Transcript Slide 1

The new isotretinoin registry
iPledge timelines
September: initial mailing to all prescribers
October: Registration by pre-populated form
Mid-October: Receive patient kits
– 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
– Ranbaxy - Sotret
– Barr - Claravis
– Genpharm (Bertek) - Amnesteem
– Roche - Accutane
• Covance selected as vendor to design, build,
implement and operate the enhanced iPLEDGE
One Central Clearinghouse…
One Program
Physician Data Entry
Registration, Education and
Activation Process
All interested parties have
• 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
How does a prescriber register
and activate?
Prescriber Education Materials
• Registered Prescriber receives
Cover letter
User name and password
Prescriber educational materials
Office staff designee(s) registration form and
• 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
How do I enroll each patient into
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 posttreatment
– they must have monthly laboratory pregnancy
– they must interact monthly with iPLEDGE
Your patient needs to interact
directly with iPLEDGE
iPLEDGE Program
• 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
(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:
– Counsels pt, confirms
– 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
– Has pregnancy test
– Logs onto system and
answers questions
– Enters her 2 forms of
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
or call 1-866-495-0654
What happens at the pharmacy?
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 Authorized
Reason for NO
Instructions to Patient
At Pharmacy
Pregnancy test NOT
Contact prescriber
Prescriber has not
confirmed 2 forms of birth
Contact prescriber
Patient counseling NOT
Contact prescriber
Patient NOT interacting
with iPLEDGE
Patient to call iPLEDGE
Pregnancy results are
STOP taking medication
and contact prescriber
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—
or call 1-866-495-0654
How will we cope with iPLEDGE?
• Kubler Ross stages of grieving
• Denial
– I’m going to put this off as long as possible
• Anger
– Threaten to stop prescribing
• Reality
– Remember how important isotretinoin is
• Acceptance
– Realize that the system is really easy once you get
used to it