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 Formulary Chapter 2: Cardiovascular system - Full Chapter
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02.02.03  Expand sub section  Potassium-sparing diuretics and aldosterone antagonists
Amiloride Hydrochloride
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First Choice
Green
 
Finerenone (Kerendia®)
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Formulary
Green plus
  • Approved as an option for treating stage 3 and 4 chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults - in line with NICE TA877:
    • add-on to optimised standard care; this should include, unless they are unsuitable, the highest tolerated licensed doses of:
      • angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) and
      • sodium–glucose cotransporter‑2 (SGLT2) inhibitors and
    • the person has an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 or more.
 
Link  NENC - Finerenone for treating chronic kidney disease in people with type 2 diabetes
Link  NICE TA877: Finerenone for treating chronic kidney disease in type 2 diabetes
 
02.02.03  Expand sub section  Aldosterone antagonists
Spironolactone
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Formulary
Green
  • Green Resistant Hypertension - Step 4 NICE NG 136 - consider seeking expert advice
  • Green plus Post-acute myocardial infarction patients and patients with heart failure treatment should be initiated on instructions from a cardiologist or GP with a specialist interest in cardiology. Spironolactone is first choice (ahead of eplerenone) for severe heart failure.
  • Spironolactone 10mg and 50mg in 5ml suspension is also approved unlicensedunlicensed.
  • 50mg/5ml - Recommended strength in children as per NPPG/RCPCH Position Statement: Using Standardised Strengths of Unlicensed Liquid Medicines in Children
 
Link  MHRA Drug Safety Update (Dec 2016): Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia—clarification, December 2016
Link  MHRA Drug Safety Update (Feb 2016): Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia.
Link  RCPCH Position Statement: Using Standardised Concentrations of Liquid Medicines in Children
 
Eplerenone
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Formulary
Green plus
  • For use in post-acute myocardial infarction patients with left ventricular dysfunction and heart failure. Only to be used in patients who are unable to tolerate the estrogenic side effects of spironolactone. Treatment should only be on advice from a cardiologist.
 
Link  NICE NG106: Chronic heart failure in adults: diagnosis and management
 
 ....
Key
Restricted Drug Restricted Drug
Unlicensed Drug Unlicensed
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
ICB
Green Low Carbon

Low carbon footprint

Amber Medium Carbon

Medium carbon footprint

Red High carbon footprint

High carbon footprint

Status Description

Red

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.   

Amber

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.   

Green plus

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 undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.  

Green

Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.  

Black

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.  

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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