Abstract
Pharmacovigilance (PV) plays a vital role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Medicines do come with their respective adverse effects. Therefore it is imperative to do Adverse Drug Reaction (ADR) monitoring while they are being marketed. PV is a part of the second MBBS curriculum, but often given less importance by the students. If this Knowledge Attitude & Practice of PV can be made effective during the MBBS course itself, it may make the students better aware about ADR monitoring.
 Aims & Objective: Our purpose was to find out the knowledge, attitude & practices amongst the second year medical students in a tertiary care hospital in North Maharashtra.
 Methods: This was an observational based study which had predesigned questions. After seeking the approval from the Institutional Ethics Committee, questionnaire was given to second year students of a tertiary care hospital in north Maharashtra. MS Excel was used for data analysis.
 Results: The overall response rate was 76%. 30% answered knowledge question correctly whereas 70% answered the attitude questions correctly. Only 4 % had reported an ADR and majority felt that busy duty hours and fear of legal action was the reason for underreporting.
 Conclusion: Our study revealed that in spite of PV being part of 2nd year MBBS, it still needs more emphasis and attention. The student feedback regarding ADR after they visit wards may help in improving the general awareness.
 Keywords: Pharmacovigilance, Knowledge, Attitude, ADR.
Highlights
Pharmacovigilance (PV) activities are essential to ensure patient safety and must be encouraged at all health-care institutes
Response to Knowledge related questions: Fig 1 shows 44% were aware of the definition of PV and 22% were aware of the purpose of PV, 15% knew the definition of Adverse Drug Reaction (ADR) and 21% could identify the types of ADR. 40% knew who can report ADR and 31% knew the necessary steps to be taken
On an average the percentage of students who answered the attitude related questions correctly were 70%. 69% agreed that it was necessary to report ADR. 82% felt that PV and ADR reporting should be taught in the undergraduate classes. 46 % had read articles related to PV. [Table 2] Following were the students views regarding underreporting of ADR: TABLE 1: Response to Knowledge questions of Pharmacovigilance
Summary
Pharmacovigilance (PV) activities are essential to ensure patient safety and must be encouraged at all health-care institutes. Lack of awareness, training, and underreporting of adverse drug reactions (ADRs) are the major hindrances in the successful implementation of PV programme [1]. Adverse drug reactions (ADRs) are described as 'a response to a medicament which is noxious and unforeseen and which happens at dosages ordinarily utilized for the diagnosis, prophylaxis or treatment of a disease or for the alteration of physiological function' [2]. Adverse Drug Reactions (ADRs) are associated with a significant morbidity and mortality. Recent estimates suggest ADRs to be the fourth major cause of death in the United States (US). In order to identify the offending drugs causing ADRs, several countries have initiated pharmacovigilance programs in the recent past. Because of the variation in drug response among individuals, prescribing habits, drug regulatory system, and availability of drugs, it has been recommended for every country to set up their own pharmacovigilance programs[3]
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