Skip to main content

Advertisement

Log in

Drug utilisation profile in the neonatal unit of a university hospital: a prospective observational study in Brazil

  • Research Article
  • Published:
International Journal of Clinical Pharmacy Aims and scope Submit manuscript

Abstract

Background Advances in neonatology have contributed to changes in the drug utilisation profile in neonates, both in the number of drugs and the pharmacotherapeutic groups. Objective To analyse drug use in the neonatal care unit of a teaching hospital in Brazil and to evaluate the associations among perinatal, clinical care and drug use data. Setting The neonatal care unit of a teaching hospital in Brazil. Methods A prospective observational study was conducted. Perinatal, clinical care and pharmacotherapy data were collected from the patients’ medical records. Labelling information regarding neonatal use was analysed for prescribed drugs. The data were analysed using univariate descriptive statistics and quasi-Poisson regression. Main outcome measure Frequency of drug use by gestational age. Results The study included 187 patients; 157 (84.0 %) received drugs. The mean gestational age was 35.8 weeks. The mean number of drugs prescribed per patient was 6.4. The number of drugs used was inversely correlated to gestational age and birth weight. The most commonly prescribed drugs belonged to the following anatomical therapeutic chemical groups: nervous system drugs, anti-infectives for systemic use, and alimentary tract and metabolism drugs. Information regarding neonatal use was given in the labelling of only 20.5 % of the prescribed drugs. Of these, only 9.5 % had information specific for preterm infants. Conclusions Drug administration to neonates is frequently and inversely correlated to gestational age and birth weight. Neonates are exposed to different therapeutic classes, reflecting scientific advances in neonatology. In Brazil, the percentage of drugs with neonate-specific labelling information is low. Consequently, there is an evident need for efforts to guarantee effective and safe pharmacotherapy for neonates.

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.

Similar content being viewed by others

References

  1. Flor-de-Lima F, Rocha G, Guimarães H. Impact of changes in perinatal care on neonatal respiratory outcome and survival of preterm newborns: an overview of 15 years. Crit Care Res Pract. 2012; 1–7.

  2. Chatterjee S, Mandal A, Lyle N, Mukherjee S, Singh AK. Drug utilization study in a neonatology unit of a tertiary care hospital in eastern India. Pharmacoepidemiol Drug Saf. 2007;16(10):1141–5.

    Article  PubMed  Google Scholar 

  3. Warrier I, Du W, Natarajan G, Salari V, Aranda J. Patterns of drug utilization in a neonatal intensive care unit. J Clin Pharmacol. 2006;46(4):449–55.

    Article  PubMed  Google Scholar 

  4. Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006;117(6):1979–87.

    Article  PubMed  Google Scholar 

  5. Lesko SM, Epstein MF, Mitchell AA. Recent patterns of drug use in newborn intensive care. J Pediatr. 1990;116(6):985–90.

    Article  CAS  PubMed  Google Scholar 

  6. Aranda J, Collinge J, Clarkson S. Epidemiologic aspects of drug utilization in a newborn intensive care unit. Semin Perinatol. 1982;6:148–54.

    CAS  PubMed  Google Scholar 

  7. Conroy S, McIntyre J, Choonara I. Unlicensed and off label drug use in neonates. Arch Dis Child Fetal Neonatal Ed. 1999;80(2):F142–5.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  8. Neubert A, Lukas K, Leis T, Dormann H, Brune K, Rascher W. Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis. Eur J Clin Pharmacol. 2010;66(1):87–95.

    Article  PubMed  Google Scholar 

  9. Jacqz-Aigrain E. Drug policy in Europe: research and funding in neonates: current challenges, future perspectives, new opportunities. Early Hum Dev. 2011;87:S27–30.

    Article  PubMed  Google Scholar 

  10. Carvalho C, Ribeiro M, Bonilha M, Fernandes M Jr, Procianoy RS, Silveira R. Use of off-label and unlicensed drugs in the neonatal intensive care unit and its association with severity scores. J Pediatr. 2012;88(6):465–70.

    Google Scholar 

  11. Sequi M, Campi R, Clavenna A, Bonati M. Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies. Eur J Clin Pharmacol. 2013;69(3):599–604.

    Article  PubMed  Google Scholar 

  12. World Health Organization. Recommended definitions, terminology and format for statistical tables related to the perinatal period and use of a new certificate for cause of perinatal deaths. Acta Obstet Gynecol Scand. 1977;56:247–53.

    Google Scholar 

  13. World Health Organization. Collaboration Centre for Drug Statistics Methodology. Anatomical-therapeutical-chemical (ATC) classification—index and guidelines. http://www.who.no/atcddd. Accessed 13 Aug 2014.

  14. Oliveira EA, Bertoldi AD, Domingues MR, Santos IS, Barros AJD. Factors associated to medicine use among children from the 2004 Pelotas Birth Cohort (Brazil). Rev Saude Publica. 2012;46(3):487–96.

    Article  PubMed  Google Scholar 

  15. Ellsbury DL, Ursprung RA. Quality improvement approach to optimizing medication use in the neonatal intensive care unit. Clin Perinatol. 2012;39(1):1–10.

    Article  PubMed  Google Scholar 

  16. Kumar P, Walker JK, Hurt KM, Bennett KM, Grosshans N, Fotis MA. Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications. J Pediatr. 2008;152(3):412–5.

    Article  PubMed  Google Scholar 

  17. Lass J, Käär R, Jõgi K, Varendi H, Metsvaht T, Lutsar I. Drug utilisation pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol. 2011;67(12):1263–71.

    Article  PubMed  Google Scholar 

  18. Dell’Aera M, Gasbarro AR, Padovano M, Laforgia N, Capodiferro D, Solarino B, Quaranta R, Dell’Erba AS. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci. 2007;29(4):361–7.

