Derbyshire Medicines Management, Prescribing and Guidelines


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Derbyshire Medicines Management, Prescribing and Guidelines DERBYSHIRE PRIMARY CARE FORMULARY
Chapter 6: ENDOCRINE SYSTEM Updated: May 2022
The following prescribing guidelines are relevant to the endocrine chapter and can be found here • Blood Glucose monitoring meter formulary • Diabetes (type 2- management in adults) • FreeStyle Libre- JAPC briefing • Hyperprolactinaemia (cabergoline & quinagolide) • Liothyronine- position statement • Menopause- local management guideline • Osteoporosis- bisphosphonate treatment break • Osteoporosis- diagnosis & management • Pioglitazone- prescribing statement
Relevant resources: • Exogenous steroids, adrenal insufficiency and adrenal crisis - Society for Endocrinology advice • When should I issue a steroid emergency alert card • Steroid emergency card - Resources for practices • Transgender and Non-Binary Adults - Primary Care guidance • Trans healthcare - Advice based on GMC guidance • Gender incongruence in primary care - Advice from BMA
6.1 Drugs used in diabetes 6.1.1 Insulins Insulins should be prescribed by brand as they are not interchangeable.
Adult patients on insulin should receive an insulin passport (http://pcse.england.nhs.uk/ for supply) to provide accurate identification of their current insulin therapy across healthcare sectors. Errors in the administration of insulin are common and consequence may be severe and can cause death. All insulin doses should be measured and administered using an insulin syringe or commercial insulin pen device, and the term ‘units’ should always be used in full without abbreviating. Do NOT use insulin needle and syringe to administer insulin withdrawn directly from a pen device or replacement cartridge due to risk of severe harm and death (NHS PSA November 2016).
Patients should be trained on how to use their insulin device, and for patients using high strength preparations, particularly on how to check the dose displayed on the prefilled pen (MHRA April 2013). Care should be taken when prescribing high strength, fixed combination and biosimilar products- prescriber and patients must understand the insulin strength of products and how to use them correctly to minimise the risk of medication errors (MHRA April 2015).
Where a biosimilar exists the most cost effective preparation should be used in new patients and considered in patients with unstable glucose control who are under close supervision.
MHRA Sept 2020 Injection of insulin (all types) can lead to deposits of amyloid protein under the skin (cutaneous amyloidosis) at the injection site which interferes with insulin absorption thus it is important to rotate injection site. There is a risk of hypoglycaemia in patients that suddenly change injection site from an area with cutaneous amyloidosis to an unaffected area (for example, changing the injection site from the torso to the leg). Patients should therefore carefully monitor blood glucose after changing injection site and consider adjusting the dose of insulin or antidiabetic medication to avoid hypoglycaemia, as needed.
GlucoRx Carepoint pen needles (4mm/31g, 5mm/31g, 6mm/31g, 8mm/31g) and GlucoRx Carepoint Ultra (4mm/32g) are the formulary choice of insulin pen needles. If this is unsuitable consider other brands costing less than £5 per 100 needles.
Safety needles should NOT be used by patients who self-administer insulin. If safety needles are indicated GlucoRx Safety Pen Needle (5mm/30g, 8mm/30g) – GREEN 1st line option (preferred brand). Safety needles with acquisition cost <£20 per 100 are classified as GREEN alternative 2nd line option. All other safety needles with acquisition cost > £20 per 100 are classified as Do Not Prescribe (DNP).
Page 1 of 11 The formulary lists the most clinically and cost effective choices for prescribing in primary care

Mealtime insulins
Basal insulins
Biphasic insulins

Insulin (all preparations are 100units/ml unless stated)

Timing of injection

Short acting human insulins

Soluble insulin (e.g., Actrapid, Humulin S, Insuman rapid)

Within 30 mins before meal

Rapid-acting analogues

Insulin aspart (Trurapi) An option for children and type 1 diabetes in patients already on treatment (NG17) Preferred cost-effective brand for new patients (adult and children) Insulin aspart (Novo Rapid) An option for children and type 1 diabetes in patients already on treatment (NG17) New patient should consider Trurapi as the cost-effective brand. Existing patients on NovoRapid should continue on treatment until the next clinical review takes place, to assess if glycaemic control is not optimal. Insulin aspart (Fiasp) (After specialist recommendation) An option for type 1 diabetes (NG17) in new adult patients Insulin lispro (Humalog) An option for type 1 diabetes (NG17)
Insulin lispro (Lyumjev) Slightly different releasing profile to Humalog – used in adults in whom a more rapid acting mealtime insulin is desirable
Insulin glulisine (Apidra)

Immediately before meal
Immediately before meal
Within 0-15 mins of meal Within 0-15 mins of meal
Up to 2min before or 20min
after starting meal
Within 0-15 mins of meal

Intermediate (NPH) human insulin

Isophane (NPH) insulin (Insulatard, Humulin I, Insuman Basal) - first line for most patients with type 2 diabetes

