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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
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
 
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Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
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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
CCG

Traffic Light Status Information

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. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

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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