Drug Development

Yamashiro, Yuichiro; Martin, Jennifer; Gazarian, Madlen; Kling, Sharon; Nakamura, Hidefumi; Matsui, Akira; Cucchiara, Salvatore; Aloi, Marina; Wynn, Erica L.; Mulberg, Andrew E.

doi:10.1097/mpg.0b013e318272af1f

Cited by 6 publications

(3 citation statements)

References 34 publications

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“…Until more data are provided, clinical decision-making should be guided by the best available scientific evidence and closely monitored while authorities, academics, and manufacturers collaborate to foster trials and authorize adequate drugs for this population. Therefore, we agree with Yamashiro et al [ 165 ], van der Zanden et al, [ 150 ], and Kaguelidou et al [ 164 ] that the most important thing is the compliance with the off-label prescription algorithm and the creation of a professional network of off-label prescriptions and their implications so that healthcare providers have a foundation to stand on when deciding whether to prescribe an off-label drug or not.…”

Section: Discussionsupporting

confidence: 88%

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: Discussionsupporting

confidence: 88%

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

Petkova,

Georgieva,

Dimitrov

et al. 2023

Pharmaceutics

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“…In addition, referencing the previously mentioned AAP or AMA articles and statements around medical necessity may be helpful. As a caveat, however, Yamashiro et al (12) make the point that “Off-label prescribing may sometimes be appropriate but is always associated with important clinical, ethical, and financial consequences, which need to be considered when assessing overall benefits and risks”. Thus, in addition to justifying the need for off-label use, the letter should state that the provider has considered benefits, risks, and alternatives, discussed those with the patient, and that both provider and patient have agreed to proceed with the prescribed treatment.…”

Section: Components Of An Effective Lomn/ Appeal Lettermentioning

confidence: 99%

How to Write an Effective Letter of Medical Necessity

Kahn

Bousvaros

2023

Journal of Pediatric Gastroenterology &Amp; Nutrition

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“…In addition, there were considerable concerns with the off-label use of pentazocine among paediatric surgical patients in Nigeria, and most children experienced between two and seven adverse 2 of 17 events [11]. Developing countries, including South Africa, are acutely affected by off-label and unlicensed use of medicines because people aged between 0 and 18 years constitute an appreciable proportion of the population, and they are more prone to infectious diseases [12][13][14][15]. For instance, Southern Africa has a high proportion of children born to mothers with HIV, which is very different from higher-income countries [16].…”

Section: Introductionmentioning

confidence: 99%

Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications

Mathevula,

Schellack,

Orubu

et al. 2023

Pharmacy

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Background: Information regarding off-label and unlicensed medicine use among South African children is limited. This is a concern as the prescribing of off-label and unlicensed medicines can lead to issues of effectiveness and safety as well as raise liability issues in the event of adverse events. This potentially exposes physicians to legal penalties. Consequently, we sought to determine the prevalence of off-label and unlicensed medicine use among paediatric patients in South Africa to provide future direction. Methods: This study retrospectively examined the use of medicine in a point-prevalence survey study (PPS) involving paediatric patients aged (0–2 years) admitted to selected public hospitals in Gauteng Province, South Africa. Data were collected per hospital over two days between February 2022 and July 2022. Demographics, duration of treatment, diagnosis, and medicines prescribed were collected from patient medical records using a mobile application. Prescribed medicines were reviewed against the medicine formularies and other databases to assess their appropriateness. Results: From three academic hospitals, 184 patient records were reviewed. A total of 592 medicines were dispensed, of which 379 (64.0%) were licensed and 213 (36.0%) were used off-label/unlicensed for paediatric patients 0–2 years of age. The most prevalent off-label and unlicensed medicines were multivitamins (n = 32, 15.0%) and ampicillin injections (n = 15, 7.0%). Conclusion: The frequency of unlicensed and off-label medicine prescribing shown in this study is consistent with the literature and can be considered high. This practice can pose a risk because it adversely affects patients if not properly regulated. Attention is needed to ensure future high-quality, safe, and effective use of medicines.

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Drug Development

Cited by 6 publications

References 34 publications

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

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

How to Write an Effective Letter of Medical Necessity

Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications

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