Policy and Practice

- Consensus Document adopted at the First International Conference on CRM

September 29 - October 1, 2000. Sigtuna, Sweden

An international meeting with wide multidisciplinary participation was convened to define the case for direct reporting by consumers of suspected, supposed or proven adverse reactions to medicines; the meeting was structured to provide participants with the tools and the inspiration needed to establish systems that capitalise on user experiences. Participants included experts from the medical and pharmaceutical professions, drug regulatory authorities, the consumer movement and the World Health Organization.

The participants examined experience with such schemes in various countries to date, and the role of such approaches in complementing existing professional-based systems for the reporting of supposed adverse drug reactions.

1. The rationale for Direct-from-Consumer reporting

1.1. General considerations

Effective use of medicines depends on the availability and effective communication of reliable information. Where adverse effects and interactions of drugs are concerned, existing professionally based systems of adverse drug reaction monitoring are an important tool for collecting, collating and analysing data as a means of establishing new knowledge and especially as a means of generating early signals of possible drug complications which were not reported in clinical studies before the drugs appeared on the market. The output from the professional-based adverse drug reporting systems complements the information appearing in the published literature and elsewhere. For a series of reasons analysed below however, these systems have important deficiencies and limitations and they cannot stand alone as representing an adequate feedback from users of medicines. An analogous input, followed by critical analysis, is also needed from the patient who is using these medicines.

There are both general and specific reasons to consider the development of systematic "Direct from Consumer Reporting" as an essential activity in health care. It is an important mechanism for consumer empowerment in the field of health, which also extends increasingly to involvement in processes such as regulation and clinical trials of drugs. Direct Reporting promotes: 

a. Consumer rights and equity, including fairness (it is the patient who assumes the risks and the costs), the fundamental right to express oneself, to be listened to, and the right to decide (informed consent).

b. Therapeutic advances: Consumers have unique perspectives and experiences. They can provide information and insight which may be crucial in advancing the effective and safe use of medicines. The sharing of information in a public reporting system also encourages consumers to help one another as well as themselves.

c. An accountable and responsive health care system: The medical establishment needs the discipline of consumer input, i.e. the standard of practice will benefit from an ongoing and active encounter with active consumer concerns regarding adverse drug effects. Consumers for their part need a willing ear and a channel through which to make their experiences and feelings known as they assume the risks and costs of using medicines. They also seek a better understanding of the relationship between benefits, harm and costs where drugs are concerned, and can themselves contribute to knowledge of that relationship. 

Some specific arguments for promoting the establishment and further development of consumer-based drug adverse reaction reporting systems are considered in more detail below under 1.2. and 1.3 below. 

1.2. Limitations of physician-based and pharmacist-based reporting 

In the thirty years since the first professional-based adverse reaction reporting systems were created they have evolved considerably and play a significant role in mobilizing data from the field. However, they have certain serious limitations. Foremost among these is the fact that only a small proportion of practising physicians (often less than 5%) and a relatively small number of pharmacists (varying from country to country) contribute data to these systems; consequently information on suspected adverse effects communicated by a patient to his physician stands a 95% chance of going no further and making no contribution to the adverse reaction reporting system.

There are various well-documented reasons why a physician or other health professional may fail to report to the system an adverse effect communicated to him by the patient. He or she may consider the effect to be sufficiently well-known already, or conversely dismiss it as being unlikely, vague or unrelated to the treatment. However it also seems clear that the prescriber may perceive risk and adverse events differently from the patient. While for instance the doctor is likely to accept the existence of any tangible or visible physical reaction (e.g.. a rash), he or she is less likely to appreciate that a consumer's description of experiencing ill-defined malaise, unease or changes in mental experiences and feelings may equally constitute an early sign of drug complications. Some physicians appear particularly hesitant to report adverse effects to a drug which they have prescribed for a non-approved indication ("off-label use"). In some countries physicians have been more generally reluctant to submit adverse reaction reports to official systems because of a fear that, particularly where a reaction is serious, the prescriber may be blamed and accused of malpractice. Above all, however, the physician who has no interest in communicating suspected adverse reactions to a central system will take no action, and what may be significant information then at best remains buried in the patient records.

It should be added that there is also a problem relating to under-reporting by patients to physicians, especially where a patient is nervous about raising the issue; this situation is regrettable but it exists, and some consumers in this situation may prove less reluctant to report their experiences to a neutral consumer-based system. The prescriber could and should do more than is usually done to alert a patient to the need to report suspected adverse effects, whatever reporting channel is used; this is particularly important where a new drug is prescribed, or an old drug is given for a new or unusual indication.

