Relationship between the RCP and MHRA – there’s hope for UK patients.

For intro­duc­tion, in the UK (Uni­ted King­dom) , RCP stands for Royal College of Phy­si­cians. It is the pro­fes­sio­nal orga­ni­za­tion of phy­si­cians with the goal of uphol­ding and impro­ving stan­dards of medi­cal prac­tice (which they have com­ple­tely fai­led when it comes to thy­roid patients).

MHRA stands for Medi­ci­nes and Health Care pro­ducts Regu­la­tory Agency.  They ensure that medi­ca­tions and medi­cal devi­ces work and are acceptable.

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In late February 2009, Sheila Tur­ner, foun­der of UK-TPA, sent me what you will find below. It gives hope to those in the UK that they might still get Armour presc­ri­bed within the NHS (Natio­nal Health Ser­vice) as long as they can get this infor­ma­tion to the Endoc­ri­no­lo­gists and they might change their minds.

Sheila explains that in a let­ter she recei­ved in 2004, the MHRA stated:

“UK and Euro­pean law recog­ni­ses that there may be cir­cums­tan­ces when licen­sed pro­ducts may not be sui­ta­ble for some patients. The regu­la­tions on medi­ci­nes allow doc­tors to presc­ribe an unli­cen­sed medi­cine for a patient to meet such a spe­cial cli­ni­cal need, on their own direct per­so­nal res­pon­si­bi­lity. Where these unli­cen­sed medi­ci­nes are not avai­la­ble in the UK they can be impor­ted by appro­pria­tely licen­sed medi­ci­nes who­le­sa­lers, for supply to a doc­tor or phar­macy, to meet these needs”.

The above clearly implies that Armour, con­si­de­red an “unli­cen­sed” medi­ca­tion, can be presc­ri­bed and can be impor­ted.  Sheila’s next move was to seek cla­ri­fi­ca­tion about the RCP and MHRA rela­tionship, and one of her mem­bers sent the below, which is hopeful:

1.  The “rela­tionship” bet­ween Medi­ci­nes and Health­care Regu­la­tory Agency and the Royal College of Physicians

From my research on the MHRA web­site, the RCP is lis­ted along with many other pro­fes­sio­nal bodies (inc­lu­ding the ROYAL COLLEGE OF GENERAL PRACTITIONERS – endor­sers of the RCP sta­te­ment on Hypothy­roi­dism) plus many, many indi­vi­dual phar­ma­ceu­ti­cal com­pa­nies, as “Sta­kehol­ders”.

It appears that these sta­kehol­ders are used to pro­vide con­sul­ta­tion input on at least two of their major projects:

a) Con­so­li­da­tion and review of medi­ci­nes legis­la­tion – con­sul­ta­tion com­ments to be in by March 2009

b) Review of unli­cen­sed medi­ci­nes – con­sul­ta­tion com­ments were to be in by 30 June 2008.

The follo­wing should give all those peo­ple who do get their Armour recom­men­ded by their NHS endoc­ri­no­lo­gist and presc­ri­bed by their GP some real hope.

What are we see­king to achieve through this review?

That cli­ni­cians should have the abi­lity in appro­priate cir­cums­tan­ces to exer­cise their pro­fes­sio­nal jud­ge­ment to com­mis­sion the supply of an unli­cen­sed medi­cine to meet the spe­cial needs of an indi­vi­dual patient.

http://www.mhra.gov.uk/Howweregulate/Medicines/Reviewofunlicensedmedicines/index.htm

2.  Can the RCP over-ride what is allo­wed by the MHRA?

The MHRA exists to assure that medi­ci­nes are regu­la­ted in accor­dance with the rele­vant sta­tu­tory ins­tru­ments, namely the Medi­ci­nes Act 1968 and in the case of Unli­cen­sed Medi­ci­nes, with the pro­vi­sions of Sche­dule 1 of The Medi­ci­nes for Human Use (Mar­ke­ting Autho­ri­sa­tions Etc.) Regu­la­tions 1994 [SI 1994/3144], (the MA Regs.)

It appears that the lat­ter “exempts from the need for a ‘mar­ke­ting autho­ri­sa­tion’,  a rele­vant medi­ci­nal pro­duct which is sup­plied to fill a “spe­cial need” and in res­ponse to a bona fide unso­li­ci­ted order, for­mu­la­ted in accor­dance with the spe­ci­fi­ca­tion of a doc­tor, den­tist or sup­ple­men­tary presc­ri­ber and for use by his indi­vi­dual patients on his direct responsibility.”

So it is a legal exemp­tion which allows a doc­tor to presc­ribe an unli­cen­sed medicine.

The RCP have then issued a sta­te­ment which they state “reflects best prac­tice of cli­ni­cal endoc­ri­no­lo­gists”. The three refe­ren­ces to the unli­cen­sed medi­cine are

1. “We do not recom­mend the presc­ri­bing of addi­tio­nal Tri-iodothyronine (T3) in any pre­sently avai­la­ble for­mu­la­tion, inc­lu­ding Armour thyroid”

2. “The College does not sup­port the use of thy­roid extracts or thy­ro­xine and T3 com­bi­na­tions without further vali­da­ted research published in peer-reviewed jour­nals.  The­re­fore, the inc­lu­sion of T3 in the treat­ment of hypothy­roi­dism should be reser­ved for use by acc­re­di­ted endoc­ri­no­lo­gists in indi­vi­dual patients”.

3.“We note that the extract mar­ke­ted as Armour thy­roid con­tains an exces­sive amount of T3 in rela­tion to T4”.

Loo­king at the above sta­te­ments, the RCP are not really over-riding the deci­sions of the MHRA. The MHRA’s role is to uphold the law and state the con­di­tions under which an Unli­cen­sed Medi­cine can be used.

The RCP are saying that “best prac­tice” is not to recom­mend presc­ri­bing Armour and that they do not currently sup­port its use (attemp­ting to subs­tan­tiate this by noting “Armour thy­roid con­tains an exces­sive amount of T3 in rela­tion to T4”)

So whilst it remains legal to presc­ribe it, the RCP state that “the inc­lu­sion of T3 in the treat­ment” (which clearly could inc­lude Armour) “should be reser­ved for use by acc­re­di­ted endoc­ri­no­lo­gists in indi­vi­dual patients”.

i.e. The RCP are not saying it can­not be used in any cir­cums­tan­ces (which would be attemp­ting to over-ride the MHRA inter­pre­ta­tion of the law) but that only (unde­fi­ned) acc­re­di­ted endoc­ri­no­lo­gists can use it with the remain­der of the medi­cal pro­fes­sion being told it is “best prac­tice” not to use it.

They have cle­verly avoi­ded con­fron­ta­tion with the dic­ta­tes of the MHRA whilst effec­ti­vely put­ting any medi­cal prac­ti­tio­ner who uses Armour, outside the “best prac­tice”.

Scou­ring the RCP web­site fails to reveal any sche­mes or sys­tems for Acc­re­di­ta­tion other than “edu­ca­tio­nal acc­re­di­ta­tion”.  So the “cli­ni­cal endoc­ri­no­lo­gists acc­re­di­ted by the Royal College of Phy­si­cians and the Royal College of Pae­dia­trics and Child Health. “appears to be another unsubs­tan­tia­ted piece of terminology.