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Quality Assurance & Quality Control Guidelines – LMHRA

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PREMISE REGISTRATION-2021

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LMHRA Public Awareness Team in Gbarnga, Bong County

Activities

Kakata City, Margibi County (Monday, January 25, 2021)

Activities

Kakata City, Margibi County (Monday, January 25, 2021)

The LMHRA Awareness and Radio Talk-show Team arrived in Kakata City, Margibi County, on Monday morning, January 25, 2021. The Team, which comprised of six persons: three persons from the Communications Unit (Abraham Kolleh Morris, Deputy Communications Manager; Jesse Gbotoe, Communications Officer and Mark S. Chea, Communications Officer), one of Liberia’s top Comedian, (Isaac Sunday Sieh, alias (Paul Flomo)) and two technical staff to include the Technical Advisor to the Managing Director, Dr. Flomoku G. Miller and Pharmacist Humphrey B. Taylor of the Evaluation and Registration Department.

In the early morning of January 25, 2021, at about 9a.m., the two technical staff, Dr. Miller, and Pharm. Taylor, along with the Deputy Communications Manager, Mr. Abraham Kolleh Morris, Sr., visited a local radio station, Radio Margibi 103.7 FM. It is located in the county’s capital, and it is one of the most popular and widely monitored stations in that part of the country. At Radio Margibi, the Team explained the danger of street peddling and the danger on the proliferation of substandard, and falsified medicines.

The two technical staff who appeared on the radio talk-show discussed a broad spectrum of issues with regards to the following:  Disabusing the minds of the public from purchasing medicines from street peddlers; the risks associated with purchasing from street peddlers; that street peddlers most of the time sell expired, falsified, substandard, or unregistered medicines.; and that those street peddlers are not trained healthcare providers, therefore they tend to misinform the public and that medicines in buckets, bags, or on market tables which may either come in direct contact with  extreme temperatures of sunlight, or absorption moisture as a result of increase humidity which negatively affects the stability of these medicines, thus becoming harmful and provide bad health outcome. All of these were explained as simple as possible to get the message across.

The Role of the LMHRA in the Area of Pharmaceutical Regulations

In response, the public also had the opportunity to call and ask questions, and also raise concerns. Many callers expressed appreciation to the LMHRA for the awareness, the exceptional work being done to mitigate street peddling, and also to ensure that affordable, safe, efficacious, and effective medicines and health products are always available on the Liberian market. Some callers stated that it was also important that the LMHRA continue to engage the public with such valuable information. Others said that the LMHRA needs to step up their strategy in combatting street peddling through more public awareness and inspections.

Immediately after the radio talk show, the team took to the main streets of Kakata, where street vendors, marketers, motorcyclists, pedestrians, etc. converged in their numbers to listen to public awareness messages from the campaign team on the danger of street peddling.

The team was mainly disseminating messages against the sales, purchase and usage of medicines sold by street peddlers, and also the danger associated with the usage of these medicines.

During the campaign, awareness flyers, stickers, and T-shirts bearing similar campaign messages were distributed to the public.

Spicing up the campaign, one of Liberia’s best comedians, Paul Flomo who was a part of the campaign team, presented the campaign message in simple terms through comedy.  

During the public awareness campaign on the main street of Kakata, a teenage boy who was seen selling in the open air, Oral Rehydration Salts (ORS) and powder milk was arrested by the team, and his goods confiscated.

Gbarnga City, Bong County

Bong County was very strategic to the public awareness campaign in that it is situated in the central region of Liberia. This county is one of the commercial hubs of the country, and a major center for trading falsified, substandard, expired, and unregistered medicines and health products.

The two technical staff, Dr. Miller, and Pharm. Taylor, along with the Regional Manager for Bong, Nimba, and Lofa Counties, Pharmacist Sancee G. Gray, visited a local radio station, Hot 107.9FM located in Gbarnga; a subsidiary of Hot FM 107.9FM located on Broad Street in Monrovia.

