Clinical pharmacy services in Germany: a national survey.

OBJECTIVES: Clinical pharmacy services in German hospitals appear to be underdeveloped compared with other European countries. However, recent developments have increased the interest in expanding these services. Detailed data about the current state of clinical pharmacy services in Germany are lacking. This survey establishes the current level of pharmacy services in Germany and the barriers to implementation. METHODS: An online survey conducted in 2017 was distributed to directors of all 389 German hospital pharmacies. The survey contained 26 questions addressing hospital and pharmacy characteristics, clinical pharmacy services provided, the number of clinical pharmacists and the frequency as well as the quality assurance of these services. RESULTS: There were 133 responses (34%). Of these, 84 (63%) pharmacies provided some form of clinical pharmacy services. Based on the 389 contacted pharmacies, a clinical pharmacy service is available in at least 22% of hospital pharmacies in Germany. On average there are 2.4 full-time equivalent (FTE) clinical pharmacists per hospital employed, although there is a wide variation in numbers (0.3-22 FTE) and service provision between hospitals. Clinical pharmacy services are generally provided on a daily or weekly basis, with a principal focus on general surgery, critical care and general medicine wards. CONCLUSIONS: This is the first survey providing a detailed picture of clinical pharmacy services in Germany. There is wide variation in clinical service provision among hospitals, with some hospitals having developed a comprehensive range of clinical services. Compared with other countries, particularly the UK where the focus has shifted to provision of 7-day clinical services, the gap in clinical pharmacy services remains large. The focus should be turned to refining clinical pharmacy services in hospital admissions and discharge planning while also improving Health IT, the opportunities for specialisation and aligning education in accordance with the EAHP common training framework.

Impact of safety warnings for fluoroquinolones on prescribing behaviour. Results of a cohort study with outpatient routine data.

PURPOSE: The need for drug-related safety warnings is undisputed, but their impact on prescribing behaviour is not always clear. Safety warnings usually do not contain therapeutic alternatives. Based on German outpatient routine healthcare data, our cohort study investigated the impact of three warnings for fluoroquinolones on prescribing behaviour. METHODS: Structural breaks were estimated in a time-series analysis (2005-2014) of 184,134 first antibiotic prescriptions for patients (≥ 18 years) diagnosed with community-acquired pneumonia (CAP), acute bacterial sinusitis (ABS), or acute exacerbation of chronic bronchitis (AECB). Subsequently, risk factors for patients' before/after safety warnings presented as risk ratios (RR) were estimated by Poisson regression. RESULTS: Following the 2008 warning for moxifloxacin, the RR of being prescribed moxifloxacin was reduced by 56% (95% CI 0.41-0.47; p < 0.001) for CAP, by 65% (95% CI 0.32-0.39; p < 0.001) for ABS, by 57% (95% CI 0.41-0.45; p < 0.001) for AECB. After the 2012 warning for levofloxacin, the RR of being prescribed levofloxacin was reduced by 31% (95% CI 0.64-0.74; p < 0.001) for CAP, by 14% (95% CI 0.77-0.96; p = 0.007) for ABS, by 27% (95% CI 0.69-0.77; p < 0.001) for AECB. We noticed a prescription-switch to other antibiotics which was not in line with the national guideline recommendations. The warning for moxifloxacin 2009 had no impact on prescribing behaviour. CONCLUSION: This study observed an impact on prescribing behaviour in response to regulatory safety warnings for two out of three warnings. Information on therapeutic alternatives should be a part of any safety warning to encourage the intended changes in prescribing behaviour.

Do drug-related safety warnings have the expected impact on drug therapy? A systematic review.

PURPOSE: The need for drug-related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety warnings on drug therapy. METHODS: Studies published in English between January 1998 and December 2018 were searched in EMBASE and MEDLINE, complemented by manual search. Randomised controlled trials, cohort studies with a before/after component, and case-control studies were included, selected to predefined criteria, and assessed for their reporting and methodological quality. RESULTS: Out of 7454 references identified, 72 studies were included. A total of 28/72 (39%) studies described the impact of safety warnings on drug therapy as being effective, whereas 12/72 (17%) studies did not. Further, 26/72 (36%) studies described a partial implementation of the warnings (one part of the warning had an impact on drug therapy and another did not). Unintended effects were investigated in 6/72 (8%) studies. While 34 (47%) studies examined safety warnings on psychotropic drugs using an interrupted time series (ITS) design (53%), a before/after (26%), and a time series design (21%), 38 (53%) studied other substances using an ITS design (34%), a before/after (40%), and a time series design (26%). The proportion of an effective impact on drug therapy was lower in the "psychotropic drugs" group (23%) than in the "others" group (53%). CONCLUSION: Drug-related safety warnings induce intended and unintended effects. The included studies are of broadly varying methodological quality. To better compare their effectiveness, studies should be conducted using standardised procedures.