WORLD HEALTH ORGANIZATION

Regional Office for the Eastern Mediterranean

EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 EM/ICP/DEM/001/RB (7404)

April 1975

REPORT ON THE WORKING GROUP ON RATIONAL DRUG THERAPY: EFFICACY,

SAFETY, ECONOMY

Alexandria, 3 - 5 March 1975

The views expressed in this Report do not necessarily reflect the official policy of the World Health Organization.

This document has been prepared by WHO Regional Office for the Eastern Mediterranean for Governments of Member States in the Region and for those who participated in the Meeting.

Participants who attended t he Working Group on Rational Drug Therapy ;

Efficacy, Safety, E conomy, held in Alexandria from 3 to 5 M.arch 1975

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TABLE OF CONTENTS

A INTRODUCTION

B REPORT

I DEFINITION OF RAT:LONAL DRUG THERAPY

1. The patient's need 2. The drugs available 3. The means available

Il PATTERNS OF DEVIATION FROM RATIONAL DRUG THERAPY AND THEIR CAUSES

1. Deviation by the physician 2. Deviation by the patient ' 3. Studies on deviant patterns

Ill HOLE OF UNDERGRADUATE AND POST-GRADUATE TEACHING IN PROMOTING RATIONAL THERAPY

l. Undergraduate education 2. Post-graduate and continuing teaching

IV DISSEMINATION OF INFORMATION AS A MEANS OF PROMOTING RATIONAL DRUG THERAPY

1. Information provided by manufacturers 2. Information provided by journals 3. Impartial bulletins 4. Formularies 5. Information on costs 6. Information to medical auxiliaries

V ROLE OF CLINICAL PHARMACOLOGY IN PROMOTING EFFICACIOUS, SAJ:'E AND ECONOMICAL DRUG THERAPY

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1. Education 9 2. Research 9 3. Service 9

VI USE OF UNIFORM NON-PROPRIETARY NAMES FOR PHARMACEUTICAL 9 SUBSTANCES

1. Non-proprietary names 9 2. List of essential drugs 10

VII TEACHING THE PUBLIC TO USE DRUGS 10

VIII THE FUNCTION OF A DRUG CONTROL ORGANIZATION IN PROMOTING 11 RATIONAL DRUG THERAPY

C SUMMARY OF RECOMMENDATIONS 12

ANNEX I TEACHING UNDERGRADUATES TO PRESCRIBE IDEALS AND REALITIES

ANNEX II AGENDA

ANNEX III LIST OF PARTICIPANTS

WHO EMRO

A INTRODUCTION

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The Director of the Eastern Mediterranean Region of the World Health Organization, Dr A. H. Taba, in his opening address formulated the aim of the Working Group as follows:

- to discuss and define major problems of rationality in drug utilization, to analyze causes for deficiencies, and to propose remedies.

Drugs are used to improve health. They can improve health if the active ingredients or metabolites of skilfully prescribed pharmaceutical preparations reach their receptors in the patient's body at the right time and in the right concentration.

Normally, prescribed drugs are self-administered. Thus, patients' drug-taking behav­iour is a critical component of rational drug therapy. Studies of the habits of out-patients in countries outside the Eastern Mediterranean Region demonstrated that up to 60 per cent of tested patients did not take their medicines correctly. A very few studies conducted in countries of this Region demonstrated that drug defaulting and errors in self-administration are common.

Tuberculosis specialists, knowing that the success of curative out-patient programmes is dependent on the reliability of the patients in drug taking, had learned to motivate and mon­itor their patients accordingly. Malariologist& who alao know that the success of certain programmes is entirely dependent on the accuracy with which drugs are taken, motivate the population at risk as well. The general practitioner, the drug prescriber for the largest part of the sick population, makes little use of this experience. His usual instruction is brief, often poor, and there is usually no follow-up to see whether drug therapy was effective or not. As a rule his instructions are not designed to protect the patient against innocent or deliberate abuse of drugs.

It is, therefore, increasingly understood that communication between physician and patient must be improved, especially in general practice and in out-patient clinics, in order to make health care more effective and rational.

The other, not less important, component of rational drug therapy is the science and art of prescribing drugs to individual patients. Much depends on the accuracy of the diagnosis, on the choice of the best suited drug among alternatives, on correct dosage and correct ap­plication.

Scientific exploration of the quality of drug recently been started in some western countries. Mediterranean countries too, since there is reason cribed in a rational manner.

prescribing by practising physicians has Such studies should be performed in Eastern to suppose that drugs are not always pres-

It is, for example, impossible to believe that all patients who took or were given multi­vitamin preparations needed the drug. It is the common pattern to prescribe anti-bacterials where a virus disease is the cause of illness. Too many physicians are too ready to pres­cribe drugs for trivial complaints.

