Global Meeting on Drug Product Labelling and Packaging Safety – Cascais, Portugal

Implementing the recommendations of the 2018 IMSN / FDA Summit

The International Medication Safety Network (IMSN) hold a meeting on October 29 and 30, 2018, in Cascais, Portugal, of drug regulators, pharmaceutical companies and IMSN members to discuss the proceedings from the June 2018 international summit at the US Food and Drug Administration (FDA). The meeting focused exclusively on ways to inspire and mobilize drug manufacturers and regulators from around the world to identify ways to reduce medication errors related to drug product labeling and packaging.


Sessions chaired by Michael Cohen on October 29 and by David U on October 30, 2018

  • Welcome on behalf of the Portuguese Association of Hospital Pharmacists (APFH - Associação Portuguesa de Farmacêuticos Hospitalares) (Paulo Tavares de Almeida)
    Read on…
  • Update on WHO Global Challenge on Medication Safety - Medication Without Harm
    Shanthi Pal, WHO Phamacovigilance Programme Coordinator
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  • Summary of ME concerns raised during the 2018 FDA/IMSN summit
    Barbrakaryne Fobi, ISMP International Fellow
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  • Strategies for Reducing Medication Errors Related to Labeling:
    the list of labeling recommendations discussed at the FDA/IMSN summit
    Lubna Merchant, Deputy Director OMEPRM , FDA
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  • Feedback of the European Medicines Agency on the labeling recommendations
    Alexios Skarlatos, Head of Labeling Review & Standards, European Medicines Agency
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  • Package Design Affects Accuracy Recognition for Medications
    Sigurd Hortemo, MD, Norway Medicine Agency (NOMA)
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  • Medication error concerns observed with the use of ampules:
    positioning of labels and use of a contrasting ceramic or paper background
    Mario Borges Rosa President, ISMP  Brasil
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  • Medication error concerns due to the limited availability of ready-to-use packaging
    Rabih Dabliz, Cleveland Clinic Abu Dhabi
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  • Producing IMSN guidance on safer labelling and packaging of medicines
    Panel discussion moderated by David Cousins, Consultant, Safe Medication Practices
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  • Discussion on bar codes on product labels
    Moderated by Michael Cohen, Chair, IMSN
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Participants agreed on the following best practices:

1. Include both the per mL and the per container quantity, not the per mL quantity alone, when presenting the concentration for injectable; with prominence given to total content per container
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, and trailing zeros (e.g., 1.0) to express strength
4. Prominently display cautionary statements on the carton and immediate container labels of NMBs, KCL concentrate injection, methotrexate, and other selected error-prone medications
5. Use contrasting label backgrounds for printing on glass ampules and recommended font size and label orientation to improve readability
6. Physically link or integrate "special" diluents for "specific drugs" with their powder component
7. Increase the adoption of RTU/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 overdose
9. Include barcodes on primary packages so they can be scanned at the bedside or other locations where medications are dispensed and administered by healthcare practitioners
10. Mention prominently international non-proprietary names (INN) on labels

Participants agreed that an IMSN White Paper targeting International best practice for safe labelling and packaging of prescription medicines should be drafted, reviewed by stakeholders, and submitted to International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Regarding the global need to use barcode in the medication use process for patient safety purpose, participant agreed that IMSN will undertake a barcode readiness assessment at international level and lobby for European Datamatrix code on unit doses.

For more details, read the minutes of the meeting.
Updated on December 17, 2018