Perspectives and achievements with Rational Pharmacotherapy
November 6th, 2002, the Institute for Rational Pharmacotherapy invited to a conference on Perspectives and Achievements with Rational Pharmacotherapy. The Conference was held in Hotel Marriott, Copenhagen. 167 persons from alltogether 17 European countries registered for the day.
The aim of the conference was to compare perspectives and achievements with rational pharmacotherapy throughout the European countries and to promote a mutual understanding on the basis of both effectual and financial points of view. The conference was opened by Dr. Jens Peter Kampmann, Chief of the Institute for Rational Phamacotherapy, who started by welcoming all the participants. The conference was efficiently chaired by journalist Eva Jørgensen.
Rational Pharmacotherapy: Contents and Scope
Jens Peter Kampmann, Chief of the Institute for Rational Phamacotherapy, openend the discussion by outlining the difference between drug information and drug advertisement. The implementation of Rational Pharmacotherapy is very dependant on the drug information given to health professionals. Therefore the drug information given should always be correct, complete, comparative and comprehensible.
Different methods have been used for dissemination of the knowledge about rational pharmacotherapy. So far academic detailing has been shown to be the most effective way to change prescribing habits. But there still are a lot of barriers to the ideas of rational pharmacotherapy, for instance the profound advertisement of single drugs, doctors indolence, patients demands and bureaucratic administrative procedures.
Jens Peter Kampmann also explained the definition of rational pharmacotherapy used at the Danish institute:
Adverse Reactions x Price
The effect is primarily evaluated on the basis of randomised, controlled trials, but in case such studies are non-existing lower levels of evidence or even extrapolation from other results might be necessary.
In the end Jens Peter Kampmann adressed the difficult role of the politicians as being forced to take care of the interest of both the pharmaceutical industry and the public health.
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Implementation of Rational Pharmacotherapy
Kees de Joncheere, Regional Advisor for Pharmaceuticals and Technology, WHO regional office for Europe, started his presentation by stating the main challenges for making pharmaceutical policies in the European countries. Those were to ensure an equitable access to safe and effective medicine when needed, to enhance the appropriate use of this medicine and to obtain the best possible value for money.
He defined rational pharmacotherapy not only as the right medication given to the right person, but also stressed that it had to be accompied by the right information and seponated or changed at the right time. There are still several problems in obtaining this goal. Some of these are lack of training and knowledge, financial incentives for irrational use and availability problems.
Throughout Europe there are still very different prescribing patterns of certain medicines. But within the 15 EU pharma markets there are also major discrepancies such as differences in licensed indications and dosages or different reimbursement and classification schemes which makes it difficult to compare and monitor drug utilisation between countries. But there still are lessons to learn from other countries. This could e.g. be done by indicator studies or intervention studies. Several examples of indicators for good prescribing habits were given, but there still is a clear need for going beyond basic statistics and for developing better analytical methods and benchmarking tools.
Kees de Joncheere also gave some ideas of how to use financial measures to improve prescribing. This could for instance be fixed and indicative budgets for prescribers, financial incentives to pharmacies for better dispensing or differential reimbursement rates. Other managerial measures could be the use of positive or negative lists or prescribing support systems.
At the end Kees de Joncheere described different ideas of promoting rational prescribing, but the remaining problem still is, that doctors may be compared with a large number of cats: if they are set free at the same place, they will never just run in one direction!
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Consequenses of the different use of drugs
Arne Melander, Chief of NEPI (Network of Drug Epidemiology), Sweden, continued by giving several examples of the major discrepancies in drug prescribing not only between countries, but also between regions of the same country and even between local areas.
There may be different explanations to this: cultural traditions, information- or marketing campaigns or maybe even religion. In the examples that were shown, Holland tended to have a more rational prescribing than the most of the other European countries. To the question of how this could be, Arne Melander answered that it might be due to an increased use of clinical pharmacists compared to other countries.
Arne Melander noted that the statistical registers of drug utilisation could be better in many countries. But of course the use of drug statistics for making comparisons like those shown doesn’t solve the problems with irrational prescribing habits itself. It may, however, be a useful tool in pointing out certain areas, where actions are necessary.