At bedtime/12 hrly

Long-acting analogues

Insulin detemir (Levemir) - preferred choice for adult type 1 diabetes (NG17) Insulin glargine biosimilar (Semglee) - positioned ahead of insulin glargine (Lantus), when a long-acting insulin analogue is indicated in new patients or patients who are having a review of treatment due to suboptimal control Insulin glargine biosimilar (Abasaglar) - when a long-acting insulin analogue is indicated. Patients already initiated on Abasaglar should remain on this Insulin glargine (Lantus) - an option to continue for existing stable patients

Once/twice daily
Once daily
Once daily Once daily

Insulin glargine 300 units/ml (Toujeo) GREY

Once daily

Onset of action
Within 30 mins
10-20 mins
10-20 mins
4 mins About 15
mins Within 20min 10-20 mins Within 1.5 hrs
0.5-1 hr
0.5-1 hr
0.5-1 hr
0.5-1 hr 0.5-1 hr

Peak

Duration of action

1.5-3.5 hrs

7-8 hrs

1-3 hrs 3-5 hrs

1-3 hrs 3-5 hrs

1-3 hrs
30-70 mins

3-5 hrs 2-5 hrs

1-3 hrs 5 hrs

About 1 1.5-4 hrs hr

4 -12 hrs

About 24 hrs

3-14 hrs

Up to 24 hrs

No peak Up to 24 hrs

No peak Up to 24 hrs
No peak Up to 24 hrs
No peak 24-36 hrs

Insulin degludec (Tresiba) 100units/ml GREY

Once daily 0.5 –1.5 hrs No peak >42 hrs

Insulin degludec (Tresiba) 200units/ml GREY

Once daily 0.5 –1.5 hrs No peak

Pre-mixed human insulin (commonly used in twice daily regimens in type 2 diabetes)

Biphasic isophane insulin (soluble insulin 30%+isophane insulin 70%; Humulin M3; Insuman Comb 25 (25%soluble/75% Isophane); Insuman Comb 50 (50% soluble/50% Isophane))

Within 30 mins Within 30

before meal

mins

2 and 8hrs

Pre-mixed analogues

(an option in type 2 diabetes if a person prefers to inject insulin immediately before a meal)

Biphasic aspart (insulin aspart 30%+ insulin aspart protamine 70%; novomix 30)

Within 0-10 mins of meal

Within 10- 1-4 hrs 20 mins

Biphasic insulin lispro (insulin lispro 25%+ insulin lispro protamine Within 0-15 About 15 About 2

75%; Humalog Mix 25)

mins of meal

mins

hrs

Biphasic insulin lispro (insulin lispro 50%+insulin lispro protamine

Within 0-15 About 15 About 2

50%; Humalog Mix 50)

mins

mins

hrs

>42 hrs
Up to 24hrs
up to 24hrs up to 24hrs up to 24hrs

Traffic light classification for high strength insulins and insulin degludec

Insulin/strength

Traffic light status

Insulin glargine 300units/ml

GREY after consultant/specialist initiation:

(Toujeo)

• for patients on insulin Degludec or

• for patients being considered for insulin pump therapy or

• for patients currently on high dose of insulin (>150units/day) who would otherwise have

been started with Humulin R U-500 or degludec.

Page 2 of 11 The formulary lists the most clinically and cost effective choices for prescribing in primary care

Insulin degludec 200units/ml (Tresiba) Insulin degludec 100units/ml (Tresiba)

GREY after consultant/specialist initiation for patients currently on high dose of insulin (>150units/day) after consideration of Toujeo. GREY after consultant/specialist initiation- restricted to those with documented nocturnal hypoglycaemia or loss of hypoglycaemia awareness despite using long acting insulin analogue, who would otherwise have been started on an insulin pump in type 1 diabetes. Or for people who need help from a carer or healthcare professional to administer injections (NG17)

1. In a meta-analysis, short-acting insulin analogues for type 2 diabetes did not improve HbA1c, hypoglycaemia, or quality of life, compared with conventional human insulin. JAPC has agreed that insulin analogues in type 2 diabetes are overused and should be considered after conventional human insulin.
2. Human NPH insulin is preferred, however, long acting analogues can be considered as an alternative in type 2 diabetes if:
• the person needs assistance from a carer or healthcare professional to inject insulin and use of detemir or glargine (ensure glargine prescribed as brand name) would reduce the frequency of injections from twice to once daily or
• the person’s lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes or • the person would otherwise need twice-daily NPH insulin injections in combination with oral glucose-
lowering drugs. 3. NICE NG17 recommends patients with type 1 diabetes should usually be offered two insulins that act in
different ways: • a background (also known as a ‘basal’ or ‘long-acting’) insulin ideally injected twice a day (insulin detemir)
AND • a ‘quick-acting’ (also known as a ‘bolus’ or ‘rapid-acting’) insulin injected before each meal to deal with the
rise in blood glucose from eating. 4. When staring an insulin for which a biosimilar is available, use the product with the lowest acquisition cost.
For existing patients discuss the possibility of switching to a lower cost biosimilar. Make a shared decision with the person after discussing their preferences. 5. Insujet the needle free insulin device classified as Do Not Prescribe (DNP).

