Clinical Pharmacology - World Health Organization

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World Health Organization itRegional Office for EuropeCopenhagen VClinical PharmacologyThe European ChallengeWHO Regional Publications, European Series, No. 39

The World Health Organization is a specialized agency of the United Nationswith primary responsibility for international health matters and public health.Through this Organization, which was created in 1948, the health professionsof some 165 countries exchange their knowledge and experience with the aimof making possible the attainment by all citizens of the world by the year 2000of a level of health that will permit them to lead a socially and economicallyproductive life.The WHO Regional Office for Europe is one of six regional officesthroughout the world, each with its own programme geared to the particularhealth problems of the countries it serves. The European Region has 31 activeMember States,a and is unique in that a large proportion of them are industrialized countries with highly advanced medical services. The European programme therefore differs from those of other regions in concentrating on theproblems associated with industrial society. In its strategy for attaining the goalof "health for all by the year 2000" the Regional Office is arranging its activitiesin three main areas: promotion of lifestyles conducive to health; reduction ofpreventable conditions; and provision of care that is adequate, accessible andacceptable to all.The Region is also characterized by the large number of languages spokenby its peoples and the resulting difficulties in disseminating information to allwho may need it. The Regional Office publishes in four languages - English,French, German and Russian - and applications for rights of translation intoother languages are most welcome.a Albania, Austria, Belgium, Bulgaria, Czechoslovakia, Denmark, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Malta,Monaco, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Spain,Sweden, Switzerland, Turkey, USSR, United Kingdom and Yugoslavia.

Clinical pharmacologyThe European challenge

WHO Library Cataloguing in Publication DataClinical pharmacology : the European challenge(WHO regional publications. European series ; No. 39)1.Pharmacology, clinical - education. 2.EuropeI.SeriesISBN 92 890 1302 8ISSN 0378 -2255(NLM Classification: QV 20)

World Health OrganizationRegional Office for EuropeCopenhagenWHO Regional Publications, European Series, No. 39Clinical pharmacologyThe European challenge

EUR/ICP/DSE 145ISBN 92 890 1302 8ISSN 0378 -2255 World Health Organization 1991Publications of the World Health Organization enjoy copyright protection inaccordance with the provisions of Protocol 2 of the Universal CopyrightConvention. For rights of reproduction or translation, in part or in toto, ofpublications issued by the WHO Regional Office for Europe applicationsshould be made to the Regional Office for Europe, Scherfigsvej 8, DK -2100Copenhagen 0, Denmark. The Regional Office welcomes such applications.The designations employed and the presentation of the material in thispublication do not imply the expression of any opinion whatsoever on the partof the Secretariat of the World Health Organization concerning the legal statusof any country, territory, city or area or of its authorities, or concerning thedelimitation of its frontiers or boundaries. The names of countries or areas usedin this publication are those that obtained at the time the original languageedition of the book was prepared.The mention of specific companies or of certain manufacturers' productsdoes not imply that they are endorsed or recommended by the World HealthOrganization in preference to others of a similar nature that are not mentioned.Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.The views expressed in this publication are those of the contributors and donot necessarily represent the decisions or the stated policy of the World HealthOrganization.PRINTED IN ENGLAND

CONTENTSPagePrefaceClinical pharmacology in Europe: an indispensablepart of the health service -WHO Working Groupon Clinical Pharmacology in EuropeThe teaching and organization of clinicalpharmacology in European medical schools -WHOWorking Group on Clinical Pharmacology in EuropeClinical pharmacology and primary health care inEurope: a gap to bridge - WHO Working Groupon Clinical Pharmacology in EuropeCountry d 16365677175777983v

