Transcript Powerpoint Template

Pharmaceutical Recall Process
PRESENTED
B Y:
Carol Goularte
Pharmacy Buyer
Sierra Nevada Memorial Hospital
August 19, 2009
Recall
NEIGHBORHOOD PHARMACY
It’s a real miracle drug, it hasn’t been
recalled by the FDA in over 20 years
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Recalls
• Raise your hand….if you enjoy drug
recalls….
• Ok, raise your hand if you would be happy
to go a few days without a recall..
• That’s what I thought, keep your hands
raised…
• How many of you have a good process in
place for handling recalls?
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Recall
• As a result of the multiple drug recalls,
CHW put together a task force to
standardize the process. Many hospital
recall processes were put together to
come up with this best practice.
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Recall Policy
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Recall Notices
How are you notified?
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Actual Recall Notice
STATUS
DISTRIBUTION FACILITY
New
00 - Recall People
SEQUENCE #
DATE OF RECALL
01-766RCL
5/4/2009
CLASS OF RECALL/WITHDRAW
DATE SENT
Unclassified
VENDOR
DATE OF LAST REMINDER
Ranbaxy Pharmaceuticals
PRODUCT RECALLED/WITHDRAWN
RETURN COMPLETED FORM TO CORPORATE BY
Nitrofurantoin Monohydrate/Macrocrystals Capsules USP7/4/2009
WHOLESALE/CUSTOMER
Wholesale, Customer
ADDITIONAL NOTES
This is a retail level recall. First ship date was 1/1/07. Fill out and return the manufacturer's recall response form.
Lot numbers provided in additional attachment.
Speedigram message to read: Unclassified retail level recall. Manufacturer recall due to certain lots of the
product not conforming with approved laboratory specifications for dissolution. Return product to Cardinal
Health.
DETAILS
CIN#:
3660842
NDC:
63304051801
Product Description: NITROFURANTOIN 100MG 100 BID
Lot Numbers:
See Attached
Click here to open the Recall document directly.
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Recall notifications
Websites for email notifications:
FDA
http://www.fda.gov/Safety/Recalls/default.htm
FDA even has Twitter
Google Alerts sign up (under Google, more and
even more, then alerts and use key words)
MediRegs www.mediregs.com
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Notifications
ASHP www.ashp.org use search field to find
out about recalls or link for shortages
Wholesaler – Notifications via emailings,
hard copies in totes
Direct from Manufacturer or Representative
Emails from your colleagues, peers
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Notifications
Be prepared when you sign up to
receive more than just drug recalls!
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Recall
First, we must understand what
constitutes a drug recall.
– Voluntary by manufacturer
– At the request of the FDA under statutory
authority
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Recall
Types of Drug Recalls
– Class I recall is a situation in which there is
a reasonable probability that the use of or
exposure to a volatile product will cause
serious health consequences or death.
– Class II recall is a situation in which use of
or exposure to a volatile product may
cause temporary or medically reversible
adverse health consequences or where
the probability of serious adverse health
consequences is remote.
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Recall
Class III recall is a situation in which
use of or exposure to a volatile product
is not likely to cause adverse health
consequences.
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Recall
This drug is so expensive, if it were recalled, the stock
market would crash!
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Recalls – steps to take
What do you do first? (Get
your combat gear on?)
•Check for purchase history
of the recalled product.
•Run a purchase history
report in your wholesaler
reporting system or quickly
look at your purchase history
in your catalog
•Save a screen print from
your computer for
documentation
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Checking for Purchase history
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Purchase History Report from Cardinal
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Establish Locations
Establish locations where drug is stored:
•All areas of central pharmacy
•All satellite or Clinical areas
•All Automated Dispensing Cabinets (Pyxis,
Omnicell, Robots)
•Alternate dispensing areas and patient
cassettes
•Check patients own meds to notify patient
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Restricting Access
Next Step, Restrict Access
Use a lock out option or recall function
on Automated dispensing cabinets.
Use a standard form to document all
areas being checked.
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Documentation
• Document, Document
• Make sure each person who checks an
area signs off on the sheet.
• Return all product to the pharmacy
• All recalled product should be
immediately isolated
• Make a copy of the recall notice and
attach to isolated product.
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Documentation
• Keep Documentation in case of inspection
in a notebook
• Keep original recall notice
• Documentation of every area that was
checked with sign offs
• Keep a running log of all recalls and
reasons
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Documentation
• Documentation of how product was
returned with proof of destruction if
possible, ie receipt of manufacture
receiving the product, on-line report
from Reverse Distributor.
• Records must be kept for no less than 3
years.
