Strengthening quality assurance systems for antimalarials in Nigeria

As the leading cause of death in Nigeria—with 61 million cases and 110,000 deaths in 2015—malaria is a major focus of public health programs in the country. Everyone in Nigeria is at risk of contracting the disease, and each year one-third of the population is diagnosed1. Preventing and treating malaria is essential for Nigeria’s future.

Yet medicines in low- and middle-income countries (LMICs) can be of poor quality, meaning they do not work as expected. In Nigeria, more than 40 percent of medicines were identified as falsified in 2001. While the number dropped to 15.7 percent in 2005, it rose to 64 percent in 20082. Malaria medicines are at a particular risk of being substandard3. A recent study found that 9.2 percent of sampled antimalarialscollected from a Nigerian city were of poor quality4. Detecting poor-quality antimalarials and removing them from the market, as well as increasing the availability of quality-assured antimalarials, is critical to fight the epidemic.

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Hon. Dr. Osagie Ehanire, Mrs. Yetunde Oni and Ms. Erin Holleran unveil the Kaduna Lab ISO 17025:2005 certificate.

The Promoting the Quality of Medicines (PQM) program, funded by the U.S. Agency for International Development (USAID) and implemented by USP, strengthens systems, structures, and processes that promote quality antimalarial medicines in LMICs. With support from the President’s Malaria Initiative (PMI), PQM collaborates with Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and local manufacturers to improve the quality of medicines used to treat malaria in Nigeria.

Since building effective systems is a long-term effort, PQM works with regulators and manufacturers on laying the foundations essential to sustain medicines quality. In Nigeria, PQM helps regulators improve their technical skills and strengthen laboratory capacity so they can survey and test medicines in their own market. To improve the reliable availability of medicines closer to patients, manufacturers in Nigeria work with PQM to enhance their capability to produce antimalarial medicines according to international standards. In addition, PQM supports regulatory agencies in adopting expedited approval processes for medicines, which then help antimalarial manufacturers that meet medicines quality standards bring them to market faster.

Nigeria has made noteworthy progress in building capacity:

  • While survey findings fluctuate depending on the location and timing of sampling, the percentage of poor-quality antimalarials found in surveys conducted by NAFDAC in 2017 was 1.6 percent, compared to 20 percent in 2012.
  • In May 2017, the NAFDAC lab in Kaduna was the third to attain ISO 17025:2005 accreditation, verifying its ability to deliver accurate test results and operate according to international standards, along with labs in Yaba and Agulu.
  • In 2017,NAFDAC and PQM developed over 100 Standard Operating Procedures now used in 3 NAFDAC labs.
  • NAFDAC staff participated in 4 PQM trainings over the course of a year in 2016–2017 on sample collection and key testing techniques, helping to build their capacity to assess the quality of medicines already on the market. 
  • With help from PQM, 4 Nigerian manufacturers are working to improve their ability to produce quality-assured sulfadoxine–pyrimethamine and artemisinin-based combination therapies (ACTs), medicines in the WHO guidelines for the prevention and treatment of malaria.
  • NAFDAC, with PQM support, is currently improving its registration system and processes required for manufacturers to market antimalarial products in Nigeria.

With guidance from PQM’s experts, four manufacturers operating in Nigeria are working to improve their ability to produce quality-assured sulfadoxine–pyrimethamine and artemisinin-based combination therapies (ACTs), medicines in the WHO guidelines for the prevention and treatment of malaria.

NAFDAC, with PQM support, is currently improving its registration system and processes required for manufacturers to market antimalarial products in Nigeria.

“The PQM program has supported NAFDAC to conduct surveys on quality medicines to generate reliable data and take regulatory actions required to protect public health and improve quality of life.”
Yetunde Oni, former Acting Director General of NAFDAC

Along with these activities, Nigeria’s commitment to improving medicines quality assurance systems is making a real difference. With support from PMI, the PQM program collaborated with Nigerian authorities to strengthen quality assurance systems to protect their population from poor-quality antimalarial medicines.
 

1. http://www.who.int/malaria/publications/country-profiles/profile_nga_en....
2.https://www.vanguardngr.com/2011/07/nigeria-leads-in-fight-against-fake-...
3.https://doi.org/10.1186/s12936-016-1357-8
4.http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0125577...

 

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