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REGULATORY HISTORY OF ISOTRETINOIN: PREGNANCY PREVENTION

REGULATORY HISTORY OF ISOTRETINOIN: PREGNANCY PREVENTION. Gordana Diglisic, MD Medical Officer Division of Dermatology and Dental Products. ISOTRETINOIN. Accutane - approved in May 1982 Indication: Severe recalcitrant nodular acne generics: Amnesteem - 11/2002 Sotret - 12/2002

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REGULATORY HISTORY OF ISOTRETINOIN: PREGNANCY PREVENTION

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  1. REGULATORY HISTORY OF ISOTRETINOIN:PREGNANCY PREVENTION Gordana Diglisic, MD Medical Officer Division of Dermatology and Dental Products

  2. ISOTRETINOIN • Accutane - approved in May 1982 • Indication: Severe recalcitrant nodular acne • generics: • Amnesteem - 11/2002 • Sotret - 12/2002 • Claravis – 4/2003 • The only drug product approved for this indication

  3. Isotretinoin remains the only approved drug product for this indication

  4. Isotretinoin - Teratogen • 1982 - pregnancy Category X • 1983 - first report of exposed infant born with malformation • 1984 - boxed warning - pregnancy testing - use of contraception for the month prior to therapy

  5. Accutane Pregnancy Prevention Program APPP1988 Advisory Committee • new educational and reminder tools • patient informed consent form • voluntary patient and prescriber surveys

  6. Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC)September 2000 • augmentation of patient education • mandatory registration of all patients and prescribers • implementation of pregnancy registration • linkage of prescription dispensing to negative pregnancy testing

  7. System to Manage Accutane Related Teratogenicity – S.M.A.R.T.October 2001 • sticker-based program • negative pregnancy test (x2) • two forms of contraception • signed patient information/consent form • Medication Guide • Prescription Compliance Survey • Accutane Survey

  8. Drug Safety and Risk Management Advisory Committee (DSaRM) and DODACFebruary 2004 • registration of all patients, prescribers, and pharmacies • tighter linkage of pregnancy testing to prescription dispensing • implementation of a pregnancy registry for root cause analysis • participation of all manufacturers in a single risk minimization action plan (RiskMAP)

  9. iPLEDGEAugust 12, 2005 • single, consolidated risk minimization action plan for isotretinoin (both innovator and generic versions) was approved • performance-linked access system - registered and qualified patients receive isotretinoin

  10. New elements of iPLEDGE program • documentation of monthly counseling (for all patients) • documentation of monthly pregnancy testing for female patients of childbearing potential (FCBP) • demonstration of comprehension by FCBPs by answering monthly questions • prescriber and patient identification of contraceptive methods chosen • pregnancy registry for root cause analysis

  11. iPLEDGE Restricted Distribution • only prescribers registered and activated in iPLEDGE can prescribe isotretinoin • only pharmacies registered and activated in iPLEDGE can dispense isotretinoin • only patients (both males and females) registered and qualified in iPLEDGE can receive isotretinoin

  12. iPLEDGE Milestones • approved in August 2005 • stakeholder registration began in September 2005 • patient enrollment opened in December 2005 • transition completed on March 1, 2006

  13. Qualifications ofMales and Females Not of Childbearing Potential (FNCBP) • prescriber registers patient w/iPLEDGE • prescriber counsels patient and confirms in iPLEDGE - teratogenic risk - do not give blood - do not share isotretinoin • patient takes Rx to registered/activated pharmacy - pick up Rx within 7-day window - followed by 23-day lockout period

  14. Qualification Female Patients of Childbearing Potential • prescriber registers patient w/ iPLEDGE • screening/confirmatory pregnancy tests • prescriber counsels patient; confirms in iPLEDGE • two forms contraception for 30 days • patient answers questions • patient takes Rx to registered/activated pharmacy - pick up Rx within 7-day window - followed by 23-day lockout period

  15. Implementation Issues • slow registration/activation of stakeholders • call center overload • prescriber acceptance • 7-day window/23-day lockout period many patients had prescriptions denied and treatment postponed because the iPLEDGE system was programmed to lock out patients for an additional 23 days if they did not fill their prescription within 7 days of the office visit

  16. Isotretinoin Prescription Counts

  17. iPledge Begins Isotretinoin Patient Counts

  18. Removal of 23-day lockout for Males and Females Not of Childbearing Potential (FNCBP) October 2006 • did not require labeling change • gave more flexibility to this subset of patients • reduced interruptions in treatment • reduced burden to stakeholders

  19. Identified areas for changenext steps • removal of 23-day lockout for female patients of childbearing potential (FCBP)* • linkage of 7-day prescription window for FCBP to date of specimen collection rather than date of office visit • extension of prescription window from 7 days to 30 days for males and FNCBP *except for the first Rx to be filled

  20. Identified areas for change These changes are intended to: • enhance flexibility of the program • reduce interruption in treatment • reduce burden to stakeholders

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