PrefaceTwenty -one years ago, a WHO study group formulated the principles ofclinical pharmacology .a Since then, it has become an established medicaldiscipline in a number of countries, notably the Nordic countries(Denmark, Norway and Sweden), the United Kingdom and the UnitedStates. Despite the consensus on the need for improvements in the designand conduct of clinical drug studies and in the teaching of the proper useof medicines to medical students in the European Region, clinicalpharmacology had a slow start in many countries and initiatives sometimes failed.It is obviously in the interest of public health and therefore of WHOthat drugs be used for the right indications and in the right dosage and thatthe choice of drugs be appropriate for the patient, his or her environmentand the local conditions. Work towards this goal in the Region has mainlyemphasized the furthering and improvement of the teaching of theprinciples of clinical pharmacology and pharmacotherapy to medicalstudents and doctors. These in turn were the purposes of the WHOWorking Group on Clinical Pharmacology in Europe, which was set upin 1986.The Working Group, consisting mainly of university teachers ofclinical pharmacology, had broad terms of reference. The Group laiddown general principles for the teaching of and training in clinicalpharmacology, and formulated general guidelines on the role of thediscipline in health care delivery with special emphasis on primary healthcare. These principles and guidelines were published in three articles inthe European journal of clinical pharmacology; the articles are reprintedin this book with the permission of the publisher, Springer Verlag.In addition, a questionnaire was sent out to medical schools and healthministries about the academic status of clinical pharmacology in the WHO Technical Report Series, No. 446, 1970 (Clinical pharmacology. Scope,organization, training: report of a WHO Study Group).vii

countries of the European Region. By the end of data collection in July1990, all countries had responded, with one exception. The responseswere then edited by a member of the Working Group, ProfessorM. l'E. Orme. Although subsequent events in Germany created uncertainty about the data obtained from the former German DemocraticRepublic, it was decided to present the data as they have been given.We would like to express our gratitude to the many colleagues in drugadministration and universities in the European Region for providinginformation on conditions in their countries. Clinical pharmacology isstill a poorly defined discipline, and definitions of an academic unit ordepartment are necessarily rather vague; thus, value judgements are farfrom uniform. Assessments of the local situation may therefore be under or overstated. By redrawing the maps presented with the country reports,however, we tried to provide a picture of clinical pharmacology for theRegion as a whole.This book includes a guide to academic programmes in clinicalpharmacology in the European Region as well as a discussion of the rolethat the discipline could play in medical schools and health care. It ishoped that this fruit of the Working Group's labours will increase interestin clinical pharmacology and thereby improve health care.F. Sjöqvist M.N.G. DukesM. l'E. OrmeI. LundeL. Offerhausviii

Clinical pharmacology in Europe:an indispensable partof the health servicesWHO Working Groupon Clinical Pharmacology in EuropeIntroductionClinical pharmacology is a medical discipline which, on a scientific basis,combines pharmacological and clinical expertise with the ultimate goalof improving efficacy and safety in the clinical use of drugs.The central role of drug therapy in many fields of medicine is thebackground for establishing clinical pharmacology as a separate discipline. The significance of modern drug therapy is undisputed. Theavailability of effective drugs for the treatment of infections, cardiovascular diseases, neuropsychiatrie disorders and certain malignantdiseases has radically changed medical treatment.In 1970 a WHO study group recommended the development ofclinical pharmacology as a discipline integrated into the health servicesystem (1). To some extent this action was stimulated by the thalidomidecatastrophe and the rapid progress in the drug field through the 1960s,with several important innovations on the drug scene. Clinical pharma-cology then developed because of the medical need to establish inscientific terms the benefits of drug therapy relative to its risks. In 1977a WHO working group further outlined the fields in which clinicalpharmacology services were needed (2).In spite of these initiatives, the development of clinical pharmacologyin many countries has been slow. Several other drug disasters, such as thecomplex adverse reactions to the cardiovascular drug practolol and to thea Reproduced by permission from the European journal of clinical pharmacology,33: 535 -539 (1988).b Members: J. Bircher, M. Bogaert, M.N.G. Dukes, M. Eichelbaum, L.F. Gram,H. Huller, M. Orme, F. Sjöqvist, G. Tognoni.1

