Supporting Medicine Safety in Developing Countries: A Systems Perspective

With increased access to essential medicines in developing countries comes an increased need to monitor and promote the safety and effectiveness of these medicines. The USAID-funded Strengthening Pharmaceutical Systems (SPS) Program recently published “Supporting Pharmacovigilance in Developing Countries: The Systems Perspective”(PDF), in the Journal of Acquired Immune Deficiency Syndromes (JAIDS), a paper describing the SPS conceptual framework and operational approach to strengthening pharmacovigilance and medicine safety systems in resource-limited settings. The publication is the first in a series that will include papers on governance in the pharmaceutical sector, pharmaceutical care, and pharmaceutical financing. [Supporting Pharmacovigilance in Developing Countries: The Systems Perspective]Supporting Pharmacovigilance in Developing Countries: The Systems Perspective

Many studies have reported the huge impact that poor product quality, adverse drug reactions, and medication errors on health care in general and on patients’ health in particular. Because most of these cases go undetected, estimating the scale of this burden is almost impossible. More than 100 deaths from adulterated cough syrup in Panama, 45 children crippled by poorly administered injections in Uganda, and injuries and deaths from heparin overdoses because of label confusion in the United States are but a few examples of recent medicine safety problems.

Many developing countries are now recognizing the need to set up systems to monitor medicine safety and effectiveness—especially for new medicines, such as artemisinin-based combination therapies and antiretrovirals. These countries often lack the resources and expertise to build a pharmacovigilance system from the ground up. Systematically addressing medicine safety has the potential to greatly reduce preventable injuries and deaths.  

MSH works with countries to develop a comprehensive system that encompasses the spectrum of medicine safety—product quality, adverse drug reactions, and medication errors—using a range of monitoring methods. Countries can implement the system in phases as they build capacity and establish necessary resources.

To achieve the objectives of a pharmacovigilance system, the SPS approach follows four steps:

  1. Assess the existing pharmacovigilance system Work with partners to assess the status of pharmacovigilance systems and diagnose the systems’ strengths, weaknesses, and gaps using a pharmacovigilance assessment methodology.
  2. Develop a customized system improvement model Use the results of the assessment and collaborate with stakeholders to identify and analyze options and to develop approaches that are customized to the country’s existing regulatory capacity and priorities, system gaps, and resource availability.
  3. Help implement the interventions identified Work with in-country stakeholders, collaborating partners, and other US Agency for International Development-funded projects to help prioritize and carry out the interventions.
  4. Monitor and evaluate medicine safety activities Provide technical assistance to local partners to develop and implement a monitoring program for their pharmacovigilance systems.

Although designed to be applied in resource-constrained settings, the SPS framework and approach will be useful to all who promote access to and rational use of essential medicines, such as ministries of health, international donors, health care workers, health care policymakers, and others who recognize the need for strong pharmacovigilance systems.