We thank our correspondent for the important comments on implementing measures to ensure and improve medication safety in the context of treatment with oral anti-cancer drugs in clinical practice, as well as with regard to potential negative effects of such measures.
First, we would like to indicate—which we also did in our review article (1)—that a multitude of studies have detected considerable deficits in the medication safety of oral anti-cancer drugs. In our opinion the unequivocal consequence is that we should act to the benefit of our patients. The areas of problems and actions teased out in our article arise mostly from the requirements of the Summaries of Product Characteristics, which are compiled by pharmaceutical manufacturers in agreement with the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), and which prescribers should adhere to by default. In our article we summarized this information from the Summaries of Product Characteristics—we did not develop it.
We also explained that high quality randomized trials that study which measures can effectively improve medication safety are few. Research is urgently needed, and it should of course focus also on the potential harms of a new measure.
The cited AMBORA research study (supported by German Cancer Aid (project grant no. 70112447/70112457, DRKS-ID DRKS00013271) (2)) is our active contribution to mproved patient treatment in a systematic and structured way. The intermediate results of the AMBORA study are promising with regard to important outcome parameters (2).
In sum, in our view the risks associated with too little medication safety in oral anti-cancer drugs dominate; it goes without saying that risks and pharma-economic aspects of newly introduced measures also need to be investigated. We think that the complexity of the described problems support the idea of establishing competent medical professionals for medication safety, for example, in comprehensive cancer centers, in order to provide structured support for patients taking oral anti-cancer drugs.
On behalf of the authors
Apotheke des Universitätsklinikums Erlangen
Lehrstuhl für Klinische Pharmakologie
und Klinische Toxikologie
Conflict of interest statement
The authors of both contributions declare that no conflict of interest exists.
|1.||Schlichtig K, Dürr P, Dörje F, Fromm MF: New oral anti-cancer drugs and medication safety. Dtsch Arztebl Int 2019; 116: 775–82 VOLLTEXT|
|2.||Dürr P, Schlichtig K, Dörje F, Fromm MF: Medication safety in patients treated with new oral antitumor agents: a prospective, randomized investigation on the impact of intensified clinical pharmaceutical/clinical pharmacological care on patient safety and well-being (AMBORA-Study – supported by the German Cancer Aid (70112447)). Naunyn-Schmiedeberg‘s Arch Pharmacol 2019; 392: 14. (Abstract).|