van der Hooft Cornelis S, Sturkenboom Miriam C J M, van Grootheest Kees, Kingma Herre J, Stricker Bruno H Ch
Pharmaco-epidemiology Unit, Department of Epidemiology & Biostatistics, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Drug Saf. 2006;29(2):161-8. doi: 10.2165/00002018-200629020-00006.
The incidence of adverse drug reaction (ADR)-related hospitalisations has usually been assessed within hospitals. Because of the variability in results and methodology, it is difficult to extrapolate these results to a national level.
To evaluate the incidence and characteristics of ADR-related hospitalisations in The Netherlands in 2001.
We conducted a nationwide study of all hospital admissions in 2001. Data were retrieved from a nationwide computer database for hospital discharge records. All acute, non-planned admissions to all Dutch academic and general hospitals in 2001 were included in the study (n = 668 714). From these admissions we selected all hospitalisations that were coded as drug-related, but intended forms of overdose, errors in administration and therapeutic failures were excluded. Hence, we extracted all ADR-related hospitalisations. We compared age, sex and the risk of a fatal outcome between patients admitted with ADRs and patients admitted for other reasons, as well as the most frequent main diagnoses in ADR-related hospitalisations and which drugs most frequently caused the ADRs. In addition, we evaluated to what extent these ADRs were reported to the Netherlands Pharmacovigilance Centre Lareb for spontaneous ADR reporting.
In 2001, 12 249 hospitalisations were coded as ADR related. This was 1.83% of all acute hospital admissions in The Netherlands (95% CI 1.80, 1.86). The proportion increased with age from 0.8% (95% CI 0.75, 0.85) in the <18 years group to 3.2% in the >/=80 years group (95% CI 3.08, 3.32). The most frequent ADR-related diagnoses of hospitalisations were bleeding (n = 1048), non-specified 'unintended effect of drug' (n = 438), hypoglycaemia (n = 375) and fever (n = 347). The drugs most commonly associated with ADR-related hospitalisations were anticoagulants (n = 2185), cytostatics and immunosuppressives (n = 1809) and diuretics (n = 979). Six percent of the ADR-related hospitalisations had a fatal outcome (n = 734). Older age and female gender were associated with ADR-related hospitalisations. Only approximately 1% of the coded ADRs causing hospitalisation were reported to our national centre for spontaneous ADR reporting.
The proportion of ADR-related hospitalisations is substantial, especially considering the fact that not all ADRs may be recognised or mentioned in discharge letters. Under-reporting of ADRs that result in hospital admission to our national centre for spontaneous ADR reporting was considerable.
药物不良反应（ADR）相关住院率通常在医院内部进行评估。由于结果和方法存在差异，很难将这些结果外推至全国范围。
评估2001年荷兰ADR相关住院的发生率及特征。
我们对2001年所有医院入院情况进行了一项全国性研究。数据从全国医院出院记录计算机数据库中获取。2001年荷兰所有学术医院和综合医院的所有急性、非计划性入院病例均纳入研究（n = 668714）。从这些入院病例中，我们选取了所有编码为与药物相关的住院病例，但排除了故意过量用药、给药错误和治疗失败等情况。因此，我们提取了所有与ADR相关的住院病例。我们比较了因ADR入院患者与因其他原因入院患者的年龄、性别及死亡风险，以及ADR相关住院中最常见的主要诊断和最常导致ADR的药物。此外，我们评估了这些ADR向荷兰药物警戒中心Lareb报告以进行自发ADR报告的程度。
2001年，12249例住院病例被编码为与ADR相关。这占荷兰所有急性住院病例的1.83%（95%可信区间1.80，1.86）。该比例随年龄增长而增加，从＜18岁组的0.8%（95%可信区间0.75，0.85）增至≥80岁组的3.2%（95%可信区间3.08，3.32）。与ADR相关的住院最常见诊断为出血（n = 1048）、未明确的“药物意外效应”（n = 438）、低血糖（n = 375）和发热（n = 347）。与ADR相关住院最常相关的药物为抗凝剂（n = 2185）、细胞毒性药物和免疫抑制剂（n = 1809）以及利尿剂（n = 979）。6%的ADR相关住院病例有致命结局（n = 734）。年龄较大和女性与ADR相关住院有关。导致住院的编码ADR中，只有约1%向我们国家的自发ADR报告中心报告。
ADR相关住院比例相当大，特别是考虑到并非所有ADR在出院小结中都可能被识别或提及这一事实。导致入院的ADR向我们国家的自发ADR报告中心报告的比例很低。
