What is drug quality and why is it important?

Poor quality medicines do not meet official standards for strength, quality, purity, packaging, and/or labeling. They may be legally registered innovator or generic products, or they could be counterfeits—deliberately mislabeled for identity, strength, or source. Whether counterfeit or unintentionally substandard, poor quality drugs result in serious health implications including treatment failure, adverse effects, increased morbidity, mortality, development of drug resistance, and wasted resources. Recent reports indicate the availability of substandard and counterfeit drugs has reached a disturbing proportion in many low-income countries.

The quality of pharmaceuticals is a global concern, and the lack of reliable drug quality assurance systems in many developing countries often contributes to the devastation of diseases, particularly those that have built up resistance to traditional first-line medicines. USP DQI presently is working in four continents: Africa, Asia, Europe, and South America to facilitate and strengthen their drug quality systems to improve public health. USP DQI encourages collaborative efforts to meet this goal by providing technical assistance and developing appropriate training programs based on rapid, low-cost, simple testing methods for detecting substandard drugs and monitoring drug quality throughout the supply chain.

Effect of substandard and counterfeit drugs

Review of Drug Quality in Asia with Focus on Anti-Infectives

The volume of poor-quality drugs available in developing countries poses a significant problem for the health sector in trying to provide safe and efficacious medicines. Many substandard products are produced in one country and exported to others, a situation exacerbated by weak laws and enforcement. USP DQI has assembled available data on drug quality in eleven Asian countries due to the increasing resistance that has resulted in increased morbidity and mortality. The Review of Drug Quality in Asia with Focus on Anti-Infectives (1.9MB) examines this issue (and aspects of health systems dealing with drug quality), identifies gaps in information, and recommends areas for potential intervention at global, regional, and national levels.

Recent reports indicate the availability of substandard and counterfeit drugs has reached a disturbing proportion in many low-income countries. To help monitor trends in poor drug quality, USP DQI continually reviews journals, newspapers, research, Internet reports, newsletters, and conference proceedings and quarterly publishes a Matrix (342KB) of drug quality problems reported in over 40 countries globally. The drug quality matrix serves as a tool to increase awareness about the gravity of this problem among healthcare professionals, policy makers, and the general public.

USP DQI activities to improve drug quality

Ensuring the Quality of Medicines in Low-Income Countries: An Operational Guide

USP DQI hopes to assist countries of limited resources advance the quality control of medicines by launching the publication Ensuring the Quality of Medicines in Low-Income Countries: An Operational Guide (197KB). A group of experts from leading organizations, including representatives from WHO, MSH/RPM Plus, PATH, and national drug regulatory agencies, worked together to prepare this comprehensive guideline, covering topics from establishing and implementing regulatory policies to procurement practices to monitoring quality assurance.

One key element to improving drug quality is establishing a drug quality baseline, determining what products are circulating in both the formal and informal markets. Sampling Guidelines (2MB) specifically tailored to enable regional and national health programs to collect data about the quality of medicines using sentinel sites throughout the country or region, assist countries in monitoring the quality of medicines at both the national and sub-national levels. Samples collected are analyzed to determine their quality; the test results are shared among stakeholders, allowing corrective actions to be taken as necessary.