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J Pediatr Pharmacol Ther. 2017 Jan-Feb;22(1):48-59. doi: 10.5863/1551-6776-22.1.48.

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

The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG

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

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

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.

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

References

  1. J Biomed Inform. 2009 Apr;42(2):377-81 - PubMed
  2. Paediatr Drugs. 2008;10(3):193-7 - PubMed
  3. PLoS Med. 2008 Aug 12;5(8):e172 - PubMed
  4. BMC Med. 2013 Nov 07;11:238 - PubMed
  5. Arch Dis Child. 2012 Mar;97(3):185-8 - PubMed
  6. Pediatrics. 1987 May;79(5):718-22 - PubMed
  7. Curr Opin Infect Dis. 2012 Jun;25(3):235-42 - PubMed
  8. Br J Clin Pharmacol. 2002 Dec;54(6):665-70 - PubMed
  9. JAMA. 2001 Apr 25;285(16):2114-20 - PubMed
  10. Arch Pediatr Adolesc Med. 2007 Mar;161(3):282-90 - PubMed
  11. Indian J Pediatr. 2008 Nov;75(11):1133-6 - PubMed
  12. Dimens Health Serv. 1976 Aug;53(8):34-5 - PubMed
  13. Eur J Pediatr. 2005 Sep;164(9):552-8 - PubMed
  14. Lancet. 1989 Aug 12;2(8659):374-6 - PubMed
  15. Arch Dis Child. 2012 Jun;97(6):564-8 - PubMed
  16. N Engl J Med. 2003 Sep 18;349(12):1157-67 - PubMed
  17. BMJ. 2004 Jan 24;328(7433):227 - PubMed
  18. BMJ. 2000 Jan 8;320(7227):79-82 - PubMed

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