International Journal of Clinical Pharmacy

, Volume 38, Issue 1, pp 80–87 | Cite as

A comprehensive intervention for adverse drug reactions identification and reporting in a Pediatric Emergency Department

  • Olga Morales RíosEmail author
  • Luis Jasso Gutiérrez
  • Juan O. Talavera
  • Martha María Téllez-Rojo
  • Víctor Olivar López
  • Juan Garduño Espinosa
  • Onofre Muñoz Hernández
Research Article


Background Physicians identify from 45.7 to 96.2 % of Adverse Drug Reactions (ADRs) in their patients, with under-reporting ranging from 6 to 100 %. In order to improve ADR reporting, several interventions have been evaluated in different studies, but not with regard to ADR identification. In addition, it is not known whether some patient characteristics might influence on ADR identification and reporting by physicians. Objectives (a) To assess the effectiveness of a comprehensive intervention directed to Emergency Department physicians and coordinated by a pharmacist in a tertiary care pediatric hospital on ADR identification and reporting. (b) To assess if some of the children’s characteristics might influence on ADR identification and reporting. Setting The Emergency Department of the Hospital Infantil de México “Federico Gómez”, which is a national pediatric institute of health in México. Methods A Quasi-experimental, pre-post test trial was designed. During the intervention, the pharmacist gave talks on Pharmacovigilance and on the program for electronic capture of data, took part in patient visits, left reminders, improved accessibility to ADR report format and performed feedback activities. To classify and quantify correctly identified ADRs and ADRs reported to the Institutional Pharmacovigilance Center (IPC), 1136 clinical records were reviewed. The models were adjusted for patient variables. Main outcome measures Total ADRs, ADRs correctly identified by physicians, ADRs reported to the IPC by physicians. Results Before the intervention, 97 % of ADRs were correctly identified and 6.1 % reported by physicians. During the intervention, 99.6 % were correctly identified and 41.2 % were reported, and after the intervention, 99.6 and 41.7 %, respectively. Identification during the intervention showed a sevenfold increase with regard to preintervention and was maintained post-intervention. ADR reporting during the intervention showed a 14-fold increase with regard to pre-intervention and was maintained during post-intervention. Conclusion Physicians do identify ADRs, but fail to report them. The intervention increased ADR correct identification and reporting. The effect was maintained after the intervention.


