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Council of Europe, safer medication practice

Council of Europe, March 2007

The Council of Europe publishes an important report [3'003 KB] on patient safety enhancement (link to CoE file here). Here some extracts:

It is recommended that European health care organisations and other related stakeholders
take steps to:
Update the national and European legislative framework to require complete and
unambiguous labelling of every single unit of use of all licensed medicines products (e.g.
tablet, vial and nebules), including the international nonproprietary name (INN), trade
name, strength, expiry date, batch number and a data matrix bar code. The data matrix bar
code should contain a GS1 Global Trading Index Number (GTIN) identifier in addition to
the expiry date and batch number.
(page 10)

It is recommended that European health authorities take steps to implement widely and to
further update as applicable European medicines regulations on design features for
packaging and labelling of medicinal products taking account of human factors and
favouring in-use safety. The above-mentioned features include

• large font sizes,
• the use of Braille on medicines’ packaging,
• use of clear descriptions for the strength of a medicinal product to minimise errors in dosage,
• prominent positioning of the INN,
• adequacy of the package design for the delivery and administration of the medicine,
• appropriate use of colour and design to minimise errors caused by mis-selection,
• clear presentation of “essential information” on at least three surfaces of the medicine pack,
• as regards multi-language packs, all information should be presented in a clear and legible manner.
• Medicines should be provided in unit dose presentations, ready for use and administration, in order to help minimising the occurrence of errors. Medicines regulations should be updated to require complete and unambiguous labelling of every single unit of all licensed medicines (e.g. tablet, ampoule, vial, nebules), including the INN, trade name, strength, expiry date and batch number and a data matrix bar code.
• The data matrix bar code should contain a GS1 Global Trading Index Number (GTIN) identifier. A unique identifier may also be included in data matrix bar codes for medicines as part of more general patient safety measures to minimise the risk of counterfeit medicines and health care products entering the supply chain.