Literature DB >> 31379392

Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature.

H Christine Allen1, M Connor Garbe2, Julie Lees2, Naila Aziz2, Hala Chaaban3, Jamie L Miller4, Peter Johnson4, Stephanie DeLeon2.   

Abstract

CONTENT: Clinician prescribing of off-label medications is common due to a lack of pediatric-specific data regarding the dosing, efficacy and safety of medications regularly prescribed to children.
OBJECTIVE: This systematic review summarizes the published incidence of off-label medication use in children from the past 10 years. We also performed a retrospective chart review to determine the incidence of off-label prescriptions for children seen in the OU Physicians clinics. DATA SOURCES: We conducted a literature search of PubMed and OVID Medline from 2007 to 2017. Search terms included off-label use of medications and all child. For the local review, the outpatient electronic medical record (EMR) was queried. STUDY SELECTION: Studies were eligible for inclusion if the study included children < 18 years of age, defined off-label use in the paper, and included the incidence of off-label drug use. DATA EXTRACTION: Each review author extracted the study data from their assigned studies. For the retrospective chart review, the EMR was queried for patients <21 years of age who had a clinic visit and received a new prescription during 2017.
RESULTS: We identified 31 studies, with off-label prescription rates from 3.2 % to 95%. The local retrospective chart review included 1,323 prescriptions; 504 were off-label (38.1%) and 819 were approved. The frequency of off-label prescriptions does not differ significantly between the meta-analysis from the systematic review and the local retrospective chart review (30.9% vs 38.1%).
CONCLUSIONS: The use of off-label medications in children remains a common practice for pediatric providers.

Entities:  

Year:  2018        PMID: 31379392      PMCID: PMC6677268     

Source DB:  PubMed          Journal:  J Okla State Med Assoc        ISSN: 0030-1876


  33 in total

1.  Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey.

Authors:  Goran Palčevski; Nataša Skočibušić; Vera Vlahović-Palčevski
Journal:  Eur J Clin Pharmacol       Date:  2012-02-04       Impact factor: 2.953

2.  Off-label use of prescription drugs in childhood and adolescence: an analysis of prescription patterns in Germany.

Authors:  Bernd Mühlbauer; Katrin Janhsen; Josef Pichler; Petra Schoettler
Journal:  Dtsch Arztebl Int       Date:  2009-01-16       Impact factor: 5.594

3.  Off-label drug prescribing in a Portuguese paediatric emergency unit.

Authors:  Marina Ribeiro; Arminda Jorge; Ana Filipa Macedo
Journal:  Int J Clin Pharm       Date:  2012-09-28

4.  Off-label use of medicines in paediatric inpatients at an Australian teaching hospital.

Authors:  Christopher D J Ballard; Gregory M Peterson; Angus J Thompson; Sean A Beggs
Journal:  J Paediatr Child Health       Date:  2012-12-21       Impact factor: 1.954

5.  Off label use of prescription medicines in children in outpatient setting in Estonia is common.

Authors:  Jana Lass; Alar Irs; Heti Pisarev; Triin Leinemann; Irja Lutsar
Journal:  Pharmacoepidemiol Drug Saf       Date:  2011-05       Impact factor: 2.890

6.  Drug utilization and off-label drug use among Spanish emergency room paediatric patients.

Authors:  Cristina Morales-Carpi; Luis Estañ; Elena Rubio; Empar Lurbe; Francisco J Morales-Olivas
Journal:  Eur J Clin Pharmacol       Date:  2010-03       Impact factor: 2.953

7.  Off-label drug use among hospitalised children: identifying areas with the highest need for research.

Authors:  Linda Hsien; André Breddemann; Anne-Kristina Frobel; Andreas Heusch; Klaus G Schmidt; Stephanie Läer
Journal:  Pharm World Sci       Date:  2008-01-26

8.  Paediatric drug use with focus on off-label prescriptions in Lombardy and implications for therapeutic approaches.

Authors:  Carla Carnovale; Valentino Conti; Valentina Perrone; Stefania Antoniazzi; Marco Pozzi; Luca Merlino; Mauro Venegoni; Emilio Clementi; Sonia Radice
Journal:  Eur J Pediatr       Date:  2013-08-03       Impact factor: 3.183

