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Purpose: Two to seven percent of the German adult population has a renal impairment (RI) with an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m 2 . This often remains unrecognized and adjustment of drug therapy is lacking. To determine renal function in clinical routine, the CKD-EPI equation is used to calculate an indexed eGFR (ml/min/1.73m 2 ). For drug dosing, it has to be individualized to a non-indexed eGFR (ml/min) by the patient's body surface area. Here, we investigated the number of patients admitted to urological wards of a teaching hospital with RI between July and December 2016. Additionally, we correctly used the eGFR non-indexed for drug and dosage adjustments and to analyse the use of renal risk drugs (RRD) and renal drug-related problems (rDRP)., Methods: In a retrospective observational study, urological patients with pharmacist-led medication reconciliation at hospital admission and eGFR indexed (CKD-EPI) of 15-59 ml/min/1.73m 2 were identified. Indexed eGFR (ml/min/1.73m 2 ) was recalculated with body surface area to non-indexed eGFR (ml/min) for correct drug dosing. Medication at admission was reviewed for RRD and based on the eGFR non-indexed for rDRP, e.g. inappropriate dose or contraindication., Results: Of 1320 screened patients, 270 (20.5%) presented with an eGFR indexed of 15-59 ml/min/1.73m 2 . After readjustment, 203 (15.4%) patients had an eGFR non-indexed of 15-59 ml/min. Of these, 190 (93.6%) used ≥ 1 drugs at admission with 660 of 1209 (54.7%) drugs classified as RRD. At least one rDRP was identified in 115 (60.5%) patients concerning 264 (21.8%) drugs., Conclusion: Renal impairment is a common risk factor for medication safety in urologic patients admitted to a hospital. Considerable shifts were seen in eGFR-categories when correctly calculating eGFR non-indexed for drug dosing purposes. The fact that more than half of the study patients showed rDRP at hospital admission underlines the need to consider this risk factor appropriately.

Aims: There are concerns that biosimilar erythropoiesis-stimulating agents (ESAs) are less effective than the originator ESAs. The objective of our study was to investigate differences between originator and biosimilar ESA utilisation based on defined daily doses (DDD), doses upon switching, differences between short- and long-acting ESAs and prescribed daily doses (PDD) of either ESA in ambulatory patients with renal anaemia undergoing chronic maintenance haemodialysis [chronic kidney disease (CKD) stage 5]., Methods: Patients with CKD stage 5 and specific pharmacotherapy with ESAs for at least six 3-month periods (accounting quarters) were selected from a population-based database of accounting information of Bavarian physicians and pharmacy claims data (January 2008 to December 2010). The DDD was used to determine mean ESA consumption. Descriptive statistics were used to describe the results., Results: In our study, 6,177 CKD stage 5 patients received ESAs for ≥6 accounting quarters, of whom 64.4 % received originator ESAs, 21.1 % received biosimilars and 14.6 % received any sequence originator and biosimilar (total of 35.7 % any biosimilar). Patients receiving either originator short-acting ESAs, long-acting darbepoetin-alfa or M-PEG epoetin-beta had a median DDD consumption of 0.77, 0.81 and 0.90, respectively. Patients receiving a biosimilar short-acting ESA had a median DDD consumption of 0.82. Doses were not increased when the therapy was switched from the originator to the biosimilar ESA. These results were confirmed in 1,886 patients receiving a continuous prescription over 12 accounting quarters, with patients receiving short-acting originator ESAs, long-acting darbepoetin-alfa and biosimilar ESAs having a median daily DDD consumption of 0.80, 0.86 and 0.81, respectively., Conclusions: We conclude that, based on a population based analysis, ESA consumption of patients on chronic haemodialysis is similar for biosimilar and originator ESAs.

Objective: Effective treatment of hypertension requires continued prescribing of antihypertensive medications for many years. Persistence in prescribing habits, however, has been reported to be low. The study described herein - which is completely independent of pharmaceutical sponsors - was undertaken to evaluate persistence with antihypertensive treatment in Germany., Methods: A total of 13,763 newly diagnosed hypertensive patients were identified in the IMS Disease Analyzer database and observed for 3 years after their first antihypertensive prescription., Results: The median age of the study cohort was 65 years, and 56% were female. One in four patient received no more than three prescriptions within 3 years. Persistence was longest for patients whose initial prescription was for a free combination based on angiotensin converting enzyme inhibitors (median: 392.5 days), followed patients initially receiving a fixed combination, including angiotensin II receptor antagonists (208.5 days) and AIIRA monotherapy (168 days). Persistence was shortest with diuretics (57 days). Across all treatment groups, persistence after 3 years was 15.2%. Insurance status, sex and comorbidities were not found to impact persistence., Conclusion: Our data indicate that persistence differs markedly among the drug classes (p < or = 0.001) but that even persistence of the best drug class is not sufficient to provide for an adequate blood pressure control in the population. The largest decline in persistence occurred in the first 3 months of treatment. More research is needed to elucidate the causes of this early drop in persistence and to develop effective means of improving the currently unsatisfactory situation.

