When medicines used to save the lives of expectant mothers are not available or of poor quality, the results can be tragic. Hypertensive disorders and hemorrhage cause the most (40 percent) deaths among expectant mothers living in low- and middle-income countries (LMICs).1 Yet preventable deaths occur because the medicines used to treat these life-threatening conditions are often not available or of poor quality in these regions.
Multiple factors can contribute to ineffective or even dangerous poor-quality medicines, including falsification, deficient manufacturing practices, or improper handling and storage. Nearly 75 percent of samples of a medicine used to treat hemorrhage during childbirth—injectable oxytocin—collected throughout Nigeria in May 2016 failed quality testing, most likely due to “degradation as a result of improper storage as well as poor manufacturing practices.”2 Oxytocin has a particularly fragile chemical structure and must be kept at 2°C–8°C under temperature-controlled conditions, or “cold chain.”
Shortages of magnesium sulfate, a medicine used for maternal hypertensive disorders, prevent timely treatment and can lead to unnecessary maternal deaths.3
Manufacturers in LMICs sometimes need support from technical experts to produce quality-assured essential medicines and reduce the risk of degradation during distribution. The Promoting the Quality of Medicines (PQM) program, funded by the U.S. Agency for International Development (USAID) and implemented by USP, helps local manufacturers strengthen their quality systems to comply with good manufacturing practices (GMPs).
While these activities can help save lives, building this capacity requires significant investments and may yield limited financial gain for local manufacturers in LMICs. A Nigerian manufacturer rose to this challenge. With significant investments on its part and technical support from PQM, the manufacturer recently earned approval from Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) for quality-assured magnesium sulfate and oxytocin injections. Soon, increased availability of quality-assured oxytocin and magnesium sulfate in Nigeria may save thousands of lives.
Complementing its support of in-country manufacturers, PQM works with local partners to build stronger medicines quality assurance systems. In Nigeria, PQM collaborated with the Federal Ministry of Health by supporting the development of the country’s first documented Quality Assurance Policy. Adopted by the National Council on Health, this policy includes quality assurance and quality control considerations throughout Nigeria’s pharmaceutical supply chain. PQM also assists NAFDAC with improving medicines quality systems by enhancing the technical skills of personnel at Nigeria’s national quality control laboratories (NQCLs), which helps NAFDAC approve quality-assured medicines and detect poor-quality ones like degraded oxytocin. As a result of PQM’s support, three NQCLs—located in Yaba, Agulu, and Kaduna—attained compliance with international standards and are now ISO 17025:2005 accredited, which attests to their capacity to deliver accurate test results.
This year, NAFDAC and PQM will put even greater emphasis on improving post-marketing surveillance to ensure timely detection of poor-quality medicines and appropriate regulatory actions, including the removal of poor-quality products from the market. Local manufacturers will continue receiving PQM’s technical assistance to strengthen their capacity to produce quality-assured priority medicines. PQM expects that by the end of September 2018, several of the local manufacturers it is working with will obtain NAFDAC approval for medicines used to prevent and treat malaria, childhood pneumonia, and diarrhea. In previous years, PQM provided support to manufacturers of chlorhexidine, which subsequently received NAFDAC approval for the prevention and treatment of umbilical cord infections. Through its continuous support to manufacturers, PQM is helping to save the lives of women and children in Nigeria and other LMICs.
All listed references were accessed on February 16, 2018.