MoH’s Statement at Launch of AKI Presidential Taskforce Report

This is the statement issued by the Minister for Health Hon Ahmadou Samateh on the release of the Acute Kidney Injury Taskforce Report on 21st July 2023 at the Ministry of Health Headquarters in Banjul.

By Minister for Health, Hon Ahmadou Samateh,

• I would like to take this opportunity to welcome you all to this gathering whereby we would like to update the bereaved families and the whole nation on the Acute Kidney Injury outbreak in The Gambia and to provide the findings of the various investigations. I want to first and foremost extend the condolences of His Excellency The President Mr. Adama Barrow and his entire government to the bereaved families whose children are no longer with us today. May Allah grant them Al-Janatul Firdaus and give you the fortitude to bear the loss.
• Acute Kidney Injury (AKI) is a sudden onset of deteriorating function of the kidneys; which manifests as Oliguria (diminished urination) or anuria (absent urination) and other symptoms such as oedema, confusion, nausea, vomiting, diarrhea, shortness of breath, coma etc. This is because the kidneys are damaged and unable to maintain the internal milieu of the body leading to accumulation of toxic products of metabolism which becomes fatal in some cases. Acute Kidney Injury has many causes, amongst these are Escherichia Coli infection, severe dehydration which might be as a result of diarrhea and vomiting, nephrotoxic drugs and substances, malaria, etc.

Background on the Outbreak

• On the 26^th July 2022, the Ministry of Health was alerted on the increasing number of children presenting at the Edward Francis Small Teaching Hospital and many of these children succumbing to their disease. The Epidemiology and Disease Control Unit of the Ministry was instructed to swing into action to get to the root of the problem. The World Health Organization (WHO) was contacted for support in handling the outbreak. An incident Management System was set up to manage the situation. The Incident Management team was Co-chaired by the Ministry of Health and WHO. The membership comprised of an experienced team from the Ministry of Health and its various Units and Directorates, Medicines Control Agency (MCA), representatives of partner institutions like WHO, UNICEF, Center for Disease Control (CDC) Atlanta Georgia, Doctors from EFSTH etc. Extensive deliberations took place in the Committee meetings and the AKI response decisions came from this Committee. Various WHO experts including the Regional Emergency Director for Africa and the Incident Manager for Africa came to the country and participated in the Incident management deliberations.
• Since this phenomenon was unprecedented in this country, it was very difficult to ascertain at first what was causing the Acute Kidney Injury (AKI). The Committee suspected that the AKI could be caused by drug toxicity since paracetamol toxicity was identified as the cause of AKI in some countries in the past. The World Health Organization Country Office helped to send patient samples and samples of the drugs used by the patients to laboratories in Senegal, Ghana, France and Switzerland.
• In the meantime, doctors noticed a convincing trend in the occurrence and worsening of the disease in some of the children on consuming certain drugs. The Ministry of Health decided to ban these drugs even before receiving the confirmation from the laboratory testing. This led to the press release instituting the ban on the consumption of paracetamol syrup in the country on the 07^th Sep 2022. This was later followed by the ban on promethazine syrup on the 10th Sep 2022. The Ministry imposed these bans despite criticisms and complaints from some people at the time that we were banning drugs without conclusive evidence.
• During this time, some patients continued to receive treatment at Edward Francis Small Teaching Hospital while some families opted to travel to Senegal for further treatment. The Government and partners put our efforts together to provide needed materials including hemodialysis equipment for children and other drugs and medical items. This involved an enormous commitment from the health workers in the hospital in providing care for the patients and in the field carrying out surveillance activities.
• The laboratory analysis confirmed that toxic levels of Ethylene Glycol (EG) and Diethylene Glycol (DEG) were found in 4 syrups namely, promethazine oral solution BP, Kofexmaline baby cough syrup, MakoFF baby cough syrup and MaGrip cold syrup. DEG and EG are organic compounds that are found in certain products such as industrial solvents and antifreeze and are used as raw materials in manufacturing polymers. Accidental or intentional ingestion of DEG and EG products has been known to cause poisoning. Illegal use of DEG to replace glycerin or propylene glycol as a solvent in medications had been reported in some countries in the past.
• All 4 of these products were manufactured by Maiden Pharmaceuticals in India and were imported to The Gambia by Atlantic Pharmaceuticals. Government immediately banned Atlantic pharmaceuticals who got their license withdrawn and their premises closed. This was followed by police investigations into their activities.
• The Medicines Control Agency sprang into action with series of steps to remove the drugs from circulation. These steps included a ban on the sale and consumption of all Maiden Pharmaceutical products in The Gambia. This was followed by a recall of these products from the drug outlets and households. The outbreak was controlled by November 2022, after the products were removed from circulation.
• We have never lost sight of the fact that, sadly, 70 children died as a result of the outbreak. The AKI outbreak was a national tragedy. This was a very difficult moment for all of us and we wish to emphasize to the bereaved families His Excellency President Barrow’s resolve and that of his government to addressing this issue. However, it was very important to establish the cause of the Acute Kidney Injury in a scientific way.
  • At the request of the Ministry of Health to the World Health Organization (WHO), a Causality Assessment Committee (CAC) was set up comprising of both local and international experts.
  • His Excellency the President also established a taskforce to inquire into the death of children as a result of consumption of contaminated medicines imported into the country from India, that is suspected to cause acute Kidney Injury. The National Assembly set up an inquiry into the AKI deaths and their report was also presented to the Ministry of Health for action.
  • The Ministry of Health in collaboration with the WHO conducted a thorough epidemiological investigation entitled: Acute Kidney Injury Outbreak among children in The Gambia; from June – September 2022. An outbreak investigation report. This was submitted to the MOH and was intended to corroborate or refute findings of the causality assessment.

