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.
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.
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.