A recent study conducted by the Promoting the Quality of Medicines (PQM) program found that poor quality medicines are a public health threat to patients around the world. In Kenya, the Ministry of Health is intensifying its efforts to ensure patient safety by improving medicines quality.
A key component of any strategy for combating the public health threat posed by falsified and substandard medicines in developing countries, including Kenya, is to focus on establishing new or strengthening existing medicines quality management systems.
Access to quality, safe and effective medicines is the cornerstone of any public health program and it requires an effective management system to ensure their quality. Thus, a big part of tackling Kenya’s problem involves increasing the capacity of its Ministry of Health’s National Quality Control Laboratory (NQCL) to ensure that the medicines available to the public are safe and of good quality.
But building a lab to world-class standards is a laborious process that carries a steep price tag. And like other developing countries in Africa that lack adequate resources, equipment and trained staff, for Kenya’s NQCL, this was a huge obstacle.
Moving Towards Sustainability
In a relatively short time, with relentless effort and dedication, and the support of the United States Agency for International Development (USAID), Kenya’s NQCL has marked several important milestones in the fight against poor quality medicines.
Recently, it announced that it has attained a top international accreditation, multi-million dollar laboratory equipment for testing the quality of medicines, a new laboratory information management system, and an upgraded website.
The new equipment will drastically improve the laboratory’s quality control testing times, accuracy and reduce contamination and the need for retesting, especially when conducting sterility testing. The NQCL also received quality certification from the International Organization for Standardization (ISO), called ISO 17025, which enables the lab’s results to be trusted by the international community.
Path to Improvement
Promoting the Quality of Medicines (PQM), a program supported by USAID and implemented by the United States Pharmacopeial Convention (USP), began providing technical support to the NQCL to help prepare it to achieve accreditation. Based on an initial assessment of the NQCL’s deficiencies, PQM prepared a corrective action plan to remedy the noted deficiencies and strengthen existing technical capacity.
PQM partnered with the NQCL to implement this plan, which ultimately aimed to help improve the laboratory’s processes and systems. The first part of that plan – earning accreditation from the South African National Accreditation System (SANAS) – was accomplished in just 10 months.
Working with another USAID-supported program, NQCL secured a multi-million dollar multi-glove microbiology isolator, only the second such laboratory equipment in Africa. It also launched an electronic laboratory information management system and upgraded its website.
Isolators are used to produce and test sterile drug products with a minimized risk of microbiological contamination from the surrounding environment. Donated to the lab by KenyaPharma, a USAID-supported program implemented by Chemonics, this equipment will provide a tremendous boost to the NQCL’s overall performance and capabilities.
PQM scientists are currently working with the NQCL’s staff to help increase their capacity to correctly test medicines samples using the newly acquired equipment and teach them how to interpret, apply and respond to (appropriately disseminate) the test results. They are also providing training to the staff on how to routinely maintain the laboratory equipment.
These milestones put Kenya’s NQCL on a par with only a very few other internationally accredited laboratories in Africa. It now has the capability of producing test results that are acceptable at different regional, national and international governmental and regulatory institutions.
Having attained both ISO accreditation and World Health Organization (WHO) prequalification status, Kenya’s NQCL can also now serve as a reference for pharmaceutical manufacturers in the region that are seeking to supply bulk medicines to procurement agencies but must first obtain WHO product prequalification to ensure that their products meet acceptable standards of quality, safety and efficacy.
PQM plans to continue to provide technical support to the NQCL and other divisions of Kenya’s Ministry of Health to help it build the nation’s capacity for the sustainable manufacturing and monitoring of quality medicines.
This expanded public health safety net is particularly needed as the Kenyan government intensifies its fight against falsified and substandard medicines.
The author, Donnell Charles, Ph.D., manages PQM’s quality management services in countries around the globe. You can contact him at email@example.com (link sends e-mail).
Learn more about PQM’s work in Africa