Spontaneous reporting of adverse drug reactions in Cuba: integrating continuous education, training and research in a network approach

Spontaneous reporting of suspected adverse drug reactions (ADRs) is the most extended drug safety monitoring method. Currently, 65 countries participate in the WHO Programme for International Drug Monitoring.

Spontaneous reporting partly depends upon prescribers’ knowledge, skills and willingness to report [1]. This can be favoured by means of close collaboration, regular contact, and provision of feedback information. The Cuban National Network of Pharmacoepidemiology (NNP) was set up in 1996. It consists in 175 centres, each one located at the chief pharmacy in every municipality of the country (with more than one centre in large cities). Each centre is run by an experienced family practitioner with additional training in pharmacoepidemiology. This was provided through a specific Diploma in Pharmacoepidemiology, with a 360 teaching hours programme in clinical pharmacology, methods in epidemiology, clinical trials, drug utilization studies, observational analytical studies, and other relevant methods for benefit/risk assessment. The whole NNP is coordinated by the Centre for the Development of Pharmacoepidemiology (CDP). The main objectives of the NNP are (a) disseminating accurate problem-orientated therapeutic information among health professionals, (b) implementing continuing education activities on drug therapy, with particular emphasis on common health problems and other therapeutic priorities identified through drug utilization studies, (c) carrying out research on drug utilization, and (d) promoting educational and administrative interventions aimed at improving drug prescription and use [2].

In 1994 Cuba became a member of the WHO Programme for International Drug Monitoring. In 1998, the Cuban System of Pharmacovigilance gathered around 900 reports (equivalent to a reporting rate of 75 per million inhabitants). In 1999 the responsibility for drug safety monitoring was transferred to the CDP, and a National Coordinating Unit of Pharmacovigilance was set up. Since then, promotion of ADR reporting became a part of the continuous education activities of the NNP. A plausible effect has been a dramatic increase in the yearly number of reports: in 1999, 21125 reports were received (1920 per million inhabitants), and in 2000 the figure was 28450 (2543 per million inhabitants). These rates are an order of magnitude higher than those achieved in those more developed countries with the highest reporting rates [3]. Table 1 shows additional information on the reports gathered in 2000.

Table 1.

Voluntary reporting of adverse drug reactions to the Cuban Pharmacovigilance System, 2000.

Number of reports received	28450 (2 543/106 inhabitants)
Number of ADRs	39777
Most frequently implicated organs/systems
Body as a whole	8258 (29.0% of reports received)
Gastrointestinal	5899 (20.7% of reports received)
Skin and appendages	4699 (16.5% of reports received)
Most frequent ADRs
Rash	3595 (9.0% of ADRs reported)
Vomiting	2501 (6.3% of ARDs reported)
Nausea	2297 (5.8% of ADRs reported)
Dizziness	2049 (5.2% of ADRs reported)
Headache	1982 (5.0% of ADRs reported)
Pruritus	1466 (3.7% of ADRs reported)
Most frequent suspected groups of drugs (ATC Classification)
Antibiotics for systemic use (J01)	5965 (21.0% of reports received)
Anti-inflammatory and anti- rheumatic products, non steroidal anti-inflammatory drugs (M01A)	4980 (17.5% of reports received)
Antihypertensives (C02)	2558 (9.0% of reports received)
Most frequent suspected individual drugs
Benzylpenicillin	3021 (10.6% of reports received)
Nifedipine	2442 (8.6% of reports received)
Indomethancin	2110 (7.5% of reports received)
Number of reports describing severe ADRs	975 (3.4%)
Number of reports describing fatal ADRs	20 (0.1%)
Number of reports with previously undescribed
ADR–drug associations	27 (0.1%)

The main limitations of spontaneous reporting are underreporting, selective reporting, and incomplete drug histories [4]. Different approaches have been tried in order to limit underreporting, such as adding a yellow card in the prescription pads of the national health system, inviting other health professionals apart from physicians (e.g. pharmacists, nurses) and even patients to report, introducing fees for reporting, coupling electronic reporting with electronic information systems and in software for electronic medical records, etc. Our approach consisted in integrating ADR reporting with training and continuous education of physicians. We feel that it is of special interest that this experience was developed in a less developed country, during a deep economic crisis, but with a universal and equitable health care system.

The efficiency of spontaneous reporting for detecting new, previously undescribed, ADRs depends both on the number and the quality of reports. Now that a high reporting rate has been achieved, the next step will be improving the relevance and quality of reporting, by specifically promoting reporting of suspicions of ADRs related with recently marketed drugs, and by encouraging reporting of severe and poorly known adverse events.