The Medical School, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Drug Saf. 2013 Jul;36(7):557-64. doi: 10.1007/s40264-013-0057-3.
Direct Healthcare Professional Communications (DHPCs) aim to quickly disseminate information to key healthcare professionals to inform practice and minimize patient harm. The Medicines and Healthcare products Regulatory Agency (MHRA) issues warnings and alerts to communicate safety information effectively in the UK.
To investigate the impact of MHRA DHPCs on prescribing practice in the secondary-care setting, looking specifically at a drug-drug interaction-the concomitant use of clopidogrel and proton pump inhibitors (PPIs) [as omeprazole]-and a drug-disease contraindication-the use of conventional (typical) antipsychotics in dementia.
The effects of the MHRA DHPCs were analysed using segmented binary logistic regression of interrupted time series. This allowed for the detection of any significant changes in prescribing practice occurring after the MHRA warnings were issued, whilst controlling for the baseline period.
Of the patients concomitantly prescribed clopidogrel and omeprazole on admission, the rate at which omeprazole was substituted for either another PPI (with the exception of esomeprazole), or for a histamine H2-antagonist showed a significant step-change increase after the DHPC was issued. The modelled rate increased from 5.1 % in the month directly before the intervention to 25.1 % in the following month (odds ratio [OR] 6.18; p < 0.001). However, the action taken in the switching of therapy was not always consistent with the advice from the current MHRA warning. The rate of typical antipsychotic prescribing in patients with dementia was declining significantly by 3.9 % per quarter prior to the DHPC being issued (OR 0.970; p = 0.035). No significant step-change was detected immediately after the DHPC (p = 0.962). However, the rate of decline increased significantly in the post-warning period to 12.3 % per quarter (OR 0.938; p = 0.006).
This study has shown that DHPCs issued by the MHRA as warnings are associated with changes in prescribing practices in secondary care. However, their impact is variable depending on the intervention described by the warning. A national initiative to ensure patient safety information is effectively translated into practice and the effect of the warning continues beyond the period of the issue would be beneficial.
直接医疗保健专业人员沟通(DHPC)旨在迅速向关键医疗保健专业人员传播信息,以告知实践并最大限度地减少患者伤害。药品和医疗保健产品监管局(MHRA)在英国发布警告和警报,以有效传达安全信息。
调查 MHRA DHPC 对二级保健环境中处方实践的影响,特别关注药物-药物相互作用(同时使用氯吡格雷和质子泵抑制剂(PPIs)[如奥美拉唑])和药物-疾病禁忌(使用传统(典型)抗精神病药治疗痴呆症)。
使用分段二进制逻辑回归分析中断时间序列来分析 MHRA DHPC 的影响。这允许在发布 MHRA 警告后检测处方实践中发生的任何重大变化,同时控制基线期。
在入院时同时开氯吡格雷和奥美拉唑的患者中,奥美拉唑被替代为另一种 PPI(奥美拉唑除外)或组胺 H2 拮抗剂的比例显示出在 DHPC 发布后发生了显著的阶跃式增加。模型率从干预前一个月的 5.1%增加到下一个月的 25.1%(优势比[OR]6.18;p<0.001)。然而,治疗转换中采取的行动并不总是与当前 MHRA 警告中的建议一致。在发布 DHPC 之前,痴呆症患者的典型抗精神病药处方率每季度显著下降 3.9%(OR 0.970;p=0.035)。在发布 DHPC 后立即未检测到显著的阶跃变化(p=0.962)。然而,在发布后警告期内,下降速度显著加快至每季度 12.3%(OR 0.938;p=0.006)。
本研究表明,MHRA 发布的作为警告的 DHPC 与二级保健中处方实践的变化有关。然而,其影响因警告中描述的干预措施而异。一项旨在确保患者安全信息有效转化为实践并使警告的影响在发布期后继续的全国性倡议将是有益的。