Literature DB >> 28337081

A Comprehensive List of Items to be Included on a Pediatric Drug Monograph.

Lauren E Kelly, Shinya Ito, David Woods, Anthony J Nunn, Carol Taketomo, Matthijs de Hoog, Martin Offringa.   

Abstract

OBJECTIVES: Children require special considerations for drug prescribing. Drug information summarized in a formulary containing drug monographs is essential for safe and effective prescribing. Currently, little is known about the information needs of those who prescribe and administer medicines to children. Our primary objective was to identify a list of important and relevant items to be included in a pediatric drug monograph.
METHODS: Following the establishment of an expert steering committee and an environmental scan of adult and pediatric formulary monograph items, 46 participants from 25 countries were invited to complete a 2-round Delphi survey. Questions regarding source of prescribing information and importance of items were recorded. An international consensus meeting to vote on and finalize the items list with the steering committee followed.
RESULTS: Pediatric formularies are most commonly the first resource consulted for information on medication used in children by 31 Delphi participants. After the Delphi rounds, 116 items were identified to be included in a comprehensive pediatric drug monograph, including general information, adverse drug reactions, dosages, precautions, drug-drug interactions, formulation, and drug properties.
CONCLUSIONS: Health care providers identified 116 monograph items as important for prescribing medicines for children by an international consensus-based process. This information will assist in setting standards for the creation of new pediatric drug monographs for international application and for those involved in pediatric formulary development.

Entities:  

Keywords:  drug monograph; drug safety; formulary; pediatrics; prescribing; therapeutics

Year:  2017        PMID: 28337081      PMCID: PMC5341532          DOI: 10.5863/1551-6776-22.1.48

Source DB:  PubMed          Journal:  J Pediatr Pharmacol Ther        ISSN: 1551-6776


  18 in total

1.  A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA).

Authors:  Nicolino Ruperto; Irmgard Eichler; Ralf Herold; Gilles Vassal; Carlo Giaquinto; Lars Hjorth; Adolf Valls-i-Soler; Christina Peters; Peter J Helms; Agnès Saint Raymond
Journal:  Arch Dis Child       Date:  2011-11-27       Impact factor: 3.791

2.  Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Authors:  Paul A Harris; Robert Taylor; Robert Thielke; Jonathon Payne; Nathaniel Gonzalez; Jose G Conde
Journal:  J Biomed Inform       Date:  2008-09-30       Impact factor: 6.317

3.  Medication errors and adverse drug events in pediatric inpatients.

Authors:  R Kaushal; D W Bates; C Landrigan; K J McKenna; M D Clapp; F Federico; D A Goldmann
Journal:  JAMA       Date:  2001-04-25       Impact factor: 56.272

4.  Off-label drug use in hospitalized children.

Authors:  Samir S Shah; Matthew Hall; Denise M Goodman; Pamela Feuer; Vidya Sharma; Crayton Fargason; Daniel Hyman; Kathy Jenkins; Marjorie L White; Fiona H Levy; James E Levin; David Bertoch; Anthony D Slonim
Journal:  Arch Pediatr Adolesc Med       Date:  2007-03

Review 5.  Antibiotic dosing in children in Europe: can we grade the evidence from pharmacokinetic/pharmacodynamic studies - and when is enough data enough?

Authors:  Charlotte I S Barker; Joseph F Standing; Mark A Turner; James C McElnay; Mike Sharland
Journal:  Curr Opin Infect Dis       Date:  2012-06       Impact factor: 4.915

6.  Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.

Authors:  Navjeet K Uppal; Lee L Dupuis; Christopher S Parshuram
Journal:  Paediatr Drugs       Date:  2008       Impact factor: 3.022

7.  Adverse drug reactions and off-label drug use in paediatric outpatients.

Authors:  Benjamin Horen; Jean-Louis Montastruc; Maryse Lapeyre-Mestre
Journal:  Br J Clin Pharmacol       Date:  2002-12       Impact factor: 4.335

8.  Medication error prevention by clinical pharmacists in two children's hospitals.

Authors:  H L Folli; R L Poole; W E Benitz; J C Russo
Journal:  Pediatrics       Date:  1987-05       Impact factor: 7.124

9.  Children are not just small adults: the urgent need for high-quality trial evidence in children.

Authors:  Terry P Klassen; Lisa Hartling; Jonathan C Craig; Martin Offringa
Journal:  PLoS Med       Date:  2008-08-12       Impact factor: 11.069

10.  Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital.

Authors:  Jennifer R Bellis; Jamie J Kirkham; Signe Thiesen; Elizabeth J Conroy; Louise E Bracken; Helena L Mannix; Kim A Bird; Jennifer C Duncan; Matthew Peak; Mark A Turner; Rosalind L Smyth; Anthony J Nunn; Munir Pirmohamed
Journal:  BMC Med       Date:  2013-11-07       Impact factor: 8.775

View more
  3 in total

1.  Development of a provisional essential medicines list for children in Canada: consensus process.

Authors:  Hannah Woods; Efosa Oronsaye; Anjli Bali; Yathavan Rajakulasingam; Taehoon Lee; Norman Umali; Eyal Cohen; Yaron Finkelstein; Martin Offringa; Nav Persaud
Journal:  CMAJ Open       Date:  2018-03-26

2.  Development of one paediatric and one neonatal formulary list in hospital settings.

Authors:  Sissel Sundell Haslund-Krog; Hanne Rolighed Christensen; Mia Bjerager; Helle Holst
Journal:  Br J Clin Pharmacol       Date:  2017-11-03       Impact factor: 4.335

3.  Development and Evaluation of a Web-Based Paediatric Drug Information System for Germany.

Authors:  Julia Zahn; Stefan Wimmer; Wolfgang Rödle; Irmgard Toni; Brita Sedlmayr; Hans-Ulrich Prokosch; Wolfgang Rascher; Antje Neubert
Journal:  Pharmacy (Basel)       Date:  2021-01-05
  3 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.