Consumption of drugs: report on a Symposium convened by the Regional Office for Europe of the World Health Organization: 3-7 November 1969, Oslo, Norway

D CONSUMPTION OF DRUGS Report on • Symposium Oslo 3-1 November 1969 REGIONAL OF FICE FOR EUROPE Wor l d Health Org.in l tat lo n C OPENHAGEN 3(02 ,OEXEO EURO 3102 CONSUMPTION OF DRUGS Report on a Symposium convened by the Regional Office for Europe of the World Health Organization Oslo 3-7 November 1969 Not for Sale Distributed by the REGIONAL OFFICE FOR EUROPE World Health Organization COPENHAGEN 1 970 Note This report has been prepared by the Regional Office for Europe of the World Health Organization for distribution to the governments of Mem- ber States in the Region and to all who participated in the Symposium on the Consumption of Drugs , Oslo, Norway. A limited number of copies are available for persons officially or professionally concerned with this field of study from the WHO Regional Office for Europe, Copenhagen. The views expressed are those of participants in the Symposium and do not necessarily reflect the policy of the World Health Organization. The designations employed and the presentation of the material do not imply the expression of any opinion whatsoever on the part of the Director -General of the World Health Organization concerning the legal status of any country or territory or of its authorities, or concerning the delimitation of its frontiers. This report is also available in French and Russian. ii CONTENTS l. Introduction 2. Study on the consumption of drugs in Europe 3. Definitions and classifications 4. Sources of information and units of measurements 5. Obtaining and interpreting data 6 . Use of data on drug consumption 7. Factors influencing drug consumption 8. Suggestions for further action or study ANNEX I Therapeutic classification of drugs used by the Pilot l 2 7 11 15 22 37 38 Research Project for International Drug Monitoring 40 ANNEX II Therapeutic classification of pharmaceutical preparations used by the Norsk Medisinaldepot 48 ANNEX III List of working documents 59 ANNEX IV Programme 60 ANNEX V List of participants 62 iii 1. INTRODUCTION The progress made in the development of new drugs has brought dra - matic benefits to public health . Like every scientific advance , this re - volution in modern drug therapy has generated new hazards, new questions and new conflicts. The problems created are enormously complex and also controversial. However, there is no difference of opinion on the ul- t imat e goal: to ensure that effective and safe drugs will be available to all who need them. Drug therapy used to be the concern of the individual physician and pharmacist. More recently, it has also become the concern of the phar - maceutical industry. Drug efficacy and safety, moreover, is nowadays a matter of public concern. The increasing consumption of drugs is at- tracting public attention and the rising cost of national drug bills has added another dimension to the problem - drug economy. At least three disci - plines meet each other in the field of drug consumption : medicine , phar - macy and ec anomic s. In the light of these considerations, the WHO Regional Office for Europe convened a S ymposium on the Consumption of Drugs w hich m e t in Oslo from 3 to 7 November 1969. The programme of the Symposium is given in Annex IV. The Symposium brought together exper ts in the fields of medicine , pharmacy and economics as well as public health administra- tors. The meeting was a ttended by 23 participants from 22 countries in the European Region. In addition to participants nominated by govern- ments, seven temporary advisers, a WHO consultant and WHO staff mem- bers participated in the m eeting. A list of participants is found in Annex V. The discussions took place on the basis of the working papers liste d in Annex III. The meeting was opened by Dr Leo A . Kaprio, Direc tor of the WHO R egional Office for Europe. Dr Kaprio recalled that WHO from the out- set, had been active in the field of drug utilization. He mentioned the Organization's work in establishing international standards fo r various biological products and pharmaceuticals, in the quality control of phar- maceutical preparations and in good manufacturing practice in the phar- maceutical industry. In the European Region three different problems had so far been dealt with: the quality control of pharmaceutical prepara- tions, the toxicology of drugs and the consumption of drugs . Quality con- trol h ad been the subject of a WHO technical meeting in Warsaw in 1 961. This was followed by a conference on the same subjec t in Helsinki in 1968. In 1964 a Symposium on the Toxicology of Drugs met to discuss prob- lems of drug safety, especially those connected with the introduction of new drugs. The present Symposium would cons ider the consumption of drugs and their potential waste or misuse. The history of the pre sent Symposium went back to 1964, when the Swedish Governm ent suggested in the WHO Regional Committee for Europe that a study of drug consumption in the Region should be undertaken. This led to a special preliminary study by two consultants , Dr Engel (Sweden) and Dr Siderius (Netherlands). Dr Kaprio believed that the Symposium was a positive step on an in- ternational scale in assisting countries of the Region in the study of this difficult subject. The meeting, moreover, might lead to specific propo- sals or suggestions for both WHO and the governments. Dr K. Evang, Director General of the Health Se rvices of Norway, welcoming the participants, emphasized the problem presented by modern pharmacotherapy for all countries of the world. Mr B. J¢'ldal was elec ted Chairman of the Symposium, Dr P . Siderius acted as Rapporteur , and Professor 0 . L. Wade as Co- rapporteur . 2. STUDY ON THE CONSUMPTION OF DRUGS IN EUROPE 2. 1 Report on the study1 1966- 1967 The preliminary study by the WHO consultants, Dr Engel and Dr Siderius was intended as a basis for a more elaborate investigation and discussion of the subject. In the course of their study the consultants collected information in Austria, France, Hungary, the Netherlands , Sweden and the United Kingdom. The findings presented in the report were thought to be representative of the situation in the European Region. It was understood, however, that some of the information collected was out of date and that changes had taken place since the report had been written. For instance, the French legislation on drug advertising cited in the report had since been changed. In their re- port, the consultants , on the basis of the information collected, reached a number of conclusions. In the first place, the question of whether there is overconsumption of underconsumption of drugs cannot be answered .on the basis of the study. In all the countries visited, the increase in drug consumption is a matter of serious concern to the health authorities. However, there is general agree - ment that, so far, the available material is inadequate to establish the pre- sent drug consumption pattern or to allow effective means of control to serve optimum levels of consumption. 2 Secondly, the study has revealed that there is considerable varia- tion in drug consumption both between and within countries. For various reasons it was not considered feasible to make a detailed comparative ta- ble on drug consumption in the countries visited. The national data ob- tained are, in general , not comparable. There may be a temptation to draw conclusions by comparing such data, but it is considered that it would be dangerous to do so. The following points, however, should, according to the authors of the report, be considered in future for more detailed studies of the subject. 2 . 1. 1 Variations between and within countries It is evident that there is a considerable variation in the drug con- sumption pattern, which is not dependent solely on differences in morbi- dity. Differences in the quantity of drugs used per head of the population and in the per capita drug cost, as well as the differences in the types of drugs used for certain diseases, call for more detailed study. 2 . 1. 2 Increase in drug consumption The rise in the cost of the supply of prescription drugs in the last 10 years is disproportionately large in comparison to the increase in na- tional income. Rising expendi tur e seems to result more from a rise in the cos t of the average prescription item than from an increased volume of prescriptions. The increased cost seems to be more evident in gen- eral practice than in the hospitals. 2. 1. 3 M edical personn el It was observed that the largest number of prescription items per head of the population was consumed in countries with the highest physician/ population ratio (Austria, Hungary). There is an indication that there may be differences in prescribing habits between specialists and general practitioners. In France specia- lists tend to prescribe less than general practitioners. The study did not reveal a correlation between the consum~tion of prescription drugs or ove r-the - counter drugs and the pharmacy/population ratio . 2. I. 4 Health insurance It is quite clear that in health insurance schemes, where prescribed medicaments are supplied under the benefits provided without payment or a t a small charge, prices are not performing their normal function of bal- ancing supply and demand. On the basis of this report it is not possible to come to a definite conclusion on the effec ts of this factor. However , in countries where there is no, or only a small prescription charge, the 3 volume of prescribing (as evidenced by the number of prescriptions per in- sured person) seems to be larger than in those where the patient contributes considerably to payment for the drugs prescribed. Health insurance authorities have attempted to compensate for the absence of "natural" consumption control by prices in a number of ways, such as persuasion of the prescriber, or by charging for prescriptions . The average cost p e r prescription item appears to be lowest in those countries where there is no prescription charge or only a small one. Whether this difference is th e result of compensatory control measures by the health insurance authorities or simply the result of including in pre - scriptions drugs which in other countries might be purchased by the patient over the counter is not clear. 2. 1. 5 Conditions with regard to manufacture and marketing There is no evidence that rigid State control over the manufacture and marketing of drugs influences the total volume of drug consumption. There is also no evidence for assuming that the presence of a large number of drugs on the market in itself significantly affects the total volume of drug consumption. A liberal policy in admitting drugs to the market will, how- ever, lead to a larger number of drugs and also to more variation, and re - sult in a less uniform consumption pattern and an increase in the consump- tion of less effective remedies . 2. 1. 6 Dissemination of information on medicaments The influence of commercial communication has been considerably intensified in recent years. It cannot be denied that this type of informa- tion is exercising a considerable influence on the prescribing habits of physicians as well as on the self-medication habits of the public . The ef- forts made by pharmaceutical manufacturers to obtain information on the effect of their sales promotion activities and to m easure their efficacy, justify this opinion. The widespread and well-organized activities of marketing research companies in the field of pharmaceuticals open up a very interesting field for further study on the part of observers outside the pharmaceutical industry. There seems to be general agreement that, while commercial com- munication is necessary, more emphasis should be placed on unbiased non-commercial information. In some countries (the United Kingdom and the Netherlands) the public health authorities distribute such informa- tion systematically to physicians. 2. 1 . 7 Studies on drug consumption by sampling In some countries interesting studies have been undertaken on the relation between drug consumption and factors such as age, sex and mor - bidity in various socio-economic population groups (France, Sweden, the 4 United Kingdom) . Such studies are most important for dete rmining the basic factors which influence drug consumption. Variations in drug consumption are at present determined by many factors such as the attitude of the public , c ommercial advertising, the practice of physicians, the teaching in medical schools, and so on. A scientific study of drug consumption would, among other things, lead to a more sophisticated use of available drugs. 2.2 Discussion on the report It was agreed by the participants that the information on drug con- sumption presented in the report was of value for at least three important purposes: 2. 2. l Health administration Drug consumption is of interest to public health and social security administrators . It represents about l Oo/o - l So/o of the total cost of med- ical care. Approximately l o/o of the gross national product (at market price) is spent on drugs. The cost of drug consumption, like other forms of expenditure on medical care, is increasing year by year . This may b e due to a number of different factors. For example, every year new drugs become available and are used in medical treatment. These in- novations have to be paid for. Then, too, present- day industrialized, urban society makes increasing demands on physical and mental health and this also leads to an increased consumption of drugs, particularly psychotropic drugs such as the minor tranquillizers, There is also a trend towards increased drug development costs . The introduction of any new therapeutic agent must now b e preceded by extensive and often costly toxicity testing and clinical trials, owing to the increasingly stringent standards of drug safety. Although good grounds for the increased expenditure on drug con- sumption can be put forward , it is to be expected that the authorities who have to meet its cost will feel a growing n eed to assure themselves that this expenditure is justified. This, in turn, calls for more extensive data on drug requirements. 