Introduction: Reporting of adverse drug reaction (ADR) is vital activity for the success of pharmacovigilance and healthcare professionals. The doctors play a pivotal role in the success of such activity. The one of the reason for under-reporting of ADR has been lack of training in undergraduate medical curriculum. Therefore, we conducted an exercise to sensitize the undergraduate students (UMS), the future doctors, regarding ADR reporting and analysed their patterns of ADR reporting.
Materials & Method: The current study was observational study, conducted at department of Pharmacology, Shri B. M. Patil Medial College & Hospital, BLDE University, Vijayapura, Karnataka. At the beginning of the 5th term (3rd term of Phase-II of MBBS), UMS were given an ADR reporting form, which was designed by department of Pharmacology keeping in 2nd year UMS. This form is different from â€˜suspected adverse drug reaction reporting form, available from Central Drugs Standard Control Organization (CDSCO). The form was printed with role number for each student. Each form was duly signed by Head of the department. The students were issued only one form bearing their role number. Immediately after distributing the forms, students were briefed about identifying the ADRs and reporting. Opportunity was also utilized teach the students about pharmacovigilance programme in India and importance of ADR reporting.
The students were given a time of 7 days from the issue of ADR form to fill the form. Once student goes to the ward he she has been posted by clinical departments, he she will go through the drugs administered to patients in a ward. He she then go through the textbooks about the medication administered to the patient first, then they were advised to examine the patient for known ADRs from the textbooks. Once they appreciate ADRs in patient and assign it to possible drug, they fill the details in the form given to them. If they donâ€™t find ADR in particular patient, they move on to next patient.
Once student identifies an ADR s, he she will write it into the form. The same was cross-checked and signed by Assistant Professor, department of Pharmacology posted in the drug information centre, situated in Shri B. M. Patil Medial College & Hospital, BLDE University, Vijayapura, Karnataka and by Clinical Pharmacist. The form then submitted to the department and were then analysed. The data was analysed by the MS Excel and Graph Pad Prism (Demo) software.
After entire exercise was over, students were given feedback about entire activity in the class and an emphasis on ADR, Pharmacovigillance was reinforced.
Results: In a class of 116 students, all were issued one ADR forms each. Only 95 students out of 116 returned with duly filled forms and submitted them to the department. Out of 11 students who did not submit the ADR forms, 7 students did not bother to collect the ADR forms, 3 did not write ADR for reasons unknown and one student reported that he lost the ADR form.
Students reported a total of 256 ADRs from 95 ADR forms over one week time. Out of these 256 ADRs, there were 33 different types of ADRs were found. A total of 77 drugs reported from these ADR forms. On an average each ADR form had 2.72 ADRs reported per prescription. The average number of drugs per patient, which students have gone through were 2.69. Though there were more than one ADR is reported for each drug, so there were 3.32 ADRs reported per drug being prescribed. Headache (n=61) and Nausea (n=60) followed by and vomiting (n=21) were commonly reported ADRs.
Conclusion: The students were interested in the activity but needs prompt guidance from the teaching faculty to correct their mistakes.
An exercise to sensitize undergraduate medical students about adverse drug reactions: An analysis