The Liberia Medicines and Health Products Regulatory Authority (LMHRA) with support from the United States Pharmacopeia & Promoting the Quality of Medicines Plus (USP PQM+) Liberia’s Program, has released results from a recently-conducted Risk-based Post-Marketing Surveillance (PMS) Round-one Sample Collection, Mini-lab, and Confirmatory Testing Report at the Cape Hotel in Monrovia.
Presenting the Risk-based PMS Round-one Sample Collection, Mini-lab, and Confirmatory Testing Report, LMHRA Director of Inspection and Post Market Surveillance, Pharmacist Teedoh Beyslow, noted that the objective of the exercise was to determine the prevalence of substandard and falsified Child Health and antimalarial medicines in circulation at selected health facilities in the randomly selected counties and outlets of the country, based on risk level prioritization; determination of the registration status of the antimalarial and Maternal Neo-natal Child Health (MNCH) medicines sampled; provide data on the quality of the antimalarial and MNCH medicines selected using a risk-based approach by the LMHRA for regulatory/administrative measures of intervention, and to make informed recommendations to address issues of medicine quality and related supply chain problems identified through the surveillance.
According to him, the LMHRA, in collaboration with the Technical Working Group used the Risk-Based Post Marketing Surveillance (RB-PMS) approach, to conduct sampling, using an established risk-based protocol; thus using the Medicine Risk Surveillance (MedRS) tool developed by the Promoting of Quality Medicines Plus (PQM+). The antimalarial and MNCH products were sampled in five of the 15 counties of Liberia, including Lofa, Nimba, Grand Gedeh, Sinoe, and Gbarpolu.
The Inspector-General of LMHRA further noted that the methodology used during the sampling took into consideration, testing of samples performed by established guidelines for Implementing Risk-based Post-Marketing Quality Surveillance in Liberia.
He said a total of 303 that is (100%) samples were screened via visual inspection (level 1); through the mini-lab (level 2); and the Compendia methods (level 3). Hence, at the time of confirmatory testing, four of the samples had expired, while another sample was observed to be limited in quantity.
Pharmacist Beyslow said level one and two screenings were performed by the LMHRA Quality Control Laboratory in Liberia, while level three testing was done at USP-Ghana Lab in Ghana.
Accordingly, Pharmacist Beyslow added that a total of 87 (29%) samples failed that round of PMS. Further, it was observed that 50 (57%) samples failed during the level one screening because they were not registered with the LMHRA. He also noted that it was also observed that 43% (37) samples failed either mini-lab (level 2) or confirmatory testing by assay or dissolution analysis (level 2). 16% of the samples collected were Government of Liberia or partners who procured medicines found in private medical stores. While 46 of the failed samples were antimalarial, 41 of the failed samples were MNCH medicines.
He said a total of 77 (89%) failed samples were collected from the private sector in the five counties, while 10 (11%) of the failed samples were collected from the public sector in Sinoe, Lofa, and Grand Gedeh. Nimba and Grand Gedeh, recorded a high number of failed samples, 10%, and 9%, respectively.
The LMHRA Inspector-General asserted that findings from that round of risk-based PMS estimate that one in every three antimalarial or MNCH medicines circulating in Liberia is unregistered, substandard, or falsified. The report also concluded that in Liberia, the majority of Government and donor procured medical products enter the pharmaceutical supply chain without being fully registered. However, the LMHRA Act requires that all medicines be registered before being used in Liberia. The inability of partners to register public sector medicines is creating a challenge to medicines regulation in Liberia.
Making official remarks at the day-long workshop, Liberia’s Chief Medicines Regulator and Managing Director of the Liberia Medicines and Health Products Regulatory Authority (LMHRA), Pharmacist Keturah C. Smith-Chineh, underscored the need for the urgent renovation of Liberia’s drug depots to ensure the safety of the medicines.
Pharmacist Smith-Chineh made the remarks at a one-day Risk-based Post-Marketing Surveillance (PMS) Round-one Sample Collection, Mini-lab, and Confirmatory Testing Report; held
According to her, as part of the PMS process, the LMHRA usually carried on unannounced inspections in Montserrado and the various counties to ascertain how medicines are stored. However, she noted that as per inspections carried out, the storage facilities of medicines in the leeward counties are ‘heartbreaking and frustrating.’
“Even at some public storage facilities where pharmaceuticals are kept, the storage conditions aren’t conducive, so the LMHRA is encouraging collaboration with these health facilities to see how we can improve the storage of our medicines in the various counties,” Managing Director Smith-Chineh emphasized.
She continued: “Because if these medicines are not stored properly; it’s not that they wouldn’t come with high quality, but gradually, their stability starts to drop, so we are encouraging pharmacists to try to reorganize their warehouses or put out a concept note to the Ministry of Health as to how we can improve our storage facilities for these medicines.”
The LMHRA boss also noted that as a way to get rid of drug peddling, the authority has produced and aired several jingles in Monrovia and the leeward counties and as well gone after these drug peddlers.
The Liberia Medicines and Health Products Regulatory Authority (LMHRA) is an autonomous agency of the Government of Liberia established by an Act of Legislature with the mandate to ensure the safety, efficacy, and quality of medicines & health products circulating the commerce of Liberia.
The authority’s mandate area is to ensure: marketing authorization for new products and variation of existing authorizations; Quality control laboratory testing; Adverse drug reaction monitoring; Provision of drug information and promotion of rational drug use; Good Manufacturing Practice (GMP) inspections and licensing of manufacturers, wholesalers, and other distribution channels; Enforcement operations; Post Market Surveillance of medicines and health products.
Remarking also during the launch of the PMS report, the Director of United States Pharmacopeia-Ghana & Promoting the Quality of Medicines Plus (PQM+) Program – USP Ghana, Kwasi Boateng, said PQM+ has been working in Liberia over the last 12 years. He said the program was awarded in 2019, and Liberia continues to be a beneficiary.
According to him, with the level of work being done by the LMHRA, USP PQM+ support to the authority will continue. Director Boateng further disclosed that as of next month, PQM+ will be officially opening its office in Liberia.
Boateng asserted that the PQM+ Liberia program focuses on four program activities, which are improving the confidence of medical products quality assurance, improving the regulatory system, increasing the supply of quality-assured medicines, and advancing global quality medicines assurance.
The Promoting the Quality of Medicines Plus (PQM+) program improves access to quality-assured priority medicines and addresses the proliferation of poor-quality medical products in low- and middle-income countries. Funded by the U.S. Agency for International Development, PQM+ strengthens medical product quality assurance systems in low- and middle-income countries through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improve maternal, newborn, and child health.
Making remarks also, the Representative of USAID and former Deputy Health Minister for Program, Planning, and Policy, Dr. Yah Zolia, welcomed the efforts of the LMHRA and further called for more collaboration with all those in the pharmaceutical sector.
She promised more USAID support to the LMHRA through a host of activities they are implementing with USP PQM+.