NPH and insulin analogue products and cost comparisons

Active substance
Isophane (NPH) insulin
Insulin glargine (and
biosimilar)

Brand name Insuman Basal Humulin I
Insulatard Semglee
Lantus
Abasaglar

Strength 100units/ml 100units/ml 100units/ml 100units/ml 100units/ml 100units/ml

Insulin type
Intermediate (NPH) human insulin
Intermediate (NPH) human insulin
Intermediate (NPH) human insulin
Long-acting analogues
Long-acting analogues Long-acting analogues

Insulin detemir

Levemir

100units/ml

Long-acting analogues

Insulin degludec

Tresiba

Insulin glargine

Toujeo

Price as per MIMs May 2022.

100units/ml 200units/ml 300units/ml

Long-acting analogues
Long-acting analogues

Cartridg e cost £17.50
(5 x 3ml) £19.08 (5 x 3ml) £22.90 (5 x 3ml)
--
£34.75 (5 x 3ml) £35.28 (5 x 3ml)
£42.00 (5 x 3ml)
£46.60 (5 x 3ml)
--
--

Pre-filled inj/pen cost £19.80
(5 x 3ml injection) £21.70
(5 x 3ml pen) £20.40
(5 x 3ml pen)
£29.99 (5 x 3ml pen)
£34.75 (5 x 3ml pen)
£35.28 (5 x 3ml pen)
£42.00 (5 x 3ml pen)
£44.85 (InnoLet 5 x 3ml)
£46.60 (5 x 3ml pen)
£55.92 (3 x 3ml pen)
£33.14 (3 x 1.5ml pen)
£64.27 (3x 3ml pen)

Vial cost
£15.68 (10ml) £7.48 (10ml)
-£25.69 (10ml)
--
--
---
--

Cost per 100 unit £1.16 -
£1.32 £1.27 £1.57 £0.75 £1.53
£1.99
£2.32 £2.57 £2.35
£2.80 £2.99
£3.10
£3.10
£2.45
£2.38

Insulin pen price comparisons Name
Autopen 24 Autopen classic
JuniorSTAR AllStar Pro HumaPen Luxura HD

Cartridge size 3ml 3ml 3ml 3ml 3ml

Price (£) 17.33 17.60 26.00 25.00 27.01

Page 3 of 11 The formulary lists the most clinically and cost effective choices for prescribing in primary care

