Labelling of medicines
Extreme multinational package
Pedea (ibuprofen) 5mg/ml solution for injection, package with 4 ampoules of 2ml, produced (marketed) by the originally Swedish company Orphan Europe in France.
In January 2006 I first got to see the Pedea package. Besides (or because) being extremely multinational it made me reflect on a lot of issues.
The package has
17 flags (UK, Ireland, Malta, Netherlands, Belgium, Germany, Austria, France, Spain, Portugal, Greece, Cyprus, Norway, Sweden, Denmark, Iceland, Finland) (not Italy)
12 different language texts (English, French and German are used in more than one country).
4 machine readable codes (3 barcodes, 1 dot matrix).
Product name and strength indication printed on 7 of 8 possible panels. Good
Product name and strength indication printed in large font size. Good
Generic name only printed in table of contents, and not close to product name. Not good
Product name and strength indication is printed in poorly readable contrast (white on pink). Not good
Each language text has a separate half panel, and is marked with relevant national flag. This makes navigation surprisingly easy. Good
There is no common (pan-European) human and/or machine readable identification. Not good.
INN is not INN
Germany uses a capital letter in INN names. And there are versions different from INN in 5 languages (French, Finnish, Portuguese, Spanish, Icelandic). Not good
There is an ampoule symbol on the top panel. Good
The main strength indication is in mg/ml, with total amount as additional info. Good
Having separate language panels makes it possible to apply dispensing label without covering text in local language. Good (Hypothetical problem since this is a package for hospital use.)
Blueboxes (contains national regulatory peculiarities) reflect 2 different aspects
- cultural differences (POM, Respecter les doses prescrites, Uso hospitalario, price information, etc)
- identificational differences (identificational numbers (Nordic countries, Germany, Portugal) and barcodes (Germany, Spain, Portugal).
Probably (hopefully) many bluebox elements will disappear as result of harmonisation, and some will become European regulatory demands.
Most remarkable here are the many countries that evidently do not yet have regulatory demand for a package identification number.
Bidimensional data matrix code printed on Lot No sticker at bottom panel. Obviously not put here by regulatory demand. The company has told me that the code indeed contains only batch number.
Voluntary (V) and compulsory (C) information.
C – Keep out of reach and sight of children. Probably wise to keep.
C – Medicinal product subject to medical prescription. Not necessary - many countries did not use it before EU regulation.
C – Intravenous use (route of administration.) Of course
V – Short infusion. Confusing. I thought that infusion meant volumes of 100ml or more. Does it have to be diluted?
C – Read the package leaflet before use. Who believes that this sentence makes any difference? Remove it.
V – From a microbiological point of view, the product should be used immediately. Useful.
V – After first opening of an ampoule any unused portions should be discarded. Useful
C – Contact address to marketing authorisation holder. Good. But it is a little hard to understand (discover), and it is only postal address – not telephone number or email address.
So much information needs space, and many such honeycell shaped packages would require large pharmacy hives.
But this extreme package seems surprisingly usable.
Second thoughts and information
Orphan Europe has made 2 outer packages (and 2 patient leaflet booklets) for Pedea, which covers the 25 countries of the European Union.
It should be kept in mind that Pedea is an orphan drug. The number of packages sold in each country is very limited - in no way comparable to other medicinal products. In addition Pedea must be delivered in emergency, within 24 hours. Also Pedea is to be administered by specialised health professionals.
I am impressed by these Pedea packages. They show that it is not only the amount of information, but rather the navigational properties that is important.
I am worried about the many less professionally designed multinational packages that wil certainly appear in the coming years.
There is much to learn from the Pedea package. But please do not believe that this is a design model suitable for the usual prescription medisine package. One language, simple design, and emphasis on critical information are still basic recommendations.