P R E S E N T E D B Y:

Carol GoulartePharmacy BuyerSierra Nevada Memorial HospitalAugust 19, 2009

Pharmaceutical Recall Process

Recall

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It’s a real miracle drug, it hasn’t been recalled by the FDA in over 20 years

NEIGHBORHOOD PHARMACY

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

Recall Notices

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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PRODUCT RECALLED/WITHDRAWN              RETURN COMPLETED FORM TO CORPORATE BY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.

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

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This drug is so expensive, if it were recalled, the stock market would crash!

Recalls – steps to take

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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

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

Year PeriodRecall

Date Manufacturer Product Description Reason for Recall

Communication Date

by

Recall communicated by Recall Level

20094th wk of Apr 04/23/09

River's Edge Pharmaceuticals BENZOYL PEROXIDE 6.5% 125ML recall due to long term stability failure 4/23/09 Derek Ho WHOLESALE

20094th wk of Apr 04/23/09

River's Edge Pharmaceuticals SODIUM SULFACET 10% 30 MDCT recall due to long term stability failure 4/23/09 Derek Ho WHOLESALE

2009 4th wk of 04/24/09 Watson SENEXON 8.6MG 100 NATRL VEG recall due to long term stability failure 4/23/09 Derek Ho WHOLESALE2009 4th wk of 04/24/09 Watson SENEXON 8.6MG 1000 recall due to long term stability failure 4/24/09 Derek Ho RETAIL2009 4th wk of 04/24/09 Watson DOCUSATE SOD/SENNA 8.6-50 100 recall due to long term stability failure 4/24/09 Derek Ho RETAIL2009 4th wk of 04/24/09 Watson DOCUSATE SOD/SENNA 8.6-50 recall due to long term stability failure 4/24/09 Derek Ho RETAIL2009 4th wk of 04/24/09 U D L Laboratories Loxapine Capsules USP LOXAPINE SUCC 10MG 100UD 4/24/09 Derek Ho WHOLESALE2009 5th wk of 04/24/09 Watson DOCUSATE SOD/SENNA 8.6-50 1000 contain small amounts of undeclared (not on label) anhydrous lactose and tartaric acid. 4/27/09 Derek Ho RETAIL2009 5th wk of 04/24/09 Watson DOCUSATE SOD/SENNA 8.6-50 100 contain small amounts of undeclared (not on label) anhydrous lactose and tartaric acid. 4/27/09 Derek Ho RETAIL2009 5th wk of 04/24/09 Watson SENEXON 8.6MG 1000 contain small amounts of undeclared (not on label) anhydrous lactose and tartaric acid. 4/27/09 Derek Ho RETAIL2009 5th wk of 04/24/09 Watson SENEXON 8.6MG 100 NATRL VEG contain small amounts of undeclared (not on label) anhydrous lactose and tartaric acid. 4/27/09 Derek Ho RETAIL

20095th wk of Apr 04/27/09 API IOPHEN-C NR100-10/5 480 API C5

Manufacturer recall because the product may contain the incorrect flavoring agent "orange-pineapple" instead of 4/27/09 Derek Ho WHOLESALE

20095th wk of Apr 04/27/09 API IOPHEN DM NR 100-10/5 480 API

Manufacturer recall because the product may contain the incorrect flavoring agent "orange-pineapple" instead of 4/27/09 Derek Ho WHOLESALE

2009 5th wk of 04/27/09 Pamlab CEREFOLIN NAC 90 SF CPLT due to unsatisfactory results from the 9 month 4/27/09 Derek Ho RETAIL2009 5th wk of 04/27/09 Taro Pharmaceuticals  DESOXIMETASONE 0.05% 15GM because the subject lot is out of trend with the product's historical values for potency 4/27/09 Derek Ho RETAIL2009 5th wk of 04/27/09 Taro Pharmaceuticals  DESOXIMETASONE 0.05% 60GM because the subject lot is out of trend with the product's historical values for potency 4/27/09 Derek Ho RETAIL

20095th wk of Apr 04/29/09 Brighton Pharmaceuticals  PE TANN/CP TANN 20-4MG/5 473ML

Manufacturer recall because product lot numbers were subject to a recall as a result of being in the unapproved drug 4/27/09 Derek Ho RETAIL

20095th wk of Apr 04/29/09 Brighton Pharmaceuticals  DM 30/PE 25/ BROM 10 TANN 16OZ

Manufacturer recall because product lot numbers were subject to a recall as a result of being in the unapproved drug 4/27/09 Derek Ho RETAIL

20095th wk of Apr 04/29/09 Brighton Pharmaceuticals  BROM-DM-PSE TAN 473ML SF AF

Manufacturer recall because product lot numbers were subject to a recall as a result of being in the unapproved drug 4/29/09 Derek Ho RETAIL

CHW RECALL NOTIFICATION LOG - April 2009

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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