| · Community pharmacy
· The Profession
· Thalidomide
· Which? report
· Art
· Alcohol metabolism
· The register
· The Society
· CPD
Letters to the Editor
|
Thalidomide
Risk management scheme needs reconsideration
From Mr R. A. Lowe, MRPharmS
I was interested in Patrick Mahaffey’s reply to Freddie
Astbury’s
letter on the nature of the Pharmion Risk Management Programme (PRMP)
for thalidomide (PJ, 6 March p278).
I agree with Mr Astbury that thalidomide is a valuable drug in the treatment
of multiple myeloma among other diverse diseases. Likewise, I fully appreciate
the principle of a risk management strategy for the use of this drug,
for obvious reasons. However I note with interest that Mr Mahaffy in
his reply did not properly answer the first point raised against PRMP,
namely, that it is highly intrusive. Indeed, I fail to see how the clinicians
and pharmacy staff involved in administering this scheme cannot be concerned
about breaches of patient confidentiality that the scheme requires for
a supply to be made. That is unless substantial changes have been made
to the scheme since I looked into it late 2003.
To give but one example: parental consent is required for the administration
of thalidomide to children under PRMP. However, for the purpose of the
scheme a child is anyone under the age of 18. According to the PRMP rules
as I understand them, any 16- or 17-year-old will require a parent or
guardian to telephone Pharmion each month and discuss with a member of
that company the sexual activity of their son or daughter and what contraception
techniques they have been using in the past month. This, of course, does
not even open the can of worms with regard to under-age sexual activity.
I cannot imagine many teenagers who may require thalidomide being enamoured
with this approach.
Finally I would like to add that just because the risk management scheme
has been approved in the US, Australia and New Zealand, this does not
mean it is suitable for the UK. I do not wish to throw cold water on
this risk management scheme, but I think it requires serious reconsideration
before it is foisted upon us all by the European Agency for the Evaluation
of Medicinal Products.
Robert Lowe
Wymondham, Norfolk
|
The
Pharmaceutical Journal