The Liberia Medicines & Health Products Regulatory Authority (LMHRA) and several stakeholders of the LMHRA have held a one-day meeting aimed at brainstorming on strategy and galvanizing resources to build an Internationally Certified Quality Control Laboratory (QCL) to ensure the general public have access to safe, effective and quality medicines.
Addressing the LMHRA stakeholders’ meeting with several counterparts in Monrovia, LMHRA’s Managing Director, Pharmacist Keturah Smith noted that if citizens and inhabitants of the country must have optimal health outcome, there is a need for the QCL of the authority to be internationally accepted and accredited by the International Organization for Standardization (ISO).
The meeting was held at the Mamba Point Hotel under the theme: “Our Vision for Ensuring the Quality of Medicines & Health Products-the Quality Control Laboratory in Perspective.”
Managing Director Smith said the meeting was called to ensure that the LMHRA and its partners brainstorm on ways and means that seek to improve the laboratory and the services the LMHRA provides.
“Therefore, LMHRA envisages a modern, state-of-the-art laboratory facility that is internationally accepted and accredited by the International Organization for Standardization (ISO 17025:2017),” Pharmacist Smith emphasized.
According to her, some of the challenges of the entity include the country’s porous borders, recruitment retention of certain technical staff (ex. Biotechnologists) as well as the proliferation of substandard and falsified medicines and health products through the pharmaceutical supply chain.
She also outlined the lack of limited supply of reagents to the lab, the lack of inspectors at various border points, as well as logistics.
MD Smith pointed out that the QCL cannot achieve optimal quality testing if it is still operating in a small space and at a low scale, as several testing equipment are down or need recalibration.
Therefore, Pharmacist Smith expressed the need to ensuring that there is a need for robust monitoring of medicines quality at all levels of the supply chain as well as the improvement of quality assurance (QA) & Quality Control (QC) activities through a quality control laboratory that provides reliable testing of all medicines and health products.
In 2010, the LMHRA Act was passed by the Legislature and approved by the President of Liberia seeking to ensure that the law provides for quality assurance through laboratory testing. Hence, a 3-year strategic plan was developed in 2013 providing for a 4-unit (physio-chemical, medical device, microbiology and cosmetics) QC laboratory.
However, the LMHRA boss lamented that up to 2011, the QC Lab operated at a very low capacity with only a maximum of 3 staff performing basic analysis of medicines via minilab, thin-layer chromatography and color reaction. Currently, the laboratory operates with twenty-two (22) staff.
Throughout the years from 2011 up to 2017, before the lab was gutted by fire, Pharmacist Smith noted that there was a progressive movement toward accreditation, increment of work force, initiation of quality management system, enhancing staff capacity through training, expansion of testing scope with the use of advanced analytical equipment such as HPLC, UV Spectrophotometer, Dissolution tester, Disintegration tester with support from the United States of America International Development (USAID) through the program Promoting Quality of Medicines (PQM) and implemented by United States Pharmacopoeia (USP). Support was also provided by the West African Health Organization (WAHO), Global Fund and the Government of Liberia.
However, she revealed that another noteworthy achievement of the LMHRA was the acquisition of 4 acres of land in King’s Farm, Careysburg, on the Monrovia–Kakata Highway that a temporary lab facility is being built and currently nearing completion and poised to relocate the Lab in October next year.
The LMHRA Boss maintained that some of the challenges in running an effective QC Lab include: recruitment and retention of qualified staff; capacity building; constant supply of electricity and clean running water; laboratory infrastructure – adequate space; laboratory commodities (equipment and their accessories, glass wares, consumables such as chemicals & reagents, reference materials including reference books, reference standards and calibration kits).
Accordingly, she pointed out that the LMHRA’s strategy is to utilize the demonstrated opportunities which have been provided by major stakeholders to include. Additionally, she stated that, the political commitment to support medicines regulation has been demonstrated by the enactment of the LMHRA 2010 Act and the budgetary support of the Government of Liberia. Moreover, Pharmacist Smith said, the willingness of development partners to collaborate with LMHRA in minimizing the challenges LMHRA is faced with, if not eliminating them. These, which include, an internationally certified and fully equipped functioning QC lab, logistics (mainly vehicles, amongst others) for inspection and Post Market Surveillance (PMS), trainings, recruitment and retention of staff, etc.
Pharmacist Smith further maintained that in order to provide expanded service delivery, reduce the negative economic and social impact of paying for substandard and falsified medications for the treatment of diseases, stakeholders’ collaboration and support could not be over emphasized so as to and improve medicines safety, quality and proper information dissemination.
She noted that if, the LMHRA QC laboratory is WHO-prequalified or ISO 17025-accredited, and then it can be used to perform QC testing of grant-funded products and increased confidence in the quality of work performed by LMHRA QC Laboratory.
Stakeholders at the one-day event however lauded the Authority for the meeting as well as the tremendous works ongoing at the institution. Some of the stakeholders who attended the meeting were representatives of: WHO, the Global Fund, Chinese Medical Team, United Nations Industrial Development Organization (UNIDO), USP/PQM+, Supply Chain Management Unit of the Ministry of Health (SCMU-MOH), MSF France, and USAID.
Meanwhile, the stakeholders have proffered several significant recommendations (key action points) to the authority, which Managing Director Smith and team are taking under due consideration and working towards, aimed at ensuring the country has a quality-control, as well as, quality-assured medicines and health products.