Expanding Access to Quality-Assured, User-Friendly Medicines

On World Patient Safety Day, it’s vital to think about how health outcomes are affected by medicine misuse and poor-quality medicines. The Promoting the Quality of Medicines (PQM) program, which is funded by the U.S. Agency for International Development and implemented by the U.S. Pharmacopeial Convention, has supported improvements in the way health products are regulated, manufactured, distributed, and used in low- and middle-income countries over the past 10 years. The program has continuously devised ways to expand people’s access to quality-assured medicines and reduce the dangers of medicines-related harm.

In 2015, five cases of irreversible blindness among infants were reported in Nigeria due to misuse of chlorhexidine solution (liquid), a low-cost medicine that is applied to umbilical cord stumps to prevent newborn infection. At the time in Nigeria, chlorhexidine was packaged in a white plastic bottle that was similar to eyedrop packaging. Many mothers who were given chlorhexidine as part of a kit for infection prevention after delivery mistakenly applied it to the eyes of their infants. Over time, the World Health Organization (WHO) reported 40 cases of identical incidents worldwide and issued a safety alert in early 2019.

Well before the safety alert, the PQM program contributed to efforts to ensure these mistakes could be eliminated in Nigeria. PQM identified a local manufacturer to produce chlorhexidine in gel form and provided them with technical assistance to meet international quality standards. As a result, a quality-assured gel product was approved by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC) and was used as a replacement for the solution product to prevent future mistakes. Over 4 million doses of chlorhexidine gel have been distributed in Nigeria and other sub-Sharan African countries to protect neonates.

Similarly, PQM supported Bangladesh’s only manufacturer of chlorhexidine solution to change its packaging from using a white bottle cap that could easily be confused for an eyedrop to a purple cap. This packaging was approved by the government and became a requirement for the marketing of the product.

There is equal concern for how health care professionals use medicines and how their practices affect patient safety.  In 2016, after 74% of oxytocin samples collected for a post-marketing surveillance study in Nigeria failed quality tests, PQM conducted a follow-up survey to assess clinical experiences in using the medicine to treat post-partum hemorrhage.  Results showed that health care professionals sometimes increased dosages by 2 to 4 times more than what is recommended by WHO because standard doses of the injection were not effective.

NAFDAC then conducted further investigation of Nigeria’s supply of oxytocin, all of which was being procured from foreign sources. The Agency found that the main contributor to poor-quality oxytocin in county was transport and storage that often broke the cold chain, which is required to maintain the medicine’s efficacy. NAFDAC subsequently imposed cold chain requirements on local companies distributing oxytocin and committed to increasing collaboration with the national customs service to ensure cold chain pharmaceutical products would be fast-tracked during port clearance. For its part, the PQM program provided technical assistance to a local manufacturer to bring to market the first oxytocin injection made in West Africa. With PQM’s further support, the manufacturer also strengthened its own cold chain capacity.

Lessons learned from addressing patient safety issues are key to strengthening quality assurance systems for medicines regulation and manufacturing. Continued investment by local and international stakeholders in medicines quality assurance activities increases confidence in health systems, reduces medicines-related harm, and advances patient safety objectives worldwide.