The local radio station has the widest coverage in the county and is mostly monitored by citizens. Appearing on the morning show again, the two technical persons along with the Deputy Manager for Communications continued the propagation of similar messages with regards to what was disseminated in Kakata in relations to disabusing the citizenry from doing business with street peddlers and the negative effects substandard and falsified medicines and health products poses to health outcomes.

The public also had the opportunity to call-in and make contributions. Some of the callers made mention of the poor storage conditions of some pharmaceutical premises, and the need for LMHRA to visit hard-to-reach areas to propagate these messages.

Immediately after the radio talk show; again, the entire team converged at one of the major commercial centers in Gbarnga in the market square; where many citizens came out again to listen to the messages against street peddling and the danger associated with using substandard, and falsified medicines.  

The public awareness team also visited major street corners, market and communities to disseminate the awareness message.  Flyers, T-shirts and stickers were also distributed to people who attended the campaign. The Technical Advisor (Dr. Miller), Pharm. Taylor and Comedian Paul Flomo were also in attendance to answer questions from the bystanders, motorcyclists and marketers and provided further clarity.

Gompa City, (Ganta City), Nimba County

Nimba County is part of the northeastern region of Liberia.  It was one of the major priorities of the campaign team in that it is the second largest county in terms of population. With Ganta city, which is also called Gompa City being one of the major commercial centers in the northern region; is associated with porous border points with Guinea and the Ivory Coast. This contributes to the influx substandard and falsified medicines.

Upon entering Nimba, the awareness team conducted a consultative meeting with authorities of the county, to include the Superintendent, City Mayor of Ganta, and other stakeholders. The campaign team then converged at a central point in Gompa city, for the public awareness campaign. The team, like the other counties, propagated messages against street peddling and the danger associated with buying medicines from street vendors.

This was done via interactive discussions with people that gathered at the awareness sites. Additionally, the playing of LMHRA jingles, and discussions through comedy and simple Liberian English by Comedian Paul Flomo easily delivered the awareness message to the people of Gompa City. Similarly, awareness flyers, stickers, T-shirts with the awareness messages were also given out to the attendees.

The team also toured major street corners and communities in Ganta, further promulgating similar messages against street peddling, and the usages of falsified and substandard medicines and health products.

In Gompa city, the team also distributed flyers, stickers, and T-shirts to people in communities where the team visited.  Later during the day, Dr. Miller, Technical Advisor to the Managing Director and a technical staff supporting the campaign team paid a visit to a local radio station, also a subsidiary of Hot FM 107.9, located in Gompa City, Nimba County.

Dr. Miller had a 30 minute exclusive interview with that station concerning the discussions against street peddling and also the statutory functions of the LMHRA.

Challenges

However, several challenges were encountered during the campaign in the three counties:

One of the major challenges encountered was with the Public Address System (PA system). The output of the LMHRA PA system was extremely low, thus creating a serious breach in communication due to the PA system being outdated or old. This served as a major impediment to the campaign in that most people who converged at the first campaign site in Kakata city could barely understand the message. The team later negotiated to rent a new PA system so as to have the campaign objective achieved.

We were also challenged with securing popular sites to carry on the public awareness due to the team not initially meeting local county authorities in both Bong and Margibi Counties. So the public awareness was implemented on main streets, and that posed harm to bystanders due to movement of vehicles.

Owing to the messaging from the Technical Advisor, Pharmacist Taylor and Comedian Paul Flomo, the attendees clamor for more flyers, T-shirts and stickers.

