Abstract
PurposeThe 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.MethodsStructural 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.ResultsFollowing 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.ConclusionThis 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.
Highlights
Written safety warnings on human drugs addressed to health care professionals intend to minimise the risk of drug therapy
We report results of a cohort study to investigate if the Dear Doctor Letters on moxifloxacin (02/2008, 01/2009) and levofloxacin (09/2012) led to an impact on prescribing behaviour in adult outpatients in the federal state of Saxony
The study was to answer the following questions: (1) Has the number of first prescriptions of moxifloxacin and levofloxacin for community-acquired pneumonia (CAP), acute bacterial sinusitis (ABS) and acute exacerbation of chronic bronchitis (AECB) been reduced in accordance with the Dear Doctor Letters? (2) Was there a prescription-switch to other antibiotics? Secondarily, we investigated the influence of the additional diagnoses of an arrhythmia or a pre-existing allergy on the prescribing behaviour
Summary
Written safety warnings on human drugs addressed to health care professionals (e.g., physicians and pharmacists) intend to minimise the risk of drug therapy. In Europe, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is responsible for initiating risk assessment procedures and recommends pertinent safety information for human drugs [5]. The EMA closely cooperates with the national competent authorities, e.g., in Germany with the Federal Institute for Drugs and Medical Devices (BfArM). German pharmaceutical companies are legally obliged to make therapy-relevant changes available to healthcare professionals.
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