2. 2. 2 Medical care Both the medical and the pharmaceutical professions are showing a growing interest in drug consumption, From the medical point of view, effective and safe drugs should be available at as low a price as possible. More information is needed in order to measure the success of the effort to reach this goal. It will require sophisticated studies of the use of drugs and the benefits derived therein and these are difficult to undertake. Re - search and pilot studies in this field are urgently required, as they may form the basis for the more effec tive use of drugs. 5 2. 2. 3 Drug manufacture The concern of the pharmaceutical industries with regard to drug consumption is evident. For various reasons they need insight into the market mechanism. In recent years, several marketing research com- panies have been establish ed to satisfy the needs of pharmaceutical com- panies for systematic information on the consumption of specified drugs. Detailed information can be supplied, not only on the sales of individual drugs or groups of drugs and the purposes for which they are used, but also on what drugs are being prescribed for specific diseases. In the light of our present knowledge, it is not possible to determine which specific pattern of drug consumption would be congruent with the needs of a specific community. Such conclusions would be premature both as regards drug consumption in general and the use of specific groups of drugs. 2. 2. 4 Collection of information on drug consumption Overall figures on drug consumption for the whole population or for a restricted area of a country are easy t o collect in those countries where there is a centralized and planned system of drug production and distribu- tion as, for example, in Hungary. Overall information on the consumption of drugs or groups of drugs being prescribed by doctors for the whole or for ce rtain groups of a po- pulation can be collected if there is central registration of prescription forms as, for example, in Austria, the Netherlands, Sweden and the United Kingdom. More detailed information on the consumption of prescribed drugs may be gathered if other data about patients, such as their age and sex are available on prescription forms as, for example, in Sweden. Information on drug consumption in relation to the diseases from which patients suffer may be obtained by surveys in which prescribing phy- sicians collaborate , as, for example, in market research. Information on the pattern of drug consumption in a population may also be obtained by surveys of a representative sample of households as has been done in France. 6 3. DEFINITIONS AND CLASSIFICATIONS 3. l Definitions The Symposium discussed the definition of a drug, A "drug" has been defined as "Any substance or mixture of substances that is manufac- tured, sold, offered for sale , or represented for use in (1) treatment, mi- tigation, prevention, or diagnosis of disease , an abnormal physical state, or the symptoms thereof in man or animal; or (2) the restoration, cor- rection, or modification of organic functions in man or animal". 1 This definition includes human and veterinary drugs, "starting materials" and partially processed components of compounded drugs, non-proprietary preparations (official and other) and proprietary prepar ations, both those prescribed by doctors and those sold over the counter. No definition of a drug yet devised is completely satisfactory and it is difficult to distinguish whether some preparations are being used as drugs or as dietary foods , infant feeds , foods , food supplements or cos- metics. Some pharmacologically active substances not normally used in therapeutics may be considered as "drugs " , e.g. , cannabis and lysergic acid diethylamide , and are so regarded in international narcotic agree - ments. Other substances, such as brandy, tobacco and coffee , although regarded as pharmacologically active material s , are not considered as drugs. Two further definitions referring to items which rank under the heading "drug" have been adopted by international groups of experts ad- vising WHO on pharmaceutical subjects. (1) Starting materials: 1 "All substances, whether active or in- active or whether they remain unchanged or become altered, that are employed solely for the manufacture of drugs". (2) Pharmaceutical speciality: 2 "A simple or compound drug ready for use and placed on the market under a special name or in a char- acteristic form" . The adoption of these definitions by an expert group advising on drug consumption statistics would allow the exclusion of numerous terms that partially or fully describe the same items from future discussions. The need to concentrate on a few well-defined technical terms seems to be ur- gent, as many terms, similar or related to "drug'!, can be found in the literature. 1 Wld Hlth Org. techn. Rep. Ser., 1969, 418 , 18 2 Wld Hlth Org. techn. Rep. Ser., 1957, 138, 14 7 The participants believed that some arbitrary decisions on the scope of the term "drug" will finally have to be agreed upon internationally if data on drug consumption are to become comparable. Apart from the definitions given above the following may also b e given: drugs consist of or contain the starting material, a biologically ac t ive or inactive material of chemical or biological origin. Drugs in their finished state may be official galenic preparations, preparations dispensed individ- ually in a pharmacy or pharmaceutical specialities. If pharmaceutical specialities can be obtained by the public on prescription only, they are prescription drugs, otherwi se they are over-the - counter drugs. Drugs marketed under a trademark are proprietary drugs, otherwise they are non-proprietary drugs. These few remarks on terminology, however, cannot deal with all the questions which arise in practice. This initial attempt to contribute to the problem of definition will show that the topic is accessible, and that the work to be done would be facilitated by the availability of certain basic internationally accepted de- finitions . 3. 2 Classification of drugs A second step in the direction of a uniform presentation of drug con- sumption data would be the establishment of an accepted system of classi- fying drugs . This is essential, not only when drug consumption data of different countries are to be compared, but also when required to follow the national drug consumption pattern, e . g. , in monitoring adverse drug re- actions and where systematic information is required on drugs and their use. A classification should be a logical index of headings and subtitles under which drugs of the same classes or categories can be grouped. A number of differ ent drug classifications are already coming into use. It still needs to be es tablished whether any one of them is suitable for nation- al statistics and for the international comparison of drug consumption data, as well as for the other purposes mentioned. It is doubted whether such a single classification suitable for all purposes could be developed since the peculiarities of individual projects would call for specific features . However, it should be possible to devise classification systems suitable for specific needs. With regard to a classification suitable for the study of the consumption of drugs, a number of basic anq special problems will have to be solved; e.g. , the best type of grouping to be used for categories under which drugs have to be classed; the number of groups and subgroups within the main categories; the avoidance of duplication of those drugs or groups of drugs which have widely different uses (e . g ., chloroquine used for malaria and for rheumatism). 8 Drugs can be classified by what they do under pharmaco-therapeutic categories, by the diseases for which they are used under diagnostic cate- gories, or in other ways , e . g. , by chemical formula. Pharmaco- the rapeutic categories include , for example: analge sics, antacids , anti- arthritic s , a ntimicrobial agents, anticoagulants, diuretics, muscle r e - laxants. Examples of diagnostic categories are: high blood pressure, arthritis and rheumatism, mental and nervous conditions, diabetes, neo - plasms, bronchitis. Each type of classification has its special merits and its specific area of applicability. Many of the published classification systems are a combination of the rapeutic and diagnostic categories with emphasis on the one or the other . Moreover, they often contain sub- groups like "vitamins", "hormones" or "enzymes" which belong neither to the one nor to the other category. It will be difficult to decide which type of classification will be most suitable for drug consumption studies. If, for example , information on drug consumption has to be based on the evaluation of prescriptions collected and provided by h e alth insurance agencies, or on over-the-counter sales figures , then the consumed drugs may have to be classified unde r therapeutic headings, because the diag- nostic bac kground to the prescription or pur chase of the drug is unknown to the statistician. To obtain information on drug consumption by dia- betics, tuberculosis patients, or ophthalmological patients, it would be an advantage for consumption figures to follow a diagnostic classification. The subdivision of a classificat ion has to be guided both by the cha- rac teristics of the subjec t and by the capacity of the available data- processing equipment and o ther technical aids. An examina tion of pub- lished therap e utic classification systems shows that they are usually com- posed of 20 to 50 major categories, 50 to 200 sub-categories and/ or 120 t o 240 specific categories . At the l evel of "clinical equivalence", a min- imum of 500 different drugs may have to be t a ken into account. The num- ber of pharmaceutical specialities will run into thousands. These fig - ures give an approximate idea of the volume of data which will have to be processed, stored and retrieved, and of the number of digit categories which will have to be provided for the data-processing procedures. The e laboration of an internationally agreed nomenclature for cate - gories and the assignment of drugs to those categories requires a detailed expert study of the matter . It may often be necessary to compromise, for instance, on drugs that are used for several therapeutic purposes and which should be listed under only one heading. Chloroquine , for example , is an anti - protozoic as well as an antirheumatic drug . Phenobarbital is used as a sedative as well as an anticonvulsant; codeine is used as a cough suppressant, but also as an analgesic . It may be advisable, in the case of such drugs, to agree on their principal therapeutic use in order to determine their category. The magnitude of this and related problems must not be underestimated since the labelling of the majority of durgs is based on a number of diff erent indications for use. The classification must also indicate the different forms and doses of drugs , whether they are used systemically or topically, whether they 9 are over-the-counter or prescription drugs. No classification of drugs yet devised is completely satisfactory. Experience in the development of the International Classification of Diseases suggests that the classification of drugs should b e flexible , so that additions , deletions and modifications may be made. In view of the rapid developments in drug therapy, the clas- sification will have to be reviewed periodically. If useful comparisons of drug consumption within or between coun- tries are to be made, the classification of drugs will have to be broad, complicated and multi-lingual . Fortunately, the storage, retrieval , grouping and analysis of information has been made easier by the use of modern data-processing equipment. With its help, full advantage could be taken of a sophisticate d system of drug classification. The facts indicate that investment of considerable time and expert ise will be necessary for the development and maintenance of such an inter- national classification. Under these conditions it would be rational in terms of cost and time if drug consumption data, extracted from the plan- ned routine statistics could be used for a variety of purposes. It seems likely that the classification to be agreed upon will be an amalgamation of many classifications already devised. The experience of WHO in the use of the therapeutic classification of drugs developed by the "pilot research project for international drug mo- nitoring" should be utilized. This classification system is presented in Annex IV. Examples of classifications used by other organizations should also be investigated. The Norsk Medisinal Depot uses a classification based on the syste m of the European Pharmaceutical Market Research Association. This classification is presented in Annex V. Several countr ies, for the purpose of producing routine statistics, use some sort of classification. It would be rational in terms of cost and time if all statistics were based on a single accepted classification system. If that were done, such data could be used for a variety of pur- poses. The participants considered an inte rnationally accepted classificati on of drugs to be urgently needed and hoped that WHO would convene an expert committe e to draw up a suitable classification as soon as possible . 10 4. SOURCES OF INFORMATION AND UNITS OF MEASUREMENT 4. 1 Types of drug consumption Drug consumption may be considered under three headings: (1) consumption of drugs supplied to the patients on their own ini- tiative without a doctor's prescription (corresponding to over-the- counter sales); (2) consumption of drugs supplied, on prescription by physicians, to patients not in institutions that supply drugs to their patients; (3) consumption of drugs supplied during stay in hospital or other institutions where drugs are supplied to patients. This first differentiation is essential, since these three types of con- sumption have different characteristics and data collection, in the case of each group, has its own specific features. The data on drugs sold or pre- scribed may not correspond to factual consumption because part of the drugs bought or prescribed may not be consumed. 