01683nas 2200397 n 450 99000904805040332120240229084553.00035-581X000904805FED01000904805(Aleph)000904805FED01000904805CNRP 0005984220161109b19501983km-y0itaa50------baitaITauu--------Rivista critica di storia della filosofia1950-1983FirenzeF. AngeliTrimestrale2001Rivista di storia della filosofia0010009050322001Rivista di storia della filosofia [1984]Rivista critica di storia della filosofia191ITACNP20090723http://acnp.cib.unibo.it/cgi-ser/start/it/cnr/dc-p1.tcl?catno=40906&person=false&language=ITALIANO&libr=&libr_th=unina1Biblioteche che possiedono il periodicoSE990009048050403321Biblioteca Centrale della Facoltà di Giurisprudenza dell'Università di Napoli Federico II1957-1983.Per. it. 238FGBCFGBCRivista critica di storia della filosofia788955UNINA866-01NA073 Biblioteca Centrale della Facoltà di Giurisprudenza dell'Università di Napoli Federico IIPer. it. 238Corso Umberto I, 80138 Napoli (NA)0812537531/330812537532itacnp.cib.unibo.itACNP Italian Union Catalogue of Serialshttp://acnp.cib.unibo.it/cgi-ser/start/it/cnr/df-p.tcl?catno=40906&language=ITALIANO&libr=&person=&B=1&libr_th=unina&proposto=NO03818nam 2200589 450 991082999240332120230807202739.01-118-91204-71-118-91206-3(CKB)4200000000000011(EBL)1895743(SSID)ssj0001400918(PQKBManifestationID)12510307(PQKBTitleCode)TC0001400918(PQKBWorkID)11349039(PQKB)10010618(PQKBManifestationID)16035861(PQKB)24137247(MiAaPQ)EBC1895743(DLC) 2014028711(EXLCZ)99420000000000001120160729h20152015 uy 0engur|n|---|||||txtccrOff-label prescribing justifying unapproved medicine /David CavallaChichester, England :Wiley Blackwell,2015.©20151 online resource (214 p.)Description based upon print version of record.1-118-91205-5 1-118-91207-1 Includes bibliographical references and index.Patient 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 evidenceDoctors 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 situationTip 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 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 ruDrugsPrescribingDrug developmentDrugsPrescribing.Drug development.615.1Cavalla David1340365MiAaPQMiAaPQMiAaPQBOOK9910829992403321Off-label prescribing4078858UNINA