Some physicians appear to be too easily persuaded by drug promotion; some seem to wish to prove either to their patients or to themselves that they are up-to-date and modern by always using the "latest drug". Additional factors which promote polypharmacy and overpres­cribing, such as diagnostic insufficiencies and over-crowded waiting rooms, are also present. The result is the well-known continuous increase in the number of prescribed items and of the drug bill in so many countries of the Region.

In addition, there are factors which promote under-prescribing and the prescribing of cheap but inappropriate alternatives for efficient drugs, such as insufficient budgetting for health care inatitutions. These factors are also detrimental to rational drug therapy.

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These and other reasons for irrational drug therapy may vary from country to country even when these are neighbours. Their presence makes it necessary to study the extent to which they cause prescribing habits to deteriorate in the individual countries of the Region.

On the basis of results of studies corrective programmes can be established. certain approaches likely to improve the situation can be seen.

But already

It is clear from exp~rience in other countries, that solutions, in so far as they are within the scope of this meeting, lie in three fields:

(a) medical education

(b) health education of the public

(c) control.

Education of undergraduate students must involve not only instruction in the principles of ideal therapy, but must also teach the student how to handle therapy under the conditions of his later professional work. Do medical schools do their best to comply with these re­quirements? Is the freshly graduated physician fit and willing to conduct rational therapy under strenuous working conditions in the frontline of health care? Was he systematically built up to practise during his later professional life nothing other than rational therapy? Was he immunized against the half-truths of persuasive industrial advertising? These are a few of the many questions which should be considered in the context of education to rational drug therapy.

~ontinuing education of physicians in drug prescribing represents another basic element for effective health care. This education must keep the physician in the field aware of developments, both favourable and unfavourable, which should influence his prescribing. Since it will be difficult to assemble physicians for post-graduate education in the less-developed countries, it should be ensured that this information is currently made available to them in printed form.

Improved health education of the public is the only means to limit unreasonable demands for rlrugs and abuse of self-medication. Tbis type of education has to be pursued by the health team.

The chancesfor the busy practitioner, working in overcrowded out-patient clinics, to participate actively in -the education of the public can only be marginal. He has, however, to take care of continuing education of the personnel of his health team in the proper administration of drugs. It is this personnel: the nurse, midwife, medical assistant, pharmacist and dispenser, who are usually responsible either for supplying drugs to patients or for giving them instructions on how to take drugs according to the physician's prescription.

The less developed the environment and the medical infrastructure in which the health team is working, the more important its educational role in respect of patients becomes. The physician himself has to be trained to accept this educating role and to pursue it in a skil­ful and efficient way.

Drug control promotes rational use of drugs by ensuring that only effective, safe and economic drugs are marketed and that the information disseminated on these drugs is adequate and reliable. Decisions concerning acceptability of drugs for the national market, adopted in other parts of the world, cannot be expected to satisfy the needs of community health services of the countries of this Region without adaptation. Indeed, new solutions may have to be originated, but the practising physician has to be informed about the facts and their scientific justification.

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In summary, the programme of this Working Group provides the opportunity to throw light on the complex matter of rationality in drug therapy from different angles.

B REPORT

The following pages present the collective views of the Working Group on this matter.

I DEFINITION OF RATIONAL DRUG THERAPY

Drug therapy is rational when it takes into account all those factors which determine the need for a drug as well as the situations in which it should be prescribed and will be used.

These factors include:

1. The patient's need

(a) Diagnosis and the symptoms - Accurate diagnosis should precede therapy. cumstances render this impossible, for example, where the time or facilities are too limited, truly rational therapy may be impossible, but therapy based diagnosis will be acceptable.

Where the cir­for diagnosis on a probable

(b) The patient's expectation- Even where there are no objective diagnostic grounds for prescribing, it may be medically desirable to issue a placebo in order to meetthe expectations of the patient, for example, as a result of common practice or his cultural background. The patient's expectation may also affect the form of the therapy given, for example the colour of tablets or the use of parenteral rather than oral administration where one is more likely to satisfy the patient than the other.

2. The drugs available

The choice of drugs is dependent on three factors:

(a) The relative efficacy of the various agents available.

(b) The relative safety and incidence of side effects of various products.

(c) The relative price of a drug and its administration, a factor which in countries in the Region may play a very important role.

These three aspects must be considered jointly; for example, where a drug is less ef­ficacious more may be needed and consequently the price of the treatment will increase.

3. The means available

(a) Funds available for prescribing.

(b) Facilities for diagnosis and treatment of the case.

(c) The circumstances under which the patient will use~e drug.

The fact that the means available are often not optimal and sometimes indeed are extremely limited, must be allowed to influence the choice of drugs or even the decision to prescribe in individual cases. The most rational drug therapy in a given situation is not always that which is ideal from a therapeutic point of view.

