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Volumn 4, Issue SUPPL.1, 2013, Pages

Pharmacovigilance in Italy: An overview

Author keywords

ADRs; AIFA; Italian; legislation; monitoring

Indexed keywords

THALIDOMIDE;

EID: 84889583288     PISSN: 0976500X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0976-500X.120942     Document Type: Review
Times cited : (64)

References (45)
  • 2
    • 0032899232 scopus 로고    scopus 로고
    • Counting the cost of drug-related adverse events
    • White T, Arakelian A, Rho JP. Counting the cost of drug-related adverse events. Pharmacoeconomics 1999;15:445-58.
    • (1999) Pharmacoeconomics , vol.15 , pp. 445-458
    • White, T.1    Arakelian, A.2    Rho, J.P.3
  • 3
    • 28244501838 scopus 로고    scopus 로고
    • Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital
    • Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60:653-8.
    • (2005) Br J Clin Pharmacol , vol.60 , pp. 653-658
    • Vallano, A.1    Cereza, G.2    Pedròs, C.3    Agustí, A.4    Danés, I.5    Aguilera, C.6
  • 4
    • 0023925775 scopus 로고
    • Spontaneous reporting of adverse drug reactions. I: The date
    • Rawlins MD. Spontaneous reporting of adverse drug reactions. I: The date. Br J Clin Pharmacol 1988;26:1-5.
    • (1988) Br J Clin Pharmacol , vol.26 , pp. 1-5
    • Rawlins, M.D.1
  • 9
    • 6344219877 scopus 로고    scopus 로고
    • Adverse drug events in two emergency departments in Naples Italy: Anobservational study
    • Capuano A, Motola G, Russo F, Avolio A, Filippelli A, Rossi F, et al. Adverse drug events in two emergency departments in Naples, Italy: Anobservational study. Pharmacol Res 2004;50:631-6.
    • (2004) Pharmacol Res , vol.50 , pp. 631-636
    • Capuano, A.1    Motola, G.2    Russo, F.3    Avolio, A.4    Filippelli, A.5    Rossi, F.6
  • 10
    • 47349113508 scopus 로고
    • Thalidomide and congenital abnormalities
    • McBride WG. Thalidomide and congenital abnormalities. Lancet 1961; 2:1358.
    • (1961) Lancet , vol.2 , pp. 1358
    • McBride, W.G.1
  • 11
    • 0031903233 scopus 로고    scopus 로고
    • The role of the WHO program on international drug monitoring in coordinating worldwide drug safety efforts
    • Olsson S. The role of the WHO program on international drug monitoring in coordinating worldwide drug safety efforts. Drug Saf 1998;19:1-10.
    • (1998) Drug Saf , vol.19 , pp. 1-10
    • Olsson, S.1
  • 12
    • 84889561503 scopus 로고    scopus 로고
    • Available from Last accessed on 2013 Jun 2
    • Available from: http://www.who-umc.org. [Last accessed on 2013 Jun 2].
  • 14
    • 69549105963 scopus 로고    scopus 로고
    • Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos Nigeria
    • Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14.
    • (2009) BMC Clin Pharmacol , vol.9 , pp. 14
    • Oshikoya, K.A.1    Awobusuyi, J.O.2
  • 15
    • 0030727881 scopus 로고    scopus 로고
    • Who cares about pharmacovigilance?
    • Edwards IR. Who cares about pharmacovigilance? Eur J Clin Pharmacol 1997;53:83-8.
    • (1997) Eur J Clin Pharmacol , vol.53 , pp. 83-88
    • Edwards, I.R.1
  • 16
    • 84889607581 scopus 로고    scopus 로고
    • Available from Last accessed on 2013 Jun 2
    • Available from: http://www.agenziafarmaco.gov.it. [Last accessed on 2013 Jun 2].
  • 17
    • 60749099873 scopus 로고    scopus 로고
    • Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions
    • Hauben M, Aronson JK. Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf 2009;32:99-110.
    • (2009) Drug Saf , vol.32 , pp. 99-110
    • Hauben, M.1    Aronson, J.K.2
  • 18
    • 0000514454 scopus 로고
    • Screening for unknown effects of newly marketed drugs
    • Strom BL editor 2nd ed. Chichester, West Sussex, England: John Wiley and Sons Ltd
    • Carson JL, Strom BL, Maislin G. Screening for unknown effects of newly marketed drugs. In: Strom BL editor. Pharmacoepidemiology. 2nd ed. Chichester, West Sussex, England: John Wiley and Sons Ltd; 1994. p. 431-47.
    • (1994) Pharmacoepidemiology , pp. 431-447
    • Carson, J.L.1    Strom, B.L.2    Maislin, G.3
  • 19
    • 84885452246 scopus 로고    scopus 로고
    • Idiopathic acute liver injury in paediatric outpatients: Incidence and signal detection in two european countries
    • Press
    • Ferrajolo C, Verhamme KM, Trifirò G, 't Jong GW, Giaquinto C, Picelli G, et al. Idiopathic Acute Liver Injury in Paediatric Outpatients: Incidence and Signal Detection in Two European Countries. Drug Saf 2013 [In Press].
    • (2013) Drug Saf
    • Ferrajolo, C.1    Verhamme, K.M.2    Trifirò, G.3    Jong, G.W.4    Giaquinto, C.5    Picelli, G.6
  • 21
    • 0029962783 scopus 로고    scopus 로고
    • Attitudes to adverse drug reaction reporting
    • Inman WH. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 1996;41:434-5.
    • (1996) Br J Clin Pharmacol , vol.41 , pp. 434-435
    • Inman, W.H.1
  • 23
    • 84889609366 scopus 로고    scopus 로고
    • Safety and efficacy of generic drugs respect to brand formulation. Brief review and case series presentation
    • Press
    • Gallelli L, Palleria C, De Vuono A, Mumoli L, Vasapollo P, Piro B, et al. Safety and efficacy of generic drugs respect to brand formulation. Brief review and case series presentation. J Pharmacol Pharmacother 2013 [In Press].
    • (2013) J Pharmacol Pharmacother
    • Gallelli, L.1    Palleria, C.2    De Vuono, A.3    Mumoli, L.4    Vasapollo, P.5    Piro, B.6
  • 24
    • 84899494066 scopus 로고    scopus 로고
    • Hypericum perforatum: Pharmacokinetic, mechanism of action, tolerability and clinical drug-drug interactions
    • Press
    • Russo E, Scicchitano F, Whalley BJ, Mazzitello C, Ciriaco M, Esposito S, et al. Hypericum perforatum: Pharmacokinetic, mechanism of action, tolerability and clinical drug-drug interactions. Phytother Res 2013 [In Press].
    • (2013) Phytother Res
    • Russo, E.1    Scicchitano, F.2    Whalley, B.J.3    Mazzitello, C.4    Ciriaco, M.5    Esposito, S.6
  • 25
    • 84889579767 scopus 로고    scopus 로고
    • Available from Last accessed on 2013 Jun 2
    • Available from: http://eudravigilance.ema.europa.eu/human/index.asp [Last accessed on 2013 Jun 2].
  • 26
    • 84889604079 scopus 로고    scopus 로고
    • Last accessed on 2013 Jun 2
    • http://www.ema.europa.eu/ema/[Last accessed on 2013 Jun 2].
  • 30
    • 84889578314 scopus 로고
    • 30 Oct converted into Law 531/87
    • Art.9-DECREE 30 Oct 1987 (converted into Law 531/87).
    • (1987) Art.9-DECREE
  • 31
    • 84889600399 scopus 로고    scopus 로고
    • D. Decree 18 Feb 1997 44 implementation of Dir 93/39/EEC
    • D. Decree 18 Feb 1997, n. 44 (implementation of Dir 93/39/EEC).
  • 32
    • 84889605195 scopus 로고    scopus 로고