HumaPen Savvio

3ml

NovoPen 5/ 6

3ml

NovoPen Echo/ Echo Plus

3ml

Price as per MIMs May 2022

27.01 26.86 26.86

6.1.2 Antidiabetic drugs A HbA1c reduction of at least 5 mmol/mol (0.5%) is considered clinically significant. At each review re-assess the person’s needs and circumstances and think about stopping any medicines that are not effective at 6 months. See local diabetes guideline.
Metformin tabs 500mg, 850mg Metformin SR tabs 500mg, 750mg, 1000mg
1. Metformin is the first-line oral hypoglycaemic for all people with type 2 diabetes (unless contraindicated). Start low and go slow. To be taken with meals for example, start metformin at 500mg od with main meal. After 1 week, increase to 500mg bd. Then increase in 500mg steps at weekly intervals to highest dose tolerated or maximum dose reached. Maximum dose in BNF is 2 g/day but doses up to 3 g/day are commonly used in clinical practice. There is additional glucose lowering benefit by increasing doses from 2 to 3 g/day, although the UKPDS used a dose of metformin of 1700mg in the morning and 850mg in the evening (target dose).
2. Metformin SR should be restricted for use in those patients who are intolerant of standard release metformin, even after slow dose titration. Try metformin SR before switching to an alternative hypoglycaemic agent.
3. The risk of lactic acidosis with metformin, especially until creatinine clearance is below 30ml/min, is very minimal. NICE advises to review the dose of metformin if the serum creatinine exceeds 130 micromol/litre or the estimated glomerular filtration rate (eGFR) is below 45 ml/minute/1.73-m2, and to stop the metformin if the serum creatinine exceeds 150 micromol/litre or the eGFR is below 30 ml/minute/1.73-m2. A Cochrane systematic review (April 2014) compared over 70,000 patient years of metformin exposure with a matched group receiving other hypoglycaemic agents and found no evidence of excess lactic acidosis.
4. NICE PH38 – type 2 diabetes-prevention in people at high risk, recommends clinicians use their judgement on whether (and when) to offer metformin to support lifestyle change for people whose HbA1c or fasting plasma glucose blood test results have deteriorated if • This has happened despite their participation in intensive lifestyle-change programmes, or they are unable to participate in an intensive lifestyle-change programme, particularly if they have a BMI greater than 35. • High risk patients are defined as HbA1c of 42-47mmol/mol (6.0-6.4%) or fasting plasma glucose of 5.56.9mmol/l • Dosage recommendation: Start with a low dose (for example, 500 mg once daily) and then increase gradually as tolerated, to 1500–2000 mg daily. If the person is intolerant of standard metformin consider using modified-release metformin. • Metformin should be prescribed for 6–12 months initially. Monitor the person's fasting plasma glucose or HbA1c levels at 3-month intervals and stop the drug if no effect is seen.
5. Metformin and reduced vitamin B12 levels (MHRA June 2022) • metformin can commonly reduce vitamin B12 levels in patients, which may lead to vitamin B12 deficiency. • the risk of low vitamin B12 levels increases with higher metformin dose, longer treatment duration, and in patients with risk factors for vitamin B12 deficiency. • test vitamin B12 serum levels if deficiency is suspected (for example, in patients presenting with megaloblastic anaemia or new-onset neuropathy). See shared care pathology. Administer corrective treatment for vitamin B12 deficiency in line with current clinical guidelines; continue metformin therapy for as long as it is tolerated and not contraindicated. • consider periodic vitamin B12 monitoring in patients with risk factors for vitamin B12 deficiency. Risk factors for vitamin B12 deficiency are wide ranging. They include: o baseline vitamin B12 levels at the lower end of the normal range o conditions associated with reduced vitamin B12 absorption (such as elderly people and those with gastrointestinal disorders such as total or partial gastrectomy, Crohn’s disease and other bowel inflammatory disorders, or autoimmune conditions) o diets with reduced sources of vitamin B12 (such as strict vegan and some vegetarian diets) o concomitant medication known to impair vitamin B12 absorption (including proton pump inhibitors or colchicine) o genetic predisposition to vitamin B12 deficiency, such as intrinsic factor receptor deficiency (Imerslund-Gräsbeck syndrome) and transcobalamin II deficiency.

Page 4 of 11 The formulary lists the most clinically and cost effective choices for prescribing in primary care

Sodium glucose co-transporter 2 (SGLT2) inhibitors

Indication
Type 2 diabetes without CKD See local guidance.

Empagliflozin
tabs 10mg, 25mg Green 1st line (NICE TA336 & TA390)

Type 2 diabetes with CKD Chronic heart failure with reduced ejection fraction
With insulin for treating Type 1 diabetes

Green Specialist initiation (NICE NG28) Green Specialist initiation (NICE TA679) see heart failure guideline -

Canagliflozin
tabs 100mg, 300mg GREY by exceptionality defined as intolerance to the preferred 1st line choice or restricted by their licensing (NICE TA315 & TA390) Green Specialist initiation (NICE NG28) -
-

Dapagliflozin
tabs 5mg, 10mg GREY by exceptionality defined as intolerance to the preferred 1st line choice or restricted by their licensing (NICE TA288 & TA390 & TA418) Green Specialist initiation (NICE TA775) Green Specialist initiation (NICE TA679) see heart failure guideline RED unlicensed

1. NICE NG28 type 2 diabetes in adults guideline (updated March 2022) recommends: based on the cardiovascular risk assessment for the person with type 2 diabetes
• If they have chronic heart failure or established atherosclerotic cardiovascular disease, offer an SGLT2 inhibitor with proven cardiovascular benefit in addition to metformin.
• If they are at high risk of developing cardiovascular disease, consider an SGLT2 inhibitor with proven cardiovascular benefit in addition to metformin.
2. The combination products dapagliflozin and metformin (Xigduo), canagliflozin and metformin (Vokanamet) and empagliflozin and metformin (Synjardy) have been classified as GREY. The combination products are cheaper than the separate components and may aid compliance; however they are limited by the inability to increase to the target metformin dose.
3. SGLT2 inhibitors used in type 2 diabetes may lead to ketoacidosis. Inform patients to seek immediate medical advice if they have signs and symptoms of DKA e.g., rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat. Test for raised ketones in patients with signs and symptoms of DKA and stop SGLT2 inhibitor treatment immediately if DKA suspected or diagnosed (MHRA April 2016).
4. SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured. MHRA March 2020
5. SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum). Rare but potentially life-threatening infection that requires urgent medical attention. MHRA February 2019.
6. Canagliflozin may increase the risk of lower-limb amputation in patients with type 2 diabetes (MHRA June 2016). Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect.

Sulfonylureas Gliclazide tabs 80mg
1. Gliclazide MR is GREY for patients with compliance problems requiring once daily dosing.

