International Journal of Clinical Pharmacy

, Volume 37, Issue 4, pp 645–655 | Cite as

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

  • Adriana Cristina de Souza Gonçalves
  • Adriano Max Moreira Reis
  • Ana Carolina Marçal Gusmão
  • Maria Cândida Ferrarez Bouzada
Research Article

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.

Keywords

Brazil Drug utilisation Infant Intensive care units Neonatal Neonatology Newborn Pharmacoepidemiology 

References

  1. 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.Google Scholar
  2. 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.PubMedCrossRefGoogle Scholar
  3. 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.PubMedCrossRefGoogle Scholar
  4. 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.PubMedCrossRefGoogle Scholar
  5. 5.
    Lesko SM, Epstein MF, Mitchell AA. Recent patterns of drug use in newborn intensive care. J Pediatr. 1990;116(6):985–90.PubMedCrossRefGoogle Scholar
  6. 6.
    Aranda J, Collinge J, Clarkson S. Epidemiologic aspects of drug utilization in a newborn intensive care unit. Semin Perinatol. 1982;6:148–54.PubMedGoogle Scholar
  7. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  8. 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.PubMedCrossRefGoogle Scholar
  9. 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.PubMedCrossRefGoogle Scholar
  10. 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. 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.PubMedCrossRefGoogle Scholar
  12. 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. 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. 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.PubMedCrossRefGoogle Scholar
  15. 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.PubMedCrossRefGoogle Scholar
  16. 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.PubMedCrossRefGoogle Scholar
  17. 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.PubMedCrossRefGoogle Scholar
  18. 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.PubMedCrossRefGoogle Scholar
  19. 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.PubMedCrossRefGoogle Scholar
  20. 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.PubMedCrossRefGoogle Scholar
  21. 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.PubMedCrossRefGoogle Scholar
  22. 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.PubMedCrossRefGoogle Scholar
  23. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  24. 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. 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.PubMedCrossRefGoogle Scholar
  26. 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.PubMedCrossRefGoogle Scholar
  27. 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.PubMedCrossRefGoogle Scholar
  28. 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.PubMedCrossRefGoogle Scholar
  29. 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.CrossRefGoogle Scholar
  30. 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.PubMedCrossRefGoogle Scholar
  31. 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.PubMedCrossRefGoogle Scholar
  32. 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.PubMedCrossRefGoogle Scholar
  33. 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.PubMedCrossRefGoogle Scholar
  34. 34.
    Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin Pharmacol Ther. 2012;91(5):796–801.PubMedCrossRefGoogle Scholar
  35. 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. 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.PubMedCrossRefGoogle Scholar
  37. 37.
    Nunn TWJ. Lack of pediatric drug formulations. Br J Clin Pharmacol. 2005;59(6):674–6.PubMedCentralPubMedCrossRefGoogle Scholar
  38. 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.PubMedGoogle Scholar
  39. 39.
    Costa PQ, Rey LC, Coelho HLL. Lack of drug preparations for use in children in Brazil. J Pediatr. 2009;85(3):229–35.CrossRefGoogle Scholar
  40. 40.
    Nahata MC. Lack of pediatric drug formulations. Pediatrics. 2009;104:607–9.Google Scholar
  41. 41.
    Nahata MC. Extemporaneous drug formulations. Clin Ther. 2008;30(11):2112–9.PubMedCrossRefGoogle Scholar

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015

Authors and Affiliations

  • Adriana Cristina de Souza Gonçalves
    • 1
  • Adriano Max Moreira Reis
    • 2
  • Ana Carolina Marçal Gusmão
    • 2
  • Maria Cândida Ferrarez Bouzada
    • 3
  1. 1.Unidade Funcional Farmácia, Hospital das ClínicasUniversidade Federal de Minas GeraisBelo HorizonteBrazil
  2. 2.Faculdade de FarmáciaUniversidade Federal de Minas GeraisBelo HorizonteBrazil
  3. 3.Departamento de Pediatria, Faculdade de Medicina, Hospital das ClínicasUniversidade Federal de Minas GeraisBelo HorizonteBrazil

Personalised recommendations