Understanding and responding to pharmaceutical promotion: A practical guide.

Pharmaceutical promotion influences how doctors and pharmacists choose to prescribe and dispense medicines. These decisions may, however, lead to sub-optimal treatment choices that damage public health and escalate health care costs.
Although the influence of pharmaceutical promotion starts early in medical and pharmacy students’ training, these students receive little to no instruction on how to assess promotion.
To address this need, HAI and WHO published a manual that schools of medicine and pharmacy can use to train students how to recognise and respond to pharmaceutical promotion before they start prescribing and dispensing medicines. This educational tool enables students to critically analyse pharmaceutical promotion and access higher-quality, unbiased and independent information about medicines.
The manual is available free-of-charge and can be downloaded in English, French, Spanish or Russian. Hard copies of the manual (in English or Spanish) may also be requested by emailing manual@haiglobal.org. Please note that shipping charges may apply.
Have you taught the manual, or used it as a student? Share your experience with us—and help us improve the next edition—by completing and submitting an evaluation form (English, French or Español).

Medicines promotion: Assessing the nature, extent and impact of regulation


Irrational use of medicines results in inappropriate treatment, a waste of resources and increased drug resistance. Many countries either rely on the pharmaceutical industry to self-regulate promotional activities through voluntary codes of practice or have introduced a legislative framework. As a result, but measure to restrain promotion vary widely in terms of content, penalty and enforcement. With the support of the Medicines Transparency Alliance (MeTA), HAI has developed an innovative methodology to assess the nature and extent of countries' pharmaceutical promotion control and its impact on promotional practices. HAI's methodology combines desk research, interviews and data collection to provide a complete profile of the national situation, highlighting the strengths and weaknesses of the regulatory framework and provide analysis of stakeholder positions. The findings will reveal transferable best practice and provide evidence on which countries can make informed policy choices to protect public health.
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Report and Preliminary Methodology for Pilot-testing



At the 118th session of the WHO Executive Board turns its attention to the Rational Use of Medicine (RUM) - But does it go far enough?

Health Action International (HAI) was pleased to support the WHO secretariat’s proposed resolution on the Rational Use of Medicines (RUM) at the 118th Executive Board (EB) meeting last week. The number of countries who spoke at the EB in support of this resolution showed how important this topic is to all Member States and HAI applauds the commitment of the EB to this crucial area of health policy. HAI also welcomes the decision of the EB to revisit the resolution next year before it goes forward to the World Health Assembly. However, whilst the resolution passed by the EB re-establishes Rational Use of Medicines as a core agenda item, the resolution that emerged from the a ’drafting group’ after a number of EB members proposed changes in the text, could go much further.

Among other things, the resolution, in the form that will progress to next years EB in January 2007, urges Member States to invest resources to ensure the appropriate use of medicines and establish national bodies to promote the rational use of medicines (including training programmes for health workers). Moreover, HAI particularly welcomes that the resolution calls on Member Sates to ’enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines’.

However, as far as HAI is concerned, one of the main objectives of the Resolution is to provide WHO with a new mandate to provide effective technical support to Member States to implement national coordinated programmes to promote RUM. (i.e. to take a health systems approach to promoting rational use of medicines). This objective was incorporated in operative paragraph 2.2 of the original document which urged the Director General ‘establish mandated multi-disciplinary national bodies to monitor medicine use and to develop national programmes to promote the rational use of medicines’ However, this paragraph was revised and weakened.

The revised paragraph no longer talks of ‘mandated multi-disciplinary national bodies to monitor medicine use and to develop and coordinate …. national programmes’ which was an articulation of the health systems approach advocated in the report as a whole and the justification for allocation of WHO resources. ‘Without this paragraph, both budget and mandate will be seriously reduced’ said a WHO source.

Tim Reed, Director of HAI Europe said ‘We are absolutely delighted that Member States are once again placing the Rational Use of Medicines at the core of WHO policy, but disappointed that the resolution stops short of giving the WHO the mandate to do anything more concrete. Next year we want a final resolution that will give the WHO the mandate and financial means to help Member States in order that we can dramatically reduce the physical harm and waste of resources that the irrational use of medicines produces.’

For further information contact Tim@haiweb.org

INTERVENTION
Rational use of medicines: progress in implementing the WHO medicines strategy
Provisional Agenda Item 5.3
EB118/6

Chairperson and distinguished Members of the Executive Board

My name is Tim Reed representing Churches Action in Health and Health Action International.

We welcome the report by the secretariat in respect of the rational use of medicines and support the secretariat in recommending that the draft resolution before you is forwarded to the World Health Assembly for consideration by Members.

The World Health Organisation has made significant strides in ensuring that people everywhere have increasing access to the essential medicines they need, and that those medicines are safe effective and of good quality.

More recently, in fact just last week, Member States took the bold step to encourage the reorientation of research and development into neglected diseases - a move that will surely ensure access to essential treatments in the future.