DPP-4 inhibitors (gliptins) Alogliptin tabs 6.25mg, 12.5mg, 25mg Linagliptin tabs 5mg

preferred 1st line DPP-4 inhibitor if alogliptin is restricted by renal/hepatic impairment

1. A review by MTRAC concluded that no significant differences were reported between the DPP-4 inhibitors with respect to blood-glucose lowering efficacy against other oral diabetic treatments.
2. Sitagliptin, saxagliptin, and vildagliptin have been classified as GREY by exceptionality defined as intolerance to the preferred choices or restricted by their licensing.
3. Patients treated with DPP-4 inhibitors should report any persistent, severe abdominal pain (sometimes radiating to the back). Discontinue DPP-4 inhibitor if pancreatitis is suspected (MHRA Sept 2012). DPP-4 inhibitors may also cause joint pain that can be severe and disabling, discontinuation of therapy with this class of drugs if severe and persistent joint pain occurs (FDA Aug 2015).

Page 5 of 11 The formulary lists the most clinically and cost effective choices for prescribing in primary care

Glucagon-like Peptide 1 (GLP-1) agonists Liraglutide 6mg/ml pre-filled pen (Victoza) Lixisenatide 20 microg for existing patient
1. Lixisenatide 10 microgram is DNP for new patients. (10 microgram strength discontinued) 2. Exenatide have been classified as GREY by exceptionality defined as intolerance to the preferred first line
choice or restricted by its license. 3. For patients who require a once weekly GLP1 preparations dulaglutide and semaglutide classified as
GREY alongside exenatide MR weekly preparation • If compliance is an issue or • If the patient requires regular visits from a nursing team to administer the drug. 4. Review after 6 months of initiation to ensure continuation is in line with NICE (HBA1c reduction of 1.0% and 3% weight loss if initial BMI above 35 (criteria has also been adopted locally for lixisenatide)). 5. Liraglutide (Saxenda) is RED as an adjunct to diet and exercise for weight loss management (NICE TA664). Prescribing for this indication is restricted to specialist tier 3 weight management service. Prescribe by brand. 6. Diabetic ketoacidosis has been reported in patients with type 2 diabetes on a combination of a GLP-1 receptor agonist and insulin who had doses of concomitant insulin rapidly reduced or discontinued. GLP-1 receptor agonists are not substitutes for insulin, and any reduction of insulin should be done in a stepwise manner with careful glucose self-monitoring. See MHRA June 2019. 7. Suliqua (insulin glargine + lixisenatide) has been classified as GREY specialist initiation and stabilisation of dosage, restricted for those patients struggling to manage multiple injections. Ongoing specialist support should be maintained for patients on this treatment. Prescriber must ensure the correct strength and number of dose steps are stated on the prescription.

Thiazolidinedione (glitazones) Pioglitazone tabs 15mg, 30mg, 45mg
1. Use of pioglitazone is associated with a small increased risk of bladder cancer. Healthcare professionals should be aware of new warnings and precautions for use in at-risk patients (MHRA Aug 2011)
2. Other known side effects and safety concerns include eye disorders, heart failure, oedema and increased risk of fractures. See pioglitazone prescribing statement.

6.1.4 Treatment of hypoglycaemia For further information refer to the BNF.
1. Dextrogel 40% gel is currently a cost-effective brand of glucose 40%

6.1.5 Treatment of diabetic nephropathy and neuropathy Refer to the neuropathic pain guideline

6.1.6 Diagnostic and monitoring agents for diabetes mellitus

See Blood Glucose monitoring meter formulary

Meter

Blood Glucose Test Strips

Category A : Patients with type 2

Tee2+

Tee2

diabetes or gestational diabetes

WaveSense Jazz

WaveSense Jazz

Category B: Patients with type 1 diabetes (T1DM) - All of which require access to ketone testing (not carb counting/ insulin pumps)

Wavesense Jazz Wireless CareSens Dual
Fora Advanced pro GD40
GlucoMen Areo 2k

WaveSense Jazz
CareSens PRO
Fora Advanced Pro GD40
GlucoMen Areo Sensor

Lancets
CareSens
AgaMatrix ultrathin
AgaMatrix ultrathin
CareSens

Ketone test strips N/A
KetoSens

Omnican Glucoject plus

Advanced pro GD40
GlucoMen Areo Ketone
Sensor

Page 6 of 11 The formulary lists the most clinically and cost effective choices for prescribing in primary care

Patients previously recommended Accu-Chek Aviva Expert Meter (Discontinued 2021)
(Previously Category C: Patients with T1DM who have been taught carbohydrate counting and require the inbuilt bolus calculator feature)

Advice following Accu-Chek Aviva Expert meter discontinuation:
1. People with T1DM but not on insulin pump or FreeStyle Libre - use any T1DM (Cat B) formulary choice meter and the My life app which can be found here: https://www.mylife-diabetescare.com/en-GB/products/therapy-
management/mylife-digital.html
2. People with T2DM who carb count- use any T2DM (Cat A) formulary choice meter and the My life app: https://www.mylife-diabetescare.com/en-
GB/products/therapy-management/mylife-digital.html.
3. Children and young people- please ask them to contact their diabetes specialist nurse for advice.

