2. iPLEDGE The new isotretinoin registry

3. 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

4. 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

5. One Central Clearinghouse… One Program iPLEDGE Clearinghous e Physician Data Entry

6. Registration, Education and Activation Process All interested parties have responsibilities: Manufacturers Wholesalers Pharmacies Prescribers Patients

7. 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

8. How does a prescriber register and activate?

9. 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

10. 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

11. How do I enroll each patient into iPLEDGE?

12. 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

13. 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

14. 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

15. Your patient needs to interact directly with iPLEDGE

16. iPLEDGE Program Walk-through Women of child bearing potential (WCBP) Women not of child bearing potential (WNCBP) and Males

17. 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

18. 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)

19. 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

20. 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)

21. 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

22. 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

23. 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

24. Prescriber Notice All pregnancies should be reported directly to Covance through the iPLEDGE program –www.ipledgeprogram.com or call 1-866-495-0654www.ipledgeprogram.com

25. What happens at the pharmacy?

26. 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

27. Prescription NOT Authorized Reason for NO Authorization Instructions to Patient At 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.

28. 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

40. If you have not received your iPLEDGE registration kit… log onto— www.ipledgeprogram.com or call 1-866-495-0654 www.ipledgeprogram.com

41. 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