antirheumatic drug benoxaprofen, have further underlined the need forbetter knowledge in this field (3). Research in clinical pharmacology hasfurther shown that optimization of therapy by pharmacodynamic andpharmacokinetic monitoring may not only reduce the risk of adverseeffects, but also improve the efficacy of drug treatment.Thus, it has repeatedly been recognized that the use of drugs issometimes associated with severe adverse reactions which are notbalanced by the therapeutic gains. The major approach to solving thisproblem has been the introduction of elaborate central drug controlsystems, particularly related to the registration of new drugs. However, inspite of a well developed control system in several countries, apparentlyunpredictable problems still arise when drugs are taken into general use.In all probability only a broader approach, with increasing emphasis onknowledge of drugs among physicians in the hospital and primary healthservices, can improve the standard of drug use.In a sense all physicians who are interested in the effects of drugs ontheir patients may be seen as clinical pharmacologists, but few of themhave been properly trained in this role. Clinical pharmacologists arefirstly physicians who have received full training in clinical medicine andhave also received training in the methods of studying and eliciting drugresponses in humans, and of studying the absorption, distribution,metabolism and excretion of drugs, and in the principles of clinical drugevaluation. They will often provide the interface between laboratoryscientists and clinicians.In western Europe the annual cost of drugs per capita is US 50 -100(4). Secondary costs derived from drug- related events, such as adversedrug reactions causing hospitalization, inability to work and other prob-lems add to the total costs. By rationalizing drug therapy in terms ofselection of drugs, dosing and treatment principles, substantial costs canbe saved, while at the same time the quality of health care may be improved.Clinical pharmacology as an independent academic discipline wasfirst established some 20 years ago. The developments over the followingyears have been strikingly different in different countries. In somecountries chairs in clinical pharmacology have now been established inmost medical schools (German Democratic Republic, Scandinavia, UnitedKingdom), whereas clinical pharmacology has hardly been recognized asan independent discipline in many other countries.In this working paper the main functions of clinical pharmacologywithin service, teaching and research will be described.2

Clinical Pharmacology ServiceClinical pharmacology service may be provided at international (e.g.through WHO), national, regional or local levels. The clinical pharmacology service at a national level is mainly provided in relation to theservices of drug regulatory agencies, whereas the service at a local orregional level usually will be associated with a regional clinical pharmacology regulatory centre.Central drug regulatory agencies deal with drug registration, controlof clinical trials, adverse drug reaction monitoring, and drug information, and thus encompass a number of clinical pharmacological functions.The services of clinical pharmacologists are necessary in particular for thefollowing purposes:- to decide whether animal data on a drug are adequate to justify itsadministration to humans;- to decide whether therapeutic trials justify release for general use;- to develop and conduct drug monitoring programmes;- to advise on restrictions on the availability of drugs or theirwithdrawal from the market.However, and mainly for historical reasons, the participation ofclinical pharmacologists in these services has varied and has been limitedin most countries. With an increasing understanding of the significant roleof clinical pharmacology in those areas, and the increasing availability ofclinical pharmacologists, this ought to change in future.At the regional and local level clinical pharmacology has a servicerole in a number of areas.Patient care is undertaken by clinical pharmacologists as a routineresponsibility in some centres (general medicine or drug problem orientedconsultations), and more indirectly, through consultative functions,"pharmacotherapeutic rounds ", and drug conferences at other centres.This will depend on local circumstances.Clinical pharmacologists play an active role in providing informationabout drugs. This may be done in collaboration with pharmacists, andthere may well be local or regional drug information centres (5). Drug orformulary committees have already been established in the hospital sectorin many countries, but are now also starting to cover the needs of primaryhealth care in some countries. The activities of such committees are3