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The role of the Authorities
Gunnar Alvan, Chief of the Swedish Medicines Agency, talked about how the authorities may have a role in implementing rational pharmacotherapy. Clearly, the authorities have huge influence on the evaluation and approval of new drugs, for which a marketing authorisation has been applied.
The premarketing influence also includes approval of clinical trials and compassionate use. But during the last years the emphasis of the authorities work has clearly shifted from solely laboratory control to a greater degree of pharmacovigilance, scientific evaluation of new documentation and therapeutic advices.
The authorities are also directly involved in drug information to the patients and the health professionals via the Summary of Product Characteristics (SPCs) and the Patient Information Leaflets (PILs). According to Gunnar Alvan these documents should however be modified in order not only to include warnings about the product but also to give a more profound description of the different opportunities.
The Swedish authorities use different ways to inform about marketed drugs e.g. on the website of the Agency, in an ”MPA Bulletin” and in a series of booklets published after expert meetings (workshops) coordinated with the Norwegian authorities on specific therapeutic areas. The Swedish Medicines Agency also produces guidelines based on scientific evidence. In general, Gunnar Alvan did not find that the drug information role of the authorities is hampered by legal requirements.
The authorities not only have a role nationally but also internationally at the EU-level, where note for guidance are made to give advise on several therapeutic pre- and postmarketing problems. To ensure transparency within the EU-system the European Public Assessment Reports, EPARs, are published at the Internet.
Professor Silvio Garattini, member of the CPMP, however questioned this transparency. Not all decissions are made in total aggreement, but the public doesn’t have access to the files revealing the actual opinion of each member state.
A question about the possibility of withdrawing the marketing authorisation for irrational and useless drugs was also raised. Gunnar Alvan explained that this is possible, but only in rare cases.
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Independent drug information and rational pharmacotherapy
Anne Toni Rodgers, Communications Director, NICE, UK, gave a presentation on the National Institute of Clinical Excellence (NICE) and how the institute promotes rational pharmacotherapy in UK.
NICE was founded 3½ years ago as a body connected to the National Health Service, but not a part of the Medicines Agency in UK. The aim of the institute is to create standards to supply patients and health professionals with authoritative, robust and reliable guidance on correct "best practice". The Institute is not a regulatory body but is supposed to give guidance on clinical relevant questions. Today NICE has a budget of £ 15 mill. /year. For the scientific work NICE mostly relies on an external network.
NICE produces both "technology appraisals" and "clinical guidelines". These documents are intended for health professionals. NICE also has a close cooperation with both the press and the medicinal industry.
According to Anne Toni Rodgers some of the the reason for the succes of NICE is the transparency in all what they are doing. It has also been very popular, that NICE always make suggestions of relevant, comparative studies, whenever such are missing.
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European Drug Statistics
Ulrich Scwabe, Professor of Pharmacology, Heidelberg University, Germany, gave a presentation on European drug statistics and the differences between countries. He first went through the ATC- and DDD-classification, which forms the basis of most of the statistics on drug utilisation in Europe. The WHO Collaboration Centre for Drug Statistics Methodology in Oslo maintains this system.
Hereafter he made it clear that there are great differeces between the European countries with respect to how drug utilisation is measured. Some countries (Greece and Ireland) have no utilisation data at all. Other countries (e.g. Austria, France, Great Britain, Spain and Portugal) do not have the statistics on a DDD-level.
But what may the various drug statistics be used for? One of the major advantages of the statistics is that it provides transparency on the drug market. It is possible to use the data as indicators for changes in drug utilisation especially when combined with other health information statistics such as prevalence of certain diseases etc. These kinds of indicators are indeed necessary in order to establish an optimal use of drugs.
Ulrichs Schwabe showed some interesting examples on how the use of statins had been increasing steadily – but differently - in various European countries during the last years, even though no one really knows what the optimal use of these products is. He also showed how the statistical indicators have been used to measure the effect of the German recommendations against the use of pentoxifylline for claudication. In Germany campaigns have aimed at reducing the enormous prescription rate of pentoxifylline as it has been shown that exercise has a much better therapeutic effect. The curves indicated a clear effect of this campaign.
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Is rational pharmacotherapy of any interest to the politicians?