A final problem with existing systems is that the input relates primarily to new drugs; reports of adverse experiences with products which have been marketed for many years are relatively few, despite the fact that new problems can emerge with such drugs even after decades of use and that old drugs may be re-developed for new indications (e.g. thalidomide for treatment of the acute leprosy reaction).

The establishment of direct consumer-based reporting of suspected unwanted events can compensate for these and other deficiencies in existing systems. 

1.3. Positive benefits of direct reporting

Some positive and direct benefits of direct consumer reporting can be identified and can already be documented from existing experience:

a. There is evidence from the field that direct consumer reporting can result in an earlier accumulation of signals, some of which will point validly to new and hitherto overlooked reactions. In at least one comparative study, consumer reports have been found to cover a wider spectrum of organ systems and adverse events than reports entering a physician-based system.

b. Direct reporting can provide exceptionally informative and vivid and more complete accounts of unwanted experiences which do not readily lend themselves to classification in any rigid system. These may include mental effects but also adverse changes in the quality of life which can be very important, real and distressing to the medicine user yet are unlikely to be clear to a prescriber.

c. Because consumer reporting can cover situations about which the physician is not informed and about which he or she therefore cannot report, it is bound to provide information lost to existing systems. Where, for example, a patient discontinues a drug because of an adverse effect, and does not return to the prescriber, the latter will have no knowledge of the event. Again, if patients experience a suspected reaction to a self-medicated drug, or to a traditional, herbal or alternative medicine which they have taken at their own initiative, no prescriber is likely to know about it; it is clear that in much of the world there is extensive self-treatment involving drugs which formally are restricted to prescription sale, and these include new and potent products with still poorly defined risks. Similarly, if a patient is being treated by two physicians (e.g. a general practitioner and a specialist) the one may not be aware of drugs prescribed by the other, and adverse effects or interactions from this cause will be missed; the onus of ensuring proper collaboration and communication in this matter clearly lies with physicians and the health system, but where it fails a consumer-based system may well provide important input.

1.4. Existing barriers to consumer participation

In addition to the above challenges, a series of reasons can be advanced as to why consumer experience has not up to the present been mobilized as a tool to develop new knowledge and monitor possible adverse effects. The most obvious of these is the fact that in most countries, reports submitted directly by patients or their representatives are not accepted by the existing physician-based systems; they may be formally excluded, or those managing the systems may simply be reluctant to accept them.

In addition, however, consumers have up to now mostly been too weak to play an active role. Problems have included lack of knowledge regarding drugs and their effects, a difficulty which is universal but especially severe in countries where lack of education and illiteracy are widespread. In some countries medical mysticism is still prominent, characterized by a desire to maintain secrecy around medical facts and thinking. Improved public education and information services, coupled with more modern attitudes on the part of professionals, can do much to remedy such problems.

The fact that drugs are still often prescribed and used irrationally creates other difficulties, e.g. where many drugs are given for a single condition when only a single drug is indicated. In much of the world, the patient has only a brief interview with the physician before receiving a prescription or therapeutic advice, and there is neither an opportunity nor a positive tradition favouring proper information and advice about the drug that has been prescribed or recommended.

A particular problem in some developing countries is that a patient may not know with which drug he/she has been treated or which dose he/she has received. Not only are drugs sold under a multitude of names, but in some instances they are selected anonymously ("take two of the blue tablets and three of the green ones every day") or dispensed without labelling (e.g. in sachets containing a few loose tablets). In such situations the active participation of users will be difficult to achieve for many years to come.

In industrialized countries medicine users increasingly report their experiences on internet-discussion sites, and to patient and consumer organisations. These reports however tend to be left as anecdotal experiences. They are not taken seriously as direct from consumer reports on drug effects.

But even in countries where the above barriers are severe, a start can be made by mobilizing consumers in the more educated classes for a limited venture which will subsequently extend into a wider group.

2. The structure of a system for direct consumer reporting

No single structure is likely to prove ideal for all countries. However, a number of firm impressions as to preferred structures can be recorded.

a. Responsible body:

The scheme should be handled by an independent body at arm's length from government and industry as far as data gathering and interpretation of information are concerned.

