Trastuzumab Biosimilars in the Therapy of Breast Cancer - "Real World" Experiences from four Bavarian University Breast Centres.

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.

Cytochrome p450 polymorphisms in geriatric patients: impact on adverse drug reactions--a pilot study.

Background And Objective: Up to 23% of the population, depending on their ethnic background, has genetically determined differences in the metabolism of drugs by the cytochrome P450 (CYP) enzymes CYP2C9, CYP2C19 and CYP2D6. The aim of this survey was to determine the relationship between genetical polymorphisms in these CYP enzymes and adverse drug reactions (ADRs) in geriatric patients.

Study Design: In a prospective 6-month cohort study of 243 patients in a geriatric rehabilitation ward, mean age 80.

The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients.

Background And Objective: Many drugs that are used to treat children are either not licensed for use in paediatric patients (unlicensed) or prescribed outside the terms of the product licence (off label). The incidence of adverse drug reactions (ADRs) associated with the use of such drugs is yet to be established. This study investigates, for the first time in a German patient population, the impact of unlicensed and off-label drug use on ADRs in paediatric patients.

Identification of adverse drug reactions in geriatric inpatients using a computerised drug database.

Introduction And Objective: Geriatric patients with multiple comorbidities are at high risk of experiencing an adverse drug reaction (ADR) during hospitalisation. The aim of the study was to compare the rate of ADRs as predicted by a computerised pharmacological database to the actual rate determined by direct observation in a sample of geriatric patients.

Study Design: During a 4-month period, geriatric patients were monitored using prospective observation.

Lack of awareness of community-acquired adverse drug reactions upon hospital admission : dimensions and consequences of a dilemma.

Objective: Adverse drug reactions (ADRs) are a well-known cause of hospital admission. Nevertheless a quantitative estimate of the preventability of and physicians' awareness of these reactions is lacking.

Study Design And Methods: Using intensive bedside and computer-assisted drug surveillance methods a 13-month prospective pharmacoepidemiological survey was carried out on patients admitted to two medical wards of the Erlangen-Nuremberg University Hospital in Erlangen, Germany.