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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 the alternatives and options that patients have when directly faced with this situation.
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WELCOME
TONIGHT’S WEBINAR: "WHAT TO DO WHEN YOUR DOC IS OUT OF 5-‐FU (OR LEUCOVORIN...OR IRINOTECAN)"
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LINDSEY B. POPPE, PHARMD, MS, BCPS CLINICAL MANAGER, ONCOLOGY SERVICE LINE AND
EMERGENCY DEPARTMENT SERVICES DEPARTMENT OF PHARMACY
UNIVERSITY OF NORTH CAROLINA HOSPITALS
Lindsey B. Poppe, PharmD, MS, BCPS Clinical Manager, Oncology Service Line and Emergency Department Services
Department of Pharmacy University of North Carolina Hospitals
"What to Do When Your Doc is Out of 5-‐FU (or Leucovorin...or Irinotecan)"
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
In the News
• “U.S. Drug Shortage Could Threaten U.S. Health System”
• “Drug Shortage Sparks Mayhem in Many Oncology Pharmacies”
Increasing Number of Drug Shortages
0
50
100
150
200
250
2005 2006 2007 2008 2009 2010 2011
Number of Drug Shortages per Year
Economic analysis of the causes of drug shortages. Available from: hMp://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml
Drug Shortages Survey
Pharmacist Survey Responses Number of responses
LiMle or no informaQon available about the duraQon of a drug shortage 85%
Lack of advanced warning from manufacturers or FDA to alert pracQQoners to an impending drug shortage and suggested alternaQves
84%
LiMle or no informaQon about the cause of the drug shortage 83%
SubstanQal resources spent invesQgaQng the shortage and developing a plan of acQon 82%
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.
Impact of Drug Shortages
Delays
Failure to treat
disease
MedicaQon errors
Increased cost
47%
28%
14%
7% 3% 1%
Reasons for Drug Shortages in 2010
Unknown
Manufacturing
Supply/Demand
DisconQnue
Raw Materials
Regulatory
Why are drug shortages happening?
Fox ER. Drug Shortages Overview & Trends. 2010. Available from: hMp://www.ashp.org/drugshortages/summitreport.
Why are drug shortages happening?
Demand
Supply
Supply Chain
Raw Materials • AcQve pharmaceuQcal ingredients
Manufacturers • Make prescripQon medicaQons
Wholesalers • Purchase drugs from manufacturers and sells to insQtuQons
Dispensers • Hospitals • Home health • Community pharmacies
PaRents
Colorectal Cancer Drug Shortages
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
Colorectal Cancer Drug Shortages
3 manufacturers Fluorouracil • Reasons for shortage: manufacturing issues leading to recall of the product
4 manufacturers Leucovorin • Reasons for shortage: manufacturing delays leading to increased demand
8 manufacturers in 2010, now 3 manufacturers Irinotecan • 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.
Alternative Agents
• Choice of alternative agent must be patient-‐specific
• Must talk with your prescriber on potential alternative agents
Addressing Drug Shortages
Health-‐Systems and Government
Addressing Drug Shortages
• Weekly drug shortage meetings • One employee dedicated to drug shortage management
• Communication with prescribers • Responsible purchasing
Health-‐System
• 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
Addressing Drug Shortages NaQonally
• 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
Addressing Drug Shortages NaQonally
ASA, ASCO, ASHP, ISMP. Summary Report—Drug Shortages Summit. 2010:1-‐7.
• 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
Addressing Drug Shortages NaQonally
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
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
NaQonally
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
Resources
• American Society of Health-‐System Pharmacists – www.ashp.org/shortage
• FDA – www.fda.gov
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!
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
WE’RE COLLECTING STORIES
www.StopDrugShortages.org
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