And yet - even with a tangible increase in access to medicines, the constant monitoring and modification of the essential drug programme, and the future hope of new treatments for neglected diseases - the strides made in access to essential medicines will be limited if drugs are not used rationally -- that is prescribed in a therapeutically and cost-effective way, and with monitored adherence to treatment regimes.

The evidence suggests that only 40 percent - 40 per cent - of all patients receiving medicines are treated in accordance with clinical guidelines and that there has been little or no improvement in rational medicines use in the past 15 years. Moreover there are few interventions promoting rational use at the local level which have been scaled up to become national policy.

Indeed less than 60 percent of countries have monitored the rationality of medicines use in the previous two years; only half of all Member States have undertaken public education programmes in medicine use and only 40 percent of countries have drug information centres or support continuing medical education of health professionals in the rational use of the medicines they themselves prescribe.

Based on this and the other evidence before you we suggest that it is crucial that the executive committee recommend the 60th World Health Assembly asks Member States to invest resources in national coordination programmes to promote and implement rational use, that Member States develop and strengthen existing training programmes and enforce or enact legislation to limit promotional activity which might distort the prescribing habits of doctors or the treatment adherence of patients.

We urge the executive board to request the Director-General to strengthen the leadership and advocacy role of the WHO in promoting the rational use of medicines and to facilitate the strengthening of WHO's technical support to Member States in order that they might establish national bodies to monitor medicine use. Moreover, we suggest that research is conducted with some urgency into sustainable nationwide interventions and the promotion of rational medicine use at all levels of the health sector, both public and private, and to health-care providers, patients and consumers.

Thank you.

Promoting the Rational Use of Medicines

Pharmaceutical companies compete for product sales and market share, and this has led to an increasing amount of spending on drug promotion aimed at health professionals and the public. But too often the promotion of drugs overstates the benefits and understates the risks of taking a particular medicine.

Promotion of drugs to consumers does not provide them with the reliable and objective information about medicines that they need. Consumers may be forced to make choices about medicines based on insufficient information about how a medicine performed in trials and how other patients have reacted to taking it. They may not be able to critically evaluate drug promotion or be aware of the basic principles of rational drug use.

In a major campaign success, EU pharmaceutical legislation passed in April 2004 maintained the ban on advertising prescription-only drugs directly to the public. But the battle is still to ensure that the information consumers receive is not advertising in disguise. HAI Europe campaigns for consumers to have access to information that is truly objective.

Unethical drug promotion targeted at health professionals includes misleading presentation by medical representatives, inappropriate inducements and gifts and promotional activities disguised as educational symposia and clinical trials. Health personnel often have insufficient training to see promotion for what it is and to critically appraise it.

HAI, together with the World Health Organisation (WHO) has produced a database of how prescribers and others are influenced by drug promotion and is involved in the production of a manual on educational initiatives to teach medical and pharmacy students skills in appraising promotional approaches by drugs companies.

Drug Promotion: what we know, what we have yet to learn
Reviews of materials in the WHO/HAI database on drug promotion

WHO/EDM/PAR/2004.3
EDM Research Series no. 32

Authors: Pauline Norris, Andrew Herxheimer, Joel Lexchin, Peter Mansfield

Published by the World Health Organization (WHO) and Health Action International (HAI).

This report is part of a project on drug promotion being carried out by WHO and HAI Europe and collated on a database (www.drugpromo.info). This stage involved collecting and analysing existing information on drug promotion. Analysis focussed on the impact that drug promotion has on professional and lay people’s attitudes to promotion; its impact as a source of drug information; its influence in prescribing habits and public health (funding of research); and the interventions that have been tried to counter promotional activities.

Educational Initiatives for medical and pharmacy students about drug promotion: an international cross-sectional survey

WHO/PSM/PAR/2005.2
EDM Research Series no. 36

Author: Barbara Mintzes, October 2005

Published by the World Health Organization (WHO) and Health Action International (HAI)

Increasing attention is being paid to the relationship between health professionals and the pharmaceutical industry. This is the first international survey to examine the extent to which medical and pharmacy students are being educated about drug promotion within the required curriculum. The report shows that although educators found many barriers to success in achieving critical appraisal of promotion, there is a broad interest in further development and work in this area.

HAI’s latest document relating to rational use of medicines has been on patients’ reporting of adverse reactions, published in July 2005. Pressure to allow patients to report details of adverse reactions directly to the relevant authorities has developed following a number of cases where the response to users’ evidence of harm had been slow and inadequate. As a result, patients’ reporting systems have recently been established in several European countries. A seminar organised by Health Action International Europe in Brussels on 26 May brought together those responsible for running these systems, as well as other key experts. A report of the meeting summarises the lessons that can be derived from early experience with receiving patients’ reports. The document urges national and European agencies to be more open to patients’ reporting and by doing so to show greater respect to those experiencing illness and taking medicines.
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