usually closely linked to the clinical pharmacology service where thelatter exists. By carrying out current drug utilization surveys, the clinicalpharmacologist can fulfil an important task by early detection of changesin prescribing habits that may be undesirable in terms of drug costs or drugeffect profiles, and by evaluating the effects of drug informationprogrammes. Adverse drug reaction monitoring programmes may servesimilarly as an early warning system, which is particularly important fornewly introduced drugs, whose potential adverse reactions have not beenfully evaluated (6). Clinical pharmacology departments can also providetrained personnel, who can quickly begin investigation of a suspectedadverse drug reaction and in some centres can also manage cases ofoverdose. It should not be forgotten that drug- related problems mayaccount for more than 10% of the admissions to general medical wards (7).Standard doses of drugs may produce widely different drug concentrations in different patients. Drug concentration monitoring is essential,therefore, for some drugs, such as certain antiepileptics and antidepressants, lithium, theophylline and digoxin. In such cases low plasmaconcentrations may result in therapeutic failure, and high plasma concentrations may produce severe adverse reactions (8, 9). The clinical pharmacologist, by virtue of his or her training, is uniquely qualified to organizethis service, both in provision and interpretation of the data, as well as indeciding whether further techniques, such as protein binding studies orpharmacogenetic evaluation, are required.Although some clinical trials are carried out by clinical pharmacologists, many are conducted by clinical specialists. The clinical pharmacologist is a source of advice to clinicians who are going to conductsuch trials, and clinical pharmacology groups sometimes provide specialservices, such as drug assays and facilities and personnel for the coordination of multicentre trials.A major goal of the clinical pharmacology service should be toestablish close contact with general practice. Primary health care physicians prescribe the majority of all drugs used, and the need for current druginformation and consultation is probably even more pronounced therethan in hospitals.Teaching in Clinical PharmacologyUndergraduate teaching in clinical pharmacology has not, in commonwith other clinical pharmacology functions, reached such an internationallevel of recognition that general rules can be given. At some medical4

schools clinical pharmacologists participate in basic pharmacology courses,usually given early in the clinical part of the study. Later in the curriculum,teaching in clinical disciplines is usually centred on symptoms anddiagnosis, and little or no time is given to the principles of drug treatment.Regular clinical pharmacology courses, usually at the end of the course,are included to a varying extent in different medical schools. This may beas formal lectures, integrated clinical teaching sessions or "therapeuticrounds ". In general there is increasing understanding of the need forclinical pharmacology courses in the undergraduate curriculum. Medicalstudents should receive a thorough grounding in the principles of clinicalpharmacology so that they can appreciate the rational use of drugs. Theywill then carry with them into their professional lives a framework whichwill allow them to interpret the actions and uses of new drugs as they areintroduced into clinical practice. We believe that clinical pharmacologyteaching should be a mandatory part of the medical curriculum and thatthis teaching should take place during the clinical years.Postgraduate teaching has traditionally been a field in which clinicalpharmacologists have played a much more prominent role than at theundergraduate level (10). Drug therapy is a dynamic, rapidly changingfield with a corresponding need for continuing education. Afterqualification doctors need a continuing source of information aboutdrugs, both new and old, and all too often doctors have relied forinformation on the promotional efforts of the pharmaceutical industry. Itis generally accepted that the standard of prescribing and use of drugs istoo low in many fields of medicine. Intensified administrative controlmeasures cannot improve this, and we believe that all doctors shouldundergo mandatory education in therapeutics at regular intervals duringtheir professional lives. Such teaching must be independent of thepharma -ceutical industry, and should be based on comparative evaluationof the best available treatments. The establishment of close contactbetween clinical pharmacology centres and general practitioners maybecome an important framework for such continuing educationprogrammes.Clinical Pharmacology ResearchIn all academic medical disciplines, service and teaching are closelyrelated to research, and this link is particularly strong in clinical pharmacology. There will be continuing interaction between these fields, and5

