Labelling of medicines

Labelling lines

 

Bundling

Bundling is a bad thing

 

Bundling is making a patient pack or hospital pack by:

 

a)      putting two or more inner packages (tablet boxes, inhalers etc) in one outer package

b)      strapping, wrapping or gluing two or more cartons together.

 

The definition is practical, and not too precise. Sometimes the terms “inner packaging” and “outer packaging” are not sufficient. I do not regard a three month’s package of contraceptive pills as bundled even if the blister sheets are individually wrapped.

 

There is usually a kind of economic argumentation behind introduction of bundled packages.

 

Very often larger packages are cheaper than single ones. This is the case when sellers use a “amount per unit plus a percentage” model for calculating profit.

 

The usual package size may vary between countries. In many European countries the reimbursement period is four weeks or a month. This is also the recommended usage time for sterile, preserved medicines like eye drops. The logical package size for a manufacturer serving many countries would then be for one month. In Norway the reimbursement period is three months. So Norway has a lot of eye drops and asthma inhalers packed three and three together.

 

Bundling is also seen on some parallel imported medicines. The reason is the 'war' between original manufacturers and parallel importers on repackaging, relabelling and trademark legislation.

The latest ruling from the European Court of Justice is that importer can repack without breaching trademark rights

Pharmaceutical Journal 28 September 2002

Case C-433/00 Judgement, and Opinion of the Advocate General

 

 

Medicines for injection or infusion are often bundled.

 

 

The labelling problem with bundling is: What kind of labelling should be on the different levels of packaging?

 

 

Very few computer systems handle (easily) bundled articles. The barcode from the manufacturer disappears with the outer packaging material. And it does not comply with the patient unit. To make it function, the inner package must be registered locally as an item in the computer system, and it must be relabelled with a local barcode. Additional work and additional error possibilities.

 

last revision 27092002