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Pharmacovigilance Activities in 55 Low- and Middle-Income Countries

A Questionnaire-Based Analysis

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Abstract

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.

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Notes

  1. 1For the purpose of this survey, sentinel sites are defined as clinics or hospitals where a pilot programme takes place, usually to serve a particular population or to manage a particular illness/disease.

  2. 2In this survey, active surveillance is defined as the periodic follow-up of patients undergoing drug treatment where the number of persons exposed to a medication is known and recorded.

  3. 3Pharmacovigilance — the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.[5]

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Acknowledgements

The authors are indebted to all the National Pharmacovigilance Centre representatives who participated in this survey. The departments of Epidemiology and Global Health at the School of Public Health, University of Washington, Seattle, WA, USA, where Andy Stergachis is affiliated, were supported in part by the Bill and Melinda Gates Foundation via the University of Washington. Andy Stergachis’ departments have received a grant via Managements Sciences for Health-United States Agency for International Development (MSH-USAID) for Strengthening Pharmaceutical Systems. No other sources of funding were used to assist in the preparation of this study. None of the other authors have any conflicts of interest that are directly relevant to the content of this study.

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Olsson, S., Pal, S.N., Stergachis, A. et al. Pharmacovigilance Activities in 55 Low- and Middle-Income Countries. Drug-Safety 33, 689–703 (2010). https://doi.org/10.2165/11536390-000000000-00000

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