Adverse drug reaction ADR reporting Mexico Pediatrics Physicians 




Conflicts of interest



  1. 1.
    Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA. 2002;287(17):2215–20.CrossRefPubMedGoogle Scholar
  2. 2.
    Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA. 1999;281(9):824–9.CrossRefPubMedGoogle Scholar
  3. 3.
    Lindell-Osuagwu L, Korhonen MJ, Saano S, Helin-Tanninen M, Naaranlahti T, Kokki H. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther. 2009;34(3):277–87.CrossRefPubMedGoogle Scholar
  4. 4.
    Meador KJ, Baker GA, Browning N, Clayton-Smith J, Combs-Cantrell DT, Cohen M, et al. Effects of breastfeeding in children of women taking antiepileptic drugs. Neurology. 2010;75(22):1954–60.CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Meador KJ, Baker GA, Browning N, Cohen MJ, Bromley RL, Clayton-Smith J, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurol. 2013;12(3):244–52.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology–drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157–67.CrossRefPubMedGoogle Scholar
  7. 7.
    Thiesen S, Conroy EJ, Bellis JR, Bracken LE, Mannix HL, Bird KA, et al. Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children—a prospective observational cohort study of 6601 admissions. BMC Med. 2013;11:237.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Rashed AN, Wong IC, Cranswick N, Tomlin S, Rascher W, Neubert A. Risk factors associated with adverse drug reactions in hospitalised children: international multicentre study. Eur J Clin Pharmacol. 2012;68(5):801–10.CrossRefPubMedGoogle Scholar
  9. 9.
    Finkelstein Y, Soon GS, Acuna P, George M, Pope E, Ito S, et al. Recurrence and outcomes of Stevens-Johnson syndrome and toxic epidermal necrolysis in children. Pediatrics. 2011;128(4):723–8.CrossRefPubMedGoogle Scholar
  10. 10.
    Gallagher RM, Mason JR, Bird KA, Kirkham JJ, Peak M, Williamson PR, et al. Adverse drug reactions causing admission to a paediatric hospital. PLoS ONE. 2012;7(12):e50127.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Oshikoya KA, Chukwura H, Njokanma OF, Senbanjo IO, Ojo I. Incidence and cost estimate of treating pediatric adverse drug reactions in Lagos, Nigeria. Sao Paulo Med J. 2011;129(3):153–64.CrossRefPubMedGoogle Scholar
  12. 12.
    Fujimoto M, Higuchi T, Hosomi K, Takada M. Association between statin use and cancer: data mining of a spontaneous reporting database and a claims database. Int J Med Sci. 2015;12(3):223–33.CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Star K, Norén GN, Nordin K, Edwards IR. Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase. Drug Saf. 2011;34(5):415–28.CrossRefPubMedGoogle Scholar
  14. 14.
  15. 15.
    Diario Oficial de la Federación. Norma Oficial Mexicana NOM-220-SSA1-2012, Instalación y operación de la Farmacovigilancia. Accessed 17 Sep 2015.
  16. 16.
    Park S, In Y, Suh GY, Sohn K, Kim E. Evaluation of adverse drug reactions in medical intensive care units. Eur J Clin Pharmacol. 2013;69:119–31.CrossRefPubMedGoogle Scholar
  17. 17.
    Becerril-Ángeles M, Aranda-Jan A, Moreno-Quiróz J. Survey of adverse reactions to drugs in hospitalized patients. Rev Alerg Mex. 2011;58:179–84.PubMedGoogle Scholar
  18. 18.
    Oehme AK, Rashed AN, Hefele B, Wong IC, Rascher W, Neubert A. Adverse drug reactions in hospitalised children in Germany are decreasing: results of a nine year cohort-based comparison. PLoS ONE. 2012;7:e44349.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Neubert A, Dormann H, Weiss J, Egger T, Criegee-Rieck M, Rascher W, et al. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf. 2004;27:1059–67.CrossRefPubMedGoogle Scholar
  20. 20.
    Haffner S, von Laue N, Wirth S, Thürmann PA. Detecting adverse drug reactions on paediatric wards: intensified surveillance versus computerised screening of laboratory values. Drug Saf. 2005;28:453–64.CrossRefPubMedGoogle Scholar
  21. 21.
    Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.CrossRefPubMedGoogle Scholar
  22. 22.
    Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013;36(5):317–28.CrossRefPubMedGoogle Scholar
  23. 23.
    Ribeiro-Vaz I, Santos C, da Costa-Pereira A, Cruz-Correia R. Promoting spontaneous adverse drug reaction reporting in hospitals using a hyperlink to the online reporting form: an ecological study in Portugal. Drug Saf. 2012;35(5):387–94.CrossRefPubMedGoogle Scholar
  24. 24.
    Goldstein LH, Berlin M, Saliba W, Elias M, Berkovitch M. Founding an adverse drug reaction (ADR) network: a method for improving doctors spontaneous ADR reporting in a general hospital. J Clin Pharmacol. 2013;53(11):1220–5.PubMedGoogle Scholar
