International Harmonization in progress

White Paper outlining Safety Considerations for Pharmaceutical Container Labelling and Packaging Design to Minimize Medication Errors for International Harmonization

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.

To advance global harmonization of container labelling and packaging standards and reduce overall harm associated with medication errors, the International Medication Safety Network (IMSN) and the US Food and Drug Administration (FDA) held a summit for regulators on drug container labelling and packaging safety in June 2018. Participants agreed to create a white paper to promulgate a minimum set of best practices for pharmaceutical container labelling and packaging aimed at reducing medication errors and the implementation of support for safety technologies such as label barcodes to be used with scanning equipment to reduce medication errors. The proceedings from the June 2018 meeting were also discussed during a follow-up meeting (as part of IMSN 13th Annual meeting) held in October 2018 (Cascais, Portugal).
Regulators and industry participants in both meetings advocated for the global acceptance of these container labeling and packaging recommendations which are outlined in the White Paper. Click here to download the IMSN White Paper
The ten recommendations brought forth in this White Paper are following:

  1. For small volume injectable products, the product strength should include the amount per mL and the total quantity per volume.
  2. Use of metric units in the strength expression for products.
  3. Eliminate potentially error-prone abbreviations and dose designations on immediate and outer container labels.
  4. Prominently display cautionary statements on outer and immediate container labels of neuromuscular blockers, potassium chloride concentrate injection, methotrexate, and other selected error-prone medications.
  5. For the labels on glass ampules, contrasting label backgrounds and appropriate font size and label orientation should be used, to improve readability.
  6. Prominently display international nonproprietary names (INN) on labels/packages.
  7. Physically link or integrate “special” diluents for “specific drugs” with their powder component.
  8. Increase the adoption of ready-to-use/ready-to-administer syringes, premixed IV solutions, unit-dose packaging, and other more efficient, safer packaging.
  9. Develop product-specific global safety standards; for example, standard packaging for non-oncologic methotrexate to prevent accidental daily use and overdose.
  10. Include barcodes on drug packaging to facilitate scanning at the bedside or other locations where medications are dispensed and administered by healthcare practitioners

Indeed, there is a need for global harmonization of product container labelling and packaging. While the content of the label and package is determined by drug manufacturers, this information is assessed and approved by drug regulators. Regulatory authorities must enforce product labels and packages designed to minimize medication errors. Harmonizing safer drug labelling and packaging globally will decrease medication errors, decrease regulatory burden on manufacturers that produce drugs for the global market, and increase the efficiency of the drug approval process. Finally when countries agree, patient safety will advance globally.