4. 1. 1 Sources of data The sources of information on drug consumption differ, and it is necessary to specify certain f eatures of the data. In the light of these features, it is possible to assess the feasibility of collecting and proces- sing the data and their value when they have been analysed. Information on drug consumption may be obtained from the following sources: 4. I. I. 1 Manufacturers, importers or wholesale distributors In countries where the production and distribution of drugs is under central control, data on their overall production and distribution are read- ily available. In countries where the pharmaceutical industry is not cen- trally controlled the extent of available data varies greatly. 4. l. 1. 2 Pharmacists and r e tailers The laws governing the public sale or dispensing of drugs differ sub- stantially from one European country to another. In some, all drugs are supplied or sold through pharmacies and good statistics may be available. In others, some drugs sold without prescription may be sold outside phar- macies. The nature of drugs sold without prescription varies from coun.- try to country and, often, the only data available are in the form of sales figures by producers, which may not accurately reflect the quantities ac- tually bought by patients . 11 4. 1. 1. 3 Insurance or national health records The proportion of a population covered by insurance or entitled to health services varies from country to country. Records in different countries may therefore not cover corresponding populations. Neverthe- less, where there is a possibility of registering prescriptions centrally, much information may be made available for comparisons of drug consump- tion within countries and some data are probably comparable between coun- tries. 4. 1.1. 4 Doctors' records Information from this source can provide an essential link between the use of drugs and the purposes for which the use is intended. Readily available information on the patient in relation to prescribing may extend to name, address, age, sex, employment, status and a classification of his disease by a code number. In many countries far less is likely to be available, except for spe- cial research or survey purposes. 4. 1. 1. 5 Hospital records Data about drugs used when patients are in hospital or attend hospital are available in some countries. However, often only the overall quanti- ties supplied to or purchased by hospital pharmacies is known. Nor is it always easy to relate the consumption of drugs to individual patients or to individual diseases. 4. 1. 1. 6 Consumer surveys The end user, whe ther he obtains drugs by a doctor's prescription, direct purchase or in other ways, is a possible source of information about drug consumption, and the only source of information about drugs which are prescribed or purchased, but not consumed. 4. 1. 2 Methods of collecting data on drug consumption The re are three methods of collecting data: ( l) general, nation-wide statistics : for example, the total number of products consumed, total expenditure, etc.; (2) surveys based on widely used documents: for example , all pre- scriptions issued by doctors, the complete hospital pharmacy files, etc .; (3) sampling surveys: interviews with individuals, surveys of medical and social insurance files, etc. 12 Studies on drug consumption generally specify relations between dif- ferent variables, for example: the relationship between disease and treat- ment, between socio-economic conditions and consumption, between treat- ment and result, between use of drugs and therapeutic accidents. This means that the value of each of the variables studied must usually be col- lected separately for each individual. 4. 1. 3 Frequency of data collection The study of changes in drug consumption calls for the periodical collection of information. It is understandable that the difficulty and cost of processing regular (for example, yearly) data will increase with their complexity. This problem leads us to select the data of greatest value or to have recourse to less complex survey methods. 4. 2 Units of measurement Drug consumption can be expressed in two types of unit: monetary or physical quantity. 4. 2. 1 Monetary units The advantage of the monetary unit is that it is common to hetero- geneous categories of products which are not commensurable. It should be emphasized, however, that it is a unit of "economic value" and that it can only be interpreted if that limitation is taken into ac- count; low consumption of a very expensive product can thus represent a higher cost than· high consumption of a cheap product. Above all, the monetary unit is neither constant in time nor compa- rable between countries. The expression of consumption in current monetary values (of the year) is valid when it is used for comparisons within a country; for example, between regions, between categories of population, between medical serv- ices, and so on. On the other hand, it is difficult to measure changes in drug consump- tion when prices have not remained stable. To compare consumption values between countries it is necessary, as a first approximation, to convert these values into a common currency (for example , the United States dollar) at the current exchange rate. The comparability of data thus converted will obviously still be very imperfect, since the prices of the same medicament can vary from country to country. The solution would be the establishment of an international index of drug prices. Such an index would be difficult to establish. 13 4. 2. 2 Units of physical quantity The comparison of quantities of drugs used expressed in common physical units (grammes, for example} is most useful for social purposes. However, this can only be applied to a single well-defined product, and is of no value where different products are used. Within a given thera- peutic group such as diuretics, the amount of each individual drug consumed, expressed in grammes, is not necessarily an index of the relative market share. For that purpose, only very rough estimates are available, such as the number of prescriptions issued or the number of items prescribed or bought, the unit in the latter case being the number of packaging sales units pre scribed or bought (number of tubes, boxes, bottles, etc . }. In fact, the common physical unit best suited to the comparative evaluation of drug consumption would be the dose unit or the average daily dose most usually prescribed for each medicament. However, the average daily dose is also an arbitrary unit, may differ according to prescribing habits in different countries or to the particular form of disease, and may alter over the years. 4.3 Measurement of the results of drug consumption In all the data mentioned so far one very important element is mis- sing. Apart from data on the use of drugs it should also be possible to estimate the result of consumption from information on the effect of the drug on the consumer . General observation tools and methods enabling the collection of relevant facts which would give an impression of the ef - fects of drug consumption are not likely to become readily available. Special studies can of course be carried out in respect of individual drugs in limited groups of patients. These studies are usually made to deter- mine the efficacy and safety of drugs. The International Drug Monitoring Project of WHO, though very lim- ited, provides a useful means of collecting data on the adverse effects of drugs. It would certainly be very valuable if studies of therapeutic effect could a lso be carried out by specially designed surveys under controlled conditions, for example, in hospitals. The participants, however, did not think it useful to go into this question in detail, notwithstanding its great importance. More rational drug therapy and reasonable drug consumption must depend largely on data of this kind becoming available. 14 5. OBTAINING AND INTERPRETING DATA In princ iple , two diffe r e nt methods of obtaining data on drug con- sumption should be r ecognized: routine reporting and special studies. The division b etween r outine reporting and special studie s is not clear- cut. Repo rting which m ay be routine in one situation or in a certain coun- try may, in another context, necessitate a special study. Special studies may be conducted as a pilot activity in preparation for the establishment of routine r eporting. In the following section "routine reporting" will r e f e r to the regular, sustained, periodic collection of data to provide the basis for temporal and geographical comparisons. "Special studies" will r e f e r to ad hoc ac - tivities, designed to answer specific questions or to test an hypothesis about possible c hanges in drug consumption and in the factors influencing it. The following scheme shows the usual routing of drugs to the con- sumer. In examining such data it must also be remembered that there may be alternative routes apart from the r egular one . Pharmacists ' records may give a complete account of drugs sold over the counter in those countries where there is no other retail channel. However, in many countries a varying a mount of drugs are sold by r e - tailers other than pharmacists. In seve r al countries there are dispensing physic ians in rural areas, who may obtain their drugs direct from wholesale sources or through pharmacies. Wholesale suppliers may be by-passed through direct sale s by the manufacturer o r i mport firm to the r e taile r, pharmacist or hospital. Some t imes a patient not in hospital may obtain drugs from the out- patient department of a hospital. 5. 1 Routine r eports on drug consumption The following routine methods can be used to provide data on drug consumption from the sources indicated. No single source will provide the information necessary for the aims set by the Symposium. The sources of information suggested are all amenable . to sampling. Indeed , for most of the data to be collected , sampling will be essential. B enchmark census information will b e needed for grossing up the sample information when sampling is used. The following census data are avail- able in most countrie s : 15 (1) censuses of production for manufacturers ' sales; (2) censuses of distribution for retailers ' sales; (3) overall insurance or national health service records of pre- scriptions; (4) numbers and types of physician; (5) censuses of population for number of households, age distribu- tion of population, social class distribution, etc . 5. 1. 1 National production figures Production statistics do not measure actual consumption. Changes in wholesalers ', retailers ' , hospital and household stocks intervene, al - though producers may, for their own marketing and production purposes, have sample information on changes in wholesale and retail stocks . This problem may not be important if the object is purely to determine, on an annual basis, drug production in the various European countries, distri - buted by agreed therapeutic groupings. Manufacturers can usually dis - tinguish between intermediate sales (to other firms in the industry) and final "product" sales, and between home sales and exports , 5 . 1. 2 Imports It may not be possible to analyse imports except according to broad groups of preparation, and then only in value terms. 5 . 1. 3 Over-the-counter sales records Routine reporting on the prevalence of self -medication among the population can be obtained from pharmacists alone in those countries where there is no retail sale of drugs outside pharmacies. In several countries , like Sweden and Hungary, such data are pub- lished on the ba :,is of pharmacists' records. A detailed classification or grouping of drugs used for self-medication does not seem to be available in any European country on a routine basis . In countries where drugs are partial] 1.· sold through other channels or where there is no real possibility of collec ting such data from pharmacists' records reliance must be placed on other sources for self-medication data. Special household surveys may be an alternative source of informa- tion. Difficulty will always arise in getting accurate details from the consumer and many preparations used for self-medication have a purely local use . This may also lead to difficulty in ensuring the proper thera- peutic classification of such drugs. The importance of this in the context of total drug consumption has still to b e evaluated. 16 I I SCHEME OF THE ROUTING OF DRUGS I I MANUFACTURE I I I I r---------------£ _________ -~-~--------------------, I I IMPORT 1 I I I a L----1----------,---------· ,--T---1--------------r-J l I 1 I t l I I I I I ' I I J, ( I I I I I I I . I I WHOLESALE1 I I I I I • • I I I I I I I I I I I I I I I I I ' I I I I I ' I I I r-~------»'--------~, : RETAIL SALE 1 ~--------,---------J I • t I • I I I • • • SELF-MEDICATION I ~ L ,_ .... _... ___ ..,.. I I -!, ~ I HOSPITAL ., ______ ...,__.. I PHARMACY I I J, l H PHYSICIAN l---◄ I I I I . ~ t THROUGH PHYSICIAN CONTACT • II HOSPITALIZED CONSUMER -----------------------► Regular pathways Alternative pathways 17 5. 1. 