In July 2022, The Gambia’s Ministry of Health was alerted to a spike in cases of acute kidney injury among children. Acute kidney injury is a sudden and rapid deterioration of kidney function, leading to a build-up of waste products in the blood and disruptions in fluid balance. Acute kidney injury, if not promptly treated, can exacerbate illness and, in severe cases, contribute to increased morbidity and mortality. From July to September 2022, there were 78 reported cases  with 66 confirmed deaths (85% mortality rate).[1] The cause of the outbreak was unknown,  prompting a comprehensive and systematic investigation to unravel the mystery and enable targeted interventions aimed at mitigating the outbreak and preventing further cases. As the first known outbreak of acute kidney injury in the country, the Ministry of Health sought assistance from WHO and other partners to conduct the investigation and response. WHO and The Gambia’s swift and proactive approach mitigated the impact of contaminated over-the-counter syrup medicines, identified as the root cause of the outbreak, and played a crucial role in saving children’s lives, both in The Gambia and abroad. This aligns with the strategic guidance and standards for the quality, safety and efficacy of health products, essential medicines and diagnostics, as espoused in The Gambia’s Country Cooperation Strategy (CCS) and the United Nations Sustainable Development Cooperation Framework (UNSDCF). 

“Since this phenomenon was unprecedented in this country, it was very difficult to ascertain at first, what was causing the acute kidney injury. The Committee suspected that acute kidney injury could be caused by drug toxicity since paracetamol toxicity was identified as the cause of acute kidney injury 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."

Dr Ahmadou Lamin Samateh, Minister for Health, The Gambia [2]

How did The Gambia, with the support of WHO, achieve this?

WHO collaborated with The Gambia and other partners to coordinate a systematic approach to investigating and responding to the outbreak. Internally, WHO activated its Grade 2 emergency procedures and activities on 23 September 2022 to manage an operational response. A Grade 2 emergency requires a moderate response by WHO, which exceeds the capacity of the country office. [3] WHO’s Incident Management System (IMS), the system which organizes and manages WHO’s response to each emergency, was activated. Within 72 hours, the Incident Management Support Team (IMST) was activated at country-level, supported by an IMST at the Regional Office for Africa and headquarters. A response plan was issued on 27 September 2022. A total of US$ 470 000 was released from the WHO Contingency Fund for Emergencies (CFE) in the last quarter of 2022, which enabled an immediate response from WHO. 

WHO immediately deployed an Emergency Medical Team (EMT) from Senegal to support clinical management of acute kidney injury cases with a focus on nephrology care. During the 14-day deployment, the EMT members attended to approximately 700 patients, including 14 suspected acute kidney injury cases. With financial and technical support from WHO, the Edward Francis Small Teaching Hospital, a referral facility situated in the capital city of Banjul, received and installed two pediatric hemodialysis machines, water treatment equipment, and the necessary medical consumables. To strengthen The Gambia’s capability to investigate and respond to the outbreak, WHO conducted training for healthcare professionals, focusing on enhancing expertise in case detection and management. Over 600 professionals underwent training from September to December 2022. To gain a deeper understanding of the outbreak, WHO took the lead in conducting a comprehensive investigation, employing various methodologies. This included a risk-based survey, a case-cohort study, and a causality assessment.

^{As part of a case-cohort study, a WHO staff member systematically gathers data on various factors, including potential exposures, risk factors, and demographic details. This will enable researchers to identify patterns and associations that may contribute to the acute kidney injury outbreak.}
Photo credit: WHO Gambia/Monik Bhatta

Based on a shared clinical presentation and rigorous epidemiological investigation that revealed a common exposure to certain medications, the enigmatic surge in cases raised suspicions of a connection to contaminated medicine. On 3 October 2022, WHO confirmed, through laboratory analysis of samples in WHO prequalified quality control laboratories, that four products (Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup) manufactured by Maiden Pharmaceuticals Limited in Haryana, India, contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. In partnership with The Gambia's Medicines Control Agency and the Ministry of Health, WHO orchestrated a nationwide recall of contaminated medicines on 5 October 2022, which included house-to-house recall and collection of products from the implicated manufacturer. In an effort to heighten awareness of the contaminated products, WHO partnered with 860 diverse stakeholders, including the media. This collaboration encompassed community awareness programs featuring radio and TV panel discussions, jingles, and community engagement meetings. On 5 October 2022, WHO issued a global Medical Product Alert for the four products, emphasizing the critical need to detect and remove these products from circulation.[4] The alert also called for heightened surveillance and diligence in countries and regions likely to be affected.

“WHO stood alongside The Gambia's government to help test suspected medicines, deployed a surge team with a wide range of expertise, procured laboratory equipment and supplies as well as medicines and dialysis machines, and supported and saving lives.”

Dr Desta Alamerew Tiruneh, World Health Organization Representative in The Gambia.

Following completion of the product recall, no further fatalities were reported in The Gambia. The outbreak spurred initiatives to enhance the regulatory capacity of the Medicines Control Agency, encompassing several of the key elements of the WHO Global Benchmarking Tool. [5] These efforts are directed towards strengthening and aligning the national regulatory system with international standards. Furthermore, the Ministry of Health has enhanced its partnership with WHO quality control laboratories included on the WHO List of Prequalified Medicines Quality Control Laboratories. [6] They have implemented measures to expedite the analysis of samples sent to these facilities while awaiting The Gambia’s finalization of plans for constructing a new quality control laboratory domestically. 

WHO and The Gambia's rapid and proactive response not only saved lives but also effectively brought the country’s acute kidney injury outbreak to a halt. Through a systematic approach, WHO's timely activation of emergency procedures, financial support, deployment of medical teams, and comprehensive training significantly contributed to the successful management of the crisis. The investigation and recall of contaminated medicines showcased international collaboration. WHO’s global alert raised awareness regarding the potential risks associated with these products, facilitating the swift detection of cases involving contaminated syrup medicines in Cambodia, Indonesia, Marshall Islands, and Micronesia (Federated States of) and Uzbekistan.[7] WHO collaborated closely with authorities in each country to proactively prevent additional incidents and guarantee the safety and quality of medicines within their respective regions.