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6.0 Endocrine

6.0 Endocrine

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  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: 
                                              >     for whom insulin therapy would have significant occupational implications or 
                                              >     weight loss would benefit other significant obesity‑related comorbidities.

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 diabetesdapagliflozin in combination therapy for treating type 2 diabetesdapagliflozin in triple therapy for treating type 2 diabetes and empagliflozin in combination therapy for treating type 2 diabetes.

.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) (prescribe by brand)
GREEN      Apidra® (insulin glulisine) 
GREEN*    Fiasp®  (insulin aspart) * restricted use/(prescribe by brand) 


* Insulin Aspart (Fiasp®) is recommended for the treatment of diabetes mellitus in adults
who are suitable for NovoRapid® and their diiabetes cannot be adequately managed with
alternative formulary choices and at least one of the following applies:
       >      Where the doctor believes a faster onset of action would be beneficial to the 
               patient
       >      Where a patient requires 'tight' control of blood sugar levels
       >      Where a patient has rapid post meal increase in blood sugar levels
 

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  is recommended for reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with impaired glucose tolerance and/or
impaired fasting glucose, and/or increased HbA1c who are:
          >       at high risk for developing overt type 2 diabetes mellitus AND 
          >       still progressing towards type 2 diabetes mellitus despite implementation
                   of intensive lifestyle change for 3 to 6 months OR
          >       are unable to participate in an intensive lifestyle-change programme.
 
GREEN    Metformin tablets (standard release)
                 *Second line treatment to intensive lifestyle-intervention

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 pre-filled disposable syringe 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

Semaglutide 
Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 
diabetes mellitus as an adjunct to diet and exercise:
     >   as monotherpay when metformin is considered inappropriate due to intolerance or
          contraindications
     >   in addition to other medicinal products for the treatment of diabetes
See NICE Guideline  NG28
 Please see antihyperglycaemic guidelines
GREEN       Semaglutide (Ozempic®) 0.25mg, 0.5mg, 1mg solution for injection pre-filled                          pens.

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®)  
 
Ertugliflozin NICE TA572
Ertugliflozin as monotherapy is recommended as an option for treating type 2 diabetes i
in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if:
     >     a dipeptidyl peptidase 4 (DPP‑4) inhibitor would otherwise be prescribed and
     >     a sulfonylurea or pioglitazone is not appropriate.

Ertugliflozin in a dual-therapy regimen in combination with metformin is recommended 
as an option for treating type 2 diabetes, only if:
     >     a sulfonylurea is contraindicated or not tolerated or
     >     the person is at significant risk of hypoglycaemia or its consequences.
 
GREEN    Ertugliflozin (Steglatro®)
                5mg, 15mg tablets
 
 
 
 

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 Glucose 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. 
 
Contour® Next 
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 approved meters and associated  functions click here. 
 
Accu-Check® Expert
Accu-Check® 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*
                   >       BD viva™ pen needles
 
Note - Omnican needles do not have an inner cap. This is simply to promote single use of the needles 
and prevent patients re-caping 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.
 

FreeStyle Libre® Glucose Monitoring System  
The Policy for the Provision of Continuous Glucose Monitoring and Flash Glucose Monitoring has been
updated based on national guidance to CCGs issued by NHS England on unifying the patient access 
criteria for Flash Glucose Monitoring.
FreeStyle Libre is now Amber traffic light for individuals that for individuals that meet the criteria set out
in the policy.
[Policy criteria for Freestyle Libre®]
 
 
Specialists are responsible for initiation, training and reviews at 3 and 6 months.  
GPs can continue to prescribe FreeStyle Libre to individuals that fit the policy criteria after an initial 
supply via the specialist. 
 
AMBER        FreeStyle Libre® sensor
 
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 
egislation 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 
BLACK       Levothyroxine liquid (all strengths)
RED            Liothyronine injection 20 microgram  (hospital use only in thyroid emergencies) 
BLACK       Armour Thyroid  
BLACK       Liothyronine tablets/capsules 
                   link to UKMi Clinical evidence  
                   link to RCP - Diagnosis and management of primary hypothyroidism


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
 

AMBER      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 [NOT receommended for use in hayfever]

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)             
 
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/dydrogesterone  continuous 'no bleed' combination)                                  
GREEN      3rd line Premique  
                   (Conj. oestrogens/ medroxyprogesterone continuous 'no bleed' combination)      
BLACK       0.45mg conjugated oestrogens & Bazedoxifene (Duavive®)
                   (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
BLACK      *Ulipristal tablets 5mg (Esmya®) 
 
*MHRA - Esmya - February 2018 - temporary safety measures have been introduced whilst EMA conducts
review following reports of serious liver injury, No new treatment courses to be prescribed until further notice
Click here to access further information 


  
 

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

RED         Demeclocycline 150mg capsules

Existing patients to be referred back to secondary care.

