Skip to main content
SpringerLink
Log in

Arzneimitteltherapiesicherheit bei Kindern

Welche Rolle spielen Dosis und Darreichungsform?

Medication safety in children

What role do dosing and formulations play?

  • Leitthema
  • Published:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Bei Kindern und Jugendlichen treten Medikationsfehler häufiger auf als bei Erwachsenen, da die Evidenz oft fehlt und die Zulassung vieler Medikamente für diese Altersgruppen eingeschränkt oder gar nicht vorhanden ist.

Die Ursachen von Medikationsfehlern sind auf verschiedenen Ebenen angesiedelt und betreffen z. B. fehlende Studien zur richtigen Dosis und zur Wirksamkeit v. a. in jüngeren Altersgruppen, den Mangel an kindgerechten Darreichungsformen, die Verwendung schädigender Hilfsstoffe sowie die komplizierte und risikoreiche ärztliche Verordnung.

Elektronische Systeme können die Verordnungsqualität in Kliniken verbessern und Medikationsfehler reduzieren. Voraussetzung dafür ist eine valide, evidenzbasierte Datenbasis. Im Gegensatz zu anderen Ländern steht eine solche in Deutschland bislang nicht zur Verfügung. Der Aktionsplan zur Verbesserung der Arzneimitteltherapiesicherheit in Deutschland 2016–2019 des Bundesministeriums für Gesundheit (BMG) enthält die Maßnahme „Schaffung einer Datenbank zur Dosierung von Arzneimitteln für Kinder“, für welche eine 2‑jährige Anschubfinanzierung vom BMG geleistet wird.

Durch systematische Literaturrecherchen und die Bereitstellung des aktuellen Wissens über Kinderarzneimittel kann die Arzneimitteltherapiesicherheit bei Kindern erhöht werden. Eine Datenbank mit für die pädiatrische Arzneimittelverordnung relevanten Informationen ist hier zielführend. Der Aktionsplan hat die richtigen Weichen für die Verbreitung evidenzbasierter Arzneimittleinformationen für Kinder in Deutschland gelegt.

Abstract

Medication errors are more common in children compared to adults due to often missing efficacy evidence and limited or missing regulatory approvals for paediatric drugs.

Roots of errors are located at different levels. They result, for example, from missing clinical studies that particularly investigate efficacy and correct dosing in younger age groups, the lack of age-appropriate dosage forms, the use of harmful ingredients, as well as the complicated and high-risk prescribing process.

Electronic systems may improve the quality of drug prescriptions and reduce medication errors. The basic assumption is valid, evidence-based data behind such a system. In contrast to other countries, such a database is not yet available in Germany. The Plan of Action for the improvement of medication safety in Germany 2016–2019 (Aktionsplan) contains an action point “Creation of a database for dosing of paediatric medicines”. Initial funding for 2 years has been granted for its implementation.

Through systematic literature searches and the availability and provision of up-to-date knowledge on paediatric medicines, medication safety for children and adolescents can be improved. A database with relevant information to support more correct prescriptions within the paediatric population appears productive. The Aktionsplan has paved the way for the dissemination of evidence-based drug information for the country’s paediatric population.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Abb. 1

Literatur

  1. Ghaleb MA, Barber N, Franklin BD, Wong IC (2010) The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Arch Dis Child 95:113–118

    Article  PubMed  Google Scholar 

  2. Kaushal R, Bates DW, Landrigan C et al (2001) Medication errors and adverse drug events in pediatric inpatients. JAMA 285:2114–2120

    Article  PubMed  CAS  Google Scholar 

  3. Wimmer S, Neubert A, Rascher W (2015) The safety of drug therapy in children. Dtsch Arztebl Int 112:781–787

    PubMed  PubMed Central  Google Scholar 

  4. Rascher W (2017) Fehlende Medikamentenzulassungen für Kinder – ein ethisches Dilemma. Pädiatrie 29:32–34

    Google Scholar 

  5. Kimland E, Odlind V (2012) Off-label drug use in pediatric patients. Clin Pharmacol Ther 91:796–801

    Article  PubMed  CAS  Google Scholar 

  6. Magalhaes J, Rodrigues AT, Roque F, Figueiras A, Falcao A, Herdeiro MT (2015) Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review. Eur J Clin Pharmacol 71:1–13

    Article  PubMed  Google Scholar 

  7. Europäische Kommission (2017) State of Paediatric Medicines in the EU 10 years of the EU Peadiatric Regulation (COM(2017)626)

    Google Scholar 

  8. Ammenwerth E, Aly AF, Burkle T et al (2014) Memorandum on the use of information technology to improve medication safety. Methods Inf Med 53(5):336–343. https://doi.org/10.3414/ME14-01-0040