The body should be able to call upon independent experts, including pharmacists, pharmacologists and physicians with experience in assessing cause-effect relationships, but it should also have expertise in consumer affairs and patients' rights.

b. Reporting channel:

The reports should be submitted through the most appropriate route, depending on the current situation in the country; the submission procedure should be as simple as possible. In some parts of the world the Internet provides a widely available means of entering reports, whereas in others the mail, telephone or personal contact are more appropriate.

c. Form of reports:

Because, as has been shown in existing physician-based systems, it is helpful to receive the essence of a report in a standardized manner, well-designed reporting forms should ideally be used; reports received by telephone, letter or through personal contact should be transferred to such forms, but with retention of any more complete description of the event which has been provided, e.g. by scanning a letter or recording the description given by telephone. The data as recorded on the standard form should be sufficiently exact to permit digital analysis, while a plain text description of the complication should also be provided since it can be valuable in recognizing unusual events not readily amenable to coding (e.g. mental sensations or changes in the quality of life). As in professional reporting systems, great care must be taken to ensure anonymity so that personal medical data do not become common knowledge.

d. Terminology:

As became clear at an early stage with professional reporting systems, there will be a need to standardize terminology, particularly bearing in mind the fact that information will arrive from different cultures and in different languages. It is possible that in this respect the system will be able to benefit from the work carried out at the Uppsala Monitoring Center.

e. Examination:

Every report received should be examined and considered; if the report is incomplete, additional details should be sought. As with existing physician-based systems it will be important to have adequate information about the user (age, sex and condition of health), the treatment (drugs, doses and background medication, with attention for misleading synonyms) and the details, timing and course of the event itself. A causality analysis should then be attempted, recognizing that there is no exact methodology to this end. An attempt must be made to determine whether the report is novel or whether it has previously been described in existing systems or in the literature. The methods of analysis will not differ greatly from those developed in the best existing professional-based systems, but a consumer perspective ("how was this even experienced by the user?") should be included.

f. Direct feedback:

Experience with existing adverse drug reaction reporting systems shows the great importance of acknowledging promptly the receipt of every report, and following this up in due course with a full reply, and where possible explanation and reassurance. It will for example be helpful to the reporter to know whether or not the report is similar to reports received earlier. In some cases the nature of the report will make it necessary to advise the reporter on immediate steps, e.g. recourse to the prescriber to some other expert.

g. Information to others:

The individual report is essentially confidential and under no circumstances should the name of the reporter, or any data on the basis of which the reporter might be identified, be transmitted to other parties. However, general information on the nature of reports received on a particular drug should in the interests of accumulation and dissemination of evidence be made available (together with the relevant assessment) to all interested parties. These are likely to include the national professional- based adverse reaction reporting scheme, the official drug regulatory authorities, the health professions, agencies responsible for rational drug se policies and programmes, the manufacturer, consumer and patient organizations and others likely to need the data. The media should have full access to the analysed data. When providing the information, disclaimers similar to those employed by existing spontaneous reporting systems should be added, so as to reduce any risk of over-interpretation or unnecessary alarm. In many instances periodic reporting on data input (e.g. quarterly) will be adequate, but it will be appropriate to disseminate more urgently groups of related reports that suggest the emergence of a hitherto unrecognized problem.

Periodic publication of reviews of the data received and the interpretation placed on them will be helpful. Special analyses of trends and new phenomena, analogous to those developed by the Uppsala Monitoring Centre will be helpful in identifying early signals once the volume of data is sufficient to justify them.

h. Collaboration:

At the very least there should be an exchange of data between public reporting schemes in different countries which will result in mutual strengthening of these systems and a further acceleration in the identification of new data. There is strong interest in establishing a global centre for consumer reports, analogous to that existing for professional reporting in Uppsala (The Uppsala (WHO) Monitoring Centre) but separate from the latter. The Uppsala Centre is however open for an input of data from the consumer system, which could form a separate data base. The Centre currently holds the data from 59 national physician-based schemes and provides reports and analyses of this worldwide material, as well as conducting methodological research. Its experience and advice could be of great value in developing consumer systems.

i. Action required:

A careful distinction must be made between a neutral system for collecting, analysing and disseminating data and an institution taking positive action in the light of emergent findings. While as noted under 2(f) above the system can and should bring its findings to the attention of other parties and agencies, it is likely to gain greatest respect if it concentrates single-mindedly on the most balanced possible analysis of data and the generation of signals. It would be more appropriate for bodies primarily concerned with the active promotion of patient and consumer interests to take whatever action seems justified in the light of the findings, e.g. in calling for the withdrawal of a product, modification of the data sheet or seeking legal redress on behalf of an injured patient.

