IQ Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
Drug Saf. 2012 Mar 1;35(3):245-59. doi: 10.2165/11596000-000000000-00000.
Two Dutch observational studies (HARM [Hospital Admissions Related to Medication] and IPCI [Integrated Primary Care Information]) have shown that approximately 5% of all unplanned hospital admissions are associated with adverse drug events (ADEs), of which 40-46% are potentially preventable. These studies prompted the initiation of a Dutch multidisciplinary task force, which was assigned to reduce the number of prescriber-related hospital admissions related to medications (HARMs) in a quick-win way.
The aim of the study was to identify the most relevant ADEs and to develop a limited number of recommendations for concrete interventions, which should be feasible and relatively easy to convert into computerized drug safety alerts.
To identify the major ADEs, crude data of HARM and IPCI were reanalysed and compared with different international studies, followed by structured literature searches for further characterization of the identified ADEs, their risk factors and potential risk-reduction strategies. Based on this information, the Task Force drew up general and drug-specific recommendations. As the recommendations of the Task Force are a mixture of evidence- and expert-based risk-reducing strategies, they have been graded in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology.
Seven pharmacologically predictable ADEs associated with ten drug classes were responsible for more than half of all potentially preventable hospital admissions in the IPCI and HARM studies, which was comparable to the results of international studies. Gastrointestinal and other bleedings were the most frequent ADE, followed by disturbances of diabetes mellitus control, electrolyte disturbances, fractures, renal insufficiency and heart failure. Nine general and 34 drug-specific recommendations were developed.
As HARMs constitute a significant public health problem, the Task Force underlines the need to implement its recommendations as soon as possible. They do not replace existing guidelines, but reinforce, complement and fine-tune existing Dutch and international guidelines. Further research is still required to assess the cost consequences and cost effectiveness of some recommendations, and to monitor the implementation of the recommendations and their effect on the incidence of potentially preventable HARMs.
两项荷兰观察性研究（HARM [与药物相关的住院] 和 IPCI [综合初级保健信息]）表明，约有 5%的所有非计划性住院与药物不良事件（ADE）相关，其中 40-46%是可以预防的。这些研究促使荷兰多学科工作组启动，其任务是尽快减少与药物相关的医嘱相关的住院人数（HARMs）。
本研究旨在确定最相关的 ADE，并制定数量有限的具体干预建议，这些建议应具有可行性且相对容易转化为计算机化的药物安全警报。
为了确定主要的 ADE，对 HARM 和 IPCI 的原始数据进行了重新分析，并与不同的国际研究进行了比较，然后对确定的 ADE 进行了结构化文献搜索，以进一步描述其特征、风险因素和潜在的风险降低策略。基于这些信息，工作组制定了一般和药物特异性建议。由于工作组的建议是基于证据和专家的风险降低策略的混合物，因此根据 GRADE（推荐评估、制定和评估）方法对其进行了分级。
IPC 和 HARM 研究中，七种与十种药物类别相关的可预测药理学 ADE 导致超过一半的可预防住院与药物相关，这与国际研究结果相似。胃肠道和其他出血是最常见的 ADE，其次是糖尿病控制紊乱、电解质紊乱、骨折、肾功能不全和心力衰竭。制定了九条一般建议和三十四条药物特异性建议。
由于 HARMs 构成了一个重大的公共卫生问题，工作组强调需要尽快实施其建议。它们不是替代现有的指南，而是加强、补充和微调现有的荷兰和国际指南。仍需要进一步研究来评估一些建议的成本后果和成本效益，并监测建议的实施情况及其对可预防的 HARMs 发生率的影响。