Recommendations

While in the three counties, (Margibi, Bong, Nimba Counties), there were many recommendations generated from both the public interactions via the radio talk shows and in the field.; Recommendation were made that there should be Billboards carrying messages against street peddling erected in each of these three counties (Margibi, Bong, and Nimba) as well as other leeward counties and major towns and villages; that there should be jingles produced in the various vernaculars (dialects) and played on various local radio stations in these leeward counties; that LMHRA carry her awareness strategy to various towns and villages, for farmers and residents of these leeward counties to be safe; that the LMHRA should work towards assigning more inspectors and surveillance officers in these counties to curtail street peddling, and the confiscation of unregistered medicines and health products.;

The communication Unit recommends that, a new and sophisticated PA system be bought to ensure that messages promulgated by the awareness team be fully understood by commuters who will converge to listen to the message; that the LMHRA Facebook page be regularly maintained and boosted so as to also carry the message live every time the campaign team is on the field, that the LMHRA purchase a modern camera for the purpose of taking quality pictures and doing recordings during public awareness campaigns, that the LMHRA regularly have public awareness campaigns and radio talk shows in every part of the country so that the public will always be furnished with essential medicine information and that the hotline be made free-to-call so as to enable the citizenry access and report street peddlers and the illegal importation of pharmaceuticals through land borders.

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Outlines of LMHRA Managing Director Pharm. Keturah C. Smith Administration October 2019- December 2020

Based on our responsibility as Communications Unit of the Liberia Medicines & Health Products Regulatory Authority (LMHRA) to project the positive image and workings of the authority; the Unit has deemed it prudent to outline the leadership and tremendous achievements of the administration of its Managing Director, Pharmacist Keturah C. Smith from October 2019 – Dec 2020.

In this light, we present a catalogue of achievements of this administration during the year under review: Regardless of the limited resources, Managing Director Smith has made significant progress in a short period of time.

Though Managing Director Smith inherited a broken system due to some political crisis, she was however innovative with the assistance of the technical team, strengthened by additional administrative staff to hit the ground running with the statutory mandate of the entity by ensuring that the country have safe, effective and quality medicines reaching the Liberian people.  

To this end, here are some of the challenges and achievements of MD Smith:

Challenges inherited:

  1. Rent for Head Office and Regional Office in Gbarnga;
  2. Financial liabilities for staff salaries
  3. Ensure health and NASSCORP insurance for employees;
  4. Indebtedness Local vendors;
  5. Lack of logistics for operations, Post Marketing Surveillance and Inspection – only 2 vehicles
  6. Inadequate staffing (both technical & support)
  7. Depleted bank accounts
  8. To build the status of QC lab to ISO 17025/ WHO standard

Currently, all previous financial liabilities incurred by past administration as a result of the internal wrangling has been fully liquidated during the period under review by Managing Director Smith administration.

The new LMHRA administration inherited a financially broken institution. Especially with the employment of new staff members, thus, meeting the needs of staff salaries and other benefits were the greatest challenge, considering that fees were not being collected as under normal administrative circumstances.

In the same vain, there was a need for total restructuring of the entity’s revenue collection structures, including reassigning of key staff.

Upon Pharmacist Smith’s ascendancy, like all other public institutions, COVID-19 also had a serious toll on the LMHRA’s resource mobilization efforts. Hence, registration of medicines and health products, and other revenue generation areas were at the lowest pace. Accordingly, a very meticulous spending and administrative regime were immediately put into place for operations of the Authority under the ongoing global pandemic.

However, these challenges did not come without significant achievements:

Achievements

  1. Since the establishment of the LMHRA by an Act of the Legislation in 2010, some employees  of the entity were being paid incentive while few were paid both incentive and GOL salary;

Nevertheless, we are delighted to report that the Government of Liberia, through lengthy negotiation of the administration of the LMHRA and the Ministry of Finance and Development Planning (MFDP), has absorbed about 99.9% of staff salaries, including the newly recruited staff;

