Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, team PHARMACOEPIDEMIOLOGY, UMR 1219, 33000 Bordeaux, France.
Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, team PHARMACOEPIDEMIOLOGY, UMR 1219, 33000 Bordeaux, France; Clinical Pharmacology, University Hospital of Bordeaux, 33000 Bordeaux, France.
Therapie. 2019 Sep;74(4):469-476. doi: 10.1016/j.therap.2018.12.007. Epub 2018 Dec 30.
To provide a tool for drug misuse or potential misuse monitoring by using a healthcare insurance database.
A cross-sectional study repeated quarterly from 2007 to 2014 was conducted using data from a 1/97th random sample of the French national healthcare reimbursement system. For each drug studied, ad hoc indicators were designed to assess drug misuse, defined as prescriptions that did not comply with the label stipulated in the summary of product characteristics, in terms of the drug (e.g., interactions) or the patient (age, medical history). We focused on specifically identified situations of drug misuse involving non-steroidal anti-inflammatory drugs (NSAIDs), antiemetics in patients with Parkinson's disease and antipsychotics in pediatrics; we also focused on direct anticoagulants, asthma and oral antidiabetic drugs but results for these latter are only shown in supplementary materials.
At-risk prescribing of NSAIDs in patients treated by diuretics or renin-angiotensin system inhibitors always remained higher than 14% over the study (maximum: 19%; 2014 quarter 4: 15.4%). Off-label prescribing of contraindicated anti-dopaminergic antiemetics with dopaminergic antiparkinson drugs was marginal (maximum: 2.2%; 2014 quarter 4: 0.5%) but represented at least 5.5% of antiemetic prescriptions. Despite the rise in antipsychotic prescriptions in pediatrics, no dramatic increase in misuse related to age was observed during the study period (2007 quarter 1: 16.1%; 2014 quarter 4: 11.1%). The highest degree of misuse was observed for aripiprazole and for second-generation antipsychotics other than risperidone and aripiprazole.
This study provides a simple tool to monitor drug misuse or potential misuse using information from a health insurance database. The results highlight the need for the Regulator to rethink risk management information campaigns and to modify the official information on products.
利用医疗保险数据库提供一种药物滥用或潜在滥用监测工具。
这是一项从 2007 年至 2014 年每季度重复进行的横断面研究，使用了法国国家医疗报销系统中 1/97 随机样本的数据。对于研究的每种药物，设计了专门的指标来评估药物滥用，定义为不符合产品特性摘要中规定标签的处方，涉及药物（例如，相互作用）或患者（年龄、病史）。我们特别关注涉及非甾体抗炎药（NSAIDs）、帕金森病患者止吐药和儿科抗精神病药的药物滥用情况；我们还关注直接抗凝剂、哮喘和口服抗糖尿病药物，但后者的结果仅在补充材料中显示。
在接受利尿剂或肾素-血管紧张素系统抑制剂治疗的患者中，NSAIDs 的风险处方率始终高于研究期间的 14%（最高：19%；2014 年第 4 季度：15.4%）。与多巴胺能抗帕金森药物联合使用禁忌的抗多巴胺能止吐药的标签外用药非常少见（最高：2.2%；2014 年第 4 季度：0.5%），但至少占止吐药处方的 5.5%。尽管儿科抗精神病药物的处方有所增加，但在研究期间并未观察到与年龄相关的滥用急剧增加（2007 年第 1 季度：16.1%；2014 年第 4 季度：11.1%）。阿立哌唑和利培酮及阿立哌唑以外的第二代抗精神病药物的滥用程度最高。
本研究提供了一种使用医疗保险数据库信息监测药物滥用或潜在滥用的简单工具。研究结果强调了监管机构需要重新思考风险管理信息宣传活动，并修改产品的官方信息。