4 Records of prescriptions dispensed by pharmacists It will be somewhat difficult to standardize routine recording of pre - scriptions dispensed, In some countries, such as Sweden and Hungary, pharmacies already report sales direct to the government. In the United Kingdom, the bulk of all prescribed medicines are dispensed under the National Health Service, and the analysis undertaken of payments to phar- macists, provides data on the consumption of prescribed drugs . Else- where, only a part of the dispensed prescriptions is routinely recorded, Where a substantial proportion of prescriptions moves through pri- vate channels. sampling the prescriptions dispensed as a whole will re - quire the voluntary or statutory co- operation of pharmacists . While samples of prescriptions dispensed by pharmacists will not provide the kind of information only obtainable from physicians ' records, they will re - flect more accurately drugs dispensed rather than merely prescrib ed, ff patients do not present prescriptions to a pharmacy, the physicians ' rec - ords may inflate the figures for drugs consumed. Where drugs p r esc r ibed under a non-proprietary or generic name are available only in proprietary form, the prescriptions dispensed could provide the name of the proprie- tary form actually supplied. Where the bulk of all prescriptions dispensed is sent to a central office for pricing, so that the pharmacist may be reimbursed, as in the United Kingdom, samples can be taken {a) from all prescriptions dispensed by all pharmacists, (b) from all prescriptions dispensed by a sample of pharmacists, or {c) from prescriptions prescribed by a selected sample of doctors. Sampling from a selected sample of pharmacists may be the easiest method. 5. 1 . 5 Physicians ' records Sampling physicians' records at regular intervals provides another source for the routine recording of drugs consumed (allowing for error owing to the drugs prescribed not being consumed). Major market research firms which do extensive work for the industry on the consumption of drugs in many European countries obtain their data from the records of a selected group of co- operating doctors . The object of such a survey is to establish the pattern of morbidity and methods of drug treatment in a given country. The extrapolated data are supposed to give a national estimate of morbidity and drug use and to allow comparability over specific periods of time. It is clearly difficult to ensure a truly representative sample of phy- s1c1ans . Those who refuse to participate or fail to report accurately may seriously affect the representative nature of the sample. Although the resulting inaccuracies may be disturbing, manufacturers appear to be fairly satisfied with the information supplied by the market research firms 18 and it was stated that consumption data derived from the reports correspond to sales data obtained by other means with a possible error of approximate- ly ± 10%. 5. 1. 6 Hospital records Any picture of national drug consumption must take into account those dispensed in hospitals, for out-patients as well as in-patients , De- pending on the e xtent of the facilities available, hospital dispensing may constitute a very varying element in total consumption figures. In the United Kingdom, for example, the total cost of drugs and dressings in the hospital services in 1967 / 68 was approximately £26 million. The net in- gredient cost of the 271 million prescriptions for drugs, dressings and ap- pliances dispensed by pharmacists under National Health Service contract in 1967 was approximately £104 million. The importance of hospital pre - scribing, where new drugs are concerned, may be even greater than these broad ratios would suggest. The practice in hospitals differs even within countries. Hospital drug purchases are not a true indication of drug consumption as inter - preted here, as drug stocks and wastage are not r eflected in purchase figures . Hospital drug consumption figures may include also drugs used in research, and in laboratories or operating theatres . Actual prescribing and/ or dispensing records in the hospitals would probably be needed to supplement other returns on drugs to obtain a full picture of hospital drug consumption. 5 . 2 Special studies Where routine methods are inadequate or fail to provide a sample representative of all drug consumption, special studies will be necessary. Suc h special studies designed to examine specific areas of interest or to provide special inter-country or intra- country comparisons, could use a number of the sources referred to in section 5. 1. The most productive might be: ( l) household surveys, (2) analyses of doctors' records, (3) analyses of national insurance or health service records. 5. 2. l Household surveys Household surveys offer inherent advantages, but also serious dif- ficulties . Drug consumption by self-medication can be related ir: detail to the characteristics of persons and households: social class , sex, age, marital status and occupation. They can provide information on doctor 19 consultations at which drugs w ere or were not prescribed, and the wastage of drugs of any kind can be assessed. Participation must be voluntary with the concomitant problem of non- response. The non-response rate may bias the findings , as non-responding households may be different from responding ones in statistically s ignifi - cant ways . By their nature, household surveys do not cove r people in hos - pitals and other residential institutions, but self-medication may be negli- gible in hospitals if not in residential institutions. Because of incomplete identification of the drugs which enter the household, recording drug con- sumption under therapeutic groups may not be feasible . A series of studies in France by RO sch et al. ,1 suggests how, from a statistically selected small sample of households, important information can be obtained about the extent to which expenditure on self-medication and the number of medicines purchased varies at different family income levels, and according to age and sex. The US Department of Health, Education and Welfare has reported on the cost incurred and number of m edicines pur- chased per person per year on the basis of a fortnight's information obtain- ed from approximately 42 000 households over a period of 52 weeks. Sim- ilar studies of this type could be made in several European countries. Where potentially harmful or undesirable drugs have been p rocured without prescription, the extent of such misuse may be estimated. The prescription of inappropriate drugs cannot be measured in such a study for two reasons : prescribed drugs will not always be identifiable, as in some countries the label on the prescription container merely gives the name of the patient and the dosage regime; moreover, the patient is not a r eliable source of information about the diagnosis for which the drug was prescribed. Although the identification of prescribed drugs presents problems, sample households can provide some information about unconsumed drugs held. Unconsumed drugs do not necessarily imply excessive prescribing. Failure to follow a prescribed chemotherapeutic regime, even among pa- tients suffering from g rave conditions, has been widely r eported . 5. 2. 2 Analysis of doctors ' records There are considerable problems in mounting special studies based on doctors ' records . However, these link in a unique way some of the most important information about drug consumption. They can provide information about drugs prescribed, the quantity and frequency, together with the regimes prescribed and the diagnoses. They can al so provide information about consultations when no drug is prescribed. 1 RO sch, G. et al. ( 1962) Une enquete par sondage sur la consomma- tion medicale, Con~mation, No. 1 20 Such special studies could help to answer, among others, questions about: consultation rates and the frequency of prescribing for patients in different age- and sex- groups in different countries; inter- regional dif- ferences in the cost of prescribing for common diagnoses; and the differ- ences in the conditions for which patients consult their doctors . Comparisons of the prescribing pattern for regions with different pre - scribing habits could be made from special studies using doctors ' pre - scribing records. Such studies have been made on a limited scale in some countries such as the United Kingdom. The methods used in these surveys are similar to that described in section 5. 1. 5. 5. 2. 3 Analysis of national insurance or health service records Where , as in the United Kingdom, most prescriptions are centrally priced, or, as in Sweden, r ecorde d under the health insurance programme, special analyses of prescribing or changes in the volume of prescribing become possible. Movements in the consumption of particular drugs or therapeutic groups of drugs , e .g., amphetamines, can be monitored, or prescriptions for excessive quantities can be extracted for scrutiny. The interest of the authorities can then be focused on those areas where a problem is developing . Another type of special study using national prescription records can test the effect of various methods of influencing the prescribing habits of doctors. Groups of doctors in high-cost, average-cost, and low- cost ca- tegories can be allocated at random to receive one or another kind of ap- proach - or none - and their prescribing costs assessed befor e and after the study period, Such studies have been made in the United Kingdom, to assess the value of educational visits by regional medical officers. Prescriptions for 106 doctors in two areas were a nalysed in order to identify, on prede- termined c riteria, doctors whose prescribing costs were high when com- pared with the costs of their area colleagues. The high- cost doctors were randomly allocated for visiting or not to be visited, and the changes in their prescribing costs were compared with each other and with changes in the same period in the costs of medium- and low- cost doctors in the area, and with changes among all doctors in England and Wales . Their presc riptions for the most important therapeutic classes of drugs were ana- lysed by number , type of drug and cost, before and after the scale, to pro- vide helpful conclusions. 21 6. USE OF DATA ON DRUG CONSUMPTION As outlined in section 2. 2, data on drug consumption may be used in connexion with studies concerning at least three important aspects of drugs: (1) the medical aspect with special reference to effective and safe therapy; (2) the economic aspect with reference to rational therapy; (3) the commercial aspect regarding the mechanisms of drug mar- keting. The common goal of all studies of this kind is to measure the results achieved by the use of drugs and to weigh these against any ill effects and their cost and, moreover, to compare the value of one drug with that of another drug, or of another form of therapy. However, these are sophis- ticated and complex exercises. To be performed competently, they may require assessment of the availability and control of other medical re- sources, e .g., surgery, hospital services, prophylactic measures, and so on. The collection, analysis and correct interpretation of- data on drug consumption require considerable resources in trained staff. Mode rn computer techniques are essential for the analysis of data, It would seem wise to approach these problems in a pragmatic fashion and arrange for pilot studies to explore small but important fie lds of drug consumption in the first instance. Full use should be made of the experience and know- ledge already available in some countries. WHO may be able to help by initiating an educational programme, facilitating the exchange of informa- tion and co-ordinating the studies undertaken. Some of the experience accumulated in different European countries is described in the following paragraphs. 6. 1 National drug consumption statistics In several countries, the annual report of the ministry of health pre- sents data on drug consumption. Such reporting may cover the field in greater or less detail. Thus in the United Kingdom, for example , the Annual Report of the Department of Health and Social Security contains figures on the pharmaceutical services under the National Health Service. Table I shows the number and cost of prescriptions over the period 1949-1968 in England and Wales. These overall figures are obtained from the complete pricing records of prescriptions dispensed by chemists, druggists and appliance contractors under the National Health Service, These figures are almost identical with the total amount of prescriptions dispensed by pharmacists in England and Wales . The data are carefully 22 Table I chemists in En 2 Total net Average Average net Year Number of Total ingredient total cost ingredient prescriptions cost per pres- cost per cost cription prescription MILLIONS £ MILLION PENCE 1949 202 0 11 30 331 13 818 36.0 16. 4 1950 21 7 145 34 805 17 495 28.5 19. 3 1951 227 694 41 662 22 689 43.9 23 . 9 1952 216 000 43 769 25 09 1 48.6 27 . 9 1953 2 19 757 44 701 25 676 48.8 28.0 1954 2 18 713 45 970 26 823 50.4 29.4 1955 226 116 50 344 29 l 59 53 .4 31. 0 1956 228 879 56 811 33 182 59. 6 34. 8 1957 207 209 60 852 37 477 70.5 43.4 1958 203 385 65 475 41 3 10 77. 3 48 . 7 1959 2 14 029 72 908 46 689 8 1. 8 52 .4 1960 218 685 79 l 94 5 1 495 86. 9 56. 5 1961 205 016 83 128 55 5 18 97.3 65. 0 1962 196 626 86 918 58 959 106. 1 72. 0 1963 205 462 95 934 64 633 112. 1 75.5 1964 209 375 105 5773 71 701 121. 0 82.2 1965 244 346 126 004 86 339 123. 8 84.8 1966 261 9 54 138 369 95 817 126.8 87 . 8 1967 271 206 146 201 103 670 129.4 91. 7 1968 267 378 151 667 11 0314 136. 1 99. 0 1 Sou r ce: England and Wales ( 1969) Annual Report of t h e Departmen t of Health and Soc ial Security for t h e year 1968, London, H. M. Stationery Office. 2 For the years 1949-63 the total cost was defined as t h e net ingre- dient cost, plus overhead cost, plus professional fee, plus containe r al- lowance. The figures shown are adjusted for arr ea r s payments. 3 From 1964 the total cost ha s been defined a s net ing r edient cost, l ess discount, plus ove rhead cost, plus professional fee, plus container allowance. 23 followed and commented on in the Annual Repor t , particularly with reference to changes in the general trend. Since there have been several changes in the prescription charge since the National Health Se r vice Act was intro- duced in 1948, the yearly figures give an opportunity to study the effect of th ese changes. 1 In addition to the yearly data on the number and cost of prescriptions, monthly data are available showing the yearly seasonal variations in the number of prescriptions. Regional figures are also listed in the Annual Report . The individual regions do not show any considerable deviation(! 