9.  Paediatric drug use with focus on off-label prescriptions in Swedish outpatient care--a nationwide study.

Authors:  J Olsson; E Kimland; S Pettersson; V Odlind
Journal:  Acta Paediatr       Date:  2011-05-11       Impact factor: 2.299

10.  Off-label medicine use in children and adolescents: results of a population-based study in Germany.

Authors:  Hildtraud Knopf; Ingrid-Katharina Wolf; Giselle Sarganas; Wanli Zhuang; Wolfgang Rascher; Antje Neubert
Journal:  BMC Public Health       Date:  2013-07-03       Impact factor: 3.295

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  14 in total

1.  Systematic Data Monitoring and Analysis of Cardiovascular Off-label Prescriptions in Pediatrics: Focus on Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Beta Blockers.

Authors:  S M Cammarata; G Capone; N Lombardi; L Pani; A Mugelli
Journal:  High Blood Press Cardiovasc Prev       Date:  2022-01-08

2.  Off-Label Drug Use in Pediatric Out-Patient Care: A Multi-Center Observational Study.

Authors:  Aeshah AlAzmi; Zahra Alasmari; Consuela Yousef; Ahmed Alenazi; Mohammed AlOtaibi; Hani AlSaedi; Adnan AlShaikh; Amani AlObathani; Omaima Ahmed; Loie Goronfolah; Mousa Alahmari
Journal:  Hosp Pharm       Date:  2020-08-31

Review 3.  Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions : Comparative regulation framework of off label prescriptions in pediatrics: a review.

Authors:  Benedetta Guidi; Andrea Parziale; Luca Nocco; Aniello Maiese; Raffaele La Russa; Marco Di Paolo; Emanuela Turillazzi
Journal:  Int J Clin Pharm       Date:  2021-09-08

Review 4.  Off-label use of drugs in pediatrics: a scoping review.

Authors:  Min Meng; Meng Lv; Ling Wang; Bo Yang; Panpan Jiao; Wenjuan Lei; Hui Lan; Quan Shen; Xufei Luo; Qi Zhou; Xuan Yu; Yangqin Xun; Ruobing Lei; Tianchun Hou; Yaolong Chen; Qiu Li
Journal:  Eur J Pediatr       Date:  2022-07-13       Impact factor: 3.860

5.  Recommendations on Off-Label Drug Use in Pediatric Guidelines.

Authors:  Min Meng; Qi Zhou; Wenjuan Lei; Min Tian; Ping Wang; Yunlan Liu; Yajia Sun; Yaolong Chen; Qiu Li
Journal:  Front Pharmacol       Date:  2022-06-09       Impact factor: 5.988

Review 6.  Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective.

Authors:  Wen Lin; Yuan Chen; Jashvant D Unadkat; Xinyuan Zhang; Di Wu; Tycho Heimbach
Journal:  Pharm Res       Date:  2022-05-13       Impact factor: 4.580

7.  I-ACT for Children: helping close the gap in drug approval for adults and children.

Authors:  Max J Coppes; Cindy Jackson; Edward M Connor
Journal:  Pediatr Res       Date:  2022-10-21       Impact factor: 3.953

8.  Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems.

Authors:  Nayoung Han; Jung Mi Oh; In-Wha Kim
Journal:  Ther Clin Risk Manag       Date:  2021-08-21       Impact factor: 2.423

9.  Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997.

Authors:  Babak Sahragardjoonegani; Reed F Beall; Aaron S Kesselheim; Aidan Hollis
Journal:  J Pharm Policy Pract       Date:  2021-01-04

10.  Effects of the Off-Label Drug Prescription in the Paediatric Population in Spain from the Adoption of the Latest European Regulation: A Pre-Post Study.

Authors:  Irene Lizano-Díez; Itziar Aldalur-Uranga; Carlos Figueiredo-Escribá; Cecilia F Lastra; Eduardo L Mariño; Pilar Modamio
Journal:  Pharmaceutics       Date:  2021-04-20       Impact factor: 6.321

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