Literature DB >> 23344644

[Off-label use of drugs in pediatric emergencies: limitations and grey areas of drug approval].

C G Erker1, M Möllmann.   

Abstract

In the medical treatment of children drugs are frequently used outside the boundaries of the approved licensing and use under the terms of off-label use is possible. However, this requires critical reasoning and experience with the drug involved. With help of a traffic light colored spreadsheet this article illustrates the limitations, problems and possibilities of pharmacotherapy in pediatric emergencies or pediatric anesthesia. Of the 45 emergency drugs listed in this article most can be used in childhood, at least under specific conditions. Licensing restrictions occur especially in the newborn period and infancy resulting in frequent off-label use. Severe pitfalls, such as the propofol infusion syndrome after long-term sedation with propofol under the age of 16 years, emphasize the need for serious reflection on the substances involved. Decisions regarding pharmaceutical therapy should be based on the current standard of medical knowledge. When official recommendations from pharmaceutical companies are missing, treatment decisions for off-label use can be based on guidelines, study and literature databases or recommendations in medical journals.

Entities:  

Mesh:

Year:  2013        PMID: 23344644     DOI: 10.1007/s00101-012-2123-0

Source DB:  PubMed          Journal:  Anaesthesist        ISSN: 0003-2417            Impact factor:   1.041


  25 in total

Review 1.  Unlicensed and off-label drug use in children: implications for safety.

Authors:  Imti Choonara; Sharon Conroy
Journal:  Drug Saf       Date:  2002       Impact factor: 5.606

2.  Uses of drugs not described in the package insert (off-label uses).

Authors: 
Journal:  Pediatrics       Date:  2002-07       Impact factor: 7.124

3.  [Old drugs and new approval procedures: Akrinor remains marketable and an application for reapproval of Arginin Vasopressin has been made].

Authors:  T Koch; V Wenzel
Journal:  Anaesthesist       Date:  2006-06       Impact factor: 1.041

Review 4.  [Opioids in anesthesia].

Authors:  C Zöllner; M Schäfer
Journal:  Anaesthesist       Date:  2008-07       Impact factor: 1.041

Review 5.  [Off-label therapy from the perspective of the medical insurance service].

Authors:  L Grell; M Rieger
Journal:  Z Rheumatol       Date:  2012-02       Impact factor: 1.372

Review 6.  Propofol for procedural sedation/anaesthesia in neonates.

Authors:  Prakeshkumar S Shah; Vibhuti S Shah
Journal:  Cochrane Database Syst Rev       Date:  2011-03-16

7.  Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates.

Authors:  Nadine Shehab; Carrie L Lewis; Darcie D Streetman; Steven M Donn
Journal:  Pediatr Crit Care Med       Date:  2009-03       Impact factor: 3.624

Review 8.  [Propofol infusion syndrome].

Authors:  J Motsch; J Roggenbach
Journal:  Anaesthesist       Date:  2004-10       Impact factor: 1.041

9.  The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients.

Authors:  Antje Neubert; Harald Dormann; Jutta Weiss; Tobias Egger; Manfred Criegee-Rieck; Wolfgang Rascher; Kay Brune; Burkhard Hinz
Journal:  Drug Saf       Date:  2004       Impact factor: 5.606

Review 10.  [Provision of information to patients. Legal and humanitarian requirements].

Authors:  J Schara; L Brandt
Journal:  Anaesthesist       Date:  2008-09       Impact factor: 1.041

View more
  1 in total

1.  [Pediatric perioperative systemic pain therapy: Austrian interdisciplinary recommendations on pediatric perioperative pain management].

Authors:  B Messerer; G Grögl; W Stromer; W Jaksch
Journal:  Schmerz       Date:  2014-02       Impact factor: 1.107

  1 in total

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