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   

Tolvaptan for treating SIADH in patients requiring cancer chemotherapy
Consultant prescribing only.
RED           Tolvaptan (Samsca®)                                                                                            (NHS England Commissioned)  

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.

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®)

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®)   

Denosumab 
Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture
Patients with any of the following clinical features may be considered for treatment with denosumab:
       >     Upper gastrointestinal abnormalities, including oesophageal stricture, achalasia, abnormalities 
              which delay oesophageal emptying, dysphagia, oesophageal disease (oesophagitis, ulcers, 
              erosions), gastritis, duodenitis, gastric ulcers, previous upper GI surgery.
       >     Inability to sit or stand upright for at least 30 minutes.
       >     Renal impairment (eGFR <35ml/min). (Denosumab’s SPC states there is no data for patients 
              with eGFR < 30ml/min. Many clinicians are happy to use if eGFR > 20ml/min, provided serum 
              calcium is closely monitored after each injection).
       >     Concerns about compliance with treatment – may include patients with cognitive impairment.
 
 
AMBER                        Denosumab (Prolia®)
SHARED CARE            access the shared care agreement here


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

Raloxifene for the PRIMARY prevention of osteoporotic fragility fractures in postmenopausal women (NICE TA160) - updated February 2018.
 (The title and guidance of TA160 have been updated to reflect the current recommendations.) 

Nice has issued up-to-date guidance  on bisphosphonates for treating osteoporosis. 
 
NICE  withdrew its guidance on the issue of etidronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures ipostmenopausal women because etidronate and strontium ranelate
are no longer marketed in the UK. 
 
For an overview of the Management of osteoporosis <click here> 
 
Alendronate 
Alendronate is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in post menopausal women.
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.

Alendronate - 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 - Second Line Bisphosphonate    
Risedronate is recommended as alternative treatment option 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  of T-score, age and number of independent clinical risk                                    factors for fracture as in the  attached  table.
                      
GREEN      Risedronate    
                   tablets 35mg once weekly + prescibe Adcal D3 1 tab twice daily 
                   tablets 5mg daily + prescribe Adcal D3 1 tab twice daily 
 
Denosumab  
Position Statement  - Denosumab as a second line treatment option for the prevention of osteoporotic                                           fragility fractures in men and women from  the age of 50 years.
                                      
Denosumab is recommended as a second line treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women and men from the age of 50 years at 
increased risk of fracture  who are unable to comply with the special instructions for administering 
alendronate and risedronate, or have an intolerance of, or a contraindication to those treatments and
the patient has a combination of T-score, age and number of independent clinical risk factors for fracture as indicated in NICE TA204 

AMBER SHARED CARE    Denosumab injection, pre-filled syringe 60mg (Prolia®) 
                                            click here for Shared Care Agreement 
 
Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours NICE TA265 

Treatment of Osteonecrosis of the Jaw  - click here 

6.6.2 Bisphosphonates and other drugs affecting bone metabolism

Raloxifene and triparatide for the SECONDARY prevention of osteoporotic fragility fractures in postmenopausal women who have osteoporosis (NICE TA161)- updated February 2018. 

(The title and guidance of TA161 have been updated to reflect the current recommendations.) Guidance on strontium ranelate and etidronate have been removed because these drugs are no longer marketed 
in the UK.
 
Nice has issued up-to-date guidance  on bisphosphonates for treating osteoporosis.  
 
For an overview of the Management of osteoporosis <click here> 
 
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.

Alendronate - 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 - Second Line Bisphosphonate 
Risedronate is recommended as alternative treatment option 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, and
      >   who also have a combination  of T-score, age and number of independent clinical risk factors for 
           fracture as in theattached table
GREEN      Risedronate  
                   tablets 35mg once weekly + prescribe Adcal D3 1 tab twice daily
                   tablets 5mg daily + prescribe Adcal D3 1 tab twice daily
 
Raloxifene and Teriparatide  - alternative SECONDARY prevention treatments for post menopausal women. 
The guidance does not cover the following: 
 
       >    The use of raloxifene or teriparatide for the secondary prevention of osteoporotic fragility
             fractures in women with normal BMD or osteopenia (that is, women with T-score between
              –1 and –2.5 SD below peak BMD).
 
       >    The use of these drugs for the secondary prevention of osteoporotic fragility fractures in women
             who are on long-term systemic corticosteroid treatment.
 
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 
see guidance 
 
RED           Teriparatide pre-filled pen 750microgram/3mL 
 
NB. Teriparatide for the treatment of osteoporosis in men at increased risk of fragility fractures has a BLACK traffic light.    
       
Raloxifene      
Raloxifene is recommended as an alternative treatment option for the secondary secondary prevention of osteoporotic fragility fractures in women: see guidance
 
GREEN        Raloxifene 60mg fc tablets (Evista®)

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.  
 
 Capture.PNG


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 zoledronate 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)

RED          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