Risk Perception and Reasons for Noncompliance in Pharmacovigilance A Qualitative Study Conducted in Canada

Background: The postmarketing safety evaluation of drugs relies on the spontaneous reporting of adverse reactions to authorities. Under-reporting is a known issue, with only 3% of all adverse reactions that occur actually being reported. Therefore, the postmarketing safety evaluation of medications is compromised. Objective: This investigation aimed to identify determining factors that influence reporting as well as corrective actions. We specifically wanted to define the perceptions physicians and pharmacists have of pharmacovigilance, of the local and national reporting systems, of their role and that of other players in reporting adverse reactions, and of its consequences in their clinical practice. Methods: Three focus groups with pharmacists and 16 semi-structured interviews with physicians from four different clinical services were conducted. Results: Four major obstacles to reporting adverse reactions were identified: (i) pharmacovigilance is seen as an unrealistic ideal; (ii) the reporting authority is perceived as a virtual and remote entity; (iii) healthcare professionals do not feel concerned by the risks associated with the medications used in their practice; and (iv) healthcare professionals are uncertain about the scope of their role in reporting adverse effects. Conclusion: In order to promote reporting and a greater awareness of the system, a redefinition of its expectations and targeted feedback seem to be essential. Increased reporting can also be achieved by the presence of an onsite professional dedicated to reporting and educating others. Several definite measures are proposed in order to achieve this goal.