Kring-apotheek BV, Den Bosch, the Netherlands.
Drug Saf. 2009;32(12):1189-97. doi: 10.2165/11316700-000000000-00000.
Patient safety and the life cycle of a drug are negatively influenced by the still increasing occurrence of potential drug-drug interactions (DDIs). Clinical risk management of potential DDIs is required in patients using drugs to influence the benefit-risk profile positively. Information about laboratory test results, in particular, may be useful in the assessment of potential DDIs for the individual patient.
The objective of this study was to examine the frequency and nature of laboratory tests required for the assessment of the clinical relevance of potential DDIs in Dutch community pharmacies. In addition, the nature and clinical relevance of these potential DDIs is analysed.
All patients from 100 Dutch community pharmacies using, according to dispensing information, two or more drugs concomitantly on a specified date (Wednesday, 4 April 2007), were included (n = 223,019). The anonymous dispensing data of the included patients were analysed against a list of DDIs requiring laboratory tests for the assessment of their clinical relevance. The number of patients at risk for these potential DDIs with severe adverse reactions was calculated. The frequency of potential DDIs requiring laboratory tests were stratified by age, sex and degree of polypharmacy.
Of the included patients, 24.4% had one or more potential DDIs (n = 54,427). In 9.0% of the included patients, one or more laboratory tests for the assessment of clinical relevance of the potential DDI were required (n = 19,968). The frequency of DDIs requiring laboratory tests increased with increasing age and number of drugs, but was not related to sex. The most commonly required laboratory tests were for renal function (42.2%), electrolytes (20.1%) and coagulation (13.1%). The percentage of patients at risk for potential DDIs requiring laboratory tests with adverse reaction category F (serious, irrecoverable disablement or death) was 2.5%; category E (increased risk of failure of life-saving therapy) was 0.6%; and category D (inconvenience with residual symptom and failure of therapy concerning serious but non-fatal diseases) was 3.8%.
A large number of patients in Dutch community pharmacies are at risk for potential DDIs requiring laboratory tests for the assessment of the clinical relevance of the interaction. There is a strong relationship between the frequency of DDIs requiring laboratory tests and age and the number of drugs concomitantly used. In the clinical risk management of potential DDIs, information about laboratory test results is of additional value. Future research is necessary in order to obtain more evidence on using laboratory tests in terms of which tests should be linked to pharmacy data, in which patients they should be done, how often and what actions should be taken when an abnormal value is found.
患者安全和药物的生命周期受到潜在药物-药物相互作用(DDI)发生率不断增加的负面影响。在使用药物的患者中,需要进行临床风险管理以积极影响潜在 DDI 的获益-风险特征。关于实验室检测结果的信息,特别是在评估个体患者的潜在 DDI 方面可能有用。
本研究旨在评估荷兰社区药房中评估潜在 DDI 的临床相关性所需实验室检测的频率和性质。此外,还分析了这些潜在 DDI 的性质和临床相关性。
根据配药信息,选择 2007 年 4 月 4 日星期三同时使用两种或两种以上药物的 100 家荷兰社区药房的所有患者纳入研究(n=223019)。对纳入患者的匿名配药数据进行分析,以评估潜在 DDI 的临床相关性,列出需要进行实验室检测的 DDI。计算发生这些潜在 DDI 并伴有严重不良反应的患者人数。按年龄、性别和药物使用种类分层分析需要进行实验室检测的潜在 DDI 频率。
在所纳入的患者中,24.4%(n=54427)有一个或多个潜在 DDI。在纳入的患者中,9.0%(n=19968)需要进行一项或多项实验室检测以评估潜在 DDI 的临床相关性。需要进行实验室检测的 DDI 频率随年龄和药物使用种类的增加而增加,但与性别无关。最常需要的实验室检测是肾功能(42.2%)、电解质(20.1%)和凝血功能(13.1%)。需要进行实验室检测的潜在 DDI 并伴有不良反应类别 F(严重、不可逆转的残疾或死亡)的患者比例为 2.5%;类别 E(增加生命挽救治疗失败的风险)为 0.6%;类别 D(存在严重但非致命疾病的治疗不适和失败的残余症状)为 3.8%。
荷兰社区药房中有大量患者存在需要进行实验室检测以评估潜在 DDI 临床相关性的风险。需要进行实验室检测的 DDI 频率与年龄和同时使用的药物种类之间存在很强的关系。在潜在 DDI 的临床风险管理中,实验室检测结果的信息具有附加价值。需要进一步研究,以获得关于实验室检测的更多证据,包括哪些检测应与药房数据相关联、应在哪些患者中进行、应多久进行一次以及发现异常值时应采取哪些措施。