nach oben

Pediatric Drugs

Erschienen in:

01.02.2012 | Editorial

Pharmacovigilance in Pediatrics

Current Challenges

verfasst von: Dr Antje Neubert

Erschienen in: Pediatric Drugs | Ausgabe 1/2012

Einloggen, um Zugang zu erhalten

Excerpt

Over the last decade, the striking shortfalls in the provision of safe and effective medicines for children and adolescents have been increasingly recognized. …

European Commission. Regulation (EC) No 1ss901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_378/l_37820061227en00010019.pdf [Accessed 2011 Aug 9]

Senate and House of Representatives of the United States of America. Pediatric Research Equity Act of 2003 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM077853.pdf [Accessed 2011 Sept 17]

The Uppsala Monitoring Centre. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre. Uppsala: WHO Collaborating Centre for International Drug Monitoring, 2000

Choonara I. Paediatric pharmacovigilance. Paed Perinat Drug Ther 2006; 7(2):50–3CrossRef

Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52(1): 77–83PubMedCrossRef

Clavenna A, Bonati M. Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child 2009; 94(9): 724–8PubMedCrossRef

Rashed A, Wong I, Cranswick N, et al. Adverse Drug Reactions in Children-International Surveillance and Evaluation (ADVISE): a multicentre cohort study. Drug Saf. In press

Gallagher RM, Bird KA, Mason JR, et al. Adverse drug reactions causing admission to a paediatric hospital: a pilot study. J Clin Pharm Ther 2011; 36(2): 194–9PubMedCrossRef

Verhamme K, Bonifazi F, Ceci A, et al. Adverse drug reactions reporting in children. Pharmaceutic Policy Law 2009; (11): 89–99

10.

Star K, Noren GN, Nordin K, et al. Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase. Drug Saf 2011; 34(5): 415–28PubMedCrossRef

11.

European Medicine Agency. Paediatric Committee (PDCO) monthly report, September 2011 [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2011/09/WC500112091.pdf [Accessed 2011 Sep 17]

12.

Olski TM, Lampus SF, Gherarducci G, et al. Three years of paediatric regulation in the European Union. Eur J Clin Pharmacol 2011; 67(3): 245–52PubMedCrossRef

13.

European Commission CORDIS. Seventh Framework Programme (FP7) [online]. Available from URL: http://cordis.europa.eu/fp7/home_en.html [Accessed 2011 Sep 23]

14.

Paediatric Medicines Section, European Medicine Agency. Report to the European Commission. EMA/163613/2011 11 A.D [online]. Available from URL: http://ec.europa.eu/health/files/paediatrics/2011_report_art50l.pdf [Accessed 2011 Sep 6]

15.

ADDUCE: Attention deficit hyperactivity disorder drugs use chronic effects [online]. Available from URL: http://adhd-adduce.org [Accessed 2011 Aug 1]

16.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29(5): 385–96PubMedCrossRef

17.

Carleton B, Poole R, Smith M, et al. Adverse drug reaction active surveillance: developing a national network in Canada’s children’s hospitals. Pharma-coepidemiol Drug Saf 2009; 18(8): 713–21CrossRef

18.

Clarkson A, Conroy S, Burroughs KCI. Surveillance for adverse drug reactions in children: a paediatric regional monitoring centre. Paediatr Perinat Drug Ther 2004; 6: 20–3CrossRef

19.

Menniti-Ippolito G, Raschetti R, Da CR, et al. Active monitoring of adverse drug reactions in children. Italian Paediatric Pharmacosurveillance Multi-center Group. Lancet 2000; 355(9215): 1613–4PubMedCrossRef

20.

Ortega A, Aguinagalde A, Lacasa C, et al. Efficacy of an adverse drug reaction electronic reporting system integrated into a hospital information system. Ann Pharmacother 2008; 42(10): 1491–6PubMedCrossRef

21.

Sanz EJ, De-las-Cuevas C, Kiuru A, et al. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet 2005; 365(9458): 482–7PubMed

22.

European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) [online]. Available from URL: http://www.encepp.eu [Accessed 2011 Aug 9]

23.

