Active surveillance of adverse drug reactions in children in five Italian paediatric wards
Mariapina Gallo, Antonio Clavenna, Maurizio Bonati, Paolo Siani, Antonio Irpino, Francesco Rossi, Annalisa Capuano
Department of European and Mediterranean Studies, Faculty of Political Studies and Higher European Education Jean Monnet, Second University of Naples, Naples, Italy.
Department of Experimental Medicine, Section of Pharmacology “Leonardo Donatelli”, Center of Pharmacosurveillance and Phar-macoepidemiology, Faculty of Medicine and Surgery, Second University of Naples, Naples, Italy.
Laboratory for Mother and Child Health, Department of Public Health, Mario Negri Institute for Pharmacological Research, Milan, Italy.
Pediatric Department, AORN A. Santobono-Pausillipon Hospital, Naples, Italy.
DOI: 10.4236/ojped.2012.22019   PDF    HTML     5,338 Downloads   9,391 Views   Citations

Abstract

Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot be compared for methodological reasons. A 6-month prospective observational study was, therefore, conducted on the paediatric wards of five hospitals in the Campania Region, Italy. Data were collected on all patients admitted to the wards during the study period through a structured questionnaire administered to the mothers and through a hospital chart review. Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most prescribed was systemic antibacterial agents (47%). Six ADRs occurred during hospitalization (incidence 0.9%; 95% CI 0.2% - 1.7%). In addition, one child was admitted to a hospital for an ADR. Five out of seven ADRs occurred in girls. The skin was the most affected organ. The medications implicated were amoxicillin, acyclovir, ibuprofen, ceftriaxone, paracetamol, and ranitidine. According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. Consequently, healthcare personnel should be alert to the possibility of ADRs. More accurate reporting of ADRs in children would result in safer use of drugs in such patients.

Share and Cite:

Gallo, M. , Clavenna, A. , Bonati, M. , Siani, P. , Irpino, A. , Rossi, F. and Capuano, A. (2012) Active surveillance of adverse drug reactions in children in five Italian paediatric wards. Open Journal of Pediatrics, 2, 111-117. doi: 10.4236/ojped.2012.22019.

