Pharmaceutical Recall Process

1. Pharmaceutical Recall Process Carol Goularte Pharmacy Buyer Sierra Nevada Memorial Hospital August 19, 2009

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

3. 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?

4. 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.

5. Recall Policy

6. Recall Notices How are you notified?

7. Actual Recall Notice STATUSDISTRIBUTION FACILITY New                                     00 - Recall People SEQUENCE #DATE OF RECALL 01-766RCL                               5/4/2009 CLASS OF RECALL/WITHDRAWDATE SENT Unclassified                            VENDORDATE OF LAST REMINDER Ranbaxy Pharmaceuticals                 PRODUCT RECALLED/WITHDRAWNRETURN 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.

8. 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

9. 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

10. Notifications Be prepared when you sign up to receive more than just drug recalls!

11. Recall First, we must understand what constitutes a drug recall. • Voluntary by manufacturer • At the request of the FDA under statutory authority

12. 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.

13. 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.

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

15. 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

16. Checking for Purchase history

17. Purchase History Report from Cardinal

18. 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

19. 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.

20. 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.

21. 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

22. 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.

23. Recall Log Example

24. 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

25. Recall • Research as much as possible • Call manufacturer first for updates • Ask wholesaler to call manufacturer for updates • Check FDA and ASHP websites

26. 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