What to Do When Your Doc is Out of 5-FU
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What to Do When Your Doc is Out of 5-FU

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Presentation from Webinar on Nov 16, 2011 from discussion with Dr. Lindsey Poppe, the Pharmacy Clinical Manager for Oncology for the University of North Carolina hospital system. She talked about......

Presentation from Webinar on Nov 16, 2011 from discussion with Dr. Lindsey Poppe, the Pharmacy Clinical Manager for Oncology for the University of North Carolina hospital system. She talked about the alternatives and options that patients have when directly faced with this situation.

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  • 1. WELCOME TONIGHT’S WEBINAR:"WHAT  TO  DO  WHEN  YOUR  DOC  IS  OUT  OF   5-­‐FU  (OR  LEUCOVORIN...OR  IRINOTECAN)"   WILL BEGIN SHORTLY…
  • 2. HOUSEKEEPING 1. WHO’S IN THE ROOM… 2. WEBINAR WILL BE ARCHIVED ON OUR WEBSITE… 3. FOLLOW UP SURVEY… 4. HOW TO ASK A QUESTION… 5. OR CALL 877-427-2111  
  • 3.       DISCLAIMER THE INFORMATION AND SERVICES PROVIDED BY FIGHT COLORECTAL CANCER ARE FOR GENERAL INFORMATIONAL PURPOSES ONLY. THE INFORMATION AND SERVICES ARE NOT INTENDED TO BE SUBSTITUTES FOR PROFESSIONAL MEDICAL ADVICE, DIAGNOSES, OR TREATMENT. IF YOU ARE ILL, ORSUSPECT THAT YOU ARE ILL, SEE A DOCTOR IMMEDIATELY. IN AN EMERGENCY, CALL911 OR GO TO THE NEAREST EMERGENCYROOM. FIGHT COLORECTAL CANCER NEVER RECOMMENDS OR ENDORSES ANY SPECIFIC PHYSICIANS, PRODUCTS OR TREATMENTS FOR ANY CONDITION.
  • 4. LINDSEY  B.  POPPE,  PHARMD,  MS,  BCPS   CLINICAL  MANAGER,  ONCOLOGY  SERVICE  LINE  AND   EMERGENCY  DEPARTMENT  SERVICES   DEPARTMENT  OF  PHARMACY   UNIVERSITY  OF  NORTH  CAROLINA  HOSPITALS  
  • 5. "What  to  Do  When  Your  Doc  is  Out  of  5-­‐FU   (or  Leucovorin...or  Irinotecan)"   Lindsey  B.  Poppe,  PharmD,  MS,  BCPS  Clinical  Manager,  Oncology  Service  Line  and  Emergency  Department  Services   Department  of  Pharmacy   University  of  North  Carolina  Hospitals  
  • 6. Objectives  •  Understand  reasons  for  drug  shortage  crises  •  Discuss  strategies  to  manage  drug  shortages   for  health-­‐systems    •  Discuss  governmental  involvement  in   response  to  drug  shortages  •  Provide  resources  that  provide  the  latest   information  on  drug  shortages  •  Discuss  what  YOU  as  a  patient  can  do    
  • 7. In  the  News  •  “U.S.  Drug  Shortage  Could  Threaten  U.S.   Health  System”  •  “Drug  Shortage  Sparks  Mayhem  in  Many   Oncology  Pharmacies”  
  • 8. Increasing  Number  of  Drug  Shortages   Number  of  Drug  Shortages  per  Year   250   200   150   100   50   0   2005   2006   2007   2008   2009   2010   2011  Economic  analysis  of  the  causes  of  drug  shortages.  Available  from:  hMp://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml  
  • 9. Drug  Shortages  Survey   Number  of   Pharmacist  Survey  Responses   responses   LiMle  or  no  informaQon  available  about  the  duraQon  of  a  drug   85%   shortage   Lack  of  advanced  warning  from  manufacturers  or  FDA  to  alert   pracQQoners  to  an  impending  drug  shortage  and  suggested   84%   alternaQves   LiMle  or  no  informaQon  about  the  cause  of  the  drug  shortage   83%   SubstanQal  resources  spent  invesQgaQng  the  shortage  and   82%   developing  a  plan  of  acQon   Difficulty  obtaining  a  suitable  alternaQve  product   80%  ISMP.  Drug  shortages:  NaQonal  survey  reveals  high  level  of  frustraQon,  low  level  of  safety.  2010;15:1-­‐6.  
  • 10. Impact  of  Drug  Shortages   Increased   Delays   cost   Failure  to   MedicaQon   treat   errors   disease  
  • 11. Why  are  drug  shortages  happening?   Reasons  for  Drug  Shortages  in  2010   1%   3%   7%   Unknown   14%   Manufacturing   47%   Supply/Demand   DisconQnue   Raw  Materials   Regulatory   28%  Fox  ER.  Drug  Shortages  Overview  &  Trends.  2010.  Available  from:  hMp://www.ashp.org/drugshortages/summitreport.  
  • 12. Why  are  drug  shortages  happening?   Demand   Supply  
  • 13. Supply  Chain   Raw  Materials   Manufacturers   Wholesalers  •  AcQve  pharmaceuQcal   •  Make  prescripQon   •  Purchase  drugs  from   ingredients   medicaQons   manufacturers  and  sells   to  insQtuQons   Dispensers  •  Hospitals   PaRents  •  Home  health  •  Community  pharmacies  
  • 14. Colorectal  Cancer     Drug  Shortages  
