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Original Research

Adverse drug reactions reporting in Calabria (Southern Italy) in the four-year period 2011-2014: impact of a regional pharmacovigilance project in light of the new European Legislation

, , , , , , , , , & show all
Pages 515-522 | Received 08 Sep 2016, Accepted 04 Apr 2017, Published online: 19 Apr 2017

References

  • Sultana J, Cutroneo P, Trifiro G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother. 2013;4:S73–S7.
  • Commission of the European communities staff working document. Brussels: European Commission. 2008.
  • Pontes H, Clement M, Rollason V. Safety signal detection: the relevance of literature review. Drug Saf. 2014;37:471–479.
  • Couzin J. Drug safety. Withdrawal of Vioxx casts a shadow over COX-2 inhibitors. Science. 2004;306:384–385.
  • EMA European medicines agency recommends suspension of Avandia, Avandamet and Avaglim. London. 2010.
  • Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly medicare patients treated with rosiglitazone or pioglitazone. Jama. 2010;304:411–418.
  • Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med. 2010;170:1191–1201.
  • European Parliament and Council. L 348/74 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 authorisation 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. Off J Eur Union. 2010. L 348/74:1–16.
  • Directive 192010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, directive 2001/83/EC on the community code relating to medicinal products for human use. Off J Eur Union. 2010. 74–99.
  • European Medicines Agency. EMA questions and answers on the withdrawal of medicines containing benfluorex. London. 2010.
  • Directive 192012/26/EU of the European Parliament and of the Council of 25 October 2012 amending directive 2001/83/EC as regards pharmacovigilance. Off J Eur Union. 2012. 1–4.
  • Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance. Off J Eur Union. 2012. 38–40.
  • EMA. Pharmacovigilance legislation. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000491.jsp&mid=WC0b01ac058058f32d
  • Calvo B, Zuniga L. EU’s new pharmacovigilance legislation: considerations for biosimilars. Drug Saf. 2014;37:9–18.
  • EMA. Implementation of the pharmacovigilance legislation. 2014. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000520.jsp&mid=WC0b01ac05804fa031
  • EMA one-year report on human medicines pharmacovigilance tasks of the European medicines agency. 2014.
  • AIFA. Rete nazionale di farmacovigilanza. Rome: Italian Medicines Agency (AIFA). 2015.
  • AIFA. Andamento delle segnalazioni di sospette reazioni avverse in Italia dal 2001 al 2013. 2014.
  • Mazzitello C, Esposito S, De Francesco AE, et al. Pharmacovigilance in Italy: an overview. J Pharmacol Pharmacother. 2013;4:S20–S8.
  • Pimpinella G, Tartaglia L. Pharmacovigilance and the italian medicines agency. J Pharmacol Pharmacother. 2013;4:S4–S6.
  • AIFA. Fondi Regionali di Farmacovigilanza. 2014. Available from: http://www.agenziafarmaco.gov.it/it/content/fondi-regionali-di-farmacovigilanza-0
  • Ministero dell Salute. Decreto 30 aprile 2015. Procedure operative e soluzioni tecniche per un’efficace azione di farmacovigilanza adottate ai sensi del comma 344 dell’articolo 1 della legge 24 dicembre 2012, n. 228 (Legge di stabilità 2013). 2015. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/DM_30_aprile 2015.pdf
  • Giofre C, Scicchitano F, Palleria C, et al. Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis. J Pharmacol Pharmacother. L 0020. 2013;4:S55–S60.
  • European Parliament and Council. Directive 192001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Communities. 2001;34–44.
  • European Medicines Agency. Guideline on good pharmacovigilance practices (GVP), in Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1). London. 2014.
  • MedDRA. Medical dictionary for regulatory activities. McLean, USA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2015.
  • ICH. MedDRA. [cited 2015 15 Oct]. Medical Dictionary for Regulatory Activities. 2015. Available from: http://www.ich.org/products/meddra.html
  • WHO. Guidelines for ATC classification and DDD assignment 2016. Oslo, Norway: WHO Collaborating Centre for Drug Statistics Methodology, Norwegian Institute of Public Health. 2015.
  • Imamura S, Hirai K, Hirai A. The glucagon-like peptide-1 receptor agonist, liraglutide, attenuates the progression of overt diabetic nephropathy in type 2 diabetic patients. Tohoku J Exp Med. 2013;231:57–61.
  • Scicchitano F, Giofre C, Palleria C, et al. Pharmacovigilance and drug safety 2011 in Calabria (Italy): adverse events analysis. J Res Med Sci. 2012;17:872–875.
  • EMA list of medicinal products under additional monitoring. 2015.
  • Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. Bmj. 2004;329:15–19.
  • Patel H, Bell D, Molokhia M, et al. Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998-2005. BMC Clin Pharmacol. 2007;7:9.
  • Franconi F, Campesi I, Occhioni S, et al. Sex and gender in adverse drug events, addiction, and placebo. Handb Exp Pharmacol. 2012;214:107–126.
  • AIFA FAQ per la gestione delle segnalazioni nell’ambito della rete nazionale di farmacovigilanza. Aggiornamento Maggio. 2014;2014.
  • Commission implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring. Off J Eur Union. 2013. 17–18.
  • AIFA. Medicinali sottoposti a monitoraggio addizionale. 2013. Available from: http://www.agenziafarmaco.gov.it/it/content/medicinali-sottoposti-monitoraggio-addizionale
  • EMA. Medicines under additional monitoring. 2015. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000365.jsp&mid=WC0b01ac058067bfff
  • AIFA. Andamento delle segnalazioni di sospette reazioni avverse in Italia (2001–2011). 2011. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/and_segn_2011_11052012def.pdf
  • OSMED. L’uso dei farmaci in Italia: rapporto nazionale anno 2012. Rome: Il Pensiero Scientifico Editore; 2013.
  • OSMED. L’uso dei farmaci in Italia: rapporto nazionale anno 2013. Rome: Il Pensiero Scientifico Editore; 2014.
  • OSMED. L’uso dei farmaci in italia: rapporto nazionale anno 2014. Rome: Il Pensiero Scientifico Editore; 2015.
  • OSMED. L’uso dei farmaci in Italia: rapporto nazionale anno 2011. Rome: Il Pensiero Scientifico Editore; 2012.
  • Khazan M, Amouzegar A, Gharibzadeh S, et al. Prevalence of hypothyroidism in patients with dyslipidemia: Tehran Thyroid Study (TTS). Horm Metab Res. 2014;46(13):980–984.

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