Strengthening Quality Assurance Systems for Medical Products

A girl holds up medication. Photo credit- iStock.

USAID and many other donors are making concerted efforts to prevent child and maternal deaths, control the HIV/AIDS epidemic, combat infectious diseases, and expand health coverage schemes. The availability of medical products that are safe, effective, and of assured quality underpins these efforts and is essential to strengthening health systems and improving health globally. However, the persistent and growing availability of poor-quality medical products undermines these efforts, presents major health and financial risks for patients, and erodes trust in health systems and governments.

This course provides an overview of essential aspects of medical product quality assurance, reviews common challenges in low- and middle-income countries, and discusses key interventions and approaches that can help improve the quality of medical products. The course also presents several lessons learned and recommendations from implementation experience to increase knowledge, awareness, and effective discourse across the diverse set of stakeholders working in this arena and related areas.

Objective

By the end of the course, learners will be able to:

  • Describe how major global health efforts, including USAID’s Vision of Health System Strengthening (HSS), rely on the quality of medical products 
  • Define key concepts related to medicines quality 
  • Explain the dangers posed by poor-quality medicines and understand the scope and magnitude of the problem 
  • Explain the challenges confronting low- and middle-income countries in assuring the quality of medical products 
  • Identify the basic elements of medicines quality assurance systems and the functions of national medicines regulatory authorities 
  • Understand how donors assure the quality of procured medicines 
  • List tools and approaches to strengthen medicines quality assurance systems and ensure the quality of medical products 
  • Describe how USAID investments have contributed to medicines quality assurance and the availability of quality-assured products 
  • Discuss lessons learned in strengthening medicines quality assurance systems and identify areas of focus for future investments 

 

Target Audience

This course is intended as an introductory offering for global health professionals including donors, implementing partners, government officials, and academics and researchers. Many diverse groups require a basic understanding of medicine quality assurance systems which are inherently complex and multifaceted. 

Credits

The course authors extend their deepest appreciation and gratitude to the many individuals who provided input, contributions, and review of this course.

Contributors:

  • PQM staff: Mustapha Hajjou, Gabriel Kaddu, Farouk Umaru, Steven Kimatu, Chinwe Owunna, Lawrence Evans, Laura Krech (consultant), Jude Nwokike

Reviewers:

  • USAID:
    • Allison Collins, Health Systems Advisor, Office of Health Systems
    • Elisabeth Ludeman, Senior Pharmaceutical Management Advisor, Office of Health Systems
    • Tobey Busch, Senior Pharmaceutical Management Advisor, Office of Health Systems
    • Helen Petach, Senior MCH Science Advisor, Office of Maternal and Child Health and Nutrition
  • Elizabeth Pisani, Associate Professor, Erasmus School of Health Policy and Management, Rotterdam