{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,11]],"date-time":"2025-12-11T07:43:17Z","timestamp":1765438997332,"version":"3.46.0"},"reference-count":54,"publisher":"Bentham Science Publishers Ltd.","issue":"1","content-domain":{"domain":["eurekaselect.com"],"crossmark-restriction":true},"short-container-title":["CPR"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The global lack of suitable formulations for children leads to off-label\nand unlicensed medicine use, posing significant risks of adverse effects. Understanding this usage\non a national level can help guide interventions for better formulations. This study aimed to measure\nthe prevalence of off-label and unlicensed medicines among children in South Africa's private\nsector.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The study used a point prevalence methodology to review medicine use in children\naged 0-2 years enrolled in a selected pharmaceutical benefit management company in South Africa\nfrom January to June 2022. A sample size of 1055 prescriptions was calculated using a 90%\nconfidence interval, 50% prevalence rate, and 5% error margin. A systematic random sampling approach\nselected every seventh entry from 91,973 total entries, resulting in a final sample size of\n13,139. Data included patient age, number and characteristics of medicines, quantity, and indications.\nDescriptive statistics analysed and reported the prevalence of unlicensed and off-label\nmedicine use.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Among the 13,139 prescribed medicines, 40% (5,246) were off-label or unlicensed, and\n60% (7,893) were on-label. Of the off-label\/unlicensed medicines, 16.85% (2,214) were unlicensed,\nand 23.08% (3,032) were off-label. Methylprednisolone was the top off-label medicine,\nprobiotics were the top unlicensed, and the ICD10 code Z76.9 was the top diagnosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The study found that 40% of children aged 0-2 years were prescribed unlicensed or\noff-label medicines in South Africa's private healthcare sector between January and June 2022.\nThis suggests a widespread practice of off-label or unlicensed prescriptions in paediatric treatment\nin the South African private sector.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2174\/0115733963303583240820043749","type":"journal-article","created":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T07:59:17Z","timestamp":1726041557000},"page":"61-70","update-policy":"https:\/\/doi.org\/10.2174\/bsp_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["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"],"prefix":"10.2174","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5228-6675","authenticated-orcid":true,"given":"Hlayiseka","family":"Mathevula","sequence":"first","affiliation":[{"name":"School of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankua, Pretoria, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4887-4757","authenticated-orcid":true,"given":"Moliehi","family":"Matlala","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankua, Pretoria, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9690-6285","authenticated-orcid":true,"given":"Natalie","family":"Schellack","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samuel","family":"Orubu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Niger Delta University, Yenagoa, Bayelsa State, Nigeria"},{"name":"Global Strategy Lab, York University, Toronto,Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"965","reference":[{"key":"ref=1","doi-asserted-by":"publisher","first-page":"2615","DOI":"10.1111\/bcp.13394","volume":"83","author":"Aronson J.K.","year":"2017","unstructured":"Aronson J.K.; Ferner R.E.; Unlicensed and off-label uses of medicines: Definitions and clarification of terminology. 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