The Causality Assessment

• The causality assessment team worked closely with The Gambian Ministry of Health (MoH), the Medicines Control Agency (MCA) and the Epidemiology and Disease Control (EDC) Unit to come up with the most plausible causal association that led to the AKI. In short, the CAC concluded that the outbreak of AKI in Children in The Gambia was attributable to Medicines contaminated with DEG/EG.  In addition to reviewing the laboratory evidence, the CAC found that the clinical presentation in these children was highly consistent with DEG/EG poisoning in previous outbreaks. Moreover, the cessation of the outbreak after the suspected pediatrics syrups were withdrawn strongly suggested that poisoning rather than other causes was behind the AKI/deaths.  The conclusions of the CAC are consistent with the conclusions made by other bodies investigating this matter, including the WHO.

Task Force

• After reviewing the findings of the causality assessment report and conducting a series of interviews and reviewing numerous documents, the Presidential taskforce made a series of findings and recommendations – a few of which will be highlighted today.
  • First, the taskforce confirmed that the deaths can be conclusively linked to the four cough syrups imported by Atlantic Pharmaceuticals from Maiden Pharmaceuticals in India.
  • The taskforce also investigated how these syrups were imported from India and distributed in the country. They learned that the affected medicines were not registered with the Medicines Control Agency, even though the Regulation requires all medicines to be registered before importation. The MCA has the legal responsibility to ensure all medicines and related products are submitted through an application for registration prior to importation.
  • The Taskforce found that there is an urgent need for a quality control laboratory to conduct proper testing on all medicines and related products imported into the country. Although the statute authorized a National Laboratory years ago, the MOH failed to establish the National Laboratory.
• One of the fundamental requirements of registration is that an applicant must submit a copy of a certificate of a qualified pharmacist and that failure to submit the requirement will render the application invalid. All licensed importers with the Medicines Control Agency are expected to have met the aforementioned requirements.
• The requirement of the law is that the licensed pharmacist will serve as the supervising pharmacist working for/with the importers to provide professional advice to the importer during the process of importation and distribution of medicines and related products.
  • The Taskforce indicated that Sait Kebbeh, serving as a supervising pharmacist for Atlantic Pharmaceuticals Company Limited, admitted to signing off for the importation of the four cough and cold syrups later found to be contaminated. According to the taskforce, Mr. Kebbeh only provided technical advice for the procurement and importation of the medicines but did not do any background check on the manufacturer.

