Publications

2

Jul, 2020

Global sales of oral antibiotics formulated for children

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Authors: Li G, Jackson C, Bielicki J, Ellis S, Hsiac Y, Sharland M

Published in: Bulletin of the World Health Organization, July 2020

Objective To investigate international consumption patterns of child-appropriate oral formulations of antibiotics by formulation type, with a focus on dispersible tablets, using data from a global sales database.

Methods Antibiotic sales data for 2015 covering 74 countries and regional country groups were obtained from the MIDAS® pharmaceutical sales database, which includes samples of pharmacy wholesalers and retailers. The focus was on sales of child-appropriate oral formulations of Access antibiotics in the 2017 World Health Organization’s WHO Model list of essential medicines for children. Sales volumes are expressed using a standard unit (i.e. one tablet, capsule, ampoule or vial or 5 mL of liquid). Sales were analysed by antibiotic, WHO region and antibiotic formulation.

Findings Globally, 17.7 billion standard units of child-appropriate oral antibiotic formulations were sold in 2015, representing 24% of total antibiotic sales of 74.4 billion units (both oral and parenteral) in the database. The top five child-appropriate Access antibiotics by sales volume were amoxicillin, amoxicillin with clavulanic acid, trimethoprim–sulfamethoxazole, cefalexin and ampicillin. The proportion of the top five sold for use as a syrup varied between 42% and 99%. Dispersible tablets represented only 22% of all child-appropriate oral formulation sales and made up only 15% of sales of 10 selected Access antibiotics on the model list for children.

Conclusion Globally most child-appropriate oral antibiotics were not sold as dispersible tablets in 2015, as recommended by WHO. There is a clear need for novel solid forms of antibiotics suitable for use in children.

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28

Apr, 2020

A comparison of five paediatric dosing guidelines for antibiotics

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Authors: Mathur S, Jackson C, Urus H, Ziarko I, Goodbun M, Hsia Y, Ellis S, Sharland M.

Published in: Bulletin of the World Health Organization, April 2020

Objective To compare dosing guidance in the paediatric formularies of high-income countries and emerging economies for 32 commonly prescribed antibiotics on the World Health Organization’s (WHO’s) 2017 Model List of Essential Medicines for Children.

Methods We identified paediatric antibiotic guidelines that were either widely used internationally or originated in countries in which antibiotic use has increased markedly in recent years (i.e. Brazil, China, India, the Russian Federation and South Africa).

Findings The study analysis considered five leading antibiotic guidelines: (i) the Manual of childhood infections: the blue book; (ii) the BNF (British national formulary) for children; (iii) the Red book®: 2018–2021 report of the committee on infectious diseases; (iv)WHO’s Pocket book of hospital care for children; and (v) Indian national treatment guidelines for antimicrobial use in infectious diseases. There was marked heterogeneity in the recommended dosing (i.e. daily dose, age dosing bands and dose frequency) for most commonly used antibiotics. The rationale for dosing recommendations was generally unclear.

Conclusion The pharmacokinetic, pharmacodynamic and clinical evidence supporting paediatric antibiotic dosing, particularly on total doses and on age or weight dosing bands, needs to be improved. Future research should consider whether the variations in guidance identified stem from different clinical disease patterns, varying levels of antibiotic resistance or drug availability rather than historical preferences. Interested global parties could collaborate with WHO’s Model list of essential medicines antibiotic working group to develop an evidence-based consensus and identify research priorities.

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