Skip to main content

Advertisement

Log in

Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

This study aims to describe the drug use on a Neonatal Intensive Care Unit (NICU) at a University Children’s Hospital in Germany, to investigate the licensing status of the drugs used and to conclude critical areas in neonatal intensive care to support prioritisation of future research.

Methods

An 11-month, prospective cohort study was conducted on the NICU at the University Children’s Hospital Erlangen, Germany. All products prescribed during the study period were analysed whether or not the SPC contains information on term and preterm neonates.

Results

A total of 183 patients (102 male) with a mean gestational age of 33.6 weeks (minimum = 24, maximum = 42) were included. The mean length of hospitalisation was 19.4 days (minimum = 2, maximum = 167). On average, patients received 11.1 drugs (minimum = 0, maximum = 46). The majority of prescriptions were accounted for by antibiotics (n = 515), which were received by 90% of all patients, followed by CNS drugs (n = 448) and respiratory drugs (n = 306). Of all the different drugs prescribed (n = 102) only 38% had information regarding their use in patients aged less than 1 month in their SPC. Analgesics and cardiovascular drugs were prescribed frequently, but without having information for use in neonates. Seventy percent of all patients and 100% of very preterm infants received at least one of these drugs.

Conclusions

Treatment strategies on a preterm intensive care unit are complex and little information is available for the drugs used. Analgesics and cardiovascular drugs are of major concern. Efforts will have to be made to conduct well-designed and powered studies in this vulnerable population.

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

Access this article

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

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

References

  1. Du W, Warrier I, Tutag Lehr V, Salari V, Ostrea E, Aranda JV (2006) Changing patterns of drug utilization in a neonatal intensive care population. Am J Perinatol 23:279–285

    Article  PubMed  Google Scholar 

  2. Saigal S, Doyle LW (2008) An overview of mortality and sequelae of preterm birth from infancy to adulthood. Lancet 371:261–269

    Article  PubMed  Google Scholar 

  3. Lindner U, Hilgendorff A, Frey G, Gortner L (2008) Drug utilisation in very preterm infants: any changes during the past decade? Klin Padiatr 220:238–242

    Article  CAS  PubMed  Google Scholar 

  4. Warrier I, Du W, Natarajan G, Salari V, Aranda J (2006) Patterns of drug utilization in a neonatal intensive care unit. J Clin Pharmacol 46:449–455

    Article  PubMed  Google Scholar 

  5. European Commission (2006) Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use. European Commission, Brussels

  6. Neubert A, Planner C, Cranswick N (2008) The new European regulation on pediatric medicines: safety and ethics perspectives. Paediatr Drugs 10:147–149

    Article  PubMed  Google Scholar 

  7. Senate and House of Representatives of the United States of America (2003) Pediatric Research Equity Act of 2003

  8. World Health Organisation (2007) Making medicines child size. World Health Organisation, Geneva

  9. Dell’Aera M, Gasbarro AR, Padovano M, Laforgia N, Capodiferro D, Solarino B, Quaranta R, Dell’Erba AS (2007) Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci 29:361–367

    Article  PubMed  Google Scholar 

  10. Turner S, Nunn AJ, Fielding K, Choonara I (1999) Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 88:965–968

    Article  CAS  PubMed  Google Scholar 

  11. WHO Collaborating Centre for Drug Statistics Methodology. Anatomical-Therapeutical-Chemical (ATC) Classification—Index and Guidelines. World Health Organisation, Geneva

  12. Daniell AJ, Darlow BA (1989) Audit of drug usage in a regional neonatal intensive care unit. Aust Paediatr J 25:207–210

    CAS  PubMed  Google Scholar 

  13. Lesko SM, Epstein MF, Mitchell AA (1990) Recent patterns of drug use in newborn intensive care. J Pediatr 116:985–990

    Article  CAS  PubMed  Google Scholar 

  14. Gortner L, Bernsau U, Brand M, Hellwege HH, Hieronimi G, Jorch G, Reiter HL, Versmold H (1991) Drug utilization in very premature infants in neonatal intensive care units. Dev Pharmacol Ther 17:167–171

    CAS  PubMed  Google Scholar 

  15. Conroy S, McIntyre J, Choonara I (1999) Unlicensed and off label drug use in neonates. Arch Dis Child Fetal Neonatal Ed 80:F142–F144

    Article  CAS  PubMed  Google Scholar 

  16. Turner MA, Lewis S, Field D (2008) Priorities in neonatal medicines research: a scoping exercise, Abstract, Biannual Meeting ESDPP, Rotterdam

  17. O’Donnell CP, Stone RJ, Morley CJ (2002) Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics 110:e52

    Article  PubMed  Google Scholar 

  18. Clark RH, Bloom BT, Spitzer AR, Gerstmann DR (2006) Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics 117:1979–1987

    Article  PubMed  Google Scholar 

  19. Gordon A, Jeffery HE (2005) Antibiotic regimens for suspected late onset sepsis in newborn infants. Cochrane Database Syst Rev CD004501

  20. Cunha GS, Mezzacappa FF, Ribeiro JD (2003) Maternal and neonatal factors affecting the incidence of bronchopulmonary dysplasia in very low birth weight newborns. J Pediatr (Rio J) 79:550–556

    Google Scholar 

  21. Sweet DG, Halliday HL (2000) A risk-benefit assessment of drugs used for neonatal chronic lung disease. Drug Saf 22:389–404

    Article  CAS  PubMed  Google Scholar 

  22. Stevens TP, Blennow M, Myers EH, Soll R (2007) Early surfactant administration with brief ventilation vs. selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome. Cochrane Database Syst Rev CD003063

  23. Soll RF, Morley CJ (2001) Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev CD000510

  24. Yost CC, Soll RF (2000) Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev CD001456

  25. Been JV, Zimmermann LJ (2007) What’s new in surfactant? A clinical view on recent developments in neonatology and paediatrics. Eur J Pediatr 166:889–899

    Article  CAS  PubMed  Google Scholar 

  26. Hughes JL, McCall E, Alderdice F, Jenkins J (2006) More and earlier surfactant for preterm infants. Arch Dis Child Fetal Neonatal Ed 91:F125–F126

    Article  CAS  PubMed  Google Scholar 

  27. Avenel S, Bomkratz A, Dassieu G, Janaud JC, Danan C (2000) The incidence of prescriptions without marketing product license in a neonatal intensive care unit. Arch Pediatr 7:143–147

    Article  CAS  PubMed  Google Scholar 

  28. Knoeppel C, Klinger O, Soergel M, Seyberth HW, Leonhardt A (2000) Anwendung von Medikamenten außerhalb der Zulassung oder ohne Zulassung bei Kindern. Monatsschr Kinderheilkd 148:904–908

    Article  Google Scholar 

  29. European Medicine Agency (2008) Priority list of off-patent medicinal products for paediatric studies. EMEA, London

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Antje Neubert.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Neubert, A., Lukas, K., Leis, T. et al. Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis. Eur J Clin Pharmacol 66, 87–95 (2010). https://doi.org/10.1007/s00228-009-0722-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-009-0722-8

Keywords

Navigation