Unsafe Naming, Labeling and Packaging of Medicines: A Global Patient Safety Threat

October 14, 2013
For Press Enquiries: Etienne Schmitt; imsn@prescrire.org

Paris, France. The International Medication Safety Network (IMSN) recognizes unsafe medicines naming, labeling and packaging as an ongoing global threat to patient safety which requires a collaborative approach. Medication errors affect millions of patients globally, sometimes leading to death or serious harm. Frequent causes of preventable errors include:

  • sound-alike or look-alike medicine names
  • similarities in packaging and labeling appearance
  • unclear, ambiguous or incomplete medicine label information.

In many countries, medicine regulation fails to recognize the importance of human factors principles, a key safety element, in the selection and design of medicine names, labels and packaging.

At the Safer Naming, Labeling and Packaging of Medicine Conference held in Paris, France on Thursday October 10 2013, which included representatives from 20 countries, it was recognized that the approach to this global challenge requires collaboration between regulators, pharmaceutical industry, healthcare providers and patient organizations. In a position statement, IMSN recommends the following as part of a comprehensive, worldwide solution:

  1. Regulations for medicines naming, labeling and packaging in all countries should be strengthened to:
    • require safer design and field testing before release for use
    • incorporate human factors theory
    • promote safer use in practice.
  2. The pharmaceutical industry should ensure that their products are safely named, labeled and packaged to minimize errors in selection and use.
  3. Healthcare providers should assess medicines names, labels and packages, as well as associated devices and software, before purchasing decisions are made and products are introduced into use, so that risks may be identified and mitigated.

Dr. Michael Cohen, chairperson of IMSN, proposed that regulators and other stakeholders join IMSN at a summit in 2014 to address this global threat to patient safety.

About IMSN: The International Medication Safety Network (IMSN) is an international network involving medication safety organizations, and medication safety experts and advocates. Established in November 2006 by the “Salamanca Declaration to Promote Safe Medication Practices Globally”, IMSN aims to prevent patient harm globally by promoting safe medication practices and collaboration between everyone involved in the medication use process. www.intmedsafe.net

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