LEADER 04489nam 2200685Ia 450 001 9910974859403321 005 20251116220309.0 010 $a0-309-17976-9 010 $a1-280-94146-4 010 $a9786610941469 010 $a0-309-10739-3 035 $a(CKB)1000000000478359 035 $a(EBL)3378272 035 $a(SSID)ssj0000264704 035 $a(PQKBManifestationID)11256329 035 $a(PQKBTitleCode)TC0000264704 035 $a(PQKBWorkID)10291612 035 $a(PQKB)10815423 035 $a(MiAaPQ)EBC3378272 035 $a(Au-PeEL)EBL3378272 035 $a(CaPaEBR)ebr10194174 035 $a(OCoLC)923277273 035 $a(BIP)53859133 035 $a(BIP)14323448 035 $a(EXLCZ)991000000000478359 100 $a20070827d2007 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aUnderstanding the benefits and risks of pharmaceuticals $eworkshop summary, Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy /$fLeslie Pray, rapporteur ; Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$dc2007 215 $a1 online resource (97 p.) 300 $aDescription based upon print version of record. 311 08$a0-309-10738-5 320 $aIncludes bibliographical references. 327 $a""Front Matter""; ""Reviewers""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Regulatory Assessment""; ""3 The Challenge of Communication""; ""4 The Importance of Context in Healthcare Decision Making""; ""5 Patient Experience with Drugs over Time""; ""6 Next Steps""; ""References""; ""Appendixes""; ""A Workshop Agenda""; ""B Discussion Leader and Speaker Biographies"" 330 $aAll pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop. 517 3 $aBenefits and risks of pharmaceuticals 517 3 $aForum on Drug Discovery, Development, and Translation 606 $aDrugs$vCongresses 606 $aDrugs$xSide effects$vCongresses 606 $aChemotherapy$vCongresses 606 $aChemotherapy$xSide effects$vCongresses 615 0$aDrugs 615 0$aDrugs$xSide effects 615 0$aChemotherapy 615 0$aChemotherapy$xSide effects 676 $a615 701 $aPray$b Leslie A$0880793 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910974859403321 996 $aUnderstanding the benefits and risks of pharmaceuticals$94469502 997 $aUNINA