Pauline Dürr1,2, Katja Schlichtig2,3, Carolin Kelz2,3, Birgit Deutsch2,3, Renke Maas2,3, Michael J Eckart4, Jochen Wilke5, Harald Wagner5, Kerstin Wolff2,6, Caroline Preuß2,7, Valeska Brückl2,8, Norbert Meidenbauer2,8, Christian Staerk9, Andreas Mayr9, Rainer Fietkau2,10, Peter J Goebell2,11, Frank Kunath2,11, Matthias W Beckmann2,7, Andreas Mackensen2,8, Markus F Neurath2,6, Marianne Pavel2,6, Frank Dörje1,2, Martin F Fromm2,3. 1. Pharmacy Department, Erlangen University Hospital, Erlangen, Germany. 2. Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Erlangen, Germany. 3. Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany. 4. Practice for Hematology and Oncology, Erlangen, Germany. 5. Practice for Hematology and Oncology, Fürth, Germany. 6. Department of Internal Medicine 1, University Hospital Erlangen, Erlangen, Germany. 7. Department of Obstetrics and Gynecology, University Hospital Erlangen, Erlangen, Germany. 8. Department of Internal Medicine 5, Hematology and Oncology, University Hospital Erlangen, Erlangen, Germany. 9. Institute of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany. 10. Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany. 11. Department of Urology and Pediatric Urology, University Hospital Erlangen, Erlangen, Germany.
Abstract
PURPOSE: Oral anticancer drugs (eg, kinase inhibitors) play an important role in cancer therapy. However, considerable challenges regarding medication safety of oral anticancer drugs have been reported. Randomized, controlled, multicenter studies on the impact of intensified clinical pharmacological/pharmaceutical care on patient safety and patient treatment perception are lacking. METHODS:Patients were eligible for the randomized, multicenter AMBORA study, if they were newly started on any of the oral anticancer drugs approved in 2001 or later without restriction to certain tumor entities. Patients were randomly assigned to receive either standard of care (control group) or an additional, intensified clinical pharmacological/pharmaceutical care, which included medication management and structured patient counseling, over a period of 12 weeks (intervention group). Primary end points were the number of antitumor drug-related problems (ie, side effects and unresolved medication errors) and patient treatment satisfaction with the oral anticancer therapy after 12 weeks measured with the Treatment Satisfaction Questionnaire for Medication, category convenience. RESULTS:Two hundred two patients were included. Antitumor drug-related problems were significantly lower in the intervention compared with the control group (3.85 v 5.81 [mean], P < .001). Patient treatment satisfaction was higher in the intervention group (Treatment Satisfaction Questionnaire for Medication, convenience; 91.6 v 74.4 [mean], P < .001). The hazard ratio for the combined end point of severe side effects (Common Terminology Criteria for Adverse Events ≥ 3), treatment discontinuation, unscheduled hospital admission, and death was 0.48 (95% CI, 0.32 to 0.71, P < .001) in favor of the intervention group. CONCLUSION: Treatment with oral anticancer drugs is associated with a broad range of medication errors and side effects. An intensified clinical pharmacological/pharmaceutical care has considerable, positive effects on the number of medication errors, patient treatment perception, and severe side effects.
RCT Entities:
PURPOSE: Oral anticancer drugs (eg, kinase inhibitors) play an important role in cancer therapy. However, considerable challenges regarding medication safety of oral anticancer drugs have been reported. Randomized, controlled, multicenter studies on the impact of intensified clinical pharmacological/pharmaceutical care on patient safety and patient treatment perception are lacking. METHODS:Patients were eligible for the randomized, multicenter AMBORA study, if they were newly started on any of the oral anticancer drugs approved in 2001 or later without restriction to certain tumor entities. Patients were randomly assigned to receive either standard of care (control group) or an additional, intensified clinical pharmacological/pharmaceutical care, which included medication management and structured patient counseling, over a period of 12 weeks (intervention group). Primary end points were the number of antitumor drug-related problems (ie, side effects and unresolved medication errors) and patient treatment satisfaction with the oral anticancer therapy after 12 weeks measured with the Treatment Satisfaction Questionnaire for Medication, category convenience. RESULTS: Two hundred two patients were included. Antitumor drug-related problems were significantly lower in the intervention compared with the control group (3.85 v 5.81 [mean], P < .001). Patient treatment satisfaction was higher in the intervention group (Treatment Satisfaction Questionnaire for Medication, convenience; 91.6 v 74.4 [mean], P < .001). The hazard ratio for the combined end point of severe side effects (Common Terminology Criteria for Adverse Events ≥ 3), treatment discontinuation, unscheduled hospital admission, and death was 0.48 (95% CI, 0.32 to 0.71, P < .001) in favor of the intervention group. CONCLUSION: Treatment with oral anticancer drugs is associated with a broad range of medication errors and side effects. An intensified clinical pharmacological/pharmaceutical care has considerable, positive effects on the number of medication errors, patient treatment perception, and severe side effects.
Authors: Sarah M Belcher; Emily Mackler; Benyam Muluneh; Pamela K Ginex; Mary K Anderson; Elizabeth Bettencourt; Ryan K DasGupta; Jennifer Elliott; Erica Hall; Michelle Karlin; Diana Kostoff; Victoria K Marshall; Vanessa E Millisor; Maegan Molnar; Susan M Schneider; Janelle Tipton; Susan Yackzan; Kristine B LeFebvre; Kapeena Sivakumaran; Haya Waseem; Rebecca L Morgan Journal: Oncol Nurs Forum Date: 2022-06-17 Impact factor: 1.803
Authors: Rossana Roncato; Lorenzo Gerratana; Lorenza Palmero; Sara Gagno; Ariana Soledad Poetto; Elena Peruzzi; Martina Zanchetta; Bianca Posocco; Elena De Mattia; Giovanni Canil; Martina Alberti; Marco Orleni; Giuseppe Toffoli; Fabio Puglisi; Erika Cecchin Journal: Front Pharmacol Date: 2022-07-22 Impact factor: 5.988
Authors: Katja Schlichtig; Lisa Cuba; Pauline Dürr; Laura Bellut; Norbert Meidenbauer; Frank Kunath; Peter J Goebell; Andreas Mackensen; Frank Dörje; Martin F Fromm; Bernd Wullich Journal: J Clin Med Date: 2022-08-04 Impact factor: 4.964