1. An overview of off-label drug use Ignoring the Label Samantha Rue

2. W HAT IS O FF -L ABEL U SE ? Prescribing medication in a way that differs from the FDA approved label. Can include changes in: – Disease being treated – Dosage – Method of administration – Patient demographics

3. H OW OFTEN DOES IT HAPPEN ? 21% to 50% of all prescriptions are given off-label

4. D OES THE FDA HAVE ANY CONTROL ? The FDA: – Approves medication for specific uses – Regulates marketing of pharmaceuticals FDA Modernization Act (1997) – FDA cannot interfere with a physician’s authority to prescribe legally marketed medication – Freedom of speech

5. S HOULD WE BAN THE PRACTICE ? Increased risk of side effects Doctors often prescribe before checking Little to no scientific support for off-label use – 96% among psychiatric drugs – 89% among allergy drugs Can raise healthcare costs Fewer pharmaceuticals will seek FDA approval

6. W HY SHOULD THE PRACTICE BE ALLOWED ? Science develops faster than regulatory policies Off-Label use is a must in some areas of medicine: – Oncology – Geriatrics – Pediatrics – Obstetrics “Orphan Diseases” – most diseases afflicting fewer than 200,000 Americans are totally without FDA- labeled treatment. FDA approval is not a guarantee of safety

7. W HAT CAN DOCTORS DO ? Research Inform the patient of risks Use assessment tools to gauge the necessity of prescribing off-label

8. W HAT CAN PATIENTS DO ? Research Ask questions Get a second opinion