Hlayiseka Mathevula, Moliehi Matlala, Natalie Schellack, Samuel Orubu
{"title":"对南非私营部门 0-2 岁儿童无证和标示外用药的定量研究:程度、挑战和影响》。","authors":"Hlayiseka Mathevula, Moliehi Matlala, Natalie Schellack, Samuel Orubu","doi":"10.2174/0115733963303583240820043749","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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 seventh 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11175,"journal":{"name":"Current Pediatric Reviews","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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.\",\"authors\":\"Hlayiseka Mathevula, Moliehi Matlala, Natalie Schellack, Samuel Orubu\",\"doi\":\"10.2174/0115733963303583240820043749\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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 seventh 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":11175,\"journal\":{\"name\":\"Current Pediatric Reviews\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2024-09-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Pediatric Reviews\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/0115733963303583240820043749\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Pediatric Reviews","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/0115733963303583240820043749","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PEDIATRICS","Score":null,"Total":0}
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.
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 seventh 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.
期刊介绍:
Current Pediatric Reviews publishes frontier reviews on all the latest advances in pediatric medicine. The journal’s aim is to publish the highest quality review articles dedicated to clinical research in the field. The journal is essential reading for all researchers and clinicians in pediatric medicine.