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 Formulary Chapter 21: Short term approval only - Full Chapter
21.01  Expand sub section  Approved under evaluation
 note 

These drugs are only to be used as part of an evaluation. Please contact your formulary Pharmacist before prescribing, ordering or dispensing these items.

Alitretinoin
(Pityriasis rubra pilaris)
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Restricted Drug Restricted
GP - Red
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NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Pityriasis rubra pilaris
Evaluation at RFL site only (JFC August 2016). Prior funding approval required.

 
Alteplase + dornase alpha intrapleural infusion
(Complex pleural infections)
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Restricted Drug Restricted
GP - Red
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Approved as intrapleural fibrinolytics (alteplase + dornase alfa) for ongoing sepsis in association with a persistent pleural collection, who have not responded to 12-24 hours of antibiotics and simple tube drainage, or there is radiological evidence (either on ultrasound and/or CT) that the effusion is unlikely to drain due to multiple loculation; rather than referring for surgical intervention. Evaluation sites to be approved at DTCs (JFC March 2019)

Notes: The majority of trials use dornase alfa (DNase) 5 mg and alteplase (t-PA) 10 mg administered intrapleurally twice daily for up to 3 days. Administration was followed by clamping of the drain to permit the study drug to remain in the pleural space for 1 hour. One study used dornase alfa (DNase) 5 mg and alteplase (t-PA) 5 mg twice daily. 

Provider notes

  • NMUH:
    • Non-formulary
  • RFL:
    • To be used as per protocol for complex pleural infections (under evaluation)
  • RNOH:
    • Non-formulary
  • UCLH:
  • WH:
    • Non-formulary
 
Cacicol
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Restricted Drug Restricted

Non-healing corneal ulcers/ persistent epithelial defects. 
Under evaluation at MEH only (restricted to corneal eye disease service only, April 2017)

 
Co‐careldopa
(Hemispatial neglect)
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Restricted Drug Restricted
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Rotigotine or co‐careldopa for Hemispatial neglect that is interfering with progress of neurorehabilitation - UCLH only
Approval was subject to Dr Swayne working with Dr Sofat and JFC support to agree the datacollection form and the duration of the pilot study. Duration of audit TBC (November 2016).

 
Diltiazem cream
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Restricted Drug Restricted
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Diltiazem cream for transrectal ultrasound guided prostate biopsy
Twelve-month evaluation at UCLH site only (March 2015)

 
Empagliflozin
(Metabolic syndromes)
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Restricted Drug Restricted
GP - Red
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NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

 

Empagliflozin for symptomatic neutropenia secondary to glycogen storage disease type 1b (GSD1b) or glucose 6 phosphatase catalytic subunit 3 (G6PC3) deficiencies
Approved under evaluation at UCLH only. 

 
Fentanyl patch
(Acute post-operative pain)
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Restricted Drug Restricted

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Fentanyl patch for acute post-operative pain in primary knee replacement surgery
30 patient evaluation at RNOH site only. Evaluation to be reviewed at JFC (April 2015)

 
Florbetapir F 18 injection
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Restricted Drug Restricted

Amyvid (florbetapir) for Alzheimer's disease
10 patient evaluation at RFL site only. Evaluation to be reviewed at JFC (JFC September 2014 and February 2015)

 
Gardasil
(Human papillomavirus vaccine)
(Recalcitrant warts)
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Restricted Drug Restricted
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NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Recalcitrant warts
5 patient evaluation at RFL site only (JFC March 2013)

 
Hyaluronic acid injection
(Ostenil Plus)
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Restricted Drug Restricted
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Hyaluronic acid injection (Ostenil Plus) to prevent surgery
Approved under evaluation at RNOH only (July 2014)

RNOH: Restricted for use in accordance with the evaluation protocol by consultants in the Shoulder and Elbow Unit

 
Ketamine oral solution
(Pain)
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Restricted Drug Restricted
GP - Red

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Acute pain unresponsive to opiates (inpatient use only; initiation by Pain team consultant or consultant Anaesthetist)
Evaluation for RFL only (approved by DTC in July-17, ratified by JFC in August-17)

 
Paracetamol IV
(Patent ductus arteriosus)
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Restricted Drug Restricted

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Paracetamol IV for closure of the patent ductus arteriosus (PDA)
Approved second line option after ibuprofen. All eligible patients in NCL to be included in the audit. Evaluation to be reviewed at UCLH or JFC in 12 months (March 2016).

