Feature: Direct reporting by consumers - First international conference, Sigtuna, Sweden

Currently, patients or consumers of the products of the pharmaceutical industry are almost completely dependent on the information about drug effects and adverse reactions provided by the manufacturers. The same is true for physicians, pharmacists and health authorities. Hence, there is a need for knowledge which can be rapidly compiled and communicated to prescribers, dispensers and consumers in order to maximize the benefits of the drug and minimize its hazards for the user.

An almost limitless and vital source of knowledge about drugs, their effects and adverse reactions remains virtually untapped. This refers to the experiences and reactions of the drug users themselves. Even in countries with existing systems for receiving reports of adverse drug reactions (ADRs), they are commonly limited to reports from physicians or other professional staff.

A broader base for collecting knowledge is therefore necessary to provide a more sophisticated and rapid information growth. This would also have the advantage of clearly demonstrating to the consumer that he/she shares the responsibility for the effects of the drug and would serve to strengthen the role of the consumer/drug user as a partner in the discussion about what drugs are needed and how and when they should be used.

The First International Conference of Consumer Reports on Medicines was held in Sigtuna, Sweden, from 29 September-1 October 2000 in order to address these issues and to give participants the tools and the inspiration needed to establish systems that take advantage of user experiences.

Before attending the Conference, participants were asked to respond to five questions. The questions relate to consumer reporting and to what extent consumers in various countries have the opportunity of accessing information on adverse effects and reactions of drugs. The objective of the brief questionnaire was to stimulate a process whereby participants investigate the situation in their respective home countries, something which could contribute to the discussion as well as providing a more realistic picture as a basis for the Conference deliberations. The responses to the questions are available on the Conference’s website (www.kilen.org - see Conference Programme).

The meeting, with wide multidisciplinary participation, examined the case for direct reporting by consumers of suspected adverse reactions to medicines. It also examined experience with such schemes in various countries to date, and the role of such approaches in complementing existing physician-based systems for the reporting of adverse drug reactions. Four main areas were identified to form a structure for such a scheme: Rationale, Reporting system, Realities of the system and Reaching out.

1. The rationale for direct consumer reporting

Existing physician-based systems of adverse drug reaction monitoring provide an important tool for collecting, collating and analysing data. However, patient-reporting schemes can complement these.

Benefits of direct consumer reporting. There is some evidence that direct consumer reporting can result in an earlier accumulation of signals some of which provide a valid pointer to new and hitherto overlooked reactions. Direct reporting can provide exceptionally informative, vivid and more complete accounts of unwanted experiences. Consumer reporting can cover situations about which the physician is not informed; it can provide information lost to existing systems.

Barriers to consumer participation. Lack of knowledge regarding drugs and their effects is probably the greatest barrier to direct consumer reporting. A particular problem in some developing countries is that a patient may not know with which drug he/she has been treated or at which dosage since not only are drugs sold under a multitude of names but also they may be dispensed without labelling. Another important barrier is that of translation and interpretation. Concepts regarding drug safety may be difficult to translate from one language to another and accounts of experiences may be difficult to comprehend when read in a different environment.

2. The structure of a system for direct consumer reporting

It is unlikely that any single structure will prove ideal for all countries. However, there are a number of considerations which are common to all.

Responsible body. Any direct consumer reporting scheme should be managed by a body independent from government and industry as far as data gathering and interpretation of information are concerned.

Reporting. The reports should be submitted as simply as possible through the most appropriate route. Data should be reported in a standardized manner and every report should be examined and considered; if the report is incomplete, additional details should be sought. A causality analysis should then be attempted using the existing systems in physician-based schemes. Follow-up is important and every report should be at least acknowledged. Confidentiality is essential and under no circumstances should the name of the reporter be disclosed although general information on the nature of the reports should be made available to all interested parties, including drug regulatory authorities, the health professions, the manufacturer and patient and consumer organizations.

Networking. An exchange of data with similar direct reporting would result in mutual strengthening of these systems.

Reports from clinical trials. It would be desirable for patients and volunteers taking part in clinical trials to report on any adverse reactions which they may experience.

Secondary services. Consumers may seek supplementary information from any system on direct reporting and the system should refer requests for medical advice to the most appropriate body.

3. Realities of a direct reporting system

Pilot project and funding. In order to gain experience and for financial reasons, it would be wise to set up a pilot project limited to a particular region or patient group. Funding for such a pilot project could be sought from research organizations. Once such a system has proved its value for public health it is believed that it should be adopted as a component of the health system.

Scope of reporting. In principle, all unwanted effects should be eligible for inclusion in the system irrespective of their nature or severity. Consumers should be encouraged to report on various neglected matters such as apparently new reactions to older drugs. Care should be taken to include information which could point to interactions with other drugs, food, alcohol, tobacco or environmental toxins.

Recruitment. A system of this type will only begin to function at a useful level if sufficient effort is made to recruit consumer support. Systems should be publicised through consumer magazines and press releases and reporting forms could be provided with prescription drugs at the moment of dispensing.

Obstacles. Lack of knowledge of drug use generally and of the medicines prescribed is a major obstacle. Improved health education supplemented by the availability of independent and appropriate information is vital. This must be available to counteract the insidious practice of Direct to Consumer Advertising where there is a real danger that public opinion will be manipulated and knowledge distorted for purely commercial purposes.

4. Reaching out

Any system for direct consumer reporting of adverse events cannot stand alone. Its value will depend on enlisting the support from a wide range of parties and institutions.

Existing physician-based reporting systems. Professional and public adverse drug reaction reporting systems should be mutually supportive and there should be no question of one undermining the other.

Health professionals. Physicians, pharmacists nurses and others should be reassured that there would be no damage to the relationship of trust and confidentiality between their patients and themselves.

Regulatory agencies. A positive effort should be made to develop the direct consumer reporting scheme as a support system to the drug regulatory agency.

Pharmaceutical industry. An effort must be made to establish and maintain a working relationship with pharmaceutical manufacturers based on mutual trust.

Consumer groups. Consumer organizations must take the primary initiative and remain involved in supporting such schemes.

Researchers. Medical and social scientists should be encouraged to conduct systematic studies on patients’ experiences. They can also play a role in evaluation of mechanisms for direct reporting.

Conclusion

This Conference was an important starting point in establishing consumer knowledge about drugs. It created awareness for countries that currently do not have a pharmacovigilance system. It was an important forum for countries to share experiences and learn from each other.

The full report can be found on the Conference’s website: www.kilen.org.

Reference: First International Conference of Consumer Reports on Medicines, Sigtuna 29 September - 1 October 2000.