Nutzung von Fachinformationen bei Hausärzten und Apothekern im Zusammenhang der Aut-idem-Regelung: Ergebnisse einer explorativen Querschnittsbefragung

Abstract

IntroductionSummaries of product characteristics (SmPC) of same-substance medications may feature content-related differences. This may cause difficulties regarding informed consent in the case of prescriptions of drugs in the context of the aut-idem regulation. A survey among family doctors (FD) and pharmacists (PH) was conducted in order to evaluate the usage behaviour of SmPCs, sources used to obtain information about drugs and the awareness of the existence of differences between SmPCs of same-substance medications. MethodsAn exploratory/non-representative, questionnaire- and telephone-based, semi-structured cross-sectional survey was performed (June to August 2018). ResultsParticipation rate of FD and PH was 29.8 % (34/114) and 73.0 % (73/100), respectively. In the previous month, all PH and 82.4 % of FD said that they had used a SmPC at least once (p=0.001). FD used SmPCs 6.4±4.9 and PH 65.0±52.5 times a month (p<0.001). In both occupational groups SmPCs were used most frequently to obtain information about dosing and/or type of application (FD: 97.1 %; PH: 98.6 %) and contraindications (97.1 % and 86.3 %, resp.). In both samples, the internet was the most frequently used drug information source (FD: 97.1 %; PH: 98.6 %), followed by the Rote/Gelbe Liste (97.1 % and 71.2 %, resp.) and the SmPCs of the original product (52.9 % and 65.8 %, resp.) or generic drug (52.9 % and 61.6 %, resp.). Only 32.4 % of the FD vs. 79.5 % of PH believed that differences might exist between SmPCs of same-substance medications (p<0.001). FD stated that they never (11.8 %) or rarely (85.3 %) use SmPCs for informed consent. It was indicated that the aut-idem substitution is excluded in 10.3 %±5.0 (FD) and 9.6 %±6,1 (PH) of issued or received prescriptions. DiscussionThe results of the present survey indicate a low utilization rate of SmPCs by FD and little awareness of the existing differences of SmPCs of same-substance medications in this occupational group. Both aspects may impede proper information of patients, particularly in cases of aut-idem prescriptions of substances for which many same-substance medications with different SmPCs are available. ConclusionPhysicians should use SmPCs regularly and keep themselves informed about differences between SmPCs of same-substance medications.