Guidance for safe design of medicines labels and packaging should be developed, improved and used by the pharmaceutical industry, medicine regulators and healthcare providers when developing and risk assessing medicines labeling and packaging.
The design of new medicines labeling and packaging, including associated devices and software, should be subject to human factors assessment and user testing by manufacturers. Evidence that these designs have been tested and are considered acceptable for use should be an essential requirement before new medicines receive a marketing authorization. The results of the human factor assessment and user testing should be made publicly available as a proposed packaging safety assessment report.
IMSN Position Statement on Safer Design of Vaccines Packaging and Labelling
Greater worldwide attention to the problem of unsafe design of vaccine packaging and labelling is needed. The statement calls on healthcare professionals, pharmaceutical companies, technology vendors, professional organizations, and regulatory/standard-setting organizations to help improve vaccine safety and efficacy. Vaccine manufacturers are strongly encouraged to revise packaging and labelling as specified, with particular attention on vaccines with diluents or two-component vaccines. (December 2015) Download PDF
IMSN Position Paper on Making Medicines Naming, Labelling and Packaging Safer
In many countries the regulation of medicines naming, labelling and packaging is not providing adequate safeguards for patients. The International Medication Safety Network issues recommendations to regulators, pharmaceutical industry and healthcare providers as part of a comprehensive, worldwide solution to the problem of unsafe medicines naming, labeling and packaging. (October, 2013) Download PDF
Global Label Project
Safe Labeling and Packaging is a primary concern for IMSN. Since 2007 IMSN members have contributed labels and packaging safety issues for discussion at IMSN meetings. IMSN strives to assure global improvements to reduce medication errors associated with the issues depicted on these slides. Download PDF
Unit-dose packaging of pharmaceutical products
The International Network of Safe Medication Practice Centres welcomes French specifications regarding the unit-dose packaging of pharmaceutical products, as it will contribute to improving patient safety. (October 2007) Download PDF