    Article  PubMed  Google Scholar 

  19. O’Donnell CPF, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics. 2002;110(5):e52.

    Article  PubMed  Google Scholar 

  20. Nguyen KA, Claris O, Kassai B. Unlicensed and off-label drug use in a neonatal unit in France. Acta Paediatr. 2011;100(4):615–7.

    Article  PubMed  Google Scholar 

  21. Du W, Warrier I, Tutag LV, Salari V, Ostrea E, Aranda JV. Changing patterns of drug utilization in a neonatal intensive care population. Am J Perinatol. 2006;23(5):279–86.

    Article  PubMed  Google Scholar 

  22. Grohskopf LA, Huskins WC, Sinkowitz-Cochran RL, Levine GL, Goldmann DA, Jarvis WR. Use of antimicrobial agents in United States neonatal and pediatric intensive care patients. Pediatr Infect Dis J. 2005;24(9):766–73.

    Article  PubMed  Google Scholar 

  23. Turner MA, Lewis S, Hawcutt DB, Field D. Prioritising neonatal medicines research: UK Medicines for Children Research Network scoping survey. BMC Pediatr. 2009;9:50.

    Article  PubMed Central  PubMed  Google Scholar 

  24. Cunha GSMF, Ribeiro JD. Maternal and neonatal factors affecting the incidence of bronchopulmonary dysplasia in very low birth weigth newborns. J Pediatr. 2003;79:550–6.

    Google Scholar 

  25. Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Halliday HL. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants—2010 update. Neonatology. 2010;97(4):402–17.

    Article  PubMed  Google Scholar 

  26. Lindner U, Hilgendorff A, Frey G, Gortner L. Drug utilisation in very preterm infants: any changes during the past decade? Klin Padiatr. 2008;220(4):238–42.

    Article  CAS  PubMed  Google Scholar 

  27. Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006;354(20):2112–21.

    Article  CAS  PubMed  Google Scholar 

  28. Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W. Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med. 2007;357(19):1893–902.

    Article  CAS  PubMed  Google Scholar 

  29. Poets CF. What are the main research findings during the last 5 years that have changed my approach to clinical practice? Arch Dis Child Fetal Neonatal. 2013;98:89–92.

    Article  Google Scholar 

  30. Nassi NDM, Agostiniani S, Lombardi E, Favilli S, Donzelli GP. Sildenafil as first line therapy in pulmonary persistent hypertension of th newborn? J Matern Fetal Neonatal Med. 2010;23(Suppl 3):104–5.

    Article  PubMed  Google Scholar 

  31. Barst RJ, Ivy DD, Gaitan G, Szatmari A, Rudzinski A, Garcia AE, Sastry B, Pulido T, Layton GR, Serdarevic-Pehar MA. Randomized, double-blind, placebo-controlled, dose-ranging study of oral sildenafil citrate in treatment-naive children with pulmonary arterial hypertensionclinical perspective. Circulation. 2012;125(2):324–34.

    Article  CAS  PubMed  Google Scholar 

  32. Abman SH, Kinsella JP, Rosenzweig EB, Krishnan U, Kulik T, Mullen M, Wessel DL, Steinhorn R, Adatia I, Hanna B. Implications of the FDA warning against the use of sildenafil for the treatment of pediatric pulmonary hypertension. Am J Respir Crit Care Med. 2012;187(6):572–5.

    Article  PubMed  Google Scholar 

  33. Davis JM, Connor EM, Wood AJJ. The need for rigorous evidence on medication use in preterm infants: is it time for a neonatal rule? Medication use in preterm infants. JAMA. 2012;308(14):1435–6.

    Article  CAS  PubMed  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  35. National Institutes of Health (NIH). Best pharmaceuticals for children act (BPCA) priority list of needs in pediatric therapeutics. http://bpca.nichd.nih.gov/prioritization/status/documents/priority_list_10-26-2012.pdf. Accessed 13 Aug 2014.

  36. Ward RM, Benitz WE, Benjamin D Jr, Blackmon L, Giacoia GP, Hudak M, Lasky T, Rodriguez W, Selen A. Criteria supporting the study of drugs in the newborn. Clin Ther. 2006;28(9):1385–98.

    Article  CAS  PubMed  Google Scholar 

  37. Nunn TWJ. Lack of pediatric drug formulations. Br J Clin Pharmacol. 2005;59(6):674–6.

    Article  PubMed Central  PubMed  Google Scholar 

  38. Tan E, Cranswick NE, Rayner CR, Chapman CB. Dosing information for paediatric patients: are they really” therapeutic orphans”? Med J Aust. 2003;179(4):195–8.

    PubMed  Google Scholar 

  39. Costa PQ, Rey LC, Coelho HLL. Lack of drug preparations for use in children in Brazil. J Pediatr. 2009;85(3):229–35.

    Article  Google Scholar 

  40. Nahata MC. Lack of pediatric drug formulations. Pediatrics. 2009;104:607–9.

    Google Scholar 

  41. Nahata MC. Extemporaneous drug formulations. Clin Ther. 2008;30(11):2112–9.

    Article  PubMed  Google Scholar 

Download references

Funding

This research was supported by a grant from Pró-Reitoria de Pesquisa da Universidade Federal de Minas Gerais for the Qualitative Improvement Program of Scientific Production.

Conflicts of interest

The authors declare no conflict of interest.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Adriano Max Moreira Reis.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Gonçalves, A.C.S., Reis, A.M.M., Gusmão, A.C.M. et al. Drug utilisation profile in the neonatal unit of a university hospital: a prospective observational study in Brazil. Int J Clin Pharm 37, 645–655 (2015). https://doi.org/10.1007/s11096-015-0109-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11096-015-0109-0

Keywords

Navigation