Impact of a Policy Change on Pharmacists’ Reporting of Adverse Drug Reactions

ABSTRACT Background: Spontaneous reports of adverse drug reactions (ADRs) form an essential component of both drug safety monitoring and patient safety initiatives. Pharmacists are well positioned to report ADRs, but many barriers exist to their doing so. Over the past decade, substantial changes have occurred with regard to drug regulations and medication safety initiatives, and it is possible that knowledge-based interventions may be needed to enhance ADR reporting by pharmacists. Objective: To determine whether ADR reporting behaviours of pharmacists improved after release of a revised policy on the reporting of medication incidents. Methods: A telephone survey was administered to pharmacists practising in the Canadian Forces Health Services Group. Self-reported behaviours and perceived barriers related to ADR reporting were compared before and 3 months after the updated policy was released. Accuracy in participants’ self-assessed ADR reporting was evaluated using independently derived workload statistics. Results: During the second survey phase (after release of the revised policy), a greater proportion of respondents reported awareness of institutional policies on ADR reporting and declared that they were able to complete all necessary ADR reports during their assigned work hours. However, the number of ADR reports submitted did not increase. Participants’ recall of their ADR reporting behaviour was corroborated by workload data. During the second survey phase, there was a noticeable reduction in the number of free-form comments mentioning lack of staff as a barrier to ADR reporting. Conclusions: Release of a more comprehensive policy was not associated with an increase in the number of ADR reports generated by pharmacists in the study setting. Interventions to strengthen the organization’s work processes for detection of ADRs and submission of individual ADR reports should be strongly considered, to reinforce and enhance existing ADR reporting behaviours among pharmacists. RESUME Contexte : Les declarations spontanees des reactions indesirables aux medicaments (RIM) sont essentielles a la pharmacovigilance et aux initiatives au profit de la securite des patients. Les pharmaciens sont bien places pour declarer des RIM, mais divers elements y font obstacle. Au cours de la derniere decennie, d’importants changements ont eu lieu en ce qui touche aux reglements sur les medicaments et aux initiatives en securite des medicaments, et il est possible que des interventions fondees sur le savoir soient necessaires pour ameliorer dans l’ensemble les declarations des RIM par les pharmaciens. Objectif : Determiner si les habitudes des pharmaciens relatives a la declaration des RIM se sont ameliorees apres la mise a jour d’une politique portant sur la declaration des incidents lies aux medicaments. Methodes : Les pharmaciens qui exercaient dans le Groupe des Services de sante des Forces canadiennes ont ete sondes par telephone. On a compare les reponses des pharmaciens quant a leurs propres habitudes de declaration et aux elements percus comme des obstacles a la declaration des RIM, avant la mise a jour de la politique et trois mois apres sa mise a jour. L’exactitude des reponses des participants a propos de leurs propres habitudes de declaration des RIM a ete verifiee a l’aide de statistiques sur la charge de travail obtenues independamment. Resultats : Pendant la deuxieme phase de l’enquete (apres la mise a jour de la politique), une plus grande proportion de repondants ont indique etre conscients des politiques institutionnelles sur la declaration des RIM et ils ont soutenu qu’ils etaient en mesure de remplir tous les rapports de declaration des RIM necessaires pendant leurs heures normales de travail. Cependant, le nombre de declarations de RIM soumises n’a pas cru. Les habitudes de declaration de RIM que les participants ont affirme avoir ont ete corroborees par les donnees sur la charge de travail. Dans la deuxieme phase de l’enquete, il y a eu une baisse notable du nombre de commentaires libres indiquant le manque de personnel comme obstacle a la declaration des RIM. Conclusions : La mise en place d’une politique plus detaillee n’a pas ete associee a une augmentation du nombre de declarations de RIM produites par des pharmaciens dans le contexte de cette etude. Des interventions visant a ameliorer, au sein de l’organisme, les methodes de travail pour la detection des RIM et le depot de declarations de RIM individuelles doivent etre fortement envisagees afin de consolider et d’ameliorer les habitudes de declaration des RIM chez les pharmaciens.