Compliance of Disease Awareness Campaigns in Printed Dutch Media with National and International Regulatory Guidelines
Compliance of Disease Awareness Campaigns in Printed Dutch Media with National and International Regulatory Guidelines
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DOI：
10.1371/journal.pone.0106599
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发表时间：
2014-09-08
期刊：
影响因子：
3.7
通讯作者：
Mantel-Teeuwisse, Aukje K.
中科院分区：
文献类型：
--
作者：
Alves, Teresa Leonardo;de Freitas, Auramarina F. Martins;Mantel-Teeuwisse, Aukje K.
背景：欧洲立法禁止处方药的广告，但允许制药公司向公众提供有关健康和疾病的信息，前提是没有直接或间接提到药品。目的：通过评估荷兰制药公司对世界卫生组织(WHO)药品推广伦理标准和荷兰制药公司提供信息指南的遵守情况，探索荷兰制药公司开展疾病宣传活动的实例。方法：收集2012年3月至5月在发行量最大的报纸和杂志上发表的涉及健康/疾病和治疗的材料。根据世卫组织道德标准和荷兰自律准则中的相关基本原则，开发了一个评价工具。收集到的疾病宣传广告被用来试验评估工具，并探索提供的信息与世卫组织和荷兰标准的一致性。结果：80份材料符合我们的纳入标准；71份材料发表在报纸上，9份材料发表在杂志上。绝大多数是新闻，但21个是疾病宣传广告，其中5个是重复的。在16个疾病宣传活动中，有15个不符合现行指南，主要原因是不平衡(n=12)、没有列出作者和/或赞助者(n=8)、使用误导性或不完整的信息(n=5)以及使用宣传信息(n=5)。没有人直接提到药品。结论：荷兰印刷媒体上存在提高疾病意识的活动。虽然没有提到品牌名称，但疾病宣传活动缺乏对当前法规的遵守令人震惊。存在信息缺失和信息偏差的证据。一个关键问题是，主要通过间接转介提供信息的背景可能支持使用赞助商的产品进行治疗。
Background: The European legislation prohibits prescription-only medicines' advertising but allows pharmaceutical companies to provide information to the public on health and diseases, provided there is no direct or indirect reference to a pharmaceutical product. Various forms of promotion have become increasingly common in Europe including "disease-oriented'' campaigns.Objectives: To explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by assessing their compliance with the World Health Organization (WHO) Ethical Criteria for medicinal drug promotion and the Dutch guidelines for provision of information by pharmaceutical companies.Methods: Materials referring to health/disease and treatments published in the most widely circulated newspapers and magazines were collected from March to May 2012. An evaluation tool was developed based on relevant underlying principles from the WHO ethical criteria and Dutch self-regulation guidelines. Collected disease awareness advertisements were used to pilot the evaluation tool and to explore the consistency of information provided with the WHO and Dutch criteria.Findings: Eighty materials met our inclusion criteria; 71 were published in newspapers and 9 in magazines. The large majority were news items but 21 were disease awareness advertisements, of which 5 were duplicates. Fifteen out of the 16 disease awareness campaigns were non-compliant with current guidelines mainly due to lack of balance (n = 12), absence of listed author and/or sponsor (n = 8), use of misleading or incomplete information (n = 5) and use of promotional information (n = 5). None mentioned a pharmaceutical product directly.Conclusion: Disease Awareness Campaigns are present in Dutch printed media. Although no brand names were mentioned, the lack of compliance of disease awareness campaigns with the current regulations is alarming. There were information deficiencies and evidence of information bias. A key concern is that the context in which the information is provided, mostly through indirect referral, is likely to support treatment with the sponsor's product.