North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 6: Endocrine system - Full Chapter

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NTAG Endocrine System Recommendations

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06.01.01.02

Intermediate- and long-acting insulins

Note: preloaded pens should only be used where cartridges are not suitable.

Isophane Insulin (Insulatard^®)

Formulary

100units/ml suspension for injection 10ml vial

Isophane Insulin (Humulin^® I)

Formulary

Approved Humulin® I formulations include:
- 10ml vials;
- 5x3ml cartridges;
- 5x3ml pens.

Insulin Glargine biosimilar Abasaglar^®
(Long acting)

Formulary

First choice long acting basal insulin in patients eligible for treatment in line with NICE and NTAG
Approved Abasaglar® formulations include:
- 5x3ml cartridge
- 5x3ml Kwikpen®.

NG17: Type 1 diabetes in adults: diagnosis and management

NTAG: Abasaglar® Insulin Glargine Biosimilar 100 units/ml for the treatment of type 1 or type 2 diabetes mellitus.

Insulin degludec 100 units/mL (Tresiba^®)
(Long acting)

Formulary

100 units/mL
Pre-filled pen and cartridges
Approved for use in patients with Type 1 diabetes with
- Nocturnal/Severe Hypogycaemia (with or without hypoglycaemic unawareness) in patients who would otherwsie progress to insuling pump treatment as per NICE TA151); or
- Recurrent DKA episodes despite good compliance and who would otherwise progress to insulin pump therapy
- Paediatric patients who cannot tolerate glargine sting
- Paediatric patients with poor control on the high HbA1c pathway
- Patients or Parents/Carers with unpredictable lifestyles such as students or shift workers.

“**Note that there are two strengths of Tresiba® (insulin degludec). Caution should be exercised when prescribing and dispensing**

Insulin degludec 200 units/mL (Tresiba^®)
(Long acting)

Formulary

200 units/mL
Pre-filled pen
Approved for use in patients with Type 1 diabetes with
- Nocturnal/Severe Hypogycaemia (with or without hypoglycaemic unawareness) in patients who would otherwise progress to insulin pump treatment as per NICE TA151; or
- Recurrent DKA episodes despite good compliance and who would otherwise progress to insulin pump therapy
- Paediatric patients who cannot tolerate glargine sting
- Paediatric patients with poor control on the high HbA1c pathway
- Patients or Parents/Carers with unpredictable lifestyles such as students or shift workers.

**Note that there are two strengths of Tresiba^® (insulin degludec). Caution should be exercised when prescribing and dispensing**

Insulin Detemir (Levemir^®)
(Long acting)

Formulary

Alternative choice long acting basal insulin.
Approved Levemir® formualtions include:
- 5x3ml cartridges;
- 5x3ml pens.

Insulin Glargine (Lantus^®)
(Long acting)

Formulary

Alternative choice long acting basal insulin.
Approved Lantus® formulations include:
- 10ml vials;
- 5x3ml cartridges;
- 5x3ml pens (Solostar® - in line with NICE).

Insulin Glargine (Toujeo^®)
(Long acting)

Formulary

Alternative choice long acting basal insulin.
Approved Toujeo® formulations include:
- 1.5mL pre-filled pen (Solostar): Dose range 1-80 units in 1 unit increments. 450 units in a pen
- 3mL pre-filled pen (DoubleStar): Dose range 2-160 units in 2 unit increments. 900 units in a pen.

**CARE: HIGH STRENGTH INSULIN**

Approved for use in patients on insulin glargine who require:

High dose (60+ units per dose for Toujeo SoloStar and 80+ units per dose for DoubleStar
Large volume of insulin and local site reactions
Twice daily insulin

NOTE: Toujeo 300 units/ml is not bioequivalent to insulin glargine 100 units/ml and is not directly interchangeable

MHRA Drug Safety Update (Sep 2020): Insulins (all types): risk of cutaneous amyloidosis at injection site

NICE NG 17: Type 1 diabetes in adults: diagnosis and management

NICE TA151: Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus

06.01.01.02

Biphasic insulins

Biphasic Isophane Insulin (Humulin^® M3)
(Conventional )

Formulary

Approved Humulin®M3 formulations include:
- 10ml vials;
- 5x3ml cartridges;
- 5x3ml pens.

Biphasic Insulin Aspart (NovoMix^® 30)
(Analogue)

Formulary

Approved NovoMix® 30 formulations include:
- 5x3ml cartridges (for use with Novopen® and Novopen® Penmate injection devices)
- 5x3ml Flexpen® pens.

Biphasic Insulin Lispro (Humalog^® Mix 25 amd Mix 50)
(Analogue)

Formulary

Approved formulations of Humalog® Mix 25 and Mix 50 include:
- 5x3ml cartridges
- 5x3ml Kwikpen®

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Key

	Restricted Drug
	Unlicensed
	Link to adult BNF
	Link to children's BNF
	Link to SPCs
	Cytotoxic Drug
	Controlled Drug

	High Cost Medicine
	NHS England
	Homecare
	ICB
	Low carbon footprint
	Medium carbon footprint
	High carbon footprint

Status	Description
	Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.
	Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.
	Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist provides the first prescription from the inpatient/outpatient setting, of sufficient supply for a patient’s immediate needs. The quantity provided should cover at least up to the point where the discharge/clinic letter has reached the GP, plus reasonable time for the practice to manage the document and issue further supplies. A GREEN+ drug can only be recommended to primary care for initiation if it does not need to be initiated urgently, taking into account clinical need.
	Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.
	Self-care – available OTC, can be purchased as part of self-care for self-limiting conditions as per NHSE policy guidance
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.