Chamber and committees

The Scottish Government has no evidence of the benefits of the combined use of triiodothyronine and levothyroxine compared with patients receiving only thyroxine.

Clinicians are expected to follow agreed national clinical guidelines when diagnosing and managing conditions affecting the thyroid. These guidelines, are based on the advice of experts in the field, including the Royal College of Physicians, and the Society for Endocrinology, the American Association of Clinical Endocrinologists, and informed by voluntary sector support groups, such as the British Thyroid Association. The British National Formulary also provides information to clinicians to support them in prescribing thyroid medication.

Latest official statistics on the gross ingredient cost of medicines dispensed by community pharmacists and dispensing doctors can be found at www.isdscotland.org/isd/2241.html. Data are available for financial years ending 31 March 2001 to 2010 inclusive.

The data show that for the financial year ended 31 March 2010 the gross ingredient cost for medicines defined in section 6.2 of the British National Formulary as involved in the treatment of a thyroid condition was £7,267,418. The data exclude the direct supply of medicines to patients from hospitals and hospital-based clinics. The gross ingredient cost is the cost of an item before any discounts are applied. It excludes adjustments and any dispensing or broken bulk fees.

Information on prescriptions issued to people is not collected. The following table shows the number of generic prescriptions dispensed in the community by community pharmacists and dispensing doctors for financial years ending 31 March 2000 to 2010 inclusive. These data exclude the direct supply of medicines to patients in hospitals and hospital-based clinics.

Number of Dispensed Items

Financial Year
2000-01	45,265,801
2001-02	48,772,555
2002-03	52,429,339
2003-04	55,707,997
2004-05	58,570,457
2005-06	61,212,593
2006-07	63,544,329
2007-08	65,754,550
2008-09	68,437,386
2009-10	71,257,525

 

It has long been the Scottish Government''s policy to encourage generic prescribing wherever clinically appropriate. This policy has resulted in a high generic prescribing rate. In 2009-10 in Scotland, 83% of prescription items were prescribed generically in primary care.

Notes:

The data shown are that for items that are written and dispensed generically and items that are written generically but dispensed proprietary.

The information in the table has been provided by NHS National Services Scotland. Further information on prescribing can be found at www.isdscotland.org/prescribing.

The safety of medicines is reserved and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). Reports of suspected adverse drug reactions (ADRs) are collected by the MHRA and the Commission for Human Medicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. The scheme relies on the voluntary reporting of suspected ADRs by health professionals and patients. There is also a legal requirement for pharmaceutical companies to report.

It is important to note that the reporting of a suspected adverse reaction does not necessarily mean it is related to the drug. The MHRA asks reporters to send suspicions of adverse drug reactions however, these are not proven. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the underlying disease being treated.

As of 8 December 2010, the MHRA has received a total of six UK spontaneous suspected ADR reports associated with thyroxine (active substance: levothyroxine) where the reporter stated that the reactions occurred upon switching between different brands of thyroxine. These ADR reports were received during the time period 1989-2010. A breakdown of the reaction terms reported is shown in the following table:

Reported Suspected Adverse Drug Reactions and their Outcomes

Case
1	Drug ineffective (Patient recovered)
2	Drug ineffective (Patient outcome not known)
3	Drug ineffective (Patient outcome not known) Blood thyroid stimulating hormone increased (Patient recovered)
4	Drug ineffective (Patient outcome not known) Blood thyroid stimulating hormone increased (Patient recovered), Hypothyroidism (Patient recovered)
5	Drug ineffective (Patient outcome not known) Activities of daily living impaired (Patient recovered) Blood thyroid stimulating hormone increased (Patient recovered) Fatigue (Patient recovered) Mental impairment (Patient recovered)
6	Rash (Patient outcome not known) Product substitution issue (Patient outcome not known) Heart rate increased (Patient outcome not known) Muscle spasms (Patient outcome not known) Fatigue (Patient has not recovered) Alopecia (Patient has not recovered) Hair texture abnormal (Patient has not recovered)

 

The Scottish Government has not met representatives of the British Thyroid Association, but would be willing to consider a meeting should the Association request one.

The Scottish Government does not have guidelines on the combined use of triiodothyronine and levothyroxine in patients with hypothyroidism.

