This document is a webinar presentation on managing drug shortages for colorectal cancer medications. It provides background on the increasing issue of drug shortages in the US, with over 200 shortages reported annually since 2010. For colorectal cancer specifically, 6 of the 9 main drugs used to treat the disease have been in shortage in the past 2 years, including 5-FU, leucovorin, and irinotecan. The presentation discusses reasons for shortages like manufacturing and supply chain issues, and strategies used by health systems and government agencies to help mitigate shortages, such as improved communication and expediting regulatory reviews of alternative products.

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, OR
SUSPECT THAT YOU ARE ILL, SEE A DOCTOR IMMEDIATELY. IN AN
EMERGENCY, CALL911 OR GO TO THE NEAREST EMERGENCY
ROOM. 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

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
“YOU'RE 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