Transcript
Outlook
Direct-to-consumer advertising of prescription drugs
How to provide the public with relevant health information: 10 concrete proposals To make informed choices, patients need independent comparative information from reliable sources. Two of the most important sources are transparent drug regulatory agencies and well-trained health professionals (1,2). This is an updated version of the proposals that were first put forward in 2006 by the Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) (1). Transparent drug regulatory agencies publishing high-quality information. Rather than investing public resources in trying to monitor information produced by pharmaceutical companies, it would be more useful to allocate funds to increasing the transparency of the European Medicines Agency and national drug regulatory agencies. We therefore propose: – Improving the content of drug databases (Eudrapharm at the European level) and making them easier to use. Priority should be given to: publishing the agendas (a few days beforehand) and extensive minutes or videos (within two weeks) of the meetings of committees that evaluate healthcare products, of pharmacovigilance committees, and of various working parties; providing the documents on which positions or decisions were based; publishing public assessment reports, pharmacovigilance alerts, marketing authorisation variations along with the detailed reasons for the changes, and drug utilisation data (which is essential in order to evaluate population exposure if adverse effects occur) for each drug, without delay (3,4). – Providing public access to all pharmacovigilance and clinical trial data, including the raw data, for example by linking assessment reports to databases that record adverse effects and clinical trials and their results (respectively, Eudravigilance and EudraCT at the European level) (a)(3,4). – Making public assessment reports more useful by including a section describing the natural course of the disease and another section comparing the new drug’s efficacy, adverse effect profile and convenience to those of the standard drug for the same indication, to determine whether or not it represents a therapeutic advance; these two new sections should be included in the summary of product characteristics and adapted for the package leaflet (4).
– Making officially approved package leaflets more useful and more accessible to patients and improving packaging safety, in particular by finally enforcing the requirement that pharmaceutical companies test package leaflets on target patient groups (Article 59 of Directive 2001/83/EC amended) (2). – Developing and strengthening existing sources of impartial comparative information on available treatment options (1,2). Better communication between patients and health professionals. To enable health professionals to provide patients with reliable information, we propose: – Ensuring that healthcare professionals receive high-quality undergraduate training free from outside influence, teaching therapeutics using international nonproprietary names (INNs), improving training in clinical pharmacology, pharmacoepidemiology and pharmacovigilance, providing specific instruction in conflicts of interest and their consequences, and in patient safety and management of the risk of errors associated with healthcare and healthcare products (5). – Encouraging the creation of independent continuing education programmes for health professionals on critical appraisal and the basic principles of evidence-based medicine (2,5).
– Requiring anyone expressing an opinion about a drug to declare their conflicts of interest, as is the case (although rarely enforced) for health professionals in France. ©Prescrire
a- Clinical trial data must be publicly accessible to enable independent researchers to end the selective reporting of data by pharmaceutical companies and to give patients and consumers a better idea of the harms and benefits of new drugs (ref. 8). 1- HAI Europe, ISDB, BEUC, AIM and MiEF “Relevant health information for empowered citizens” Joint declaration; 3 October 2006. english. prescrire.org: 9 pages. 2- AIM, ESIP, HAI Europe, ISDB, MiEF “BigPharma’s health information: a growing danger in Europe” Joint briefing paper; Brussels, 6 March 2009: 7 pages. 3- ISDB, MiEF “Proposal for amendments on “Information” to Patients – Directive” (12 April 2010): 36 pages. 4- ISDB, MiEF “Proposal for amendments on “Information” to Patients – Regulation” (13 April 2010): 20 pages. 5- Prescrire Editorial Staff “Prescrire’s proposals to France’s national conference on medicines policy: patients’ interests and public health should come first” 8 March 2011. english.prescrire.org. 6- Prescrire Rédaction “Une loi de “sécurité du médicament” trop faible” Rev Prescrire 2012; 32 (342): 292-304. 7- Godlee F “A sunshine act for Europe” BMJ 2011; 343: d6593. 8- The Cochrane Collaboration “The Cochrane Collaboration urges free access to all data from all clinical trials: end to selective reporting can reduce the risk of harm to patients” Press Release 5 October 2011. http://ccnc.cochrane.org accessed 16 December 2011: 3 pages.
– Pre-screening promotional materials aimed at health professionals in Europe, to prevent the dissemination of biased information and the promotion of off-label use of drugs (as introduced in France by the “drug safety˝ bill that was adopted at the end of 2011) (6). – Extending a “Sunshine Act” across Europe, along the lines of the “Physician Payment Sunshine Act” introduced in several US States and in several European Union Member States, and as adopted at the end of 2011 in France’s “drug safety˝ law (6,7). The requirement for pharmaceutical companies to publicly declare the value of any payments or other benefits given to doctors enables the detection of conflicts of interest and fosters a culture of independence from the drug industry among health professionals.
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