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传达药物警报。荷兰阿维A的案例研究。

Communicating a drug alert. A case study on acitretin in The Netherlands.

作者信息

Sturkenboom M C, de Jong-van den Berg L T, Cornel M C, Stricker B H, Wesseling H

机构信息

Department of Pharmaceutical Pharmacology and Clinical Pharmacy, University of Groningen, The Netherlands.

出版信息

Eur J Clin Pharmacol. 1994;47(2):125-32. doi: 10.1007/BF00194961.

Abstract

In October 1990, a recall procedure was initiated for the teratogenic drug acitretin, and the recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years due to the possibility of its conversion to the lipophilic compound etretinate. The aim of the present study was to evaluate the communication procedures and their effects as a drug alert from the health authorities, the pharmaceutical company and professional associations of health professionals to the population at risk. A model was used to evaluate communication between three hierarchical levels. Data were obtained via semi-structured interviews and structured questionnaires. Communication procedures were evaluated according to channel characteristics and by analysis of their contents. The effect was measured as whether the drug dispensers identified acitretin users, contacted physicians, and whether physicians communicated in person with the population at risk. The penetration of direct mail from the health authorities and from the pharmaceutical company ranged from 97-98% and 65-94% at Level 2 (health professionals). The population at risk was informed via personal communication with health professionals, and/or the mass media. Of the women at risk, 19% were contacted by a dermatologist, 30% by their GP, and 39% by the pharmacist. 35% was never informed by any health professional. The Dutch health care system is adequately equipped for effective communication between health authorities, pharmaceutical industry and health professionals.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

1990年10月,启动了对致畸药物阿维A的召回程序,由于阿维A有可能转化为亲脂性化合物依曲替酯,其治疗后推荐的避孕期从2个月延长至2年。本研究的目的是评估从卫生当局、制药公司以及卫生专业人员专业协会向高危人群发出药物警示的沟通程序及其效果。采用一个模型来评估三个层级之间的沟通情况。通过半结构化访谈和结构化问卷获取数据。根据渠道特征并通过分析其内容来评估沟通程序。以药剂师是否识别出阿维A使用者、联系医生以及医生是否亲自与高危人群沟通来衡量效果。在二级层面(卫生专业人员),卫生当局和制药公司直邮的渗透率分别为97 - 98%和65 - 94%。通过与卫生专业人员的个人沟通和/或大众媒体向高危人群传达信息。在高危女性中,19%被皮肤科医生联系过,30%被全科医生联系过,39%被药剂师联系过。35%从未被任何卫生专业人员告知过。荷兰医疗保健系统具备卫生当局、制药行业和卫生专业人员之间进行有效沟通的充分条件。(摘要截选于250词)

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