重点监控药品政策对样本地区质子泵抑制剂使用的影响研究

目的:探究安徽省、四川省重点监控药品政策对样本医院质子泵抑制剂(PPI)使用的影响,为减少质子泵抑制剂滥用现象、促进质子泵抑制剂合理使用、完善与推进重点监控药品管理政策提供依据。方法:以全国各省份监控目录形成的重点监控药品库为基础,结合安徽省、四川省的重点监控药品目录,综合考虑药品典型性及临床替代品等因素,遴选出安徽省奥美拉唑被监控品种(商品名)作为样本药品,奥美拉唑未被监控品种及4种PPI(通用名)作为对照药品,另外四川省纳入5种PPI(通用名)作为研究对象,进一步提取安徽省3家三级医院2014年11月至2017年9月的月度数据、四川省成都市9家三级医院2014年一季度至2017年一季度的季度数据。研究通过有对照的间断时间序列(interrupted time series,ITS)模型,分析样本药品及对照药品用量与金额的变化。结果:(1)安徽省、四川省实施重点监控政策后,除四川省埃索美拉唑使用下降趋势不显著外,被纳入监控目录的PPI品种的用量、金额均出现显著下降(P值均小于0.05);(2)安徽实施重点监控政策后,奥美拉唑未被监控品种(商品名)使用显著上升,所有奥美拉唑(通用名)使用显著下降(P值均小于0.05)。(3)安徽省将奥美拉唑纳入监控目录后,其他PPI品种(通用名)的使用显著下降,PPI类药品的整体使用受到有效限制(P值均小于0.05)。结论:安徽省重点监控药品政策有效限制了奥美拉唑的使用,同时使PPI类药品的整体使用显著下降。四川省重点监控药品政策使纳入监控目录的5种PPI整体的使用受到有效限制,政策效果显著。

Influence of key monitoring drugs policy on the change of proton pump inhibitors in sample areas

OBJECTIVE:To examine the influence of key monitoring drugs policy in Anhui Province and Sichuan Province on the change of proton pump inhibitors for reducing its abuse, promote its rational use and provide a basis for policy formulation.METHODS Based on the key monitoring drug libraries formed in the monitoring catalogs of all the provinces, combining the key monitoring drug catalogs in Anhui Province and Sichuan Province, taking into account factors such as the typicality of the drugs and clinical alternatives, the study selected omeprazole monitored species (brand name) in Anhui Province as a sample drug, omeprazole unmonitored species and four kinds of PPI (generic name) as reference drugs. In addition, Sichuan Province included five kinds of PPI (generic name) as the research objects. The study extracted monthly data from 3 hospitals in Anhui Province from November 2014 to September 2017 and quarterly data from 9 hospitals in Chengdu, Sichuan Province in the first quarter of 2014 to the first quarter of 2017. Interrupted time series (ITS) model was used to analyze the changes of dosage and amount of sample drugs and reference drugs.RESULTS After the implementation of the key monitoring drugs policy in Anhui and Sichuan provinces, except for the downward trend in the use of esomeprazole in Sichuan Province was not significant, the dosage and amount of PPI included in the monitoring catalogs decreased significantly (P ≤ 0.05). After the implementation of the key monitoring drugs policy in Anhui, the dosage and amount of omeprazole unmonitored species (brand name) significantly increased, and the dosage and amount of all omeprazole (generic name) decreased significantly (P ≤ 0.05). After the inclusion of omeprazole in the monitoring catalog in Anhui Province, the dosage and amount of other PPI (generic name) decreased significantly, and the overall use of PPI was effectively limited (P ≤ 0.05).CONCLUSION The key monitoring drugs policy in Anhui Province effectively limits the use of omeprazole, and make the overall use of PPI dropping significantly. The key monitoring drugs policy in Sichuan Province effectively restricts the overall use of the five PPIs included in the monitoring catalog, and the policy has achieved remarkable results.