Clinicians are expected to follow agreed national clinical guidelines when diagnosing and managing conditions affecting the thyroid. These guidelines, are based on the advice of experts in the field, including the Royal College of Physicians, and the Society for Endocrinology, the American Association of Clinical Endocrinologists, and informed by voluntary sector support groups, such as the British Thyroid Association. The British National Formulary also provides information to clinicians to support them in prescribing thyroid medication.

The regulation and control of medicines are reserved and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA''s primary aim is the protection of public health that includes assessment of medicinal products to ensure that they are of satisfactory safety, quality and efficacy and that they have a positive balance of benefit:risk. The following information has been provided by the MHRA.

Thyroxine (Levothyroxine) is used to treat patients with underactive thyroid glands (hypothyroidism). It has been established on the UK market for over 50 years.

The following levothyroxine products are currently authorised in the UK:

Levothyroxine Tablets 25, 50 and 100 micrograms

Levothyroxine Oral Solution 25, 50 and 100micrograms in 5mL.

The tablets are marketed by six different licence holders and the oral solution is marketed by one licence holder.

The stability issues associated with levothyroxine are known and as part of the procedure for granting an authorisation, the MHRA would have assessed the applicant company''s data to ensure satisfactory quality standards are maintained during manufacture and for the duration of the approved storage shelf life.

With respect to levothyroxine tablets, the drug substance is present in very low quantities and finished product manufacture may be considered complex. The product''s quality specification will, as a minimum, be required to conform to the British Pharmacopoeia monograph for levothyroxine tablets BP. Due to known stability issues with levothyroxine, it is expected that a proportion of the drug will be lost during its shelf life. The monograph for levothyroxine tablets in the British Pharmacopoeia (which publishes quality standards for a range of products) has been revised for the 2011 edition, to tighten the limits for levothyroxine content from 90% to 110% of the declared content to 90% to 105% that reduces possible variability, between products and between batches of the same product.

With respect to Levothyroxine Oral Solution, there is no pharmacopoeial monograph; nevertheless, the approved quality specification of the authorised product is in compliance with current general Pharmacopoeial requirements for oral liquid preparations.

As is the case for any medicinal product, the MHRA will investigate and take appropriate action in relation to any reported defect of a product marketed in the UK.

Information on prescriptions issued to people is not collected. The following table shows the number of generic prescriptions dispensed in the community by community pharmacists and dispensing doctors for drugs defined in section 6.2 of the British National Formulary as involved in the treatment of a thyroid condition. These data exclude the direct supply of medicines to patients in hospitals and hospital-based clinics.

Number of Dispensed Items

Financial Year
2000-01	1,175,394
2001-02	1,298,665
2002-03	1,421,991
2003-04	1,537,656
2004-05	1,643,371
2005-06	1,754,542
2006-07	1,842,267
2007-08	1,924,964
2008-09	2,019,172
2009-10	2,129,128

Notes:

Propranolol can be used to treat thyrotoxic symptoms and beta blockers can be used in neonatal thyrotoxicosis and in supraventricular arrhythmias due to hyperthyroidism. These products can be used to treat other conditions and it is not possible to identify from prescribing data collected centrally the reason why a particular product has been prescribed.

The data shown are that for items that are written and dispensed generically and items that are written generically but dispensed proprietary.

The information in the table has been provided by NHS National Services Scotland. Further information on prescribing can be found at www.isdscotland.org/prescribing.

The Scottish Government does not provide advice on the clinical management of individual patients. The management of a patient is an agreement between the clinicians involved and the patient and their carers, following an assessment of the patient''s condition.

GPs are expected to follow agreed national clinical guidelines when diagnosing and managing conditions affecting the thyroid. These guidelines, are based on the advice of experts in the field, including the Royal College of Physicians, and the Society for Endocrinology, the American Association of Clinical Endocrinologists, and informed by voluntary sector support groups, such as the British Thyroid Association. The British National Formulary also provides information to clinicians to support them in prescribing thyroid medication.

Medicines legislation requires pharmacists to dispense medicines in accordance with a prescription. This means that medicines dispensed by or under the supervision of a pharmacist should be exactly what are written on the prescription. In addition, under their terms of service, pharmacists are required to supply medicines that conform to standards specified in the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary or the Drug Tariff.

The Scottish Government does not provide guidelines to pharmacies regarding prescriptions for generic drugs for thyroid patients.

Medicines legislation requires pharmacists to dispense medicines in accordance with a prescription. This means that medicines dispensed by or under the supervision of a pharmacist should be exactly what are written on the prescription.