Gahalaut Pratik, Chauhan Sandhya, Mishra Nitin, Rastogi Madhurkant, Thakur Richa
Department of Dermatology, Shri Ram Murti Smarak Institute of Medical Sciences, Bareilly, Uttar Pradesh, India.
Indian J Dermatol Venereol Leprol. 2014 Mar-Apr;80(2):115-21. doi: 10.4103/0378-6323.129381.
Though drug promotion regulations exist worldwide, low quality of journal drug advertising is a global issue. Medical journals are regarded as a leading source of information for new drugs. They may also modulate prescribing behavior of physicians without their knowledge. A comparative analysis of advertisements from different countries may provide insights regarding strengths and weaknesses of different regulating systems.
Prescription drug advertisements from the Indian Journal of Dermatology, Venereology, and Leprology (IJDVL) and Journal of American Academy of Dermatology (JAAD) were compared to check their compliance with criteria of World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
All the prescription drug advertisements of at least one page length appearing in all the issues of IJDVL and JAAD from January 2012 till December 2012 were included in this study. The contents of both advertisements were compared for compliance regarding different criteria of ethical codes for drug advertising of WHO and IFPMA. Statistical analysis was done using Fisher's exact test.
Compared to IJDVL, more advertisements in JAAD complied with WHO and IFPMA codes. On the whole, advertisements in IJDVL had significantly less information regarding the approved usage, dosage, abbreviated prescribing information (API), summary of scientific information, safety information regarding the drug, and references to the scientific literature to support various claims. However, JAAD had more advertisements with multiple claims than IJDVL, and many advertisements interspersed between scientific articles while IJDVL had none.
The complex issue of ethical drug advertising in dermatology journals requires constant review and discussion. Dermatologists should be cautious in assessing any advertisement or claim even if it seems evidence-based. The results from our study highlight the need for a global, proactive and effective regulatory system to ensure ethical medicinal drug advertising in medical journals.
尽管全球都有药品推广规定,但期刊药品广告质量低下是一个全球性问题。医学期刊被视为新药的主要信息来源。它们还可能在医生不知情的情况下影响其处方行为。对不同国家的广告进行比较分析,可能有助于了解不同监管体系的优缺点。
比较《印度皮肤病学、性病学和麻风病学杂志》(IJDVL)和《美国皮肤科学会杂志》(JAAD)上的处方药广告,以检查它们是否符合世界卫生组织(WHO)和国际制药商协会联合会(IFPMA)的标准。
本研究纳入了2012年1月至2012年12月期间在IJDVL和JAAD所有期次中出现的所有至少一页篇幅的处方药广告。比较了两本杂志广告内容在WHO和IFPMA药品广告道德规范不同标准方面的合规情况。使用Fisher精确检验进行统计分析。
与IJDVL相比,JAAD中有更多广告符合WHO和IFPMA规范。总体而言,IJDVL上的广告在批准用途、剂量、简化处方信息(API)、科学信息摘要、药物安全信息以及支持各种声明的科学文献参考文献方面的信息明显较少。然而,JAAD中包含多项声明的广告比IJDVL多,而且许多广告穿插在科学文章之间,而IJDVL则没有。
皮肤病学杂志中复杂的药品广告道德问题需要持续审查和讨论。皮肤科医生在评估任何广告或声明时应谨慎,即使它看起来有循证依据。我们的研究结果凸显了建立一个全球、积极且有效的监管体系以确保医学期刊上药品广告符合道德规范的必要性。