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Letters to the Editor
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Tritace
Why the change from capsules to tablets?
From Mr H. Argomandkhah, MRPharmS
May I ask a simple question of Aventis Pharma, manufacturer of Tritace
capsules, and the licensing authorities? I received a telephone call
recently to tell me that from November 2003 Aventis Pharma will be withdrawing
the capsule variant of Tritace and replacing it with tablets. All general
practitioners are being advised of this and will be receiving free programmes
to switch their patients from capsules to tablets. What other reason
can be given for the switch other than the ending of the patent?
I have also been informed by one major generics manufacturers that it
is about to launch ramipril capsules, presumably much cheaper and saving
the National Health Service a great deal of money.
One wonders what importance patients and their safety have played in
the decision? Switching from easily recognisable capsules in differing
colours to an unfamiliar tablet form will put many patients at risk,
because doctors, pharmacists, nurses, patients and carers could fail
to recognise a wrong dosage. The potential for errors is huge because
the dosage form covers an eight-fold increase from 1.25mg to 10mg.
I plead with both manufacturers and prescribers to keep the capsule format
until the generic variants are available, and thus to put patient safety
rather than profit first on the agenda.
Hassan Argomandkhah
Liverpool
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Dr MARTIN FORD, medical director, Aventis Pharma, replies:
We are
grateful for the opportunity to address the concerns that Mr
Argomandkhah raises.
Turning to the most important issue first, namely, that of patient
safety, we are totally confident that patient safety will not
be compromised in any way
by the change to the presentation of Tritace from capsules to tablets for
the following reasons. First, the two presentations are bioequivalent
and so they
perform in the same pharmacokinetic and therefore pharmacodynamic manner.
Secondly, as generic products almost always have physical characteristics
that are different
from the branded product they copy, we are confident that patients will adapt
to this change in presentation in the same way as they do when they are dispensed
generic solid dosage form pharmaceuticals. Thirdly, as the product is presented
in original packs with artwork and information enclosures licensed by the
Medicines and Healthcare products Regulatory Agency, we are certain that
pharmacists will
not be confused during normal good dispensing practice.
Concerning the questions and comments regarding why we have initiated this
change, quite simply, the transition from Tritace capsules to tablets is
happening due
to global manufacturing rationalisation within Aventis. The United Kingdom
is one of few countries that sell capsules. As a result of a worldwide initiative
to streamline our manufacturing operations it is more economical to produce
tablets.
Importantly, with the loss of patent next year in the UK and the considerable
drop in forecast volumes, the economic sense of switching to tablets becomes
overwhelming.
Finally, we know that there will be several generic presentations on the
market from the beginning of 2004, thus ensuring strong price competition
to the considerable
benefit of the NHS. |
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