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Original Research

Filling quality of the reports of adverse drug reactions received at the Pharmacovigilance Centre of São Paulo (Brazil): missing information hinders the analysis of suspected associations

, , , & ORCID Icon
Pages 1329-1334 | Received 26 Apr 2017, Accepted 09 Aug 2017, Published online: 23 Aug 2017

References

  • Pan-American Health Organization. Good pharmacovigilance practices for the Americas. PAHRF network, technical document Nr 5. Washington (DC): PAHO; 2011.
  • Krumholz H, Ross JS, Pressler AH, et al. What have we learnt from Vioxx? Br Med J. 2007;334:120–123.
  • Tandon VR, Mahajan V, Khajuria V, et al. Under-reporting of adverse drug reactions: a challenge for Pharmacovigilance in India. Indian J Pharmacol. 2015;47:65–71.
  • Sánchez-Sánchez B, Altagracia-Martinez M, Kravzov-Jinich J, et al. Evaluation of completeness of suspected adverse drug reaction reports submitted to Mexican National Pharmacovigilance Centre. Drug Saf. 2012;35:837–844.
  • Doherty MJ. Algorithms for assessing the probability of an adverse drug reaction. Respir Med CME. 2009;2:63–67.
  • Bergvall T, Nóren GN, Lindquist M. VigiGrade: a tool to identify well-documented individual case reports and highlight systematic data qualify issues. Drug Saf. 2014;37:65–77.
  • Plessis L, Gómez A, García N, et al. Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia - a restraint to the potentiality for signal detection. Eu J Clin Pharmacol. 2017;73:751–758. DOI:10.1007/s00228-017-2223-5
  • ANVISA. Pharmacovigilance regulations for marketing authorization holders of medical drugs for human use. (Resolução RDC No. 4, de 10 de fevereiro 2009). [cited 2017 Jun 28]. Available from: http://portal.anvisa.gov.br/documents/33880/2568070/res0004_10_02_2009.pdf/05f05642-1cae-4a60-9485-5ff63cfb22af
  • Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Pharmacoepidemiol and Drug Saf. 2007;16:581–587.
  • Théophile H, André M, Arimone Y, et al. An updated method improved the assessment of adverse drug reaction in routine pharmacovigilance. J Clin Epidemiol. 2012;65:1069–1077.
  • Meyboom RHB, Hekster YA, Egberts ACG, et al. Causal or casual? The role of causality in pharmacovigilance. Drug Saf. 1997;17:374–389.
  • Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–245.
  • Tuccori M, Giustarini G, Blandizzi C, et al. Quality of adverse drug reaction (QADRA) reports: an algorithm to appraise the efficiency of spontaneous reporting systems in pharmacovigilance. J Public Health. 2013;21:365–372.
  • Varallo FR, Planeta CS, Herdeiro MT, et al. Imputation of adverse drug reactions: causality assessment in hospitals. PLoS One. 2017;12:e0171470.

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