Paul Schüder, Director of the 4th Division in the Ministry for the Interior and Health, Denmark, gave a speach on behalf of the Minister, who unfortunately had been hindered in attending the conference. He stated that the principles of rational pharmacotherapy are the only relevant way to go – both for public health reasons and from a financial point of view.
If rational pharmacotherapy has to be implemented thoroughly the best way to do this is by using academic detailing as previously discussed. In Denmark this concept has already been applied in several counties. He was also proud to say that Denmark is one of the countries in the world with the best statistical registers for drug utilisation. It is now beeing discussed how these data might be used more directly in implementing a better use of drugs. A new idea is to place the data on the Internet with a restricted admittance, that will allow the treating physician to have a view of the prescribed medicine for his or her own patients. The Medicines Agency is now preparing the establishment of such a system. Another option is to allow all physicians to follow their own prescribing statistics via the Internet. The Medicines Agency is also currently working on this idea.
If rational pharmacotherapy has to be implemented it is, however, necessary to include all health professionals. This also includes the employees at the pharmacies, who have a very close contact to the patients. The Ministry has recently appointed a committee, who has to explore the possibilites of using clinical pharmacy in order to obtain a more rational use of drugs.
Concludingly Paul Schüder made it clear that is is important to distinguish between information and advertising. He also stressed the necessity of establishing some kind of a public, neutral drug information service as the Institute for Rational Pharmacotherapy in Denmark or similar institutions seen in other countries.
Health Economy and its correlation to rational pharmacotherapy
Alan K Maynard, Professor of Health Economics, University of York, UK, presented his view on how health economy could be used in implementing rational pharmacotherapy. He started by outlining the ”delicate balance”: The trade-off between the treatment of patients and the wealth of the pharmaceutical industry.
Alan K Maynard found that it is a problem to be honest and fair in this setting. The irrational drug use shown by the previous speakers have always been there, but the authorities do nothing to change the situation!
Health economy is a science based on the fact that resourses are scarce. This forces us to make a choice of which patients to treat and which not to treat. The answer to this problem is very different depending on whether your point of view is from the society or from the individual. The methods normally used when ranking drugs are either clinical effectiveness or cost effectiveness. It is however a problem that many published cost effectiveness studies do not fulfill the basic requirements for health economy studies.
Often it is seen that politicians may have an obstructive effect on the implementation of rational pharmacotherapy by interfering in single cases brought to public knowledge by the press.
Another barrier for rational pharmacotherapy is the fact that the industry convinces the patients or patients organisations that a certain drug must be used. This leads to demanding patients and sometimes followed by demanding politicians. It may be very difficult for the doctors to oppose these demands.
If rational pharmacotherapy has to be implemented we need:
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- better randomised, controlled trials
- better health economy studies
- to find out, how doctors prescribing may be better in spite of the marketing activity from the pharmaceutical industry.
Drug Industry and Rational Pharmacotherapy
Teddy Hebo Larsen, Chairman of the Danish Association of the Pharmaceutical Industry (Lif), Denmark, started his presentation by pointing out, that rational phamacotherapy indeed is a toxic coctail of higher taxes, sick people and private profits. He expressed the need for a broader definition of rational pharmacotherapy than the one proposed by the Institute for Rational Pharmacotherapy and formerly presented by Jens Peter Kampman. The real aim of rational pharmacotherapy should be to obtain the optimum patient care and for this reason the price would only be one element of many.
The cost-effectiveness of course would be relevant to include. According to Teddy Hebo Larsen rational pharmacotherapy also ought to embrase the aspects of drug information and eventually to aim at ”the good life”.
The tough question in this debate is the doctor’s dilemma that includes four problems:
- Maximisation of the efficacy of a therapy
- Minimisation of the risk posed by the therapy
- Regard for the patient’s right to choose
- Regard for the economic consequences/minimising costs
Teddy Hebo Larsen aknowledged the difficulties in obtaining consensus on the definition of rational pharmacotherapy but made it clear that the pharmaceutical industry is very interested in playing an active role in getting closer to a solution to the problems. Presentation (47 KB)
The role of the press in impementation of rational pharmacotherapy
Simon Andersen, journalist, Roskilde University, Denmark, gave his view on which role the press has in this setting. Is it the voice of the public, adulation of doctors or watchdog?