Recommendations

The Taskforce came up with some recommendations for implementation by government.  Some of these recommendations are in progress, and we will highlight a few today.

1. The Government of The Gambia should ensure that the MoH urgently facilitates the establishment of a fully operational National Medicines Quality Control Laboratory (NMQCL), as mandated by the Act.

Response: The World Bank is helping The Government of The Gambia in establishing a Food and Drug Quality Control Laboratory in Brusubi. The architectural design and the development of the BOQ is currently going on and construction work will start soon thereafter. Government has already tasked MCA to get support from partners. This is already ongoing with support from WHO and the Pakistani Drug Regulatory Authority. This step will continue and will be enhanced.

2. The MCA should establish a fully functional Pharmacovigilance Department to include: a Medicines Safety Expert Committee, Regional Hospital Monitoring and Investigation Teams, and Focal Persons at the Regional Health Directorates and Health Facilities as required by the Regulation.

Response: MCA has already started this process and MCA is instructed to ensure the  expansion of the scope for increase coverage and efficiency.

3. MCA should recruit students who have graduated from UTG in Bio-chemistry, Chemistry and Biological sciences to strengthen its human resources capacity.

Response: MCA is being instructed to act on this.

4. The Government of The Gambia should refer the matter of Sait Kebbeh the Supervising Pharmacist for Atlantic Pharmacy to the Pharmacy Council for appropriate disciplinary action.

Response: The matter of Sait Kebbeh will be immediately referred to the Pharmacy Council for appropriate disciplinary action.

5. The Government through the Pharmacy Council, Ministry of Higher Education Research Science and Technology and the University of The Gambia should prioritize the establishment of a School of Pharmacy at the University of The Gambia to meet the growing demand of Pharmacists in the country.

Response: This process has started and advertisement for the recruitment of consultants for the curriculum development will soon be out. This initial phase is being funded by the World Bank. Preliminary discussions in this line have also been held with the WHO Director General which will be followed up urgently. Other possibilities with other partners and potential partners will be explored.

6. The Government of The Gambia to permanently revoke the importation license issued to Atlantic Pharmacy Company Limited and their Directors.

Response: The license of Atlantic Pharmacy Company Limited has been permanently revoked.

7. The Government of The Gambia, through the MOH, should review the laws and regulations surrounding granting importation license and instill stringent conditions so as to ensure that importers are approved based on their qualifications operating with a sense of accountability and responsibility rather than being principally driven by profit.

Response: The Ministry of Health has retained an experienced firm that is currently carrying out a review of all the health-related Legislation in The Gambia. This will be carried out as part of this ongoing review of the acts under the MOH.

8. The Government of The Gambia should, with immediate effect, dismiss the Executive Director and Deputy Executive Director and consider prosecuting them in line with the relevant laws for their abdication of their official duties.

Response: Considering the foregoing, for the purpose of strengthening the MCA and restoration of public confidence in the institution, Executive Director of MCA has been dismissed with immediate effect and also the contract of the Deputy Executive Director is terminated with immediate effect.  The report will also be forthwith transmitted to the Gambia Police Force for further action.

9. The Government of The Gambia through the Ministry of Justice and Ministry of Foreign Affairs should forthwith explore the possibility of instituting further legal action against Atlantic Pharmaceuticals and Maiden Pharmaceuticals, and should engage with the Government of India, to seek criminal and civil redress on behalf of families of victims of AKI outbreak.

Response: Government is far advanced in exploring avenues for potential legal action against Atlantic Pharmaceuticals and Maiden Pharmaceuticals, as well as potential redress through engagement with the Government of India. The Government is currently benefiting from legal advice from a top tier international law firm.

Following this Press Briefing, Copies of the entire are hereby released.

In addition, we are also releasing copies of the Causality Assessment Report and the Epidemiological Survey Report, both of which were worked on by The World Health Organisation and The Ministry of Health.