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Joint Arthritis & Drug Safety and Risk Management Advisory Committee February 18, 2005

Joint Arthritis & Drug Safety and Risk Management Advisory Committee February 18, 2005 Anne E. Trontell, M.D. Deputy Director Office of Drug Safety (ODS). Options for Action. Voluntary limitations on marketing No DTC Detail, ads only to selected specialists Labeling Black box warning

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Joint Arthritis & Drug Safety and Risk Management Advisory Committee February 18, 2005

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  1. Joint Arthritis & Drug Safety and Risk Management Advisory Committee February 18, 2005 Anne E. Trontell, M.D. Deputy Director Office of Drug Safety (ODS)

  2. Options for Action • Voluntary limitations on marketing • No DTC • Detail, ads only to selected specialists • Labeling • Black box warning • Limits reminder ads, makes DTC very difficult • Change indication to 2nd line • Contraindicate in select pt groups

  3. Options • Education/Outreach • Public announcements, DHCP letters • Medication guide for patients • ‘Academic detailing’ to targeted prescribers • Reminders • Patient agreement or informed consent • Physician attestation of appropriate use e.g. 2nd line or intolerant of other therapies • Limit amount supplied, or limit refills

  4. Options • Performance Linked Access • Define an appropriate prescribing physician and/or patient group and set up a process system that restricts prescribing to them, may involve pharmacists as well • Examples include clozapine, thalidomide • Drug not dispensed/shipped unless defined conditions are met

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