Monitoring the quality of medicines in circulation is the responsibility of every country toward securing its supply chain and ensuring patients are safe from poor-quality products. This critical regulatory quality assurance function can only be achieved when a country has a well-staffed and adequately equipped laboratory that is recognized as following international standards of quality.
Funded by the U.S. Agency for International Development (USAID) and implemented by the U.S. Pharmacopeial Convention (USP), the Promoting the Quality of Medicines (PQM) program provides technical and material support to national quality control laboratories (NQCLs) and regulatory authorities to strengthen their ability to ensure that only quality-assured medicines reach patients and that those of poor quality are promptly taken off the market.
Traditional laboratory training approaches follow a one-to-one, or mentorship modeling, method. Using this approach, staff in a given laboratory are trained by foreign experts who provide short-term, in-country technical assistance. However, due to attrition and a lack of sustained local support, this model often prevents countries from effectively achieving scale.
PQM has piloted an innovative approach to laboratory-strengthening activities and is now using it widely after strong results were observed. Adopting a Collaborative Learning Model, PQM first gathers staff from multiple laboratories within each country and provides consolidated trainings to them. This ensures that the material delivered is consistent, reduces costs typically incurred from decentralized training operations, and promotes country ownership and collaboration among laboratory staff. In addition, if one laboratory experiences a high rate of attrition, new staff can be mentored by previously trained, tenured colleagues from neighboring laboratories, rather than relying on foreign assistance again.
PQM’s Collaborative Learning Model allows for standardized, sustainable learning and encourages collaboration among country laboratories.
In Nigeria, the Collaborative Learning Model was applied to trainings for two laboratories, Agulu and Kaduna. Performed at the Agulu laboratory, the Kaduna team was able to transfer lessons learned back to their laboratory.
In Burma, the most advanced laboratory, Nay Pyi Taw, was the first to receive PQM’s technical assistance beginning in 2015. Thereafter, two other laboratories, Mandalay and Yangon, sent their technical staff to Nay Pyi Taw to leverage existing expertise and build capacity and knowledge sharing across the three laboratories simultaneously.
In Kazakhstan, PQM performed initial assessments of three NQCLs in Karaganda, Pavlodar, and Kostanay to assess their compliance with World Health Organization prequalification requirements. Staff from all three laboratories attended each laboratory assessment in order to learn from each other’s experience and facilitate consistent progress across the three sites.