Acute Kidney Injury Among Children Likely Associated with Diethylene Glycol–Contaminated Medications — The Gambia, June–September 2022

Bastani, Parsa; Jammeh, Anna; Lamar, Frederica G.; Malenfant, Jason H; Adewuyi, Peter; Cavanaugh, Alyson M.; Calloway, Kimberly; Crisp, Carolyn; Fofana, Nuha; Hallett, T Christy; Jallow, Amadou T.; Muoneke, Uzoamaka; Nyassi, Momodou; Thomas, Jerry R.; Troeschel, Alyssa N.; Yard, Ellen E.; Yeh, Michael W.; Bittaye, Mustapha

doi:10.15585/mmwr.mm7209a1

Cited by 13 publications

(8 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Between 2022 and 2023, three major incidents due to the contamination of oral syrups with ethylene- and diethylene-glycol (excipients) caused the death of at least 300 children across The Gambia, Indonesia, and Uzbekistan, tragically highlighting the lack of protection for children in resource-limited settings from substandard medicines. 85 – 88…”

Section: Discussionmentioning

confidence: 99%

Challenges of Antibiotic Formulations and Administration in the Treatment of Bloodstream Infections in Children Under Five Admitted to Kisantu Hospital, Democratic Republic of Congo

Tack,

Vita,

Ntangu

et al. 2023

The American Journal of Tropical Medicine and Hygiene

View full text Add to dashboard Cite

Severe bacterial infections in children need prompt, appropriate antibiotic treatment. We report challenges observed within a prospective, cohort study on antibiotic efficacy in non-typhi Salmonella bloodstream infection (NCT04850677) in Kisantu district hospital (Democratic Republic of Congo). Children (aged > 28 days to < 5 years) admitted with suspected bloodstream infection (August 1, 2021 through July 31, 2022) were enrolled and followed until day 3 or discharge for non-typhi Salmonella patients. Antibiotics were administered to 98.4% (1,838/1,867) of children, accounting for 2,296 antibiotic regimens (95.7% intravenous, 4.3% oral). Only 78.3% and 61.8% of children were, respectively, prescribed and administered antibiotics on the admission day. At least one dose was not administered in 3.6% of children, mostly because of mismatch of the four times daily cefotaxime schedule with the twice-daily administration rounds. Inappropriate intravenous administration practices included multidose use, air-venting, and direct injection instead of perfusion. There was inaccurate aliquoting in 18.0% (32/178) of intravenous ciprofloxacin regimens, and thus administered doses were > 16% below the intended dose. Dosing accuracy of oral suspensions was impaired by lack of instructions for reconstitution, volume indicators, and/or dosing devices. Adult-dose tablets were split without/beyond scoring lines in 84.4% (27/32) of tablets. Poor availability and affordability of age-appropriate oral formulations contributed to low proportions of intravenous-to-oral switch (33.3% (79/237) of non-typhi Salmonella patients). Other quality issues included poor packaging, nonhomogeneous suspensions, and unsafe water for reconstitution. In conclusion, poor antibiotic products (no age-appropriate formulations, poor quality and access), processes (delayed prescription/administration, missed doses), and practices (inaccurate doses, [bio]safety risks) must be urgently addressed to improve pediatric antibiotic treatment.

show abstract

Section: Discussionmentioning

confidence: 99%

Challenges of Antibiotic Formulations and Administration in the Treatment of Bloodstream Infections in Children Under Five Admitted to Kisantu Hospital, Democratic Republic of Congo

Tack,

Vita,

Ntangu

et al. 2023

The American Journal of Tropical Medicine and Hygiene

View full text Add to dashboard Cite

show abstract

“…Without a stable, well-functioning and integrated regulatory system, Africans are therefore at risk of injury or death following the consumption of SF medical products. This was seen when at least 60 children, mostly under the age of five, died from acute kidney injury in The Gambia after consuming cough syrup contaminated with ethylene glycol and diethylene glycol ( Bastani et al ., 2023 ). The AMA can address the circulation of SF medical products in Africa by providing technical and strategic support to countries in order to improve vigilance functions and safety surveillance capacity.…”

Section: Introductionmentioning

confidence: 99%

The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies

Ncube,

Dube,

Ward

2024

Health Policy and Planning

View full text Add to dashboard Cite

The vision of the African Medicines Agency (AMA) is to ensure that all Africans have access to affordable medical products that meet internationally recognised standards of quality, safety and efficacy for priority diseases/conditions. The AMA is being established by a treaty which had to be ratified by a minimum of 15 African countries. Although there was no deadline, the ratification process has been slower than expected. This study therefore analysed the rationale, perceived benefits, enabling factors and challenges of the AMA’s establishment. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of 45 African countries. The heads of NRAs and a senior NRA staff member were contacted to complete self-administered questionnaires. The existence of mature NRAs, the desire to have harmonised regulatory systems, the presence of strong political will and appropriate advocacy to expedite treaty signing are all enabling factors for AMA treaty signing. The challenges reported include the fact that the process is slow and there is limited understanding of the process. Competing national priorities, changes in office bearers in the public system and stagnation of the process at the ministerial level were also challenges reported. This study has improved the understanding of the treaty signing and ratification process, and the perceived benefits and enabling factors of signing and ratification from African NRAs’ perspective. NRAs also highlighted challenges encountered in the process. Addressing these challenges will result in effective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level.

show abstract

“…Last year, similar cases have been reported in Indonesia (AKI cases in toddlers n5325; mortality n5174; mortality rate 54.8%) and Gambia (.100 fatalities; mortality rate 84.62% in pediatric patients with AKI) linked to the use of these syrups containing toxic levels of DEG or EG. [1][2][3][4][5] Similar outbreaks have occurred in the past and can recur in the future and have been typically associated with the contamination of ingestible pharmaceutical products. [1][2][3][4] During the outbreak in Nigeria in 1990, it was found that wholesale distributors substituted DEG for propylene glycol in paracetamol syrups when selling to small pharmaceutical manufacturers to reduce expenses.…”

mentioning

confidence: 99%

“…[1][2][3][4][5] Similar outbreaks have occurred in the past and can recur in the future and have been typically associated with the contamination of ingestible pharmaceutical products. [1][2][3][4] During the outbreak in Nigeria in 1990, it was found that wholesale distributors substituted DEG for propylene glycol in paracetamol syrups when selling to small pharmaceutical manufacturers to reduce expenses. 6,7 These outbreaks serve as a reminder of the difficulties faced in less resourced nations for improvement in regulation, enforcement, or strict implementation of quality control procedures in the pharmaceutical industry.…”

mentioning

confidence: 99%

Sudden Spurt in Pediatric Patients with AKI in Uzbekistan: A Call for International Drug Quality Control and Pharmaceutical Legislation

Murtalibova,

Sethi,

Raina

et al. 2023

Kidney360

View full text Add to dashboard Cite

show abstract

Acute Kidney Injury Among Children Likely Associated with Diethylene Glycol–Contaminated Medications — The Gambia, June–September 2022

Cited by 13 publications

References 6 publications

Challenges of Antibiotic Formulations and Administration in the Treatment of Bloodstream Infections in Children Under Five Admitted to Kisantu Hospital, Democratic Republic of Congo

Challenges of Antibiotic Formulations and Administration in the Treatment of Bloodstream Infections in Children Under Five Admitted to Kisantu Hospital, Democratic Republic of Congo

The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies

Sudden Spurt in Pediatric Patients with AKI in Uzbekistan: A Call for International Drug Quality Control and Pharmaceutical Legislation

Contact Info

Product

Resources

About