Importance of Premarket Labeling and Packaging Safety Evaluations in Minimizing Postmarket Medication Errors

Medication errors reported by healthcare practitioners to the ISMP National Medication Errors Reporting Program (ISMP MERP) demonstrate the need for the pharmaceutical industry to be more proactive in identifying error-prone characteristics of drug product labeling and packaging. Much progress has been made in advancing premarket safety testing of medication brand names. However, in comparison, not enough is being done to assure that safety evaluations of proposed labeling and packaging are being conducted prior to product launch. Look-alike products and misleading container labeling represent more than 25% of the error reports submitted to ISMP. This free program will utilize case examples and product images to illustrate common safety issues that lead to dispensing and administration errors made in community pharmacies and hospitals, as well as in the home.

Some topics that will be discussed include:

• Look-alike labeling involving different products

• Inconsistent and unclear expression of product strength

• Misleading abbreviations on container labels

• Cluttered labeling

• Overemphasis of company name and logos

• Distracting, highly stylized label graphics

• Improper use of colors on labels

• Inadequate prominence of reminders and warnings

• Labels that fail to take human factors into account

• Error-prone packaging that can lead to wrong route errors

• Unreadable barcodes

Intended Audience:

• Product managers

• Regulatory affair professionals

• Medical affair professionals

• Individuals involved with labeling and packaging design

• Pharmacovigilance professionals

• Risk and quality improvement professionals 

• Healthcare practitioners in industry roles

• Patient and Medication Safety Officers

• Anyone interested in improving pharmaceutical product safety 

Learning Objectives:

Following completion of this activity, participants will be able to:

1. Identify common container labeling pitfalls that lead to medication errors

2. Understand the importance of labeling and packaging safety evaluations in the premarket phase

3. Identify relevant USP standards, FDA guidance, and ISMP recommendations to prevent medication errors

Speakers:

Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, President, ISMP

Rebecca Lamis, PharmD, FISMP, Manager, Medication Safety Board

Price:

Free

This activity is funded by Novartis Name Creation and Regulatory Strategy.

CE Accreditation

No continuing education credits are available for this activity.