HÉCTOR BUSCHIAZZO, ALBIN CHAVES,
ALBERT FIGUERAS, JOAN-RAMON LAPORTE*

Since the inauguration of the WHO European Drug Utilization Research Group (DURG) in the 1970s¹ similar networks have been set up in other regions. In the case of Latin America this occurred in September 1991 at the First Meeting of Latin American Groups for Drug Epidemiology held in Barcelona. Discussions in Barcelona involved health professionals from eight Latin American countries and representatives from Spain’s Ministry of Health, the Catalan Pharmacological Society and WHO/EDM. Participants expressed concern that in most Latin American countries drug utilization (DU) data were scarce and fragmentary. Some local drug regulatory authorities were unable to guarantee the efficacy and safety of products marketed, and had no access to quantitative or qualitative drug consumption data. The few drug consumption studies that had been done showed an alarming situation in terms of prescribing, dispensing and use of medicines. Agreeing that information on DU patterns would be a useful tool for designing drug policy and drug education programmes, delegates pointed out that the lack of local clinical pharmacology research meant that data had to be extrapolated from studies carried out in very different countries and cultural settings. Diminishing resources were limiting the efficiency of public health care systems and decreasing the already eroded access to the health care, including essential medicines. DURG-LA was formed to help overcome these problems.

Meeting a need in Latin America

DU research points to and profiles the gap between controlled research, therapeutic practice and population health needs, and it is a tool for implementing interventions to promote a healthier use of medicines.¹ DURG-LA promotes such research in Latin American countries, and exchanges experiences and information among the participating groups. It uses the knowledge acquired to give technical advice to drug regulatory authorities and to guide pharmacology teaching. DURG-LA also produces and disseminates information aimed at improving drug use, and collaborates on training of health professionals in pharmacoepidemiology and therapeutics.

By the end of 2002 there had been eight DURG-LA meetings, covering a wide range of subjects (see Table 1). Other general topics, such as bioequivalence, and promotion of the use of drug policies and generic medicines, have been the focus at several meetings. Oral and poster presentations on specific DU studies are given frequently, and their design, results and interpretation discussed.

Promoting drug utilization studies

Part of the initial core group participated in the first multicentre collaborative DU study, which was on self-medication and self-prescription, carried out in a sample of more than 240 pharmacies in 11 regions in six countries.² Since then the different participant groups have made presentations on a number of local and multicentre DU studies, involving nearly all DU methods. Methodologies include quantitative and qualitative analysis of drug prescription and consumption, and time trends of general patterns of drug use, together with analysis of specific areas of therapeutics. Some of these studies have been published in local or international journals, spreading DURG-LA’s message to a wider audience. Cuba provides one outstanding example of success, with more than 160 municipal centres for pharmacoepidemiology set up during the 1990s, run by general practitioners trained in the discipline. The Cuban network is involved in problem-oriented continued medical education and therapeutic information, drug utilization research and pharmacovigilance, with over 20,000 adverse drug reactions reported each year.^3,4

The Third DURG-LA meeting in 1997 called for the creation of a permanent observatory on the quantitative and qualitative time trends of drug use in Latin America. By the end of the meeting a draft of the data collection form to be used in this work was ready. A first evaluation was done, including qualitative and quantitative analyses of the 50 most consumed products (both by number and by value) in 11 countries (Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, Nicaragua, Peru and Uruguay). Data were presented and discussed at the 1999 meeting (see Table 1), and will soon be published. It is hoped that funding will be found to set up a permanent observatory for the region.

Selecting essential information

In parallel with the exchange of information about participants research and support activities, DURG-LA groups have been discussing another area of concern - the new challenges of the information and telematics revolution in relation to clinical pharmacology. Teaching, drug information, drug selection at different levels of the health system, drug regulation, pharmacovigilance and research have all been debated. While scientific information grows and is more accessible, this does not necessarily mean that knowledge - the ability to appropriately interpret and use information for decision-making - increases accordingly; rather, an excess of information may contribute to confusion regarding therapeutic priorities. In addition, access to scientific literature is more difficult for many of the 400 million Spanish-speaking community because of language barriers.

To address these concerns SIETES (Sistema de Información Esencial en Terapéutica y Salud; System of essential information on therapeutics and health) was created, and the system was presented at the Fourth DURG-LA meeting in 1998. It is a database of selected bibliographic references, more than 30% of them with an abstract and/or a comment in Spanish. SIETES contains manually selected articles, short communications, letters, editorials, review articles and news published in over 80 journals, including both the major general and speciality medical journals, and leading clinical pharmacology, therapeutics and pharmacoepidemiology journals. Between 5,000 and 6,000 new references are added each year. By March 2003, the SIETES database contained more than 60,000 references, which are retrievable by various means including use of keywords (there are over 8,000), name of author, journal, year, terms in the title, the abstract or the text, etc.

SIETES, which receives support from WHO/EDM, covers all areas of therapeutics, with special focus on new drug evaluations, comparative drug evaluations, translation of evidence into clinical practice, natural history and epidemiology of diseases, research in drug utilization and pharmacoepidemiology, and methodology in all areas of clinical pharmacology. Also covered are international health, with a focus on global inequalities, pharmacoeconomics and cost-effectiveness, pharmacology teaching, training, continuing education in drug prescribing, drug regulation, drug policy, and news of interest, focusing on Spain and Latin America.

Participants at the DURG-LA meeting in San Jose, Costa Rica, in 2000

Photo: DURG -LA

In 1999 a CD-ROM version was launched, and since 2001 SIETES can be accessed at: http://www.icf.uab.es or http://www.sietes.org Participants in DURG-LA use it regularly, and promote its use among health professionals and students in their respective countries.

