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

WELCOME

TONIGHT’S WEBINAR: "WHAT TO DO WHEN YOUR DOC IS OUT OF 5-‐FU (OR LEUCOVORIN...OR IRINOTECAN)"

WILL BEGIN SHORTLY…

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

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, OR SUSPECT THAT YOU ARE ILL, SEE A DOCTOR IMMEDIATELY. IN AN

EMERGENCY, CALL 911 OR GO TO THE NEAREST EMERGENCY ROOM. FIGHT COLORECTAL CANCER NEVER RECOMMENDS OR

ENDORSES ANY SPECIFIC PHYSICIANS, PRODUCTS OR TREATMENTS FOR ANY CONDITION.

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


•  6 of 9 drugs used in treatment have been on shortage in past 2 years – Leucovorin – Levoleucovorin – Fluorouracil (5-‐FU) – Oxaliplatin –  Irinotecan – Capecitabine


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


•  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


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


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


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