Poster Presentations
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ABSTRACTS
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Poster Presentations P.125 Improving Reporting of Adverse Drug Reactions: Cluster-Randomised Trial among Portuguese Pharmacists 3 ´ M.T. Herdeiro,1 A. Figueiras,2 J.J. Polonia ´ ´ 1 CESPU- Instituto Politecnico de Saude do Norte, Gandra-Porto, Portugal; 2 Universidade Santiago de Compostela, Santiago de Compostela, Spain; 3 Unidade de Farmacovigilˆ ancia do Norte, Faculdade de Medicina da Universidade do Porto, Porto, Portugal Background: The spontaneous reporting of ADR is fundamental to the safety surveillance of market medicines, although a number of studies have suggested that fewer than 10% of ADR are reported. The underreporting reasons are not clear, nevertheless look like associate to inadequate knowledge and attitudes concerning to the ADR, in health professionals. With intention to reduce ADR underreporting in Northern Region of Portugal, we performed two studies in pharmacists and also physicians population; first a case-control study to identify knowledge-attitudes associated with underreporting and second a cluster randomised controlled trial to modify such knowledge and attitudes among an educative intervention. In this abstract we present the results of the second study (educative intervention) in pharmacists, that has as main objective the evaluation of the effectiveness of educational outreach visits to increase ADR reporting, and as others objectives assess the rate and relevance of reporting and the duration of the effect. Methods: Study population comprised all pharmacists (that work in community pharmacy and hospital pharmacies) working in geographic area corresponding to the Northern Region Health Administration. We designed a controlled cluster-randomised trial. To each spatial-cluster belong all pharmacists working in the selected geographic area. Using unequal randomization, 4 spatial-clusters were assigned to the intervention group (n=342) and 11 to the control group (n=1091. The intervention took the form of one-hour-long outreach visits tailored to training needs detected in a previous study, with a 13 to 16-month follow-up (March-June 2004 through June 2005). Results: Intervention increase total report ratios about 6-fold (RR=5.87; p=0.001) during the post-intervention period, the reporting rate maintain about 3.0-fold higher than control group, in the second and third 4-months period, RR for second, third 4-months period is between 3.3 and 4.8-fold higher and statically significance. The intervention multiples by 10-fold (RR=9.79; p=0.002) the serious ADR reporting; by 9-fold (RR=8.67; p=0.002) the ratio of report ADR the defined or probable causality; in 4-fold (RR=4.41; p=0.04) the ratio to report ADR unexpected and finally increase in 9-fold the ratio of reporting to the new medicines (RR=9.33; p
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