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II PATTER!lS OF DEVIATION FROM RATIONAL DRUG THERAPY AND THEIR CAUSES

1. Deviation by the physician

~OE~O

Three main patterns of irrational prescribing can be identified, i.e. overuse of drugs, underuse of dr.ugs and other forms of incorrect use.

(a) Overuse may involve the prescription of too large a quantity of a drug, its provision for too long a period, the prescription of an entirely unnecessary drug or the issuing of too many drugs at the same time to the patient. Over-prescribing results in wastage of drugs and money, confusion in the patient's mind and sometimes adverse reactions due to toxicity or drug interaction.

Some of the main factors leading to over-prescribing in the countries of the Region which can he identified include:

- Inadequacy of time and facilities available for dia~osis. The issuing of a prescription is commonly the only means of providing some form of help and satisfaction to the patient in the given circumstances even though an alternative approach without the use of drugs might therapeutically be preferable.

- Lack of knowledge of drugs and prescribing principles. The physician may not realize that he is in fact over-prescribing and where he is inadequately informed he may, in the patient's interest, prefer over-treatment to the risk of under-treatment.

- Pressures exerted by patients. Many patients appear to expect that a good doctor will always prescribe drugs, and a physician who prescribes heavily tends to be popular.

- Excessive and improper advertising techniques, including distribution of samples. Lack of control on advertising in countries of the Region has clearly led to misinformation of prescribers and waste of funds.

-The wish to retain the patient's good will by prescribing an active drug where none is needed.

(b) Underuse - Common causes of underuse of drugs include:

- Lack of funds. This may result in failure to issue a prescription at all, in the issuing of a prescription for particular drugs which the patient is unable to afford, in the prescription of a cheaper but less suitable drug, or in the prescription of inadequate quantities for proper treatment.

- Lack of information. The physician may, for example, prescribe a drug for too short a period or in insufficient dosage as a result of which it is in­effective.

(c) Other forms of incorrect use of drugs include prescription of the wrong drug by the physician sometimes, for example, an antibacterial for the treatment of a common virus disease, e.g. an upper respiratory infection. The factors leading to such incorrect pres­cribing are similar to those which cause overuse and underuse, particularly lack of informa­tion and lack of adequate facilities for diagnosis.

2. Deviation by the patient after a drug has been prescribed; the patient may fail to take the treatment or may instead find treatment of another kind. Some of the common problems

WHO J:;~ll(O

encountered in the Region are the followjng:

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- Failure to have the prescription filled. This may result from purely financial difficulties, fear, lack of faith in the physician or the drug, or lack of availability of the prepan tion in th~ pharmacy; in the latter event, substitution by the pharmacist mc1y take place.

- Failure to tak.~ prescribed dr~s sufficiently long or at all. This, again, may result from fear, lack of faith or financial problems. Many patients are prone to stop treatment as soon as the initial symptoms disappear, even where long-term therapy has been rightly prescribed.

- Failure to follow the physician's instruction. Whilst the same factors may play an important role, here a more common problem appears to be failure to understand the physician's instructions, particularly if there is a language problem, or the treatment is relatively complicated and the patient uneducated. A very high proportion of drugs prescribed in the Region are not being used as inteuded.

- Treatment by more than one physician. For various reasons some patients appear to consult more than one physician and thereby obtain multiple prescriptions.

- Self-medication with potent drugs. Whilst in certain countries a limited role has been defined for self-medication of symptoms with simple drugs (analgesics, laxatives, antacids, etc.), many countries in the Region have ~urrently no ef­fective restriction on the sale of more potent drugs without prescription. Consequently, there is a considerable sale of such drugs to patients who have not consulted a physician. This results in real hazards.

3. Studies on deviant patterns

The Working Group was of the opinion that whilst general information on many of the above problems is available, more precise information is needed if these problems are to be adequately analyzed and solved in the Region. In particular, studies in different countries of the Region, and different populations within these countries, are needed on such matters as:

(a) Influences exerted upon the physician which determine his prescribing pattern;

(b) drug-taking behaviour in the population, attitudes towards prescription of drugs and popular knowledge of the properties and proper use of drug products.

III ROLE OF UNDERGRADUATE AND POST-GRADUATE TEACHING IN PROMOTING RATIONAL THERAPY

1. Undergraduate education

The rapid increase in the number and complexity of drugs, as well as knowledge of exist­ing drugs, means that the teaching of pharmacology and therapeutics needs to be reassessed. It is particularly important that this teaching be adapted to the student's understanding and be so designed that he will be prepared for the conditions under which in fact he is going to work. It is important that all "teaching" referred to in this section be consider­ed in the context of clearly defined learning objectives laid down in a total educational plan within each medical school.

