David Cavalla

Off-label Prescribing (eBook, PDF)

Justifying Unapproved Medicine

• Format: PDF

Produktbeschreibung

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 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 aspect of his or her prescribing choice. The book examines how and why this occurs, what the various medical professions have to say about it, and how pharmaceutical companies benefit by moving into this poorly regulated area. Off-label Prescribing pulls these complex issues together in one volume, to highlight current practice, its advantages and weaknesses and how the author suggests practice should evolve in the future. It will therefore be of interest to all those who prescribe (and receive) medicines, combined with a greater objective to provide more transparency and discussion for professionals.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 216
• Erscheinungstermin: 19. Dezember 2014
• Englisch
• ISBN-13: 9781118912058
• Artikelnr.: 42774329

Autorenporträt

David Cavalla, is an expert on secondary uses for existing drugs, or drug repurposing. He currrently operates through his consultancy, Numedicus Ltd, having worked in drug repurposing for 15 years. Previously he was CEO of Arachnova, and prior to that held various senior positions in pharmaceutical drug discovery at GSK and Napp Research Centre. He has written widely on drug discovery strategy, and is the author of 70 published papers and patents.

Inhaltsangabe

Foreword
ix Acknowledgement
xi Author's note on the cover design
xiii Introduction
xv 1 What is off-label medication
and how prevalent is it?
1 What is 'off-label' medicine?
2 Scope of the issue
8 2 Where it all went right: new uses for existing drugs supported by good evidence
19 Examples where products have been through regulatory approval for a secondary use
19 Finasteride: pseudohermaphroditism and hair growth
19 Sildenafil: re-tasking the blue pill for a life-threatening illness
21 Doxycycline: from killing bugs to protecting gums
22 Raloxifene: from cancer to bone disease and back again
23 Galantamine: using snowdrops to improve memory
24 Cyclosporine: preventing immune attack on organs and skin
25 Dimethyl fumarate: a remarkable drug for multiple sclerosis
26 Botox: a drug to kill or cure you
27 Examples where evidence is uncertain and not to regulatory standards
28 Tricyclic antidepressants: for curing more than emotional pain
28 Aspirin for cancer
30 Retrospective data: looking back to create future therapies
30 3 Shared decision making and consent
33 Viewpoint of the patient
34 Viewpoint of the prescriber
37 Professional guidelines
38 Patient awareness
41 Practitioner attitudes
41 Diagnosis
44 4 Gaming the system: the role of the pharmaceutical industry
47 Normal drug development and drug repurposing development
48 Gaming the system
53 Orphan use
56 Pharmaceutical marketing
61 Expanding uses for non-pharmaceuticals
64 DTC advertising
64 Patents and genericisation
65 Conclusion
68 5 Do no harm: Safety and efficacy
71 Relative safety
73 Different therapeutic uses
73 Chronic versus acute dosing
78 Different dose
81 Differences between children and adults
82 Other patient populations
86 Fatal ADRs
87 Quality of evidence
88 Strong evidence
89 Poor evidence
91 Doctors do not know evidence
94 Proximity of off-label to on-label
96 Debunking medical myths
101 6 Liability
injustice and reimbursement: who should pay?
105 A prescriber's ethical and professional duties
105 Medical professional participation in off-label promotion
105 A prescriber's legal position
106 Consent
106 Liability
111 Reimbursement
113 Compendia
115 NICE
117 Compassionate access
120 Cost
as a driver for off-label medicine
121 7 The role of regulation in off-label medicine
125 Regulators do not regulate medical practice
126 Off-label marketing
128 Off-label fines
130 Whistle-blowers
134 European situation
134 Tip of the iceberg
136 Free speech
138 8 Justifying unapproved medicine
143 Constraints on making changes
144 Moves to enhance off-label medicine
145 Diagnosis shifting
146 A partial solution: clinical trial transparency
147 A solution based on increased regulatory supervision
152 My solutions
153 Professional standards
153 Reimbursement and pricing
156 Outcomes
159 Conclusion
173 References
175 Index
191