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日本实施多种药物治疗减少政策后精神药物处方的变化:基于大规模索赔数据库的研究。

Changes in Prescription of Psychotropic Drugs After Introduction of Polypharmacy Reduction Policy in Japan Based on a Large-Scale Claims Database.

机构信息

Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.

Rare Disease Therapeutic Area Medical Affairs, Pfizer Pharmaceuticals K.K., Shibuya-ku, Tokyo, Japan.

出版信息

Clin Drug Investig. 2019 Nov;39(11):1077-1092. doi: 10.1007/s40261-019-00838-w.

Abstract

BACKGROUND AND OBJECTIVES

In Japan, polypharmacy reduction policy, which reduces the reimbursement of medical cost, was introduced to address unnecessary psychotropic polypharmacy. The rule was applied to the prescriptions of three or more anxiolytics or three or more hypnotics in the policy introduced in 2012. The prescriptions of four or more antidepressants or four or more antipsychotics were added to the rule in the policy revised in 2014. Furthermore, the prescriptions of three or more drugs of anxiolytics, hypnotics, antidepressants, or antipsychotics were subject to the reduction criteria of the policy revision in 2016. Benzodiazepine receptor agonists (BZs) are classified both into anxiolytics and hypnotics, and the reduction rule was not applied to the category of BZs before April 2018. This study aimed to examine the effect of the policy on the prescriptions of four drug categories as well as BZs from the point of view of the number of drugs and doses.

METHODS

This was a retrospective observational study using a large-scale Japanese health insurance claims database. Patients who were prescribed at least one psychotropic drug (anxiolytic, hypnotic, antidepressant, or antipsychotic) during the study period (from April 2011 to March 2017) were selected. Segmented regression analysis was used to analyze the proportions of patients with three or more or four or more drugs as well as patients above clinically recommended doses, and the means of the average daily doses by drug category.

RESULTS

A total of 312,167 patients were identified as a study population. The proportions of patients with three or more drugs in anxiolytics, hypnotics, antidepressants, and antipsychotics significantly decreased after the introduction or revisions of the policy, but not BZs. The proportions of patients with three or more drugs in March 2017 were 0.9%, 2.0%, 1.2%, 2.4%, and 8.9% in anxiolytics, hypnotics, antidepressants, antipsychotics, and BZs, respectively. The effect of the policy in reducing the proportions of patients above clinically recommended doses was identified in antipsychotics after the revision in 2016, but not identified in the sum of anxiolytics and hypnotics as well as BZs after the revision in 2014, and antidepressants after the revision in 2016. The proportions of monotherapy were increased from April 2011 to March 2017 only for antidepressants (76.9% → 80.8%) and antipsychotics (79.8% → 82.1%), and not changed or decreased for anxiolytics (85.2% → 85.7%), hypnotics (78.6% → 77.6%), sum of anxiolytics and hypnotics (68.1% → 65.7%), BZs (68.0% → 67.3%), and sum of psychotropic drugs (52.1% → 49.9%).

CONCLUSIONS

The polypharmacy reduction policy reduced the proportions of patients with three or more drugs in four drug categories, but not BZs. Only limited effects were seen for reducing the proportions of patients above clinically recommended doses. The policy was revised in April 2018 again. Further investigation is needed to examine the effect of the revision in 2018.

摘要

背景与目的

在日本,为了解决不必要的精神药物多药治疗问题,引入了减少医疗费用报销的多药治疗减少政策。该规则于 2012 年引入的政策中适用于三种或三种以上的抗焦虑药或三种或三种以上的催眠药处方。在 2014 年修订的政策中,增加了四种或四种以上的抗抑郁药或四种或四种以上的抗精神病药的处方。此外,在 2016 年修订的政策中,三种或三种以上的抗焦虑药、催眠药、抗抑郁药或抗精神病药的处方也适用该政策的减少标准。苯二氮䓬受体激动剂(BZs)既被归类为抗焦虑药又被归类为催眠药,在 2018 年 4 月之前,减少规则不适用于 BZ 类别。本研究旨在从药物种类和剂量的角度,研究该政策对四类药物以及 BZ 处方的影响。

方法

这是一项使用大型日本健康保险索赔数据库的回顾性观察研究。选择在研究期间(2011 年 4 月至 2017 年 3 月)至少开一种精神药物(抗焦虑药、催眠药、抗抑郁药或抗精神病药)的患者。采用分段回归分析分析三种或四种以上药物以及临床推荐剂量以上患者的比例,以及药物种类的平均日剂量均值。

结果

共确定 312167 名患者为研究人群。抗焦虑药、催眠药、抗抑郁药和抗精神病药中三种或三种以上药物的患者比例在该政策引入或修订后显著下降,但 BZ 类药物除外。2017 年 3 月,抗焦虑药、催眠药、抗抑郁药、抗精神病药和 BZ 类药物中三种或三种以上药物的患者比例分别为 0.9%、2.0%、1.2%、2.4%和 8.9%。在 2016 年修订后,抗精神病药中发现了减少推荐剂量以上患者比例的政策效果,但在 2014 年修订后,抗焦虑药和催眠药以及 BZ 类药物中未发现,在 2016 年修订后,抗抑郁药也未发现。从 2011 年 4 月至 2017 年 3 月,仅抗抑郁药(76.9%→80.8%)和抗精神病药(79.8%→82.1%)的单药治疗比例增加,抗焦虑药(85.2%→85.7%)、催眠药(78.6%→77.6%)、抗焦虑药和催眠药总和(68.1%→65.7%)、BZ(68.0%→67.3%)和精神药物总和(52.1%→49.9%)的比例没有变化或下降。

结论

多药治疗减少政策减少了四类药物中三种或三种以上药物的患者比例,但 BZ 类药物除外。对于减少推荐剂量以上患者的比例,只看到了有限的效果。该政策于 2018 年 4 月再次修订。需要进一步调查以检验 2018 年修订的效果。

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