(a) Basic pharmacology: In order to become a skilled prescriber, the student must have had training in basic pharmacology. This should generally be given, as in the past, during the late pre-clinical or early clinical phase depending on the structure of the medical

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curriculum alongside with the teaching of physiology because of the links between the two.

Stress should be laid on those topics which play a role in practical therapy, for example, drug kinetics.

The teaching should be given by a basic pharmacologist but student interest and understand­ing will be promoted if clinicians and patients are involved, e.g. by supplementing the pharma­cological teaching and practical work where possible with a relevant clinical demonstration to illustrate the direct practical relevance of the facts taught.

(b) Clinical pharmacology and therapeutics: The teaching should primarily lay stress on broad principles and on the characteristics of classes of drugs rather than on detailed infor­mation with respect to individual products. Since the drugs available to the physician are constantly being replaced by others, it is more important for the future physician to be able to judge a preparation critically than to have an encyclopaedic knowledge of those drugs currently available. In this connexion, he must acquire independence of thought and a cri­tical approach.

In so far as attention is devoted to individual drugs, stress should be laid on those which are generally available for the treatment of the population at large.

Physicians working in the field, including those from health centres, should be consulted as to the pattern of teaching and, where possible, involved in teaching. Students should gain experience in working under the conditions which actually exist in typical out-patient departments, general practice and health centres. This will accustom the future physician to developing a rational or at least a reasonable therapeutic approach where conditions are not optimal.

It is necessary that students obtain a clear idea of the problems raised by side effects and interactions of drugs and learn to monitor their own practice in this respect.

In teaching students, attention must be devoted to the patient as a person, his expecta­tions and the way in which these csn and should influence therapy.

Economical prescribing should be taught as an integral part of the approach to critical drug selection.

The emphasis laid on the teaching of therapeutics is generally inadequate; it should be comparable to that given to other major disciplines. In addition to existing appointments in basic pharmacology, the appointment of professors of clinical pharmacology and therapeutics within clinical departments will ensure that therapeutic teaching is sufficiently stressed whilst avoiding a situation in which it is isolated from the remainder of clinical education. Other organizational forma may be adapted where justified by local conditions.

2. Post-graduate and continuing teaching

Few countries and perhaps none have aolved the problem of maintaining the standards which a physician attains after qualifying.

As medicine changes and becomes more complex, the physician -rldng in a relatively isolated situation baa enormous difficulties in keeping abrea•t. Every effort should be made to encourage the physician to read at least one good medical journal. In future, it may prove possible to introduce schemes for self-assessment, such as are in the United States, by which a doctor can check his own current knowledge at any time.

Possibilities for maintaining and improving standards of practice include:

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(a) Post-graduate courses: Annual post-graduate courses in therapeutics should be instituted in major centres, supplemented by one-day seminars on therapeutics, accessible to all practi­tioners. Where possible, incentives should be provided to participate in these events. The organization of such teaching would be greatly stimulated by instituting chairs of clinical pharmacology and therapeutics, as proposed above. Whilst such courses will probably reach only a minority of physicians, their influence will improve standards of medical practice as a whole.

(b) Other forms of training for busy physicians working in the field, for example, the favour­able e~perience gained in some countries with medical refresher courses given by tape or radio; comparable approaches using modern communication techniques should be more widely developed.

IV DISSJ::NINA'fiON OF INFORHATION AS " MEANS OF PROMO'l'ING RATIOHAL DRUG THEAAPY

Many problems in drug therapy result from the fact that the physician has inadequate in­formation on drugs or that he has been supplied with misleading information. It is of the greatest importance that this situation be corrected.

1. Information provided by manufacturers

Drug advertising and contacts with representatives of pharmaceutical firms are often the matn sources of information for a physician on drugs and sometimes the only ones. Such in­formation is always influenced by commercial interests. The basic theme of promotional material is that a drug will provide the answer to a distressing clinical problem. Little attention is given to aiding the physician to use his clinical judgement. Unfavourable aspects and complications of such treatment rarely receive sufficient attention.

It is recommended that:

(a) Excessive promotion by the pharmaceutical industry be discouraged.

(b) Official control be instituted on the content of advertising material,

(c) The direction folders issued with drugs be similarly subject to official approval to ensure that information is balanced and sufficiently complete to meet the prescriberrs needs.

(d) Drug control authorities should officially require and approve data sheets for every new drug and ensure that manufacturers make these available to physicians.

(e) The issuing of samples by drug representatives to physicians be rapidly controlled or prohibited. It may be useful to show a new preparation to the physician so that he can sub­sequently recognize it, but the provision of samples does not usually improve the physician's understanding of a drug or enable him to test it adequately, In addition, samples are commonly misused.

2. Information provided by Journals

National medical journals, where they exist and are regularly published, should be en­couraged to provide current articles on new drugs and on drug therapy, designed to aid the general practitioner.

