Abstract

Background:
The thalidomide disaster of the 1960s exposed major safety concerns for regulators and the public. Adverse drug reactions (ADRs) lead to significant morbidity, mortality, and hospitalizations, with limited data on prevalence.

Aim:
This study sought to enhance awareness and pharmacovigilance among healthcare professionals in a tertiary care facility in Kerala.

Methods:
A survey of 115 healthcare professionals at the Amala Institute of Medical Sciences in Thrissur, Kerala, assessed their understanding of pharmacovigilance and ways to enhance reporting of spontaneous ADRs. Google Forms were used in this study. The participants included 28 men and 87 women, averaging 23–36 years. The association between different parameters of pharmacovigilance and designation was also investigated.

Results:
Among 115 healthcare professionals, the mean age was 29.88 ± 9.02 years, and 75.7% were female. The majority were nursing staff (37.4%) and interns (33.0%). The mean knowledge score regarding ADR reporting was 5.66 ± 1.90, with 47.8% demonstrating moderate knowledge, 43.5% poor knowledge, and only 8.7% good knowledge. Knowledge level was not significantly associated with designation (p = 0.137). Awareness regarding reporting ADRs for newly marketed drugs and serious ADRs for established products differed significantly across designations (p = 0.001 and p = 0.016, respectively). The most common motivators for ADR reporting were serious reactions (86.1%), reactions associated with new drugs (71.3%), and unusual reactions (70.4%). Major barriers included uncertainty about the correctness of reports (49.6%), insufficient clinical knowledge (40.9%), and lack of time (30.4%). Most participants considered ADR reporting a professional obligation (72.2%) and supported compulsory reporting (74.8%). However, 73.9% had not received formal ADR reporting training. The participants suggested training programs, awareness activities, simplified reporting procedures, and dedicated support staff as measures to improve ADR reporting.

Conclusion:
Most participants were aware of the importance of ADR reporting and the National Coordination Centre. The key barriers included inadequate clinical knowledge, lack of confidence, and perceived complexity of reporting forms. The participants recommended undergraduate training, awareness programs, and newsletters to improve reporting. These findings highlight the need for regular pharmacovigilance training and simplified reporting systems to strengthen ADR reporting practices.

Key words: Adverse drug reactions; Healthcare professionals; Pharmacovigilance; Pharmacovigilance Programme of India.