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

Drug Safety and Risk Management Advisory Committee May 5, 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.

Drug Safety and Risk Management Advisory Committee May 5, 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”

Drug Safety and Risk Management Advisory Committee May 5, 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

Drug Safety and Risk Management Advisory Committee May 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

Drug Safety and Risk Management Advisory Committee May 5, “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.”

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

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

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

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

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

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

Drug Safety and Risk Management Advisory Committee May 5, 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

Drug Safety and Risk Management Advisory Committee May 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

Drug Safety and Risk Management Advisory Committee May 5, 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.”

Drug Safety and Risk Management Advisory Committee May 5, 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.”

Drug Safety and Risk Management Advisory Committee May 5,

Drug Safety and Risk Management Advisory Committee May 5,

Drug Safety and Risk Management Advisory Committee May 5, 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.”

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

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

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

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

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

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

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

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

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

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

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

Drug Safety and Risk Management Advisory Committee May 5, 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