Drugs in general practice: report on a WHO meeting, Schlangenbad, 19–22 October 1982

World Health Organization -/.. ~ Regional Office for Europe ~ ~ Copenhagen ~ ~ EURO Reports and Studies 91 111 Drugs in general practice Report on a WHO meeting The World Health Organization i~ a spec ia lized agency of the United Nations w11h primary responsibility fo r international health matters and publi c healt h. Th ro ugh this Organization, which wa, created in I 948. the health profes\10 ns of ·o me 160 countries exchange their knowledge and experience with the aim of making possible the attainment by all ci tizens of the world by the year 2000 of a lc,·el of hea lth that will permit them to lead a sociall y and economically prod uctive li fe. The WHO Regio nal Office for Europe is one of six regional offices th roughout the world , each with its own progra mme geared to the particular hea lth p roble ms of the countries it serves . The Eu ropean Region ha s 33 active Membe r State,. u a nd 1s unique in that a large proport io n of them are industrialized countries with highly adva nced medical se rvices . The European programme therefore differs from those of other regions in concent ra ting on the problems associated wnh indu ·trial society. In its strategy for attaini ng the goa l of "hea lt h for all by 1 he year 2000" the Regional Office is arranging it s activities in three main areas : promotion ot li fe- tyles co nduci ve to heal th; red uctio n of preve ntable co nditions; and provi si011 of ca re that is adequate, accessible a nd acceptable to all. The Region is a lso characterized by the large number of languages spoken by its peoples, a nd the resu lting difficulties in dis,eminating informatio n to all who may need it. The Regional Office publishes in fo ur languages - English, French, German and Ru ssian - and applicatio ns tor rights of translation into o ther languages are mo t welcome. n Albania. Austria, Belgium . Bulgaria. Czechuslovalua, Denmark. f inl nd. France. German Demo- cra ti c Republic, Federal Republic ofGerman v. Greece . Hungur}, Iceland, Irela nd. Israel. llal ). Lu«m• bou rg. Mal ta. MonJco, Morocco, Netherland,. orwa) , Poland. Portugal. R" mania San Marino. Spain . Swe<lcn, Sw1t 1<rland, Tu rkey , L:SSR. United kingdom and Yuj!oslana . World Health Organization -/,. ~ Regional Office for Europe~ ~ Copenhagen 'SI ~ ~ EURO Reports and Studies 91 Drugs in general practice Report on a WHO meeting Schlangenbad, 19-22 October 1982 ICP/ PHB 009(111 ISBN 92 890 1257 9 © World Health Organization 1985 Publications of the World Health Organization enjoy copyright protection in accordance with the provisio ns of Protocol 2 of the Universal Copyright Conven- tion. 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The views expressed in this publication are those of the participants in the meeting and do not necessarily represent the decisions or the stated policy of the World Health Organization. PRINTED IN DENMARK ISSN 0250-8710 CONTENTS Page Introduction The current situation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Prescribing in general practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 WHO and primary hea lth ca re . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Factors affecting prescribing 3 Differences in prescribing in hospital a nd general practice . . . . . . . . . . . 5 Education of general practitioners . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Undergraduate/ basic training Specialist/vocational training Continuing education ... . . . ......... . .......... . .... .. .. . ... . . . Audit in general practice .. .............. .. ................... . Accessibility ... ................. . .. ....... .... ............... . Use of a udit data ............................................. . Conclusions ........................ . .... . .......... . ..... .. . . Drug information and the general practitioner ............... . Categories of information . .. .... . ..... ... .... ..... ....... .. ... . Pa tient package inserts ............ ... .. . . . .. ....... . ....... .. . . Miscellaneous problems .... . . ................ .. . . .... . ... . ... . Drug resea rch in general practice . . .... . .... . ... . ..... . ...... . .. . Books on prescribing in genera l practice ....................... . . . The influence of th e media . . ........ . . .. ....... . .. ....... .. . ... . 7 7 8 9 10 II II 12 12 17 17 17 18 18 111 The role of practitioner/patient communication . . . . . . . . . . . . . . 19 Compliance and non-compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Provision of information to patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 The general practitioner and the law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Education of general practitioners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Drug evaluation and prescribing in general practice . . . . . . . . . . . . . . . . 22 Drug information and the general practitioner . . . . . . . . . . . . . . . . . . . . . 23 Auditing of prescribing in general practice . . . . . . . . . . . . . . . . . . . . . . . . 24 Doctor/patient communication on prescribing . . . . . . . . . . . . . . . . . . . . . 24 Annex I. Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Summaries in French, German and Russian . . . . . . . . . . . . . . . . . . 33 IV INTRODUCTION The eleventh Euro pean Sym posium on Clinical Pharmacological Eva luation in Drug Control was held in Schlangenbad, Federal Republic of Germany, from 19 to 22 October I 982. Professor L. von Manger-Koenig, Special Consulta nt on Health Affairs to the Ministry for Youth, Family Affairs and Health of the Federal Republic of Germany, opened the meeting . He se t the task of the meeting against the general background of WHO's declared objective of health for all by the year 2000. He emphasized that in many countries , primary health care services are being expanded rapidly and the role of general practice extended. Problems need to be solved in general practice and the solutions adopted will often be different to those used in hospitals. Dr Leo A. Kaprio , WHO Regional Director for Europe, em- phasized that health for all by the year 2000 should be thought of not as a Utopian vision but as something it was truly possible to implement. The world is growing smaller and this should enable people to come closer to one another. Whether this is achieved as a result of angst or not, closer international cooperation should be aimed at, irrespective of the governmental or socioeconomic system involved. All would agree that health should be improved, and there is much agreement on the way thi s should be achieved. Health has always been a logical and promising field for international coop- eration, as one can apply the advances in scientific knowledge universally, though necessarily in a manner adapted to each par- ticu lar culture and society. In the European Region of WHO there are three main aims: the improvement of lifestyles, the reduction of pollution in the environment and the more rational use of high technology. Some of the tasks to be performed are very broad ones. The improvement of lifestyles , for example, must involve not only specific areas such as the reduction of tobacco and alcohol con- sumption and their consequences, but also broader matters relating to family and working relationships . Other areas in which WHO is directly involved are highly specific and technological; the field of pharmaceuticals is one of these. Ten or fifteen years ago it would have seemed impossible to have an organized conference dealing solely with drugs prescribed in general practice. Today , we realize that this is not only an important topic , often occupying a central place in patient care, but one th a t raises specific and basic problems. These ca ll for spec ifi c so luti ons if primary ca re is to pl ay an optimal ro le in maintaining a nd ad- va ncing th e health of the society it serves. Professor G. Fiilgraff was e lec ted Chairman, Professo r Y. K. Lepakhin and Professor M . H assa r Vice-Chai rm en, a nd Dr L.T. Newman Ra pporteur. THE CURRENT SITUATION Prescribing in general practice General prac titi o ners are of para mo unt impo rta nce as prescri bers through o ut th e world. Drugs are large ly developed, studied a nd controlled by others, but in the grea t major ity o f cases it is a ge neral practitioner who prescr ibes th em to a pati ent. For that reaso n he ca rries much of th e ultimat e respo nsibility for the ma nn er in which th e patient uses th e drugs, and is partl y res ponsibl e for th eir ulti- mate effects, desired or undesired . Since the increas ing cost of hea lth care ma kes it vita l tha t it sho uld be meaningful , efficient a nd eco no mica l, th e ge nera l prac- titi o ner is today inevi tably concerned with the cost-effecti veness of his way of workin g, and this must in clude a crit ica l approac h to the benefits, costs a nd risks of his own prescribing practices. WHO and primary health care In M ay 1977 the Thirti eth World H ea lth Assembly decided that the basic target of governments and WHO sho uld be the attainmen t by a ll citi zens oft he world by the year 2000 of a leve l of hea lth t hat will permit th em to lead a soc ia ll y and econo mi ca ll y productive life. In 1978, the Internationa l Conference on Prim ary H ea lth Care met at Alma-A ta, and produced a declaration th at brought primary health care to the forefront. The a im has been to cha nge uni versa l primary hea lth care from a n idea l int o a fun cti oning reality. Primary hea lth care means different thin gs in different pa rts of the wo rld , but in most the genera l practitioner