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

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.

Pre-randomization decisions and group stratification in a randomized controlled trial to improve prescribing.

OBJECTIVE: To select and evaluate characteristics of primary care practice groups relevant for stratification prior to randomization. METHOD: Structured telephone interviews and pre- and post-intervention prescription data. SETTING: Additional study in an RCT to rationalize prescribing in primary care, addressing groups of pharmacists and doctors. Representatives of 61 primary care practice groups in the Netherlands. MAIN OUTCOME MEASURES: Identification and evaluation of primary care practice group characteristics related to changes in prescribing. These characteristics were evaluated by estimation of incidence rate ratios (Poisson regression). RESULTS: Of practice groups 40 representatives (66%) participated in our study. Three characteristics were found to be most relevant for stratification: the purpose of the practice groups (whether they participated in information exchange (n = 14) or binding consensus on pharmacotherapy (n = 26)), the use of a formulary (22 practice groups did and 18 groups did not) and the use of feedback data (22 groups did and 18 groups did not). These characteristics strongly modified the effect of the program on prescribing behaviour. While the overall effect of the program was to significantly reduce the prescribing of the targeted drugs, this change was not consistent in all strata. CONCLUSION: Assessment of the characteristics of practice groups made it possible to define factors to be used for a stratified randomization of practice groups which in retrospect indeed modified the effect of an educational intervention directed to change prescribing. Such pre-randomization assessments can be a useful tool in interventions designed to improve practice patterns in groups of physicians.