我国部分省份医疗美容机构药物警戒现状调查研究
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作者简介:

郜娅娜(1982.4-),女,甘肃静宁县人,本科,工程师,主要从事药物警戒工作

通讯作者:

方壬德(1991.8-),男,广东揭阳人,本科,主管药师,主要从事药物研发与药物警戒工作

中图分类号:

R622

基金项目:

广东省药理学会医疗美容机构PV现状调查及构建PV体系研究项目基金(编号:GDPHARS-X20210011)


Investigation on the Current Status of Pharmacovigilance in Medical Aesthetic Institutions in Some Provinces of China
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    摘要:

    目的 调研我国部分省份医疗美容机构药物警戒现状,分析当前存在的问题并提出针对性改进建议。方法 研究时间为2024年1月-6月,采用多阶段非概率便利抽样法,选取537家医疗美容机构(占全国总数10736家的5%)作为研究对象,对各机构管理人员及医护人员开展问卷调查,调查内容涵盖药物警戒组织机构、人员培训、设备资源、不良反应(ADR)报告提交、制度规程及ADR发生情况等。结果 共回收有效问卷653份,有效回收率为100.00%。仅40.00%的机构设立药物警戒专职部门,77.29%的机构未配备药物警戒相关负责人;77.30%的机构未使用《国家药品不良反应监测系统》上报ADR;仅38.92%的机构制定安全突发事件应急预案,39.46%的机构明确ADR上报流程,16.76%的机构未建立药物警戒监测制度;仅49.19%的医护人员参与过药物警戒相关培训,60.50%的医护人员不熟悉ADR上报流程,34.60%的医护人员自认ADR判断能力不足。ADR发生类型以皮肤及皮下组织类疾病为主(占88.17%),70.81%的机构认为患者对ADR认知不足是药物警戒工作的主要难点。结论 我国部分省份医疗美容机构药物警戒体系建设不完善,存在专职部门缺失、ADR上报机制不健全等问题,医护人员药物警戒认知水平与执行能力存在明显短板,需针对性完善相关措施以提升医美机构药物警戒管理水平。

    Abstract:

    Objective To investigate the current status of pharmacovigilance in medical aesthetic institutions in some provinces of China, analyze existing problems and put forward targeted improvement suggestions. Methods The study was conducted from January to June 2024. A multi-stage non-probability convenience sampling method was used to select 537 medical aesthetic institutions (accounting for 5% of the national total of 10 736) as the research subjects. Questionnaire surveys were administered to the management personnel and medical staff of these institutions, covering the organizational structure of pharmacovigilance, personnel training, equipment and resources, adverse drug reaction (ADR) report submission, institutional regulations and procedures, as well as the occurrence of ADRs. Results A total of 653 valid questionnaires were collected, with an effective recovery rate of 100.00%. Only 40.00% of institutions set up full-time departments for pharmacovigilance, and 77.29% had no designated person in charge of pharmacovigilance. 77.30% of institutions did not report ADRs through the National Adverse Drug Reaction Monitoring System. Only 38.92% formulated emergency plans for safety emergencies, 39.46% clarified ADR reporting procedures, and 16.76% had not established a pharmacovigilance monitoring system. Only 49.19% of medical staff hadparticipated in pharmacovigilance-related training, 60.50% were unfamiliar with ADR reporting procedures, and 34.60% considered themselves insufficient in ADR judgment ability. The most common type of ADR was skin and subcutaneous tissue diseases (88.17%), and 70.81% of institutions regarded patients’ insufffcient awareness of ADRs as the main difffculty in pharmacovigilance work. Conclusion The construction of pharmacovigilance system in medical aesthetic institutions in some provinces of China is imperfect, with problems such as lack of full-time departments and incomplete ADR reporting mechanisms. Medical staff have obvious shortcomings in pharmacovigilance awareness and implementation capacity. Targeted measures should be improved to enhance the level of pharmacovigilance management in medical aesthetic institutions.

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郜娅娜 ,李家兆 ,朱衍志 ,等.我国部分省份医疗美容机构药物警戒现状调查研究[J].医学美学美容,2026,35(5):164-168.

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  • 在线发布日期: 2026-04-09
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