is th e co rn ers to ne of this care, since he is the patient's point of first contact with the hea lth 2 se rvices. The co nce pt of ge nera l prac ti ce a lso di ffers a m o ng co un- tri es, in assoc ia ti o n with different sys tems of hea lth ca re a nd medi- ca l tra inin g; in so me. th e paedi a tri cia n a nd o bste tri c ia n will be in vo lved in prima ry care. s in ce th ey see pa ti ent s in th eir ow n ho me a nd pa ti ent s have direc t access to the m. A co mm o nl y acce pt ed d efiniti o n o f a ge nera l prac titi o ne r, ho w- ever , is th a t he o r she is a d oct o r wh o pro vides perso na l prima ry a nd co ntinuin g medi ca l ca re to indi vidu a ls a nd th eir famili es. H e acce pts the respo nsib il ity for ma kin g a n in iti a l dec is ion o n eve ry pro ble m the pa ti ent may prese nt , co nsult ing a nd ref e rr ing to spec ia li sts when a ppro p ria te. Hi s di ag noses will be co mposed in ph ys ica l. psyc ho logica l a nd soc ia l terms a nd he will int erve ne educati o na ll y. preve nti ve ly a nd rh erapr u- rically. to p ro mo te h is pa ti ent s' hea lth .a FACTORS AFFECTIN G PR ESC RIBING In the most simpli sti c vi ew, a dru g will be prescribed o nl y whe re th ere is a direct a nd definabl e need fo r it , i.e . in th e prese nce o f a sy mpt o m th a t it ca n a ll ev ia te o r a di so rd er th a t it can cure. In rea lit y, presc ribin g in ge nera l p rac ti ce is influ enced by a multitu de o f o th er fa cto rs, so me o f which tend to lead to ove rpresc ribin g. So me o f the m os t impo rt a nt a re: - Th e overstraining of medical resources. e.g. as a res ult o f grea ter lo ngev it y, the g rea te r surviva l ra tes o f the co nge nit a ll y a nd c hro nica ll y ill , the in creas in g co mpl ex it y of medi cine, th e availa bilit y o f free m edi ca l ca re a nd , a t tim es, th e co nse- quences o f eco no mic recess io n o n th e p ro vi sio n o f a deq ua te se rvices. D octor/pa ti ent co mmuni ca ti o n is p robl em a ti ca l a t a ll tim es, but is aggrava ted by differences in th e age a nd sex o f the docto r a nd pa tient concerned , a nd increased by the effec ts o f mi gra ti o n. Wh ere medica l reso urces are ove rstra in ed, th e a Fro m th e "G~ncral prac t it ione r learni ng and teaching". Royal Co ll ege of Ge nera l Prac t it ioners . 3 4 issuing of a prescription may represent an attempt to deal rapidly with a problem (perhaps psychosocial or psychoso- matic) that in fact calls for more thorough but much more time-consuming measures. - The increase in stress-related diseases. These are aggravated by social factors such as poverty, unemployment and the fear of nuclear war. These again create situations in which the proper solution is likely to be complex and time-consuming; the temptation to send the patient away with a prescription for an anxiolytic drug instead of attempting complete investi- gation and treatment is very great. - Exaggerated expectations as to the role of medicaments in prophylaxis and treatment. The concept of medicaments as the most fundamental and universal tool for the practice of medicine has always been deeply rooted in the minds of patients, and has been strengthened since the onset of the antibiotics era which, for the first time, provided the physician with curative tools. In consequence, the patient expects his encounter with the physician - and certainly the general practitioner - to culminate in the prescribing of a drug, and if he does not receive one he will be likely to feel that he has not received adequate care. - Relationships between women patients, general practitioners and the pharmaceutical industry. A common sit uation is that in which a younger woman patient has difficulty in communi- cating adequately with a general practitio ner who is often male and middl e aged. There are likely to be problems with respect to emotional, sexual, obstetrical and gynaecological matters. The pharmaceutical industry, on the other hand, has recognized the potential market among women patients, com- municating very effectively with them. Such factors can lead to overprescribing for women. - Commercial pressures. The fact that few medicines are indeed curative, and that from time to time true breakthroughs in drug development do occur, means that physicians are more prepared than they would otherwise be to accept claims of this type, even where they are not verifiable. Many physicians have, because of the attractiveness and ready availability of th e info rm a ti o n suppli ed ve rball y a nd in pri nt by th e phar- maceuti ca l industry, beco me mo re d epende nt tha n th ey need be o n co mm ercia l in fo rma ti o n . Since th ere is no a na logo us press ure to co nsider no n-ph a rm aco logica l meth ods o f trea t- ment , th e ph ys icia n is very likel y to allow hi s p rac tice to be domin a ted by the prescribing o f drugs, a nd pa rti cul a rl y by the use o f new drugs . Differences in prescribing in hospital and general practice Alth o ugh th e ge nera l prac titi o ner , b roa dl y speak in g. has access to the sa me ran ge o f drugs as the hos pit a l ph ys icia n o r spec ia li st , hi s prescribing tends to be pa rti cul a rl y influ enced by a number o f' element s th a t a ppl y less to his hospit a l co ll eagues. T hese include: - hi s spec ifi c t ra ini ng as a ge nera l prac t iti one r. in cou ntri es where such t ra inin g has beco me usua l; - hi s rela ti ve iso la ti o n fro m o bj ecti ve so urces of in fo rm a tio n a nd fro m teac hin g a nd resea rch ce ntres, whi c h ca n lead to a degree o f co nse rva ti sm in presc ribin g but a lso rend er him vulnerabl e to the pressures o utlined a bove ; - lo ca l a nd regio na l influences a nd trad iti ons, such as th e pre- scribing ha bit s o f ce rta in loca l spec ia li sts or hos pit a ls to whom he regul ar ly refers pa ti ent s; - the fr equ ent need fo r sy mpt o ma tic trea tm ent of rela ti ve ly minor ailm ents; - his involve me nt in long-t erm ma int e na nce trea tm e nt o f chronic disord ers; - his need , in a situ a tio n wh ere th e pa tient ca nn o t be co n- tinu o usly mo nito red a nd may fail to return fo r fo ll ow- up , fo r prepa ra ti o ns th at ac t ra pidl y a nd exe rt o nl y minim a l side effec ts; - the fa ct th a t he is no rm a ll y dealin g with a mbul a nt pa ti ent s sometim es exp osed to special en viro nm ent a l press ures , e.g. s hift wo rkers; - the influ ence o f pa ti ent press ures, so metim es influe nced in turn by the medi a . 5 In some countries, the freedom of the general practitioner to prescribe drugs may be restricted on grounds either of pricing or of safety, and this will have a further effect on his prescribing patterns. Where hospitals attempt for economic reasons to reduce their own prescribing expenditure, the onus of prescribing for ambulant pa- tients will in part devolve on the practitioner. EDUCATION OF GENERAL PRACTITIONERS There is clearly no simple solution to the problems of good pre- scribing in general practice. In part they are problems of a broader nature, not related exclusively to drugs , such as when the general practitioner can and should most properly recognize the limits of his own competence and refer the patient to a specialist or a hospital. The most fundamental approach to these problems clearly involves appropriate training for general practice. It is a fact that, even now, many general practitioners have not been specifically trained to deal with the branch of medicine in which they are involved. Irrespective of the system of health care, improved education must be provided for general practitioners and their teams. This improved education must be provided during undergraduate, specialist/vocational training, and during post- graduate or continuing education for general practice; it shou ld continue throughout the physician's career. The role of the various bodies and experts who can contribute to the education of the general practitioner is discussed elsewhere in this report. Those involved include official agencies, professional bodies, pharmacists and clinical pharmacologists , whose activities complement one another. A common desideratum is that as man y as possible of those involved in teaching for general practice should have had extensive experience in general practice themselves. In the present context it is evident that the content of this training at all phases should extend to the proper use of drugs and to those situations in which the general practitioner will have to make a responsible choice between pharmacological and other forms of treatment. 