If none of the above meters are suitable use any meter with blood glucose test strips costing less than £9 for 50 for patients in Category A; costing less than £10 for 50 blood glucose and less than £10 for 10 ketone strips for patients in Category B.
In patients where the above lancets are unsuitable consider any lancets under £3 per 100 lancets. Safety lancets are designed so that the sharp retracts after use. These are primarily for the benefit of healthcare workers to avoid needle stick injury, NOT to be used by patients self-monitoring blood glucose. Unistik Touch is the recommended cost effective safety lancet.
1. NICE NG28 recommends do NOT routinely offer self-blood glucose monitoring (SBGM) for adults with type 2 diabetes. For details see local diabetes guidance.
2. NICE NG17 recommends type 1 diabetics should test their blood glucose at least 4 times a day and up to 10 times a day if any of the following apply: • Desired target HbA1c level is not achieved, • Frequency of hypoglycaemic episodes increases, • There is a legal requirement to do so (e.g., such as before driving , in line with DVLA guidance) • During periods of illness • Before, during and after sport • When planning pregnancy, during pregnancy and while breastfeeding • If there is a need to know blood glucose levels >4 times a day for other reasons (e.g., impaired awareness of hypoglycaemia, high-risk activities). Newly diagnosed patients with (or are suspected to have) type 1 diabetes may need to test for both ketones and glucose.
3. Blood glucose testing for people with diabetes who drive - see chapter 3 of “assessing fitness to drive – guide for medical professionals for the latest information.
4. Freestyle Libre is GREY after diabetic consultant/specialist initiation within a Derbyshire Diabetes service - see JAPC briefing
6.2.1 Thyroid Hormones See also shared care pathology guideline
Levothyroxine (thyroxine) tabs 25, 50, 75, 100 microgram (taken preferably 30 minutes before breakfast)
1. In the elderly, and in patients with significant ischaemic heart disease or long-standing profound hypothyroidism, thyroid hormones should be commenced at a low dose and increased very cautiously, since angina and arrhythmias can be precipitated on starting treatment. If the patient is very unstable, contact an endocrinologist for advice.
2. Local endocrinologists advise to use lower doses and taper up according to bio markers and QoL markers with an informed decision with the patient. They also recognise that NICE NG145 (2019) recommends consider starting dose for primary hypothyroidism in adults: • Age under 65 and no history of CVD: 1.6 micrograms/kg/day (rounded to nearest 25 micrograms) • Age 65 and over and adults with a history of CVD: 25-50 micrograms/day/with titration.
3. TSH level can take up to 6 months to normalise for people who had a very high TSH level before starting levothyroxine or a prolonged period of untreated hypothyroidism.
4. As levothyroxine (thyroxine) has a long half-life (about 7 days), full effects may not be seen for several weeks, and dosage adjustments should be made at 2-3 monthly intervals. Repeating thyroid function tests with a view to adjustment of replacement dosage any more frequently is inappropriate.
5. Follow up & monitoring for adults age 16 and over:
Page 7 of 11 The formulary lists the most clinically and cost effective choices for prescribing in primary care

