North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 2: Cardiovascular system - Full Chapter

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Academic Health Science Network (North East and North Cumbria) - Atrial Fibrilation

NICE NG148: Acute kidney injury: prevention, detection and management

NICE NG191: COVID-19 rapid guideline: managing COVID-19

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02.11

Antifibrinolytic drugs and haemostatics

Tranexamic Acid

Formulary

Also available as a 500mg in 5ml syrup unlicensed.

Efanesoctocog alfa

(Altuvoct^®)

Formulary

250 IU, 500 IU, 750 IU, 1000 IU, 2000 IU, 3000 IU, 4000 IU Powder and solvent for solution for injection
Approved option for treating and preventing bleeding episodes in people 2 years and over with haemophilia A (congenital factor VIII deficiency) in line with NICE

NICE TA1051: Efanesoctocog alfa for treating and preventing bleeding episodes in haemophilia A in people 2 years and over

Marstacimab

(Hympavzi^®)

Formulary

150mg/1ml pre-filled pen
Approved as an option for preventing bleeding episodes caused by severe haemophilia B (congenital factor 9 deficiency) in people 12 years and over in line with NICE

NICE TA1073: Marstacimab for treating severe haemophilia A or B in people 12 years and over without anti-factor antibodies

Tranexamic Acid Injection

Formulary

100mg/ml Solution for Injection

Aminocaproic acid

Unlicensed

Approved for the use in paediatric patients undergoing extracorporeal membrane oxygenation (ECMO).

Aprotinin

Unlicensed

For limited use in cardiothoracic surgery.

02.11

Blood-related products

A range of blood factors including factors VII & VIII are stocked at the RVI for use in the treatment of haemophilia etc.

Antithrombin III (Kybernin^®)

Formulary

Beriplex - P/N®
(Dried Prothrombin Complex)

Formulary

Approved for reversing the effects of oral anticoagulants in patients with life or limb threatening bleeding in accordance with a regional protocol.

Etranacogene dezaparvovec

(Hemgenix^®)

Formulary

Approved for treating moderately severe or severe haemophilia B in line with NICE

NICE TA989: Etranacogene dezaparvovec for treating moderately severe or severe haemophilia B

Factor IX
(Fraction, Dried)

Formulary

Factor VIIa
(Recombinant)

Formulary

Factor VIII
(Fraction, Dried)

Formulary

Factor VIII
(Inhibitor Bypassing Fraction)

Formulary

Factor XIII
(Fraction, Dried)

Formulary

Fibrinogen

Formulary

Octanate

Formulary

Approved for patients with severe Haemophilia A and an inhibitor and in whom there is agreement to undertake immune tolerance induction with a plasma derived product.

Octaplas and Octaplas LG

Formulary

Solution for infusion containing 45-75mg/ml human plasma proteins.

Protein C Concentrate (Ceprotin^®)

Formulary

Prothrombin Complex Concentrate (Octaplex^®)

Formulary

....

Non Formulary Items

Marstacimab

(Hympavzi^®)

Non Formulary

150mg/1ml pre-filled pen
Not approved for preventing bleeding episodes caused by severe haemophilia A (congenital factor 8 deficiency) in people 12 years and over in line with NICE

NICE TA1073: Marstacimab for treating severe haemophilia A or B in people 12 years and over without anti-factor antibodies

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.