6 Good information systems must support and complement the improvements in educati on . Undergraduate/basic training A good grounding in pharmacology is basic to the creation of sound prescribing habits. Prior to medical qualification, three phases of t raini ng can be distinguished and they should be designed to com- plement one another. The first involves teaching in basic pharma- cology, including an introduction to the main drug classes, during the preclinical phase. The second involves therapeutics, and is taught during the clini ca l phase, involving both therapy and practice; ideally, this should involve teaching at the bedside backed up by semina rs. The third step , commonly neglected, is the teaching of actual prescribing during the last clinical year , i.e. the application of these therapeutic principles to practice including decision-making; here again both theoretical and pract ical work must be combined. Whilst the above phases mu st be distinguished, they must be coordinated with one another, particularly because basic pharma- co logy may otherwise be viewed by the student as a discipline largely divorced from practical medical realities . In one way or another a student should certainly have the opportun it y, during the undergraduate phase, to relate what he is learning to what qualified general practitioners are in fact doing; this will among other things enable him to assess his own interest in genera l practice. The amount of contact that medical students curre ntl y have with general practice varies; in some countries there is st ill no compulsory teaching, in others it is required to spend several weeks of the undergraduate curriculum in general practice. The type of teaching also depends on the availability of an ad- equately staffed department of general practice to organize and supervise this phase of training, as well as on the aims and methods of such a department. Specialist/vocational training At one time, the newly qualified physician could go directly into general practice without undertaking any spec ia li st or vocational training, the view apparently being that this was the simplest form of medicine. In certain countries this situation sti ll prevails. With 7 the realization of the specialist demands that this branch of medicine makes on the practitioner, training programmes have increasingly been introduced, generally involving part-time study combined with the early years of general practice. The duration of such training currently varies, but may be up to six years. In certain countries (e.g. those that have established professional "colleges of general practice") there is a voluntary examination for a diploma. There can be no doubt that such training programmes are needed and that the proper use of drugs (including knowledge of adverse reactions and interactions, drug costs , the selecti on of thera- peutic agents and self-auditing) shou ld form part of the curriculum. During and subsequent to such training, the young general practitioner should learn to adjust his presc ribing to his practice situation. He may find that prescriptions given both by the spe- cialists to whom he refers patients and the other practitioners around him are often at variance with the teaching he has received . One of the objectives of his training will be to teach him to withstand such influences, prescribing scientifica ll y irrespective of what others may do. Continuing education Quite apart from the fact that in most countries too little provision is made for the lifelong "continuing education" of the general practitioner, a number of specific shortcomings can be pinpointed with regard to avai lable programmes relating to drugs and pre- scribing. The first of these is their all too selective impact. Evening, weekend and summer courses, all involving the practitioner in some expenditure of time and money, often tend to attract the general practitioner who is least in need of such support since he is already conscientiously keeping abreast of developments through the litera- ture and other channels . Whilst views on the introduction of com- pulsory continuing education may vary, it is a fact that much more could be done to motivate practitioners to follow such training. To some extent , however, continuing education will always to a degree be self-education, the major initiative lying with the physician himself. A second shortcoming relates to those forms of continuing education provided in the form o f didactic lectures given by hospital 8 specialists, completely unaware of the needs of general practitioners. Most formal continuing education programmes should involve general practitioners both at the planning stage and as teachers, and courses should provide an opportunity for discussion . Finally, so me effo rts to achieve continuing education allocate a purely passive role to the general practitioner himself. By according him a n active role, including his involvement in resea rch projects rel a ting to drugs and prescribing, his interest will be aroused and a substantially greater impact assured. The pharmaceutical industry ma y be involved in programmes of furth er education but must be encouraged to do so without undue promotion of its own products. These activities, which are claimed to be educational, are often in fact largely promotional and should be clearly identifiable as such. AUDIT IN GENERAL PRACTICE Audit is a term used to describe a review of medical work, in this case prescribing. To be effective it should consist of three com- ponents: - se tting of standards - evaluation of care - modification of practice in the light of this evaluation. It is clearly the ultimate purpose of auditing to improve the quality of prescribing and thus of medical care. This very fact, however, and the suggestion in the term "audit" that the practi- tioner is being subjected to a form of control and supervision, has so metimes led to defensive ness and even host ility to the concept. Certainly, in most societ ies, the general practitioner remains ac- countable to no-one except his patients for the quality of hi s pre- scribing. Though society must and does create special mechani sms to detect exceptional gross failings (e.g. the reckless prescribing of narcotics) the auditing approach is entirely different and is essen- tially conceived as a means to assist the doctor in studyi ng and adapting his own prescribing habits . 9 Bearing in mind this purpose, the type of data likely to be needed, and which can often be derived by simple techniques from existing records, will include information on: - the nature, identity and quantity of drugs prescribed - the indications for which they have been described - the categories of patients receiving them - the prescribing costs. Experience shows that, whilst the practitioner should in theory be able to continuously review his prescribing habits in these re- spects, few practitioners in fact contrive to do so without help. When presented, however, with a systematic analysis of his own prescribing compared to that of his colleagues over the same period, he will be enabled to pick out common trends and differences. The results of such confrontations are likely, as shown by exist- ing drug utilization studies, to be an improvement in the standard of prescribing, including a more cost-conscious and safety-conscious selection of drugs. Accessibility In a few countries, drug utilization data and even some detailed prescribing data are to a large extent available from the records of health insurance and reimbursement services; in others broad fig- ures on drug utilization are available and can have some value in auditing. To mobilize such data for auditing purposes however (and to obtain analogous data in those situations where prescribing records are not so systematically kept) national and local initiatives are needed, and in this respect organizations of general practitioners can and should play an initiating or catalytic role, collaborating in this area with official bodies, research institutions and patients' associations. In most countries there is still very little information on pre- scribing patterns for private patients, with regard either to their cost or their content. Experience has shown that adequate guarantees of confiden- tiality can be built into auditing systems to avoid the dissemination of those types of individual data that should not be available to anyone other than the physician or his patient. Use of audit data Data from prescription audits can be most usefully employed in the following ways. • For self-audit, the physician being able to view his own prescrib- ing in retrospect, perhaps comparing it with that of other in- dividual physicians or with a local or national average. • For group audit, in which collaborating physicians (e.g. in a group practice) study each other's prescribing patterns or volun- tarily submit these for peer review. Essential ingredients for success here are honesty and confidence within the group and a recognition that all are likely to fall short of perfection in prescribing practice. • For educational purposes, taking (anonymous) data on average and individual prescribing patterns to form a basis for con- clusions and recommendations to improve the quality of prescribing. Conclusions As with continuing education, one of the problems with pre- scription auditing is likely to be that the very physicians who most need it are least likely to undertake it, especially since it involves some expenditure of time and effort; in this instance, the prac- titioner himself will experience no concrete benefit except that he will have the satisfaction of knowing that he has created an op- portunity to serve his patients better. In view of the therapeutic and other benefits resulting from an improved quality of prescribing and the avoidance of waste, encouragement needs to be given to this technique by official bodies, as well as by professional associations, health insurance agencies, patients' associations and others who recognize its importance and the benefits to society and the indi- vidual that it can offer. Some financial provision may need to be made to compensate general practitioners for the time and expendi- ture involved. 