PUBLIC PETITIONS COMMITTEE
AGENDA
16th Meeting, 2013 (Session 4)
Tuesday 1 October 2013
The Committee will meet at 10.00 am in Committee Room 2.
2. PE1463 - effective thyroid and adrenal testing, diagnosis and treatment:
The Committee will take evidence in a round table format from —
• Michael Matheson, Minister for Public Health,
• Professor Graham Leese, CMO Specialty Adviser for Endocrinology,
• Mark O’Donnell, Head ofQuality and Planning Division, and Lesley Metcalf, Policy Manager, Clinical Priorities Team, Scottish Government;
• Sandra Whyte, Marian Dyer, and Lorraine Cleaver, Petitioners;
• Tara Wilmott, Head of Approvals, Education and Standards Directorate,General Medical Council;
• Dr Anthony Toft, Consultant Physician, Spire Murrayfield Hospital,Edinburgh;
• Lyn Mynott, Chair/Chief Executive, Thyroid UK;
• Professor Graham Williams, President, British Thyroid Association andTreasurer, Society for Endocrinology.
Agenda item 2
PE1463 Note by the Clerk PPC/S4/13/16/1
PRIVATE PAPER PPC/S4/13/16/2
• Petitioner Letter of 26 June 2013
PE1463/P
• Medicines and Healthcare Products Regulatory Agency Letter of 5 August 2013
PE1463/Q
• Amdipharm Mercury Letter of 20 August 2013
PE1463/R
• Thyroid Patient Advocacy Email of 19 September 2013
PE1463/S
• Royal College of Physicians Letter of 11 September 2013
PE1463/T
• Dr John E Midgley Letter of 20 September 2013
PE1463/U
• Petitioner Letter of 24 September 2013
PE1463/V
• Eric Pritchard Letter of 24 September 2013
PE1463/W
PPC/S4/13/16/1
Public Petitions Committee
16thMeeting, 2013 (Session 4), Tuesday 1 October 2013PE1463 on effective thyroid and adrenal testing, diagnosis and treatment
Note by the Clerk
PE1463 – Lodged 19th December 2012
Petition by Sandra Whyte, Marian Dyer and Lorraine Cleaver calling on the Scottish Parliament to urge the Scottish Government to take action to ensure GPs and
endocrinologists are able to accurately diagnose thyroid and adrenal disorders andprovide the most appropriate treatment.
Link to petition webpage
Purpose
1.The Committee last considered this petition on
25 June 2013 and agreed to holda round-table discussion on the issues raised by the petition at a future meeting. Since then, several submissions have been received. Following the round-tablediscussion, the Committee is invited to agree what action it wishes to take on the petition.
Background
2. Hypothyroidism is a condition in which the thyroid gland produces insufficient amounts of Thyroxine, which can result in symptoms such as tiredness, weightgain and depression. It is estimated that 3.7% of patients registered with a GPpractice in Scotland have been diagnosed with hypothyroidism[1], resulting in an estimated 103,000 people being seen annually by either a GP or practice nurse[2].
3. A patient presenting with the above symptoms would typically undergo a thyroid function test to confirm diagnosis. This test measures the levels of Thyroid Stimulating Hormone (TSH) and free Thyroxine (T4) in a person’s blood. Once diagnosed, hypothyroidism is usually treated in primary care with the prescription of Thyroxine (T4) tablets (Levothyroxine).
4. SIGN (
The Scottish Intercollegiate Guidelines Network/red.) has not published any guidelines on the diagnosis and management of hypothyroidism. However there are guidelines which were co-published in 2008 by a number of professional bodies[3], and revised in June 2011[4]
5. The guidelines specifically address point 3 of the petition which relates to alternative treatments to T4 alone, including the combined use of T3 (see footnote 5) and T4. It states:
“The RCP does not support the use of thyroid extracts or levothyroxine and T3 combinations without further validated research published in peerreviewed journals. Therefore, the inclusion of T3 in the treatment of hypothyroidism should be reserved for use by accredited endocrinologists in individual patients.”
Scottish Parliament Action
6. Elaine Smith MSP, who made a submission to the Committee, has lodged a number of questions and a motion on this issue since 2010, most recently question
S4W-15415 on the impact of the recent shortage of liothyronine (T3) medication.
Committee Consideration
7. Following initial consideration on
5 February 2013, a large number of submissions (approximately 185) were received, the majority of which were personal accounts from thyroid and adrenal disorder patients, supporting the petition. Two charitable organisations also submitted their support.
8. The General Medical Council stated that it was satisfied that the submissions from the respective Royal Colleges in relation to the content and requirements of the curricula that cover thyroid and adrenal testing fulfil its standards. The Scottish Intercollegiate Guidelines Network confirmed that it has no guideline, or plans for such, on thyroid and adrenal disorders.
9. The Scottish Government acknowledged that consideration should be given to exploring a mechanism to examine all published clinical evidence. Following its meeting on
16 April 2013, the Committee wrote to the Scottish Government recommending it establish a short-life working group to do this. In its response, the Scottish Government stated that it has already taken steps to inform its decision. This included requesting an evidence note from the Scottish Health Technologies Group at HIS which, if accepted, may take four to six months to complete.
10. The Committee considered the petition again on
28 May 2013 and, at its meeting on
25 June 2013, took evidence from the Cabinet Secretary for Health and Wellbeing on the interruption to the supply of Liothyronine medicine, and other related issues. Following this, the Committee agreed a list of individuals and organisations to invite to participate in a round-table discussion on the petition.
11. Since that meeting, the following submissions have been received —
• PE1463/P: Petitioner Letter of 26 June 2013
• PE1463/Q: Medicines and Healthcare Products Regulatory Agency Letter of 5 August 2013
• PE1463/R: Amdipharm Mercury Letter of 20 August 2013
• PE1463/S: Thyroid Patient Advocacy Email of 19 September 2013
• PE1463/T: Royal College of Physicians Email of 11 September 2013
• PE1463/U: Dr John E Midgley Letter of 20 September 2013
• PE1463/V: Petitioner Letter of 24 September 2013
• PE1463/W: Eric Pritchard Letter of 24 September 2013
12. The first three of these submissions concern the recent interruption to the supply of Liothyronine medicine and the evidence session on this issue with the Cabinet Secretary for Health and Wellbeing. The petitioners raise questions over the management of this drugs shortage, highlighting that the issue was brought tothe attention of the MHRA by patients and not the manufacturer. They also reiterate their concerns over the guidance to clinicians on prescribing unlicensed drugs, and the efficacy of the medication that is prescribed.
13. The Royal College of Physicians submitted its published statement on the diagnosis of primary hypothyroidism, as well as an article from the BMJ. In its email, the College states:
“We have no plans to review our policy”; and, “We do not intend to respond to the petition. This is because we have already responded over a period of time in England, and produced our official response”.
14. Of those the Committee invited, the Royal College of Physicians is the only organisation that did not field a representative for the round-table discussion. Dr Midgley, Thyroid Patient Advocacy and E Pritchard have submitted evidence in order to inform the Committee’s consideration of those issues that are likely to be raised during the round-table discussion.
Action
15. Subject to the outcome of the round-table discussion, the Committee is invited to agree what action it wishes to take. Options include —
(
1) To defer consideration of the petition to a future meeting to awaitcompletion of the work being undertaken by the Scottish Government;
(
2) To recommend that the Minister propose to SIGN that guidelines be developed on the diagnosis and management of hypothyroidism;
(
3) To take any other action that the Committee considers appropriate.
Kilde:
http://www.scottish.parliament.uk/S4...s_20131001.pdf
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