FDA/IMSN Joint Global Summit on Labelling and Packaging

A global summit for regulators on drug container labelling and packaging safety took place on June 19 and 20, 2018, at the US Food and Drug Administration (FDA) White Oak (Silver Spring) campus in MD. The event was co-sponsored by FDA and the International Medication Safety Network (IMSN). The meeting brought together regulators, FDA staff, IMSN members, and invited speakers. The World Health Organization (WHO) was one of the attendees at the meeting, which aligned with the WHO’s current Global Patient Safety Challenge: Medication Without Harm.

The meeting was co-chaired by FDA’s Lubna Merchant, Deputy Director of the Office of Medication Error Prevention and Risk Management, and Acting Director of the Division of Medication Error Prevention and Analysis; along with Michael Cohen, chairperson of the IMSN and ISMP president. Participating regulators included:

  • Brazilian Health Regulatory Agency (ANVISA)
  • Mexico Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
  • European Medicines Agency (EMA – European Union)
  • Health Canada
  • Portugal National Authority of Medicines and Health Products (INFARMED)
  • Netherlands Medicines Evaluation Board (MEB)
  • United Kingdom Medicines & Healthcare products Regulatory Agency (MHRA)
  • Saudi Food and Drug Authority (SFDA)
  • US Food and Drug Administration (FDA)

To reduce overall harm related to medication errors, harmonization at the global level is necessary. Many product containers exhibit labelling and packaging issues that contribute to errors in various countries. Also, domestic drug manufacturing does not exist in many countries, so drugs are commonly imported, often with features that can result in safety issues. Some international regulators have undertaken successful packaging and labelling changes that have reduced the risk of errors. The meeting provided an opportunity to share these experiences.

One of the goals of the meeting was to create a minimum set of best practices for labelling and packaging aimed at reducing medication errors. Another goal was to promote the use of technologies to reduce medication errors, which led to discussions regarding the need for an international barcode standard. Representatives from GS1, a global standards organization for barcodes, were among the invited speakers.

Participants agreed that guidelines are needed regarding the presentation of critical label information to deal with look-alike labels, noting that logos and highly stylized graphics detract from readability of the label. They also suggested review of existing guidelines and consideration of the following best practices related to drug labelling and packaging:

  1. Include both the per mL and the per container quantity, not the per mL quantity alone, when presenting the concentration for injectables
  2. Use metric units for products, and eliminate ratio expressions
  3. Eliminate potentially error-prone abbreviations and dose designations on labels, such as U for units, IU for international units, or trailing zeros (e.g., 1.0) to express strength
  4. Prominently display cautionary statements on carton and immediate container labels of neuromuscular blockers, potassium chloride concentrate injection, methotrexate, and other selected error-prone medications
  5. Use contrasting label backgrounds for the printing on glass ampules, and recommend font size and label orientation, to improve readability
  6. Physically link or integrate diluents with drugs that are powders
  7. Increase the adoption of ready-to-use/ready-to-administer syringes, premixed IV solutions, unit-dose packaging, and other more efficient, safer packaging, while considering the overall cost of implementation
  8. Develop product-specific world safety standards; for example, standard packaging for non-oncologic methotrexate to prevent accidental daily use and overdoses
  9. Include barcodes on packages so they can be scanned at the bedside or other locations where medications are dispensed or administered by healthcare providers

A discussion was also held on the processing and sharing of medication error information by global pharmacovigilance (PV) centers. A recommendation was made for the PV centers to seek input from healthcare practitioners and medication/patient safety organizations such as those already established in many of the IMSN member countries. Finally, participants agreed to create a white paper to promulgate these best practices. Further meetings and discussions are planned, including a follow-up meeting this fall in Cascais, Portugal, during which industry participation will be sought.


8:00 AM Registration
8:30 AM – 8:45 AM Opening Remarks

Welcome from the International Medication Safety Network (IMSN) and the United States Food and Drug Administration (US FDA) representatives and opening

Mike Cohen (IMSN) and Lubna Merchant (US FDA)
8:45 AM – 9:00 AM Opening remarks Janet Woodcock (US FDA)
9:00 AM – 9:30 AM Introductions of all participants All
9:30 AM – 9:45 AM Importance of this summit to the World Health Organization (WHO): Medication Without Harm Shanti Pal (WHO)
9:45 AM – 10:00 AM Purpose of summit Mike Cohen (IMSN) and Lubna Merchant (US FDA)
10:00 AM – 10:15 AM Break
10:15 AM – 11:15 AM Session one: Labeling
Discuss errors seen with expression of Strength, abbreviations and dose designations Mike Cohen- IMSN (20 minutes)
Special warning (NMB, Vinca alkaloids, KCL concentrate injection) Jan MacDonald- MHRA (20 minutes)
Format and design (prominence of drug name, strength and dosage) Irene Chan-US FDA (20 minutes)
11:15 AM – 12:30 AM Group discussion on Labeling Moderator: Danielle Harris (US FDA)

Group discussion (all regulators)

12:30 PM – 1:30 PM Lunch
1:30 PM – 2:30 PM Session Two: Packaging
Ampules (Use of a contrasting ceramic or paper background, Positioning of label on ampules) Lisiane Leal – ISMP Brazil (20 minutes)
Ready to use packaging Rabih Dabliz- UAE (20 minutes)
Methotrexate Alexios Skarlatos- EMA (20 minutes)
2:30PM – 3:15 PM Group discussion on Packaging Moderator: Claudia Manzo (US FDA)

Group discussion (all regulators)

3:15 PM – 3:30 PM Break
3:30 PM – 4:00 PM Session Three: Barcodes Greg Bylo (GS1)

Geraldine Lissalde Bonnet (GS1)

4:00 PM – 4:30 PM Group discussion on Barcode Moderator: Ilisa Bernstein (US FDA)
4:30 PM – 4:45 PM Group Picture
4:45 PM – 5:00 PM Ending day 1 and Close: Instructions for dinner/transportation/topics for next day
8:30 AM – 10:00 AM Session Four: Pharmacovigilance and Medication Error Reporting Programs

· Learning about systems in varied jurisdictions (US FDA slides)

· Improved collaboration

- Improved reporting
- Information Sharing
- Harmonization
Approaches to harmonization: Sonja Brajovic (US FDA)

WHO - Shanthi Pal
ANVISA - Douglas Simoes Costa Souto
US FDA - Jo Wyeth
Ghana - Dennis E. Dorbu-Amedzeame
Saudi FDA - Nasser M. Alqahtani

Moderator: Michael Hamilton (ISMP Canada)

10:00 AM – 10:15 AM Break
10:15AM – 12:30 PM Session Five: Safety Guidance

Review of current safety guidance that might exist for each of the above items

All international regulators present a 5-10 min perspective from their guidance/practices on what they have in place to address the issue identified so far

Lubna Merchant (US FDA) and Mike Cohen (IMSN)

12:30 PM – 1:30 PM Lunch- on your own
1:30 PM – 3:00 PM Session Six: Next Steps

· White paper

· Harmonized International Guidance document on drug labeling and packaging

· Follow up meeting

Lubna Merchant (US FDA) and Mike Cohen (IMSN)
3:00 PM – 3:30 PM Ending day 2 and Closing Remarks

· Invite attendee's participation and membership to IMSN

Mike Cohen (IMSN)