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Letters to the Editor
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Brand names
What is the point of the MHRA guidance?
From Mr R. Lowe, MRPharmS
In June of last year I was moved to write to The Journal about my
professional dislike of an “umbrella” brand name being
used for over-the-counter medicines containing completely different
active ingredients (PJ, 7 June
2003, p792). I was much heartened, therefore when the Medicines and Healthcare
products Regulatory Agency addressed this issue in December 2003 when
it published the “MHRA naming policy guideline with respect to
umbrella segments of product names” (MHRA guidance note number
29, PDF (190K)).
To quote two of the general principles of this document (points 6 and
8, respectively): “Directive 2001/83/EC requires that an invented
name should not be liable to confusion with the common name. In addition
product names, including umbrella segments, should not be misleading
with respect to the following:
1. Therapeutic effects of the product
2. Composition of the product
3. Safety of the product
4. Confusion of the product with other products with similar names
In the MHRA view any of the above could raise concerns about the safety
of the product.” And: “Industry is encouraged to give less
prominence to the umbrella segment and greater prominence to the active
ingredient(s).”
Imagine my surprise, then, to discover that Reckitt Benckiser had rebranded
the over-the-counter pack sizes of Fybogel as Senokot Hi Fibre in mid
August. There has certainly been no reformulation of the old Fybogel
product to include any senna. In search of an answer as to how this could
be sanctioned by the licensing authority I again consulted guidance note
number 29. Under the “Specific circumstances” section of
the guidance, the MHRA provides some useful examples of its thinking
as to the use of umbrella brand names and the following example (point
11) seems to fit the bill: “The proposed product for which an umbrella
segment will be used in the name contains different active ingredients
and is for use in the same therapeutic area as the existing product”.
The guidance states that in such a circumstance: “If in the opinion
of the licensing authority the existing original product name is associated
with a particular active ingredient, the licensing authority will need
to be convinced that the use of the umbrella segment will not give rise
to safety issues or efficacy issues due to differential efficacy and
speed of onset of effect. This scenario is likely to be the most difficult
one for which to obtain approval.”
I would therefore like to congratulate Reckitt Benckiser in convincing
the MHRA that there is no association between Senokot and senna and achieving
what the MHRA has set as the most unlikely of goals in gaining its approval.
Perhaps I am a grumpy old pharmacist in need of the benefits of a stimulant
or bulk-forming laxative to improve my outlook on life. Perhaps this
is of trivial importance, but it does leave me wondering what is the
point of the MHRA guidance.
Robert Lowe
Wymondham, Norfolk
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The
Pharmaceutical Journal