The authors thank Dr Lehmann for her contribution.
Regarding the study question: The analysis we conducted of the risk potential of PRISCUS drugs is a subanalysis of a study that included more than 2200 patients in an emergency unit prospectively in an intensive drug safety test. The data on younger patients were reported only for completeness’s sake. As Dr Lehmann rightly comments, the PRISCUS-independent comparison of younger and older patients shows an increase in medication errors and adverse drug reactions in older patients.
Regarding the study design: The design of a prospective, randomized, placebo-controlled study (RCT) was not feasible for our research question. By means of an intensified drug safety test conducted by two independent expert teams and an additional sample of the patient files that were primarily assessed to be normal, a new gold standard in the clinical evaluation of adverse drug reactions was defined. We wish to point out that it was not the aim of our study to evaluate the safety of the PRISCUS drugs compared with possible alternative preparations. An RCT would formally be better in that setting, albeit difficult to implement in practice.
Regarding the classification: Only 52 of the 166 medication errors manifested clinically. In our analyses we distinguish between many events on the basis of medication errors and adverse effects that occur even when the drug is taken as instructed.
In the context of the present study we established that the classifications of medication errors and adverse drug reactions as used up to now are coming up against their limitations, if several drugs contribute to an adverse reaction and medication errors are observed additionally (2).
The authors agree with Dr Lehmann that medication therapy requires particular attention especially in at-risk populations such as elderly and multimorbid patients. The focus should therefore not be exclusively on PRICUS drugs.
Prof. Dr. med. Harald Dormann
Conflict of interest statement
All authors declare that no conflict of interest exists.
|1.||Dormann H, Sonst A, Müller F, Vogler R, et al.: Adverse drug events in older patients admitted as an emergency—the role of potentially inappropriate medication in elderly people (PRISCUS.) Dtsch Arztebl Int 2013; 110(13): 213–9 VOLLTEXT|
|2.||Bürkle T, Müller F, Patapovas A, et al.: A new approach to identify, classify and count drug-related events. Br J Clin Pharmacol 2013; 76(Suppl S1): 56–68 CrossRef MEDLINE|