Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

Abstract

Objectives:Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated.Materials and Methods:The module consisted of (a) e-mailing an ADR narrative and online filling of the “suspected ADR reporting form” (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012–2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013–2014. The evaluation consisted of recording the number of students responding and the scores achieved.Results:A total of 171 students in 2012–2013 batch and 179 in 2013–2014 batch participated. In the 2012–2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013–2014 batch, the number (n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months.Conclusion:This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians.

Urgent need to modernize pharmacovigilance education in healthcare curricula: review of the literature

“… Number of reported ADRs – 4a Significant increase in the number (42 → 310) of ADRs documented. Tripathi et al [ 77 ] India Medical (second year) 180 Working group on ADR reporting and monitoring One working group (time unknown) Quality score of ADR report After 1 and 6 months 2b Significant increase in ADR-reporting skills after 1 and 6 months. ADRs , adverse drug reactions a Kirkpatrick’s four levels of training evaluations are as follows: Level 1—participation: covers learners’ views on the learning experience, its organization, presentation, content, teaching methods, and aspects of the instructional organization, materials, and quality of instruction; Level 2a—modification of attitudes and perceptions: outcomes relate to changes in the reciprocal attitudes or perceptions between participant groups toward the intervention or simulation; Level 2b—modification of knowledge or skills: for knowledge, this relates to the acquisition of concepts, procedures, and principles; for skills, this relates to the acquisition of thinking problem solving, psychomotor, and social skills; Level 3—behavioral change: documents the transfer of learning to the workplace or willingness of learners to apply new knowledge and skills; Level 4a—change in organizational practice: wider changes in the organization or delivery of care, attributable to an educational program; Level 4b—benefits to patient or clients: this relates to any improvement in the health or well-being of patients clients as a direct result of an educational program …”

“…Four articles evaluated student satisfaction regarding pharmacovigilance education [ 65 , 67 , 75 , 77 ]. Students found clinical experience more educational than lectures and/or solving fictional casuistry [ 67 ].…”

“…Students found clinical experience more educational than lectures and/or solving fictional casuistry [ 67 ]. Students also stressed that pharmacovigilance training should be repeated during the internships [ 77 ]. Six articles examined students’ intentions and attitudes toward ADR reporting after a pharmacovigilance intervention [ 65 – 67 , 73 , 74 , 77 ].…”

Knowledge, attitude and practice of undergraduate medical students and interns towards pharmacovigilance

“…16 Educating MBBS students will produce health-care professionals competent in pharmacovigilance. 28 The learning of PV should start as early as possible in medical school. 27 The amount of time dedicated to teaching of PV in undergraduate and postgraduate courses in Pharmacology is low.…”

Is Medical Schools, Curricula Content of Pharmacovigilance and Rational Pharmacotherapy- Related Subjects Sufficient for Future Physicians?

“…15,16 Interventions to educate students and healthcare professionals on pharmacovigilance have proven to be effective in increasing their knowledge and awareness, and their pharmacovigilance activities. [17][18][19][20][21][22]25,[30][31][32][33][34][35][36][37] However, as these interventions are costly or fail to produce clinically relevant and long-term effects, it is essential to provide pharmacovigilance education to healthcare students at the university level, which will be more effective in improving their knowledge and skills for a safer pharmacotherapy and future use of these skills in their career. 7,15,25 In 2016, a meeting organized by the Netherlands Pharmacovigilance Centre on behalf of the WHO stakeholders addressed and agreed on the pharmacovigilance competencies medical students need to have and the essential aspects of the subject that should be taught.…”