  • Within a year, under the instrumentality of the Managing Director, through the Board of Directors, the LMHRA has constructed a mini-Office Building currently in use as Quality Control Laboratory in Careysburg, Montserrado County.
  •  The MD in short a while, also ensured robust inspection by the Inspectorate Department of LMHRA for all pharmacies, medicine stores, pharmaceutical importers warehouses as well as health facilities in and outside of Montserrado.
  • MD Smith as head of the entity, also ensured that every department or unit of the LMHRA network and collaborate to ensure the core objectives of the institution is achieved.
  • As it is common knowledge, since the establishment of the LMHRA for the sole purpose of ensuring that quality, efficacious and safe medicines and health products are regulated; under MD Smith’s stewardship, the Communications Unit in consonance with the Medicines Information Unit, were able to produce and is currently airing several  jingles on street peddling, medicines registration, adverse drug reaction and as well as the discouragement of the citizenry on the purchasing of fake, expired and substandard medicines and health products from street  peddlers (Black Baggers) on several radio stations in Monrovia and around the country.
  • As was in the past, little or nothing was heard of or known by the public of the workings of the LMHRA; but under this illustrious youthful Managing Director and her technicians as well as administrative support staff, there has been several radio and/or media appearances of the MD Smith and other Technical Staffs and newspaper publications highlighting the achievements, prospects and challenges of the entity, thus so far giving the general public a broader understanding of the workings of LMHRA.
  • MD Smith leadership has also ensured that premier is placed on the sensitization of the public about the harm of purchasing from street peddlers and counterfeit medicines and health products poses to the citizenry of Liberia.
  • In adherence to the Public Procurement Law as well as the Public Financial Management Law, Madam Smith, under her administration mandated that all procurement and financial transactions of the LMHRA are in strict adherence to the PPCC and PFM Laws of Liberia.
  • MD has also ensured full collaboration and networking with other key ministries agencies and partners both in the health and Governmental sectors. Thus, leading to the Liberia Revenue Authority (LRA) confiscating and turning over to the LMHRA on several occasions, expired, sub-standard and counterfeit medicines from two of Liberia’s land border points.
  1. The LMHRA Boss through her leadership spearheaded a 5-day technical and administrative retreat that led to the production of various Standard Operating Procedures and Departmental manual for the smooth running of the authority.
  1. Madam Smith leadership was also instrumental in the establishment for the first time; a 21st century website as well as a social media platform (Facebook) page. She has likewise maintained a very cordial relation with every staffer and thus making her office accessible as well as ensure senior and general staff meeting regularly.
  1. The LMHRA under Madam Smith has also established two hotlines service for the public to make inquiries and also report the smuggling, peddling and sale of counterfeit medicines and health products.
  1.  Signed a memorandum of understanding (MOU) in March 2020 with Ghana FDA for third party testing of medicines and health products
  1. In an effort to strengthen the Authority, Managing Director Smith  also established Programs & Planning, , with the role and responsibilities: to lead the resource mobilization efforts of the LMHRA and manage donor funds; design, monitor and evaluate programs, projects and implementation of work plan; lead and keep records of approved development plans (including construction works), projects and budgets of the Authority and their execution time schedule as specified; help support preparation of annual budgets and rolling plans in collaboration with Administration and the Finance Department.
  1. For the first time the entity also secured security for head office and as well secured a private security firm for her new mini quality control lab in Careysburg, Montserrado County.
  1. For further sensitization and information dissemination purposes and as a way to further expose the working of the Authority, the administration the LMHRA also ensure the erection of five by eight meter billboards, along the Congo Town, VAMOMA House, Tubman Blvd., Robert International Airport and Freeport vicinities to acquaint the general public about the LMHRA and its workings.
  1.  Madam Smith has placed premier on the issue of employees’ empowerment thus ensuring that all employees of the authority having access to health and National Social Security and Welfare Corporation insurance schemes.
  1. During the period under review, the following trainings/seminars/workshops were attended by LMHRA staff:
    1. Foreign: Several staff attended foreign trainings and meetings during the period under review, including:
  • The MD attendance of the 7th Steering Committee Meeting of the West Africa Medicines Regulatory Harmonization (WA-MRH) Project of the West Africa Health Organization (WAHO) in Dakar, Senegal this year with the following terms of reference:Providing strategic and policy directionApproving technical documents
  • Quality Management System training in Ghana by three (3) staff members, drawn from the Lab, Internal Audit & Office of the MD. Attendance of 3rd Edition of the African Medicines Quality Forum in Nigeria from   February 24 – 28, 2020 by the Quality Control Manager.  Attendance of the Annual Meeting of the National Medicines Quality Control Laboratories \in the Ivory Coast in November of 2019 by the Quality Control Manager and his deputy.
  • Local: Several local trainings were conducted since her appointment, including:
  •  Quality Management Training for one week in March of 2020;
    •  GHPP assessment of Marketing Authorization System, leading to capacity building in February 2020;
  • Staff Retreat: A staff retreat, with the main objective of reviewing guidelines and other administrative policies and documents, was held from April 1 – 7, 2020. The final report, along with reviewed and updated guidelines, Standard Operating Procedures (SOPs) and other relevant documents were shared with Board for their perusal and subsequent approval.

