6.0 Endocrine

Diabetes Blood Glucose Testing Patient Information Leaflet 2016 v6.pdf [pdf / 369KB]

06 Blood Glucose Mon itoring Guideline Nov 16.pdf [pdf / 294KB] 06 Blood Glucose Mon itoring Guideline Nov 16pdf

06 Blood Glucose Meters Range _Chart.pdf [pdf / 37KB]

06 East Lancs Diabetes Record card final june16.pdf [pdf / 932KB]

Diabetes care should be tailored to the needs and circumstances of individuals with diabetes, taking into account their personal preferences, comorbidities, risks from polypharmacy, and their ability to benefit from long‑term interventions because of reduced life expectancy. Such an approach is especially important in the context of multimorbidity. Reassess the person's needs and circumstances at each review and think about whether to stop any medicines that are not effective.

Structured education should be offered to all adults with type 2 diabetes and/or their family members or carers at and

around the time of diagnosis, with annual reinforcement and review. It should be explained to people that structured

education is an integral part of diabetes care.

The process for referrals to EMPOWER for structured diabetes education can be accessed here

It should be remembered that control of modifiable cardiovascular risk factors such as smoking cessation, lipids and

blood pressure are the most important interventions to be made in patients with type II diabetes.

Blood glucose management

In adults with type 2 diabetes, HbA1c levels should be measured at:

> 3 - 6 monthly intervals (tailored to individual needs), until the HbA1c is stable on unchanging therapy

> 6 monthly intervals once the HbA1c level and blood glucose lowering therapy are stable

For adults with type 2 diabetes they should be involved in decisions about their individual HbA1c target. Encourage

them to achieve the target and maintain it unless any resulting adverse effects (including hypoglycaemia), or their

efforts to achieve their target, impair their quality of life.

For adults with type 2 diabetes managed either by lifestyle and diet, or by lifestyle and diet combined with a single drug

not associated with hypoglycaemia, support the person to aim for an HbA1c level of 48 mmol/mol (6.5%).

For adults on a drug associated with hypoglycaemia, support the person to aim for an HbA1c level of 53 mmol/mol

(7.0%). 1.6.8In adults with type 2 diabetes, if HbA1c levels are not adequately controlled by a single drug and rise to

58 mmol/mol (7.5%) or higher:

> reinforce advice about diet, lifestyle and adherence to drug treatment and

> support the person to aim for an HbA1c level of 53 mmol/mol (7.0%) and intensify drug treatment.

Consider relaxing the target HbA1c on a case‑by‑case basis, with particular consideration for people who are older or

frail, for adults with type 2 diabetes:

> who are unlikely to achieve longer‑term risk‑reduction benefits, for example, people with a reduced life

expectancy

> for whom tight blood glucose control poses a high risk of the consequences of hypoglycaemia, for example,

people who are at risk of falling, people who have impaired awareness of hypoglycaemia, and people who drive or operate machinery as part of their job

> for whom intensive management would not be appropriate, for example, people with significant comorbidities.

If adults with type 2 diabetes achieve an HbA1c level that is lower than their target and they are not experiencing

hypoglycaemia, encourage them to maintain it. Be aware that there are other possible reasons for a low HbA1c level,

for example, deteriorating renal function or sudden weight loss.

For guidance on HbA1c targets for women with type 2 diabetes who are pregnant or planning to become pregnant, see

the NICE guideline on diabetes in pregnancy.

Initial Drug treatment

Standard-release metformin is the initial drug treatment for adults with type 2 diabetes.

The dose of standard‑release metformin should be gradually increased over several weeks to minimise the risk of gastrointestinal side effects. If an adult with type 2 diabetes experiences gastrointestinal side effects with standard‑release metformin then consider a trial of modified‑release metformin.

In adults with type 2 diabetes, review the dose of metformin if the estimated glomerular filtration rate (eGFR) is below 45 ml/minute/1.73m ² :

Stop metformin if the eGFR is below 30 ml/minute/1.73m 2 .
Prescribe metformin with caution for those at risk of a sudden deterioration in kidney function and those at risk of eGFR falling below 45 ml/minute/1.73m 2
If metformin is contraindicated or not tolerated, consider initial drug treatment with:
- a sulfonylurea or a dipeptidyl peptidase‑4 (DPP‑4) inhibitor or pioglitazone.

First intensification of drug treatment

In adults with type 2 diabetes, if initial drug treatment with metformin has not continued to control HbA1c to below the

person's individually agreed threshold for intensification, consider dual therapy with:

> metformin and a DPP‑4 inhibitor or

> metformin and pioglitazone [ 4 ] or

> metformin and a sulfonylurea.

In adults with type 2 diabetes, if metformin is contraindicated or not tolerated and initial drug treatment has not

continued to control HbA1c to below the person's individually agreed threshold for intensification, consider dual

therapy with:

> a DPP-4 inhibitor and pioglitazone or

> a DPP-4 inhibitor and a sulfonylurea or

> pioglitazone and a sulfonylurea

Treatment with combinations of medicines including sodium–glucose cotransporter 2 (SGLT‑2) inhibitors may be appropriate for some people with type 2 diabetes; see the NICE guidance on canagliflozin in combination therapy for treating type 2 diabetes, dapagliflozin in combination therapy for treating type 2 diabetes and empagliflozin in combination therapy for treating type 2 diabetes.

Second intensification of drug treatment

In adults with type 2 diabetes, if dual therapy with metformin and another oral drug has not continued to control HbA1c to below the person's individually agreed threshold for intensification, consider either:

triple therapy with:
- metformin, a DPP‑4 inhibitor and a sulfonylurea or
- metformin, pioglitazone [ 4 ] and a sulfonylurea or
starting insulin-based treatment
glucagon‑like peptide‑1 (GLP‑1) mimetic for adults with type 2 diabetes who:
- have a BMI of 35 kg/m 2 or higher (adjust accordingly for people from black, Asian and other minority ethnic groups) and specific psychological or other medical problems associated with obesity or
- have a BMI lower than 35 kg/m 2 and:

Only continue GLP‑1 mimetic therapy if the person with type 2 diabetes has had a beneficial metabolic response (a reduction of at least 11 mmol/mol [1.0%] in HbA1c and a weight loss of at least 3% of initial body weight in 6 months).

In adults with type 2 diabetes, if metformin is contraindicated or not tolerated, and if dual therapy with 2 oral drugs has not continued to control HbA1c to below the person's individually agreed threshold for intensification, consider insulin‑based treatment .

In adults with type 2 diabetes, only offer a GLP‑1 mimetic in combination with insulin with specialist care advice and ongoing support from a consultant‑led multidisciplinary team.

