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2000
Volume 22, Issue 1
  • ISSN: 1573-3963
  • E-ISSN: 1875-6336

Abstract

Background

The global lack of suitable formulations for children leads to off-label and unlicensed medicine use, posing significant risks of adverse effects. Understanding this usage on a national level can help guide interventions for better formulations. This study aimed to measure the prevalence of off-label and unlicensed medicines among children in South Africa's private sector.

Methods

The study used a point prevalence methodology to review medicine use in children aged 0-2 years enrolled in a selected pharmaceutical benefit management company in South Africa from January to June 2022. A sample size of 1055 prescriptions was calculated using a 90% confidence interval, 50% prevalence rate, and 5% error margin. A systematic random sampling approach selected every 7th entry from 91,973 total entries, resulting in a final sample size of 13,139. Data included patient age, number and characteristics of medicines, quantity, and indications. Descriptive statistics analysed and reported the prevalence of unlicensed and off-label medicine use.

Results

Among the 13,139 prescribed medicines, 40% (5,246) were off-label or unlicensed, and 60% (7,893) were on-label. Of the off-label/unlicensed medicines, 16.85% (2,214) were unlicensed, and 23.08% (3,032) were off-label. Methylprednisolone was the top off-label medicine, probiotics were the top unlicensed, and the ICD10 code Z76.9 was the top diagnosis.

Conclusion

The study found that 40% of children aged 0-2 years were prescribed unlicensed or off-label medicines in South Africa's private healthcare sector between January and June 2022. This suggests a widespread practice of off-label or unlicensed prescriptions in paediatric treatment in the South African private sector.

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A Quantitative Review of Un-licensed and Off-label Medicines Use in Children Aged 0-2 Years in the Private Sector in South Africa: Extent, Challenges, and Implications
Curr Pediatr Rev 22, 61 (2026); https://doi.org/10.2174/0115733963303583240820043749
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  • Article Type:     Research Article
Keyword(s): Adult medications; drug use; quantitative review, unlicensed medicines, private healthcare sector, paediatric treatment

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