Simon Andersen referred three cases, where the stories about new drugs had reached the headlines of Danish media. This always serves as very good advertisements for the drugs and according to Simon Andersen the journalists and the daily media very often are used by the pharmaceutical industry for this purpose. In one of the cases mentioned, the publicity actually led to an approval of a product due to political pressure.
Simon Andersen accused journalists of being to easy to seduce by the pharmaceutical industry, as they only rarely are able to comprehend the entire scientific documentation of a product. The journalists by tradition also have a blind belief in doctors – in spite of the fact, that these might have been paid by the industry to conduct clinical studies. Pharmaceutical companies often use this, Simon Andersen claimed.
Simon Andersen proposed the independent institutions and the authorities to spend more time on explaining journalists the background for cases and associated problems. This could simply be done by inviting a few relevant persons from the press for lunch!
Arne Melander, NEPI, Sweden, added that doctors also very easily get seduced by the industry.
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Debate: Why is it so difficult to implement rational pharmacotherapy?
Three persons were invited to give a contribution to the debate about how to implement rational pharmacotherapy and what the barriers might be.
Silvio Garattini, Professor, the Mario Negri Institute, Italy, found that some of the major problems in implementing rational pharmacotherapy are:
- The industrial versus the public health interest (the case of EMEA)
- The SPC versus advertisements (how to promote rational pharmacotherapy?)
- Passive versus active pharmacovigilance (the need to centralise information on adverse reactions).
- Revision of useless drugs (only for toxicity?)
According to Silvio Garattini there also is a clear need for more comparative studies and less equivalence studies. This problem is founded in the European legislation. More independent studies are also necessary. The establishment of a European Fund for independent clinical trials could perhaps encourage this?
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Hanne R. Christensen, Chairman for the Danish Society of Clinical Pharmacology, Denmark, started by asking the question ”Rational for whom?” when talking rational pharmacotherapy. She gave several examples on situations where rationality could be disputed and would be very different based on individual points of view.
She also claimed, that several therapeutic guidelines already exist, and that it also has been proven that doctors in fact know and remember these guidelines very well. The problem is, however, that patients only rarely are as described in guidelines!
For this reason the doctors have to extrapolate and it becomes difficult to fulfil the requirements of rational pharmacotherapy. Psychology and sociology are indeed skills that are important for doctors who sincerely want to implement a rational way of prescribing!
Danielle Bardelay, Senior Editor, La Prescrire, France, put into perspective how people, who eventually become doctors, in fact have been raised. The first problem arises already in the childhood, as we tend to forget to educate children in the correct use of medicine. As the child grows up and starts university he will learn a lot about different illnesses, but not enough about pharmacotherapy.
Danielle Bardelay also questioned whether the universities are proper models for independent education. Once the newly educated doctor starts to work at a hospital, he will experience that the reference books available aren’t always up to date, that doctors use far more time on discussing diagnoses than treatment regimens and that the only information on new drugs is provided by representatives from the pharmaceutical industry.
One may ask, whether the continuing education system for doctors is good enough and what kind of role the health insurance bodies play. Could they provide a better support for the doctors in order to improve a rational use of medicine?
The concluding discussion mainly focused on what strategies to use, if rational pharmacotherapy has to be implemented. It was claimed that changing prescribing habits is possible – but needs at lot of time. An example given was a change in the prescribing of antibiotics in Denmark. It took 5-7 years before the new treatment strategy came through for real. Changes like that also require some kind of independent body to co-ordinate.
It was also pointed out that it probably is very important to acknowledge the problems of the real world as described by Hanne R. Christensen, if the doctors are expected to listen to you and actually change their habits into something better. It should also thoroughly be considered whether financial incentives for the general practitioners would be a good idea.
Silvio Garattini ended the debate by concluding that rational pharmacotherapy for sure would be implemented sooner or later. The expenses on medicine are growing so fast, that we simply can’t afford not to use the drugs in a rational manner!
The Danish Institute for Rational Pharmacotherapy would like to draw a special attention to the following problems and suggestions:
- A better definition and understanding of the concept ”rational pharmacotherapy” is needed
- Better public drug statistics encompassing the use of drugs in both price and DDD should be introduced in all European countries.
- The possibility of co-operation between drug information offices invarious countries should be considered
- It seems to be necessary to increase the transparency in various official organs (e.g. knowledge on the voting results).