Treatment with combinations of medicines including SGLT‑2 inhibitors may be appropriate for some people with type 2 diabetes; see the NICE guidance on canagliflozin in combination therapy for treating type 2 diabetes, dapagliflozin in combination therapy for treating type 2 diabetes, dapagliflozin in triple therapy for treating type 2 diabetes and empagliflozin in combination therapy for treating type 2 diabetes.

6.1.1 Insulins

Patients starting on insulin should receive an insulin passport. For full details click here

6.1.1.1 Short-acting insulin

GREEN Human Actrapid®

GREEN Humulin S®

The insulin analogues have a faster onset and shorter duration of action than standard soluble insulin.

They should be injected immediately before or, when necessary, shortly after a meal.

GREEN Humalog® (insulin lispro)

GREEN NovoRapid®(insulin aspart)

GREEN Apidra® (insulin glulisine)

6.1.1.2 Intermediate and long-acting insulin

Intermediate

GREEN Insulatard®

GREEN Humulin I®

Long acting insulin

Long-acting recombinant human insulin analogues should be used in accordance with NICE guidance.

Biosimilars of insulin glargine 100 units/mL (Lantus®) are recommended for use in patients with type 1

and type 2 diabetes mellitus. The prescribing of biosimilar preparations should be by brand name,

followed by the concentration and recommended daily dose in units and a statement of the formulation.

Treatment should normally be started with the least expensive drug. The initiation of biosimilar insulins

should be in NEW patients or patients assessed to need a medication change, with close monitoring of

their blood glucose to ensure good control is achieved.

GREEN Abasaglar® (insulin glargine)

GREEN Lantus® (insulin glargine)

GREEN Levemir® (insulin detemir)

Toujeo is a High strength basal Insulin product it is Not bioequivalent to glargine or other insulins. Units

are exclusive to the potency of Toujeo®.

Dose adjustment is needed if switching patients to or from Toujeo®

Insulin glargine 300 units/mL (Toujeo®) is recommended as an option in adults with type 2 diabetes

mellitus (T2DM) only in accordance with the recommendations in NICE NG28 and in those who suffer

from symptomatic nocturnal hypoglycaemia whilst being treated with a first-line long-acting insulin

analogue. it is also recommended as an option in adults with type 1 diabetes mellitus in accordance

with NICE NG17 and in those patients who experience an unacceptable frequency and/or severity of

nocturnal hypoglycaemia on attempting to achieve better glycaemic control during treatment with first-

line long-acting insulin analogues; or as a once daily insulin therapy for patients who require assistance

with administering injections.

AMBER Toujeo® (insulin glargine)

Insulin Degludec (Tresiba®▼)
Recommended as an alternative treatment option in patients over the age of 1 year experiencing poor glycaemic control or recurrent hypoglycaemic episodes with existing long-acting basal insulin. to be initiated by diabetes specialist only.

AMBER Tresiba®▼ (insulin degludec)

Insulin degludec plus liraglutide (Xultophy®▼)
The combination product insulin degludec plus liraglutide (Xultophy®▼) is not recommended to treat type 2 diabetes mellitus (T2DM) to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone, or combined with basal insulin, do not adequately provide glycaemic control.

BLACK Xultophy®▼
Click here to access New Medicines Assessment for this product

Biphasic

GREEN Humulin M3®

GREEN Insuman Comb 25®

GREEN Humalog Mix25®, Humalog Mix50® (insulin lispro)

GREEN NovoMix 30®

Biphasic analogue insulins (e.g. Novomix, Humalog Mix) do not offer any advantage over conventional

human biphasic insulins in terms of efficacy, long term outcomes or safety but cost considerably more.

The above brands of insulin are recommended for new diabetics and are available in a variety of vial,

cartridge and pre-loaded pen presentations. The hospital pharmacy will keep stocks of other brands and

species for established diabetics. Insulin is usually available in 3mL cartridges, 10mL vials, and 3mL

disposable pens. Not all insulin cartridges fit all pens. Pens are available on prescription except

OptiPen® and HumaPen®.

The National Patient Safety Agency issued an alert in June 2010 for the safer administration of insulin.

Click here to access the full documents online.

GREEN Gliclazide tablets 80mg

GREEN Glimepiride tablets 1mg, 2mg, 4mg

GREEN Tolbutamide tablets 500mg

Glibenclamide and chlorpropamide are specifically not recommended and should not be

used due to the greater risk of hypoglycaemia, especially in the elderly.

GREEN Metformin tablets 500mg, 850mg

Review metformin dose when serum creatinine >130 micromol/litre or eGFR <45 ml/min/1.73 m2.
Stop metformin if serum creatinine >150 micromol/litre or eGFR <30 ml/min/1.73 m2.
Prescribe metformin with caution in those at risk of sudden deterioration of kidney function, or at risk of a decline of eGFR to <45 ml/min/1.73 m2.

Metformin Oral Solution SF

Use restricted to those with swallowing difficulties/enteral tube feeding

GREEN Metformin 500mg/5ml oral solution SF

Meformin Sustained Release (SR) Tablets

In patients in whom slow dose titration does not reduce GI adverse effects, metformin sustained release tablets should be used ONLY where intolerance to the immediate release preparation had been clearly documented and where it prevents continuation of metformin therapy. A review of the evidence on the use of sustained release metformin preparations did not find that their use in unselected patients reduced gastro-intestinal side effects.

Metformin sustained release tablets are supported purely as an attempt to ensure the largest number of patients are able to stay on metformin therapy, hopefully delaying progression to other new drugs which often have a reduced evidence base and/or additional safety concerns.

GREEN Metformin sustained release (SR)

tablets 500mg, 750mg, 1000mg

Repaglinide & Nateglinide

Repaglinide and nateglinide stimulate insulin release. They have a rapid onset of action and

short duration of activity, and only need to be taken at mealtimes (shortly before each

main meal). This makes them particularly useful alternatives to sulphonylureas for patients

with irregular meal patterns or lifestyles (where hypoglycaemia would otherwise pose a

risk).

Repaglinide may be given as monotherapy for patients who are not overweight or for those

in whom metformin is contra-indicated or not tolerated, or it may be given in combination

with metformin.

GREEN Nateglinide

tablets 60mg, 120mg, 180mg

GREEN Repaglinide

tablets 1mg, 2mg

Thiazolidinediones (Glitazones)

Glitazone Safety Concerns

Pioglitazone causes weight gain and increases the risk of heart failure (especially in combination with insulin). It may also worsen existing heart failure. Do not start or continue pioglitazone if the patient has current evidence or a history or heart failure, or is at a higher risk of fracture. If prescribing pioglitazone, warn about significant oedema and tell the patient what to do if this happens. Patients should be closely monitored for signs of heart failure.

There are no restrictions on the use of pioglitazone in acute coronary syndrome, ischaemic heart disease or peripheral arterial disease.

