LEADER 04891nam 2200733Ia 450 001 9910966003403321 005 20250603143419.0 010 $a0-309-17979-3 010 $a1-280-84426-4 010 $a9786610844265 010 $a0-309-66330-X 035 $a(CKB)1000000000522906 035 $a(EBL)3378241 035 $a(SSID)ssj0000276695 035 $a(PQKBManifestationID)11237826 035 $a(PQKBTitleCode)TC0000276695 035 $a(PQKBWorkID)10226733 035 $a(PQKB)10810889 035 $a(MiAaPQ)EBC3378241 035 $a(Au-PeEL)EBL3378241 035 $a(CaPaEBR)ebr10176197 035 $a(CaONFJC)MIL84426 035 $a(OCoLC)923278172 035 $a(BIP)53857491 035 $a(BIP)14085706 035 $a(EXLCZ)991000000000522906 100 $a20070420d2007 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aAdverse drug event reporting $ethe roles of consumers and health-care professionals : workshop summary /$fJeffrey M. Drazen ... [et al], rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy ; Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$dc2007 215 $a1 online resource (82 p.) 300 $aSummary of a workshop which took place on November 3 and 4, 2005, in Washington, D.C. 311 08$a0-309-10276-6 311 08$aPrint version: Adverse drug event reporting. Washington, D.C. : National Academies Press, ©2007 9780309102766 (DLC) 2007276545 (OCoLC)123902805 320 $aIncludes bibliographical references. 327 $aIntroduction -- Current adverse event reporting systems -- Active surveillance systems -- Consumer involvement in reporting adverse events -- Drug-drug interactions -- Drug labels. 330 $aRecent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting these events during premarket studies, but also about the responsibility for ongoing surveillance of drugs once they are on the market. Sometimes serious adverse drug reactions are fully appreciated only after a drug has been on the market for years. Therefore, when a drug is approved and released to the market, large numbers of patients will be exposed before all the potential adverse effects have been identified and thoroughly studied. Currently, there is no clearly defined process for addressing safety questions about drugs after premarketing research has occurred. In November 2005, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation convened a workshop to explore issues associated with the reporting of ADEs. The workshop addressed the following questions: How can ADEs be effectively identified, particularly when the adverse effects are rare? How can the direct, causal effects of drugs be distinguished from simple associations? How can health-care professionals and their patients' aid in the identification of drug-related adverse events? How can knowledge of ADEs be more effectively used in clinical practice? Adverse Drug Event Reporting reviews current sources of information on adverse drug events, including the FDA's MedWatch program and the AERS, institutional review boards, and the CMS. This report considers the ways that consumers and advocacy groups can be involved in reporting adverse events, and discusses drug interactions, problems with current databases for capturing and evaluating interactions, and difficulties in communicating information about adverse drug interactions. This report also describes new requirements for information contained on drug labels and how labels can be used to communicate information about risks and drug interactions to consumers and practitioners. 606 $aDrugs$xSide effects$vCongresses 606 $aDrug monitoring$vCongresses 606 $aDrugs$xSide effects 606 $aDrug-Related Side Effects and Adverse Reactions$3(DNLM)D064420 606 $aDrug Monitoring$xmethods 615 0$aDrugs$xSide effects 615 0$aDrug monitoring 615 0$aDrugs$xSide effects. 615 2$aDrug-Related Side Effects and Adverse Reactions. 615 2$aDrug Monitoring$xmethods. 676 $a362.29 701 $aDrazen$b Jeffrey M.$f1946-$01821342 701 $aDrazen$b Jeffrey M.$f1946-$01821342 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 712 02$aInstitute of Medicine (U.S.).$bBoard on Health Sciences Policy. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910966003403321 996 $aAdverse drug event reporting$94385188 997 $aUNINA