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Dispensing
Law appears to allow generic substitution by drug companies
From Mrs C. J. Hutchinson, MRPharmS
We all know that a prescription for a branded product requires the supply
of that branded product. At no point is generic substitution even an option.
However, it appears that pharmaceutical companies can do it and have the
law on their side. I refer to the product Innovace 5mg, its parallel import
and the branded generic Rinetec (enalapril, also made by Merck).
Recently, a customer returned a packet of parallel-imported Innovace saying
that the contents were not Innovace. On examining the pack, I found it
contained Rinetec foils which had been overlabelled “Innovace”.
My supplier contacted the licence holder, who said that since the product
was made by the same company and the leaflet referred to all three variants
(Innovace, Rinetec and enalapril), this was permitted within the licence.
I then contacted the Royal Pharmaceutical Society which referred my query
to the Medicines and Healthcare products Regulatory Agency. I received
a reply which quoted licensing law, also stating that the product was legal
since it met the criteria for equivalence to the original brand.
I then questioned my local inspector, who said she was aware that such
products existed but this was nothing to do with the Society. She said
that if I thought the product was unethical then I could refuse to use
it. (Great, I thought, but I bet I will not be paid to use the British
product.)
Has anyone else come across this problem? Am I making a mountain out of
a molehill? Does the (unintentional) supply of Rinetec constitute a dispensing
error in that what the GP wanted has not been supplied? I have, after all,
had boxes of Rinetec on the shelf but only used them for enalapril prescriptions.
Other opinions would be gratefully received (e-mail carol@hutchinson
family.freeserve.co.uk).
Carol Hutchinson
Rugby, Warwickshire |
The
Pharmaceutical Journal