10%) from the average for England and Wales , except for Wales where the average number of prescriptions per person is about 30% above the average for England and Wales. The therapeutic group distribution of the number and cost of pre- scriptions under the National Health Service is also shown in the Annual Report. They are divided into 16 main categories, with a total of 48 sub- groups (including dressings and appliances). In Sweden, information of the same type as in the United Kingdom is supplied on a yearly basis th r ough the Annual R eport of the Board of Health. In addition to data on prescriptions, the Swedish statistics also cover drugs supplied through hospitals and the over - the - counter sale of drugs . S uch data, however, give only an indication as to the amount of mon ey spent, not of volume. Table II summarizes some of the information provided by the Swedish Board of Health. Hungary is another country where information is collected systema- tically on the overall expenditure on drugs . Table III shows the type of information available. 1 Initially, prescribed medicaments were completely free of charge, but in June 1952, a charge of 1/- per prescription was introduced. In December 1956, this was changed to 1 / - per prescription item and, in April 1961 , to 2/ - per prescription item. This charge was abolished com- pletely on 1 February 1965. On each occasion the effect of the introduction of a payment or extra payment has been a temporary reduction in the an- nual increase of the total cost of prescriptions as can be seen from table I. The withdrawal of the charge evidently increased the cost for the year 1965. The Government reintroduced a prescription charge of 2/6 per prescription item in June 1968. This affected the total numb er of prescription s signi - ficantly, but the total cost of prescriptions d i d not increase so sharply as in the preceding instances. 24 Table II Year 1954 19 56 1958 1960 1962 1964 1966 1968 Pharmacy sales figures, bulk sales to hospitals p rescription d r ugs, over -the-counter drugs, number of prescriptions in Sweden! Millions Swedish Kroner Total sale Hospitals Individually Over - the-prescribed counter 214 3 1 105 78 278 37 148 93 353 . 5 47.8 193. 5 112. 2 413.4 55 . 8 236. 3 121. 3 500.6 68.5 293. I 139.0 613.8 88.3 365. I 160.4 773.2 108.4 467 .5 197. 3 1101.7 140. 9 644. 0 226.8 1 Source : National Board of Health, Stockholm Table III Estimated distribution of e · ure on dru s in 19 5 in Hun Millions Number of prescriptions 20.9 21. 4 23 . 9 26.3 28 . 5 3 1. 2 33.8 38. 1 Millions of forints P e rce ntage of total Hospitals 600 20 Public pharmacies 2300 80 Prescriptions with 15o/o c h arge 1860 65 Prescriptions without charge 90 3 Over-the - counter drugs 350 12 Total 2900 100 1 Source: Ministry of Health, Hungary 25 In addition to these figures, there are some specific data on the sale of pharmaceutical specialities (77% of the total sale) by therapeutic groups (30 in all). A specific feature of these data is that they include sales of prescription drugs, hospital use and over-the-counter sales as well (table IV). 6. 2 Studies comparing drug consumption data in different groups of the population Special studies have been undertaken in several countries to analyse the consumption pattern in relation to age , sex, marital status , socio- economic groups, etc. In Franc e , household surveys have been published by Dr G. R(Ssch in co-operation with Professor H. P e quignot and others. The surveys have been unde rtaken by CREDOC and INSEE (Institut national de la Sta- tistique e t des Etudes economiques) in co-operation with CNAM (Caisse Nationale d' Assurance Maladie). Several studies on the consumption of medical care and drugs have , since 1960, been published by the group in the journal "Consommation". Figure 1 shows data on the consumption of medical care by age and sex. Graph 3 of figure l s hows the consumption of drugs . It includes prescription drugs as well as over-the-counter sales. Females appear, at all ages except under two, to be greater consumers of drugs than males. Drug consumption is highest in France during the first two years of life. It decreases rapidly but, from the ages of 20-30 consumption rises grad- ually to a peak at the ages of 60- 70. Other interesting facts can be derived from the French surveys. It appears, for example, that households of two persons show the highest per capita drug cost. Single persons come next, whereas, in households of several persons, drug costs decrease with the number of members . With regard to socio-economic groups, the data show that the quanti- ty of pharmaceutical products bought without prescription decrease with increasing family income (fig. 2). Other f eatures of the study are that expenditure on medicaments is about 50% highe r in the rural than in the urban population. It appears also that in France general practitioners prescribe drugs more often than specialists. General practitioners gave prescriptions at 77% of all con- sultations, specialists only at 57%. Detailed studies by surveys such as those in France have been un- dertaken in some countries . The US Department of Health, Education and Welfare has reported similar studies on the cost and number of drugs purchased per person per year, on the basis of a household survey. 26 Tabl e IV Total sales of pharm aceut ical specialitiesl in Hungary in 1965 by th e r a p eutic grouys for hos p ital s and p u bli c p h a rmacies Antibiotics Analgesic antipyretics Vitamins Vasodilator s Chemotherapeutics Dermatological preparations Antianaemics Hypnotics Psychotherapeutic drugs Respiratory medicaments S teroid hormones Antidiabetics Heart glycosides Spasmolytics Analgesics Antiseptic and antimycotics Total s ales in millions of fo r ints 571 287 1 9 1 16 1 126 Sedatives and anti -epileptics Anabolic steroids and geriatric drugs Digestives 94 8 1 68 63 58 56 48 4 6 45 4 0 36 30 28 24 20 16 Cholagogue s Histamines and antihistamines Antihaemorrhoid and antivaricose preparations Laxatives Analeptics External applications for rheumatic diseases Anticholinergics Diuretics and urine disinfectants Anaesthetics Local anaesthetics Miscellaneous Total 1 5 1 5 1 5 14 1 3 12 11 11 66 2 261 G r oup sales as pe r centage of total s ales 25 . 2 1 2 . 7 8 . 4 7 . l 5. 6 4.2 3. 6 3 . 0 2 . 8 2. 6 2 . 5 2 . 1 2 . 0 2 . 0 1. 8 1. 6 1. 3 1. 2 1.1 1. 0 1 The sale of specialities represents 77 % of the total pha r maceu t i cal sales. 2 Source: NepegeszsegUgy, 47 , (1 966 ), 264, t a ble 4. 27 !:.i&.:....!.., Medical care consumption in France by a ge and sex 1 Numbe r of visits per Number of dental sessions person per year per person per year l 2 1 .. ~..._ ............. _.,___.__._.....___,'---' ~ ................ _ ...... _.__._ ............ _... Number of pha rmaceutical Expenditure per year I It ' • ., . ... . >-.. N .. ., -0 C ::> It ,. ,. • • • !'! Ill " t .. .. • • t .. • • • • ., • ~ , " > 0 -0 C "' 0 co Graph I - Doctor visits Graph 2 - Dental ca r e in NF) ... t ,. ,. t a ' ... . >-,. • • • • • • !'! N " R ' II I ... ., -0 C ::> Graph 3 - Pharmaceutical p r oducts Graph 4 - fotal medical expenditure (excluding dental and hospital c h arges ) Men: plain line Women: dotted I ine t ... • ., > " 0 -0 C "' 0 co Source: Rtlsch, G., Rempp , M. M. and Magdelain e , M. ( 1962) Une enqu@te par sondage sur la consommation medicale, Consommation, No . I 28 Fig. 2. Purchase of pharmaceutical products in France by hous e h old i n come I Numb er of pharmaceu tical products per p e rson p er year IO • J • ~-I I 1 ' s I -, ' ' ~~ I \' I ~j -, - \ • ~ \ \. / I -""' ,, ., •- 30.000 l Sour ce: see footnote fig . I. 29 Pre s cription ~ e ms ---- --- ,, ,, ·, ~ , ... ........ Over -the - - I counter products se.llO Household income In Sweden, a sample study has been made from all persons aged 16 or over in Sweden, born on a certain date and registered as members of the health insurance scheme. On the basis of the collected prescriptions the occurrence of drug consumption through prescriptions was analysed according to age, sex and marital status, as well as geographical (urban or rural) location. The results of this study show some interesting facts which are par- tially reproduced in table V. It appears from the study that, in Sweden, the urban population is consuming more drugs than the rural population, but that, as in France, there are more women consumers than men, and that there is an increase in the number of consume rs from the age of 16. Table V shows that mar - ried persons of both sexes are significantly more often consumers than unmarried persons . Special studies such as those mentioned in this section are certain- ly of importance in asce rtaining the drug consumption pattern. It is quite clear that some of the observations reflect differences in the pre - valence and nature of disease in the various population groups . The mor - bidity pattern reflects many of the factors mentioned, such as age struc - ture, socio-economic and environmental conditions . 6 . 3 Studies on the prescribing habits of physicians There are many reasons for undertaking anal ytical studies of the dif- ferences in prescribing by physicians on an individual, regional or inter- national basis. In the first place, such studies are essential if rational pharmacotherapy is to be achieved. The history of drug therapy over the last twenty years has shown that ever more potent drugs with concomitant side effect s are becoming available. This process is likely to continue , the choice of drugs b e - coming more and more complex. It will be increasingly difficult for the physician to remain familiar with all aspects of drug the rapy on top of his other responsibilities . He will be more and more in need of some type of expert guidance in the rational use of available drugs . Such ad- vice calls for detailed knowledge on the therapeutic effects , biological availability, adverse reactions, and so on, on the part of experts, who should be classified as clinical pharmac ologists . The participants in the Symposium also considered the developing role of the pharmacist in this field. In some countries therapeutic com- mittees (including a pharmacist as a member of the team) have already been established in hospitals . Other ways of assisting physicians , such as general practitioners , who have no hospital links may also have to be considered. 30 Table V P e rcentage of drug consumers Age Unmarried (2600) % 16-19 34 (!:2 ) 20-29 32 ('!:2 ) 30-39 35 ("!: 3 ) 40-49 32 (!:3 ) 50 -59 44 ("!: 3 ) 60-69 43 (!4) 70-79 45 ("!:6) 80- 45 (!11) Total 3 5 ("!: 1 ) accordin~ to sex and marital status _during one year )1 Men Women Married Previousl y Unmarried Married (5095) married (2155) (5015) (547) % % % % - - 52 (!2) 57 (!13 ) 39 (!:2) 7 1 (!17) 58 (!:2) 59 ("!:2) 43 (!:2 ) 39 ("!:9) 6 1 (°!:4) 58 ("!: 1) 4 7 ("!: 1) 48 (!:6) 56 (!4) 59 (!1) 49 (!:1) 46 (!:6) 4 9 ("!:4) 63 ("!:2) 59 (!2 ) 57 (! 5 ) 48 ("!:3) 65 (!2 ) 58 ("!:3 ) 47 ("!:4) 60 ("!:4) 70 ("!:3 ) 67 (!6) 65 (!5) 67 (!6) 7 1 (!7 ) 49 ("!: 1) 52 (!:2) 5 5 ("!: 1) 6 1 (!: 1) Previously married ( 1149) % - 74 ("!:9) 56 ("!:6) 64 ("!:5) 6 1 ("!:4) 62 ("!:3) 70 ("!:2) 70 ("!:4) 66 ("!: 1) 1 S ource: Smedby, B. (1966) Prescription study 1963 . Consumption of drugs during one year for a sample of persons studied through prescri}tion data, Swedish National Insurance Board (SOU, 1 966 : 28 Moreover, certain attempts are being made by agencies to influ - ence prescribing pattern s through regulations. In some countries a fair- ly strict control i s exercis ed , mainly for socio -economic reasons, in o r - der to limit p r escription drug cost s. This is effected by e stablishing l ists of drugs which may be prescribed or which are subject to reim- bursement. S ome countries also fix the maximum quantities which may be dis - pensed on any singl e prescription. In the treatment of chronic condi- tions which do not demand frequent medical supervision, however, it of- ten serves the convenience of both patient and physician when large quan- tities are prescribed. 31 The control of excessive and inappropriate prescribing is inherent- ly difficult. Pharmacists might be required to maintain records of pre - scriptions for specified drugs or for quantities declared excessive , much in the same way as registers are now maintained for dangerous drugs dispensed. Routine reporting from such registers might provide a basis for both education and control. Routine recording of prescriptions written by individual physicians could provide data for a periodical comparison of the cost of prescribing and the frequency of prescribing within a designated area. In some coun- tries such periodical analyses are performed. In general , this is sol ely with a view to controlling prescribing costs. The prescriptions by " high- cost" prescribe rs are examined to disclose acceptable reasons , s uch as a r e lative ly high proportion of high-risk patients (e.g., the aged ). As already m e ntioned, it is quite evident that such prescr ipt ion analyses may not only throw light on the cost aspects , but a l so serve in promoting the rational use of drugs. On the basis of facts obtained sound advice or educational activities could be deve loped to that end. Activities , such as those carried out by market research firms , outlined in paragraph 5. 1. 5, could probably be used successfully fo r edu- cational and advisory activities by the medical profession and the respon- sible authorities (if the figures collected could be made available for that purpose). 6. 4 Studies on the use of psychotropic drugs The rapid increase in the use of psychotropic drugs is causing con - ce rn to publi c h ealth authorities in many European countries. The R egional Office for Europe has initiated a special study on methods of measuring the consumption of psychotropic drugs. The study has not yet progressed sufficiently to allow any final conclusions to be drawn. S everal of the participants showed interest in the subject and it was reported that studies are being prepared or have been undertaken i n some countries . Some preliminar y observations r e l ative to the WHO stu dy are the refore included here . Psyc hotropic drugs , in this context , are defined as substances acting on the central nervous system and comprise three principal groups: (1 ) halluc inogens, (2 ) stimulants, and (3) depressants , including seda - tives and tranquillizers. 