Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia—a restraint to the potentiality for signal detection
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The aim of this study is to analyze the quality of the information contained in the adverse drug reactions (ADR) reports and to describe the magnitude and characteristics of the lacking information.
All reports of serious ADR received by the Catalan Center of Pharmacovigilance in 2014 were analyzed using the VigiGrade and a more clinical and qualitative approach.
Up to 824 reports describing serious ADR were included in the study; of them, 503 (61.0%) were sent by health care professionals (HPs) and the remaining 321 (39.0%) came from pharmaceutical companies (PhC). More than 80% of missing variables such as ‘onset date’ or ‘time-to-onset’ of the ADR were from PhCs reports. ‘Onset of treatment date’ was not filled in 28 (22.2%) of the reports including an ‘additional monitoring’ medicine, and ‘end of treatment’ date was not completed in 53 of those reports (42.1%). In summary, 39% of the reports involving a black triangle medicine sent by PhCs lacked some essential information such as the onset date of treatment.
More than one third of the reports coming from manufacturers did not include information that is considered a limiting factor to evaluate any causal relationship, and can be an issue for the detection of safety signals. To take advantage of this huge amount of potentially important information that is almost useless at present, data mining tools and new algorithms should be developed and tested with the aim of finding formulas to deal with a huge amount of low quality data without losing it, nor generating a number of false associations.
KeywordsPharmacovigilance Pharmaceutical industry Database Data mining
This work was supported in part by the Departament de Salut de la Generalitat de Catalunya, a government institution of Catalonia.
Contributions of authors
Lorraine Plessis designed the initial study protocol, retrieved and selected the reports, analyzed and discussed the results and prepared the first draft of the manuscript.
Ainhoa Gómez contributed to the data analyses and prepared tables for the discussion of results. She also participated in the discussion of the manuscript draft, and improved the last version of the manuscript.
Núria Garcia trained LP in the use of the FEDRA Database, contributed to the data analyses and prepared tables for the discussion of results. She also participated in the discussion of the manuscript draft, and improved the last version of the manuscript.
Gloria Cereza participated in the design of the study protocol, coordinated the meetings to discuss the assessment of the included reports, indicated the results to be included in the manuscript and actively participated in the first draft review.
Albert Figueras proposed the idea of the study, contributed to the study protocol, participated in the general results discussions and reviewed the second draft of the manuscript and prepared the final draft.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
- 6.Grundmark B, Holmberg L, Garmo H, Zethelius B (2014) Reducing the noise in signal detection of adverse drug reactions by standardizing the background: a pilot study on analyses of proportional reporting ratios-by-therapeutic area. Eur J Clin Pharmacol 70:627–635CrossRefPubMedPubMedCentralGoogle Scholar
- 7.Lindquist M (2008) VigiBase, the WHO global ICSR database system: basic facts. Drug Inf J 42:409–419Google Scholar
- 8.Lindquist M (2003) Seeing and observing in international pharmacovigilance: achievements and prospects in worldwide drug safety. Uppsala Monitoring Centre, UppsalaGoogle Scholar
- 11.European Medicines Agency (2014) Guideline on good pharmacovigilance practices (GVP) Module VI. EMA http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/09/WC500172402.pdf. Accessed 7 Dec 2016
- 12.BOE (2007) Real Decreto 1344/2007, de 11 de Octubre, por el que se regula la farmacovigilancia de los medicamentos de huso humano. Boletin oficial del Estado http://www.boe.es/boe/dias/2007/11/01/pdfs/A44631-44640.pdf. Accessed 7 Dec 2016
- 13.European Medicines Agency-Medicines under additional monitoring (2016) List of medicines under additional monitoring. EMA http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp. Accessed 7 Dec 2016
- 16.Faillie JL, Robin P, Bres V, Pinzani V, Bos-thompson MA, Hillaire-buys D (2013) The Athe score: a new quality score for spontaneous adverse drug reaction reports. Fundam Clin Pharmacol 27:106–107Google Scholar