Knowledge, Attitude, and Perception toward Black-Box and Scheduled Drug Warnings Among Undergraduate Medical Students A Cross-Sectional Study in a Tertiary Medical Institution in Andhra Pradesh, India

Abstract

Introduction: Black Box Warnings (BBW) issued by the U.S. Food and Drug Administration (FDA) identify serious or life-threatening risks associated with certain medicines. In India, scheduled-drug warnings issued under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) restrict the sale and dispensing of specified medicines.

Aim and objectives: To assess knowledge, attitudes, and perceptions regarding BBWs and scheduled-drug warnings among undergraduate medical students, including confidence in identifying medicines carrying such warnings and sources of drug-safety information.

Methods: This was a cross-sectional study conducted at Maharajah’s Institute of Medical Sciences, Vizianagaram. Responses were collected using a 29-item structured questionnaire with a Cronbach’s alpha of 0.81. A total of 243 complete responses were analysed.

Statistical analysis: Descriptive statistics were used. Knowledge was scored across eight items and categorised as high (>70%), moderate (50–69%), or low (<50%). Percentages are accompanied by 95% confidence intervals (CIs) where appropriate.

Results: The mean age was 19.9 ± 1.4 years, and 69.5% reported formal pharmacology education. The mean knowledge score was 4.07 ± 2.01, with 24.7% showing high knowledge, 30.9% moderate, and 44.4% low. Only 26.3% of students felt confident identifying medicines carrying BBWs, and textbooks remained the primary source of learning.

Conclusion: Awareness of scheduled-drug warnings and BBWs among the participating medical students was inadequate. Incorporating regulatory-specific clinical pharmacology coursework and structured student evaluation of these warnings may help strengthen medication-safety education and preparedness for prescribing.