The European Committee on Medicinal Products for Human Use has recommended the suspension of the marketing authorisations of Rosiglitazone (Avandia®) and it's combination product with metformin (Avandamet®) across the European Union. Full details can be found under Drug Alerts & Withdrawals - Click Here

Pioglitazone to be prescribed in accordance with NICE guidance (CG87). LFT measurements are needed prior to treatment and periodically thereafter. It should be remembered that control of modifiable cardiovascular risk factors such as smoking cessation, lipids and blood pressure are the most important interventions to be made in patients with type II diabetes.

GREEN Pioglitazone tablets 15mg, 30mg, 45mg (generic only)

Intestinal alpha glucosidase inhibitor

Consider acarbose for a person unable to use other oral glucose-lowering medications.

Delays the digestion and absorption of starch and sucrose. Timing of doses is crucial:

tablets should be chewed or swallowed whole with the first mouthful of food.

GREEN Acarbose tablets 50mg, 100mg (Glucobay®)

Gliptins

GREEN Sitagliptin 25mg, 50mg,100mg tablets (Januvia®)

GREEN Linagliptin 5mg (Trajenta®)

GREEN Alogliptin 6.25mg, 12.5mg, 25mg tablets (Vipidia®)

Glucagon-like Peptide-1 agonists

Exenatide

It should be remembered that control of modifiable cardiovascular risk factors such as

lipids and blood pressure are the most important interventions to be made in patients

with type II diabetes.

Consider adding exenatide to metformin and a sulfonylurea if a person has:

a body mass index (BMI) ≥ 35 kg/m2 in those of European descent, with appropriate adjustment in tailoring this advice for other ethnic groups and other specific psychological or medical problems associated with high body weight
a BMI < 35 kg/m2 and for whom initiation of insulin therapy would have significant occupational implications, or where weight loss would benefit other significant comorbidities such as sleep apnoea.
Continue exenatide only if beneficial response occurs and is maintained (≥ 1.0 percentage point HbA1c reduction in 6 months and weight loss ≥ 5% at 1 year).

Exenatide is licensed for use with metformin, sulphonylurea and pioglitazone. Exenatide is not licensed for use with any other oral antidiabetic drug. Up to 50% of patients experience nausea and vomiting, and due to its effects on slowing gastric emptying, may interact with a variety of drugs including the contraceptive pill and antibiotics.

Exenatide 5mcg and 10mcg only is licensedas adjunct to basal insulin.

Exenatide 2mg is a long acting formulation administered once a week

GREEN Exenatide pre-filled pen 5 micrograms, 10 micrograms (Byetta®)

Exenatide 2mg vial with solvent (Bydureon®)

Liraglutide

Liraglutide is a treatment option for patients whose diabetes is not controlled with

Metformin, and or sulphonylure and/or glitazone. Patients prescribed liraglutide should be

regularly reviewed and treatment should be in line with the recommedations of NICE NG28 (replaced TAG203): only continue liraglutide if reduction in HbA1c of at least 1 percentage point and weight loss of at least 3% of initial body weight at 6 months. Liraglutide should only be used at a maximum dose of 1.2mg daily, the 1.8mg/day dose should not be used.

GREEN Liraglutide pre-filled pen 18mg (Victoza®)

Lixisenatide

Lixisenatide is a treament option for all patients when a licensed GLP-1 mimetic is clinically

indicated in line with SMC recommendation.

GREEN Lixisenatide pre-filled pen (Lyxumia®)

50 micrograms/mL (10 micrograms/dose)

100 micrograms/mL,(20 micrograms/dose)

Dulaglutide

Appropriate for initiation and ongoing prescribing in both primary and secondary care

when prescribed in the following clinical circumstances (see NICE NG28):

> after second intensification of therapy fails to achieve targets combined with

metformin and a sulfonylurea if the patient:

> has a BMI of >35kg/m2 and specific psychological or other medicinal

problems associated with obesity (adjust accordingly for people from black,

Asian and other minority ethnic groups) or

> has a BMI <35kg/m2 and

> if insulin therapy would have significant occupational implications or
> if weight loss would benefit other significant obesity related comorbidities
Or, with specialist care advice and on going support from a consultant-led multidisciplinary
team:

> combined with insulin at second intensification of treatment in patients who cannot take metformin

Dulaglutide may only be continued if the person has a beneficial metabolic response, defined as follows:

a reduction of HbA1c by at least 11 mmol/mol [1.0%] and
a weight loss of at least 3% of initial body weight in 6 months

GREEN Dulaglutide (Trulicity®)

0.75mg/0.5mL solution for injection/pre-filled pen

1.5mg/0.5mL solution for injection/pre-filled pen

SGLT2 Inhibitors NICE technology appraisals guidance (TA390)

Canagliflozin (Invokana,), Dapagliflozin (Forxiga,) and Empagliflozin (Jardiance,) are all selective sodium‑glucose cotransporter 2 (SGLT‑2) inhibitors, which block the reabsorption of glucose in the kidneys and promote excretion of excess glucose in the urine. Through this mechanism these drugs may help control glycaemia independently of insulin pathways.

They all have UK marketing authorisations for treating type 2 diabetes to improve glycaemic control in adults:

as monotherapy: when diet and exercise alone do not provide adequate glycaemic control in people for whom the use of metformin is considered inappropriate due to intolerance or contraindications
as add‑on combination therapy: with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Dapagliflozin reversibly inhibits sodium-glucose co-transporter 2 (SGLT2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion. Dapagliflozin is not recommended for people with moderate to severe renal impairment (people with a creatinine clearance rate of less than 60 ml/min or an eGFR of less than 60 ml/min/1.73 m2). For full details of adverse reactions and contraindications, see the summary of product characteristics.

GREEN Dapagliflozin (as propanediol monohydrate)

5 mg, 10 mg tablets (Forxiga®)

Canagliflozin

The recommended starting dosage of canagliflozin is 100 mg orally once daily. In people

tolerating canagliflozin 100 mg once daily who have an estimated glomerular filtration rate

(eGFR) of at least 60 ml/minute/1.73 m² or creatinine clearance of at least 60 ml/minute

and who need tighter glycaemic control, the dose can be increased to 300 mg once daily.

For people with renal impairment, canagliflozin should not be started in people with an

eGFR of less than 60 ml/minute/1.73 m² or creatinine clearance of less than 60 ml/minute.

In people tolerating canagliflozin whose eGFR persistently falls below 60ml/minute/1.73m²

or whose creatinine clearance persistently falls below 60 ml/minute, the dose of

canagliflozin should be adjusted to or maintained at 100 mg once daily. Canagliflozin

should be discontinued when eGFR is persistently below 45 ml/minute/1.73 m² or

creatinine clearance is persistently below 45 ml/minute..

A signal of increased lower limb amputation (primarily of the toe) in people taking

canagliflozin compared with placebo in a clinical trial in high cardiovascular risk

patients is currently under investigation. Click here for prescribing advice.

