LMHRA, USP-PQM+ Set-up Post-Marketing Surveillance Technical Working Group For Liberia

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In bid to sustainably strengthen pharmaceuticals and medical product quality assurance systems in Liberia, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) in collaboration with the United States Pharmacopeia Convention (USP), Promoting the Quality of Medicines Plus, on December 18, 2020, established a Post Market Surveillance Technical Working Group (PMS-TWG) for Liberia.

The goal of the PMS-TWG is to ensure the coordination of the relevant stakeholders in the building of PMS systems and periodic planning of PMS activities to assure the quality of medical products in the country.

The PMS-TWG seeks to ensure the building of a robust risk-based post-market surveillance systems for medicines that are found on the Liberian market.

Addressing the official opening of the one-day PMS-TWG Stakeholders’ meeting held at the Mamba Point Hotel in Monrovia; LMHRA Managing Director, Pharmacist Keturah Smith, lauded the participants for gracing such auspicious occasion.

She informed the gathering that with the setting up of the PMS-TWG, it will ensure that there is strategies and approaches to ensure substandard and counterfeit medicines are minimized on the market.

According to her, in this age and time, individuals should not be dying because of the proliferation of fake, substandard and falsified medicines and health products.

So with the establishment of the PMS-TWG, Managing Director Smith indicated that the LMHRA looks forward to a successful collaboration with the TWG to ensure substandard and falsified medicines are raided of the Liberian society.

She encouraged every well-meaning Liberian to be on the alert by reporting those in the habit of infesting the market with substandard and falsified medicines in the country.

Making two virtual presentations, the Director of USP-Ghana, Kwasi Poku Boateng, indicated that Promoting the Quality of Medicines Plus (PQM+) Program is a five-year cooperative agreement between USAID and the U.S. Pharmacopeia Convention (USP) to sustainably strengthen medical product quality assurance systems in low-and middle-income countries.

He further stressed that the program is geared to improving medical product quality through systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system.

According to Director Boateng, by sharing scientific expertise and providing technical support and leadership, PQM+ is helping to create a resilient and robust local health systems that addresses diseases such as HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as improve maternal, newborn, and child health.

Director Boateng recalled that in 2010, with technical support from the predecessor promoting the Quality of Medicines (PQM) Program, the Government of Liberia established the Liberia Medicines and Health Products Regulatory Authority (LMHRA) through an Act of Legislation.

He said from 2013 to 2019, PQM helped NMCP and LMHRA conduct six rounds of monitoring of the quality of antimalarial medicines where (over 600 antimalarial medicines samples were collected and tested).

Boateng further disclosed that building on the work conducted under PQM+, USP-Liberia will work with the LMHRA and other stakeholders to adopt a risk-based sustainable approach to post-marketing surveillance.

According to him, his institution in consonance with the LMHRA, will ensure an effective, risk-based PMS programs that will optimize the use of resources and promote sustainability so that post market surveillance is integrated and implemented as a core regulatory function.

Quoting Dr. Vladimir Lepakhin: Director Boateng noted that:“Dying from a disease is sometimes unavoidable, but dying from a medicine is unacceptable.”

The Director of USP-Ghana also recalled that in September 2019, the USAID/Liberia Mission invited the PQM+ program to engage in efforts to strengthen Liberia’s medicine quality assurance systems which led to a scoping visit by members of the PQM+ leadership team in December 2019 to understand the current state of medicine quality assurance systems and mission priorities.  Based on the findings of a scoping visit, Boateng asserted that the following where undertaken: a rapid assessment of pharmaceutical market to identify threats to quality-assured medicines in Liberia; an analysis of select LMHRA functions and fees; an in-depth assessment of laboratory needs to allow basic functionality and developed a plan for specific activities to be implemented.

Accordingly, Boateng said moving from a sporadic medicines quality monitoring activities toward robust risk-based-PMS programs is critical for a country to ensure the quality of medicines and medical products.

He also maintained that effective risk-based PMS programs will also optimize the use of resources and as well support countries in transitioning from donor-supported surveys to locally funded and sustainable PMS programs that are integrated and implemented as a core regulatory function.

In order to achieve these initiatives, Director Boateng outlined the need for regulatory agencies to have the legal mandate and scope to perform PMS; have sound PMS governance structure, which is independent, accountable, transparent, responsive, and equitable; ensure financial resources allocated to implement effective PMS program; recruit/utilize personnel with requisite training and expertise to undertake PMS activities; plan and coordinate PMS activities with relevant stakeholders, and develop an implementation plan with clearly defined roles and responsibilities and as well conduct a risk-based sampling methods for areas and medicines that are most vulnerable and represent the greatest risk to public health

The PMS-TWG will provide technical inputs, develop guidance documents and protocols for PMS activities in Liberia; determine priorities and sampling plans for annual PMS rounds; develop and disseminate PMS reports in a timely and coordinated manner; monitor regulatory actions taken as a results of PMS findings; monitor progress on implementation of PMS activities in Liberia; advocate for funding for annual PMS activities and provide quality-related recommendations to the Procurement Division of the Ministry of Health.

Members of the newly established PMS-TWG include: the LMHRA as Head of Secretariat;  Health Programs; the Ministry of Health (MoH) Disease Control Programs (NACP, NMCP, NLTP, EPI, County referral Hospital, CHT, SCMU etc.); Central Medicine Store (CMS); Global Fund, (GF)and World Health Organization (WHO), UNICEF, UNFPA, UNDP, USAID, PQM+;  and the Liberia National Police.

Others organizations also forming part of the PMS-TWG are: Liberia Drugs Enforcement Agency; Liberia Revenue Authority (Custom), Liberia Custom Brokers Association; Ministry of Commerce; Liberia Marketing Association; Pharmaceutical Importers’ and wholesalers’ Association; Ministry of Finance & Development Planning and the Environmental Protection Agency (EPA).

Meanwhile, at the close of the meeting, Pharmacist, Alex Korkolea, Director for Operations, Central Medical Store (CMS), as Chairman and Madam Tabadeh Kollah of the National Malaria Control Program (NMCP),as Vice Chairperson; with a mandate to serve for a term of three (3) years.

For their part, the leadership and members of the newly-established PMS-TWG pledged their unwavering support and collaboration to the monitoring and making informed policy and governance decision of Liberia’s PMS system.

PMS-TWG vowed to work with the LMHRA, USP-Liberia to ensure that the objective for which the PMS-TWG was established is fully met.

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