32 Psychotropic drugs include: (1 ) a number of substances , some of them under international control some of them not; (2) substances extensively used in accepted medical practice or that could be so used as well as substances that at present have no accepted use in medical practice , These two facts have greatly affected the possibility of measuring the consumption of these drugs . 6 , 4 . 1 Legal consumption In principle, methods of measuring the legal consumption of psycho- tropic drugs do not differ from the methods available for measuring the consumption of other categories of drug, As the substances under study are mostly sold only on prescription, they lend themselves extremely well to prescription studies. This may take the form of a continuous re- gistration (local or centralized) with the purpose of keeping track of (i . e ., accumulating information on)the total sales and their distribution by sub- stances, Pres criptions may, however, also be anal ysed in special sample studies, taking either prescription samples, or population samples: for example, a study of all prescriptions for a sample population, e . g ., all persons born in a particular year or all persons born on a particular date . The possibility of obtaining information on the legal consumption of psychotropic drugs through population surveys involving interviews of in- dividuals or households should also be mentioned. Such studies are in- dicated, not only where prescription studies are not possible , but in par - ticular in order to evaluate the distribution of the actual intake of drugs by individual consumers - whether the drug in question was originally prescribed for them or not, It is also probably the best way to obtain information on consumption in circumscribed groups. 6 , 4. 2 Misuse or abuse of legally obtained drugs The whole question of the misuse or abuse of legally obtained drugs is a very complicated one . It involves both the situation in which the physician prescribes what amounts to overdoses of a particular drug, and the situation where the patient sees several physicians to obtain pre- scriptions, so that none of these physicians have any clear idea of the amounts actually prescribed. Prescription studies may be of some help in identifying individual consumers legally acquiring large doses for ex- tended periods of time, again, provided that the information system per - mits the linkage of prescribed drugs to individual consumers . If 33 identification of abusers seeing several doctors is sought, a central na- tional prescription r egister may be necessary. In cases whe r e othe r - wise l egal p sychotropic drugs are obtained on the black market the situ- ation close ly resembles that of the illicit use of narcotic drugs, 6 . 4 . 3 Ille gal consumption Fina lly the special g roup of drugs which is illegally consumed - which may or may not be drugs under the strict definition - presents a really difficult problem, In trying to identify the produc tion/import fig- ures , r e liance must be placed on the ve ry uncertain indices afforded by the number of persons sentenced for clandestine production and the amount of illicit drugs seized by the police or customs . The illicit drug trade index, again, only reflects the number of c ri- minal offences invol ving the illicit sale o f these drugs . It has been suggested that the c hange in black market prices which may be registered immediately after the seizure of large quantities of a particular drug to some exte nt reflects the total size of this marke t , but this princ iple may not work in practice. The n umber of people convi c ted of the illicit posses sion or illicit us e of psyc hotropic drugs is one indicator of the number of illicit c on- sumer s - but, as in other case - finding studies, the numbe r of cases even- tually detected depends to a large extent on the effort put into the case - finding campaign , The number of cannabis users arrested, for example , in Copenhagen doubled after the police on this assignment had been tre - bled, Most countr ies maintain some fo rm of r egistration of nar cotic drug addicts known to the public health authorities , Such r egisters, for ob- vious r easons , will onl y give minimum figures for the preval ence a nd b e - lated figur es fo r changes in the incidence of drug addiction, Neverthe - less, the figures are of some int e r es t nationally as we ll as international- l y , as they form the basic material for the annual surveys of the United Nations Commission on Narcotic Drugs. Some use has been made of studies of the hospitalization of indivi- duals dependent on various psychotropi c drugs in estimating the r e l ative frequency of various forms of abuse , Howeve r, this only touch es the top of the epidemiol ogical iceberg. Mild forms of abuse will not reach the hospital. Such studies may, nevertheless , r e flect changes in the drug abuse patterns and in the age and sex groups involve d. Special studies analysing all c ases of drug dependence known at a given t ime o r all new cases detected in a certain period in medical , so- cial and criminal institutions as well as by doctors , public health nurses , 34 social workers, and so on, have been made in Sweden and Switzerland. Such studies give useful supplementary information on the prevalence and incidence, but with some of the same limitations mentioned for hospital admission studies . To obtain more reliable data on the prevalence of the illicit use of psychotropic drugs in the population, a number of surveys have been made of selected groups. Among these studies , surveys among schoolchildren and other youth groups stand out as having been particularly rewarding . Of course, certain reservation must be made as to the reliability of the data obtained. But at least there seems to have been little reluc - tance in supplying the information wanted, where anonymity was guar - anteed. In Denmark, a representative sample of school pupils and other young people (14-25 years old) in education at institutions in 1 968 filled in a questionnaire on their knowledge and their personal experience of psychotropic drugs: 12 '7o had tried, used or were using psychotropic drugs and approximately three -qua rte rs of them had used cannabis alone . Out of the sample , only 1 % used drugs regularly, and nearl y all of these had tried other drugs as well as cannabis . Another fact emerging from this study is that, of the sample, l '7o had tried LSD, and 2 . 8o/o had tried stimulants or opiates. Similar surveys have been carried out on conscripted male youths in both Denmark and Sweden with valuable results . 6 . 4 . 4 Preliminary conclusions The preliminary conclusions to be drawn from these observations would seem to be that prescription studies with prescriptions linkable to individual consumers, combined with sample surveys would provide the best means of measuring the consumption and use of legally obtainable psychotropic drugs . Studies on the total distribution of drugs through wholesale statistics would be valuable in supplying crude estimates of consumption trends . Where the illegal acquisition and use of psychotropic drugs is con- cerned, the best method of study would seem to be in the development of refined survey techniques, which take into account the reluctance of re - spondents and total neutrality in the attitude of the observer. Such studies should be supplemented with recurring census studies of all persons known by social and medical institutions and personnel at a particular moment to be abusing psychotropic drugs . 35 6 . 5 Inte rna tional compara bility of data Though it m ay b e tempting to compar e data on drug statistics from d iffe r ent countries or results from spec i a l studies on drug consumption, such comparisons in general do not as yet seem to be feasibl e . The par- ticipants discussed this matter on the basis of the consultants ' r e port r e - £erred to in Section 2. In addition, other special compa r a tive studie s undertake n w e r e dis- cussed, a nd special r efe r ence made to the compa rative study published in "Les Cahiers d e l ' Industrie Pha rmaceutique", No . 5 (1 969) . The sub- j ect of this study was the consumption of over-the - count er as well as pre- sc ription drugs in Belgium, France, t h e Federal Republic of Germany a nd Italy . The data we r e obtained from a m a rket r e sea rch bureau opera ting in the Common Market countries . The stud y r evealed that the total per capita consumption of drugs in the four countries concerned, expressed in a common monetary unit, varied only marginally . For the year 1966 the ave rage was 121 F, where- as the lowest figure was 11 3 F (for Italy) a nd the highest, 129 F (in France) . Expr essed in p e r capita consumption of package units of drugs, the dif- fe r e n ce b etween the countries was not ve ry m a rked e ithe r. The results a r e summarized in table VI. Great care should be taken in drawing conclus ions from such com - parisons . The a uthor's view that there a r e only minor differences b e- tween the drug markets of the countries of the Common Market is cer- tainly premature , There is considerable evidence for exampl e , that drug consumption, in money v a lue , in the Neth e rlands, is much lowe r than the average for the four countries cove r e d by the study. The figures do not justify a conclusion with r egard to similarity of the market. Examples presented at the Symposium showed tha t within ther apeuti c groups there a r e con siderable inte r-country differences in t h e consumption of drugs , It i s known that the per capita antibiotic con - sumption volume, in m oney value as well as in calculated daily dosage, varies considerably and may be more than twice as high in one country as in another . Comparing the use of indiv idual antib iotics, the differ - ences are even more impo rtant. As an extreme example, the p e r ca- pita use of chlor amph e nicol in one country appear e d to be about twenty- five times as high as in various oth er countri es . It was concluded tha t, for overall compa r a tive purpose s, no a d e - quate basic unit was as yet available . The most practical proce dur e , it was thought, would be to express gross national consumption data in the form of an index such as a p ercentage of expenditure for hospitals o r of total medical expens es . However, such units might also b e in- flue n ced by othe r factors and monetary c hange s . It was agreed tha t further study should be unde rtaken with a view to developing a practical unit for purposes of inte rnational comparison, 36 Table VI Consumption, in units , pe r inhabitant l Consumption Average Consumption in value, public in units per public price {francs) price {fran cs) person Units Index Federal Republic 122 5. 1 3 24 105 of Germany Belgium 122 6 . 03 20 87 France 129 5,34 24 105 Italy 11 3 5.01 23 100 Average 1 21 5 .1 5 23 100 1 Source: Les Cahie rs de 1 'lndustrie Pharmaceutique (1969 ), No. 5 Public health coul d profit particularl y from an international com- parative study on the consumption of certain well-defined groups of drugs . The feasibility and usefulness of such a study was discussed in the light of data on the consumption pattern of antibiotics in six European coun- tries. The. participants concluded that inter - and intra-country studies of the consumption pattern of certain well-defined groups of drugs ex- pressed in daily doses would be very valuable, The study of regional inter -country differences in drug consumption would be of special inter - est, since it would be easier to undertake and be more reliabl e , 7. FACTORS INFLUENCING DRUG CONSUMPTION It was agreed that part of the tendency towards an incr ease in drug consumption was due to factors relating to social change, It was evident• that considerable variation occurred in drug consumption between and within countries , That variation could not only be explained by differ - ences in morbidity . Various factors were advanced as having a 37 significant effect on drug consumption: age , sex, marital status, age at marriage, income, socio-economic and environmental circumstances , the retail price of drugs , etc . The following examples were referred to: (1 ) Dr R~sch and his collaborators had shown that differe nces in the quantity of drugs used per capita of the population and in per capita drug cost varied greatly in France. The expenditure on medicaments - as on m e dical care - is , in general, lower among the agricultural pop- ulation. Another interesting observation with regard to the consump- tion pattern is the inverse relation between household income and ex- penditure on over -the - counter drugs in France. People of lesser means are, according to this study, more inclined to buy over-the- counter drugs and, on the other hand, to consult a doctor less fre - quently . (2) Studies in Sweden and France showed differences in drug con- sumption in age- and sex - g roups. People between 10 and 4 0 years of age in general consume less drugs than other age -groups . A study in Sweden r e vealed that married or divorced people of all ages use drugs more frequently than the unmarried, (3) It may be accepted that the retail price of drugs, to a certain extent, affects consumption. The influence of price on consumption is r e fle cted in Sweden and the United Kingdom by changes in prescrip- tion charges. However, it has not b een shown that such changes are of r eal significance with regard to the overall consumption. The prevalence and the nature of the disease pattern is certain- ly of paramount importance as a factor in drug c onsumption. The influence of many of the other factors m e ntioned, such as age , sex, socio-economic and environmental conditions, a c tually r e fle c ts the morbidity pattern. 8, SUGGESTIONS FOR FURTHER ACTION OR STUDY European countries could do mor e to collect routine data on the over- all consumption of drugs as part of their health statistics. Suc h statis - tics should include overall drug consumption figures as well as data on therapeutic classes, It would b e well if governments had at their disposal m eans for the expert evaluation of data on drug consumption. 