts, Regulatory Standards, Critical Evaluation, Medical Students.
Abstract
Background: Package inserts (PIs) are critical tools in drug labelling, offering evidence-based information to ensure the safe and effective use of medications. In India, the format and content of PIs are governed by the Drugs and Cosmetics Act (1940) and Rules (1945), specifically Schedule D, Sections 6.2 and 6.3. However, studies indicate inconsistencies in the completeness of PIs. Well-structured PIs also serve as practical learning tools for medical students. This study aimed to critically evaluate the clinical and pharmaceutical content of PIs marketed in India, using regulatory standards.
Methods: A cross-sectional study was conducted among 150 second-year medical students from a Government Medical College in Kerala, India. Each student assessed one PI using a standardized 34-item checklist based on regulatory guidelines and published literature. Each item was scored as present (1) or absent (0). Based on total scores, PIs were classified as Grade A (24–34), Grade B (13–23), or Grade C (0–12).
Results: Of the 150 PIs reviewed, only 62.67% used appropriate font size and 68% used proper font colour. Core content like generic name, dosage, and indications was present in all PIs. However, safety-related data such as ADR classification (45.33%), drug interactions (90.67%), and ADR reporting instructions (43.33%) were inconsistently reported. Among 40 injectable PIs, gaps were noted in incompatibility and storage data. Overall, 35 PIs were graded A, 53 as B, and 12 as C.
Conclusion: Significant variability in PI content highlights the need for improved standardization and regulatory oversight. Incorporating PI evaluation into medical training may enhance safe prescribing and drug literacy.
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Dr. Sneha Prabha M. P
Assistant Professor, Department of Pharmacology, Government Medical College, Kollam, Kerala, India.
Dr. Sonish S. Prabhakaran
Assistant Professor, Department of Pharmacology, Government Medical College Thiruvananthapuram, Kerala, India.
Dr. Vinimol C
Assistant Professor, Department of Pharmacology, Government Medical College Thrissur, Kerala, India.