Leprosy mailing list – May 3rd, 2005
Ccn: all.
Ref.: MDT
and clofazimine availability.
From:
B Naafs
, Munnekeburen, The Netherlands.
Dear Salvatore,
Just to inform you that I received clofazimine from WHO. I
got the following letter from Dr Steve Lyons, WHO Geneva; this may
help the other leprologists in need of clofazimine.
Ben
Dear
Dr Naafs,
Thanks
you for your message regarding the availability of clofazimine from
WHO. I sent an email to Prof. Faber this morning him giving him more
details of the clofazimine donation by Novartis through WHO, which is
specifically for the treatment of severe ENL reactions in leprosy, and
the procedures that need to be followed to apply for it. This email
summarises the key points of that email:
1)
Leprosy:
In
countries where a national leprosy elimination programme exists within
the MoH, MDT blister packs and loose Lamprene (clofazimine) are
available from WHO on official request. In Europe and in other
countries where no such government programme exists, and where no
national distribution agent has been officially appointed, WHO will
supply these drugs on request from individual physicians or
pharmacists, where the intended use is clearly for the treatment of
existing leprosy patients. No individual patient details are needed
and a simple letter, fax or email giving the number and type of
patients needing drugs, and the full consignee address, are usually
all that is required.
2)
MDR-TB:
In
exceptional circumstances, clofazimine may be made
available for the treatment of MDR-TB cases, at the
sole
discretion of the TB Greenlight Committee in WHO Geneva. Any such
requests received by WHO will be forwarded to the GLC who will decide
whether a supply is appropriate. Please note however, that the
Committee can not consider requests for individual patients. Its role
is to consider only projects (including for groups of patients, or for
a national treatment protocol, or for NGO projects previously approved
by the governments concerned). The person in WHO to contact for MDT-TB
requests or for clarification of this policy is Dr Fuad Mirzayev (mirzayevf@who.int)
3)
Other,
non-leprosy “off-label” use:
Regarding
other non-leprosy use of clofazimine, WHO is not involved in any
direct supply or recommendations. Any requests for such off-label use
should be made direct to Novartis (milka.bedikian@novartis.com). For
the
Netherlands
, our understanding is that there is (or is soon going to be) an
arrangement between the government and Novartis along similar lines to
the existing arrangement WHO has with SwissMedic in
Switzerland
.
In
all cases where a supply is made, WHO provides the drugs free of
charge, covering freight/delivery charges (usually by DHL courier for
small quantities). WHO is not responsible however for covering local
costs such as taxes or customs charges which remain the responsibility
of the requesting physician, pharmacist or hospital.
Best
regards,
Steve
Dr
Steve Lyons
Leprosy Elimination Group
World
Health Organization, Avenue Appia, CH-1211,
Geneva
27,
Switzerland
Direct Fax : WHO Geneva: +41 22 791 4850;
UK
+44 1298 812 531
Tel:
UK
+44 1298 812 531
eMail: WHO Geneva: lyonss@who.int ;
UK
: lyonss@btinternet.com
WHO/LEP web site: http://www.who.int/lep/
