Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutical companies with the aim of enhancing product sales. We look in greater detail at promotion techniques aimed at prescribers, such as sales representatives, pharmaceutical advertisements in medical journals and use of key opinion leaders, along with the quality of information provided and the effects thereof. We also discuss promotion to the public, through direct-to-consumer advertising, and its effects. Finally, we consider initiatives to regulate promotion that come from industry, government and nongovernmental organizations.
BackgroundThe 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.ObjectivesTo 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.MethodsMaterials 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.FindingsEighty 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.ConclusionDisease 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.
This study aimed to assess the level of therapeutic innovation of new drugs approved in Brazil over 13 years and whether they met public health needs. Comparative descriptive analysis of therapeutic value assessments performed by the Brazilian Chamber of Drug Market Regulation (CMED) and the French drug bulletin Prescrire for new drugs licensed in Brazil, from January 1st 2004 to December 31st 2016. The extent to which new drugs met public health needs was examined by: checking inclusions into government-funded drug lists and/or clinical guidelines; comparing Anatomical Therapeutic Chemical Classification (ATC) codes and drug indications with the list of conditions contributing the most to the national disease burden; and assessing new medicines aimed to treat neglected diseases. 253 new drugs were approved. Antineoplastics, immunossupressants, antidiabetics and antivirals were the most frequent. Thirty-three (14%) out of 236 drugs assessed by the Brazilian chamber and sixteen (8.2%) out of 195 assessed by the French bulletin Prescrire were considered innovative. Thirty-six drugs (14.2%) were selected for coverage by the Brazilian Unified National Health System (SUS), seven of which were therapeutically innovative, and none were aimed to treat neglected disease. About 1/3 of the drugs approved aimed to treat conditions among the top contributors to Brazil’s disease burden. Few therapeutically innovative drugs entered the Brazilian market, from which only a small proportion was approved to be covered by the SUS. Our findings suggest a divergence between public health needs, research & development (R&D) and drug licensing procedures.
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