research functions must be considered an integral part of any clinicalpharmacology centre. The goals of the research will be to improve drugtherapy, not only by developing means to avoid unwanted effects, but alsoby improving the efficacy of therapy through various means of drug andeffect monitoring.Clinicalpharmacokinetic studies of absorption, distribution, metabolism and excretion of drugs have traditionally had a prominent role inmany clinical pharmacology research centres. Research may includekinetic studies during single and multiple dosing, drug concentration/effect studies, and the role of active metabolites in drug action. Central tothis research is interindividual variability in pharmacokinetics, whichseems to be a major determinant of variations in the effects of many drugsin humans (11). Genetic factors seem to be of considerable importanceand they have been particularly well documented in relation to drugmetabolism. This may shed new light on the occurrence of rare, severeadverse drug reactions (12). In general, the scope of pharmacokineticresearch is to provide a scientific basis for safer and more effective clinicaluse of drugs by understanding interindividual variability.Clinical pharmacodynamic studies encompass a wide variety oftechniques and principles. The measurement of therapeutic drug effectsin relation to drug evaluation is a classical problem. The development ofmore sophisticated techniques for studying drug- receptor interactionsin vivo and in vitro can add new dimensions to clinical pharmacodynamic research, and clinical pharmacologists should play a rolein bridging the gap between experimental pharmacology and clinicalmedicine.Drug evaluation and therapeutic trials aim at defining the potentialbenefits and hazards of new drugs (13,14). It is increasingly accepted thatthe requirements for such studies are considerable and demand expertisein various fields, with the clinical pharmacologist in a central role. Theserequirements relate to the precision with which true differences betweennew and old drugs can be established in terms of therapeutic efficacy andsafety in the smallest number of patients. We see the role of clinicalpharmacologists as ideally fitting them to help in the design of clinicaltrial protocols by which the mechanisms of action of the drugs which aretested, and the reasons for variability of their effects may besystematically explored in carefully defined populations.Drug epidemiology /utilization has been an area of growing concernand research interest during recent years (15). International collaborativestudies have shown considerable differences in drug consumption in6

different countries, and even within countries pronounced differencesoften occur. The results, mainly based on sales figures and prescriptiondata, ought to be further examined in relation to morbidity, social andeconomic factors, patient and doctor attitudes, medical education, andreferral and prescription patterns, etc.Training of Clinical PharmacologistsFormal training programmes in clinical pharmacology exist only incountries in which clinical pharmacology has been recognized as aseparate medical speciality, but proposed training programmes are available for some other countries.In general the programmes require an academic degree in medicine(e.g. MD) followed by combined clinical and clinical pharmacologicaltraining. We recommend, on the evidence presented above, that theclinical training period should typically include service functions, teaching and research in clinical pharmacology. More specifically, it shouldinclude basic clinical service in one of the main clinical specialties, whilethe emphasis should be in specialist training in clinical pharmacology,which may include experimental pharmacology. The overall trainingperiod after the period of residency in hospital will normally be five to sixyears.Clinical Pharmacology CentresIn those countries where clinical pharmacology has been established as amedical discipline, clinical pharmacology departments (units, divisions,centres) have been established at or in conjunction with a universityhospital. The departments may have been established either as separateunits or within existing departments of pharmacology or internalmedicine. In either case the clinical pharmacologists may have directclinical responsibilities, using, in the latter case, hospital beds whichbelong to the department. The size of existing clinical pharmacologydepartments varies considerably, and the optimal organization of clinicalpharmacology units within the health system has yet to be defined. Theexisting departments usually cover regions with populations of 1 -3million, but smaller units have been proposed.The present location of clinical pharmacology departments in anacademic setting in a university hospital dictates a relatively strong7

emphasis on research and teaching relative to service. The introduction ofclinical pharmacology into district general hospitals would shift the mainbasis to service functions, as already described. We can expect furtherdevelopments in this direction in primary health care.Perspectives: Use of Clinical Pharmacological ExpertiseIn the pharmaceutical industry the central role of clinical drug testing indrug development has been acknowledged, and the employment ofclinical pharmacologists in the industry is already increasing. Use of moreclinical pharmacological expertise in central, national drug controlagencies, in conjunction with an improved regional clinical pharmacological service, seems to be essential to achieve a better and moreintegrated system for the development and control of new drugs. However, the major goal of the development of clinical pharmacology will beto provide service and research facilities to both hospitals and the primaryhealth sector. Precisely how such facilities should be organized has notbeen generally defined, and local and national circumstances have to beconsidered. There is, however, a need for definition of the minimalrequirements for clinical pharmacological expertise in this part of thehealth sector.An integrated development, such as that outlined in this paper, shouldallow clinical pharmacologists to express more fully their role withrespect both to medicine and society. It would also provide the capacityto answer the increasing and justified requests from patients for a morecomplete understanding of the role of drug therapy in the prevention andtreatment of disease.References1. WHO Technical Report Series, No. 446, 1970 (Clinical pharmacology.Scope, organization, training: report of a WHO Study Group).2.Clinical pharmacological services: report on a Working Group.Copenhagen, WHO Regional Office for Europe, 1977 (unpublisheddocument ICP /PHA 005).3. DUKES, M.N.G. The seven pillars of foolishness. In: Dukes, M.N.G.,ed. Side -effects ofdrugs annual. Amsterdam, Elsevier, 1984 (No. 8).4. TAYLOR, D. & GRIFFIN, J. Does Britain spend too much on pharmaceuticals? Pharmaceutical journal, 234: 228 -230 (1985).8