11 DRUG INFORMATION AND THE GENERAL PRACTITIONER Of the total range of drug products available, the general practi- tioner is likely to use only a limited number, often of the order of 300 or so. His choice of drugs will , however, differ as time goes on, and particularly as new products are introduced. If he is to select his drugs critical ly and take proper decisions as to the replacement of one drug in his armamentarium by another, the physician will require balanced information on all the products he is likely to need. He will also need data on their comparative merits, risks, presentations and prices, and the principles that he should employ when deciding for or against the use of any of them in the individual case. This ideal is by no means always fulfilled. The general practi- tioner, to a greater extent than the specialist, is likely to find himself overwhelmed by a very large quantity of information emanating from various sources and all competing for his attention. He will receive more in the way of positive data on individual drugs than information on the means of choosing between them, and he will receive more information on drugs than on the conditions they are intended to treat. When new drugs are introduced or new problems or possibilities arise with existing drugs, he will in many cases have difficulty in forming an objective view on these matters, even when they are of immediate and pressing importance to him. There can be no doubt that the information flow to the general practitioner is a problem of major proportions, and that too little is known at present about the way in which the various forms of information affect him. This entire topic of"drug information" will be discussed in a subsequent report in this series; the present report is limited to a number of matters relating specifically to the general practitioner. Categories of information Information available to the general practitioner falls broadly into three categories - official, professional and commercial - though there is naturally some overlap between them. All information 12 should clearly be produced with the specific needs of the general practitioner in mind. Professional information This information may be provided during the various stages of training in general practice and subsequently. It may emanate from other physicians, from clinical pharmacologists or from pharma- cists, and may be in the form of information provided spontaneously or replies to queries. The pharmacist is in almost all countries a much under-used so urce of information by the general practitioner. Professionally trained as drug experts, and to an increasing extent specifically trained in pharmacotherapy a nd drug toxicity, many members of the pharmaceutical profess ion still find themselves fulfilling a pri- marily distributive role. Experience in various count ries shows the potential of the pharmacist as a source of drug information for the general practitioners in his area, possibly as a counsellor to the patient when the drug is dispensed, and as an active participant in drug auditing and adverse reaction monitoring schemes. In par- ticular, the formation of groups of ph ysicians and pharmacists to maintain joint contacts with drug industry representatives appears to lead to a better standa rd of commercial information. The entire role of the pharmacist in thi s field dese rves careful study. The role of the clinical pharmacologist is at present restricted , e.g. since problems in general practice prescribing have not a lways been well defined , so that it is difficult for clinical pharmacologists to provide solutions . In addition, there are st ill too few clinical pharmacologists and their functions are often limited by the health care sys tems under which they work; often one finds them active only in undergraduate teaching, research and in an advisory role. It is still exceptional for a clinical pharmacologist to play a local or regional role. Where their numbers permit , the contribution made by clinical pharmacologists to general practice can be in various fields . • To assist in the organization of general practitioner courses and by their prese nce as "resource persons" during group dis- cussions of general practitio ners. The success of this and other forms of interaction will be affected by th e quality and lengt h of 13 the personal relationship that develops between the clinical pharmacologist and the general practitioners involved. • To provide information and advice on request to single-handed general practitioners or to groups of general practitioners. Topics might include advice on the use of new drugs, prescribing problems (including the management of drug overdosage) and the initiation of research projects, including the use of computer data. • To participate with local practitioners m the audit of pre- scriptions. • To create links between general practitioners and other bodies such as drug regulatory agencies and adverse drug information centres (see later). Many of the larger hospitals can provide valuable information to general practitioners through shared prescribing formularies, by organizing joint clinical pharmacological conferences and other joint meetings with general practitioners, e.g. on local adverse drug reaction committees. Official information Official information largely distinguishes itself from professional and commercial information because it emanates from bodies that are necessarily concerned primarily with the welfare of society at large. Official information may reach general practitioners from vari- ous official sources, e.g. the government itself, the drug regulatory agency, the financial authority paying for drugs, and the adverse drug reaction centre. In addition there may be an official infor- mation service, such as that issuing a drug bulletin. It is vital that the information should be objective, be general practice oriented, deal with real problems, and be attractively presented and convincing, since to a large extent its role will be to counterbalance other sources of information that do not meet this ideal. Communication between the drug regulatory agency and general practitioners is usually poor. This is regrettable since the agency is 14 likely to have at its disposal information on drug matters (including new drugs and current problems) that is both timely and complete. Matters on which it can be important to provide information of importance to the average general practitioner include: - why a particular drug has been accepted for marketing - its efficacy/toxicity ratio - its innovative character - its relative merits - its price - reasons for the withdrawal or modification of a drug. WHO should encourage international distribution of this in- formation. In principle one could also envisage a contact in the reverse direction, the regulatory agency receiving data from general practice on the use and effects of particular drugs. Such data could be of value in enabling the agency to adjust its policies to the real needs of the practitioner. In this respect it must be noted, however, that regulatory agen- cies in many countries do not currently have the authority to com- municate direct with prescribers. Positive experience with those that do have such authority suggests that such a legal limitation requires correction. Finally it would seem desirable for agencies to involve general practitioners in their day-to-day assessment work, e.g. as committee members or external assessors. The financial authorities are concerned essentially with what society is prepared to pay for its pharmaceutical supplies. In some countries they are an independent body, in others a subdivision of the health ministry. They may be an authority that has a monopoly of the drugs produced in (or imported into) the country. The influ- ence of such a body on prescribing will necessarily vary with the national situation, but in all circumstances the authority should publish and explain its policies. Adverse drug reaction centres, most of which function nationally to collect reports of suspected adverse effects from prescribers, shou ld make their data and the interpretation thereof known to general practitioners. Up to now, however, this has commonly not 15 been the case. A truly reciprocal exchange of data will clearly aid practitioners to identify drug problems and encourage them to participate in this challenging form of research . Drug bulletins, most of which have appeared within the last 10-20 years, seek to provide the prescriber with impartial infor- mation and advice on the use of drugs. Most such bulletins have been issued or sponsored by official bodies, though some emanate from professional associations or independent foundations. Despite their modest presentation (and in some respects because they dis- tinguish themselves so emphatically from commercial publications) the bulletins appear to have exerted a considerable influence on prescribing, particularly among younger prescribers seeking a ra- tional approach to therapy. The further development of such channels must be encouraged , and the possibility should be introduced of exploiting the newer media (television, videotape, teletext, etc.) to reach the physician more adequately. Information from the pharmaceutical industry Information made available from the pharmaceutical industry to the practitioner is sometimes termed "commercial information", but the phrase may be misleading, referring as it does to the origin of the material but not to its content or standard, which can vary considerably. In western Europe it has become a tradition that pharmaceutical companies provide practitioners both with data relating directly to their products (properties, indications, dosage, warnings, etc.) and with more general information on therapeutic matters involving these products. The latter activity may variously be regarded as comprising a service or as supporting the sale of the products in question. To meet legal requirements in most countries the basic infor- mation provided on a drug product must correspond exactly to that on an officially approved "data sheet". A pharmaceutical company is, however, as a rule free to supplement this with a great volume of additional material relating directly or indirectly to the drug, pre- sented in many cases visually or verbally. It is undoubtedly this type of material that dominates the presentation to the prescriber. 