j. Hospital reports:

Appropriate arrangements will have to be made to enable hospitalized patients to report directly to the proposed scheme when they experience the need to do so, either during their hospital stay or later.

k. Reports from trials:

It would be very desirable for patients and volunteers taking part in clinical drug trials to report when they so wish to a central system on adverse reactions which they experience. It is well known that many adverse reactions occurring in such trials provide early pointers as to drug injury, and that the data in question sometimes fails to become generally known either in a timely manner or at all. In particular, adverse events experienced by subjects dropping out of a trial may be lost to the records despite the fact that precisely these events may provide the first indications of a serious problem.

The principle of the subject's freedom to report should be laid down in the Guidelines for Good Clinical Practice drawn up by the International Conference on Harmonization and now accepted by the European Commission. The same principles should be incorporated in clinical trial protocols subject to approval by ethics committees and analogous bodies. Confidentiality agreements concluded between an industrial sponsor and a clinical investigator should never be allowed to impede reporting of adverse effects by participants.

l. Active reporting:

In the course of the years there have been several successful though labour-intensive ventures into "intensive monitoring" or "active reporting", seeking to obtain integral registration of all adverse events from a particular patient group or at a particular location. Such efforts are justified, in direct consumer reporting as in physician-based reporting, where there is a special reason to anticipate certain problems and to quantify them within a short period.

m. System monitoring:

The functioning of all aspects of a system of this type should be monitored internally and its usefulness should be evaluated periodically so that modifications can be introduced as necessary. Field trials of modified procedures may be called for.

n. Secondary services:

It seems clear from experience that once consumers have established contact with the proposed system they will seek supplementary services from it, in particular requesting advice and information. While the system should refer requests for medical advice to the most appropriate body (generally the patient's own physician) sympathetic assistance should be given where factual information or reassurance is sought. Such information may also need to be communicated to other bodies, especially where it points to a problem which, though it may not concern adverse effects, demands attention and correction.

Finally, much information regarding adverse drug experiences is now to be found on the Internet, but it is scattered and of very variable reliability. Consumer reporting systems could in due course perform a useful role by periodically sampling the relevant content of the Internet and disseminating with all necessary reservations selected data that appear significant.

o. Pitfalls & problems:

The reasons sometimes advanced in the past for rejecting the principle of direct consumer reporting need to be borne in mind since they can provide pointers to necessary action. The mistaken view that physician-based systems cover the need adequately has been dealt with under Section (1) above. The opinion that information emanating directly from consumers is less reliable than that communicated by way of physicians (or pharmacists) is only valid insofar as the professional reporter may provide preliminary screening and useful background information when submitting the report. Provided there is proper feedback and careful expert analysis of reports, it will not necessarily be more difficult to eliminate mischievous, misleading or ambiguous reports than has been the case in professional-based systems, where entirely similar problems arise.

A problem deserving particular attention, especially in international collaboration between systems, is that of translation and interpretation. Concepts regarding drug safety and subjective experiences (e.g. concerning the quality of life) may prove difficult to translate from one language to another, and plain text accounts of experiences may simply be difficult to comprehend when read in a different environment. These are intercultural as well as linguistic challenges which will have to be met.

3. The realities of a direct reporting system

a. The initiative:

Whatever the ultimate structure of the system (see 2(a) above), the initiative to bring it into being should come primarily from the consumer movement which is highly motivated to see it established. Such an initiative would in any case be unlikely to come from any other quarter. The consumer movement could however solicit support in other circles and do much to bring about a broad acceptance of the need for such a system. KILEN in Sweden, having much experience with its existing "RE:ACT" project in this field, can serve as an important nucleus for development.

It is not impossible that some parallel initiatives might be taken elsewhere (e.g. in patient organizations establishing systems for their own sub-group) but links with these could readily be established to avoid unnecessary duplication of effort. Where parallel initiatives are taken, mechanisms for co-ordinating the systems should also be worked out so that the information can be shared and duplication of effort avoided.

Once such a system has proven its value it might well be adopted as a component of the health system.

b. Pilot projects:

Both for financial reasons and in order to gain experience it would be wise to initiate such a venture in any country by setting up one or perhaps more pilot projects, e.g. limited to a particular region or patient group.

c. Sources of funding:

If a system for direct consumer reporting, having proven its value to public health, is adopted as a component of the health system, its funding is likely to be assured; such funding might be derived from purely public funds or from drug licensing fees, though the latter possibility will depend on how far the drug regulatory agency is willing and able to collaborate.

