Unlicensed and Off-Label Medication Use in Pediatric and Neonatal Intensive Care Units: No Change Over a Decade

Nir-Neuman, Hadar; Abu-Kishk, Ibrahim; Toledano, Michal; Heyman, Eli; Ziv‐Baran, Tomer; Berkovitch, Matitiahu

doi:10.1007/s12325-018-0732-y

Cited by 40 publications

(48 citation statements)

References 26 publications

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“…30,31 Öte yandan pediatrinin, EDİK'in yüksek görüldüğü alanların başında olduğu bilinmektedir. 6,32 ŞEKİL 2: Türkiye'de klinik araştırmalar ile ilgili atılan ve çocukları yakından ilgilendiren adımların kısa tarihçesi.…”

Section: çOcuklarda Endi̇kasyon Dişi İlaç Kullaniminin Dünyadaki̇ Günceunclassified

“…33,[35][36][37] Bu tespitler, çocuklarda EDİK'in yapılacak hedef popülasyona özgü çalışmalarla azaltılması ve/veya daha rasyonel hâle getirilmesi gereken bir halk sağlığı konusu olduğunu ortaya koymaktadır. 11,32,[38][39][40][41] Çocuklarda EDİK'i etkileyen faktörlerin iyi bilinmesi, uygulamanın rasyonel yönetilmesine katkı sağlayabilir. Yaş, çocuklarda EDİK oranını değiştiren kriterlerden biridir.…”

Section: çOcuklarda Endi̇kasyon Dişi İlaç Kullaniminin Dünyadaki̇ Günceunclassified

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Off-Label Drug Use in Pediatrics

Kırmızı¹,

Aydin²,

Akıcı³

et al. 2020

J Lit Pharm Sci

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Yeni ilaç geliştirme; uzun zaman dilimi, yüksek miktarda maliyet ve çok sayıda yetişmiş insan gücü gerektiren bir süreçtir. 1,2 İlaç adayı bu süreçte kalitesi, etkililiği ve güvenliliği açısından pek çok konuda araştırmaya tabi tutulur ancak ilacın kullanılabileceği olası her türlü endikasyona ve yaş grubuna araştırma sürecinde tümüyle yer verilemez. İlaç firmaları maliyetin artması ve sürenin uzaması gibi riskleri asgariye indirmek için, ruhsatlandırılacak ilaç ile ilgili araştırmaları daha standart özellikteki kişiler/hastalar

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Section: çOcuklarda Endi̇kasyon Dişi İlaç Kullaniminin Dünyadaki̇ Günceunclassified

Off-Label Drug Use in Pediatrics

Kırmızı¹,

Aydin²,

Akıcı³

et al. 2020

J Lit Pharm Sci

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“…18 Off-label use of drugs presents an even larger and more complex issue in preterm and full-term neonates, in infants and children ages <2 years, in children with rare or chronic diseases, and in those who are critically ill. In fact, Nir-Neuman et al 19 reported that among the 1064 prescriptions for 49 medications in critically ill neonates, 64.8% involved off-label use. Likewise, the number of critically ill pediatric patients receiving at least 1 off-label medication was 88.7%.…”

Section: Introductionmentioning

confidence: 99%

Key PotentiallyInappropriateDrugs in Pediatrics: The KIDs List

Meyers¹,

Thackray²,

Matson³

et al. 2020

The Journal of Pediatric Pharmacology and Therapeutics

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OBJECTIVES The safe use of medications in pediatric patients requires practitioners to consider the unique pharmacokinetics and pharmacodynamics of drugs prescribed in this age group. In an effort to create a standard of care for the safe use of medications in this population, a list of drugs that are potentially inappropriate for use in pediatric patients has been developed and titled the “KIDs List.” METHODS A panel of 7 pediatric pharmacists from the Pediatric Pharmacy Association were recruited to evaluate primary, secondary, and tertiary literature; FDA Pediatric Safety Communications; the Lexicomp electronic database; and product information for drugs that should be considered potentially inappropriate for use in pediatric patients. Information was rated using predefined criteria. A PubMed search was conducted using the following terms: adverse drug events OR adverse drug reactions. The search was limited to humans; age <18 years; case reports, observational studies, or clinical trials; and English language. No date range was used. Results were used to create an evidence-based list of candidate drugs that was then peer-reviewed and subjected to a 30-day public comment period prior to being finalized. RESULTS A PubMed search yielded 4049 unique titles, of which 210 were deemed relevant for full review. Practitioner recommendations highlighted an additional 77 drugs. FDA Pediatric Safety Communications and the Lexicomp database yielded 22 and 619 drugs, respectively. After critical analysis, peer review, and public review the final KIDs List contains 67 drugs and/or drug classes and 10 excipients. CONCLUSIONS This extensive effort led to compilation of the first list of drugs that are potentially inappropriate for prescribing in all or in a select subgroup of pediatric patients. If avoidance is not clinically possible, the drug should be used with caution and accompanied by appropriate monitoring.

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“…In addition, there has been an increase in the use of unlicensed and off‐label medication on inpatients (particularly neonates and inpatients in the paediatric intensive care unit). The propagation of preschool and neonates exposed to such medicine use is high …”

Section: Introductionmentioning

confidence: 99%

Parental views and attitudes towards use of unlicensed and off‐label medicines in children and paediatric clinical trials: an online cross‐sectional study in the Arab world

Mukattash

Jarab

Daradkeh

et al. 2019

J Pharm Health Serv Res

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Objectives The present study aimed to explore views and attitudes of parents towards the use of unlicensed and off-label medicines in children, paediatric clinical trials, and the role of pharmacists in the safety and effectiveness of medicines. Methods A cross-sectional electronic survey was conducted over social media networks in the Arab world to assess parents' views and attitude towards use of unlicensed/offlabel medicines and clinical trials in children. Validated questionnaire was adopted to achieve the study goals. Key findings A total of 4740 respondents completed the online questionnaire. 55.2% have no previous knowledge of use of unlicensed medicines in children. Most of parents thought that they should be told about the use of such medicines, with the doctor (55.0%) selected as the person who should tell parents. Respondents thought that the use of medicines in children was extremely safe or safe. However, this proportion is decreased dramatically (P < 0.001; McNemar test). Views of parents towards clinical trials vary according to child health (child in good health 14.8% versus child suffering of life-threatening condition 50.4%). The majority of respondents thought that pharmacist has a significant role in assuring the safety and efficacy of medicines. Conclusions Limited parents' knowledge about the use of medicines in children and the importance of clinical trials. General consensus about pharmacists' role in ensuring medicines' safety and efficacy.

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Unlicensed and Off-Label Medication Use in Pediatric and Neonatal Intensive Care Units: No Change Over a Decade

Cited by 40 publications

References 26 publications

Off-Label Drug Use in Pediatrics

Off-Label Drug Use in Pediatrics

Key PotentiallyInappropriateDrugs in Pediatrics: The KIDs List

Parental views and attitudes towards use of unlicensed and off‐label medicines in children and paediatric clinical trials: an online cross‐sectional study in the Arab world

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