16 Whil st the in vo lvemen t of pharmaceutical companies inevitably means th a t a proport io n of the mat erial presented will a lways be promotional, a clear distinction sho uld be drawn between such presentations and th e provision of o bj ective ly selected a nd bala nced in fo rmatio n . It is obvious th a t th e pharmace utical industry mus t be a bl e to o btain a fair recompense for its inves tm ents and the large ex pendi- ture associated with the development of new drugs, but o ne mu st be a bl e to ex pect of it a pro per balance in its communication with th e practitioner, who is genera ll y not in a positio n to verify com pletely th e correctn ess and re levance of the informatio n supp li ed. Wh ere reference books (e.g. drug co mpendi a) are provided to practitioners by th e pharmaceutical industry as a who le, as is th e case in so me countries, one sho uld reasonably expect th a t the information provid ed on individual drugs is in accorda nce with a pproved data shee ts. Patient package inserts The lega l status of th ese var ies from country to cou ntry. They sho uld be derived from the a ppro ved da ta shee t and updated at regular interva ls, a nd th e date o f th eir last updating sho uld be menti o ned in th e tex t. Genera l practitioners sho uld be aware of their co nt ents, since th ey may grea tl y affect th e behaviour of pa- tients with res pec t to the drugs present ed and eve n th eir reac ti o ns to them. Great press ure is exe rt ed by pa ti ent s o n th eir d octo rs to pre- scribe . Beca use of thi s, pa ti ents have to be informed of th e poss ibl e benefit s and ri sks of a drug. The tran smi ss io n of thi s information should build up greater tru st between patient s a nd th eir doctors. MISC ELLANEOUS PROBL E MS Drug research in general practice It ha s become cl ea r tha t th e effec ts o f and ad ve rse reac ti o ns to drugs, as they emerge fro m clini ca l investigations co nduct ed in hospit a ls and specialized ce ntres, ma y differ somewhat from th ose 17 that subsequently emerge in genera l practice . In th e latter si tu a ti o n a range of interfering factors can affect drug performance: un avoid - ab le variat ions in compliance, the presence of co ncurren t di sease not represented in the original trial population, a greater degree of concurrent medica ti o n , and expos ure of a ra nge of po pulation subgroups not included in the original studi es. Under the condition s of genera l practice a drug may prove to be mo re o r less useful (and more o r less safe) than originally fo reseen. Such factors render it very necessary to provide for clinica l studies of drugs under genera l practice conditions, both prio r to and fo ll owin g marke ting. It is now well recognized that clinical tri a ls in ge nera l practice are not easy to co ndu ct in an accurate a nd co nsist- ent ma nn er, but su itable techniques ha ve been deve lo ped (e .g . by ge nera l practitione r research gro ups) a nd they sho uld be much more widely employed . The mere distribution of d ru g sa mpl es and research forms for so-call ed confirma to ry tri a ls in ge nera l practice is unlikely to pro- vide a ny evidence of scientific value; it amounts to mere commercial sa mpling and is commonly des igned only to familiarize the practi- tioner with th e use of the drug in question. Books on prescribing in general practice Despite th e multiplication of medical boo ks, there is still an identi- fiable lack in most countries of reliable handboo ks a nd smaller guides o n genera l practice prescribing. Those th a t are ava il a ble are often not distributed in more than o ne language or suited to the needs o f other co untries. WHO might well consider taking ac tion to remedy this situation . The influence of the media The lay media have in so me cou ntri es come to exert a co nsiderable infl uence on th e public with regard to its ex pectati o ns of ge neral practice a nd drug prescribing. New drug introductions and the discovery of new adverse effects have o ft en been th e subject of sensat io nal publicity. The media clearly can play a valuable edu- cative role but should be discou raged from sensationalizing phar- macotherapeutic questions. 18 THE ROLE OF PRACTITIONER/PA TI ENT COMMUNICATION The importance of adequate practitioner/patient communication is becoming increasingly recognized in all fields. It is vital with regard to prescribing. Unless the physician understands fully the reasons why his patient is anxious (or occasionally not anxious) to have a drug prescribed, he will not be able to react appropriately and in the best interests of the patient. The latter, similarly, needs to under- stand why the physician has prescribed a particular drug (or has decided not to prescribe one); the patient must also receive clear instructions as to the drug's use and the risks that it may present. These objectives will not be achieved unless the physician/pa- tient relationship is properly developed and the consultation is not rushed. The patient who has had a fully satisfactory explanation from his general practitioner will be the most inclined to follow the advice given, i.e. compliance will be better (see below). Where a patient has a choice of several doctors the temptation may arise for him to seek assistance from more than one general practitioner at a time, and even to obtain prescriptions from all of them. The risks of overdosage and interactions under these con- ditions are clear. Whilst a better education of the public in health matters is the only lasting means to avoid such situations, it is often necessary to create mechanisms (e.g. via the pharmacist) to avoid the risks of multiple prescribing for a single patient. Where a patient is associated with a group practice, the records of each patient should be centralized within the practice as a means of avoiding the issuing of double or incompatible prescriptions by different physicians. Compliance and non-compliance It is as a rule assumed that if the patient complies with the physician's instructions he will stand an optimal chance of benefiting, but this is not always the case. Particularly in the case of minor or psycho- somatic complaints, the patient who can bring himself to set aside prescribed medication, especially where this has been prescribed largely at his own insistence, may serve his own interests better than 19 if he were to take it. For this and comparable situations the concept of "intelligent non-compliance" has been introduced. Non-compliance with essential (e.g. curative antibiotic) therapy, however, is clearly not likely to be in the patient's interest, and the general practitioner should be aware of the factors that can lead to non-compliance. These include the patient's misunderstanding of the nature of the drug and its effect, and the severity of the condition to be treated . Compliance can be endangered where the patient has failed to understand the physician's explanation of these matters for any reason (e.g. lack of education or presence of a language or other barrier) or where he is afraid to take the medicine. The latter is merely one of many possi ble consequences of inadequate communi- cation between the physician and the patient. The personality of the doctor is most important. Provision of information to patients It has been pointed out before that the physician should provide his patient with the information and advice that he needs to use a medicament properly. The normal conditions under which drugs are prescribed are not, however, such that full explanations are always possible (e.g. as to highly unusual adverse reactions) and subsidiary channels of information to the patient are essential. The patient package insert , normally supplied by the manu- facturer but subject to official approval at the time the drug is registered, can play a useful role, particularly in general practice. However, in some countries a number of legal anomalies require correction. • Requirements that the insert contains full prescribing infor- mation. This may render it more useful for the physician (who is unlikely to use the insert) but unintelligible for the patient. • Requirements that the insert be removed by the pharmacist when dispensing the drug, except in specified cases. This would appear largely to defeat the purpose of the insert. • Legal requirements as to the language in which the insert must be written. For migrant populations this may not be the most appropriate language. 20 • Provisions as a result of which inserts are present in small packages but not in the bulk containers from which precriptions are often filled. In this situation , no insert is likely to be available for the individual patient. Such considerations suggest the need for a clearer and more consistent policy and appropriate adaptations to national laws. Provision should also be made for the physician to receive the texts of all package inserts, e.g. as a compendium . The pharmacist who dispenses the drug may, as pointed out in an earlier section, play a role in drug information. If he is to provide information to the patient, however, there must be a clear understanding and cooperation between the prescriber and the pharmacist. Patients obtain information on drugs (and views on the same drugs) from family and friends, from health education, literature designed for the lay reader, and from the general media. The in- fluence of the media can, as pointed out elsewhere, be considerable; new items and their interpretation by the media can raise false expectations or create anxiety among users of a particular drug. The physician should be aware of such influences when prescribing. The general practitioner and the law Patients should clearly receive a fair explanation of the possible benefits and risks of a drug when it is prescribed . Beyond this, it is doubtful whether the physician should be required to carry further responsibility for possible ill effects of taking a drug that has been prescribed with due care for a real indication. Should a trend arise towards holding physicians legally responsible for unforeseen (but foreseeable) consequences of drug prescribing, it might become necessary to introduce patient consent procedures similar to those usual in surgery. 