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Recall Log Example
CHW RECALL NOTIFICATION LOG - April 2009
Year
Period
4th wk of
2009 Apr
4th wk of
2009 Apr
2009 4th wk of
2009 4th wk of
2009 4th wk of
2009 4th wk of
2009 4th wk of
2009 5th wk of
2009 5th wk of
2009 5th wk of
2009 5th wk of
5th wk of
2009 Apr
5th wk of
2009 Apr
2009 5th wk of
2009 5th wk of
2009 5th wk of
5th wk of
2009 Apr
5th wk of
2009 Apr
5th wk of
2009 Apr
Recall
Date Manufacturer
04/23/09
04/23/09
04/24/09
04/24/09
04/24/09
04/24/09
04/24/09
04/24/09
04/24/09
04/24/09
04/24/09
River's Edge
Pharmaceuticals
River's Edge
Pharmaceuticals
Watson
Watson
Watson
Watson
U D L Laboratories
Watson
Watson
Watson
Watson
04/27/09 API
04/27/09
04/27/09
04/27/09
04/27/09
Product Description
Reason for Recall
Com
munic
ation Recall
Date communi
by cated by Recall Level
BENZOYL PEROXIDE 6.5% 125ML
recall due to long term stability failure
4/23/09 Derek Ho
SODIUM SULFACET 10% 30 MDCT
SENEXON 8.6MG 100 NATRL VEG
SENEXON 8.6MG 1000
DOCUSATE SOD/SENNA 8.6-50 100
DOCUSATE SOD/SENNA 8.6-50
Loxapine Capsules USP
DOCUSATE SOD/SENNA 8.6-50 1000
DOCUSATE SOD/SENNA 8.6-50 100
SENEXON 8.6MG 1000
SENEXON 8.6MG 100 NATRL VEG
recall due to long term stability failure
4/23/09 Derek Ho WHOLESALE
recall due to long term stability failure
4/23/09 Derek Ho WHOLESALE
recall due to long term stability failure
4/24/09 Derek Ho RETAIL
recall due to long term stability failure
4/24/09 Derek Ho RETAIL
recall due to long term stability failure
4/24/09 Derek Ho RETAIL
LOXAPINE SUCC 10MG 100UD
4/24/09 Derek Ho WHOLESALE
Derekanhydrous
Ho RETAIL
contain small amounts of undeclared (not4/27/09
on label)
lactose and tar
Derekanhydrous
Ho RETAIL
contain small amounts of undeclared (not4/27/09
on label)
lactose and tar
Derekanhydrous
Ho RETAIL
contain small amounts of undeclared (not4/27/09
on label)
lactose and tar
4/27/09
Derek
Ho
RETAIL
contain
small
amounts
of
undeclared
(not
on
label)
anhydrous
lactose and tar
Manufacturer recall because the product
may contain the incorrect flavoring
4/27/09 Derek Ho WHOLESALE
agent
"orange-pineapple"
instead
of
Manufacturer
recall because
the product
may contain the incorrect flavoring
4/27/09 Derek Ho WHOLESALE
agent "orange-pineapple" instead of
due to unsatisfactory results from the 9 month 4/27/09 Derek Ho RETAIL
Derek
Ho RETAIL
because the subject lot is out of trend 4/27/09
with the
product's
historical values
Derek
Ho RETAIL
because the subject
lot is out
of trend
with the
product's
historical values
Manufacturer
recall because
product
lot 4/27/09
numbers were subject to a recall as a
result of being
in the
unapproved
drug
Manufacturer
recall
because
product
lot 4/27/09 Derek Ho RETAIL
numbers were subject to a recall as a
result
of being
in the
unapproved
drug
Manufacturer
recall
because
product
lot 4/27/09 Derek Ho RETAIL
numbers were subject to a recall as a
result of being in the unapproved drug 4/29/09 Derek Ho RETAIL
IOPHEN-C NR100-10/5 480 API C5
API
IOPHEN DM NR 100-10/5 480 API
Pamlab
CEREFOLIN NAC 90 SF CPLT
Taro Pharmaceuticals
DESOXIMETASONE 0.05% 15GM
Taro Pharmaceuticals
DESOXIMETASONE 0.05% 60GM
04/29/09 Brighton Pharmaceuticals
PE TANN/CP TANN 20-4MG/5 473ML
04/29/09 Brighton Pharmaceuticals
DM 30/PE 25/ BROM 10 TANN 16OZ
04/29/09 Brighton Pharmaceuticals
BROM-DM-PSE TAN 473ML SF AF
WHOLESALE
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Results of many Recalls
• Work with your Director and Clinical
Pharmacist
• Alternative products may have to be
used
• Different strengths, example Norco
325/5 vs 500/5
• Post “Pharm-a-grams” Communication
• Alternatives may go on shortage and
become scarce
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Recall
•Research as much
as possible
•Call manufacturer
first for updates
•Ask wholesaler to
call manufacturer for
updates
•Check FDA and
ASHP websites
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Help Resolve the Problem
Be Proactive!
• Notify GPO (if applicable) if sole awarded or
problem with supply
• Notify Wholesaler to try to increase inventory
of available alternative products
• Work with Manufacturer to check status on
supply
• Communicate updates to Staff and Physicians
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