Recently, MD Smith along with other senior staff from the Inspectorate and Registration and Evaluation Departments as well as senior staff from USP-Liberia, travelled to Accra, Ghana for a study tour of the Ghanaian Food and Drug Administration (FDA) and approve on our system in Liberia. 

Decentralization of Regulatory Activities:

Her able leadership has for the first time in the history of the entity established offices at the National Port Authority (NPA) and the Robert International Airport (RIA) to streamline medicines and health products and as well confiscate illegal, expired counterfeit and banned medications or health products from entering the local market.

As the LMHRA continue to find avenues for strengthening of the LMHRA for full execution of its mandate, MD Smith also ensure the securing of office spaces for decentralization of regulatory activities by:

  • The establishment of Ports and Border Services Unit, thus leading to the opening of offices at the Freeport of Monrovia and Robert International Airport (RIA) with plans to extend next year to other border points including (Bo-Waterside in Grand Cape Mount County, Ganta-Guinea Border in Nimba); with the already existing regional office in Gbarnga, Bong County. Several staff have already been deployed at these various regional and port offices and operations smoothly ongoing.
  • Thirteen (13) staff have been assigned at the RIA after holding several meetings with the RIA Authority for permanent posting of LMHRA staff;
  • There has been a rigorous restructuring of the Regional Office in Gbarnga – with posting of additional staff with logistical support (procurement of motorbikes) to strengthened and enforced regulatory activities
  • Construction Works

In order to further improve service rendered by the LMHRA, MD Smith organized a one-day stakeholder roundtable pharmaceutical and health sector meeting with various players in the health sector in the country to discuss the construction of the quality control lab.

  1. MD Smith through her lobbying skills and collaboration with other sector of Government, was instrumental in securing a two-storey fully furnished office building for the authority up Mamba Point, in Central Monrovia, with rent being fully covered by the Government of Liberia.
  1. The illustrious and youthful LMHRA Managing Director, upon her ascendency met a logistically-challenge authority, leading to limited Post Market Surveillance (PMS) inspection due to the lack of vehicle or the entity having only old two vehicles. Through her innovation and leadership skill, Madam Smith through Global Fund, was able to acquire two brand new High-top Land Cruiser Jeeps with funding from Global Fund; one 18-seated bus for staff of the Quality Control Lab and another vehicle for the office of the Managing Director.
  • Pharmacist Smith through her lobbying power, is expected to acquire from the World Bank, reagents, chemical and equipment for the Quality Control Laboratory. Through the Madam leadership, the United States Pharmacopeia Convention (USP), Promoting the Quality of Medicines Plus (USP-PQM+) is expected to procure additional equipment, reagents and chemical for the QC Lab.
  • The LMHRA through fees collected over the years, has also procured additional equipment, reagents and chemical for the QC Lab in order to continue visual testing and physiochemical analysis.
  • Though in 2017, QC Lab was gutted by fire thus leading to only visual inspection being conducted by the LMHRA, the lab was later transferred to another location at Sophie Community where the lab graduated from just visual inspection to both visual inspection and physiochemical analysis. After few months in office again. In 2019, MD Smith ensure the laboratory moved to its current location in Kings Farm, Careysburg, Montserrado County; where a full visual inspection and physiochemical analysis are being conducted.
  • Currently, a fully fenced and furnished mini QC Lab estimated worth of US$165,000.00 has been constructed and fully operationalized; with plans for official dedication His Excellency President Dr. George Manneh Weah Sr., in early 2021.
  • Also, there is a Memorandum of Understanding with the Global Fund for the construction of US$4.3million dollars state-of-the-art International Organization for Standardization (ISO 17025) and World Health Organization (WHO) standard Quality Control Lab.
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LMHRA Commends LRA For Collaboration

