Off-label prescribing for children with chronic diseases in Nigeria; findings and implications

Oshikoya, Kazeem Adeola; Oreagba, Ibrahim Adekunle; Godman, Brian; Fadare, Joseph; Orubu, Samuel; Massele, Amos; Senbanjo, Idowu O

doi:10.1080/14740338.2017.1344639

Cited by 8 publications

(8 citation statements)

References 30 publications

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“…In a hospital setting, the disease and patient’s condition are of primary importance. Oshikoya et al [ 99 ] reported a low rate of off-label prescriptions in the chronic treatment of epilepsy, asthma, and sickle cell anemia, while in the most vulnerable group of NICU patients, the percentage skyrocketed to 94% [ 90 ]. Comparative data on the extent of off-label prescribing in children 0 to 18 years in different countries and regions, published in medical literature from 2012 to 2022, are summarized in Table 1 .…”

Section: Resultsmentioning

confidence: 99%

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

Petkova,

Georgieva,

Dimitrov

et al. 2023

Pharmaceutics

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Off-label prescribing is widespread among pediatricians, and it is unlikely that this trend will soon be bound by a uniform legal framework. This is necessitated by the fact that there are four variables: the patient’s health condition, the physician’s experience and knowledge, the legislative measures (laws, directives, guidelines, and recommendations), and finally, the pharmaceutical industry. There is considerable concern worldwide about the use of off-label medicines in children. We may call it an enormous global problem that is much talked about and written about; however, we should not forget that the goal around which everyone should unite is the patient’s life. For healthcare providers, the most important thing will always be the health and preservation of the patient’s life, particularly when it comes to children with life-threatening conditions in neonatal and pediatric intensive care units (NICU and PICU). The study aimed to examine the prevalence of off-label drug use in pediatrics. Literature research was conducted, and we included studies from 2012 to 2022 that evaluated off-label drug prevalence in various pediatric patient populations.

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Section: Resultsmentioning

confidence: 99%

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

Petkova,

Georgieva,

Dimitrov

et al. 2023

Pharmaceutics

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“…This includes key areas such as the integration of biomedical information enhancing for instance the rational use of medicines which will benefit all SSA communities [60]. Key areas will also include assessing prescribing against agreed national guidelines including using tools such as DU90% as well as assessing the extent of off label prescribing and potential drug-drug interactions as a prelude to developing future activities based on on-line support [61][62][63][64][65][66][67].…”

Section: Discussionmentioning

confidence: 99%

Reported needs of information resources, research tools, connectivity and infrastructure among African Pharmacological Scientists to improve future patient care and health

Ogunleye

Fadare

Eriksen

et al. 2019

Expert Review of Clinical Pharmacology

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Introduction: The potentials of Africa for growth and economic transformation through science remains challenging because of existing gaps in knowledge and infrastructure. The Africa Pharmacological Science Gateway project and the Medicines Utilization Research in Africa Group seeks to meet the research needs of African pharmacologists. This study aimed at identifying priority needs that might be met by access to information and tools through einfrastructure. Methods: A web-based cross-sectional study among 472 members of pharmacological societies in Africa to obtain information on their research interests and skills, available resources, needs and knowledge gaps. Descriptive analyses were done. Results: A total of 118 responses from 13 countries were received, mostly from Nigeria (48.3%) and South Africa (21.3%). Respondents had wide ranges of research interests predominantly in drug utilization research.The desired resources included drug utilization research training and tools, pharmacokinetics and pharmacometrics modelling training and tools, drug-drug interaction and medicine prices resources, statistical analysis resources, access to journals, training in specific laboratory techniques, equipment and funding for research-related activities. Conclusions: Key areas of needs not currently provided by the African Pharmacological Science Gateway e-infrastructure were identified to guide further provision of resources on the e-infrastructure and potentially enhance research capacity within the continent.

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“…Um estudo espanhol realizado em uma unidade de cuidados intensivos demonstrou que, do total de prescrições avaliadas, 8,6% estavam sendo prescritas em condições não licenciadas, e aproximadamente 54% estavam sendo utilizadas de forma off-label 9 . Na África do Sul, identificou-se que 7% dos receituários médicos ocorrem de maneira off-label nos ambientes ambulatoriais geral e altamente especializados, semelhante à porcentagem encontrada em pesquisa realizada na Nigéria, em que situações como essas acontecem em 7,7% dos casos 18,34 . Em pesquisa realizada em hospitais terciários da Coreia do Sul, foi apontado um percentual bastante elevado dessas prescrições, em que mais de 80% dos pacientes receberam um ou mais medicamentos off-label 24 .…”

Section: Prevalência Do Uso De Medicamentos Off-label E Não Licenciadosunclassified

“…Um medicamento classifica-se como off-label pela frequência ou dosagem quando esses parâmetros estão em discordância com o que está especificado na bula, sendo utilizados em dose e/ou frequência maiores ou menores do que o aprovado. Dentre os estudos que relatam os produtos utilizados dessa forma (Quadro 4), destacam-se a cefotaxima e a gentamicina, pertencentes à classe terapêutica dos anti-infecciosos de uso sistêmico 6,9,15,16,18,20,22…”

Section: Frequência E Dosagemunclassified

Medicamentos off-label e não licenciados no âmbito pediátrico: uma revisão descritiva dos últimos dez anos

Balsan

Gobetti

Garcia

2023

CBR

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A falta de medicamentos contendo bulas prevendo o tratamento de pacientes pediátricos representa um problema frequentemente observado em hospitais, principalmente nos setores de unidade de terapia intensiva (UTI) pediátrica e neonatais. Sabe-se que, para que um tratamento seja considerado seguro e eficaz, uma série de estudos clínicos são necessários, no entanto, relata-se um baixo número dessas pesquisas envolvendo crianças, principalmente devido a questões éticas que dificultam a condução das mesmas. Assim, poucos são os medicamentos que provam ser adequados para o tratamento desses pacientes, tornando necessário recorrer ao uso de medicamentos off-label e não licenciados. Os medicamentos são classificados como off-label quando seu uso se dá de maneira que difere de suas especificações aprovadas, por sua vez, produtos não licenciados são classificados desta forma por não possuírem aprovação para sua comercialização no país ou não possuírem comprovação de segurança e eficácia. O preparo de protocolos de estudo organizados, relato de informações aos pais e à criança de maneira clara e objetiva, aproximação entre pesquisadores e pais para o estabelecimento de uma relação de confiança e a condução das pesquisas em momentos de disponibilidade da família demonstram-se estratégias importantes para facilitar a realização dos ensaios clínicos.

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Off-label prescribing for children with chronic diseases in Nigeria; findings and implications

Abstract: Off-label prescribing for children with epilepsy, asthma and sickle cell anaemia occurs. Encouragingly, the overall rate appears low in Nigeria.

Cited by 8 publications

References 30 publications

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

Reported needs of information resources, research tools, connectivity and infrastructure among African Pharmacological Scientists to improve future patient care and health

Medicamentos off-label e não licenciados no âmbito pediátrico: uma revisão descritiva dos últimos dez anos

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