38 An internationally accepted classification of drugs is urgently re - quired, It is suggested that WHO should: (1) convene an expert committee to draw up a suitable international classification of drugs at an early date; (2) assist Member States in obtaining uniform and internationally comparable data on drug consumption; (3) assist in making available to Member States relevant informa- tion on drug consumption statistics and on special studies in this field; (4) promote and co -ordinate pilot studies on a limited scale simultaneously and periodically in different countries, for instance, on drug consumption by means of surveys of a representative sample of households; (5) convene a group of experts to advise on the contribution clini- cal pharmacology could make to medicine and public health, with particular reference to the rational use of drugs and the expert eval - uation of trends in pharmacotherapy; (6) investigate the function of the pharmacist with regard to the distribution of information to physicians and to the public on the use of drugs. 39 ANNEX I THERAPEUTIC CLASSIFICATION OF DRUGS USED BY THE PILOT RESEARCH PROJECT FOR INTERNATIONAL DRUG MONITORING (Based on their m a in therapeutic indications) This classification of drugs is intended fo r the use of this proj ect only . It does not cover all drugs, and new categories will be added, or changes made, if adverse reactions to d r ugs not previ ousl y reported are submitted or new knowledge on therapeutic use of drugs accumulated . A.0 . 0 A . l . 0 A . l . l A . 1 . 2 A . l . 3 A. 1 . 4 A. l . 5 A . l. 6 A. 1. 7 A . 2 . 0 A . 2. l A . 2 . 2 A . 3 . 0 A . 3 . l A . 3 . 2 A . 3 . 3 A . 3 . 4 A . 4. 0 B. O. 0 B . l . 0 c . o. 0 C . 1 . 0 C . 2 . l CENTRAL NERVOUS SYSTEM DRUGS CNS depressants General anaesthetics Hypnotics - sedatives Antiepileptic s Antiparkinsonism drugs Narcotic analgesics Analgesic -antipyrectics (code also unde r antiphlo- gistic U . 0 . 0 drugs if appropriate) Other analgesi cs CNS stimulants Analeptics (including opiate antagonists) Psychostimula nts Psychopha rmac olgic s Anxiolytic sedatives Anti psychotics (neurolepti c s) Antidepressants Psychotogenics (hallucinogens) Neurovegetative sytnptomatology drugs PERIPHERAL NERVOUS SYSTEM DRUGS Local anaesthetics (if used as eye, ear , nose p r epa- ration code there) MUSCLE RELAXANTS Centrally acting muscle r elaxants Periphe rally acting muscle rel axants 40 D . O. 0 E. O. 0 F . O. 0 G . 0. 0 F. 1. 0 F. 2. 0 F. 3. 0 F. 4. 0 F . 5. 0 F. 6. 0 F. 7. 0 F . 8. 0 G . 1. 0 G. 1. 1 G . 1. 2 G. 2. 0 G. 2 . 1 G. 2. 2 G . 2 . 3 G . 2 . 4 G . 2. 5 G. 2. 6 G . 3. 0 Annex I SPASMOLYTICS (including anticholinergics) ANTIALLERGICS (including antihistamines, de sensiti - zation drugs, etc.) CARDIOVASCULAR DRUGS Cardiac glycosides and drugs with similar indica- tions Antiarrhythmic drugs (including heart rate "slowers", betareceptors blockers) Coronary vessel dilators Antihyperte nsive drugs (including rauwolfia alkaloids) Antiarterosclerosis drugs Anti varicose drugs (including drugs fo r haemor - rhoids, sclerosing drugs, etc.) P e ripheral vasoconstrictors (if applied as eye, ear, nose and throat preparation cod e there ) Peripheral vasodilators BLOOD AND HAEMOPOIETIC SYSTEM DRUGS Antianaemia drugs Antimicrocytic anaemia drugs Antimacrocytic anaemia drugs (including Vit. B . 1 2, folic acid, liver and stomach preparations) Blood clotting drugs and haemostyptics Anticoagulants Anticoagulant antagonists Coagulants (including fibrinogen, Vit. K) Fibrinol ytic s Antifibrinolytics Haemostyptics Blood, blood proteins and their fractions (except gamma globulins and fibrinogen) 41 Annex I G. 4 . O H,0,0 H. 1. 0 H . 2 . 0 H. 2. 1 H. 3. 0 H . 3. 1 H . 4. 0 H. 4. 1 H . 4. 2 H. 4. 3 H. 4 . 4 H . 4 . 5 H. 5. 0 H . 6. 0 H. 7 . 0 H . 7. 1 H . 7 . 2 H . 7 . 3 H . 8 . 0 H. 9. 0 J . O. O J . 1. 0 J . 2.0 J. 3. 0 Blood substitutes (macromolecular) GASTROINTESTINAL TRACT DRUGS Antisecretory drugs (including cholinergics ) Antacids (including adsorbents) Antacids with spasmolytics Cathartics Intestinal atonia drugs GI Anti-infectives (c ode here only if administered orally a nd fo r GI pathology) Anthelminthics Antitre matodes drugs Antibiotics (code also under anti-infectives if R. 7. 0 appropriate ) Sulphonamides Mis c . GI c hemothe rapeutics Antidiarrhoics (code also under GI ant i-infectives if H . 4. 0 appropriate ) Antiprotozoal drugs Diges tants Stomachic s Chole reties Digestive enzymes Antiemetics Emetics RESPIRATORY TRACT DRUGS Antitussives - expectorants Antiasthmatics (code here when the drug form and/or indication permits. Code also under main the rapeutic indication if different (e.g . g lu- coc orticosteroid s)) Systemic anti-common cold drugs 42 K. O. 0 L. O. 0 L. l. 0 L. 2. 0 L. 2.1 L. 2. 2 L. 3. 0 L. 4 . 0 L . 5. 0 L. 6 . 0 L. 7 . 0 L . 8 . 0 L. 9. 0 M. O. 0 N. O. 0 M. l. 0 M. 2. 0 M. 3. 0 M. 4 . 0 M. 5. 0 M. 6 . 0 N . l. 0 N. 2. 0 Annex I ANTINEOPLASTIC DRUGS (glucocorticoids code also under antiphlogistics) METABOLISM AND NUTRITION Anorexiants Dietetics (including parenteral foods and salt and sugar substitutes ) Parente ral foods Foodstuff substitutes Antilipaemic drugs Lipotropic drugs Antidiabetics Anabolics (including anabolic steroids , STH etc. ) Thyroid and thyroid stimulating drugs Antithyroid drugs Diagnostic 1 31 I Prepar ations code under Diagnos- tic aids Uricosurics WATER AND E LE CTROLYTE METABOLISM DRUGS Diuretics (including aldosteron antagonists, acidi- fying agents, etc . ) Antidiure tic hormone prepara t ions Mineralosteroids Water and mine ral salts supply Alkalizing drugs Cation exchange resins VITAMINS (Vit. B.12 and K code under Blood) A 43 Annex I N . 3. 0 N. 4. 0 N. 5. 0 N. 6 . 0 N. 7 . 0 N . 8 . 0 N. 9. 0 P.O. 0 P. 1. 0 P. 2. 0 P. 2. 1 P. 2. 2 P. 2. 3 P. 2. 4 P. 2. 5 P . 3. 0 P. 4. 0 a. o. o Q. 1. 0 Q . 2. 0 R . 0. 0 R. O. 1 R. 1. 0 R . 2. 0 B. 2 B . 6 C D E Vitamins NOS (including multivitamin preparations) Misc. Vitamins SEXUAL HORMONE DISORDERS AND RELATED CON - DITIONS Male Female Estrogens Proge s to gens Oral contraceptives Oral contraceptives combined Oral contraceptives sequential Gonadotropins (and gonadotropin secretion stimu- lating drugs) Uterine contractility drugs IMM UNO LOGICALS Sera Vaccines ANTI-INFECTIVES (Antiprotozoal drugs and some other anti-infectives code also under system-organ groups if appropriate) Antiseptics Antiprotozoal drugs Fungicides 44 s . o. o R. 3. 0 R . 4 . 0 R . 5 . 0 R . 6 . 0 R . 6. 1 R . 7. 0 R . 7. 1 R . 7 . 2 R. 7 . 3 R . 7 . 4 R. 7. 5 R. 8 . 0 R. 8. 1 R . 8. 2 R . 9 . 0 s . 1. 0 s . 1. 1 s . 1. 2 s. 1. 3 s. 1. 4 s. 1. 5 s. 1. 6 Annex I Sulphonamides Antituberculosis drugs (including antileprotics and specific antibiotics) Urinary tract chemotherapeuti cs Miscellaneous chemotherapeutics Antiviral chemotherapeutics Systemic antibiotics (except antineoplasma and and antibiotics used only topically) Limited spectrum antibiotics I - primarily against gram positive microorganisms Limited spectrum antibiotics II - primarily against acid fast bacteria and gram negative microor - ganisms Broad spectrum antibiotics Antimycotic antibiotics Mis cellaneous systemic antibiotics Topical antibiotics (except antineoplasma) Limited spectrum antibiotics I - primarily against gram positive microorganisms Limited spectrum antibiotics II - p r imarily against gram negative microorganisms Immunity increasing drugs SKIN AND MUCOUS MEMBRANE PREPARATIONS (Code this term together with any appropriate group(s) whenever this drug form is used) Anti-infectives (code here only if administered topically) Antibiotics (code also under anti-infectives R . 7 . 0 or R . 8.0 appropriately ) Sulphonamides Fungicides (if applied locally) Scabicides and pediculicides Misc . local anti-infectives Repellants , insec ticides 45 Annex I s. 2. 0 s. 3. 0 s. 4. 0 s. 5. 0 S . 6.0 S.7.0 S,8.0 S . 9 . 0 T . O. 0 T. 1. 0 T . 1. l T . 1. 2 T. 1. 3 T . 1. 4 T. 1. 5 T . l. 6 T. 1. 7 T. 1. 8 U . o. 0 U . 1. 0 V. O. 0 w. o.o W.1. 0 W.1.1 Anti-inflammatory drugs Antipruritics and anaesthetics applied locally Astringents Detergents Pharmaceutical adjuncts (including basic s ol vents, powders, oils , etc. ) Emolients, demulcents and protectants Keratolytic and keratoplastic drugs Miscellaneous EYE, EAR, NOSE AND THROAT PREPARATIONS Anti-infective s Antibiotics (code also under anti-infectives R . 7. 0 or R. 8. 0 appropriately) Sulphonamides Miscellaneous anti-infectives Anti-inflammatory drugs Local anaesthetics Miotics Mydriatics Vasocons trictor s ANTIPHLOGISTICS (including glucocorticoids, ACTH, phenylbutazone and antipyretic -anal gesics if appro- priate) Glucocorticoids antagonists IMMUNO SUPPRESSING DRUGS (glucocorticoids code a l so under antiphlogistics) DIVERSE DRUGS Diagnostic aids Radiology 46 W. l. 2 w. 1. 3 w. 2. 0 W. 3. 0 W. 4. 0 W . 5. 0 X . O. 0 x. 1. 0 Radioisotopes Other diagnostic aids Antidotes, chelating agents, antagonists Alcohol deterrents Annex I Pharmaceutical adjuncts (if used in external pre - pa rations code appropriately) D ental drugs MISCELLANEOUS THERAPEUTIC USES Geriatric s, tonics, etc. 47 ANNEX II THERAPEUTIC CLASSIFICATION OF PHARMACEUTICAL PREPARATIONS USED BY THE NORSK MEDISINALDEPOT This classification is based upon the classification of the European Pharmaceutical Market Research Association and has the same main groups. Numbers The first two figures indicate the main group and the two last the sub-group. Preparations on prescription have odd numbers as last fig- ures, prescription-free preparations have even numbers as last figures. Figures for main groups are international. Figure s for sub -groups are made by NMD. Main groups 01 ANTI-AMOEBICS 02 ANALGESICS 03 ANAESTHETICS 04 ANTACIDS 05 ANTHELMINTICS 06 ANTI-INFLAMMATORY AGENTS INCLUDING THOSE USED FOR GOUT 07 URINARY-ANTISEPTICS (NOT SULPHONAMIDES) 08 ANTIBIOTICS 09 ANTICOAGULANTS FOR SYSTEMIC TREATMENT 10 ANTI -EPILEPTICS 11 ANTIDIARRHOEALS AND AGENTS FOR GASTRO- INTESTINAL DISORDERS 12 ANTI -ALLERGICS (NOT HORMONES) 13 ANTIMALARIALS 14 ANTI-EMETICS (NOT SIMPLE VITAMIN B6 PREPARATIONS) 15 ANTI-OBESITY PREPARATIONS 16 ANTISPASMODICS AND ANTICHOLINERGICS 17 PSYCHOPHARMACEUTICALS 18 CHOLERETICS 19 BIOLOGICALS 20 ASTHMA REMEDIES 21 AGENTS FOR CIRCULATORY DISORDERS 22 GYNAECOLOGICAL PREPARATIONS 23 COUGH AND COLD PREPARATIONS 24 DERMATOLOGICAL PREPARATIONS 25 ANTIDIABETICS 26 DIAGNOSTIC AIDS 27 DIURETICS 48 28 ENZYMES AND DIGESTANTS 29 HAEMATINICS 30 HAEMORRHOIDAL PREPARATIONS 3 1 HAEMOSTATICS 32 HORMONES 33 INFUSION SOLUTIONS 34 LAXATIVES Annex II 35 LIPOTROPIC AND CHOLESTEROL REDUCERS 36 MUSCLE RELAXANTS 37 AGENTS USED IN OBSTETRICS 38 PARASYMPATHOMIMETICS AND SYMPATHOLY- TICS 39 SEDATIVES AND HYPNOTICS 40 SULPHONAMIDES FOR SYSTEMIC USE 41 TUBERCULOSTATICS 42 THYROID AGENTS 43 VITAMINS 44 MINERAL ADDITIVES 45 TONICS 46 OPHTHALMIC PREPARATIONS 47 OTIC PREPARATIONS 48 CYTOSTATICS 49 NUTRITIONAL PREPARATIONS 50 MISCELLANEOUS 60 AGENTS FOR VETERINARY USE 70 ADHESIVE PLASTERS AND DRESSINGS 49 Annex II THERAPEUTIC C L ASSIFICATION 01 ANTI-AMOEBICS 0100 - Prescription-free 010 1 - On prescription 02 ANALGESICS 0200 020 1 0202 0203 0204 0205 0206 0207 - Narcotics, presc ription-free 11 on prescription - Othe rs , prescription-free 11 on prescription - Agents for influenza, prescription-free 11 11 11 on prescription - Agents , spe cific for migraine, prescription-free 11 11 11 11 on prescription 0 3 ANAESTHETICS 0300 030 1 0303 0304 0305 - Preparations for gene ral anaesthesia, prescription-free 11 11 11 11 on prescr iption - Local anaesth e tics for injection, on prescription 11 11 11 external use , prescription - free 11 11 11 11 11 on prescription 04 ANTACIDS 05 06 0400 0 40 1 0402 0403 - Antacids, plain, prescription-free 11 11 on prescription - Antacids with antispasmodics , prescription -free 11 11 11 on prescription ANTHELMINTICS 0500 - Prescription-free 0501 - On prescription ANTI-INFLAMMATORY AGENTS INCLUDING THOSE USED FOR GOUT 0600 - Sys t e mic anti-inflammatory agents , prescription-free (not horm. ) 060 1 0602 0603 0605 0606 0607 11 11 11 11 on prescriptio n - Topical agents fo r rheumatism, presc'ription-free 11 11 11 11 on prescription - Combinations of analgesics and corticosteroids , on prescr. - Spec ific agents for gout, prescription-free 11 11 11 11 on prescription 50 07 URINARY -ANTISEPTICS (NOT S ULPHONAMIDES) 0700 - Prescription-free 0701 - On prescription 08 ANTIBIOTICS - Broad-spectrum antibiotics, prescription-free 11 11 11 on prescription - Penicillin and derivatives, pre scription-free 11 11 11 on pres c ription Annex II 0800 080 1 0802 0803 0804 0805 0806 0807 0808 - Combinations of penicillin and strept o mycin, prescr . -free II II II II fl on prescr. - Antibiotic -sulphonamide combinations, prescription -free 11 11 11 on pres c ription - Streptomycins and dihydrostreptomycin including combina- tions, prescription-free 0809 0810 0811 - Streptomycins and dihydrostreptomycin including combina- tions , on prescription - Others, prescription-free 11 on prescription 09 ANTICOAGULANTS FOR SYSTEMIC TREATMENT 0900 - Prescr iption -free 090 1 - On prescription 10 ANTI-EPILEPTICS 1000 - Prescription-free 100 1 - On prescription 1 1 ANTIDIARRHOEALS AND AGENTS FOR GAST RO -INTESTINAL DISORDERS 11 00 - Lactic acid ferments and intestinal adsorbents , prescr . -free 11 01 - 11 11 11 11 II II on prescr . 