Pharmacy Service of Clinical Center, Flemmingstrasse 2, 09116, Chemnitz, Germany.
Center for Evidence-Based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
Infection. 2021 Jun;49(3):447-455. doi: 10.1007/s15010-020-01549-7. Epub 2020 Nov 30.
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.
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.
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.
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.
药物相关安全性警告的必要性是毋庸置疑的，但它们对处方行为的影响并不总是明确的。安全性警告通常不包含治疗替代方案。基于德国门诊常规医疗保健数据，我们的队列研究调查了三种氟喹诺酮类药物的安全性警告对处方行为的影响。
在对 184134 名（≥18 岁）社区获得性肺炎（CAP）、急性细菌性鼻窦炎（ABS）或慢性支气管炎急性加重（AECB）患者的抗生素首诊处方进行时间序列分析（2005-2014 年）中，估计了结构断裂。随后，通过泊松回归估计了患者安全性警告前后的风险因素，表现为风险比（RR）。
在 2008 年莫西沙星警告之后，CAP 的莫西沙星处方 RR 降低了 56%（95%CI 0.41-0.47；p<0.001），ABS 降低了 65%（95%CI 0.32-0.39；p<0.001），AECB 降低了 57%（95%CI 0.41-0.45；p<0.001）。在 2012 年左氧氟沙星警告之后，CAP 的左氧氟沙星处方 RR 降低了 31%（95%CI 0.64-0.74；p<0.001），ABS 降低了 14%（95%CI 0.77-0.96；p=0.007），AECB 降低了 27%（95%CI 0.69-0.77；p<0.001）。我们注意到一种与国家指南建议不符的抗生素处方转换。2009 年的莫西沙星警告对处方行为没有影响。
本研究观察到，针对三项警告中的两项，监管安全性警告对处方行为产生了影响。关于治疗替代方案的信息应成为任何安全性警告的一部分，以鼓励预期的处方行为改变。
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