21 RECOMMEND A TIO NS Education of general practitioners I. General practice should be regarded as a medical specialty, for which special training is required to cope with the range of health- related problems and patient expectations compared, for example, with the situation in hospitals. As the selection and use of the drugs prescribed is often not optimal, there should within the framework of special training for general practice (and even where such training has not yet been established) be specific teaching of drug therapy for the general practitioner. 2. Such teaching should be founded on an adequate undergraduate course in drug therapy during basic medical training, in which pharmacological teaching is integrated into the clinical situation. 3. Following qualification, training in drug therapy should be given both in early postgraduate vocational training and in the form of continuing education throughout the doctor's career. 4. In all these phases, education should be given by teams , includ- ing experienced general practitioners, clinical pharmacologists and other specialists. 5. In view of changes in the drug field it is essential to ensure that this continuing education in drug therapy is available to all prac- titioners, and practitioners should be encouraged to participate. 6. Educational material should be attuned to the circumstances of general practice; it should be well presented and use must be made of modern and readily available communication techniques . Drug evaluation and prescribing in general practice 7. A more critical and cost-conscious approach than that often adopted to drug prescribing in general practice is desirable. This is particularly feasible where practitioners collaborate to improve prescribing patterns; such approaches must be encouraged, particu- larly by the active involvement of practitioners' associations. 22 8. Appropriate prescribing and the provision of information to the patient will be optimized and simplified if the general practitioner limits the number of drugs that he uses regularly and familiarizes himself with these. 9. It should be recognized that prescribing a drug is only one means of therapy, and a means that should be employed only if there is a good indication for it. 10. Drugs that are likely to be used in general practice should be investigated under these conditions. This will involve performing well planned and ethically acceptable clinical trials . Clinical phar- macologists should collaborate wi th general practitioners in the design and assessment of such trials. 11. To ensure that drug regulatory agencies function in a way that meets the needs of the general practitioner and his patients, such agencies should involve general practitioners in their work. Drug information and the general practitioner 12. The practitioner needs a range of drug information but is often overwhelmed by competing information. He may find difficulty in obtaining essential and up-to-date facts on drugs and their differ- ences a nd comparative merits when he needs it. All bodies providing drug information and/or engaged in drug regulation should examine this problem. 13. Clinical pharmacological services should play a particular role in providing practitioners in their area with balanced information and advice on specific drugs and prescribing problems. 14. The physician has an absolute right to reliable , comprehensive and up-to-date data on marketed drugs and their properties; exist- ing systems to provide such data should be further developed at na tional and international levels. Where information is supplied by drug companies, pure information must be carefully distinguished from promotion. 15. Drug regulatory agencies should ensure that practitioners are informed not only of their decisions but also the reasons for major decisions likely to affect them. 23 16. Agencies should seek to recruit the help of practitioners in dealing with current problems, particularly the detection of hitherto unknown adverse effects, and the study of the frequenc y of known adverse effects. 17. The general practitioner should be presented with drug utiliz- ation data in a form that will aid him in comparing his own pre- scribing practices and those of others. 18. Data from impartial sources on drugs should be accessible at all times. Auditing of prescribing in general practice 19. In practice, a need emerges for various types of prescription auditing, including that performed by funding agencies and the internal or self-auditing conducted by physicians, either indepen- dently or collaboratively, and which will identify inappropriate prescribing. 20. A part of education for general practice should be devoted to teaching self-auditing techniques. Doctor/patient communication on prescribing 21. The provision of informatio n to patients on the drugs pre- scribed for them is essentially the task of the prescriber, but he cannot in practice perform this task adequately unless he can also rely on supplementary sources of data, e.g. information given by the pharmacist and by patient package inserts . The latt er should be attuned to patients' needs a nd the practitioner must be aware of their contents. 22. Many avoidable problems arise in practice because of one-sided and sensational data on drugs in the media. Official bodies and medical associations can do much to ensure that journalists are helped to provide balanced and reliable information to the public and that misleading data are promptly countered. 24 23. The physician should make every effort to explain to the patient why particular drugs are being prescribed or why no drug is being given. This helps the patient to share responsibility for the course of treatment. 25 Annex 1 PARTICIPANTS Austria Dr I. Eichler, Director, Federal Institute of Experimental Phar- macology and Balneology, Vienna Belgium Dr P. Bruaux, Institute of Hygiene and Epidemiology, Brussels Bulgaria Dr V. Vlahov, Head , Department of Clinical Pharmacology, Medical Academy, Sofia Czechoslovakia Dr J. Elis, Director, Inst itute for Drug Control, Prague Dr R. Dzurik, Research Institute of Medical Bionics, Research Laboratory of Experimental Therapy, Bratislava Denmark Mr J. Overn, Deputy Director-General, National Board of Health , Copenhagen Finland Dr E. Alhava , Medical Officer for Pharmacology, Pharmaceu- tical Office, National Board of Health , Helsinki Germany, Federal Republic of 26 Professor S. Haussler, Chairman, Association of Teachers in General Medicine, Stuttgart Greece Dr M . Maragoudakis, Chairman, Department of Pharmacology, University of Patras Medical School, Patras Hungary Dr G . Retsagi, Chief of Medicine , Central State Hospital , Budapest Iceland Dr L. Dungal, Health Centre, Reykjavik Ireland DrT. O'Dwyer, Senior Medical Officer, Department of Health, Dublin Italy Dr R. Capasso, Ministerial Counsellor to the General Direc- torate of Pharmaceuticals, Ministry of Health, Rome Morocco Dr M. Hassar, Professor of Clinical Pharmacology, Faculty of Medicine and Pharmacy, Rabat (Vice-Chairman) Netherlands Dr H.A. Nolet, Berg en Dalseweg 3, Nijmegen Norway Dr 0. Rutle, Health Services Research Group, Oslo Dr J . Setekleiv,0 Associate Professor, Institute of Pharmacology, University of Oslo a Participation expenses no t pa id by WHO. 27 Poland Professor T . Chrusciel, Deputy Director, Institute of Drug Re- search and Control, Warsaw Portugal Ms M. Oliveira, Directorate-General of Health, Lisbon Spain Dr L. Ramirez Ruiz, Head of Clinical Pharmacology and Drug Monitoring, National Centre of Pharmacology, Ministry of Health, Madrid Sweden Professor K. Strandberg, Head, Department of Drugs , National Board of Health and Welfare , Uppsala Switzerland Dr W. Flury, Intercantonal Office for Drug Auditing, Berne Turkey Professor R.K. TUrker, Pharmacology Department, Medical Faculty, University of Ankara USSR Dr V. Lepakhin, First Vice-President, Pharmacological Com- mittee of the Ministry of Health, Moscow ( Vice-Chairman) United Kingdom 28 Dr R.G. Penn , Principal Medical Officer, Medicines Division , Department of Health and Social Security , London Yugoslavia Dr V. Varagic, Department of Pharmacology, Faculty of Medi- cine, Belgrade Representatives of other organizations Commission of the European Communities Mr F. Sauer,0 Administrator, Directorate-General , Internal Market and Industrial Affairs, Brussels, Belgium International Federation of Pharmaceutical Manufacturers As- sociations (IFPMA) Dr D. Schuppan,° Federal Association of Pharmaceutical In- dustries, Frankfurt am Main, Federal Republic of Germany Dr E. Snell,° Director of Medical and Scientific Affairs, As- sociation of the British Pharmaceutical Industry , London, United Kingdom International Society of General Practice Dr O.M. Olsen,0 Post Box 20, Viby Sj, Denmark Observers Dr P. Bennett,° Department of Clinical Pharmacology, Royal United Hospital, Bath, United Kingdom Professor L. Blumenbach,0 Division of Experimental and Clini- cal Pharmacology, Pharmacological Institute, Federal Health Office, Berlin (West) a Participation expenses not paid by WHO . 