3. Impartial bulletins

It is strongly recommended that, in the countries of the Region, impartial drug infor.a­tion bulletins be instituted to provide physician• with reliable and readily accessible in­formation on drugs. Experience with such bulletins, published for example by consuaer

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~rganizations or government agencies in other areas of the world, has shown that they meet a real demand amOng physicians and that they can couD.teract or supplement where necessary the information provided by manufacturers. In particular, it is recommended that:

(a) Such journals be provided free of charge to all practitioners and students.

(b) Such journals be issued frequently so as to deal with matters of current importance.

(c) The articles should be simple and attractive, in order to compete with commercial drug advertising.

(d) Such articles should be exchanged internationally, both within and outside the Region, in order to make use of the experience already gained elsewhere and to avoid costly duplica­tion of work. For locating the respective references and information, use should be made by universities and health authorities of the WHO Medline Centre. The services are available through the Regional Office.

4. Formularies

A formularly designed for national use or for use in hospitals and health centres will comprise a selection of drugs with brief notes on their properties and use. Only those drugs needed in the situation for which the formulary is intended should be included. In view of ·the. constantly changing drug scene, it is vitally important that formularies be kept up to date. Hitherto, formularies have commonly been distributed on a l:bnited basis; they should be made available more widely and at low cost or free of charse.

5. Information on costs

Physicians should be provided with information on the true cost of drugs and drug treat­ment in order to take these into account when selecting treatment.

6. Information to medical auxiliaries

Since the medical auxiliary is, in many countreis of the Region, entitled to issue and employ a limited range of drugs, it is of great importance to ensure that he is kept adequately informed, for example by means of a properly adapted formulary or bulletin. on the drugs available to him, their properties and proper use.

V ROLE OF CLINICAL PHARMACOLOGY IN PROMOTING EFFICACIOUS, SAFE AND ECONOMICAL DRUG THERAPY

Clinical pharmacology comprises all aspects of the scientific study of drugs in manl.

The need for trained clinical pharmacologists bas. arisen because of the enormous increase in available drugs, as well as in knowledge about drugs, that bas occurred in the past thirty years.

The scope of clinical pharmacology includes:

(a) Pharmacodynamic&: the biological and therapeutic effects of druse,

(b) Pharmacokinetics: absorption, distribution, metabolism and excretion,

(c) Controlled therapeutic trials to determine ~ther a drug is useful in treating disease and its value in comparison with other drugs,

1 Wld Hlth Org. techn. Rep. Ser., 1970, No. 446

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(d) Therapeutic auditing: the assessment of efficacy and safety in relation to the individual and the community in which it is used. The practicality of drug use with the available medical skills and environmental situation, etc.

The clinical pharmacolngist is particular-ly concerned with the introduction of new drugs.

Clinical pharmacology is particularly useful in:

1. Education

(a) Undergraduates need to apply the principles of pharmacological science to the clinical situation, to understand how and why drugs work and to develop a critical attitude to thera­peutic claims. It is of the utmost importance that undergraduates learn to think logically and critically about drugs.

(b) Practising physicians need continuous supporting education and information to assist them in choosing and using drugs.

Research into drug actions, adverse reactions, prescribing patterns and problems.

3. Service

(a) Monitoring drug use

(b) Information, in collaboration with pharmacists

(c) Government drug regulatory agencies to advise on introduction of drugs, therapeutic claims, etc.

(d) Design of clinical drug studies

(e) Management of poisoning.

The activities of the clinical pharmacologist contribute to safe, effective and economical drug use. "To safeguard individual and public health, an immediate and substantial expansion of clinical pharmacology is essential"!.

The Working Group recoUID.ends that "centres of excellence" in clinical pharmacology should be established in medical schools in the Region in order to serve its special needs.

(The opinion of members of the Working Group on a number of questions relating to medical education was expressed in the answers to a questionnaire distributed during the meeting; the questions are annexed to the present report).

VI USE OF UNIFORM NON-PROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES

1. Non-proprietary names

WHO is at present operating a programme for the selection of International Non-proprietary Names.. Over 3 000 names have been published and approximately 200 new ones are added yearly. In countries where the Governments provide free drugs under the medical care programme, there was some argument as to whether drugs should be used under their non-proprietary or their brand names.