• Primary hypothyroidism: TSH every 3 months until level stabilised within reference range then once a year; Consider FT4 if symptoms persist after starting levothyroxine
• Subclinical hypothyroidism (untreated or stopped levothyroxine treatment): consider measuring TSH and FT4 once a year if they have features suggesting underlying thyroid disease e.g., thyroid surgery or raised level of autoantibodies; otherwise, every 2-3 years.
6. A normal TSH may be found in patients with secondary hypothyroidism from pituitary disease – if clinically suspicious check FT4 level as well.
7. If pregnancy is being considered, a target TSH of the bottom end of the normal range, 0.4 to 2.0, is recommended. Refer to the endocrine antenatal service if further advice needed or if patient become pregnant (urgent thyroid testing required).
8. The effects of warfarin may be potentiated when thyroid hormones are started. 9. Liothyronine in combination with levothyroxine is AMBER - for existing patients following review of benefit by
an NHS endocrinologist and the treatment dose stabilised for 3 months. See shared care guideline. Liothyronine is classified as Do Not Prescribe (DNP) for new patients; RED when used as monotherapy for resistant depression and in doses which exceed 60 microgram per day. See local position statement. 10. Desiccated thyroid products are classified as Do Not Prescribe (DNP) e.g., Armour/ERFA/Nature thyroid. These are unlicensed products in the UK, derived from pig thyroid, and contain an excessive amount of LT3 in relation to L-T4 For further information see the Liothyronine position statement. 11. MHRA May 2021 Generic prescribing of levothyroxine remains appropriate for the majority of patients, and the licensing of these generic products is supported by bioequivalence testing. If a patient reports symptom(s) after changing their levothyroxine product, consider testing thyroid function. If a patient is persistently symptomatic after switching levothyroxine products, whether they are biochemically euthyroid or have evidence of abnormal thyroid function, consider consistently prescribing a specific levothyroxine product known to be well tolerated by the patient. If symptoms or poor control of thyroid function persist despite adhering to a specific product, consider prescribing levothyroxine in an oral solution formulation. Note levothyroxine oral solution is very expensive.
6.2.2 Antithyroid Drugs See also shared care pathology guideline
Carbimazole 5mg, 20mg tabs
1. Hyperthyroid patients should be referred. Carbimazole may be initiated in primary care pending a patient referred to the specialist. Check FBC and LFT before starting but not again during treatment unless there is a clinical suspicion of agranulocytosis or liver dysfunction. See UKMI drug monitoring.
2. Carbimazole: increased risk of congenital malformation, particularly when used in the first trimester and at doses above 15mg/day. Women of childbearing potential should use effective contraception during treatment with carbimazole. (MHRA Feb 2019)
3. Carbimazole: risk of acute pancreatitis. If acute pancreatitis occurs during treatment with carbimazole, immediately and permanently stop treatment. Re-exposure to carbimazole may result in life-threatening acute pancreatitis with a decreased time to onset. (MHRA Feb 2019)
4. Counsel patient to report signs and symptoms suggestive of infection, especially sore throat due to risk of neutropenia and agranulocytosis.
5. See UKMI drug monitoring in adults in primary care for baseline and on-going monitoring. 6. Hyperthyroid patients are generally more sensitive to oral anticoagulants; increased dosage of
anticoagulant may be necessary as the hyperthyroidism becomes controlled. Frequent review of INR is therefore recommended. 7. Specialist review of women on thyroid medication is recommended as early as possible in pregnancy.
6.3 Corticosteroids 6.3.1 Replacement Therapy
Fludrocortisone tabs 100 microgram
6.3.2 Glucocorticoid therapy
Prednisolone tabs 1mg, 5mg Dexamethasone tabs 500microg, 2mg Hydrocortisone tabs 10mg, 20mg
1. Corticosteroids should preferably be taken in the morning after breakfast.
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2. Plain prednisolone tablets can be crushed and dispersed in water for patient with swallowing difficulties. Prednisolone soluble tablets (5mg) are classified GREY restricted for use in patients with fine-bore tubes only. They are considerably more expensive than the plain tablets.
3. Hydrocortisone replacement therapy – doses are usually taken with the 3 main meals of the day to mimic the normal diurnal rhythm and to avoid insomnia because of late administration of hydrocortisone.
4. MHRA Dec 2018 Hydrocortisone muco-adhesive buccal tablets: should not be used off-label for adrenal insufficiency in children due to serious risks of insufficient cortisol absorption and life-threatening adrenal crisis.
5. Steroid warning cards should be carried by those on long term treatment, both replacement and therapeutic. Patients on replacement therapy should be fully educated about the need to increase dosage during intercurrent illness. Abrupt withdrawal of steroids following long term therapy (> 3 weeks) should be avoided.
6. National patient safety alert August 2020 - steroid emergency card to be issued by prescribers to help healthcare staff to identify appropriate patients and gives information on the emergency treatment if they are acutely ill, or experience trauma, surgery or other major stressors. Examples include patients who have received long-term course of glucocorticoids at ≥5mg prednisolone or equivalent; or 3 or more short courses of high-dose oral glucocorticoids within 12months. For further guidance on this see Exogenous steroids, adrenal insufficiency and adrenal crisis-who is at risk and how should they be managed safely.
7. Prolonged courses of corticosteroids can increase susceptibility to infection and serious infections can go unrecognised. Unless already immune, patients are at risk of severe chickenpox and should avoid close contact with people who have chickenpox or shingles. Precautions should also be taken against contracting measles.
8. Patients on or commencing high dose oral corticosteroid long-term (7.5mg or more per day prednisolone or its equivalent for 3 months or more) should be offered bone protection with bisphosphonate. See local osteoporosis guideline.
9. See BNF for information on initiating corticosteroids and equivalent doses. 10. Advise patients to report any blurred vision or other visual disturbances due to rare risk of central serous
chorioretinopathy with corticosteroids (MHRA Aug 2017).
6.4 Sex Hormones 6.4.1 Female Sex Hormones 6.4.1.1 Oestrogens and HRT See local menopause guideline.
6.4.1.2 Progestogens and progesterone receptor modulators
Norethisterone tabs 5mg
1. Ulipristal acetate (Esmya) 5mg tablets is classified as Do Not Prescribe (DNP) due to risk of serious liver injury- see MHRA February 2021. and MHRA March 2020. Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. Advise recent users to seek immediate medical attention if they develop signs and symptoms of liver injury and perform LFTs 2-4 weeks after stopping Esmya.
2. Micronised progesterone vaginal capsules (Utrogestan) are Green after consultant/ specialist initiation for the prevention of miscarriage as per NICE NG126 (off-label). GP may continue until 16 completed weeks of pregnancy. RED for the supplementation of luteal phase during assisted reproductive technology cycles.
6.4.2 Male Sex Hormones and Antagonists
Testosterone preparations for androgen deficiency follow consultant advice Finasteride tabs 5mg
1. Alpha blockers remain the drug of first choice for the medical management of benign prostatic hypertrophy (BPH). See section 7.4.1.
2. Choice of testosterone preparation should be based on cost-effectiveness and patient preference. 3. Dutasteride designated as GREY second line option to finasteride. Exceptional criteria being finasteride is
not tolerated or patient does not respond to it after an adequate trial. 4. Combodart is classified as Do Not Prescribe (DNP) as is significantly more expensive that the individual
components of dutasteride and tamsulosin. 5. Finasteride 1mg is classified as Do Not Prescribe (DNP) for male baldness.
6.4.3 Anabolic Steroids
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No drug is recommended for this section.
6.5 Hypothalamic and pituitary hormones and anti-oestrogens 6.5.1 Hypothalamic and anterior pituitary hormones and anti-oestrogens For growth hormones (Somatropin) follow shared care guideline All other drugs in this section are for specialist use only.
6.5.2 Posterior pituitary hormones and antagonists To be initiated after specialist advice
Desmopressin nasal spray 10 microgram/metered spray Desmopressin tabs 100, 200 microgram
1. GREEN for nocturnal enuresis and GREEN after specialist recommendation for diabetes insipidus. 2. Desmopressin tablets are expensive and should be reserved for those patients who have problems with
nasal preparations. The exception is primary nocturnal enuresis where only tablets are licensed. For prescribing advice see NICE CG 111 Bedwetting in under 19s. 3. See BNF for warning regarding hyponatraemic convulsions: Patients being treated for primary nocturnal enuresis should be warned to avoid fluid overload (limit fluid intake from 1 hour before until 8 hours after administration and avoid ingesting during swimming) and to stop taking desmopressin during an episode of vomiting and diarrhoea (until fluid balance normal). The risk of hyponatraemic convulsions can also be minimised by keeping the recommended starting doses and by avoiding concomitant use of drugs which increase secretion of vasopressin (e.g., tricyclics)
6.6 Drugs affecting bone metabolism 6.6.1 Calcitonin and parathyroid hormone No drug is recommended for this section.
6.6.2 Bisphosphonates and other drugs affecting bone metabolism See local osteoporosis and bisphosphonate treatment length guideline for further detail. Calcium + Vitamin D preparations are listed in Nutrition & blood formulary chapter .

