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Introduction With the introduction of the first trastuzumab biosimilar in the summer of 2018, biosimilar antibodies for breast cancer have found their way into the area of gynaecological oncology. The switch of anti-human epidermal growth factor receptor 2 (HER2) therapy from the reference drug Herceptin® to a biosimilar has presented challenges to the clinics. In addition to structural and organisational measures, training of employees as well as patient briefing and acceptance were major challenges. The study presented here records – within the context of quality assurance – how the switch to a trastuzumab biosimilar was implemented at four Bavarian university clinics in the Purchasing Association of Bavarian University Pharmacies. Materials/Methods Questionnaires on treatment figures and the switching process were sent to breast centres and pharmacies of four Bavarian university clinics between July and December 2019. The neoadjuvant, adjuvant and metastasised anti-HER2 therapy with trastuzumab with or without pertuzumab was recorded, evaluated and summarised. Results In the anti-HER2-therapy, trastuzumab was used intravenously (i. v.) and subcutaneously. Between July and December 2018, all four clinics in the Purchasing Association switched the i. v. trastuzumab therapy from the reference drug (Herceptin) to a biosimilar (for 2018: Kanjinti®). Over 200 patients were treated with trastuzumab i. v. in each of the two half-years of 2018 (before and after the switch). The spectrum of side effects and pCR rates under therapy with the biosimilar were comparable to the experiences made with the reference drug. Three out of four clinics provided training to employees and informed patients by means of a defined information leaflet. Patient acceptance was high. Summary The anti-HER2 therapy could be switched successfully and safely to trastuzumab biosimilars at the Bavarian university hospitals. This may serve as guideline for the further implementation of biosimilars. The structures necessary for this initial switching process have been prepared with trastuzumab as an example.

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What Is Known and Objective A ‘renal pharmacist consultant service’ (RPCS) reviewing patients' charts with renal impairment (RI) for drug‐related problems (DRP) can foster patient safety. However, the benefit of this service in the new setting of a computerized physician order entry (CPOE)‐system with a clinical decision support (CDS)‐system is unknown. The aim of our study was to evaluate the general need for an RPCS on wards with a CPOE‐CDS‐system already in use and its effectiveness on prescription changes to ensure in‐hospital patient safety. Methods Over a period of 3 months (02‐04/2021), elective orthopaedic and trauma patients with eGFRabsolute/CrCl <60 ml/min at a German University Hospital received a medication review by a renal pharmacist for all medication entered into the CPOE‐system (Meona®) by the treating physicians. Written consultations explaining identified DRP and recommending interventions to solve them, for example, dose or drug adaptation, were shared with the physicians directly in the drug chart tab of Meona®. In complex cases, DRP were additionally discussed via phone. The prescription changes were evaluated retrospectively. Results and Discussion During 53 working days, 712 (30.5%) of 2331 screened patients were included with an eGFRnon‐indexed/CrCl <60 ml/min and a pharmacist‐led medication review was performed for all medication presented in the CPOE‐system (Meona®). In 79 of 712 (11.1%) patients, one or more DRP were detected (median 1 DRP (1–3) per patient) and written recommendations concerning 106 of 1090 (9.7%) drugs were shared via Meona®. In total, 104 DRP were identified, mostly caused by ‘dosage too high’ (n = 55, 52.9%), ‘dosage regime wrong’ (n = 13, 12.5%), and ‘contraindication’ (n = 9, 8.7%). Acceptance rate of recommendations was 74.0% (n = 77/104). In nine cases (8.7%), despite of specific recommendations, no adjustment of drugs was made because of lack of alternatives. In 11 (10.6%) cases, prescription remained unchanged for unknown reasons and in seven (6.7%) cases, the result was unknown due to discharge. What Is New and Conclusion In the setting of prescribing in a CPOE‐CDS‐system, that provides physicians with advice for drug or dose adaption, the pharmacist‐led medication reviews still identified DRP in orthopaedic and trauma patients with RI. A RPCS forwarding recommendations to solve DRP via the electronic medical record increased appropriate prescribing by physicians and, thus, may further improve patient safety.

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