Reporting adverse drug reactions: contribution, knowledge and perception of German pharmacy professionals

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RESEARCH ARTICLE

Reporting adverse drug reactions: contribution, knowledge and perception of German pharmacy professionals Anna Laven1   · Katharina Schmitz1 · Wilhelm‑Hubertus Franzen2 Received: 6 January 2018 / Accepted: 7 June 2018 © Springer International Publishing AG, part of Springer Nature 2018

Abstract Background The detection, assessment and prevention of adverse drug reactions along the product’s life cycle is known as pharmacovigilance. German pharmacists are obliged by law to conduct pharmacovigilance measures, a specific training is not required. Objectives To assess the knowledge, contribution and perception of German pharmacy professionals regarding pharmacovigilance activities, in order to identify their needs to report better on the issue. Setting A semi-quantitative survey among German pharmacy professionals was conducted in November 2017. Method A questionnaire with 20 questions was developed and distributed to pharmacy professionals in four different German regions. Main outcome measures To assess the knowledge the number of right answered questions were examined; for perception a six-point-Likert was used and for contribution, yes or no questions. Results The participation ratio was 64.5% (n = 127). Nearly half of the participants (47.2%, n = 60) stated that they had already reported adverse drug reactions. Regarding the knowledge questions, there was neither a statistically significant difference between the correct answers of pharmacists and pharmacy technical assistents (p = 0.7209), nor between the different regions (p > 0.5054). For better reporting, the participants recommended better training, shorter forms to fill in and/or a contact person to call. Conclusion For the successful integration of pharmacovigilance reporting in daily practice, we suggest the following: (1) A structured, mandatory training of the pharmacy team. (2) The preparation of a standard operating procedure for the pharmacy or its integration into the pharmacy software. Keywords  Adverse drug reactions · Community pharmacy · Germany · Pharmacovigilance · Questionnaire · Survey

Impacts on Practice • Pharmacists are drug specialists with a good understand-

ing of clinical symptoms; they have their focus on the complete medication including OTC drugs. Thus, they play an important role in the detection of suspected adverse drug reactions, but need additional training on pharmacovigilance. • Up to now there is no data available for Germany concerning this matter. Further research in this field has to be done to customise training programs based on the determined needs. * Anna Laven [email protected] 1

Pharmabrain GmbH, Research and Training Center, Schumannstr. 7b, 10117 Berlin, Germany



Takeda Pharma Vertrieb GmbH & Co. KG, Jaegerstr. 27, 10117 Berlin, Germany

2



• Our results are similar to those from other countries and

show that there is room for improvement among pharmacy professionals concerning pharmacovigilance matters.

Introduction The detection, assessment and prevention of adverse drug re