GREEN Canagliflozin

100mg, 300 mg, tablets (Invokana®) as an option for Dual or Triple Therapy.

Empagliflozin

The recommended starting dosage is 10 mg orally once daily for monotherapy. The dose

can be increased to a maximum of 25 mg daily for people who tolerate empagliflozin well

and need tighter glycaemic control, if they have an eGFR of 60 ml/min/1.73 m² or more.

GREEN Empagliflozin

10mg, 25mg tablets (Jardiance®)

6.1.4 Treatment of hypoglycaemia

In the unconscious diabetic glucagon is an alternative to IV glucose 50%.

GREEN Glucagon injection 1 mg (GlucaGen® HypoKit)

6.1.6 Diagnostic and monitoring devices for diabetes mellitus

Blood Monitoring

A patient information leaflet on self-testing can be found here

Blood glucose monitoring using a meter gives a direct measure of the glucose concentration at the time of the test and can detect hypoglycaemia as well as hyperglycaemia. Patients should be properly trained in the use of blood glucose monitoring systems and be empowered to take appropriate action on the results obtained. Inadequate understanding of the normal fluctuations in blood glucose can lead to confusion and inappropriate action.

A range of meters have been evaluated and approved locally for adults with Type 2 diabetes. These meters are:

TEE 2
Contour Next
Contour XT
Contour Next USB
Contour Next Link
CareSens N
CareSens N POP
CareSens N Voice

TEE 2

Following a comprehensive evaluation of blood glucose meters undertaken by the Greater Manchester Medicines Management Group which engaged with patients and reviewed a whole range of meters according to NICE guidance and ISO standards. The meter that scored the highest in terms of quality was the TEE2 meter. It was agreed to add the TEE2 meter to formulary as first line choice for ALL Type 2 diabetic patients.

The Contour Next meter is a choice for Type 1 diabetics and those patients with low haematocrit levels.

It is recognised that paediatric patients and certain Type 1 diabetics may require meters with additional functions such as carb counting and compatibility with Ketone test strips. A range of additional blood glucose testing meters that fulfil such criteria are therefore available for these specific patients. To see the agreed list of appoved meters and associated functions click here.

Accucheck Expert has been approved for use by paediatric patients only as it allows greater flexibility with respect to the incremental dosing that is often required for these patients.

The choice of meter should be governed by individual need and suitability following a discussion with a clinician. For all paediatric patients the meter and initial supply of consumables will be made by the specialist service.

In all instances of blood glucose monitoring a testing regimen should be agreed with the patient and must include the frequency of testing. This should be recorded in the patient's written management plan.

For Type 2 diabetics that are diet controlled or on metformin alone then routine testing of blood glucose is NOT indicated.

CLICK here to download the Guide to Blood Glucose Monitoring Patient Information Leaflet

TEE2, CareSens N, Contour Next are the formulary test strips of choice in the following patient groups.

Type 1 or 2 diabetics on insulin alone
Type 1 or 2 diabetics on insulin + oral therapy
Gestational Diabetes
Those under the care of a secondary care/intermediate care specialist e.g. renal
patients with low haematocrit levels

GREEN TEE 2

GREEN CareSens N

GREEN Contour Next

GREEN Universal fit insulin pen needles

Insupen
GlucoRX finepoint
Omnican Fine

*Note - Omnican needles do not have an inner cap. This is simply to promote single use of the needles and prevent patients recaping the needle to use again. The Omnican needle can be safely disposed of by screwing the plastic case back on to the needle and screwing it off the insulin pen.

(A formulary review exercise will be undertaken in 12 months time)

Ketone Testing

Ketone testing is occasionally required for some patients for example pregnant women, patients with recent/frequent DKA, those under 17 years of age. All Type 1 diabetic patients should be offered the option to test for Ketones as part of Dose Adjustment For Normal Eating Type 1 education programme. (DAFNE).

Patients required to self-test for ketones should be identified by the diabetes specialist service and they are responsible for making the initial supply of consumables and providing a meter. The service should provide the patient with structured, meaningful education on the use of the device including what action to take depending on the readings obtained. It may be necessary for primary care to repeat prescribe such strips. The use must be carefully monitored and it is not expected that this will exceed more than one pack per year, with the exception of insulin pump patients.

In East Lancashire the Ketone testing strip of choice is FreeStyle Optium β Ketone test strip which is compatible with either a FreeStyle Optium Neo or FreeStyle Optium meter. Please note that these machines are reserved for Ketone testing only. Patients will also need to be issued with an additional formulary choice glucose meter if they are required to self-monitor their blood glucose.

GREEN FreeStyle Optium β Ketone

EU directive 2010 – to prevent sharps injury

This directive required organisations to put measures in place to improve safety in advance of the legislation which came into force 11 May 2013. Such measures include assessing the risk or occurrence of sharps injuries to health care workers, reviewing procedures and changing to safety engineered devices where practicable to do so.

Existing insulin pen needles remain exposed after insulin administration. Insulin syringes also have exposed needles after use. To prevent sharps injury the following devices should be prescribed if the patient is having their insulin administered by a community nurse or other healthcare professional:

BD AutoShield™ Duo is a second generation safety pen needle. The product contains two protective shields at both the patient and non-patient ends of the pen needle. Both shields will automatically lock after the injection to prevent accidental needle stick injuries on both sides of the needle. Order:

GREEN BD AutoShield™ Duo Safety Engineered / 5mm / 30G / Pip Code 360-5615 / FTR1083

6.2.1 Thyroid hormones

GREEN Levothyroxine tablets 25, 50, 100 microgram

RED Liothyronine injection 20 microgram (hospital use only in thyroid emergencies)

BLACK Armour Thyroid link to UKMi Clinical evidence

BLACK Liothyronine tablets/capsules

6.2.2 Antithyroid drugs

Carbimazole is the drug of choice, with propylthiouracil used for patients with sensitivity to carbimazole or in pregnancy. Warn patients that if a sore throat develops in the first 6 - 8 weeks of therapy they should stop treatment and seek medical advice.

GREEN Carbimazole tablets 5mg, 20mg

GREEN Propylthiouracil tablets 50mg

Partial thyroidectomy

Iodine may be given for 10 - 14 days before surgery.

RED Aqueous iodine oral solution 100mL (Lugol’s solution)

Equivalent anti-inflammatory doses of corticosteroids:

Prednisolone 5mg

Betamethasone 750 microgram

Cortisone Acetate 25mg

Deflazacort 6mg

Dexamethasone 750 microgram

Hydrocortisone 20mg

Methylprednisolone 4mg

Triamcinolone 4mg

6.3.1 Replacement therapy

A combination of hydrocortisone and the mineralocorticoid fludrocortisone are needed in primary adrenal deficiency states.