    Article  PubMed  CAS  Google Scholar 

  9. Fortescue EB, Kaushal R, Landrigan CP et al (2003) Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Pediatrics 111:722–729

    Article  PubMed  Google Scholar 

  10. Ghaleb MA, Barber N, Franklin BD, Yeung VW, Khaki ZF, Wong IC (2006) Systematic review of medication errors in pediatric patients. Ann Pharmacother 40:1766–1776

    Article  PubMed  Google Scholar 

  11. de Wildt SN, Tibboel D, Leeder JS (2014) Drug metabolism for the paediatrician. Arch Dis Child 99:1137–1142

    Article  PubMed  Google Scholar 

  12. Use ICoHoTRfRoPfH (2000) Guideline (E11) Clinical Investigation of Medicinal Products in the Pediatric Population.

  13. Seyberth HW, Kauffman RE (2011) Basics and dynamics of neonatal and pediatric pharmacology. In: Seyberth HW, Rane A, Schwab M (Hrsg) Pediatric clinical pharmacology. Springer, Berlin, Heidelberg, S 3–49

    Chapter  Google Scholar 

  14. Agency EM (2017) Reflection paper on the use of extrapolation in the development of medicines for paediatrics (Draft) (EMA/199678/2016).

  15. Neubert A, Wimmer S, Rascher W (2017) Extrapolieren hilft. Dtsch Apoth Ztg 11:50

    Google Scholar 

  16. Anderson BJ, Holford NH (2013) Understanding dosing: children are small adults, neonates are immature children. Arch Dis Child 98:737–744

    Article  PubMed  Google Scholar 

  17. Holford NHG (1996) A size standard for Pharmacokinetics. Clin Pharmacokinet 30:329–332

    Article  PubMed  CAS  Google Scholar 

  18. Anderson BJ, Holford NH (2017) Getting the dose right for obese children. Arch Dis Child 102:54–55

    Article  PubMed  Google Scholar 

  19. Collier H, Nasim M, Gandhi A (2017) Prescribing in obese children: how good are paediatricians? Arch Dis Child 102:61–62

    Article  PubMed  Google Scholar 

  20. European Medicines Agency (2006) Reflection Paper: Formulations of Choice for the Paediatric Population (EMEA/CHMP/PEG/194810/2005)

    Google Scholar 

  21. Van Riet-Nales DA (2016) Safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects. Arch Dis Child 101:662–669

    Article  PubMed  PubMed Central  Google Scholar 

  22. Walsh J, Cram A, Woertz K et al (2014) Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients. Adv Drug Deliv Rev 73:14–33

    Article  PubMed  CAS  Google Scholar 

  23. Neubert A, Wimmer S (2014) Inhaltliche Kriterien für eine gute Verordnung bei Kindern. Ther Umsch 71:352–365

    Article  PubMed  Google Scholar 

  24. Knopf H, Wolf IK, Sarganas G, Zhuang W, Rascher W, Neubert A (2013) Off-label medicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health 13:631

    Article  PubMed  PubMed Central  Google Scholar 

  25. Wong IC, Ghaleb MA, Franklin BD, Barber N (2004) Incidence and nature of dosing errors in paediatric medications: a systematic review. Drug Saf 27:661–670

    Article  PubMed  Google Scholar 

  26. Ziegler J (2013) Verätzte Babyaugen, Strafbefehle gegen Arzt und zwei Apothekerinnen. Deutsche Apotheker Zeitung Online. https://www.deutsche-apotheker-zeitung.de/news/artikel/2013/08/01/strafbefehle-gegen-arzt-und-zwei-apothekerinnen. Zugegriffen: 16.07.2018

  27. Solanki R, Mondal N, Mahalakshmy T, Bhat V (2017) Medication errors by caregivers at home in neonates discharged from the neonatal intensive care unit. Arch Dis Child 102:655–658

    Article  Google Scholar 

  28. American Academy of Pediatrics (2013) Electronic prescribing in pediatrics: toward safer and more effective medication management. Pediatrics 131:824–826

    Article  Google Scholar 

  29. Johnson KB, Lehmann CU (2013) Electronic prescribing in pediatrics: toward safer and more effective medication management. Pediatrics 131:e1350–e1356

    Article  PubMed  Google Scholar 

  30. King WJ, Paice N, Rangrej J, Forestell GJ, Swartz R (2003) The effect of computerized physician order entry on medication errors and adverse drug events in pediatric inpatients. Pediatrics 112:506–509

    Article  PubMed  Google Scholar 

  31. Maaskant JM, Vermeulen H, Apampa B et al (2015) Interventions for reducing medication errors in children in hospital. Cochrane Database Syst Rev. https://doi.org/10.1002/14651858.CD006208.pub3