1 Wld Hlth Org. techn. Rep. Ser., 1970, No. 446

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Where the use of the non-proprietary nomenclature was introduced, it allowed substitution between pharmaceutical preparations having the same active ingredient by a governmental purchas­ing agent or by the pharmacist filling the prescriptions. Practical experience has shown that this procedure results in saving funds because many of the non-proprietary preparations are cheaper than their alternatives sold under a brand name. Although savings may be considerable, this procedure compels health authorities, in principle, to ensure therapeutic equivalence of interchangeable products. A few authorities publish this information based on data produced by governmental laboratories. In countries of this Region where facilities and manpower for these studies are limited; where even now the pharmaceutical analysis of identity and purity of the active compound of a preparation creates problem, where bioavailability studies cannot be conducted, authorities have to choose between saving funds and taking the risk of occasional therapeutic inequivalence of interchangeable drugs, or the adoption of a liberal prescribing practice which may be somewhat more expensive but passes the responsibility for selecting the appropriate preparation to the physician. (Problems of "Bioavailability of Drugs" are dis-cussed in WHO Technical Report Series, 1974, No. 536).

2. List of essential drugs

In order to make available to health services throughout the country high quality drugs at reduced prices, some countries have made a decision to compile a list of essential drugs or introduce a basic medicines' scheme. In such countries, legislation gives authority to the Government or to a designated agency to draw up a restricted list of necessary medicines avail­able to the National Health Services.

The requirements for the drugs selected for this list are the same as those used in drug evaluation in connexion with drug registration. These lists are used to simplify and ration­alize drug purchase, drug distribution, drug prescribing and drug quality control. Further, these lists simplify the introduction of undergraduates to drug usage. They also simplify the information on the use of these drugs to the medical profession.

Experience has demonstrated that if such lists are to be introduced, or if only non­proprietary names are to be used, the medical and pharmaceutical profession should be well prepared beforehand, and consulted on their compilation and updating.

It was recommended that, in this connexion, WHO should play a role in assisdng national authorities in the appropriate introduction of new nomenclature and the establishment and use of the selected drug lists.

VII TEACHING THE PUBLIC TO USE DRUGS

It is necessary that the public be helped to acquire the proper attitude to drugs, both prescribed and non-prescribed. They need to learn to use drugs in a responsible manner, but should also learn that in many conditions, drugs are not a necessary part of the treatment.

The Working Group noted that, in some other Regions, principles have been developed accord­ing to which such learning can be encouraged. These will necessarily need to be adapted to local conditions, taking into account the degree of literacy of the public, social and cultural traditional patterns o{ misuse which have eaerged and other local problems resulting from the pattern of disease and treatment in that area.

The Working Group recommended that goveruaenta develop and control plans for such instruc­tion of the public and ensure that they are carried out in a co-ordinated manner. The principal elements in such programmes could be:

(a) Development of better instruction via physicians and other health workers; every health worker should regard himself as a health teacher. Excellent opportunities to teach proper use of drugs exist in some types of out-patient departments, e.g. diabetic clinics. In other

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situations, the medical auxiliaries can be entrusted with such instruction in view of their often very cloHe contacts with the population.

(b) Radio, television, posters and other forms of mass communication have been successfully employed.

(c) Use of community leaders, e.g. religious leaders. These have successfully collaborated in programmes to combat drug abuse and abuse of alcohol.

(d) Instruction in schools as part of elementary health education.

The publication in journals directed to the public of medical articles and medical advice in which specific treatments and drugs are recommended is to be regarded as unethical and contrary to thE! interests of public hf>al th.

Advertising of drugs direct to the public should be subject to strict control.

VIII THE FUNCTION OF A DRUG CONTROL ORGANIZATION IN PROMOTING RATIONAL DRUG THERAPY

Although some countries in the Region have long-established drug control organizations, they are handicapped by shortage of skilled manpower and technical facilities. But not all have a comprehensive drug control system that supervises quality, safety and efficacy of drugs.

It has long been impossible for the individual physician to make his own assessments in these areas and a strong drug control otganization is essential to ensure that he is offered only products that have been adequately assessed. It also protects the public.

Drug control organizations review data on each product under the following heads:

(a) chemistry and pharmacy

(b) pharmacology and toxicology

(c) clinical pharmacology and therapeutic use.

Each product must be evaluated to standards that are generally agreed to represent good practice.

In addition, the organization supervises promotion to the"physician and to the public to ensure that information is both complete and truthful.

A drug control organization requires a highly skilled decision-taking body comprising pharmacists, pharmacologists, toxicologists, clinical pharmacologists, clinicians, medical statisticians and lawyers. These should be independent in the sense that their decisions are made on medical and scientific grounds. However, the drug control committee will require to be serviced by a competent full-time scientific staff.

The cost of this organization can be reduced by fees paid in connexion with applications for registration of medicines.

In view of changing standards, and accumulation of new knowledge on existing drugs, registration of a drug should be recorded for a limited period only, after which re-evaluation can if necessary be performed.

Plainly it would be extremely wasteful if all countries made independent decisions on all products. International collaboration on decisions and exchange of information is essential. The Working Group recommended that WHO should actively help in establishing such interchange.

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Most countries control medicines under a miscellany of regulations. In order to establish efficient drug control these will generally require to be rationalized under one law which may also cover other aspects of drug control, e.g. inspection, etc.

