Hallas J
Department of Clinical Pharmacology, University of Odense.
Dan Med Bull. 1996 Apr;43(2):141-55.
It is well established in the literature that adverse drug reactions (ADRs) and drug non-compliance contribute substantially to the admissions at medical wards. Some important questions, however, remain unanswered. The purpose of this thesis was to characterise the drug-related hospital admissions (DRH) and to assess the magnitude of the problem seen in relation to the demographic parameters and drug use of the background population. In addition, an attempt was made to reduce the DRH incidence by an intervention program. The scope of the study program was adverse drug reactions, intended self-poisoning, non-compliance, underdosing and interactions. The material included 1999 admissions to six departments of internal medicine at Odense University Hospital. The patients were reviewed prospectively, while they were still in the wards, but use of standardised criteria fOR assessment of drug-ADR causality. With inclusion of a definite, probable and possible causal relationship, ADRs and toxic reactions were found as an important factor in 8.4% of all admissions. The incidense of ADR related admissions was 400 per 100,000 per year for the background population as a whole, but showing a strong increase with age. The drug-specific ADR incidences were generally small compared to the drug sales figures. Non-compliance contributed to 2.0% of admissions with diuretics and anti-asthmatics as the drugs most frequently involved. Two departments were re-investigated after an intervention program, primarily targetting general practitioners. The over-all incidence of DRHs was unaffected by the intervention, but the subset classified as avoidable DRHs showed a significant decline. The case material was subject to a blinded evaluation by an external peer group using the same criteria as the investigators. There was no indication that the observed decline in avoidable DRHs should be explained by a shift in the investigators' assessment of cases. It was concluded that the intervention probably had a specific effect on avoidable DRHs. Admissions caused by adverse ractions to over-the-counter remedies, usually salicylates, were characterised by a particularly inappropriate use of drugs, suggesting that the public may also be a suitable target for interventions. In 1990 the author established the Odense PharmacoEpidemiologic Database (OPED), a research registry with person-identifiable data on computerised refund claims from Funen County. The registry was validated by a cohort study on the association of non-steroidal antiinflammatory drugs (NSAID) and admission for severe upper gastrointestinal bleeding (UGB). All 31,503 recorded NSAID users in Odense during a 19 month period and a control cohort were studied. For both cohorts we obtained data on admissions caused by UGB and other diagnosis- and prescription-data that would be relevant for confounder control. The standardised incidence ratio was 5.5, controlled for age, sex and previous peptic ulcer episodes. A multivariate analyse revealed a number of other risk factors, but no other important confounders. The standardised incidence of UGB was particularly high during the first month of NSAID therapy. The size of the data set permitted an estimate of excess risk within various patient categories. NSAID users over 75 years of age or with a previous peptic ulcer episode had particularly high excess risks. The utilization pattern of NSAIDs was surprisingly sporadic and appeared to favour a high UGB rate for a given sales volume. It is pointed out that individualised dispensing data may be an important tool in future endeavors to control DRH incidences. The data may be used for generating or confirming hypotheses on unknown and suspected ADRs, for studies on risk factors of ADRs, for characterising the population's drug utilization, for identifying objects for interventions and for monitoring the effect of interventions.
文献中已充分证实,药物不良反应(ADR)和药物不依从性是导致内科病房收治患者的重要因素。然而,一些重要问题仍未得到解答。本论文的目的是对与药物相关的住院情况(DRH)进行特征描述,并评估该问题在背景人群的人口统计学参数和药物使用方面的严重程度。此外,还尝试通过一项干预计划来降低DRH的发生率。研究计划的范围包括药物不良反应、故意自我中毒、不依从性、用药不足和药物相互作用。研究材料包括奥登塞大学医院六个内科科室1999年的住院病例。对患者进行前瞻性评估,当时他们仍在病房,但使用标准化标准评估药物与ADR之间的因果关系。若纳入明确、很可能和可能的因果关系,则在所有住院病例中,ADR和毒性反应是8.4%病例的重要因素。整个背景人群中,与ADR相关的住院发生率为每年每10万人中有400例,但随年龄增长显著增加。与药物销售数字相比,特定药物的ADR发生率通常较低。不依从性导致2.0%的住院病例,利尿剂和抗哮喘药是最常涉及的药物。在一项主要针对全科医生的干预计划实施后,对两个科室进行了重新调查。DRH的总体发生率未受干预影响,但归类为可避免的DRH子集显示出显著下降。外部同行小组使用与研究人员相同的标准对病例材料进行了盲法评估。没有迹象表明可避免的DRH的观察到的下降应归因于研究人员对病例评估的转变。得出的结论是,该干预可能对可避免的DRH有特定影响。由非处方药物(通常是水杨酸盐)的不良反应导致的住院病例,其药物使用特别不当,这表明公众也可能是干预的合适目标。1990年,作者建立了奥登塞药物流行病学数据库(OPED),这是一个研究登记处,包含来自菲英岛县计算机化报销申请中可识别个人身份的数据。该登记处通过一项关于非甾体抗炎药(NSAID)与严重上消化道出血(UGB)住院关联的队列研究进行了验证。研究了奥登塞在19个月期间记录的所有31503名NSAID使用者以及一个对照队列。对于两个队列,我们获取了由UGB导致的住院数据以及其他与混杂因素控制相关的诊断和处方数据。标准化发病率比为5.5,对年龄、性别和既往消化性溃疡发作情况进行了控制。多变量分析揭示了一些其他风险因素,但没有其他重要的混杂因素。NSAID治疗的第一个月内,UGB的标准化发病率特别高。数据集的规模允许估计不同患者类别中的额外风险。75岁以上或既往有消化性溃疡发作的NSAID使用者的额外风险特别高。NSAID的使用模式出人意料地零散,对于给定的销售量,似乎导致较高的UGB发生率。指出个体化配药数据可能是未来控制DRH发生率努力中的重要工具。这些数据可用于生成或证实关于未知和疑似ADR的假设、ADR风险因素的研究、描述人群的药物使用情况、识别干预对象以及监测干预效果。