Particularly during the initial phases of operation, other funding sources will have to be sought. In most countries it would be undesirable to accept support either from an individual pharmaceutical company or from the drug industry generally. For an experimental pilot project designed to test the feasibility and usefulness of such a system, project funding could be sought from research organizations (or in Europe from the European Union) or from health services.

d. Scope of reporting:

It is evident that the system should cover all drugs, diagnostic agents and vaccines. The system should also be willing to accept in addition reports on closely analogous products including herbal and traditional remedies, medical cosmetics, contraceptives, foods making health claims and medical devices, except where any of the latter are the subject of their own specific systems for adverse reaction reporting.

As has been the experience in physician-based systems, it will be vital to convey the message that the reporting of adverse or unwanted events during or following drug treatment is the primary tool, irrespective of whether at the moment of reporting a drug association seems likely or not; only in this way will many potentially important early signals enter the system.

In principle, all unwanted effects should be eligible for inclusion in the system, irrespective of their nature or severity; physical and mental effects, dependency and allergy will all be relevant as will subjective sensations and quality-of-life experiences. While it would be tempting to limit the volume of reports by excluding certain types of incident, there is a considerable risk that potentially important information would thereby be lost. On the other hand, consumers can be encouraged to report particularly on various neglected matters, such as apparently new reactions to older drugs.

The consumer is likely to bring to the attention of such a system certain matters which do not relate strictly to suspected adverse reactions, e.g. complaints as to the apparent quality of the drug or its lack of effect. Such submissions should be dealt with sympathetically, bearing in mind the role which such a system can play in assisting the patient who is in need of contact to discuss a drug-related problem, and they should be passed on to the appropriate authority (e.g. a quality control laboratory). Care should be taken to include information which could point to interactions, e.g. with other drugs, food, alcohol, tobacco or environmental toxins.

From time to time it may be appropriate for these systems, acting alone or in concert with professional-based schemes, to appeal to the community to report particular types of effect, or problems associated with a particular drug; this will be the case especially where suspicion regarding a serious effect has arisen and more evidence is urgently required in order to confirm or discount it.

e. Recruitment:

A system of this type will only begin to function at a useful level if sufficient effort is made to recruit consumer support.

Apart from general channels of publicity (e.g. through consumer magazines and press releases) one could envisage drug-related educational efforts, such as reporting forms provided with prescription drugs at the moment of dispensing; this would require the support of pharmacy organizations and would demand at least a neutral and preferably a supportive attitude on the part of the medical profession. In some countries there are proposals for pharmacists to provide patients with counselling sheets as part of their advisory activities, and reporting forms could be part of these.

It will be essential to assure potential reports through all channels that their reports will be treated in strict confidentiality. It will be necessary to have the patient's name and address in order to accept a report, in order to ensure that it is genuine and that feedback can be provided, but there must be an absolute assurance that these personal details will be transmitted no further.

Last but not least, it should be stressed that the development of a system of this type has its rewards for the participating consumer. He or she receives the assurance that his or her problem has been recognized and listened to, that his contribution to the scheme represents a contribution to public knowledge and management of the problem generally, and that it can also result in improved management of his or her own case.

f. Removing obstacles:

Over a longer period society needs to counter various obstacles which now impede the development of the consumer's role in his own health care. These relate particularly to his lack of knowledge (e.g. of drug use generally and of individual products). Only improved health education, supplemented by the availability of neutral and appropriate written information for the lay person (e.g. on the Internet or in Patient Drug Compendia) will bring about substantial improvement.

g. New obstacles:

While developing consumer empowerment, one must also seek to counter new and harmful influences which could positively undermine the development of a stronger and better-informed consumer position. Current efforts are being made by the pharmaceutical industry to extend "Direct to Consumer Advertising" for prescription drugs to Europe and other parts of the world; it has been officially permitted for some years in the USA and New Zealand, and long practised more or less surreptitiously in a range of developing countries. Examination of this practice, e.g. in the US, shows the real danger that public opinion will be manipulated and knowledge distorted for purely commercial purposes.

h. Country-specific matters:

While the above principles are likely to be universally applicable, the opportunities and constraints are likely to differ considerably in different parts of the world, and especially between industrialized and developing countries. In the latter, where there is often a considerable educational gap between upper-income and lower-income groups, initial efforts could concentrate on the better educated, in the belief that the practice of direct reporting will then spread to other groups through active promotion of a cascade effect.

i. Education:

Education regarding the system, the nature of the reports and the conclusions which can be drawn from them will also be required. This education should be targeted towards those to whom the reports are disseminated, particularly consumer and patient organisations and the media, as in many countries these groups have not been subject to education campaigns on existing drug reporting systems..