Alendronic acid once-weekly tabs 70mg Risedronate once-weekly tabs 35mg

1st line alternative option

1. Patients should be made aware of the adverse reactions associated with oral bisphosphonates (MHRA Dec 2014, Dec 2015):
• Serious oesophageal reactions- ensure administration direction adhered to • Osteonecrosis of the jaw- ensure good oral hygiene & regular dental check up • Atypical fractures- report any thigh, hip, or groin pain • Osteonecrosis of external auditory canal (rare)- report any ear pain, discharge from ear or ear infection 2. Alendronic acid and risedronate should be taken whole on arising, on the same day each week on an empty stomach (at least 30 minutes before the first food, beverage or medicinal product of the day) with a full glass (not less than 200ml) of plain water only (not mineral water). Patients should be advised to stay fully upright for at least 30 minutes after swallowing the tablet. 3. Alendronic acid 70mg effervescent tablet (Binosto) is GREY for use in patients with dysphagia/long-term swallowing difficulties only. Patients with short-term swallowing difficulties should omit this treatment. Binosto should be fully dissolved in no less than 120ml of plain water and taken as per administration direction above. Patient should take 30ml of plain water after taking the dose. 4. Ibandronate 150mg monthly for osteoporosis is GREY due to lack of data on safety and effectiveness. 5. Ibandronate 50mg has been designated as GREEN after consultant/specialist initiation- use in postmenopausal women with breast cancer as per NICE NG101. Cost effective to prescribe generically. 6. Denosumab is AMBER for the prevention of osteoporotic fractures in post-menopausal women and men. SCG can be found here. Denosumab (Prolia): should not be used in patients under 18 years due to the risk of serious hypercalcaemia (MHRA May 2022) 7. Other drug treatments for osteoporosis include raloxifene (Green specialist initiation as per NICE TA161); teriparatide and zoledronate (zoledronic acid) which are classified RED. 8. Be aware that long-term treatment with some antiseizure medications (such as carbamazepine, phenytoin, primidone and sodium valproate) is associated with decreased bone mineral density and increased risk of osteomalacia. Follow the MHRA safety advice on antiepileptics: adverse effects on bone and consider vitamin D and calcium supplementation for people at risk.

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Derbyshire Medicines Management, Prescribing and Guidelines