Objective: To examine the prescription of drugs in Germany prior to, during and after pregnancy., Methods: For the first time, prescription data of a large cohort of pregnant women, from a German statutory sickness fund, were available for scientific analysis. For each woman who gave birth between June 2000 and May 2001 reimbursed prescriptions for two periods (90 days each) before pregnancy, three during and two after delivery were considered. The drugs were classified according to the ATC code., Results: Of the 41,293 women, 96.4% received at least one drug during pregnancy. A median of 7 drugs per women was prescribed. Excluding vitamins, minerals, iodide and iron, 85.2% received at least one drug and the median was 3. Magnesium, which was seldom prescribed outside of pregnancy, was by far the most frequently prescribed substance (20% of all prescriptions, 61% of the women). Iron (54% of the women) and iodide (31%) were also prescribed often. The prescription rates of gynaecological antiinfectives (maximum in third trimester: 23% of the women), antacids (max. in third trim.: 11%), as well as antiemetics and antinauseants (max. in first trim.: 8%) during pregnancy considerably increased. A decrease was seen for analgesics, antiinflammatory and antirheumatic drugs, muscle relaxants, ophtalmologicals and anti-acne preparations, for example. Potential teratogenic drugs were prescribed to 1.3% of the women., Conclusion: This analysis of a large nation-wide cohort of pregnant women showed that during pregnancy drugs were prescribed to most women, even when vitamins, minerals, iodide and iron were omitted. Magnesium and iron seemed to have been over-prescribed. On the other hand, the official recommendation for iodide substitution, to prevent thyroid diseases in mother and child, was insufficiently implemented. In our opinion, regular analysis of prescription data can identify potential harmful therapies and focal points where guidelines are needed and can check their implementation.

INTRODUCTION. Nicotine replacement therapies (NRT) are effective for smoking cessation. After having received over-the-counter (OTC) status in Germany, concerns grew about effectiveness, increased risks, especially of adverse cardiovascular reactions, and inappropriate use of NRT. Thus, a pharmacy-based cohort study was launched. OBJECTIVES. To assess effectiveness, safety and appropriateness of use of an OTC nicotine patch (Nicotinell, Novartis Ltd.). Every customer who bought an OTC Nicotinell patch was eligible. All data were collected by self-administered questionnaires at weeks 2, 4, 8, 12 and 24 after inclusion. Six hundred and thirty-three customers were admitted, median duration of smoking was 19 years. Of the participants, 6% smoked up to 10 cigarettes per day, 43.6% between 11 and 20, 34.3% between 21 and 30, and 16.1% more than 30 cigarettes. Twenty-four weeks later, 351 participants replied: 28% (177 of 633) had quit smoking completely. Considering replies only the proportion of complete responders raised to 50.4%. There were no serious adverse events reported; 62.9% complied with the directions for use and did not use the patch for more than 3 months. About 45% smoked simultaneously with NRT. Pharmacy-based cohort studies are feasible. This study indicates that the nicotine patch is effective and safe in an OTC setting. There is still room to improve compliance with the directions for use.

Objective: To estimate incidence rates of drug-related hospitalizations (DRHs) in a longitudinal population-based study with prospective event assessment., Design: Cohort study and time-trend analysis., Setting: All departments of internal medicine and emergency departments in the urban regions of Jena and Rostock, Germany, serving about 520,000 residents., Participants: All patients admitted between October 1997 and March 2000. Patients with severe cutaneous reactions were excluded., Main Outcome Measures: Incidence of DRH was defined by symptoms or diagnoses at admission that were very likely, likely, or possibly caused by prescription medications, according to a standardized assessment., Results: The incidence of DRH was 9.4 admissions per 10,000 treated patients [95% confidence interval (CI) 9.0-9.9]. Rates were highest for antithrombotics with 26.9 admissions per 10,000 treated patients (95% CI 23.6, 30.1). Most frequent events were gastroduodenal lesions and bleeding (45%). Digitalis preparations showed a linearly increasing trend from 2/10,000 to 14/10,000 during ten quarters ( P<0.0001), which was exclusively attributable to digitoxin, the major source of digitalis in the study area (93%). The incidence of DRH increased with age (4/10,000 to 20/10,000). The mean length of stays in patients with DRH was 13+/-10.6 days. Cumulative direct costs for hospitalization were Euro 4 million in the two urban study areas. The annual direct costs for Germany were estimated to be Euro 400 million., Conclusions: DRHs are a considerable public health and economic burden. A longitudinal design can observe changes in population-based incidence over time. This approach can be used for public-health planning or to evaluate outcomes of quality management programs designed to reduce drug-induced illness.