1. Medication Errors and Low-Density Polyethylene (LDPE) Plastic Vials Drug Safety and Risk Management Advisory Committee Meeting Rockville, Maryland May 5, 2004 Marci Lee, PharmD Division of Medication Errors and Technical Support Drug Safety and Risk Management Advisory Committee Meeting Rockville, Maryland May 5, 2004 Marci Lee, PharmD Division of Medication Errors and Technical Support Center for Drug Evaluation and Research

2. Drug Safety and Risk Management Advisory Committee May 5, 2004 2 Objectives Describe LDPE medication error reports and feedback from patients and practitioners. List factors that contribute to medication errors involving products in LDPE containers. Describe some packaging and labeling approaches. Describe LDPE medication error reports and feedback from patients and practitioners. List factors that contribute to medication errors involving products in LDPE containers. Describe some packaging and labeling approaches.

3. Drug Safety and Risk Management Advisory Committee May 5, 2004 3 LDPE Error Analysis 87 relevant medication error reports Sources of reports –ISMP/USP Medication Error Reporting Program (MERP) –FDA MedWatch and Drug Quality Report System (DQRS) Actual error reports Potential error reports Outcomes ranged from “no patient harm” to “difficulty breathing” 87 relevant medication error reports Sources of reports –ISMP/USP Medication Error Reporting Program (MERP) –FDA MedWatch and Drug Quality Report System (DQRS) Actual error reports Potential error reports Outcomes ranged from “no patient harm” to “difficulty breathing”

4. Drug Safety and Risk Management Advisory Committee May 5, 2004 4 Other Interested Parties Institute for Safe Medication Practices (ISMP) United States Pharmacopeia (USP) Safe Medication Use Expert Committee United States Senator Harkin Institute for Safe Medication Practices (ISMP) United States Pharmacopeia (USP) Safe Medication Use Expert Committee United States Senator Harkin

5. Drug Safety and Risk Management Advisory Committee May 5, 2004 5 Factors Contributing to Errors Difficult-to-read containers Look-alike packaging Routine user handling of LDPE containers Difficult-to-read containers Look-alike packaging Routine user handling of LDPE containers

6. Drug Safety and Risk Management Advisory Committee May 5, 2004 6 “Difficult-to-read” Labeling “…raised lettering in clear plastic…very difficult to see clearly the name of the drug, the product ingredients, the lot numbers, and the expiration date.”

7. Drug Safety and Risk Management Advisory Committee May 5, 2004 Look-Alike Packaging

8. Drug Safety and Risk Management Advisory Committee May 5, 2004 8 “Look-Alike” Packaging

9. Drug Safety and Risk Management Advisory Committee May 5, 2004 Look-Alike Packaging Injectable, Oral, and Ophthalmic Drug Products

10. Drug Safety and Risk Management Advisory Committee May 5, 2004 10 Heparin Lock Flush Solution, USP

11. Drug Safety and Risk Management Advisory Committee May 5, 2004 11 Naropin 2 mg/mL (Ropivacaine HCl Injection) POLYAMP DUOFIT

12. Drug Safety and Risk Management Advisory Committee May 5, 2004 12 Timoptic OCUDOSE Dispenser

13. Drug Safety and Risk Management Advisory Committee May 5, 2004 13 Gastrocrom Oral Solution Squeeze liquid contents into a glass of water. Stir solution. Drink all of the liquid. Discard the empty ampule. © 2001, Celltech Pharmaceuticals, Inc.R535

14. Drug Safety and Risk Management Advisory Committee May 5, 2004 14 Factors Contributing to Errors Difficult-to-read containers Look-alike packaging Routine user handling of LDPE containers Difficult-to-read containers Look-alike packaging Routine user handling of LDPE containers

15. Drug Safety and Risk Management Advisory Committee May 5, 2004 15 Routine Handling of LDPE Vials “While the foil pouch is clearly marked, we have noted the practice of opening the pouch, taking the vials out and then discarding the pouch. The result is loose vials that are not clearly marked.”

16. Drug Safety and Risk Management Advisory Committee May 5, 2004 16 Routine Handling of LDPE Vials “...noticed the potential medication error on their epidural cart when the medications were removed from their original packaging so that they would fit in the cart.”

17. Drug Safety and Risk Management Advisory Committee May 5, 2004 17

18. Drug Safety and Risk Management Advisory Committee May 5, 2004 18

19. Drug Safety and Risk Management Advisory Committee May 5, 2004 19 Routine Handling of LDPE Vials “Our respiratory therapists often carry individual unit dose containers in their pockets without the outside packaging.” “It is easy to administer one strength for another when both strengths are kept in a respiratory therapists pocket.” “Our respiratory therapists often carry individual unit dose containers in their pockets without the outside packaging.” “It is easy to administer one strength for another when both strengths are kept in a respiratory therapists pocket.”

20. Drug Safety and Risk Management Advisory Committee May 5, 2004 Packaging and Labeling Approaches

21. Drug Safety and Risk Management Advisory Committee May 5, 2004 21 Paper Label

22. Drug Safety and Risk Management Advisory Committee May 5, 2004 22 Label on Flange of Vial

23. Drug Safety and Risk Management Advisory Committee May 5, 2004 23 Embossed Flange Area

24. Drug Safety and Risk Management Advisory Committee May 5, 2004 24 Embossed Body of Vial with “V” Shaped Tip on Vial

25. Drug Safety and Risk Management Advisory Committee May 5, 2004 25 Embossed Vial Tips

26. Drug Safety and Risk Management Advisory Committee May 5, 2004 26 Glass Vials with Paper Label

27. Drug Safety and Risk Management Advisory Committee May 5, 2004 27 Pulmicort Respules

28. Drug Safety and Risk Management Advisory Committee May 5, 2004 28 Colored Plastic Vials

29. Drug Safety and Risk Management Advisory Committee May 5, 2004 29 Individual Overwrap

30. Drug Safety and Risk Management Advisory Committee May 5, 2004 What other approaches should we consider?

31. Drug Safety and Risk Management Advisory Committee May 5, 2004 31 DiscussionDiscussion Identify alternative packaging and labeling options for drug products in LDPE vials Address ingress concern/product integrity Address legibility Address look-alike containers Does not create new problems Identify alternative packaging and labeling options for drug products in LDPE vials Address ingress concern/product integrity Address legibility Address look-alike containers Does not create new problems