ALVAN, G. ET AL. Problem- oriented drug -information: a clinicalpharmacological service. Lancet, 2: 1410 -1412 (1983).6. RAWLINS, M.D. Postmarketing surveillance of adverse reactions todrugs. British medical journal, 288: 879 -880 (1984).7. BERGMAN, U. & WIHOLM, B. -E. Drug related problems causingadmission to a medical clinic. European journal of clinical pharmacology, 20: 193 -200 (1981).5.8.ANONYMOUS. What therapeutic drugs should be monitored? Lancet, 2:9.AMERICAN PSYCHIATRIC ASSOCIATION. Tricyclic antidepressants309 -310 (1985).-blood level measurements and clinical outcome: an APA Task ForceReport. American journal of psychiatry, 142: 155 -162 (1985).10. BRECKENRIDGE, A. ET AL. Postgraduate education in therapeutics:experience in Merseyside. British medical journal, 2: 671 -672(1978).11. BRODIE, B.B. Of mice, microsomes and man. Pharmacologist, 6:12 -26 (1964).12. EICHELBAUM, M. Defective oxidation of drugs: pharmacokinetic andtherapeutic implications. Clinical pharmacokinetics, 7: 7 -22 (1982).13. WHO Technical Report Series, No. 403, 1968 (Principles for theclinical evaluation of drugs: report of a WHO Scientific Group).14. WHO Technical Report Series, No. 563, 1975 (Guidelines for evaluation of drugs for use in man: report of a WHO Scientific Group).15. BERGMAN, U. ET AL., ED. Studies in drug utilization. Copenhagen,WHO Regional Office for Europe, 1979 (WHO Regional Publications, European Series, No. 8.)9

The teaching and organizationof clinical pharmacologyin European medical schools"WHO Working Groupon Clinical Pharmacology in EuropebClinical pharmacology has brought two central themes to the treatmentand management of patients, firstly, the reliance on scientific data to makerational therapeutic decisions and, secondly, to try to individualize drugtherapy (1). Clinical pharmacology has also contributed much to theresearch area of drug development. However, the advances in clinicalpharmacology have not necessarily found their way into routine medicalcare as rapidly as they could. It is clear that medical students shouldreceive a good grounding in clinical pharmacology during their undergraduate course so that they can easily understand current therapies aswell as evaluate and assimilate new therapeutic advances in the future.However, the status of clinical pharmacology varies from country tocountry in Europe, and thus in 1983 the WHO Regional Office for Europeset up a task force to try to ascertain the status of clinical pharmacologyin the various countries of the Region (1). One of the initiatives of thatgroup was to try to find out about the organization and teaching of clinicalpharmacology in European medical schools.Materials and MethodsA simple questionnaire concerned with clinical pharmacology teachingwas sent to all deans of medical schools in the European Region. TheWHO European Region comprises continental Europe (including theUSSR) together with Israel and Turkey. The questionnaire was initiallysent out in February 1987, and at that time there were 350 medical schoolsa Reproduced by permission from the European journal of clinical pharmacology,38: 101 -105 (1990).b Members: J. Bircher, M. Bogaert, M.N.G. Dukes, M. Eichelbaum, L.F. Gram,H. Huller, I. Lunde, M. Orme, F. Sjöqvist, G. Tognoni.11 pa

Working Group on Clinical Pharmacology in Europe, which was set up in 1986. The Working Group, consisting mainly of university teachers of clinical pharmacology, had broad terms of reference. The Group laid down general principles for the teaching of and training in clinical pharmacology

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