iPledge timelines
• September: initial mailing to all prescribers• October: Registration by pre-populated form• Mid-October: Receive patient kits • November:
– iPLEDGE goes live, doctors activate in system– New pts start on iPLEDGE
• November/December: transition old pts from SMART to iPLEDGE or finish course by 12/31
• Jan 1, 2006: Not registered=no drug
iPLEDGE Background
• iPLEDGE is an mandatory FDA initiative• All manufacturers of isotretinoin under one
plan:– Ranbaxy - Sotret– Barr - Claravis– Genpharm (Bertek) - Amnesteem– Roche - Accutane
• Covance selected as vendor to design, build, implement and operate the enhanced iPLEDGE program
Registration, Education and Activation Process
All interested parties have responsibilities:
• Manufacturers• Wholesalers• Pharmacies• Prescribers• Patients
Distribution
• Manufacturers can only ship isotretinoin to registered wholesalers
• Wholesalers can only ship isotretinoin to registered pharmacies
• Registered pharmacies can only dispense isotretinoin when they receive iPLEDGE clearinghouse approval
Prescriber Education Materials
• Registered Prescriber receives– Cover letter • User name and password• Prescriber educational materials• Office staff designee(s) registration form and
instructions• Activation instructions sheet
Designee Clarification
– Office staff designee--can enter information as an extension of an individual prescriber
– Office delegate • Doctors within a practice can designate each other to
ensure continuum of care• No need to change doctor’s name on registry• There is no limit on designation(s) allowed• Resident clinics
- Designees and delegates have their own numbers
Patient Registration by Prescriber
– Logs onto system and enters:• usual demographic data• patient risk category (Male, WCBP, WNCBP)• Confirmation of consent form(s) and HIPAA completion
– Provide patient with iPLEDGE card– Provides and documents patient with counseling and
educational materials
Patient Registration (all groups)
• Registers with the iPLEDGE system• Attests that they have:
– signed Informed consent form(s)– received education and counseling on
isotretinoin & iPLEDGE requirements
Patient Registration (WCBP only)
• Additional informed consent• Attest that they understand:
– they should not become pregnant– they must use 2 forms of contraception for 30
days prior to, during and 30 days post-treatment
– they must have monthly laboratory pregnancy testing
– they must interact monthly with iPLEDGE system
iPLEDGE Program Walk-through
• Women of child bearing potential (WCBP)• Women not of child bearing potential (WNCBP)
and Males
WCBP Pre-Treatment
• Screening pregnancy test in prescriber’s office• Prescriber documents in system
– Patient registration– Informed consent form(s) completed– Patient education and counseling– Contraceptive methods discussed with patient– Date of negative screening pregnancy test (only
time office test is okay)
• Initiate or continue appropriate contraception
WCBP monthly• Laboratory-conducted pregnancy test
– Results forwarded to prescriber
– Lab must be CLIA certified
• Prescriber documents in system– Patient education & counseling
– Contraceptive methods (must match patient input)
– Pregnancy test results
• Prescriber provides prescription (paper, phone, fax, e-mail)
• Patient interacts with iPLEDGE system– Answers monthly educational questions
– Lists contraceptive methods (must match prescriber input)
WCBP – Completion of therapy
• Laboratory-conducted pregnancy test immediately upon treatment discontinuation
• Appropriate contraception continued for 30 days after last dose of isotretinoin
• Final laboratory-conducted pregnancy test 30 days post treatment discontinuation
• Pregnancy test results documented in system
Pre-Treatment (WNCBPs and Men)
• Prescriber enters into the system– Patient registration…men included– Informed consent form(s) completed– Patient education and counseling
• Prescriber provides prescription (paper, phone, fax, e-mail)
Each Treatment Month (WNCBPs and Males)
• Prescriber documents in system– Patient education & counseling
• Prescriber provides prescription (paper, phone, fax, e-mail)
• WNCBP and men do not need to interact monthly with system
Every month for WCBP:
Prescriber– Counsels pt, confirms
contraception– Logs onto system to:
• Enter 2 forms of contraception patient has agreed to use
• Enter negative pregnancy test result
• Confirm pt counselled
• Patient– Has office visit and
counselling– Has pregnancy test– Logs onto system and
answers questions– Enters her 2 forms of
BC
What is counselling?
For everyone• Risks of birth defects• Don’t share drug• Don’t donate blood
Additional for WCBP• Don’t get pregnant• Use two forms of BC
Prescriber Notice
• All pregnancies should be reported directly to Covance through the iPLEDGE program– www.ipledgeprogram.com
or call 1-866-495-0654
Dispensing Isotretinoin(All Patients)
• Patient presents prescription to pharmacy within 7 days of the office visit– Can be paper, phone, fax, e-mail – No “yellow stickers” in iPLEDGE
• Pharmacist accesses iPLEDGE for prescription authorization
• If prescription authorized, isotretinoin dispensed at the pharmacy
• Pharmacy sticker prohibits sale after 7 days
Prescription NOT AuthorizedReason for NO Authorization
Instructions to PatientAt Pharmacy
Pregnancy test NOT entered
Contact prescriber
Prescriber has not confirmed 2 forms of birth
control
Contact prescriber
Patient counseling NOT confirmed
Contact prescriber
Patient NOT interacting with iPLEDGE
Patient to call iPLEDGE
Pregnancy results are positive
STOP taking medication and contact prescriber
immediately.
Transition Plan (cont.)November 1 to December 31, 2005• Explanatory leaflet for prescribers and
pharmacists to distribute to patients – Announces the launch of iPLEDGE– Encourages patients to talk to their physician– Provides information about iPLEDGE
If you have not received your iPLEDGE registration kit…log onto—www.ipledgeprogram.com or call 1-866-495-0654