Can Decisional Algorithms Replace Global Introspection in the Individual Causality Assessment of Spontaneously Reported
- PDF / 99,716 Bytes
- 6 Pages / 505 x 720 pts Page_size
- 83 Downloads / 163 Views
ORIGINAL RESEARCH ARTICLE
© 2006 Adis Data Information BV. All rights reserved.
Can Decisional Algorithms Replace Global Introspection in the Individual Causality Assessment of Spontaneously Reported ADRs? Ana F. Macedo, Francisco B. Marques and Carlos F. Ribeiro ´ ´ Administra¸ca˜ o Regional de Saude do Centro, Nucleo de Farmacovigilˆancia do Centro, Faculdade de Medicina, Faculdade de Farm´acia, Universidade de Coimbra, Coimbra, Portugal
Abstract
Aim: The usefulness of algorithms for assessing the causality of suspected adverse drug reactions (ADRs) has yet to be established and, since the validation of causality algorithms depends upon their sensitivity and specificity, our study was carried out to evaluate these measures. Method: In this study, an expert panel assessed causality of adverse reports by using the WHO global introspection (GI) method. The same reports were independently assessed using 15 published algorithms. The causality assessment level ‘possible’ was considered the lower limit for a report to be considered to be drug related. For a given algorithm, sensitivity was determined by the proportion of reports simultaneously classified as drug related by the algorithm and the GI method. Specificity was measured as the proportion of reports simultaneously considered non-drug related. The analysis was performed for the total sample and within serious or unexpected events. Results: Five hundred adverse reports were studied. Algorithms presented high rates of sensitivity (average of 93%, positive predictive value of 89%) and low rates of specificity (average of 7%, negative predictive value of 31%). Conclusion: Decisional algorithms are sensitive methods for the detection of ADRs, but they present poor specificity. A reference method was not identified. Algorithms do not replace GI and are not definite alternatives in the individual causality assessment of suspected ADRs.
Introduction Adverse drug reactions (ADRs) are one of the leading causes of morbidity and mortality in healthcare[1-5] that could, for the most part, be prevented.[4,6-9] Causality assessment of identified adverse events is crucial in pharmacovigilance activities because of
its implications on the benefit-risk ratio evaluations of medicines. Causality assessments of reported ADRs are important as they are included in periodic safety update reports of the involved drugs. The safety profile of approved products is continuously monitored through signal detection, issue evaluation, the updating of product labelling and liaison with regulatory authorities.
698
The ‘N´ucleo de Farmacovigilˆancia do Centro’ (NFC) or the central Portugal regional pharmacovigilance unit started receiving ADR reports from family physicians and community pharmacists in January 2001. According to regulatory responsibilities, spontaneous reporting of suspected ADRs is mandatory and it is supported by a national reporting form developed according to CIOMS standards. As a component of the adopted standard operating procedures the global introspection (GI) meth
Data Loading...
