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药物不良反应该由谁报告?

日期:2018-07-16 15:47:58 浏览次数: 字号:【 视力保护色:

 我国《药品不良反应监测管理办法》(试行)(以下简称"《办法》")规定"药品生产经营企业和医疗预防保健机构按规定报告所发现的药品不良反应"。《办法》明确规定了报告的单位,但未明确报告人。由于ADR报告的质量和报告人的药物知识和临床经验有关,因此,报告人通常为医师、药师,以及护师等卫生技术人员。至于患者是否可以报告ADR,各国规定不尽相同。按《办法》第二十条规定,个人发现药品引起的ADR可以报告。但英国ADR监测机构不直接收患者的ADR报告,而建议患者通过医师、药师填写黄卡上报,并对此作出说明如下:

We do not accept reports directly from patients , as we consider that medical interpretation of the suspected reaction is vital. We advise patients who suspect they have had an adverse reaction to their medicine to discuss this with their doctor or pharmacist. The doctor or pharmacist may then report this via the yellow card scheme, if they consider it to be appropriate.

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