29 Dr G. Harter,° Lecturer in General Medicine, University of Heidelberg , Reilingen/Mannheim, Federal Republic of Germany Professor H . Kewitz,° Director, Clinical Pharmacology Depart- ment, Free University of Berlin, Berlin (West) Dr Kuschinsky,° Pharmacological Institute, Federal Health Office, Berlin (West) Dr V.M.K . Venho,° Chief, Pharmacological and Microbiologi- cal Division, National Medicines Control Laboratory, Hel- sinki, Finland International Organization of Consumer Unions (/OCU) Dr A. Herxheimer,° Department of Pharmacology, Charing Cross Hospital (Fulham) Medical School, London, United Kingdom Nordic Council on Medicines Mrs M. Granat,° Secretary-General , Uppsala, Sweden Temporary advisers 30 Professor G. Fulgraff, Secretary of State, Federal Ministry for Youth, Family A ff airs and Health, Bonn, Federal Republic of Germany ( Chairman) Dr C. Gaudich,° Federal Ministry for Youth, Family Affairs and Health , Bonn, Federal Republic of Germany Professor H. H tiller, Institute of Clinical Pharmacology, Hum- boldt University, Berlin , German Democratic Republic Dr K .H. Kimbel ,a Secretary-General, Drug Commission of the German Medical Profession, Cologne, Federal Republic of Germany a Participation expenses not paid by WHO . Professor L. von Manger-Koenig,° Special Consultant on Medi- cal Affairs for the Federal Ministry for Youth, Family Affairs and Health, Bad Honnef-Rhondorf, Federal Re- public of Germany Professor D.G. McDevitt, Department of Therapeutics and Pharmacology, Queen's University of Belfast, United Kingdom Dr L.T. Newman, Abbey Medical Centre, London, United Kingdom (Rapporteur) Professor H. Wesseling, Institute of Clinical Pharmacology, State University of Groningen, Netherlands Professor B. Vrhovac, Head, Section of Clinical Pharmacology, Department of Medicine, University Hospital Medical School, Zagreb, Yugoslavia WHO Regional Office for Europe Dr M.N.G. Dukes, Regional Officer for Pharmaceuticals and Drug Utilization Dr H. Vuori, Regional Officer for Primary Health Care Dr A.H. W. Wahba, Director, Development of Comprehensive Health Services a Participation expenses not paid by WHO. 31 R ESU M E Introduction Co m me ce u x q ui l'o nt precede, le o nzie me sy mpos iu m de ce tt e se ri e a pu et re o rga ni se grace a l'appui fin a ncier du Mini ste re d e la jeun esse, d e la fa mill e et de la sa nte de la Republique federa le d' A ll emagne. Ce sy mpos ium a ete co nsac re a "! ' u til isa ti o n d es med ica ments en medecin e ge nera le" et a rasse mbl e des p ra ti ciens ge nera li stes, des spec ia listes en ph a rm acologie clinique et des fo ncti o nna ires cha rges de la reglem ent a ti o n des medi ca ment s. Les pa rt icipa nt s et !es o bserva teurs ass ista nt a ce sy mpos ium ve na ient de pays do tes de sys temes d e so ins d e sa nt e tres differe nt s, a ll a nt de !'a bse nce to ta le de medec ins ge nera li stes a d es sys temes tres co mpl exes de medec in e genera le. En d e pit d e ces differe nces, !es pa rti ci pa nts so nt co nve nu s de !' impo rta nce de cin q gra nds do mai nes : - la fo rma ti o n d u pra ti cien genera liste; - !'eva lu a ti o n d es medica ments et leu r presc ripti o n en medec ine ge nerale; - !'informa ti o n pha rm aco logique en medecin e genera le; - le co ntro le des presc ript io ns en medecin e ge nera le; - la communi ca ti on entre le pra ti cien ge nera li ste et le pa tient en med ecin e ge nera le. Conclusions et recommandations La fo rmation des praticiens generalistes La med ec ine ge nera le es t un e spec ia lit e qui necessit e un e fo rm a ti o n specifique a fin d e po uvo ir reso udre les differen tes ca tego ri es de pro bl emes d es pat ient s et repo ndre a leurs a tt entes, qui ne so nt pas !es memes qu e dans le cas des pa ti ents hos pita lises. La ma ni ere de presc rire en medecine genera le d evra it fa ire pa rtie int egra nte de ce tte fo rm a ti o n spec ifiq ue O U etre ense ignee se pa remen t Si ce tte fo rm a ti o n n ' ex iste pas. L 'objecti f de ce tt e for ma ti o n , dont les bases 33 d evrai ent etre prepa rees des les etudes universita ires de medecine, d evrait etre d' a meli o rer le cho ix et !'utilisati o n d es medi ca ments prescrit s. La pha rm aco logie d ev ra it fa ire pa rtie d e la fo rm a ti o n medi ca le de base. L' enseignement d e la pharmaco logie et de la th erapeutiqu e d evrait etre integre a l'ense ignement clinique to ut a u lo ng des etudes. La fo rm a ti o n en th e ra peutique d evra it se po ursui vre a pres l'obt enti o n du dipl 6 me, a u d ebut de la spec ia lisa ti o n , et fa ire pa rtie d e la fo rm a ti o n pe rm a nent e du med ecin to ut a u lo ng d e sa ca rri ere. C et ense ignement d ev ra it etre ass ure a to us les stades pa r des equipes qui d evra ient et re co mposees de medecins ge nera li stes, de speci a listes d e pha rmacologie clinique et , si poss ibl e a uss i, d' autres catego ri es d e specia li stes. C o mpte tenu des mod ificati o ns frequ ent es de la ga mme des medi ca ments dispo nibl es, ii es t esse nti el d ' in fo rm er en perma nence to us les pra tic iens ge nera li stes de ces modifi ca t io ns. Le ma teri el pedagogique utili se devrait etre ada pt e a la medecine genera le, etre bien prese nte et tirer pa rti des techniqu es modernes de communica ti o n . Evaluation et prescription des medicaments en medecine genera/e II fa ut ad o pter un e app roc he plus critiqu e et qui ti enn e dava nt age co mpt e des as pects eco nom iques. Les associa tions de medecins genera li stes dev ra ient encou rager leurs membres a co ll a bo rer po ur modi fier leurs habi tudes en ce se ns. Le medeci n ge nera li ste, q ui limite le nom bre d es medica ments q u' il prescr it et q u i se fa mili ar ise avec ces med ica ments, es t a lo rs a meme de presc ri re de fa~o n plus a pp ro priee et de mi eu x in forme r ses pa ti ents. II ne fau t oub li er que la p resc ripti o n n'est q ue l' un e des for mes de therapie. Les medicame nts ne d oiven t do ncjama is etre p rescr its a la lege re o u sa ns indica ti o n co nve na ble. Les med icaments ut ili ses en med ecine ge nera le d evra ien t ctre et ud ies en fo nct io n de ce tte utili sa t io n . II fa u t, par co nsequen t , q ue les medecins genera li stes et !es specia li stes de pharmacologic clini q uc coo perent , d a ns cctte optiqu e, po u r proceder a d es essa is cl ini q ues deonto logiqu emen t accep ta bles. 34 Les organismes de reglementation pharmacologique devraient repondre aux besoins des medecins generalistes en faisant participer ces medecins a leurs travaux. L'information pharmaco/ogique et /es medecins generalistes Le medecin generaliste doit recevoir une information pharmaco- logique abondante, sans pour autant etre submerge de donnees contradictoires. Ce probleme devrait etre etudie par tous Jes organes fournissant cette information ou participant a la reglementation en matiere de medicaments. Les services de pharmacologie clinique devraient fournir aux edecins generalistes de leur region des informations et des conseils concernant Jes problemes de prescription. Le medecin generaliste doit disposer de donnees fiables, completes et a jour sur Jes medicaments commercialises et Jes problemes lies a leur utilisation. Ces donnees devraient etre fournies aux niveaux national et international. Les organismes de reglementation en matiere de medicaments devraient informer Jes medecins generalistes de leurs decisions et des raisons qui Jes ont motivees et chercher a obtenir leur aide pour etudier Jes eff ets adverses connus et inconnus. Les donnees sur )'utilisation des medicaments devraient etre fournies au medecin generaliste par des sources impartiales et sous une forme Jui permettant de comparer ses habitudes avec celles d'autres medecins. Controle des prescriptions en medecine generate II faut proceder a differents types de cont role en medecine generale, y compris le controle externe, qui peut etre realise par des organes de financement, et le controle interne realise par Jes medecins gene- ralistes eux-memes, travaillant seuls ou en groupes. Le principal objectif de ces controles devrait etre d'identifier Jes prescriptions inappropriees. Les techniques de controle devraient faire partie de la formation des medecins generalistes. 35 Communication entre le medecin generaliste et le patient en ce qui concerne /es prescriptions L'importance de la communication entre le medecin generaliste et son patient est de plus en plus reconnue par tous. II est essentiel que le medecin generaliste dispose, en prescrivant, de donnees suffisantes pour son information comme pour celle du patient. Les notices d'emploi doivent correspond re aux besoins des patients et le medecin generaliste doit en connaitre le contenu. Le role des medias dans la fourniture d'informations sur les prescriptions est de plus en plus important. Cette information ne devrait pas avoir un caractere sensationnel ou tendancieux. Les organismes officiels doivent fournir aux journalistes des informa- tions fiables et veiller a rectifier sans tarder toute information trompeuse. Les patients devraient etre encourages a partager la responsa- bi lite de leur traitement. Pour cela, ii faut les informer de l'action esperee des medicaments prescrits ou leur expliquer pourquoi, dans certains cas, aucun medicament n'a ete prescrit. 