The Liberian Medicines &Health Products Regulatory Authority (LMHRA) is commending the Liberia Revenue Authority (LRA) for the level of collaboration in recent time especially in helping combating the illicit flow of pharmaceutical products in the country.

The LRA in recent has been instrumental in confiscating thousands of dollars illegal pharmaceutical products smuggled in the country by some unscrupulous individuals.

It can be recalled that the Customs Department of the LRA turned over to the LMHRA huge consignment of pharmaceutical products illegally imported in Liberia from Guinea, by an individual identified as Abdulla Kamara.

The pharmaceutical products, according to LRA officials were intercepted by Customs Anti-Smuggling Officers along the Somalia Drive following a tip-off.

According to a Customs investigation report, the assorted pharmaceutical products were smuggled into the country through the Guinea, Ganta Border.

The report further stated that the assorted medicines were concealed in twelve (12) Jomo size boxes under other goods being legally imported in the country.

The assorted medicines or pharmaceutical products included: Pain killer, Multi-Vitamin, Cold Caps, and Amoxicillin among others and is valued at over Five Thousand United States Dollars (US$5,000.00).

Presenting the confiscated medicines to the LMHRA, LRA Manager of Anti-Smuggling& Investigation Unit (ASIU), Masu Fahnbulleh noted that the LRA will remain steadfast and engaged in ensuring effective border security and protection under its border management strategy.

He disclosed that the importer identified as Abdullai Kamara without permit imported and smuggled the assorted medicines into Liberia.

Receiving confiscated products on behalf of the LMHRA, the Deputy Inspector-General of the LMHRA, Dr. Thomas Kokulo, thanked the LRA for the seizure and described the collaboration between the two government agencies as vital in curbing the illegal importation of medicines and other harmful products into the country.

The seizure is part of an LRA on-going regional customs enforcement operation under the auspices of the World Customs Organization (WCO) code name: “Cripharm V” targeted at combating the illicit flow of pharmaceutical products.

Also speaking upon receiving the illegal pharmaceuticals at the head offices of the LMHRA, the Inspector General of the LMHRA, Pharmacist Teedoh Beyslow, frowned on illegal importation of pharmaceuticals, and health products and medical devices in the country without the expressed approval of the LMHRA; especially through land borders and under harsh conditions.

He vowed to ensure those caught in smuggling medicines, and health products and medical devices in Liberia, to be drastically dealt with in accordance with the law and regulations governing the entity.

Pharmacist Beyslow also disclosed plans in the coming days, to turn the culprit to the Independent Hearing Board of the LMHRA for investigation and as after which findings, they authority will seek Court order to have the confiscated medicines (pharmaceuticals)burned (incinerated).

He also thanked the Liberia Revenue Authority for the continual cooperation and mutual respect existing between the two entities and further urged the LRA to remain more vigilant in ensuring that those involved in the smuggling of medicines, and health products and medical devices are brought to book and punished in accordance with the laws of the country. In April of 2020, the LRA Customs Department again turned over to the LMHRA, huge consignment of pharmaceuticals illegally imported through the Liberian-Sierra Leonean border post at Bo Waterside in Grand Cape Mount County.