Public debate on the role of drug regulatory agencies and health
authorities in assessing and preventing the risks of medication errors
Summary : Safe design of healthcare products, a key strategy for reducing preventable harm
Medication errors frequently occur because of confusion from: sound-alike or look-alike medicine names; similarities in packaging and labelling appearance; unclear, ambiguous or incomplete medicine label information. These problems can lead to errors in selecting and using medicines including wrong drug, wrong dose, wrong formulation, wrong route and method of administration.
In many countries the regulation of medicine naming, labelling and packaging does not provide adequate safeguards for patients. There is little recognition of the importance of the human factor in the selection and the design of drug names, labels and packages with a view of minimizing error risks and enhancing medication safety. Current approaches to labelling and packaging favour commercial interests, such as “trade dress” or “umbrella” brands, and overlook the context in which the medicine will be used.
The Paris conference on safer naming, labelling and packaging of medicines featured a public debate on the role of drug regulatory agencies and health authorities in assessing and preventing the risks of medication errors. The conference was aimed at: regulators and policy makers, healthcare professionals, patients, drug companies.
Programme
Welcome and introduction
Naming, labelling and packaging of medicines put patients at risk
Case studies from different countries
- France - Étienne Schmitt - Prescrire Programme Preventing the Preventable
> Download the presentation (Pdf, 3 222 Ko)
- Spain - María José Otero - ISMP-Spain, IBSAL
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- UK - David Cousins, Head of Safe Medication Practice, NHS England
> Download the presentation (Pdf, 556 Ko)
- Ireland - Ciara KIRKE - Drug Safety Coordinator, Tallaght Hospital, Dublin
> Download the presentation (Pdf, 1 149 Ko)
- New Zealand - Beth Loe - Health Quality & Safety Commission
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- Canada - Dr David U - Institute for Safe Medication Practices Canada
> Download the presentation (Pdf, 682 Ko)
IMSN Position Statement
"Making Medicines Naming, Labelling and Packaging Safer"
European Medicines Agency's role in the review of labelling/packaging to prevent risks of medication errors
Assessing risks related to brand names of medicines
Assessing risks related to non proprietary names of medicines
- The WHO INN Programme and the safety of INN’s - Dr Raffaella G. Balocco Mattavelli, Manager of theInternational Nonproprietary Name (INN) Programme, Department of Essential Medicines and Health products, World Health Organization
> Download the presentation (Pdf, 726 Ko)
- IMSN Position Statement "Improving the safety of international nonproprietary names of medicines (INNs)" - Étienne Schmitt, Prescrire Programme Preventing the Preventable
> Download the presentation (Pdf, 153 Ko)
Assessing risks related to the design of labelling and packaging
Press release
Unsafe Naming, Labeling and Packaging of Medicines: A Global Patient Safety Threat
> Download the press release (pdf, 107 Ko)
©Prescrire October 2013
