Pharmacovigilance Teaching to Undergraduates of Medicine and Surgery School: the Experience of Verona University

Background/Introduction: Teaching pharmacovigilance (PV) to undergraduates of Medicine and Surgery School is an educational objective of great importance. Their acquisition of theoretical bases and practical skills in detecting and reporting adverse drug reactions (ADRs) is an essential pre-requisite for their future contribution to pharmacovigilance activities. Unfortunately, at national level pharmacovigilance is not compulsory within the Degree Course of Medicine and Surgery (MD) in Italy and its introduction within the course of Pharmacology depends on the individual initiative of some professors. Objective/Aim: Pharmacovigilance teaching to undergraduates of Medicine and Surgery School at University’s Verona, Italy. Methods: The teaching methods included 15 h of frontal teaching, problem based learning (PBL) and problem solving (PS). The course aimed to the development of pharmacovigilance knowledge and skills and focused on basis of pharmacovigilance, regulatory aspects and benefit/ harm assessment. With regard to PBL and PS, students, divided into groups with the presence of a tutor, were trained on drug–drug interactions, medical diagnosis, recognizing, managing and reporting ADRs through the analysis of a clinical case report. At the end of the course the students’ knowledge was assessed through an oral exam. Results: At the University of Verona pharmacovigilance has been taught within the Degree Course of MD for at least 20 years, since the professors of Pharmacology are involved in the activities of the Regional PV Centre. Until last year the teaching of pharmacovigilance was only among the training objectives of the Pharmacology course, whereas, starting from the academic year 2017–2018, the course has been divided into two modules: General/Special Pharmacology (8 Educational Credits-ECTS) and Pharmacovigilance (1 ECTS), both carried out during the fourth year of education (120 students). At the conclusion of the PV module students: [were able to understand the mechanisms of ADRs, [were able to understand the classification of ADRs, [knew the epidemiological data on ADRs, [were able to fill in a reporting form. Conclusion: Teaching PV is particularly important for MD students, since their knowledge on PV can influence their future ability to prescribe and monitor drug therapies. As a matter of fact, a physician who has the ability to identify ADRs and the habit of reporting them, will certainly pay attention to all aspects related to the patient’s health and consequently to both positive and negative effects of a drug therapy.