{"product_id":"offlabel-prescribing-9781118912072","title":"Offlabel Prescribing","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eToday'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.\u003c\/p\u003e \u003cp\u003eBut 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.\u003c\/p\u003e \u003cp\u003eOff-label Prescribing looks into the corners of our medicated lives, where drug regulation runs up against medical practice, and concerns the use of a drug that has been approved for one use (in medical parlance, indication') being used for a different indication; alternatively, being used on a different set of patients from the ones it is approved for, or at a different dose. Usually the patient is unaware of what is going on, having not been informed by their doctor of this \u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e“Despite a rather uninspiring title I found this book to be a fascinating read providing great insight into medicine development and regulation with many interesting examples provided to support the authors views . In my opinion it is actually a lot more balanced and intellectually satisfying than the much higher profile \"Bad Pharma\" (although that too is also worth reading). I would recommend this book as essential reading for anyone with a professional interest in helping ensure that medicines are used safely in an appropriately governed way and more generally to anyone that is interested in the world of medicine use.”  (\u003ci\u003eDirector of Medicines Information at Guy's and St Thomas' Hospital\u003c\/i\u003e, 29 May 2015)\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eForeword, ix\u003c\/p\u003e \u003cp\u003eAcknowledgement, xi\u003c\/p\u003e \u003cp\u003eAuthor’s note on the cover design, xiii\u003c\/p\u003e \u003cp\u003eIntroduction, xv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 What is off-label medication, and how prevalent is it?, 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhat is ‘off-label’ medicine?, 2\u003c\/p\u003e \u003cp\u003eScope of the issue, 8\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Where it all went right: new uses for existing drugs supported by good evidence, 19\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eExamples where products have been through regulatory approval for a secondary use, 19\u003c\/p\u003e \u003cp\u003eFinasteride: pseudohermaphroditism and hair growth, 19\u003c\/p\u003e \u003cp\u003eSildenafil: re-tasking the blue pill for a life-threatening illness, 21\u003c\/p\u003e \u003cp\u003eDoxycycline: from killing bugs to protecting gums, 22\u003c\/p\u003e \u003cp\u003eRaloxifene: from cancer to bone disease and back again, 23\u003c\/p\u003e \u003cp\u003eGalantamine: using snowdrops to improve memory, 24\u003c\/p\u003e \u003cp\u003eCyclosporine: preventing immune attack on organs and skin, 25\u003c\/p\u003e \u003cp\u003eDimethyl fumarate: a remarkable drug for multiple sclerosis, 26\u003c\/p\u003e \u003cp\u003eBotox: a drug to kill or cure you, 27\u003c\/p\u003e \u003cp\u003eExamples where evidence is uncertain and not to regulatory standards, 28\u003c\/p\u003e \u003cp\u003eTricyclic antidepressants: for curing more than emotional pain, 28\u003c\/p\u003e \u003cp\u003eAspirin for cancer, 30\u003c\/p\u003e \u003cp\u003eRetrospective data: looking back to create future therapies, 30\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Shared decision making and consent, 33\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eViewpoint of the patient, 34\u003c\/p\u003e \u003cp\u003eViewpoint of the prescriber, 37\u003c\/p\u003e \u003cp\u003eProfessional guidelines, 38\u003c\/p\u003e \u003cp\u003ePatient awareness, 41\u003c\/p\u003e \u003cp\u003ePractitioner attitudes, 41\u003c\/p\u003e \u003cp\u003eDiagnosis, 44\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Gaming the system: the role of the pharmaceutical industry, 47\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eNormal drug development and drug repurposing development, 48\u003c\/p\u003e \u003cp\u003eGaming the system, 53\u003c\/p\u003e \u003cp\u003eOrphan use, 56\u003c\/p\u003e \u003cp\u003ePharmaceutical marketing, 61\u003c\/p\u003e \u003cp\u003eExpanding uses for non-pharmaceuticals, 64\u003c\/p\u003e \u003cp\u003eDTC advertising, 64\u003c\/p\u003e \u003cp\u003ePatents and genericisation, 65\u003c\/p\u003e \u003cp\u003eConclusion, 68\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Do no harm: Safety and efficacy, 71\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eRelative safety, 73\u003c\/p\u003e \u003cp\u003eDifferent therapeutic uses, 73\u003c\/p\u003e \u003cp\u003eChronic versus acute dosing, 78\u003c\/p\u003e \u003cp\u003eDifferent dose, 81\u003c\/p\u003e \u003cp\u003eDifferences between children and adults, 82\u003c\/p\u003e \u003cp\u003eOther patient populations, 86\u003c\/p\u003e \u003cp\u003eFatal ADRs, 87\u003c\/p\u003e \u003cp\u003eQuality of evidence, 88\u003c\/p\u003e \u003cp\u003eStrong evidence, 89\u003c\/p\u003e \u003cp\u003ePoor evidence, 91\u003c\/p\u003e \u003cp\u003eDoctors do not know evidence, 94\u003c\/p\u003e \u003cp\u003eProximity of off-label to on-label, 96\u003c\/p\u003e \u003cp\u003eDebunking medical myths, 101\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Liability, injustice and reimbursement: who should pay?, 105\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eA prescriber’s ethical and professional duties, 105\u003c\/p\u003e \u003cp\u003eMedical professional participation in off-label promotion, 105\u003c\/p\u003e \u003cp\u003eA prescriber’s legal position, 106\u003c\/p\u003e \u003cp\u003eConsent, 106\u003c\/p\u003e \u003cp\u003eLiability, 111\u003c\/p\u003e \u003cp\u003eReimbursement, 113\u003c\/p\u003e \u003cp\u003eCompendia, 115\u003c\/p\u003e \u003cp\u003eNICE, 117\u003c\/p\u003e \u003cp\u003eCompassionate access, 120\u003c\/p\u003e \u003cp\u003eCost, as a driver for off-label medicine, 121\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 The role of regulation in off-label medicine, 125\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eRegulators do not regulate medical practice, 126\u003c\/p\u003e \u003cp\u003eOff-label marketing, 128\u003c\/p\u003e \u003cp\u003eOff-label fines, 130\u003c\/p\u003e \u003cp\u003eWhistle-blowers, 134\u003c\/p\u003e \u003cp\u003eEuropean situation, 134\u003c\/p\u003e \u003cp\u003eTip of the iceberg, 136\u003c\/p\u003e \u003cp\u003eFree speech, 138\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Justifying unapproved medicine, 143\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eConstraints on making changes, 144\u003c\/p\u003e \u003cp\u003eMoves to enhance off-label medicine, 145\u003c\/p\u003e \u003cp\u003eDiagnosis shifting, 146\u003c\/p\u003e \u003cp\u003eA partial solution: clinical trial transparency, 147\u003c\/p\u003e \u003cp\u003eA solution based on increased regulatory supervision, 152\u003c\/p\u003e \u003cp\u003eMy solutions, 153\u003c\/p\u003e \u003cp\u003eProfessional standards, 153\u003c\/p\u003e \u003cp\u003eReimbursement and pricing, 156\u003c\/p\u003e \u003cp\u003eOutcomes, 159\u003c\/p\u003e \u003cp\u003eConclusion, 173\u003c\/p\u003e \u003cp\u003eReferences, 175\u003c\/p\u003e \u003cp\u003eIndex, 191\u003c\/p\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":53186830074199,"sku":"9781118912072","price":39.85,"currency_code":"GBP","in_stock":false}],"url":"https:\/\/bookcurl.com\/products\/offlabel-prescribing-9781118912072","provider":"Book Curl","version":"1.0","type":"link"}