Data from: Identification and prevalence of adverse drug events caused by potentially inappropriate medication in homebound elderly patients: a retrospective study using a nationwide survey in Japan

Objectives: A nationwide large-scale survey was conducted to identify the prevalence and causal medications of adverse drug events (ADEs) that are caused by potentially inappropriate medications (PIMs) given to homebound elderly patients, factors associated with ADEs, and measures taken by pharmacists to manage ADEs and their effects on ADEs. Settings: A questionnaire was mailed to 3321 pharmacies nationwide. It asked about the details of PIMs and ADEs of up to 5 patients for whom home visits were provided by a pharmacist. Questionnaire forms were filled in by pharmacists who visited the patients. Design and participants: Between 23 January and 13 February 2013, comprehensive assessment forms were sent to 3321 pharmacies. Data collected from 1890 pharmacies including data of 4815 patients were analysed and 28 patients of unknown sex were excluded. Their average age was 82.7 years. PIMs were identified based on the 2003 Beers Criteria Japan. Results: There were 600 patients who did not provide valid answers regarding the medications. In the remaining 4243 patients, one or more medications that were considered to be PIMs had been prescribed to 48.4% of patients. PIM-induced ADEs were found in 8% of these patients by pharmacists during home visits. The top ADE-inducing medications were strong anticholinergic antihistamines, benzodiazepines, sulpiride and digoxin. The most common ADEs associated with benzodiazepines were frequent lightheadedness, somnolence and sleepiness, which increase the risk of falls and subsequent fractures in elderly patients. The following factors associated with ADEs were identified: sex, pharmacist awareness of prescription issues, frequency of visits and time spent at patients’ homes, and the frequency of detailed checks for patient adverse reactions by pharmacists. Conclusions: The PIM prevalence associated with home healthcare in Japan was relatively high, as reported in previous studies. The present study suggests that pharmacists could reduce the incidence of PIMs and consequent ADEs.

研究目标：本研究通过开展全国性大规模调查，旨在明确居家老年患者使用潜在不适当用药（Potentially Inappropriate Medications, PIMs）引发的药品不良反应（Adverse Drug Events, ADEs）的患病率、致病药物，与药品不良反应相关的影响因素，以及药师应对药品不良反应的措施及其对不良反应的影响。

研究实施场景：向全国3321家药房邮寄问卷，内容涵盖药师上门巡诊的至多5名患者的潜在不适当用药与药品不良反应详情，问卷由为患者提供上门服务的药师填写。

研究设计与研究对象：2013年1月23日至2月13日期间，向3321家药房发放综合评估表。最终纳入1890家药房的4815名患者的数据进行分析，排除28名性别信息不明的患者，纳入患者的平均年龄为82.7岁。潜在不适当用药的判定依据2003年版日本比尔斯标准（2003 Beers Criteria Japan）。

研究结果：600名患者未提供有效的用药相关应答数据。在剩余的4243名患者中，48.4%的患者被开具了一种及以上潜在不适当用药。药师在上门巡诊期间发现，此类患者中有8%发生了潜在不适当用药引发的药品不良反应。引发药品不良反应的主要药物包括强效抗胆碱能抗组胺药、苯二氮䓬类、舒必利及地高辛。与苯二氮䓬类相关的最常见不良反应为频繁头晕、嗜睡及困倦，此类反应会升高老年患者跌倒及后续骨折的风险。本研究还明确了与药品不良反应相关的多项影响因素：患者性别、药师对处方问题的认知程度、上门巡诊频次与驻留时长，以及药师为患者详细排查不良反应的频次。

研究结论：如既往研究所示，日本居家医疗相关的潜在不适当用药患病率相对较高。本研究表明，药师可有效降低潜在不适当用药的发生率及其引发的药品不良反应。