Teaching and Learning Pharmacovigilance

Teaching and Learning Pharmacovigilance

INTRODUCTION

There are two closely connected primary dimensions of educational need associated with the field of pharmacovigilance. The principal dimension is that of the clinical practitioner who needs knowledge, under-standing and wisdom about effects of pharmaceuticals in their day-to-day healthcare practice. The secondary dimension is that of professionals in the field who must amass and evaluate emerging evidence from broad populations exposed to pharmacotherapies. A vital nexus between these two dimensions is found in the spontaneous adverse drug reaction (ADR) report that, for many years to come, is likely to remain a key element in the intelligence-gathering systems of professional pharmacovigilists.

The educational needs of practitioners in each of these fields have considerable interdependency. On the one hand, beyond personal empirical obser-vation, the healthcare practitioner needs to learn to continually discriminate benefits and risks associ-ated with the pharmacotherapies they are supervising. On the other hand, the professional pharmacovigilist needs to develop and maintain the same fundamental clinical knowledge and discriminatory skill as well as mastery of increasingly complex systems of signal generation, systematic investigation of signal mean-ing and effective communication back to the public and healthcare practitioners.

This chapter therefore addresses the educational needs, opportunities and challenges for both groups: characterized here as learners and teachers of phar-macovigilance.

In recent years, two significant political under-currents have powerfully influenced the field of pharmacovigilance: these currents have created a notable undertow that has magnified interest in and extended the scope of teaching in this field. Addi-tionally, these forces have resulted in a more lively interest in the communication of findings from the field of pharmacovigilance to those engaged in over-seeing pharmacotherapy in practice.

The first of these currents derives from publicity and revitalized public interest in mistakes and mishaps in conventional healthcare provisions. The second has emerged from concerns about medicinal drug therapy, and the contemporary expectation that available ther-apies should be uniformly ‘safe’ in customary use. Both of these movements will be examined in this chapter. Implications will be discussed for both the individual practitioner’s need to learn pharmacovigi-lance in the care of their patients and also for training health professionals in pharmacovigilance manage-ment techniques.