GREEN Fludrocortisone tablets 100 microgram

6.3.2 Glucocorticoid therapy

The proportions of glucocorticoid to mineralocorticoid activity determine the uses of these corticosteroids:

Glucocorticoid and mineralocorticoid activity

These are suitable for adrenal replacement therapy and as injection for emergency management of some conditions.

GREEN Hydrocortisone

tablets 10mg, 20mg

RED Hydrocortisone sodium succinate injection 100mg

Glucocorticoid activity mainly

Most common corticosteroid for long term disease suppression.

GREEN Prednisolone

tablets 1mg, 5mg, 25mg

(N.B- the 5mg tablets will disperse in water.)

tablets e/c 2.5mg

High glucocorticoid activity with insignificant mineralocorticoid activity

Suitable for high dose therapy when water retention would be a disadvantage.

GREEN Betamethasone tablets 500 microgram

RED Betamethasone injection 4mg/mL

GREEN Dexamethasone

tablets 500 microgram, 2mg

oral solution 2mg/5mL

RED Dexamethasone injection 8mg/2mL

Other corticosteroid preparations

RED Methylprednisolone injection 500mg, 1g (Solu-Medrone®)

GREEN Methylprednisolone acetate injection 40mg/mL (Depo-Medrone®)

GREEN Triamcinolone injection 40mg/mL

Deflazacort

Deflazacort may only be initiated by a paediatrician for the management of Duchenne Muscular Dystrophy. Deflazacort

should only be used for patients in whom oral prednisolone is not tolerated due to cushingoid side effects. Treatment

is likely to be long term and prescribers should continue to monitor patients for side effects routinely (especially

asymptomatic cataracts and weight gain). Therapy may be transferred to the primary care prescriber (following prior

agreement) once therapy has been initiated by the specialist. Duration of treatment and dose adjustments should be

clearly communicated at regular intervals.

AMBER Deflazacort tablets 1mg, 6mg, 30mg

6.4.1 Female sex hormones

6.4.1.1 Oestrogens and HRT

Guidance is given below on the type of product required in different situations. The choice of actual

preparation (tablet, patch, gel) to remain with the prescriber bearing in mind patient preference and the

cost differences between the preparations.

Note: HRT should only be used for osteoporosis prevention in patients where other therapies are contra-

indicated, not tolerated, or there is a lack of response. This should ideally be under the direction of a

specialist.

Women with uterus

Sequential preparations for patients with an intact uterus & perimenopausal i.e. have not yet had 1 year amenorrhoea.

GREEN 1st line Elleste Duet 1mg, 2mg

(Estradiol / norethisterone combination)

GREEN 2nd line Femoston 1/10, 2/10

(Estradiol / dydrogesterone combination)

GREEN 3rd line Prempak-C 0.625, 1.25

(Conjugated oestrogens/ norgestrol combination)

Continuous combined preparations for period free HRT, should only to be used in patients who are

amenorrhoeic for 1 year or over 54 years if currently on sequential preparation.

GREEN 1st line Elleste-Duet Conti

(Estradiol/ norethisterone continuous 'no bleed' combination)

GREEN 2nd line Femoston-Conti

(Estradiol/ norethisterone continuous 'no bleed' combination)

GREEN 3rd line Premique

(Conj. oestrogens/ medroxyprogesterone continuous 'no bleed' combination)
BLACK 0.45mg conjugated oestrogens & Bazedoxifene
(click here for New Medicines Recommendation)

HRT should be trialled for 4 months and reviewed. If progesterone side effects are reported consider

switching to Femoston products. If oestrogen side effects are reported switch to Prempak-C/ Premique. If

side effects of both are severe, consider transdermal patches (Evorel Sequi or Evorel Conti)

HRT patches should be reserved for use in patients with diabetes, liver disease or severe side effects.

GREEN Evorel Sequi 50,and 50/170 micrograms in 24 hours

(Estradiol/ norethisterone sequential combination)

GREEN Evorel Conti 50/170 micrograms in 24 hours

(Estradiol/ norethisterone continuous 'no bleed' combination)

Women without uterus Unopposed oestrogen is used for patients with hysterectomy, however in endometriosis, endometrial foci may remain and the use of combination preparations should be considered.

GREEN 1st line Elleste Solo 1mg, 2mg

(Estradiol)

GREEN 2nd line Premarin 0.625, 1.25

(Conjugated oestrogens)

HRT patches should be reserved for use in patients with diabetes, liver disease or severe side effects.

GREEN Evorel 25, 50, 75, 100 (micrograms in 24 hours)

(Estradiol)

Where patches are not tolerated but symptoms of menopause require treatment, estradiol gel is an option.

GREEN Estradiol gel (Sandrena), 500mcg/sachet & 1mg/sachet

Tibolone

Tibolone increases the risk of breast cancer recurrence in women with a history of breast cancer. Tibolone should not be used in women with known or suspected breast cancer, or in those with a history of breast cancer. It should be used for loss of libido only.

GREEN Tibolone tablets 2.5mg

6.4.1.2 Progestogens and progesterone receptor modulators

GREEN Medroxyprogesterone tablets 5mg,10mg

GREEN Norethisterone tablets 5mg

GREEN Progesterone pessaries 200mg, 400mg

AMBER Ulipristal tablets 5mg (Esmya®)

Click here to download recommendation for use of ulipristal for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

6.4.2 Male sex hormones and antagonists

Used for replacement therapy in pituitary or testicular disease. NOT licensed or indicated for use in increasing libido

AMBER Testosterone

esters injection (Sustanon 100®, Sustanon 250®)

depot injection 250mg/mL (Nebido®)

transdermal gel 50mg/5gram sachet (Testogel®)

transdermal gel 20mg/1gram pump dispenser (Tostran®)

(One press of the canister piston delivers 0.5 g of gel containing 10 mg testosterone).

The dose should be applied either to the abdomen, or spread over both inner thighs.

Anti-androgens

Finasteride is used for benign prostatic hyperplasia, cyproterone is used for severe hypersexuality and

sexual deviation in males, and to treat hyperandrogenism in women with polycystic ovary syndrome

(unlicensed).

GREEN Cyproterone tablets 50mg (Androcur®)

GREEN Finasteride tablets 5mg

Dutasteride

Consultant Urologist initiation only then primary care prescribing. Only to be used for 1 years treatment, when patients should be reviewed by the consultant urologist to either stop dutasteride, switch to finasteride, or progress to other management strategies and this communicated to the GP. Dutasteride is restricted for a high risk patient group, used in combination with tamsulosin in patients with moderate to severe symptoms (IPSS>12) with larger prostates (>30cc) and elevated PSA (>1.5ng/mL).

)AMBER Dutasteride capsules 500mcg (Avodart®)

6.5.1 Hypothalamic and anterior pituitary hormones and anti-oestrogens

Clomifene is used in the treatment of female infertility. The gonadatrophins found in this section (but not listed) are only used by specialist centres who should retain all the prescribing – GPs should not be asked to prescribe.