  25. 25.
    Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D. Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013;69(2):237–44.CrossRefPubMedGoogle Scholar
  26. 26.
    Johansson ML, Hägg S, Wallerstedt SM. Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study. BMC Clin Pharmacol. 2011;11:14.CrossRefPubMedPubMedCentralGoogle Scholar
  27. 27.
    Herdeiro MT, Ribeiro-Vaz I, Ferreira M, Polónia J, Falcão A, Figueiras A. Workshop- and telephone-based interventions to improve adverse drug reaction reporting: a cluster-randomized trial in Portugal. Drug Saf. 2012;35(8):655–65.CrossRefPubMedGoogle Scholar
  28. 28.
    Lopez-Gonzalez E, Herdeiro MT, Piñeiro-Lamas M, Figueiras A, GREPHEPI Group. Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial. Drug Saf. 2015;38(2):189–96.CrossRefPubMedGoogle Scholar
  29. 29.
    Jasso Gutiérrez L, Ovando Hernández R, Castellanos Solís EC, Escorza Peña J, Santos Preciado JI. Diseño e implantación de un programa electrónico de Farmacovigilancia con captura en línea en el Hospital Infantil de México Federico Gómez. Bol Med Hosp Infant Mex. 2009;66:51–9.Google Scholar
  30. 30.
    Cook TD, Campbell DT. Quasi-experimentation. Design and analysis issues for field settings. Chicago: Rand McNally College Publising Company; 1979.Google Scholar
  31. 31.
    Uppsala Monitoring Centre. Glossary of terms used in Pharmacovigilance. Accessed 17 Sep 2015.
  32. 32.
    Truven Health Analytics. Micromedex 2.0. Accessed 17 Sep 2015.
  33. 33.
    Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.CrossRefPubMedGoogle Scholar
  34. 34.
    Martínez González MA. Bioestadística Amigable. 2nd ed. España: Diaz de Santos; 2006.Google Scholar
  35. 35.
  36. 36.
    European Medicines Agency. ICH Topic E 11. Clinical Investigation of Medicinal Products in the Paediatric Population. Accessed 17 Sep 2015.
  37. 37.
    International Statistical Classification of Diseases and Related Health Problems 10th Revision. Accessed 17 Sep 2015.
  38. 38.
    Langebrake C, Hilgarth H. Clinical pharmacists’ interventions in a German university hospital. Pharm World Sci. 2010;32(2):194–9.CrossRefPubMedGoogle Scholar
  39. 39.
    Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, Erickson JI, Bates DW. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 1999;282(3):267–70.CrossRefPubMedGoogle Scholar
  40. 40.
    Forster AJ, Jennings A, Chow C, Leeder C, van Walraven C. A systematic review to evaluate the accuracy of electronic adverse drug event detection. J Am Med Inform Assoc. 2012;19(1):31–8.CrossRefPubMedPubMedCentralGoogle Scholar
  41. 41.
    Neubert A, Dormann H, Weiss J, Criegee-Rieck M, Ackermann A, Levy M, et al. Are computerised monitoring systems of value to improve pharmacovigilance in paediatric patients? Eur J Clin Pharmacol. 2006;62(11):959–65.CrossRefPubMedGoogle Scholar
  42. 42.
    Haffner S, von Laue N, Wirth S, Thürmann PA. Detecting adverse drug reactions on paediatric wards: intensified surveillance versus computerised screening of laboratory values. Drug Saf. 2005;28(5):453–64.CrossRefPubMedGoogle Scholar
  43. 43.
    Weiss J, Krebs S, Hoffmann C, Werner U, Neubert A, Brune K, et al. Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection. Pediatrics. 2002;110(2 Pt 1):254–7.CrossRefPubMedGoogle Scholar
  44. 44.
    Phansalkar S, Hoffman JM, Nebeker JR, Hurdle JF. Pharmacists versus nonpharmacists in adverse drug event detection: a meta-analysis and systematic review. Am J Health Syst Pharm. 2007;64(8):842–9.CrossRefPubMedGoogle Scholar
  45. 45.
    van Grootheest AC, de Jong-van den Berg LT. The role of hospital and community pharmacists in pharmacovigilance. Res Soc Adm Pharm. 2005;1(1):126–33.CrossRefGoogle Scholar
  46. 46.
    Khalili H, Mohebbi N, Hendoiee N, Keshtkar AA, Dashti-Khavidaki S. Improvement of knowledge, attitude and perception of healthcare workers about ADR, a pre- and post-clinical pharmacists’ interventional study. BMJ Open. 2012;2:e000367.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015

Authors and Affiliations

  • Olga Morales Ríos
    • 1
    Email author
  • Luis Jasso Gutiérrez
    • 1
  • Juan O. Talavera
    • 2
  • Martha María Téllez-Rojo
    • 3
  • Víctor Olivar López
    • 1
  • Juan Garduño Espinosa
    • 1
  • Onofre Muñoz Hernández
    • 1
  1. 1.Hospital Infantil de Mexico Federico GomezDistrito FederalMexico
  2. 2.Centro Médico Nacional Siglo XXI (IMSS)Distrito FederalMexico
  3. 3.Instituto Nacional de Salud PúblicaCuernavacaMexico

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