The Working Group recommended that WHO should assist in establishing guidelines for a good law and good drug control practice.

C SUMMARY OF RECOMMeNDATIONS

(a) Studies on such matters as:

(i) Influences exerted upon the physician which determine his preaeribing pattern;

(ii) Drug-taking behaviour in the population, attitude towards prescription of drugs and popular knowledge of properties and proper use of drugs should be undertaken in countries of the Region and different populations.

(b) Undergraduate teaching with respect to drug therapy should prepare the future physician for the conditions under which he is likely to work. The emphasis laid on the teaching of therapeutics should be comparable to that given to other major disciplines.

(c) Post-graduate and continuous teaching of physicians should be developed to maintain and improve standards of drug therapy.

(d) The supply of information on drugs to practising physicians should be strictly controlled and expanded to ensure objectivity and completeness.

Measures which are required include:

(i) control on advertising of drugs;

(ii) strict limitation of drug sampling;

(iii) improved drug information in journals;

(iv) establishment of impartial &r~ 1Dformation bulletins;

(v) institution of formularies;

(vi) ready availability of information on costs.

(e) Medical auxiliaries should similarly receive adequate drug information.

(f) In view of the great importance of clinical pharmacology in education, research and drug control and the contributions which this science can make to safe, effective and economic drug use, "centres of excellence" in clinical pharmacology should be established in medical schools.

(g) Further studies on the problem of distribution of medicines under brand names or non­proprietary names are required.

(b) Programmes should be developed to ensure that the public learn to use drugs in a responsible manner.

(i) In view of the basic importance of effective drug control, the establishment of drug control organizations in countri .. in the Region is a .. tter of ursency.

(j} International collaboration through WHO is needed in order to accelerate this development and avoid duplication of efforts.

WHO EMRO EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 Annex I page i

ANNEX I

TEACHING UNDERGRADUATES TO PRESCRIBE IDEALS AND REALITIES!

Please express your views by the means provided below as an introduction to further discussion.

For each statement circle the initials on the right which correspond to your views:

SA = STRONGLY AGREE D = DISAGREE

A= AGREE SD = STRONGLY DISAGREE

N = NO OPINION

1. If we have taught pharmacology and the art of prescribing, but the students have not learned, there must be something wrong with the students.

2. A student who was not carefully introduced to the principles of pharmacology during his pre­clinical education will not become a skilled prescriber.

3. The actual conditions of out-patient practice should have a great influence on the prescribing skill taught.

4. The average general practitioner prescribes not more than about thirty different preparations. He must, nevertheless, at one time of his univer­sity education be introduced to the whole wealth of the preventive and curative armamentarium.

5. It is essential that a student learn pharmacological principles before he learn~ about therapeutics and prescribing.

6. Learning about therapeutics is more efficier.t if teaching is separated from other topic~ such as human pathology~ examination of p:ttients ar:.d lntro­duction to specialized clinical dis ielines.

7. The time and attention given t<.1 ... herapeutics in present clinical education is adequate, bPcause the introduction to the more complex matl,. diagnosis merits priority.

8. The introduction of undergraduates to the average practice of medicine in out-patient clinics during his clinical study years can conft:se him and inter­fere with the goals of preventive medical education.

9. The skills and thinking patterns a student learns about pharmacology and therapeutics should be very similar to those he must use as a physician.

SA A N

SA A N

SA A N

SA A N

SA A N

SA A N

SA A N

SA A N

SA A N

D SD

D SD

D SD

D SD

D SD

D SD

D SD

D SD

D SD

l(A survey used by the Working Group to precipitate opinion, stimulate discussion and explore views)

EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 Annex I page ii

10. The drugs and drug groups which must be emphasized most in teaching are those used in the treatment of the most common diseases and conditions of the population.

11. It is useless to motivate undergraduates to adbere to principles of rational therapy after leaving the university. The enviroraental forces are stronger.

12. Conduct of rational therapy in cases wbere a defiaite diagnosis cannot be made has to be taught in medical schools.

13. Students must be trained and motivated to monitor the rationality of their drug prescribing in their later practice.

14. The five most important skills or abilities in pres­cribing that the graduated student should be abla to perform are:

He must be able to:

1. 2. 3. 4. 5.