Dormann H, Muth-Selbach U, Krebs S, et al. Incidence and costs of adverse drug reactions during hospitalisation: computerised monitoring versus stimulated spontaneous reporting. Drug Saf 2000; 22(2): 161–8PubMedCrossRef

24.

Egger T, Dormann H, Ahne G, et al. Identification of adverse drug reactions in geriatric inpatients using a computerised drug database. Drugs Aging 2003; 20(10): 769–76PubMedCrossRef

25.

Evans RS, Pestotnik SL, Classen DC, et al. Development of a computerized adverse drug event monitor. Proc Annu Symp Comput Appl Med Care 1991; 23–7

26.

Jha AK, Kuperman GJ, Teich JM, et al. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J Am Med Inform Assoc 1998; 5(3): 305–14PubMedCrossRef

27.

Seger AC, Jha AK, Bates DW. Adverse drug event detection in a community hospital utilising computerised medication and laboratory data. Drug Saf 2007; 30(9): 817–24PubMedCrossRef

28.

Haffner S, von Laue N, Wirth S, et al. Detecting adverse drug reactions on paediatric wards: intensified surveillance versus computerised screening of laboratory values. Drug Saf 2005; 28(5): 453–64PubMedCrossRef

29.

Neubert A, Dormann H, Weiss J, et al. Are computerised monitoring systems of value to improve pharmacovigilance in paediatric patients? Eur J Clin Pharmacol 2006; 62(11): 959–65PubMedCrossRef

30.

Takata GS, Mason W, Taketomo C, et al. Development, testing, and findings of a pediatric-focused trigger tool to identify medication-related harm in US children’s hospitals. Pediatrics 2008; 121(4): e927–35PubMedCrossRef

31.

Matlow AG, Cronin CM, Flintoft V, et al. Description of the development and validation of the Canadian Paediatric Trigger Tool. BMJ Qual Saf 2011; 20(5): 416–23PubMedCrossRef

32.

European Commission. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Official Journal of the European Union 2010: L 348/1–16 [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:en:pdf [Accessed 2011 Sept 6]

33.

European Commission. FP7 Cooperation Work Programme: Health-2012, European Commission C(2011)5068 of 19 July 2011 [online]. Available from URL: http://ec.europa.eu/research/fp7/pdf/wp2012/wp2012_cooperation_health.pdf [Accessed 2011 Sep 17]

Titel: Pharmacovigilance in Pediatrics
Current Challenges
verfasst von: Dr Antje Neubert
Publikationsdatum: 01.02.2012
Verlag: Springer International Publishing
Erschienen in: Pediatric Drugs / Ausgabe 1/2012
Print ISSN: 1174-5878
Elektronische ISSN: 1179-2019
DOI: https://doi.org/10.2165/11596590-000000000-00000

Update Pädiatrie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen

Springer Medizin

Pharmacovigilance in Pediatrics

Current Challenges

Excerpt

Neu im Fachgebiet Pädiatrie

Neuer Typ-1-Diabetes bei Kindern am Wochenende eher übersehen

Neue Studienergebnisse zur Myopiekontrolle mit Atropin

Spinale Muskelatrophie: Neugeborenen-Screening lohnt sich

Fünf Dinge, die im Kindernotfall besser zu unterlassen sind

Update Pädiatrie

Springer Medizin

Excerpt

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 1/2012

Management of Pediatric Eosinophilic Esophagitis

Drug Exposure and Pregnancy Outcome in Mozambique

Celiac Disease in Pediatric Patients with Autoimmune Hepatitis

Pneumococcal Polysaccharide Conjugate Vaccine (13-Valent, Adsorbed) [Prevenar 13®]

Defining Juvenile Idiopathic Arthritis Remission and Optimum Time for Disease-Modifying Anti-Rheumatic Drug Withdrawal

Anesthetic-Related Neurotoxicity and the Developing Brain

Neu im Fachgebiet Pädiatrie

Neuer Typ-1-Diabetes bei Kindern am Wochenende eher übersehen

Neue Studienergebnisse zur Myopiekontrolle mit Atropin

Spinale Muskelatrophie: Neugeborenen-Screening lohnt sich

Fünf Dinge, die im Kindernotfall besser zu unterlassen sind

Update Pädiatrie