    Article  PubMed  Google Scholar 

  32. Rinke ML, Bundy DG, Velasquez CA et al (2014) Interventions to reduce pediatric medication errors: a systematic review. Pediatrics 134:338–360

    Article  PubMed  Google Scholar 

  33. van Rosse F, Maat B, Rademaker CM, van Vught AJ, Egberts AC, Bollen CW (2009) The effect of computerized physician order entry on medication prescription errors and clinical outcome in pediatric and intensive care: a systematic review. Pediatrics 123:1184–1190

    Article  PubMed  Google Scholar 

  34. Caldwell NA, Power B (2012) The pros and cons of electronic prescribing for children. Arch Dis Child 97:124–128

    Article  PubMed  Google Scholar 

  35. Chappell K, Newman C (2004) Potential tenfold drug overdoses on a neonatal unit. Arch Dis Child Fetal Neonatal Ed 89:F483–F484

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  36. Pharmaceutical Press (2017) British National Formulary for Children (BNFC) 2017–2018

    Google Scholar 

  37. Taketomo CK (2017–2018) Pediatric & Neonatal Dosage Handbook, 24th Edition, Lexicomp, Hudson, Ohio

  38. van der Zanden T, de Wildt SN, Liem Y et al (2017) Developing a paediatric drug formulary for the Netherlands. Arch Dis Child 102:357–361

    Article  PubMed  Google Scholar 

  39. Benda GI, Hiller JL, Reynolds JW (1986) Benzyl alcohol toxicity: impact on neurologic handicaps among surviving very low birth weight infants. Pediatrics 77:507–512

    PubMed  CAS  Google Scholar 

  40. European Medicines Agency (2017) Annex to the European Commission guideline on “Excipients in the labelling and package leaflet of medicinal products for human use” (SANTE-2017-11668)

    Google Scholar 

  41. American Academy of Pediatrics (1983) Benzyl alcohol: toxic agent in neonatal units. Pediatrics 72:356–358

    Google Scholar 

  42. Gershanik J, Boecler B, Ensley H, McCloskey S, George W (1982) The gasping syndrome and benzyl alcohol poisoning. N Engl J Med 307:1384–1388

    Article  PubMed  CAS  Google Scholar 

  43. American Academy of Pediatrics (1997) „Inactive“ ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics 99:268–278

    Article  Google Scholar 

  44. Arulanantham K, Genel M (1978) Central nervous system toxicity associated with ingestion of propylene glycol. J Pediatr 93:515–516

    Article  PubMed  CAS  Google Scholar 

  45. Glasgow AM, Boeckx RL, Miller MK, MacDonald MG, August GP, Goodman SI (1983) Hyperosmolality in small infants due to propylene glycol. Pediatrics 72:353–355

    PubMed  CAS  Google Scholar 

  46. MacDonald MG, Getson PR, Glasgow AM, Miller MK, Boeckx RL, Johnson EL (1987) Propylene glycol: increased incidence of seizures in low birth weight infants. Pediatrics 79:622–625

    PubMed  CAS  Google Scholar 

  47. American Academy of Pediatrics (1984) Ethanol in liquid preparations intended for children. Pediatrics 73:405–407

    Google Scholar 

  48. Zuccotti GV, Fabiano V (2011) Safety issues with ethanol as an excipient in drugs intended for pediatric use. Expert Opin Drug Saf 10:499–502

    Article  PubMed  CAS  Google Scholar 

  49. Breitkreutz J, Boos J (2007) Paediatric and geriatric drug delivery. Expert Opin Drug Deliv 4:37–45

    Article  PubMed  CAS  Google Scholar 

  50. Reinke CM, Breitkreutz J, Leuenberger H (2003) Aluminium in over-the-counter drugs: risks outweigh benefits? Drug Saf 26:1011–1025

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Kinder- und Jugendklinik, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Loschgestraße 15, 91054, Erlangen, Deutschland

    Antje Neubert &  Wolfgang Rascher

Authors
  1. Antje Neubert
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Wolfgang Rascher
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Antje Neubert.

Ethics declarations

Interessenkonflikt

A. Neubert und W. Rascher, dass kein Interessenkonflikt besteht.

Dieser Beitrag beinhaltet keine von den Autoren durchgeführten Studien an Menschen oder Tieren.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Neubert, A., Rascher, W. Arzneimitteltherapiesicherheit bei Kindern. Bundesgesundheitsbl 61, 1139–1145 (2018). https://doi.org/10.1007/s00103-018-2792-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00103-018-2792-1

Schlüsselwörter

Keywords

Search

Navigation