11 02 - Gastro-intestinal antiseptics , pres c ription -free 11 03 11 11 11 on pre s c ription 12 ANTI -ALLERGICS (NOT HORMONES) 1200 - Pres c ription-free 1201 - On prescription 1 3 ANTIMALARIALS 1300 - Prescription-free 1 30 1 - On prescription 14 ANTI-EMETICS (NOT SIMPLE VITAMIN B6 PREPARATIONS) 1400 - Prescription-free 1401 - On prescription 5 1 Annex II 15 ANTI-OBESITY PREPARATIONS 1500 1 50 1 1 502 1 503 - Appetite suppressants and c ombinations, prescription-free 11 11 11 11 on prescription - L ow-calorie dietetics, prescription-free 11 11 11 on prescription 16 ANTISPASMODICS AND ANTICHOLINERGICS 1600 160 1 1602 1603 1604 1605 - Anticholinergics , prescription-free 11 on prescription - Other antispasmodics , pre scription-free 11 11 on prescription - Agents for Parkinsonism, prescription-free 11 1 1 11 on prescription 17 PSYCHOPHARMACEUTICALS 1700 - Neuroleptics, prescription-free 1701 11 on prescription 1703 - Meprobamate 1704 - Other tranquillisers, prescription-free 170 5 - 11 11 on prescription 1706 - Antidepressants (incl. MAO-inhibitors) prescription -free 1707 - 11 11 on prescription 1708 - Psychostimulants, prescription-free 1709 - 11 on prescr iption 18 CHOLERETICS 19 20 1800 - Prescription-free 1801 - On prescription BIOLOGICALS 190 1 - Sera 1 903 - Vaccines 1905 - Biological extracts 1907 - Allergens ASTHMA REMEDIES 2000 - B ronchodilator s , prescription-free on prescription prescription -free 2001 - II 2002 - Others, 2003 II on prescription 21 AGENTS FOR CIRCULATORY DISORDERS 210 1 - Rauwolfia, plain 2103 - 11 combinations 2105 - Other hypotensives 52 2107 - Coronary vasodilators 2109 - P e ripheral vasodilators 2111 - Cardiac gl ycosides 2113 - Antiarrhythmics 2115 - Sympathomime tics and analeptics 211 7 - Others 22 GYNAECOLOGICAL PREPARATIONS 2200 2201 2202 2203 2204 2205 2206 2207 - Vaginal antiseptics, prescription-free 11 11 on prescription - Vaginal therapeutics , prescription-free 11 11 on prescription - Antitrichomonals, prescription -free 11 on prescription - Other s , prescrip t ion -free 11 on prescription 23 COUGH AND COLD PRE PARATIONS 2300 - Cough and cold preparations , prescription-free 2 301 11 11 11 11 on p r escription Annex II 2 302 - Cough preparations containing antihis tamines , prescr. -free 2 303 11 '' 11 11 on prescr . 2 304 - Agents for percutaneous appl ication, prescr iption-free 2305 11 11 11 11 on prescription 2306 - Nasal decongestants , prescription -free 2307 11 11 on prescription 2 308 - Throat medicaments, prescription-free 2309 11 11 o n prescription 2310 - Inhalants, prescription -free 2 311 - 11 on prescription 2312 - Others , prescription-free 2 31 3 11 on prescription 24 DE RMATOLOGICAL PREPARATIONS 2400 - Fungicides (including corti cos teroids), prescription-free 2401 11 11 11 on prescription 2402 - Protective agents for the skin, prescription-free 2403 11 11 11 11 11 on prescription 2404 - Woundhealing promoters , prescription-free 240 5 11 11 on prescription 2406 - Counter -irritants, prescription-free 2407 11 11 on prescription 2408 - Tar- , sulphur-, resorcin agents , prescription-free 2409 11 11 11 11 on prescription 2410 - Antibiotic and sulphonamide preparation, prescr iption-free 2411 11 11 11 11 on prescription 241 2 - Corticosteroids, prescription-free 241 3 11 on prescr iption 53 Annex II 2414 2415 2416 2417 2418 2419 - Combinations of chemotherapeutic and corticosteroid prepa- ration, pres er iption -free - Combinations of chemothe rapeutic and c orticosteroid prepa- ration, on prescription - L ocal antiseptics , prescription-free it II on prescription - Othe rs, prescription-free 11 on prescription 25 ANTIDIABETICS 2501 - Insulin 2503 - Oral antidiabetics 26 DIAGNOSTIC AIDS 2600 2601 2602 2603 - X-ray contrast media, prescription-free t1 it ti on presc ription - Others , prescription -free t1 on prescription 27 DIURETICS 2700 - Prescription-free 270 1 - On prescription 28 ENZYMES AND DIGESTANTS 2800 280 1 2802 2803 2804 2805 2806 2807 2808 2809 - Proteolyti c agents, prescription-free t1 it on prescription - Digestants , prescription-free it on prescription - Hyaluronidase preparations , prescription-free it t1 on prescription - Fibrinolytic agents , prescription - free 11 11 on prescription - Enzyme inhibitors , prescription -free 11 11 on prescription 29 HAEMATINICS 2900 - P reparations with vitamin B l2 including live r extracts , prescription-free 290 1 - Preparations with vitamin B 12 including liver extracts , on prescription 2902 - Other s , prescription-free 2903 t1 on prescription 54 Annex II 30 HAEMORRHOIDAL PREPARATIONS 3000 - Haemorrhoidal preparations for local treatment, prescr . -free 3001 - fl 11 11 11 fl on prescr . 3002 - Agents for systemic treatment of varices , prescription -free 3003 11 11 fl fl 11 11 on prescription 3004 - Agents for local treatment of varices, prescription-free 3005 11 fl 11 11 11 fl on prescription 31 HAEMOSTATICS 3100 - Systemic and local haemostatics including vitamin K prescription-free 310 1 - Systemic and local haemostatics including vitamin K on pres crip tion 32 HORMONES - Pituitary extract , prescription-free 11 11 on prescription - Corticosteroids, prescription -free 11 on prescription 3200 3201 3202 3203 3204 3205 3206 3207 3208 3209 3210 3211 321 2 321 3 3214 321 5 3216 3217 - Corticosteroids in combinations, prescription-free 11 11 11 on prescription - Androgens, prescription-free 11 on prescription - Oestrogens, prescription-free 11 on prescription - Combinations of androgens and oestrogens , prescription-free on prescription comb., prescr. -free II II II ti fl - Progestogens and progestogen/oestrogen 11 11 II 11 - Anabolic agents, prescription - free 11 11 on prescription - Others, prescription-free fl on prescription 33 INFUSION SOLUTIONS 3300 - Prescription-free 330 1 - On prescription 34 LAXATIVES 3400 - Prescription-free 3401 - On prescription 35 LIPOTROPIC AND CHOLESTEROL RECUCERS 11 on prescr. 3500 - Lipotropic and liver protecting preparations, prescr , -free 3501 - 11 11 11 11 11 on prescr , 3502 - Cholesterol reducers , prescription-free 3503 11 fl on prescription 55 Annex II 36 MUSCLE RELAXANTS 3601 - Curare preparations 3603 - Others 37 AGENTS USED IN OBSTETRICS 3700 - Prescription-free 3701 - On prescription 38 PARASYMPATHOMIMETICS AND SYMPATHOLYTICS 3800 - Prescription-free 3801 - On prescription 39 SEDATIVES AND HYPNOTICS 3900 - Barbiturate preparations, prescription-free 3901 11 11 on prescription 3902 - Barbiturate combinations, presc ription-free 3903 11 11 on prescription 3904 - Non-barbiturates , prescription-free 3905 11 11 on prescription 3906 - Combination preparations , barbiturate -free, 3907 II II II 11 prescr. -free on prescription 40 SULPHONAMIDES FOR SYSTEMIC USE 4000 - Prescription-free 4001 - On pres c ription 4 1 TUBERCULOSTATICS 4100 - Prescription-free 4101 - On presc ription 42 THYROID AGENTS 420 1 - Thyroid agents 4203 - Antithyroid agents 43 VITAMINS 4300 - Multivitamins, including mineral combinations , prescr. -free 4301 - 11 11 11 11 on prescr , 4302 - Multivitamins for paediatric use, prescription-free 4303 11 11 11 11 on prescription 4304 - Multivitamins for geriatri c use, prescription-free 4305 11 11 11 11 on prescription 4306 - Vitamins A, D and A & D , prescription-free 4307 - II II II II II II on prescription 4308 - V itamin B 1 and combinations , prescription-free 4309 11 11 11 11 on prescription 56 4310 4311 4312 - Vitamin B6, prescription-free 11 11 on prescription - Vitamin B 12, excluding agents for use · in anaemia prescription-free 4313 - Vitamin B 1 2 , excluding agents for use in anaemia on prescription 4314 - Vitamin B -complex, prescription-free 4315 - 11 11 on prescription 4316 - Vitamin C , prescription-free 4317 - 11 11 on prescription Annex II 4318 - Other simple vitamins , excluding P and K , prescription-free 431 9 11 11 11 11 11 11 11 on prescription 44 MINERAL ADDITIVES 4400 - Calcium preparations, prescription-free 4401 - 11 11 on prescription 4402 - Others, prescription-free 4403 - 11 on prescription 45 TONICS 4500 - Prescription-free 450 1 - On prescription 46 OPHTHALMIC PREPARATIONS 4600 460 1 4602 4603 4604 4605 4606 4607 - Antibioti c s and sulphonamides , pre scription-free 11 11 11 on prescription - Corticosteroids, pre scription-free 11 on prescription - Combination of chemotherapeutics and corticosteroids , prescription -free - Combination of chemotherapeutics and corticosteroids , on prescription - Others , prescription-free 11 on prescription 47 OTIC PREPARATIONS 4700 - Prescription-free 4701 - On prescription 48 CYTOST A TICS 4800 - Prescription-free 4801 - On prescription 49 NUTRITIONAL PREPARATIONS 4900 - Prescription-free 4901 - On prescription 57 Annex II 50 MISCELLANEOUS 60 5000 5001 5002 5003 - Stomatologicals, prescription -free on prescription - Others, prescription -free II on prescription AGENTS FOR VETERINARY USE 6000 - Anthelmintics, prescription-free 600 1 11 on prescription 6002 - Antibiotics and chemotherapeutics , prescription-free 6003 11 11 11 on prescription 6004 - Vitamins, prescription-free 6005 11 on prescription 6006 - Hormones , prescription-free 6007 11 on prescription 6008 - Others, prescription-free 6009 11 on prescription 70 ADHESIVE PLASTERS AND DRESSINGS 7000 - Plasters 7002 - Dressings 58 EURO 3 102/4 EURO 3102/5 EURO 3102/6 EURO 3 102/7 LIST OF WORKING DOCUMENTS Definition and Classification of Drugs - Dr H. Friebel ANNEX III Indices and Sources of Information on the Consumption of Drugs - Dr G . R~sch Methods of Obtaining Data on Drug Consumption - Mrs Kay Daniels Factors Influencing Drug Consumption - Dr A . Engel Background Document EURO 310 1 The Consumption of Drugs, Report on a Study 1966-1 967-Dr A. Engel and Dr P. Siderius 59 ANNEX IV Monday, 3 November 9 . 00 10.00 11.00 - 12.00 13.30 - 15.00 15.30 - 16.30 Tuesday, 4 November 9 . 00 - 10.30 11.00 - 12.00 13.30 - 15. 00 15.30 - 16.30 Wednesday, 5 Novembe r 8. 45 - 9. 45 16.00 - 17.30 PROGRAMME Registration of participants Opening session Nomination of Chairman and announcements Introduction of report "Consumption of Drugs in Europe" (Dr Siderius) International Comparability of Data: introduced by Dr Siderius Presentation of paper "Definition and Classi- fication of Drugs" (Dr Friebel) Presentation of papers "Indices and Sources of Informa tion on the Consumption of Drugs" and "Me thods of Obtaining D::i.ta on Drug Cun - sumption" (Dr RBsch and Mrs Daniels) Measurement of the use of psychotropic drugs (Dr Holst) Group discussions Group discussions Group discussions {Official visits) Group discussions 60 Thursday, 6 November 9 . 00 - 10 . 30 11. 00 - 12. 00 13. 30 - 15. 00 15. 30 - 16. 30 Friday, 7 November 9 . 00 - 10 . 30 11.00 - 12 . 00 12 . 00 - 12.30 12 . 30 - 13.00 Annex IV Plenary session: reports on group discus- sions Panel discussion Presentation of paper "Factors Influencing Drug Consumption 11 (Dr Engel) Discussion Suggestions for further study Discussion of outstanding points Summing-up Closing session 61 ANNEX V LIST OF PARTICIPANTS ALBANIA 1 Dr N . Bocka Ministry of Public Health, Tirana AUSTRIA Dr A. Breit Federal Ministry for Social Affairs, Vienna BELGIUM Mr B. J . Huyghe Inspector -General of Pharmaceutics, Minis try of Public Health and Family We lfare, Brussels CZECHOSLOVAKIA Professor M . Salava Ministry of Health, Czech Socialist Republi c , Prague Mr J . Sykora 1 Ministry of Health, Czech Socialist Republi c , Prague DENMARK Dr A . Harrestrup Andersen Chairman, Danish Drug R egistration Board, Hellerup FINLAND Mr P , H. Tuominen 1 Chief, Pharmaceutical Department, National Board of Health, Helsinki Expenses not paid by WHO 62 Annex V FRANCE D r H. Nargeolet Chief, Department of Pharmacy and Drugs , Ministry of P u blic Health and Social Security, Paris HUNGARY Dr K. F~ller State Institute for Pharmacy, Budapest ITALY Dr G. Carotenuto Deputy Chief, Division of Pharmacy, Ministry of Health , Rome NETHERLANDS Dr C . Teijgeler Director -in-Chief of Public Health (Drugs ), Ministry of Social Affairs and Public Health, L eidschendam NORWAY Mr B. JJdal (Chairman) POL AND Chief, Pharmaceutical Division, The Health Services of Norway, Oslo Mrs Marie Herzyk PORTUGAL Department of Pharmacy, Ministry of Health and Welfare, Warsaw Dr M . Godinho de Matos Junior 1 1 Director , The P r actice of Pharmacy and of Drugs Control, Ministry of Health and W e l fare , Lisbon Expenses not paid by WHO 63 l Annex V ROMANIA Mr I. Ionescu Director, Central Pharmaceutical Office, Bucharest SPAIN Dr C. Luis , Chief, Pharmaceutical Registration, Directorate -General of Health, Madrid SWEDEN Dr O. Bartley Professor of Radiology, University of Goteborg SWITZERLAND Dr P . A . Gygi Economist, Federal Office of Social Insurance , Bern TURKEY USSR Dr Kaymakcalan Professor of Pharmacology, Faculty of Medicine , University of Ankara Mr M.E. Volosin Chief, Central Department of Pharmaceutics , Ministry of Health of the RSFSR, Moscow UNITED KINGDOM MrA. B . Rees Department of Health and Social Security, London YUGOSLAVIA Dr S . Zlatic Adviser, Council for Public Health, Establishments of Croatia and Yugoslavia , Zagreb 64 Annex V REPRESENTATIVES OF OTHER ORGANIZATIONS International Association of Social Security Dr L . L . Linneberg Medical Adviser , National Insurance Institute Rikstrygde- verket, Oslo International Pharmaceutical Federation Dr A. 0 . Wilund Society of Pharmacists, S tockholm OBSERVERS Mr T. W. Edwin Director, Joint Office of the Norwegian Pharmaceutical Industry, Oslo Mr I. Johannessen Chief Chemist, Stabekk Apotek, Oslo Mr M. Moe Director, Norwegian Drug Monopoly , Oslo Professor T . B . S e rnes Pharmacological Institute, University of Berge n, Norway Mr R . H . Rolao Gon9alves President, Corporation of Merchants of Drugs and Chemical and Pharmaceutic al Products of the South, Lisbon Mr M. Kodra Pharmacist, Ministry of Public Health, Tirana 65 Annex V WHO CONSULTANT Dr P . Siderius (Rapporteur) Director -General of Public Health, Ministry of Social Affairs and Public Health, Leidschendam, Netherlands WHO TEMPORARY ADVISERS Mrs Kay Danie l s Statistician, Statistics and Research Division, Department of Health and Social Security, London Dr A . G . W . Engel Thule International Symposia, The Skandia Group , Stockholm Dr M. Hlach Regional Chief Medical Officer , Regional National Council, Geske Budejovice, Czechoslovakia Dr E . Holst Associate Professor of Social Medicine , University of Copenhagen Professor H . Pequignot Hopital Cochin, Paris Dr G . Rl:isch Deputy Director of CREDOC, Paris Professor O . L . Wade (Co-rapporteur) Chief, Department of Therapeutics and Pharmacology, Queen's University, Belfast, Northern Ireland 66 Annex V WORLD HEALTH ORGANIZATION R e gional Office for Europe Dr M. Sedeuilh (Secretary) R egional Officer for Public Health Dr E . Krohn Regional Officer for Epidemiology and Health Statistics Headquarters Dr H. Friebel Chief , Drug Safety Unit 67