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1] Lazarou, J., Pomeranz, B.H. and Corey, P.N. (1998) Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 279, 1200-1205. doi:10.1001/jama.279.15.1200
[2] Schneeweiss, S., Hasford, J., G?ttler, M., Hoffmann, A., Riethling, A.K. and Avorn, J. (2002) Admissions caused by adverse drug events to internal medicine and emergency departments in hospitals: A longitudinal population-based study. European Journal of Clinical Pharmacology, 58, 285-291. doi:10.1007/s00228-002-0467-0
[3] Temple, M.E., Robinson, R.F., Miller, J.C., Hayes, J.R. and Nahata, M.C. (2004) Frequency and preventability of adverse drug reactions in paediatric patients. Drug Safety, 27, 819-829 doi:10.2165/00002018-200427110-00005
[4] Moore, T.J., Weiss, S.R., Kaplan, S. and Blaisdell, C.J. (2002) Reported adverse drug events in infants and children under 2 years of age. Pediatrics, 110, e53. doi:10.1542/peds.110.5.e53
[5] Le, J., Nguyen, T., Law, A.V. and Hodding, J. (2006) Adverse drug reactions among children over a 10-year period. Pediatrics, 118, 555-562. doi:10.1542/peds.2005-2429
[6] Boots, I., Sukhai, R.N., Klein, R.H., Holl, R.A., Wit, J.M., Cohen, A.F. and Burggraaf, J. (2007) Stimulation programs for pediatric drug research—Do children really benefit? European Journal of Pediatrics, 166, 849-855. doi:10.1007/s00431-006-0381-z
[7] Hoppu, K. (2008) Paediatric clinical pharmacology: At the beginning of a new era. European Journal of Clinical Pharmacology, 64, 201-205. doi:10.1007/s00228-007-0390-5
[8] Titchen, T., Cranswick, N. and Beggs, S. (2005) Adverse drug reactions to nonsteroidal anti-inflammatory drugs, COX-2 inhibitors and paracetamol in a paediatric hospital. British Journal of Clinical Pharmacology, 59, 718-723 doi:10.1111/j.1365-2125.2005.02444.x
[9] Clarkson, A. and Choonara, I. (2002) Surveillance for fatal suspected adverse drug reactions in the UK. Archives of Disease in Childhood, 87, 462-466. doi:10.1136/adc.87.6.462
[10] Ward, M.R. (1997) Reye’s syndrome: An update The Nurse Practitioner, 22, 45-46.
[11] Yis, U., Ozdemir, D., Duman, M. and Unal, N. (2005) Metoclopramide induced dystonia in children: Two case reports European Journal of Emergency Medicine, 12, 117-119. doi:10.1097/00063110-200506000-00004
[12] Clavenna, A. and Bonati, M. (2009) Adverse drug reactions in childhood: A review of prospective studies and safety alerts Archives of Disease in Childhood, 94, 724-728. doi:10.1136/adc.2008.154377
[13] Smyth, R.M., Gargon, E., Kirkham, J., Cresswell, L., Golder, S., Smyth, R. and Williamson, P. (2012) Adverse drug reactions in children—A systematic review. PLoS One, 7, e24061. doi:10.1371%2Fjournal.pone.0024061
[14] Aagaard, L., Christensen, A. and Hansen, E.H. (2010) Information about adverse drug reactions reported in children: A qualitative review of empirical studies. British Journal of Clinical Pharmacology, 70, 481-491. doi:10.1111/j.1365-2125.2010.03682.x
[15] Conroy, S., Choonara, I., Impicciatore, P., Mohn, A., Arnell, H., Rane, A., Knoeppel, C., Seyberth, H., Pandolfini, C., Raffaelli, M.P., Rocchi, F., Bonati, M., Jong, G., de Hoog, M. and van den Anker, J. (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for drug investigation in children. British Medical Journal, 320, 79-82. doi:10.1136/bmj.320.7227.79
[16] Pandolfini, C. and Bonati, M. (2005) A literature review on off-label drug use in children. European Journal of Pediatrics, 164, 552-558. doi:10.1007/s00431-005-1698-8
[17] Choonara, I. and Conroy, S. (2002) Unlicensed and off-label drug use in children: implication for safety. Drug Safety, 2, 1-5. doi:10.2165/00002018-200225010-00001
[18] Neubert, A., Dormann, H., Weiss, J., Egger, T., Criegee-Rieck, M., Rascher, W., Brune, K. and Hinz, B. (2004) The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Safety, 27, 1059-1067. doi:10.2165/00002018-200427130-00006
[19] Impicciatore, P., Mohn, A., Chiarelli, F., Pandolfini, C. and Bonati, M. (2002) Adverse drug reactions to off-label drugs on a paediatric ward: An Italian prospective pilot study. Paediatric Perinatal Drug Therapy, 5, 19-24. doi:10.1185/146300902322125118
[20] Menniti-Ippolito, F., Da Cas, R., Bolli, M. and Capuano, A. (2007) Studio multicentrico sulla sicurezza dei farmaci in pediatria. Quaderni ACP, 14, 98-102.
[21] Menniti-Ippolito, F., Sagliocca, L., Da Cas, R., Saggiomo, G., Di Nardo, R. and Traversa, G. (2001) Niflumic acid and cutaneous reactions in children. Archives of Disease in Childhood, 84, 430-431. doi:10.1136/adc.84.5.430
[22] World Health Organization (2002) International drug monitoring of adverse reaction terminology. The Uppsala Monitoring Centre, Uppsala.
[23] Naranjo, C.A., Busto, U., Sellers, E.M., Sandor, P., Ruiz, I., Roberts, E., Janecek, E., Domecq, C. and Greenblatt, D.J. (1981) A method for estimating the probability of adverse drug reactions. Clinical Pharmacology and Therapeutics, 30, 239-245. doi:10.1038/clpt.1981.154
[24] Clavenna, A. and Bonati, M. (2009) Drug prescriptions to outpatient children: A review of the literature. European Journal of Clinical Pharmacology, 65, 749-755. doi:10.1007/s00228-009-0679-7
[25] Clavenna, A., Berti, A., Gualandi, L., Rossi, E., De Rosa, M. and Bonati, M. (2009) Drug utilisation profile in the Italian paediatric population. European Journal of Pediatrics, 168, 173-180. doi:10.1007/s00431-008-0725-y
[26] Buajordet, I., Wesenberg, F., Br?rs, O. and Langslet, A. (2002) Adverse drug events in children during hospitalization and after discharge in a Norwegian university hospital. Acta Paediatrica, 91, 88-94. doi:10.1111/j.1651-2227.2002.tb01647.x
[27] Jonville-Béra, A.P., Giraudeau, B., Blanc, P., Beau-Salinas, F. and Autret-Leca, E. (2002) Frequency of adverse drug reactions in children: A prospective study. British Journal of Clinical Pharmacology, 53, 207-210. doi:10.1046/j.0306-5251.2001.01535.x
[28] Neubert, A., Dormann, H., Weiss J., Criegee-Rieck, M., Ackermann, A. and Levy, M.(2006) Are computerised monitoring systems of value to improve pharmacovigilance in paediatric patients? European Journal of Clinical Pharmacology, 62, 959-965. doi:10.1007/s00228-006-0197-9
[29] Ciofi Degli Atti, M.L., Raponi, M., Tozzi, A.E., Ciliento, G., Ceradini, J. and Langiano, T. (2008) Point prevalence study of antibiotic use in a paediatric hospital in Italy. Euro Surveillance, 13, 41.
[30] Star, K., Norén, G.N., Nordin, K. and Edwards, I.R. (2011) Suspected adverse drug reactions reported for children worldwide: An exploratory study using vigibase. Drug Safety, 34, 415-428. doi:10.2165/11587540-000000000-00000
[31] Weiss, J., Krebs, S., Hoffmann, C., Werner, U., Neubert, A., Brune, K. and Rascher, W. (2002) Survey of adverse drug reactions on a pediatric ward: A strategy for early and detailed detection. Pediatrics, 110, 254-257. doi:10.1542/peds.110.2.254
[32] Hasford, J., Goettler, M., Munter, K.H. and Muller-Oerlinghausen, B. (2002) Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. Journal Clinical Epidemiology, 55, 945-950. doi:10.1016/S0895-4356(02)00450-X
[33] Herdeiro, M.T., Figueiras, A., Polónia, J. and Gestal-Otero, J.J. (2005) Physicians’ attitudes and adverse drug reaction reporting: A case-control study in Portugal. Drug Safety, 28, 825-833. doi:10.2165/00002018-200528090-00007
[34] Figueiras, A., Herdeiro, M.T., Polónia, J. and Gestal-Otero, J.J. (2006) An educational intervention to improve physician reporting of adverse drug reactions: A cluster-randomized controlled trial. JAMA, 296, 1086-1093. doi:10.1001/jama.296.9.1086
[35] Arencibia, Z.B., Sotomayor, D.N., Mollinedo, N.C., Choonara, I., Manzano, E.F. and Leyva, A.L. (2010) Adverse drug reactions in children in Camagüey Province, Cuba. Archives of Disease in Childhood, 95, 474-477. doi:10.1136/adc.2009.180786

Copyright © 2024 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.