The EAHP position and statement were drafted and distributed to European Commission representatives and some targetted Members of the European Parliament. On the occasion of a public consultation on Patient Safety, the EAHP statement and call for action was sent to Commissioner Androula Vassiliou and her head of Directorate General (DG) Health and Consumers (SANCO). The statement was published in the European Journal of Hospital Pharmacists, EJHP and further discussed with EU officers working in the field of patient safety on numerous occasions, by Catherine Hartmann, Executive Director of the EAHP.

The latter also presented the request for bar-coded unit doses to the European Federation of Pharmaceutical Industry (EFPIA), the European Industrial Pharmacists Group (EIPG), the GS1, the Standing Committee of European Doctors (CPME), the European Federation of Nurses (EFN) and the European Patient Forum (EPF).

The statement was slightly amended in June 2010.

EAHP calls for :

- the production of single dose-packed drugs from the pharmaceutical industry,
- the mandatory inclusion of a barcode on each single dose.

Hospital pharmacists are also calling on decision makers, politicians and national administrations to implement the introduction of bar-coded single dose-packed drugs in national and European regulations.

Requirements

A. The primary packaging of a medical product must fulfil 3 basic functions:
• precisely describe the content of the drug up to final control at bedside
• enable easy and safe use of the drug
• provide protection against environmental influences such as light, moisture, pressure and microbial contamination during transport, handling and storage.

To enhance the comfort of use, the packaging should be light in weight and additional labelling needs to be easily possible. The package material has to be compatible with the drug and should be environment-friendly in regards to production and disposal.

B. Requirements for the single dose packaging
1. Size and form

• single dose packing for a single application, preferably in a standardized size (e.g. 3,5x3,5 cm),
• alternatively, perforated multiple dose blister packs that can be easily divided into single doses packing (each of them must contain the whole information),
• ready to use, no further manipulation necessary,
• easy to pack into automatic dispensing systems.

2. Information on the single doses
The printing must be easy to read, durable and clear. Each single dose must contain the:

• trade name
• application form
• active substance(s)
• quantity of active substance(s)
• manufacturer’s name
• expiry date
• batch number
• barcode including the identification of the drug (GTIN), the expiry date and the batch number. When the production facility is incompatible with an on-line printing of variable data, the barcode can temporarily be limited to the identification of the drug.

Hospital pharmacists strongly recommend the use of the recognized international GS1 (ex- EAN) identification system for bar codes. The GS1-128 (ex- EAN-128) standard appears to be the best standard for the traceability of single dose units. Taking into account the problem of the available space, we recommend printing it as a datamatrix.

• For ampoules and vials, the same information should be provided on a label (not engraved on the glass), with additional information regarding the total amount and volume (x mg = y ml) and the concentration of the solution (z mg/ml).