    • D. Decree of 8 Apr 2003, n. 95
    • D. Decree of 8 Apr 2003, n. 95.
  • 33
    • 84889579013 scopus 로고    scopus 로고
    • D. M. Dec 12 2003
    • D. M. Dec 12, 2003.
  • 34
    • 84889563965 scopus 로고    scopus 로고
    • Leg. 219 24/04/2006-artt.129-134
    • Leg. 219 24/04/2006-artt.129-134.
  • 35
    • 84889594524 scopus 로고    scopus 로고
    • Legislative Decree 219 of 24/04/2006
    • Legislative Decree no. 219 of 24/04/2006.
  • 36
    • 84889573410 scopus 로고    scopus 로고
    • Available from Last accessed on 2013 Jun 2
    • Available from: http://www.agenziafarmaco.gov.it/en/content/ postmarketing-surveillance. [Last accessed on 2013 Jun 2].
  • 37
    • 78649240044 scopus 로고    scopus 로고
    • Drug-induced hepatic injury in children: A case/non-case study of suspected adverse drug reactions in VigiBase
    • Ferrajolo C, Capuano A, Verhamme KM, Schuemie M, Rossi F, Stricker BH, et al. Drug-induced hepatic injury in children: A case/non-case study of suspected adverse drug reactions in VigiBase. Br J Clin Pharmacol 2010;70:721-8.
    • (2010) Br J Clin Pharmacol , vol.70 , pp. 721-728
    • Ferrajolo, C.1    Capuano, A.2    Verhamme, K.M.3    Schuemie, M.4    Rossi, F.5    Stricker, B.H.6
  • 38
    • 84889580694 scopus 로고    scopus 로고
    • Available from Last accessed on 2013 Jun 2
    • Available from: http://www.who-umc.org/graphics/24965.pdf. [Last accessed on 2013 Jun 2].
  • 40
    • 72049091737 scopus 로고    scopus 로고
    • Association between drug and vaccine use and acute immunethrombocytopenia in childhood: A case-control study in Italy
    • Bertuola F, Morando C, Menniti-Ippolito F, Da Cas R, Capuano A, Perilongo G, et al. Association between drug and vaccine use and acute immunethrombocytopenia in childhood: A case-control study in Italy. Drug Saf 2010;33:65-72.
    • (2010) Drug Saf , vol.33 , pp. 65-72
    • Bertuola, F.1    Morando, C.2    Menniti-Ippolito, F.3    Da Cas, R.4    Capuano, A.5    Perilongo, G.6
  • 42
    • 84871254994 scopus 로고    scopus 로고
    • Safety of attention-deficit/hyper activity disorder medications in children: An intensive pharmacosurveillance monitoring study
    • Ruggiero S, Rafaniello C, Bravaccio C, Grimaldi G, Granato R, Pascotto A, et al. Safety of attention-deficit/hyper activity disorder medications in children: An intensive pharmacosurveillance monitoring study. J Child Adolesc Psychopharmacol 2012;22:415-22.
    • (2012) J Child Adolesc Psychopharmacol , vol.22 , pp. 415-422
    • Ruggiero, S.1    Rafaniello, C.2    Bravaccio, C.3    Grimaldi, G.4    Granato, R.5    Pascotto, A.6
  • 43
    • 84889584305 scopus 로고    scopus 로고
    • Available from Last accessed on 2013 Jun 2
    • Available from: http://www.ema.europa.eu/docs/en-GB/document-library/ Other/2012/07/WC500129593.pdf [Last accessed on 2013 Jun 2].
  • 44
    • 79955101543 scopus 로고    scopus 로고
    • Italian post marketing surveillance for adverse event reports after MF59-adjuvanted H1N1 vaccination
    • Parretta E, Ianniello B, Ferrazin F, Rossi F, Capuano A. Italian post marketing surveillance for adverse event reports after MF59-adjuvanted H1N1 vaccination. Vaccine 2011;29:3708-13.
    • (2011) Vaccine , vol.29 , pp. 3708-3713
    • Parretta, E.1    Ianniello, B.2    Ferrazin, F.3    Rossi, F.4    Capuano, A.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.