[e-drug] Labelling of fixed dose combinations

[David.PughWilliams@cdhb.govt.nz]

E-DRUG: Labelling of fixed dose combinations
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Hello Stein,

I was interested in your recent posting noting that the recent WHO
document on fixed dose combinations did not give any guidance of how
these products should be labelled in regards to strength.

Recently the TGA of Australia and Medsafe of New Zealand jointly
issued a draft document "Labelling requirements for medicines" (can be viewed
at www.jtaproject.com)  This is part of a project which aims to
establish consistency in all medicine regulatory matters between
Australia and New Zealand. Although the document has many proposals
which are both welcome and sensible (if adopted) there was no guidance
on how FDC's should be labelled.

I have made a submission which included a recommendation to label
FDC's along the same lines as you are proposing eg Sinemet 100/25.

In our hospital we have recorded a number of incidents involving FDC's
which are a direct result of confusion caused by inconsistent
labelling.

In New Zealand the strength of Sinemet has only ever been referred to
as 100/25 etc but the similar product Madopar is given a 'strength' of
125.

Augmentin (amoxicillin clavunate) is labelled as 500mg tablets but
when another brand Synermox became available the label stated 625mg whereas
I believe both products should be labelled as 500/125

Regards

David Pugh-Williams
Operations Supervisor
Pharmacy
Christchurch Hospital
Christchurch
New Zealand
ph 64 33640840
fax 64 33640838
David.PughWilliams@cdhb.govt.nz
http://www.cdhb.govt.nz