LEADER 03818nam 2200589 450 001 9910829992403321 005 20230807202739.0 010 $a1-118-91204-7 010 $a1-118-91206-3 035 $a(CKB)4200000000000011 035 $a(EBL)1895743 035 $a(SSID)ssj0001400918 035 $a(PQKBManifestationID)12510307 035 $a(PQKBTitleCode)TC0001400918 035 $a(PQKBWorkID)11349039 035 $a(PQKB)10010618 035 $a(PQKBManifestationID)16035861 035 $a(PQKB)24137247 035 $a(MiAaPQ)EBC1895743 035 $a(DLC) 2014028711 035 $a(EXLCZ)994200000000000011 100 $a20160729h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aOff-label prescribing $ejustifying unapproved medicine /$fDavid Cavalla 210 1$aChichester, England :$cWiley Blackwell,$d2015. 210 4$dİ2015 215 $a1 online resource (214 p.) 300 $aDescription based upon print version of record. 311 $a1-118-91205-5 311 $a1-118-91207-1 320 $aIncludes bibliographical references and index. 327 $aPatient awarenessPractitioner attitudes; Diagnosis; Chapter 4 Gaming the system: the role of the pharmaceutical industry; Normal drug development and drug repurposing development; Gaming the system; Orphan use; Pharmaceutical marketing; Expanding uses for non-pharmaceuticals; DTC advertising; Patents and genericisation; Conclusion; Chapter 5 Do no harm: Safety and efficacy; Relative safety; Different therapeutic uses; Chronic versus acute dosing; Different dose; Differences between children and adults; Other patient populations; Fatal ADRs; Quality of evidence; Strong evidence; Poor evidence 327 $aDoctors do not know evidenceProximity of off-label to on-label; Debunking medical myths; Chapter 6 Liability, injustice and reimbursement: who should pay?; A prescriber's ethical and professional duties; Medical professional participation in off-label promotion; A prescriber's legal position; Consent; Liability; Reimbursement; Compendia; NICE; Compassionate access; Cost, as a driver for off-label medicine; Chapter 7 The role of regulation in off-label medicine; Regulators do not regulate medical practice; Off-label marketing; Off-label fines; Whistle-blowers; European situation 327 $aTip of the icebergFree speech; Chapter 8 Justifying unapproved medicine; Constraints on making changes; Moves to enhance off-label medicine; Diagnosis shifting; A partial solution: clinical trial transparency; A solution based on increased regulatory supervision; My solutions; Professional standards; Reimbursement and pricing; Outcomes; Conclusion; References; Index; Supplemental Images; End User License Agreement 330 $a Today's medicines are regulated for their efficacy and safety and, once approved, they can be marketed for certain uses as justified by the data. Regulatory bodies in developed countries are constituted by legal statute and operate as parts of government, ostensibly in the interests of the people as patients. But once approved, medicines can be used for any purpose the prescriber thinks fit and appropriate for the patient. One in five prescriptions is therefore written outside regulatory purview. Off-label Prescribing looks into the corners of our medicated lives, where drug regulation ru 606 $aDrugs$xPrescribing 606 $aDrug development 615 0$aDrugs$xPrescribing. 615 0$aDrug development. 676 $a615.1 700 $aCavalla$b David$01340365 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910829992403321 996 $aOff-label prescribing$94078858 997 $aUNINA