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[e-drug] Fixed dose drug combinations

  • Subject: [e-drug] Fixed dose drug combinations
  • From: "Stein Lyftingsmo" <[email protected]>
  • Date: Mon, 30 Sep 2002 04:34:51 -0400 (EDT)

E-drug:  Fixed dose drug combinations

Wilbert Bannenberg's article about clavulanic acid is interesting.

I do not like Fixed Dose Combinations, FDCs, either. They offer advantages
in certain therapies, like antiretroviral cocktails and TBC treatment. But
the convenience of FDCs to the patients is counterbalanced by lack of
flexibility, by dose confusion, by risk of overdosing with one of the
components, by lack of regulatory standards for strength indication, and so

One of the problems linked to FDCs is the lacking availability of single
substance products. Last year MSD without warning withdrew Dichlotride, the
only hydrochlorothiazide tablet on the Norwegian market. It made the
situation difficult for a lot of patients, and there were no mechanisms by
which MSD could be forced to keep the single substance formulation on the
market. At the same time MSD is marketing 4 different combination products
containing hydrochlorothiazide (different strengths not counted). And not
one of these FDCs have numerical strength indication in the product name.

But since FDCs are de facto on the market, the largest problem is the lack
of regulatory standard for strength indication. With the increase in
generics and parallel import of medicines, the danger to the patients is
increasing even more rapidly.

Sinemet is a combination of carbidopa and levodopa. 'Sinemet 10/100' is also
called 'Sinemet mite', 'Sinemet 100', and 'Sinemet 110'. Sinemet is
extensively parallel imported in Europe, so a patient may over a period of
time receive all these varieties from one single pharmacy.
I have written an article about this problem in Pharmaceutical Journal.

Neither the European Union nor USA has established regulatory standards for
strength indication for FDCs. The process will certainly take time. Is it
possible in the meantime to include a recommendation in the WHO model list
for essential medicines?

Stein Lyftingsmo
Hospital pharmacy of Elverum, Norway
[email protected]
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