Another successful initiative to promote information exchange was launched in 2000, when at EDM’s suggestion, the electronic discussion list e-farmacos was set up. This is the Spanish equivalent of the electronic list “E-Drug” (http://www.essentialdrugs.org) e-farmacos generates more than 400 messages per year and has nearly 300 subscribers.^5,6

Table 1
Main topics discussed at the eight DURG-LA meetings*

 

* Each meeting included oral presentations of one centre or multicentre drug utilization studies by the attending groups. The meetings in São Paulo and Mexico also included poster presentations.

DU = drug utilization; SIETES = Sistema de Información Esencial en Terapéutica y Salud); EAMI = Encuentro de Autoridades Competentes en Medicamentos de los Países Iberoamericanos.

Knowledge production and sharing

DURG-LA was born and has grown in response to changes in the pharmaceutical sector. The past 10 years has seen extraordinary growth in the world medicines market, but globally inequalities in access to medicines have deepened.⁷ The WTO TRIPS Agreements, the International Conference on Harmonisation, and consensus between the global pharmaceutical industry and the regulatory authorities of the main pharmaceutical markets may be seen to have contributed to accelerate market innovation and pharmaceutical company mergers. These companies may exert strong influence on drug regulatory authorities^8,9 and may have an increasing, sometimes overwhelming, presence in continuing education of physicians and other health professionals.^10,11

On the other hand, poor public investment in health, privatisation of health systems and deregulation impose additional barriers to access to good quality essential medicines.¹² Rational selection, prescribing and use are critical in improving access to drugs, but they involve not only providing the right drug at the correct dosage and duration of use, but also providing information and patient education on its use.¹³ DURG-LA works to ensure the updating of continuing education and training programmes both in universities and health care organizations using independent problem-oriented information. The group sees one of the most exciting challenges for clinical pharmacology as selecting those information materials which are essential, i.e., which help to build up knowledge oriented to satisfying health needs in a cost-effective, equitable and respectful way. Problem-oriented learning, as described in the very widely used Guide to Good Prescribing,¹⁴ is a basic methodological component of this strategy, and one which has been discussed at numerous DURG-LA meetings.

The group is going from strength to strength. To date more than 80 health professionals from 26 university departments, drug regulatory authorities, and hospital and primary care centres from 18 countries (Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Mexico, Nicaragua, Panama, Peru, Spain, Uruguay, the US, and Venezuela) have attended DURG-LA meetings on a regular basis. And the group has attracted funding from a wide range of sources. In the global society, networking and knowledge sharing are essential in order to meet the research, teaching and service goals of clinical pharmacology. We believe that the most original contribution of the DURG-LA is its specific focus on sharing and transferring knowledge.

* Hector Buschiazzo is Past President of the DURG-LA (1999 - 2002) and Director, Faculty of Pharmacology at the National University of La Plata, Argentina. Albin Chaves, is President of DURG-LA and Director of the Departament of Pharmacotherapy, Caja Costarican Social Security, San Jose, Costa Rica. Albert Figueras works on International Cooperation at the Catalan Institute of Pharmacology, and is Associate Professor in the Department of Pharmacology, Therapeutics and Toxicology at the Autonomous University of Barcelona, Spain. Joan-Ramon Laporte is Director, Catalan Institute of Pharmacology, and Professor in the Department of Pharmacology, Therapeutics and Toxicology at the Autonomous University of Barcelona, Spain.

References

1. MNG Dukes (ed.) Drug utilization studies. WHO Regional Publications, European Series No. 45. Copenhagen, 1993: 5-22.

2. Drug Utilization Research Group, Latin America. Multicenter study on self-medication and self-prescription in six Latin American countries. Clinical Pharmacology and Therapeutics 1997;61:488-493.

3. Debesa F, Jiménez G, Figueras A, Diogène E, Pérez-Peña J, Ávila J, Laporte JR. Spontaneous reporting of adverse drug reactions in Cuba: integrating continuous education, training and research in a network approach. British Journal of Clinical Pharmacology 2002;54:335-336.

4. Diogène E, Pérez-Peña J, Figueras A, Furones JA, Debesa F, Laporte JR. The Cuban experience in focusing pharmaceuticals policy to health population needs: initial results of the National Pharmacoepidemiology Network (1996-2001). Pharmacoepidemiology and Drug Safety (accepted for publication).

5. WHO. Useful web sites and electronic discussion groups on pharmaceutical issues. Essential Drugs Monitor 2001;30:8.

6. Figueras A, Laporte JR. Regulatory decisions in a globalised world: the domino effect of phenylpropanolamine withdrawal in Latin America. Drug Safety 2002;25(10):689-693.

7. Velásquez G, Boulet P. Globalization and access to drugs. Perspectives on the WTO/TRIPS Agreement. Revised. Health Economics and Drugs EDM Series No. 7. Geneva: World Health Organization; 1999.

8. Moynihan R. Alosetron: a case study in regulatory capture, or a victory for patients rights? British Medical Journal 2002;325:592-5.

9. Abraham J. The pharmaceutical industry as a political player. Lancet 2002;360:1498-1502.

10. Angell M. Is academic medicine for sale? New England Journal of Medicine 2000; 342:1516-18.

11. Bodenheimer T. Uneasy alliance clinical investigators and the pharmaceutical industry. New England Journal of Medicine 2000; 342:1539-1544.

12. Sachs JD. Macroeconomics and health: investing in health for economic development. Report of the Commission on Macroeconomics and Health. Geneva: World Health Organization; 2001.

13. Rawlins, MD. Education and training in rational use of drugs for health professionals and the population. In: WHO (ed.) Rational use of drugs. Report of the Nairobi Expert Conference, 25-29 Nov. 1985. Geneva: World Health Organization; 1985.pp. 276-286.

14. de Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA. Guide to good prescribing. Geneva: World Health Organization; 1997.