SA

SA

SA

SA

WHO EMRO

A N D SD

A N D SD

A N D SD

A N D SD

WHO EMRO EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 Annex II

ANNEX II

AGENDA

1. Opening Address

2. Adoption of the Agenda

3. Rational drug therapy in Mediterranean countries: present situation

Eastern the

4. Problems in supply and uae of drugs

(a) Need for information on drug use

(b) Over-prescribing

(c) Superfluous and irrational products

(Dr A.H. Taba, WHO Director, Eastern Mediterranean Region)

(Dr H.H. Friebel)

(Dr A. Raategar)

(Dr A. Rastegar)

(Dr M.N.G. Dukes)

5. Teaching undergraduates to prescribe: (Dr M.H. Ghanem) ideals and realities

6. Continuing education and information; (Dr N.D.W. Lionel) sources of information; the role of formularies, journals, official bul-letins, industry

1. Experience of a national policy to (Dr F. Fazli) use only non-proprietary names

8. Role of clinical pharmacology (Dr D.R. Laurence)

9. Teaching the public how to use drugs; (Dr T.A. Baasher) prescribed, non-preacribed

10. The function of a government drug (Dr M.N.G. Dukes) control agency in promoting rational drug therapy

11. Formulation of conclusions and recommendations

12. Closing Session

WHO EMRO

ANNEX III

EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 Annex III page i

LIST OF PARTICIPANTS

Dr H.M.A. Abu Sabaa Lecturer in Medicine and Therapeutics Faculty of Medicine University of Khartoum Khartoum SUDAN

Dr Abdulla Al-Rifai Director of Curative Medical Services Ministry cf Public Health Kuwait KUWAIT

Dr J .E. Azar Professor and Chairman Department of Infectious Diseases

and Epidemiology American University of Beirut Beirut LEilANON

Dr T.A. Baas her Regional AJviser on Mental Health WHO Region.al Office for the

Eastern Mediterranean Alexandria EGYPT

Dr M.N.G. Dukes Head Division of Pharmacotherapy Ministry of Public Health and

Environmental Hygiene Leidschendam NETHERLANDS

Dr N. El Girbi Director Department of Pharmaceuticals

and Medical Equipment Ministry of Health Tripoli LIBYA

Dr M.N. El Mahallawi President Ain Shams University Cairo EGYPT

EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 Annex III page ii

Dr A. El Sherif Professor of Cardiology Universiry of Cairo Cairo EGYPT

Dr T. Fakouhi P1:ofesaor and Chairman of Pharmacology Department of Pharmacology Medical School Pahlavi University Shiraz IRAN

Dr z. Farid Rapporteur Head, Department of Tropical Medicine US Naval Medical Research Unit No. 3 American Embassy Cairo EGYPT

Dr F.R.Y. Fazli Deputy Director-General (Pharaacy)/

Drugs Controller Ministry of Health and Social Welfare Islamabad PAKISTAN

Dr D.L. Ford Consultant in Education Planning

and Technc logy WHO Regional Office for the Eastern Mediterranean

All!lUlndria EGYPT

Dr H.H. Friebel Secretary Regional Adviser on Prophylactic

and Therapeutic Substances WHO Regional Office for the Eastern Mediterranean

Alexandria EGYPT

Dr M.H. Ghanea Profeaaor of Interul Medicine Faculty of Medicine Alexandria University

Dr D. Habte Associate Profesaor and Head

Department of Paediatrics Ethio-Swediah Paediatric Clinic Addis Ababa ETHIOPIA

WHO EMRO

WHO EMRO

Dr A. Khalidi Department of Pharmacology Faculty of Medicine University of Baghdad Baghdad IRAQ

Dr A. Khogali Regional Adviser on Medical Education

WHO Regional Office for the Eastern Mediterranean

Alexandria EGYPT

Dr D.R. Laurence Professor of Pharmacology and

Therapeutics University College Hospital Medical School

University of London London ENGLAND

Dr N.D.W. Lionel Chairman Associate Professor of Pharmacology Department of Pharmacology Faculty of Medicine University of Sri Lanka Colombo SRI LANKA

Mr N.P.H. Milner WHO Pharmacist Crater Aden DEMOCRATIC YEMEN

Dr Samir Najjar Chairman a~d Professor of Paediatrics American University of Beirut Beirut LEBANON

Dr A. Navab Dean Faculty of Medicine Isfahan University Isfahan IRAN

EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 Annex III page iii

EM/PHARM/66 EM/WG.RTC.DRG.THR.EFF.SAF.ECON./4 Annex III page iv

Dr A. Rastegar Associate Professor of Medicine Saadi Hospital Pahlavi University Shiraz IRAN

Dr A. Robertson Public Health Administrator

(Health Manpower Develop~~~ent) WHO Regional Office for the Eastern Mediterranean

Alexandria EGYPT

Dr A. Sharaf Senior Chest Physician Shaab Hospital for Chest and Heart Diseases

Khartoum SUDAN

Dr A.H. WabM Regional Officer for Biology

Pharmacology and Toxicology WHO Regional Office for Europe

Dr A.B. Taba Director WHO Eastern Mediterranean Region

Dr K.O. Shoib Director, Health Services WHO Eastern·Kaditarranean Region

WHO EMRO