Protecting Patients from Bad Drugs: A Risk-Based approach to medicines quality surveillance (Part 1)

Although quality-assured medicines are fundamental to reaching global health goals, many low- and middle-income countries lack robust regulatory systems and programs to monitor the quality of medicines due to limited local resources and capacity, and competing priorities. Poor-quality medicines can cause treatment failure and adverse reactions, increase morbidity and mortality, and contribute to the development of drug resistance. They also waste resources that could otherwise be used to benefit public health. Designing and implementing programs that monitor medicines quality, also known as post-marketing surveillance, through a risk-based approach allows countries to tailor activities according to local needs, optimize limited resources, and focus efforts on areas that present the greatest risks to public health.