  • 15. Colorectal  Cancer  Drug  Shortages  •  6  of  9  drugs  used  in  treatment  have  been  on   shortage  in  past  2  years   –  Leucovorin   –  Levoleucovorin   –  Fluorouracil  (5-­‐FU)   –  Oxaliplatin   –  Irinotecan   –  Capecitabine  
  • 16. Colorectal  Cancer  Drug  Shortages   Fluorouracil   3  manufacturers   •  Reasons  for  shortage:  manufacturing    issues  leading  to  recall  of   the  product   Leucovorin   4  manufacturers   •  Reasons  for  shortage:  manufacturing  delays  leading  to  increased   demand   Irinotecan   8  manufacturers  in  2010,  now  3  manufacturers   •  Reasons  for  shortage:  5  manufacturers  disconQnued  making  the   product,  other  3  manufacturers  cite  delays  as  they  cannot  keep   up  with  demand  CDER  Drug  Shortage  Program.    Available  from:  hMp://www.fda.gov/ohrms/dockets/ac/06/slides/2006-­‐4204-­‐S1-­‐03-­‐02-­‐FDA-­‐Goldberger_files/frame.htm.  
  • 17. Alternative  Agents  •  Choice  of  alternative  agent  must  be  patient-­‐ specific    •  Must  talk  with  your  prescriber  on  potential   alternative  agents  
  • 18. Addressing  Drug  Shortages   Health-­‐Systems  and  Government  
  • 19. Health-­‐System  Addressing  Drug  Shortages  •  Weekly  drug  shortage  meetings  •  One  employee  dedicated  to  drug  shortage   management  •  Communication  with  prescribers  •  Responsible  purchasing  
  • 20. NaQonally  Addressing  Drug  Shortages  •  FDA’s  Action   –  Prevented  137  shortages  in  2010  and  2011   –  Expediting  review  of  regulatory  submission   –  Encourage  remaining  manufacturers  to  increase   supply   –  Does  not  have  authority  over  manufacturers  
  • 21. NaQonally   Addressing  Drug  Shortages   •  Drug  Shortages  Summit   –  Expand  FDA’s  authority     –  Evaluate  current  definition  of  “medically   necessary”   –  Improve  approval  process  for  medically  necessary   drugs   –  Enhance  communication  throughout  supply  chain   –  Develop  options  for  products  in  short  supply  ASA,  ASCO,  ASHP,  ISMP.  Summary  Report—Drug  Shortages  Summit.  2010:1-­‐7.  
  • 22. NaQonally   Addressing  Drug  Shortages   •  President  Obama’s  Executive  Order   –  Instructs  the  FDA  on  specific  steps  to  take  to   address  the  shortages:   •  Report  potential  shortages  sooner   •  Expedite  review  of  manufacturing  processes   •  Investigate  price  gouging  Obama  B.  ExecuQve  Order  –  Reducing  PrescripQng  Drug  Shortages.  2011.  Available  from:  hMp://www.whitehouse.gov/the-­‐press-­‐office/2011/10/31/execuQve-­‐order-­‐reducing-­‐prescripQon-­‐drug-­‐shortages    
  • 23. NaQonally  Addressing  Drug  Shortages  •  Preserving  Access  to  Life  Saving  Medications  Act   –  Directs  FDA  to  regulate  drug  shortages   •  Requires  drug  manufacturers  to  notify  FDA  about   manufacturing  problems  or  when  a  drug  will  be   discontinued   •  Fines  manufacturers  $10,000  per  day  for  failure  to    report   •  Requires  FDA  to  maintain  an  online  list  of  drugs  in  shortage   –  Develop  criteria  for  drugs  vulnerable  to  shortage   –  Annual  report  to  Congress,  then  report  every  5  years  
  • 24. What  can  you  do  as  a  patient?  •  Be  your  own  advocate!    •  Understand  drug  shortage  crises  •  Know  the  names  and  doses  of  your   medications  •  Contact  your  legislators  to  support  the  drug   shortage  bills  in  both  Senate  and  House      http://link.fightcrc.org/S296  
  • 25. Resources  •  American  Society  of  Health-­‐System   Pharmacists   –  www.ashp.org/shortage  •  FDA  –  www.fda.gov  
  • 26. Future  of  Drug  Shortages  •  Not  going  away  –  unfortunately    •  Legislation  will  help  the  issue    •  Health-­‐systems  partnering  with  government   agencies  to  ensure  FDA  authority  for  shortage   regulation    •  Understand  the  crises,  know  your  own   medications,  &  contact  your  legislators!  
  • 27. Summary  •  Major  increase  in  drug  shortages  over  past  5   years  •  Multiple  reasons  for  drug  shortages  –  most   common  with  manufacturing  changes  •  Health-­‐systems  and  government  addressing   the  issue  
  • 28.  
  • 29. WE’RE  COLLECTING  STORIES  www.StopDrugShortages.org  
  • 30. THANK YOU UPCOMING WEBINARS“THE BEST OF EASTERN AND WESTERN MEDICINE” WEDNESDAY, DECEMBER 14, 2011 8 - 9:30 PM EASTERN TIME “YOURE NOT LOSING IT. YOU HAVE CANCER.” WEDNESDAY, JANUARY 18, 2012 8 - 9:30 PM EASTERN TIME   REGISTER AT WWW.FIGHTCOLORECTALCANCER.ORG FIGHT CRC ANSWER LINE 1-877-427-2111