 
Link  RFL: Guidelines for Use of IV Paracetamol
Pitolisant
(Narcolepsy)
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Restricted Drug Restricted

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Pitolisant for narcolepsy with or without cataplexy
Under evaluation at UCLH only (June-17)

 
Pregabalin
(Spinal-cord injury)
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Restricted Drug Restricted

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Spinal-cord injury neuropathic pain 
Approved under evaluation for 1 year; restricted to RNOH site (March 2015)

 
Ribavirin
(Chronic norovirus in PID)
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Restricted Drug Restricted
GP - Red
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NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Chronic norovirus in PID
3 patient evaluation at RFL site only (JFC January 2015)

 

 
Rotigotine patch
(Hemispatial neglect)
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Restricted Drug Restricted
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NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Rotigotine or co‐careldopa for Hemispatial neglect that is interfering with progress of neurorehabilitation - UCLH only.
Approval was subject to Dr Swayne working with Dr Sofat and JFC support to agree the datacollection form and the duration of the pilot study. Duration of audit TBC (November 2016).

 
Sirolimus tablets
(Vascular)
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Formulary
GP - Red
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Sirolimus for low-flow vascular malformations in the head and neck.

Evaluation for RFL only (JFC April 2018) - see local policy for use / dose.

 
Tetrahydrocannabinol + Cannabidiol Oromucosal Spray
(Sativex)
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Restricted Drug Restricted
GP - Red

Sativex for Tourette’s syndrome
Evaluation for UCLH only (March-17)

 
Tropicamide + Lidocaine hydrochloride + Phenylephrine hydrochloride eye drops
(Mydrane)
(Ophthalmic)
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Restricted Drug Restricted

Mydrane for obtaining intraoperative pupil dilatation and intracamerular anaesthesia during topical anaesthesia cataract surgery
Evaluation for MEH only (approved by DTC in January-17, ratified by JFC in April-17)

 
 ....
 Non Formulary Items
Maribavir

View adult BNF View SPC online View childrens BNF
Unlicensed Drug Unlicensed

Maribavir for resistant CMV infections was 'approved under evaluation' at RFL only in January 2015 however is now not available. 

Octreotide long acting injection
(Sandostatin Lar)
(Polycystic liver disease)

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Non Formulary
GP - Red
NHS England

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Octreotide long-acting injection for polycystic liver disease was 'approved under evaluation' at RFL only (JFC August 2015) however is now not available. 

Vernakalant

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Non Formulary
GP - Red

Vernakalant (pilot study) for new-onset atrial fibrillation was 'approved under evaluation' at RFL (Barnet) only in January 2017 however is now not available. 

  
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
Display tracking information
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Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
Homecare
Homecare

Traffic Light Status Information

Status Description

GP - 1st

Medicines suitable for first-line use within primary care.

Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing.

  

GP - 2nd

Medicines suitable for second-line use within primary care.

Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing.

  

GP - Amber

Medicines that should be initiated by a specialist. Prescribing can be transferred to primary care once the patient has been stabilised.

Shared care: For drugs with regular, ongoing need for monitoring and/or assessment of efficacy or toxicity. Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred. The shared care protocol must have been agreed by the relevant secondary care trust Drugs and Therapeutics Committee(s) (DTC) and approved by the North Central London JFC.

Fact sheet: For drugs with some concerns surrounding safety or efficacy but do not require regular monitoring and/or monitoring of effectiveness/toxicity.

  

GP - Red

Medicines which should normally be prescribed by specialists only (hospital only).

For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care.

See link for the complete NCL Red List https://www.ncl-mon.nhs.uk/wp-content/uploads/2017/08/ncl_red_list.pdf

  

GP - Grey

Medicines on hospital formularies which have not been reviewed for suitability in primary care.  

Black

Medicines not recommended for routine use in primary or secondary care.

Medicines, which the North Central London JFC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.

  

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