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Compliance of disease awareness campaigns in printed Dutch media with national and international regulatory guidelines.

ABSTRACT: 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.

SUBMITTER: Leonardo Alves T

PROVIDER: S-EPMC4157805 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Compliance of disease awareness campaigns in printed Dutch media with national and international regulatory guidelines.

Leonardo Alves Teresa T Martins de Freitas Auramarina F AF van Eijk Martine E C ME Mantel-Teeuwisse Aukje K AK

PloS one 20140908 9

<h4>Background</h4>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.<h4>Objectives</h4>To explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by ...[more]

PMID: 25198776

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Project description:BackgroundDiabetes is among the most common chronic conditions people live with across the world. While it can be managed to a substantial degree, it can result in significant complications. As such, easy access to accurate tools to aid diabetes management is useful in minimizing these complications. Mobile apps are highly accessible and widely used, but there is a gap in the literature examining their compliance with medical guidelines.ObjectiveThe aims of this study are to develop the Analysis of Diabetes Apps (ADA) checklist to evaluate apps' compliance to guidelines set by the International Diabetes Federation (IDF) on the treatment and management of type 2 diabetes; to assess type 2 diabetes apps in the Apple App Store and the Android Google Play Store, and their compliance with international guidelines using the ADA framework; and to compare the novel ADA checklist against both the Mobile App Rating Scale (MARS) tool kit and app ratings for each store.MethodsWe will develop a checklist based on the "IDF Clinical Practice Recommendations for Managing Type 2 Diabetes in Primary Care." Type 2 diabetes apps will be scraped from 6 countries' app stores using web scraping tools. These countries include Australia, Brazil, India, Nigeria, the United States, and the United Kingdom, which were selected based on the largest population of English-speaking people in each continent. The apps will be searched on the web-based scraper using the search terms "blood sugar," "diabetes," "glucose level," "insulin," "sugar level," and "type 2 diabetes." Apps will be excluded if they are paid or are not in English. The apps will be assessed using the ADA checklist to evaluate their compliance to the international diabetes guidelines. Once scored, the results will be analyzed with descriptive statistics. The most popular apps will be further analyzed using the MARS tool kit. The ADA checklist scores will then be compared to both the MARS tool kit score and app ratings for each store.ResultsThe ADA checklist developed based on the IDF guidelines focuses on general information, risk factors, diagnosis, pharmacology, lifestyle modification, glycemic recommendations, and medications. The initial stress testing of the protocol resulted in 173 included apps. This will vary in the final search as the app stores are constantly changing.ConclusionsThe protocol presents the development of a checklist to investigate the compliance of type 2 diabetes apps with international guidelines. The checklist will hopefully form the basis of a scoring system for future research on compliance of mobile apps with international guidelines. High standardization of the ADA checklist will make it a robust tool for people with diabetes and their health care providers alike in assessing type 2 diabetes apps in the future.International registered report identifier (irrid)PRR1-10.2196/48781.

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Compliance of disease awareness campaigns in printed Dutch media with national and international regulatory guidelines.

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Compliance of disease awareness campaigns in printed Dutch media with national and international regulatory guidelines.

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