4. Constructive contacts with other parties

A system for direct consumer reporting of adverse events cannot stand entirely alone. Its value will depend in an important measure on enlisting support from a wide range of parties and institutions, allaying unjustified concerns and countering possible misunderstandings. Among the parties important in this respect are:

a. Existing systems:

Professional and public Adverse Drug Reaction reporting systems should be mutually supportive, and there should be no suggestion of one undermining the other. In recruiting consumers for public reporting, the need to make suspected adverse effects known to one's medical practitioner, who may wish to report them, should be stressed. As noted above, the Uppsala Monitoring Centre has expressed interest in collaboration with a consumer reporting system. However, a degree of healthy competition between public and professional systems could well develop and prove conducive to better adverse reaction reporting across the board.

b. Health professionals:

Doctors, pharmacists, nurses and others should be reassured that the public system will in no sense undermine the relationship of trust and confidentiality between their patients and themselves, and that the public adverse reaction reporting system will seek positively to encourage reporting through professional channels as well. One must seek to promote a better interchange of knowledge, experiences and wishes between patients and doctors in both directions.

c. Regulatory agencies:

Quite apart from any future funding prospects (see 3(d) above) a positive effort should be made to develop the public adverse reaction reporting scheme as a support system to the drug regulatory agency and the body implementing national drug policy, enabling these institutions to secure faster and more complete feedback from the field.

d. Drug industry:

The pharmaceutical industry has at no time been warm in its support for existing adverse reaction systems, though it has worked with them; the view has sometimes been expressed that firms could well handle themselves the collation and reporting of supposed adverse drug effects. Nevertheless industry always proves able to adjust to new situations which it cannot prevent, is likely to accept a well-structured and impartial public reporting system as a new source of information which it may not welcome but to which it cannot validly object. An effort must be made to establish and maintain a working relationship with companies, based on whatever degree of mutual trust can be established.

e. Consumer groups:

As noted above, the primary initiative is likely to be taken by consumer organizations, though these might later fall into the background as primary sponsors as the system develops a wide degree of support and acquires its own status and organization. Consumer groups will however remain closely involved in terms of supporting input and taking whatever action is needed in the light of the output of these systems (see 2(g) above). Groups active in the fields of human rights, civil liberties and equity, should be approached as allies whose work and ideals parallel those of the consumer reporting venture.

f. Patient groups:

Patient groups have generally not been active in the field of adverse reaction monitoring, but they should be encouraged to become involved in direct reporting, e.g. encouraging their members to participate. These groups could also play an important role in pilot projects as suggested under 3(c) above.

g. Women's groups:

Particularly because women play the dominant role in use of medicines in the family, as well as themselves being major users of medicines, the women's moment should be actively involved in developing the input to direct reporting systems.

h. Researchers:

Medical and social scientists should be encouraged to conduct systematic studies on people's experiences with medicines and to liaise with the bodies handling direct- from-consumer reporting and professional adverse drug reaction reporting. Researchers can also play a role in above-mentioned evaluation of the mechanisms for direct reporting and in the secondary analysis of both consumer reports and material from the Internet or collected by patient and consumer organizations. There is also a need for more extensive studies than hitherto on what influences the way in which people use drugs and how they experience safety and efficacy.

I. Educationalists:

It is striking that whereas teaching on consumerism and consumer rights is now part of university education in the social sciences, no similar teaching is given in medical or pharmaceutical faculties, despite the fact that health professions directly serve consumers and are in daily contact with them. This defect should be corrected as part of curriculum reform.

j. Media:

The media should have full access to the analysed data. The media should also be kept informed on developements and should be assisted in accessing and interpreting data in the System.

k. Complementary projects:

In developing public monitoring schemes one should have an open mind for the complementary role which differently based schemes may play in mobilizing knowledge, e.g. the DIPEX programme (collection of data on individual patient experiences in the United Kingdom).


Oslo/Stockholm, October 25, 2000



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