RED Clomifene tablets 50mg

RED All gonadatrophins listed in section 6.5.1 of the BNF

Corticotrophins RED Tetracosactide 250microgram injection (Synacthen®)

RED Tetracosactide 1mg depot injection (Synacthen depot®)

Growth hormone

In line with NICE guidelines for adults and children.

AMBER Somatropin injection

(all brands included within section 6.5.1 of the BNF - Omnitrope is the least costly brand)

Growth hormone receptor antagonists

Only to be initiated and prescribed by tertiary referral centres

RED Pegvisomant (Somavert®)

6.5.2 Posterior pituitary hormones and antagonists

Desmopressin

Desmopressin is a synthetic analogue of vasopressin, and is indicated for treatment of primary nocturnal enuresis (PNE); nocturia associated with multiple sclerosis when other treatments have failed; and diagnosis and treatment of vasopressin-sensitive cranial diabetes insipidus; it is also indicated for establishment of renal concentration capacity.

At the request of the MHRA, the indication for the treatment of primary nocturnal enuresis (PNE) has been removed from all desmopressin nasal spray products. Desmopressin nasal sprays remain available for the treatment of patients with cranial diabetes insipidus or nocturia associated with multiple sclerosis. In comparison with oral formulations of desmopressin, nasal forms were associated with the majority of serious adverse drug reactions (ADRs) reported in patients with PNE.

Rare, serious ADRs included hyponatraemia, water intoxication and convulsions. As the risk benefit profile of the oral formulations is more favourable than the nasal spray, the nasal form should no longer be used for the treatment of PNE in adults and children.

Treatment of primary nocturnal enuresis (PNE)

GREEN Desmopressin tablets 100, 200 microgram

oral lyphilisate 120microgram (Desmomelt®)

NB- 120microgram melt is equivalent to 200 microgram oral tablet)

BLACK Nasal spray 10microgram/metered spray (see notes above)

Used for diagnosis and treatment of pituitary diabetes insipidus

GREEN Desmopressin tablets 100, 200 microgram

oral lyphilisate 120microgram (Desmomelt®)

(NB- 120microgram melt is equivalent to 200 microgram oral tablet)

nasal spray 10microgram/metered spray (see notes above)

RED Desmopressin injection 4 microgram/mL

Used for bleeding oesophageal varices

RED Terlipressin injection 1mg

Used for treatment of hyponatraemia associated with inappropriate secretion of anti-diuretic hormone

AMBER Demeclocycline 150mg capsules

Autosomal dominant polycystic kidney disease

Tolvaptan for treating autosomal dominant polycystic kidney disease is recommended as an option in NICE TA358

RED Tolvaptan (Jinarc®)

tablets 15mg, 30mg,45mg, 60mg, 90mg

Management of Patients Receiving Treatment with Bisphosphonates

Treatment of Osteonecrosis of the Jaw

RED Pentoxyfylline tablets (off licence use, consultant use only)

RED Vitamin E tablets (off licence use, consultant use only)

Osteoporosis occurs most commonly in postmenopausal women and in those taking long-term oral corticosteroids (glucocorticosteroids). Other risk factors for osteoporosis include low body weight, cigarette smoking, excess alcohol intake, lack of physical activity, family history of osteoporosis, and early menopause.

Those at risk of osteoporosis should maintain an adequate intake of calcium and vitamin D and any deficiency should be corrected by increasing dietary intake or taking supplements

See section 9.5.1.1 for calcium and 9.6.4 for vitamin D replacement.

The treatment of corticosteroid-induced osteoporosis

To reduce the risk of osteoporosis, doses of oral corticosteroids should be as low as possible and courses of treatment as short as possible. The risk of osteoporosis may be related to cumulative dose of corticosteroids; even intermittent courses can therefore increase the risk. The greatest rate of bone loss occurs during the first 6-12 months of corticosteroid use and so early steps to prevent the development of osteoporosis are important. Long-term use of high-dose inhaled corticosteroids may also contribute to corticosteroid-induced osteoporosis.

Patients taking (or who are likely to take) a corticosteroid for 3 months or longer should be assessed and where necessary given prophylactic treatment; those aged 65 years are at a greater risk. Patients taking oral corticosteroids who have sustained a low-trauma fracture should receive treatment for osteoporosis. The therapeutic options for prophylaxis and treatment of corticosteroid-induced osteoporosis are the same.

First Line Bisphosphonate

GREEN Alendronate tablets 70mg once weekly + prescribe Adcal D3 1 tab twice daily

An effervescent formulation of alendronic acid , for specific patients with swallowing difficulties, is available as an alternative to improve compliance. Consultant initiation only.

AMBER Alendronic acid effervescent tablets 70mg (Binosto®)

Second Line Bisphosphonate

GREEN Risedronate tablets 35mg once weekly + prescribe Adcal D3 1 tab twice daily tablets 5mg daily + prescribe Adcal D3 1 tab twice daily

Third Line Bisphosphonate

GREEN Disodium Etidronate 400mg + Calcium Carbonate eff 1.25g (Didronel PMO®)

6.6.1 Calcitonin and teriparatide

Calcitonin

Calcitonin is sometimes used in patients with hypercalcaemia of malignancy.

RED Calcitonin (Salmon)/Salcatonin injection 50 units/ml

Teriparatide (NICE TA161)

Teriparatide is recommended as an alternative treatment, after Alendronate, Risedronateand Raloxifene have been considered, for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:

who are unable to take alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined in section 2), or who have an insatisfactory response (as defined in section 3) to treatment with alendronate, risedronate or etidronate and
who are 65 years or older and have a T-score of -4.0 SD or below, or a T-score of -3.5 SD or below plus more than two fractures, or who are aged 55 - 64 years and have a T-score of -4 SD or below plus more than 2 fractures.

1. For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

2. For the purposes of this guidance, intolerance of alendronate, risedronate or etidronate is defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly.

3. For the purposes of this guidance, an unsatisfactory response is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline.

NB. Teriparatide for the treatment of osteoporosis in men at increased risk of fragility fractures has a BLACK traffic light.

RED Teriparatide pre-filled pen 750microgram/3mL

6.6.2 Bisphosphonates and other drugs affecting bone metabolism

NICE guidance for the PRIMARY prevention of osteoporotic fragility fractures in postmenopausal women (NICE TA160)

Guidance This guidance relates only to treatments for the primary prevention of fragility fractures in postmenopausal women who have osteoporosis. Osteoporosis is defined by a T-score of -2.5 standard deviations (SD) or below on dual-energy X-ray absorptiometry (DXA) scanning (T-score relates to the measurement of bone mineral density (BMD) using central (hip and/or spine) DXA scanning, and is expressed as the number of standard deviations (SD) from peak BMD). However, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible.

