Poor quality medicines are the source of an alarming, but often overlooked global health crisis. A report from the International Policy Network estimates that 700,000 people die every year from fake anti-malarial and tuberculosis drugs alone.
The scourge of illegal medicines is especially problematic in developing countries. Tackling the problem is difficult, because it requires systemic change – strengthening regulatory environments as well as local pharmaceutical and healthcare industries. But for anyone who has lost a loved one because of poor quality medicine, the stakes could not be higher.
The good news is that many countries are taking concrete steps to turn back the tide, and USP is there to help. Since 1992, USP has worked cooperatively with the United States Agency for International Development (USAID) in the “Promoting the Quality of Medicines” (PQM) program to help developing countries address critical issues related to poor quality medicines and their appropriate use.
One approach PQM has employed is to help national quality control laboratories operate with good laboratory practices to meet internationally recognized standards of proficiency. Last week, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) Central Drug Control Laboratory (CDCL) Yaba, Lagos became the 3rd national quality control lab in Africa to achieve ISO 17025 accreditation with support from PQM. National Quality Labs in Ghana and Ethiopia were the other two. The accreditation of the laboratory in Nigeria is particularly important, because Lagos is a primary port of entry for medicines, not just for Nigeria, but also for all of West Africa.
“Pharmaceutical services is one of the pillars of the health care industry in Nigeria,” explained Dr. Paul Orhii, Director General of NAFDAC. “The ISO accreditation will support not only Nigeria’s own pharmaceutical industry, 80% of which are located in or around the commercial capital Lagos, it will help monitor the quality of imported products and help ensure that only safe, quality medicines are distributed to its nearly 170 million citizens. Plus, as an internationally accredited quality lab, NAFDAC CDCL can contribute to the quality of medicines in the entire region by serving as a reference laboratory for pharmaceutical manufacturers seeking WHO product prequalification.”
To further strengthen the quality of medicine and tighten the public health safety net throughout the continent, USP helps facilitate and promote coordination among a network of official medicine control laboratories (NOMCoL). In Africa, participants in the NOMCoL program include labs in Ethiopia, Ghana, Kenya, Liberia, Mali, Mozambique, Nigeria, Senegal, Sierra Leone, Tanzania, Zambia, Zimbabwe, Burundi, Botswana, Cote d’Ivoire and Uganda.
To ensure that laboratories with limited resources do not rely on outdated, secondary, or inadequately documented standards which may compromise quality control testing or lead to questionable analytical results, USP’s Technical Assistance Program (TAP) offers resources such as: a comprehensive package of primary Reference Standards selected from USP’s catalog, documentary standards, and analytical data to test medicines. Currently, 25 countries in Africa participate in the TAP program.
But labs require more than just good methods and good resources – they need technically trained staff. So, to promote sustainability and strengthen pharmaceutical testing capabilities both within the national quality labs and beyond, USP’s Center for Pharmaceutical Advancement and Training (CePAT) facility in Ghana provides technical training for national and local regulatory authorities and officers; quality assurance and quality control professionals; manufacturers and others in the pharmaceutical industry. To date, CePAT has trained nearly 200 technicians representing 19 countries throughout Africa.
And knowing that despite improved surveillance, poor quality medicines may still enter the drug supply, especially via illicit markets in remote areas, USP’s PQM program helps countries strengthen and expand their postmarketing surveillance by establishing a Medicines Quality Monitoring Program (MQM) which uses the Global Pharma Health Fund (GPHF) Mini-labs®. The Minilabs® serves as portable, inexpensive testing kits that inspectors can use out in the field to rapidly screen for counterfeit medicines before they are sent to quality labs for comprehensive verification of results utilizing pharmacopeial methods. Together, each program builds capacity for medicines regulatory control and represents a tightening of a knot in the wider public health safety net in Africa.
This article marks the celebration of African Heritage and Health Week. If you enjoyed reading it, you might also enjoy a similar article discussing how women scientists are helping to shape Africa's pharmaceutical landscape.