Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis.

BACKGROUND: The WHO Programme for International Drug Monitoring aims to develop a comprehensive global pharmacovigilance strategy that responds to the healthcare needs of low- and middle-income countries. However, first there is a need to measure and understand existing conditions and pharmacovigilance initiatives intended in these settings. Very few investigations have carried out such a systematic assessment of the pharmacovigilance landscape in recent years in low- and middle-income countries. OBJECTIVE: To assess current and planned pharmacovigilance activities in low- and middle-income countries, identify gaps and the most urgent pharmacovigilance priorities at national and international levels, and define the elements of a sustainable global pharmacovigilance strategy. METHODS: A standardized questionnaire was sent to 114 representatives of countries participating in the WHO Programme for International Drug Monitoring (but excluding Australia, Canada, New Zealand, Switzerland and the International Conference on Harmonization countries, i.e. countries in Europe, Japan and the US) and to a few other identified contacts from non-member countries. The questionnaire was sent out between March and July 2008 and was designed to collect information on the structure, resources, functions and achievements of pharmacovigilance systems in low- and middle-income countries, with a focus on pharmacovigilance activities supported by national health authorities including public health programmes. All questionnaires that were returned by the end of July 2008 were used in the analysis. RESULTS: Fifty-five completed questionnaires were received by July 2008, representing a response rate of 55.5%. Forty-five percent of the pharmacovigilance centres in the analysis were established during the 1990s and 49% were set up later; 69% were affiliated with their Drug Regulatory Agency, 20% with the Ministry of Health and 9% with a university or other scientific body. Few countries (23 of 55) have any budget allocated for pharmacovigilance. Public health programmes (44%), the Global Fund to fight AIDS, Tuberculosis and Malaria (36%), universities (26%), poison centres (21%), Management Sciences for Health (18%) and Rational Use of Drugs networks (15%) sponsor some pharmacovigilance activities. In addition to direct pharmacovigilance activities, many centres are also involved in other activities such as drug information (63%), promoting patient safety (52%), rational use of drugs (46%) and poison information (15%). Some countries have sentinel sites to monitor HIV/AIDS patients (in seven countries) and other special groups. Information gathered through pharmacovigilance activities is used to assist regulatory functions in most countries (n = 42), lack of training and funding were mentioned as being major challenges to pharmacovigilance in many countries. CONCLUSIONS: This study has helped identify some of the special challenges and barriers to promoting pharmacovigilance in low- and middle-income countries. A pharmacovigilance strategy in these settings needs to help build health systems that can serve the purpose of multiple health conditions. It needs to identify and implement feasible systems, governance, infrastructures, human resource, training and capacity building, sustainable methodologies and innovations in pharmacovigilance; a key component will be the dissemination of medicines safety information to policy makers and regulators and knowledge sharing with healthcare professionals through high quality informatics and learning tools, with rational use of medicines and patient safety as the ultimate goal of pharmacovigilance.

Pharmacists' role in reporting adverse drug reactions in an international perspective.

INTRODUCTION: The participation of the pharmacist in national spontaneous reporting systems for adverse drug reactions (ADRs) has not always been a matter of course. Even today, there are a number of countries, in particular the Scandinavian countries, where pharmacists are not authorised to report ADRs. In those countries in which they are allowed to report, they do not always use this opportunity. METHODS: We have conducted a review of the literature to investigate the involvement of pharmacists in ADR reporting. In addition, we evaluated the pharmacists' actual contributions in 2001 by means of an international questionnaire-based survey among the countries participating in the WHO Drug Monitoring Programme in September 2002. Apart from the numbers of pharmacists' reports, respondents were asked to indicate their assessment of both the quality and the significance of the contribution. Of the 68 participating countries, 41 responded by returning the questionnaire. RESULTS AND CONCLUSIONS: The appreciation of pharmacists' ADR reports is high in those countries that have more experience with greater numbers of pharmacists' reports. The countries that received fewer reports from pharmacists gave lower scores to their contribution. If the specific contribution pharmacists can make to the quantity and quality of ADR reports were to be exploited to a greater extent, this could lead to a substantial improvement of the international adverse drug reactions reporting system.