This guidance assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and vitamin D supplementation should be considered.

This guidance does not cover the following:

The treatment of women who have sustained a clinically apparent osteoporotic fragility fracture (for recommendations for the treatment of women with a prior osteoporotic fragility fracture, see below for the NICE guidance for the secondary prevention of osteoporotic fragility fractures in postmenopausal women).
The use of alendronate, etidronate, risedronate or ralifoxene for the primary prevention of osteoporotic fragility fractures in women with normal bone mineral density (BMD) or osteopenia (that is, women with a T-score between -1 and -2.5 SD below peak BMD).

Alendronate

Alendronate is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in the following groups:

Women aged 70 years or older who have an independent clinical risk factor for fracture or an indicator of low BMD (see section 6 below) and who are confirmed to have osteoporosis (that is, a T-score of - 2.5 SD or below). In women aged 75 years or older who have two or more independent clinical risk factors for fracture or indicators of low BMD, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
Women aged 65-69 years who have an independent clinical risk factor for fracture and who are confirmed to have osteoporosis (that is, a T-score of - 2.5 SD or below).
Postmenopausal women younger than 65 years who have an independent clinical risk factor for fracture and at least one additional indicator of low BMD and who are confirmed to have osteoporosis (that is, a T-score of - 2.5 SD or below).

When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available

First Line Bisphosphonate

GREEN Alendronate tablets 70mg once weekly + prescribe Adcal D3 1 tab twice daily

Apart from alendronate, no other bisphosphonate (or any other treatment) should be initiated first line for primary or secondary prevention of osteoporosis.

An effervescent formulation of alendronic acid , for specific patients with swallowing difficulties, is available as an alternative to improve compliance. Consultant initiation only.

AMBER Alendronic acid effervescent tablets 70mg (Binosto®)

Risedronate Risedronate (and etidronate) are recommended as alternative treatment options for the primary prevention of osteoporotic fragility fractures in postmenopausal women:

who are unable to comply with the special instructions for the administration of alendronate, or have a contraindication to or are intolerant of alendronate and
who also have a combination T-score, age and number of independent clinical risk factors for fracture as indicated in the following table.

T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate cannot be taken

If a woman aged 75 years or older who has two or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.

In deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients.

Second Line Bisphosphonate

GREEN Risedronate tablets 35mg once weekly + prescibe Adcal D3 1 tab twice daily tablets 5mg daily + prescribe Adcal D3 1 tab twice daily

Strontium ranelate - removed from formulary after recent EMA recommendations.

Raloxifene

NICE guidance TA160 for the primary prevention of osteoporotic fragility fractures in postmenopausal women, does not recommended Raloxifeneas a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women.

Denosumab

NICE TA204 - Denosumab for the prevention of osteoporotic fractures in postmenopausal women

1. Denosumab is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures:

who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or contraindication to, those treatments and

who have a combination T-score1, age and number of independent clinical risk factors for fracture (see section 3) as indicated in the following table.

T-scores (SD) at (or below) which denosumab is recommended when alendronate and either risedronate or etidronate are unsuitable

1. T-score measures bone mineral density using central (hip and/or spine) dual-energy X-ray (DXA) scanning, and is expressed as the number of standard deviations (SD) below peak bone mineral density.

2. Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments.

3. For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of more than 4 or more units per day, and rheumatoid arthritis.

4. People currently receiving denosumab for the primary or secondary prevention of osteoporotic fragility fractures who do not meet the criteria specified above should have the option to continue treatment until they and their clinician consider it appropriate to stop.

Denosumab 60mg to be administered as single subcutaneous injection once every 6 months into the thigh, abdomen or back of arm.

The patient must be adequately supplemented with calcium & vitamin D

Clinical monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia or patients with severe renal impairment (creatinine clearance < 30ml/min).

SHARED CARE Denosumab injection, pre-filled syringe 60mg (Prolia®)

click here for Shared Care Agreement.

NICE TA265 - Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours

Denosumab is recommended as an option for preventing skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from breast cancer and from solid tumours other than prostate if:

bisphosphonates would otherwise be prescribed and
the manufacturer provides denosumab with the discount agreed in the patient access scheme.

RED Denosumab injectionpre-filled syringe 120mg (XGEVA®)

6.6.2 Bisphosphonates and other drugs affecting bone metabolism

NICE guidance for the SECONDARY prevention of osteoporotic fragility fractures in post menopausal women (NICE TA161)

Guidance This guidance relates only to treatments for the secondary prevention of fragility fractures in postmenopausal women who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture. Osteoporosis is defined by a T-score of - 2.5 standard deviations (SD) or lower on dual-energy X-ray absorptiometry (DXA) scanning (T-score relates to the measurement of bone mineral density (BMD) using central (hip and/or spine) DXA scanning and is expressed as the number of standard deviations (SD) from peak BMD). However, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible.

This guidance assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and/or vitamin D supplementation should be considered.

This guidance does not cover the following:

The use of alendronate, etidrobate, risedronate, raloxifen or teriparatide for the secondary prevention of osteoporotic fragility in women with normal bone mineral density (BMD) or osteopenia (that is, women with a T-score between -1 and-2.5 SD below peak BMD)

Alendronate Alendronate is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis (that is, a T-score of - 2.5 SD or below). In women aged 75 years or older, a DXA scan may not be required if the responsible clinician considers it to be inappropriate or unfeasible.

When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.

First Line Bisphosphonate

GREEN Alendronate tablets 70mg once weekly + prescribe Adcal D3 1 tab twice daily

Apart from alendronate, no other bisphosphonate (or any other treatment) should be initiated first line for primary or secondary prevention of osteoporosis.

An effervescent formulation of alendronic acid , for specific patients with swallowing difficulties, is available as an alternative to improve compliance. Consultant initiation only.

AMBER Alendronic acid effervescent tablets 70mg (Binosto®)

Risedronate Risedronate (and etidronate) are recommended as alternative treatment options for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:

who are unable to comply with the special instructions for the administration of alendronate, or have a contraindication to or are intolerant of alendronate (as defined in section 7 below) and
who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see section 6 below) as indicated in the following table.

T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate cannot be taken

_a = Treatment with risedronate or etidronate is not recommended.

If a woman aged 75 years or older has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.

In deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients.

Second Line Bisphosphonate

GREEN Risedronate tablets 35mg once weekly + prescribe Adcal D3 1 tab twice daily

tablets 5mg daily + prescribe Adcal D3 1 tab twice daily

Strontium ranelate - removed from formulary after recent EMA recommendations

Patients currently on strontium should be individually assessed to determine their on-going fracture risk. In brief this would be assessing individual risk using clinical risk factors and also FRAX, Clinicians may also wish to refer for DXA. As a general principle if patients are below intervention threshold on FRAX, it is usually reasonable to stop treatment. In high risk patients considerations should be given to alternative treatments, and patients can be referred to the falls and bone health clinics for advice on the best course of action.

