NGO Pharmaceutical Roundtable
9 October 1998, WHO Geneva, Switzerland.
Rational drug use and independent drug information
Speaker notes of Ellen 't Hoen, International Society of Drug Bulletins
Introduction
I would like to thank WHO in particular Dr Brundtland and Dr Scholz for organising this meeting to exchange information about our work, views on drug policy issues and to discuss how cooperation between WHO and NGO's can be improved. My name is Ellen 't Hoen and I am the co-ordinator of the International Society of Drug Bulletins (ISDB). ISDB is not an organisation in official relationship with WHO but certainly an organisation in active relationship with WHO.
Principles of rational drug use
The rational use of drugs means: the appropriate drug, available at the right time, correctly dispensed, in the right dose, at the right intervals, for the right length of time, effective, good quality and acceptably safe. Drug information is essential to promote the rational use of drugs. Doctors, prescribers, pharmacists, consumers and patients need reliable, objective and comparative information to assure that drugs are used rationally. A medicinal product without the information that helps deciding whether to use it and how is a chemical substance with little value at best and can possibly even be dangerous.
Background of the independent drug information movement
The independent drug information movement was a response to the developments in the pharmaceutical field after the Second World War. In this period there was an increase in the flow of new drugs and large pharmaceutical companies were establishing. In the increasingly competitive pharmaceutical market aggressive marketing and promotion became an inevitable part of the drug manufacturers strategy to survive. At the same time there was a tremendous lack of unbiased comparative drug information to help physicians make good therapeutic choices. Groups of doctors and pharmacists who felt that they needed much more critical and reliable information then they were getting tried to fill this gap. The first drug bulletin "The Medical Letter" was published in 1959 in the United States.
Present key issues with regards to drug information
Many years later these concerns still remain the key mover behind the work on independent drug information. Present main concerns are:
· The industry is not less fierce in its marketing. Particularly new drugs are promoted aggressively at the time we know little about the product.
· Most of the drug information that reaches doctors and consumers is not aimed at providing well balanced evidence based information but is aimed at selling a product. Companies promote their products by emphasising positive aspects and mentioning negative aspects, advantages of competitors' products and non-drug solutions as little as possible. While advertisement might have some information, its primary purpose is to increase consumption not to promote rational drug use. There is considerable evidence to show that promotion encourages irrational prescribing and use.
· New information technologies carry promotion across borders, reaching many more people and addressing consumers directly about prescription only drugs.
· Even in this technology age many people have no access to well balanced, evidence based, independent information. The World Bank report Knowledge for Development published last week, stresses that "knowledge makes a difference between sickness and health, between poverty and wealth" and warns for the knowledge gap between rich and poor. Many parts of the world people do not have access to the technologies. This is often also the case for those who are editing an independent drug bulletin.
· There are great differences between countries. In some countries commercial information about drugs is the only kind that is available.
· Much potentially useful information is not in the public domain but kept secret by drug regulatory agencies and drug companies.
· Independent drug information forms the counterbalance of commercial information. But there is a tremendous imbalance in resources available for the production and dissemination of independent, comparative information as compared to the resources spent on commercial information.
At the international WHO meeting on drug information held in 1985 in Madrid independent drug information was defined as follows: "Independent drug information comprises both data and interpretations which attain the highest possible degree of objectivity and which are provided by the bodies having no commercial or other interest in the promotion of particular patterns of drug treatment, their sole aim being to optimise such treatment in the interest of the patient and the society at large."
The formation of the International Society of Drug Bulletins was a direct result of this meeting. It gave a strong impulse to the development of bulletins.
The aim of ISDB is to encourage and further the development of independent drug bulletins; - to promote international exchange of good-quality information concerning drugs and therapeutics. ISDB now has 80 members of which 52 are full members. These members need to fulfil a set of criteria concerning quality and independence and are not permitted to accept advertising.
The ISDB definition of a drug bulletin reads as follows: Drug bulletins aim at providing good quality drug information to health professionals which is scientifically valid, clarifies current consensus and distinguishes between what is established and what is not. Drug bulletins help the user of the information to optimise his or her clinical decision in the best interest of the patient. There are many different types of initiatives and bulletins play different roles in different settings according to needs and target groups. They all aim at bridging the gap between scientific evidence and daily practice.
The main characteristic of a drug bulletin is its independence. The work is carried out free from commercial influence. Financing of these initiatives is a challenge and often problematic.
Independent drug information is the "raw material" on which all initiatives and interventions to promote rational drug use depend. For example the work of drug bulletins may have an effect on regulatory decisions, reimbursement decisions, actions following ADR reports, form the basis for consumer information, it is used in medical training and as basis for formularies and treatment guidelines.
Many of the drug bulletins engage also in advocacy work to improve the regulatory and policy environment for the availability of high quality drug information. Some examples include: promoting the WHO ethical Criteria on medicinal drug promotion, publication of drug donation guidelines, the organisation of public seminars on broader issue such as national drug policy, monitoring of behaviour and quality of the information provided by medical sales representatives, debates with drug regulators about the improvement of the information provision and access to information, co-operation with consumer organisations, medical schools, those involved in medical technology assessment to increase efforts to disseminate drug information.
Collaboration with WHO
In the history of ISDB and of many individual drug bulletins co-operation with WHO has always been very important. WHO has stood at the cradle of ISDB and has been involved in many initiatives since. A few examples of collaboration include organisation of training workshops for editors of drug bulletins, support for setting up of new bulletins and provision and sharing of information. At the moment ISDB and WHO are jointly working on a project to produce a manual for starting or improving drug bulletins to which 58 people from around the world contribute.
Conclusion
In a rapidly changing world and increasingly globalised drug market the provision of high quality independent drug information is an even greater challenge. There are new trends such as direct to consumer advertising, rapidly developing information technologies and international harmonisation of drug regulation that requires a constant refocusing of the work of bulletins. An important challenge remains to bridge the gap between science and daily medical practice and the gap between those who have access to information and those who have not.
Those involved in independent drug information will need increased support, collaboration and guidance from WHO, particularly in the South where resources and support is scarce.
Ellen 't Hoen
International Society of Drug Bulletins
PO Box 459
75527 Paris Cedex 11
France
Tel: + 33 1 47 00 33 20
Fax: + 33 1 47 00 28 64
E-mail: isdb@compuserve.com
http://prn.usm.my/sites/isdbdr1.html