gms | German Medical Science

Background: The German pharmacovigilance system is based on spontaneous reporting. Because of their responsibility as a part of the health care system and the provision of the Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung, ApBetrO,) pharmacists must support it. In 2016 the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) was informed about 64.108 suspected adverse drug reactions (ADR), 4 % of these reports were provided by the Drug Commission of German Pharmacists (Arzneimittelkommission der Apotheker, AMK) [1].

The aim of this study is to investigate the awareness of pharmacists about the pharmacovigilance system and its importance. Results of their reporting behaviour are compared to the results of a previous study of the NRW Centre for Health (Landeszentrum Gesundheit NRW, LZG.NRW) [2].

Materials and Methods: Within 12 months, structured interviews with managing pharmacists in community pharmacies in North Rhine-Westphalia (NRW) are performed by pharmaceutical officers of the local public health authorities. Pharmacy inspectors in cooperation with the LZG.NRW developed a data form which is used as guideline for interviews. The forms are completed by pharmacy inspectors after the interview and are collected and analysed by the LZG.NRW.

Results: In total, 43 of 53 districts and cities took part in the study. The results from 499 interviews can be analysed. In 8 % of the pharmacies is no pharmacovigilance system implemented, in 26 % it is very basic. In the last 12 months before the interview 31 % of the pharmacies detected pharmaceutical risks. Especially complaints about quality of drugs are documented. Suspected ADR, interactions or drug abuse are reported rarely. The quality of reports to AMK or BfArM often don`t meet the minimum criteria.

Conclusion: In many community pharmacies, there is no well-functioning pharmacovigilance system. The quality of reports needs obviously improvement.

Based on the results, the conclusion must be drawn, that training courses and education for pharmacists about pharmacovigilance are necessary and important. During inspections, pharmacies should be reminded and supported more in assuming their responsibility in the pharmacovigilance system.