36 ZUSAMMENF ASS UNG Einleitung Wie die vorangegangenen Symposien dieser Reihe wurde das Elfte Symposium aufgrund der finanziellen UnterstUtzung seitens des Ministeriums fi.ir Jugend, Familie und Gesundheit der Bundesrepu- blik Deutschland ermoglicht. Es fand unter dem Thema ,,Arzneimittel in der Allgemeinpra- xis" statt , und es nahmen Allgemeinmediziner, klinische Pharma- kologen und Verantwortliche der Arzneimitteltiberwachungsbe- horden daran teil. Die Teilnehmer und Beobachter kamen aus Lan- dern mit sehr unterschiedlichen Gesundheitsversorgungssystemen; dieses Spektrum reichte von Landern, in welchen es i.iberhaupt keine Allgemeinmediziner gibt, bis zu Landern , in welchen das Allgemeinpraxiswesen sehr vielschichtig ist. Trotz dieser Unter- schiede wurde i.iber die Bedeutung von fi.inf groBen Bereichen Eini- gung erzielt, und zwar: - Ausbildung der Allgemeinmediziner - Arzneimittelbewertung und Medikation in der Allgemein- praxis - Arzneimittelinformation in der Allgemeinpraxis - Pri.ifung der Medikation in der Allgemeinpraxis - Kommunikation zwischen Allgemeinmediziner und Patient in der Allgemeinpraxis. SchluBfolgerungen und Empfehlungen A usbildung der Al/gemeinmediziner Die Allgemeinpraxis ist ein medizinischer Spezialbereich, der eine besondere Ausbildung dari.iber erfordert , wie die unterschiedlichen Probleme und Erwartungen des Patienten im Verg]eich zu denjeni- gen von Krankenhauspatienten bewaltigt bzw. erfi.illt werden kon- nen. Eine Schulung i.iber Arzneimittelverordnungen in der Allge- meinpraxis sollte ein integraler Bestandteil dieser besonderen Aus- bildung sein oder, wenn es derartige Unterrichtungsmoglichkeiten 37 nicht gibt, sollte die Medikation anderweitig selbst erlernt werden. Das Ziel sollte eine bessere Auswahl und Anwendung der ver- schriebenen Medikamente sein. Der Grundstein zu einer derartigen Ausbildung sollte bereits in den Studienplanen fur die Universi- tatsausbildung gelegt werden. Pharmakologie sollte den Studenten als Tei! ihrer medizini- schen Grundausbildung vermittelt werden. Die Unterrichtung in Pharmakologie und Therapeutik sollte auf alien Stufen in die klini- sche Ausbildung integriert werden. Die Ausbildung in Therapeutik sollte nach AbschluB des Stu- diums zu Beginn der postgraduierten Ausbildung (der beruflichen Weiterbildung) fortgeftihrt werden und Tei! der Fortbildung von Arzten wahrend iluer gesamten Tatigkeit sein. Die Schulung sollte auf alien Ebenen <lurch Teams erfolgen , zu denen erfahrene Allgemeinmediziner, klinische Pharmakologen und gegebenenfalls auch sonstige Spezialisten gehoren. Es gibt haufig Anderungen in bezug auf die auf dem Markt be- findlichen Arzneimittel sowie auch hinsichtlich der Rezeptierung. Deshalb ist es unbedingt erforderlich, daB eine fortlaufende Unter- richtung samtlicher Allgemeinmediziner sichergestellt wird , um sie i.iber derartige Anderungen auf dem laufenden zu halten. Das Schulungsmaterial sollte den Bedi.irfnissen der Allgemein- praxis angepaBt sein, eine ansprechende Darstellungsform haben und moderne Informationstechniken beri.icksichtigen. Arzneimittelbewertung und Medikation in der Allgemeinpraxis Es sollte kritischer und kostenbewuBter verfahren werden. Die All- gemeinmedizinerverbande sollten ihre Mitglieder anhalten, zu einer Verbesserung der Verschreibungsgewohnheiten beizutragen. Wenn der Allgemeinmediziner die Anzahl der von ihm ver- schrie benen Medikamente verringert und sich selbst mit ihnen ver- traut macht, wird er in der Lage sein, sie gezielter zu verordnen und seine Patienten besser dari.iber zu informieren. Es ist zu bedenken , daB die Verordnung nur eine Form der Therapie ist. Aus diesem Grund darf sie niemals leichtfertig oder ohne eindeutige lndikationen erfolgen. Die in der Allgemeinpraxis i.ibliche Medikation sollte unter diesen Voraussetzungen untersucht werden. Deshalb besteh t ein 38 Bedarf an ethisch vertretbaren klinischen Versuchen <lurch Allge- meinmediziner und klinische Pharmakologen in Zusammenarbeit, unter den Bedingungen einer Allgemeinpraxis. Arzneimitteltiberwachungsbehorden sollten den Bedurfnissen des Allgemeinmediziners durch <lessen Einbeziehung in ihre Arbeit gerech t werden . Arzneimittelinformation und A llgemeinmediziner Der Allgemeinmediziner benotigt eine Reihe von Informationen uber Arzneimittel, allerdings ohne mit gegensatzlichen Informatio- nen uberschutte t zu werden . Dieses Problem sollte von alien Stel- len , die Informationen uber Medikamente weitergeben oder die auf dem Gebiet der Arzneimitteluberwachung tatig sind , untersucht werden . Klinisch-pharmakologische Einrichtungen sollten den Allge- meinmedizinern in ihrem jeweiligen Einzugsgebiet Informationen uber die Rezep tierung vermitteln und sie bei diesbezuglichen Schwierigkeiten beraten. Der Allgemeinmediziner hat ein Anrecht auf zuverlassige, ver- standliche und aktuelle Angaben uber die auf dem Markt befind- li chen Arzneimittel und die damit verbundenen Probleme. Diese Informationen sollten auf nationaler und internationaler Ebene verfugbar sein . Arzneimi ttel uberwach ungs beh or den soll ten Allgemein medizi- ner sowohl uber ihre Entscheidungen als auch uber die zugrunde liegenden Begrundungen unterrichten und sich bemuhen, deren Mitwirkung bei der Untersuchung der bekannten und der nicht be- kannten schadlichen Nebenwirkungen sicherzustellen. Ein Allgemeinmediziner sollte von unparteiischen Stellen Oa- ten uber die Anwendung von Arzneimitteln in einer Form erhal- ten, die ihm einen Vergleich seiner Verordnungsgewohnheiten mit denen anderer A.rzte ermoglicht. Priifung und Medikation in der A llgemeinpraxis Es besteht die Notwendigkeit einer verschiedenartig gestalteten Revision in der Allgemeinpraxis - einschlie~li ch der externen Pru- f ung, die durch die Abrechnungsstellen vorgenommen werden konnte, sowie der internen bzw. eigenen Prufung durch entweder 39 einzelne oder in Gruppen zusammenarbeitende Allgemeinmedizi- ner. Ziel dieser Pri.ifverfahren soil die Ermittlung unzweckmaBiger Verschreibungspraktiken sein . Pri.ifmethoden sollten Tei) der Ausbildung zur Fiihrung einer Allgemeinpraxis sein. Kommunikation zwischen Allgemeinmediziner und Patient iiber die Verordnung Die Wichtigkeit der Kommunikation zwischen dem Allgemeinme- diziner und dem Patienten wird in alien Bereichen in zunehmen- dem MaBe erkannt. Es ist unbedingt erforderlich, daB der Allge- meinmediziner bei der Verschreibung hinreichende Oaten sowohl zu seiner eigenen Information als auch zur Unterrichtung des Pa- tienten zur Verfi.igung hat. Die Beipackzettel fi.ir den Patienten mi.issen den Bedi.irfnissen des Patienten angepaBt sein und der All- gemeinmediziner muB ihren InhaJt kennen. Den Medien kommt eine immer wichtigere Stellung im Hin- blick auf Infom1ationen Uber Verschreibungen zu. Diese Informa- tionen sollten nicht den Charakter von Sensationsmeldungen ha- ben oder einseitig sein. Offizielle Stellen mi.issen JoumaJisten zu- verlassige Angaben zukommen !assen und gewahrleisten, daB irre- fi.ihrende Berichte unverzi.iglich korrigiert werden. Patienten sollten motiviert werden , einen Tei! der Verantwor- tung for ihre Behandlung selbst zu tragen . Das kann geschehen, in- dem ihnen gesagt wird, welche Wirkung die bestimmten verschie- denen Arzneimittel haben sollen oder warum in einem besonderen Fall kein Medikament verschrieben wurde. 40 PE3DME Bae.oeHHe KaK H npe.m,uzy!J1He coae111aHHR no .oaHHoo TeMe, 0.IlHHHaill.l3TblH CHMI103HYM Obin npoae.oeH npH ¢HHaHCOBOH no.n.aepllO<e ¢e.oepam,ttoro MHHHCTepc-raa no .oenaM Mono.oen-i, ceMbH H 3.opaBOOXpaHeHHR ¢e.oepa.THBHOH Pecny0.TIHKH repMaHID!. )laHHoe COBel!laHHe OblJJO nOCBR!lleHo npoOneMe "fleKapcTBeHHhle cpe.OCTBa B oOl!leH npaKTHJ<e". B HeM npHHJUtH y,.iaCTHe BP3'IB oOl!leH npaKTHKH, K.JlHHH'iecKHe ¢apMaKonorn H pa.OoTHHKH opraHOB neKapcTBeHHOro KOHTpo.lUI. OHH npe.ocTaBJlRJlH CTpaHhl C pa3.1Il-NHblMH CHCTeMaMH Me]lHKO-- CaffiITapHOH nOMOl!lH: B TO BpeMR, KaK B HeKOTOPblX H3 HHX BOoOl!le OTcyTCTByeT HHCTHTYT oOl!lenpaKTHKYl(IIIHX apaqcii, B .opyrnx - Bpaq!,i oOl!leH npaKTHKH pa.OoTalOT B pa.MJ<ax qpe3BbNaHHO cnOXCHblX CHCTeM 3.IlpaBOOXpaHeHHR. 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KpaHHe HeoOXO,llHMO, tiToObl npH Ha3HatieHHH OOJibHOMY JieKapcTBeHHOro Cpe,llCTBa Bpati oOmeH npaKTHKH pacnonaran 6bl COOTBeTCTBYJ(lllHMH .llaHHblMH, H3 KOTOPblX OH Mor 6bl noqepnH,'Tb HH¢>oPMaUHIO, KaK .llJl.FI Ce6.FI J}Ht{HO, TaK H .llJl.FI OOJibHOro. CBe.lleHHR, co,llep!(31llHeCR B npHJiaraeMOH K npenapaTy JIHCTOBKe-BKJlaJlhlblY, ,llOJillOihl oOecnetiHBa.Tb OOJibHOro Heo0XO,llHMOH H nOH.FITHOH eMY HH¢>opMaUHeH: 0 CO,llep!(aHHH JIHCTOBKH ,llOJlllteH HMeTb npe,llCTaBJieHHe H oOmenpaKTHKYJ(lllHH spaq. Cpe,llCTBa MaCCOBOH HH¢>oPMa.UHH HrpalOT BCeB03pacTal<lllyJO poJib B pacnpocrpaHeHHH ,llaHHbJX, KaCaJOlltHXC.FI npHMeHeHH.FI JieKapcTBeHHblX Cpe,llCTB. TaKa.FI HH¢>oPMauH.FI He ,llOJI!(Ha HOCHTb ceHCauHOHHblH HJlH O,llHOCTOpoHHHH xapaKTep. Q¢HUHaJibHblM opraHaM CJie,llyeT o6ecnetiHBa.Tb !(ypHaJIHCTOB Ha,lle!(HOH HH¢x)pMauHeH H no3aOOTHTbC.FI O TOM, tiToObl B nO.FIBHBmHec.FI HeBepHl,le CBe,lleHH.FI 6b1CTpo BHOCHJIHCb HeoOXO,llHMbie KOppeKTHBbl. 44 Cne.oyeT CTpeMHTbCfi K TOMY, '-IToObl OOJlbHble HeCJlH CBOIO .nomo OTBeTCTBeHHOCTH 3a pe3yJibTaTbl rrpoBO.llHMOro neqeHHfi, 9Toro MOJIHO .noOHTbCfi B TOM cnyqae, Kor.na OOJlbHble 3HaIOT o npe.nnonaraeMOM ,UeHCTBHH Ha3Ha'ieHHblX HM KOHKpeTHbl.X npenapaTOB, a TaK~e O npH'IBHaX B03MOJtHOro B OT,UeJTbHblX cnyqaRX OTKa3a B Bbl.naqe peuema. 45 WHO publ1ca11ons may be obtained . direct or through booksellers from· ALGERIA tn1repn~ na11nnJtc- Ju L1\rl' lf'-.\U. J hd Z1rout Youli:I ..\UIIERS ARGENTINA · Carlos H tr<~"h RL. FlondJ lb5. (iaknas <.,ut.'mc.•~ [hntuno J53 465. Ill !--'ill", ..\IRES AUSTRALIA : Huntc:r Pu bllca11,1nt., 5b.\ Li1pp1i "itrcet C V I u,l,V.t )(.lfJ \ IC. J066 - .\u,trJhan (,jo1,.c: rnm,,:nt Pub:1,hing Scn.11.:c \/.J tl ,, .. ,....,, ,,,./n,. 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