Publication:

Pharmacovigilance programme of India from the perspective of nursing students

Background Lack of knowledge and awareness of reporting adverse drug reactions is common among the nursing staff. As the nursing staffs are more close to the patients, this study was undertaken to evaluate their knowledge, attitude and perception about pharmacovigilance and ADR reporting. The objective of this study was to assess the knowledge, attitude and perception of nursing staff about pharmacovigilance programme and finding out the ways of improving the ADR reporting rate.

Methods Across-sectional, anonymous, questionnaire based study was conducted at the Government hospital, Nizamabad among the nursing staff. A predesigned, pretested and validated questionnaire consisting of 15 questions and 8 statements on knowledge, attitude and practice aspects of Pharmacovigilance programme in India. All the nursing staffs were explained about the purpose of the study and the questionnaire was distributed. Adequate time was given to fill them. Data spread on the excel sheet and the results were analysed using Microsoft office 2007 version.

Results Out of 65 students, 74.1% were aware of the term pharmacovigilance, 44.4% of the pharmacovigilance programme in India and 70.4% of the pharmacovigilance cell in their institute. 22.2%stated that known reactions, 14.8% unknown and 63% that all ADRs are to be reported.63% stated herbal drugs are safe, 44.4% that over the counter drugs are safe. Reporting system stated was by making call/by e-mail (25.9), written form (29.6%). Underreporting was due to lack of awareness (51.9%), lack of time (22.2%), feeling of creating negative impression on heath personnel (11.1%), or due to the feeling of waste of time (14.8%).

Conclusions Lack of facilities and clinical knowledge about ADR discourages them from reporting. Educational interventions and improvement of facilities were also suggested to enhance reporting rate in the hospital.