Teriparatide Teriparatide is recommended as an alternative, after Alendronate, risedronate and raloxifene have been considered, for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:

who are unable to take alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined in section 2), or who have an insatisfactory response (as defined in section 3) to treatment with alendronate, risedronate or etidronate and
who are 65 years or older and have a T-score of -4.0 SD or below, or a T-score of -3.5 SD or below plus more than two fractures, or who are aged 55 - 64 years and have a T-score of -4 SD or below plus more than 2 fractures.

NB. Teriparatide for the treatment of osteoporosis in men at increased risk of fragility fractures has a BLACK traffic light.

RED Teriparatide pre-filled pen 750microgram/3mL

Raloxifene Raloxifene is recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in women:

who are unable to comply with the special instructions for the adminstration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined in section 3)
who also have a combination T-score, age and number of independent clinical risk factors for fracture (see section 2) as indicated in the following table:

T-scores (SD) at (or below) which raloxifene is recommended when alendronate and either risedronate or etidronate cannot be taken

_a Treatment with raloxifene is not recommended.

1. If a woman aged 75 years or older who has one or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinical considers it to be clinically inappropriate or unfeasible.

2. For the purposes of this guidance, indicators of low BMD are low body mass index (defined as less than 22kg/m2), medical conditions such as ankylosing spondylitis, Chron's disease, conditions that result in prolonged immobility, and untreated premature menopause (rheumatoid arthritis is also a medical condition indicative of low BMD).

3. In deciding between strontium ranelate and raloxifene, clinicians and patients need to balance the overall proven effectiveness profile of these drugs against their tolerability and other effects in individual patients.

4. For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

5. For the purposes of this guidance, intolerance of alendronate, risedronate or etidronate is defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly.

6.For the purposes of this guidance, intolerance of strontium ranelate is defined as persistent nausea or diarrhoea, either of which warrants discontinuation of treatment.

For the purposes of this guidance, an unsatisfactory response is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline.

Chronic Kidney Disease NICE CG73

Bone Conditions

Bisphosphonates appear to have benefits in people with CKD without an increased risk of adverse effects:

use when needed for the prevention and treatment of osteoporosis in people with stage 1, 2, 3A or 3B Chronic Kidney Disease
check the Summary of Product Characteristics for any recommendations on dose adjustment according to GFR

When needed, give vitamin D supplementation as follows:

stage 1, 2, 3A or 3B CKD - cholecalciferol or ergocalciferol,
stage 4 or 5 CKD - alfacalcidol or calcitriol.

Ibandronic acid

Oral Ibandronic acid

Ibandronic acid is recommended for the treatment of post menopausal osteoporosis to prevent vertebral fractures when a weekly bisphosphonate is not tolerated or where there is poor adherence. Only to be initiated on the recommendation of a specialist. Recommendation may involve discussion with a GP over the telephone or by letter. Efficacy on femoral neck (hip) fractures has not been established. See full review online - click here to access it.

AMBER Ibandronic acid tablets 150mg once monthly (Bonviva®) + prescribe Adcal D3 1 tab twice daily

Intravenous Zoledronic acid

Intravenous zolendronate should only be initiated and prescribed by a specialist in the management of osteoporosis. It should be used in preference to pamidronate for the treatment of osteoporosis in postmenopausal women in all new patients. It is also indicated for treating osteoporosis in men. It should be reserved for patients who are intolerant, unresponsive or unsuitable for oral treatment with bisphosphonates and other oral treatments such as strontium ranelate. Patients must still receive supplemental calcium and vitamin D.

RED Zoledronic acid injection 5mg annually (Aclasta®)

+ prescribe Adcal D3 1 tab twice daily

For the treatment of bone pain in cancer

AMBER Sodium clodronate capsules 400mg (Bonefos®)

For the treatment of bone metastases in breast cancer

SHARED CARE Ibandronic acid tablets 50mg daily (Bondronat®)

Zoledronic Acid

For the treatment of hypercalcaemia of malignancy and bone damage in advanced malignancies

RED Zoledronic acid injection 4mg (Zometa®)

Caution - There are two different strengths of IV zoledronic acid, please ensure you have selected the right strength.

For the treatment of Paget’s disease of the bone

Zoledronic acid should be prescribed only by physicians with experience in treatment of Paget's disease of the bone in line with its licensed indication. It may be used first line, or as subsequent therapy in patients for whom other treatments are not tolerated, ineffective or inappropriate. Patients must be appropriately hydrated prior to administration of zoledronic acid and this is especially important for patients receiving diuretic therapy. In addition, it is advised that supplemental calcium corresponding to at least 500 mg elemental calcium twice daily (with vitamin D) is prescribed for patients with Paget's disease for at least 10 days following administration of zoledronic acid. For further recommendations on the use of zoledronic acid 5mg for Paget's disease, refer to the new drug review which can be accessed online at www.elmmb.nhs.uk.

RED Zoledronic acid injection 5mg (Aclasta®)

Caution - There are two different strengths of IV zoledronic acid, please ensure you have selected the right strength.

6.7.1 Bromocriptine and other dopaminergic drugs

First line

AMBER Cabergoline tablets 500 microgram

Second line

AMBER Bromocriptine tablets 2.5mg

6.7.2 Drugs affecting gonadotrophins

Danazol combines androgenic, antioestrogenic and antiprogestogenic activity

GREEN Danazol capsules 100mg, 200mg

Gonadorelin analogues:-

Goserelin and leuprorelin are recommended for use within their licensed indications, with goserelin recommended as the first line product. Any unlicensed uses (e.g. precocious puberty) should not be transferred to primary care prescribers –prescribing should be retained by secondary care. There are two shared care protocols in place for the use of goserelin (the preferred LHRH analogue). One covers the use in gynaecology, the other covers the use in oncology settings (breast & prostate cancer), and they can be accessed online at www.elmmb.nhs.uk/shared-care .

First Line

AMBER with SHARED CARE Goserelin injection 3.6mg, 10.8mg

Second Line

AMBER with SHARED CARE Leuprorelin injection 3.75mg, 11.25mg

(currently no shared care protocols exist for the use of leuprorelin locally as it is a second line agent)

AMBERwith SHARED CARE Triptorelin SR 3mg

(currently no shared care guideline available for triptorelin)

Specialist initiation only. For use in patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration.

For pre-operative oral treatment option of uterine fibroids with moderate to severe symptoms, three month course of Ulipristal has been approved where the first one is supplied by secondary care and if to continue prescribing, month two and three by GP

AMBER Ulipristal tablets 5mg (Esmya®)

6.7.3 Other Endocrine Drugs

Management of Cushing's Syndrome (specialist supervision in hospital)

RED Metyrapone capsules 250mg