Formulary Chapter 20: Unlicensed Medicines & Off-Label Use - Full Chapter
|
Notes: |
THIS CHAPTER IS UNDER REVIEW AND CURRENTLY ONLY CONTAINS UNLICENSED MEDICINES INFORMATION SPECIFIC TO CUHFT.
FOR FURTHER ADVICE PLEASE CONTACT YOUR LEAD PHARMACIST OR CCG MEDICINES OPTIMISATION TEAM (PRIMARY CARE ENQUIRIES ONLY) |
|
Chapter Links... |
UKMI Q&A: Where can I find free online information about pharmaceutical products licensed in other countries |
Details... |
20 |
Unlicensed Medicines |
|
|
|
Medicines that do not have a UK Marketing Authorisation (UK License). |
|
Budesonide Viscous slurry (Oral preparation)
|
Restricted
|
- Second line treatment for eosinophilic esophagitis in adults and paediatric patients unable to manage administration of fluticasone.
- A slurry can be made by mixing the contents of budesonide nebules with a sugar solution- a patient instruction leaflet exists with directions on how to do this, see below.
|
Oral viscous budesonide for eosinophilic oesophagitis patient information leaflet
|
3,3’,5-triiodothyroacetic acid 350mcg oral tablets (TRIAC)
|
Restricted
|
- Unlicensed medicine, still in phase 3 trials
- JDTC May 2018:- Approved for use to treat resistance to thyroid Hormone due to defective MCT8 thyroid hormone transporter (Allan Herndon Dudley Syndrome) continuation of therapy post trial, on a compassionate access basis
|
|
Acetarsol (Suppositories )
|
Restricted
|
Discontinued August 2016.
|
|
Acetylcysteine (Tablets)
|
Restricted
|
Vascular Surgeons for radio-contrast patients.
|
|
Acetylcysteine (Effervescent Tablet)
|
Restricted
|
- Used in the treatment of pulmonary fibrosis at a dose of 600mg THREE times daily.
- Off-label for meconium ileus in neonates (often these neonates go on to be diagnoses with CF) and Distal Intestinal Obstructive syndrome in CF
|
|
Ajmaline (Injection)
|
Restricted
|
For the diagnosis of Brugada Syndrome
|
|
Albendazole (Tablet)
|
Restricted
|
Micro/ID Recommendation only.
|
|
ALUM Bladder Irrigation 10% (Irrigation fluid)
|
Restricted
|
For treatment of bladder haemorrhage by consultant urologists.
|
|
Aminosalicylic acid (PASA) (Para Aminosalicylic Acid) (Oral preparation)
|
Restricted
|
Multi-drug resistant TB.
ID consultants and respiratory consultants only.
|
|
Amiodarone (Liquid)
|
Restricted
|
250mg/5mL suspension 50mg/5mL suspension Paediatric cardiology patients for arrhythmias.
|
|
Anti-Thymocyte Globulin (ATG) (Rabbit) (Injection)
|
Restricted
|
Transplant only – treatment of steroid resistant rejection.
Prophylaxis in kidney/pancreas and paediatric liver transplant.
|
|
Arginine Hydrochloride (tablets, oral solution, injection) (Tablet)
|
Restricted
|
Available as (all unlicensed):
L-arginine 5g/10ml injection (emergency treatment)
L-arginine oral solution 100mg/ml (on drug tariff specials list)
L-arginine tablets 1g Urea cycle disorders, MELAS, Mitochondrial disorders (neuro)
- Adult and Paediatric - Metabolic Disorders.
- Powder is licensed for urea cycle disorders.
For paediatric use must be specialist prescribed
- Powder is non formulary
|
|
Artesunate (Injection)
|
Restricted
|
- CUHFT and NWAFT: Severe malaria falciparum.
- ID/Micro recommended only.
|
|
Bacteriostatic water
|
Restricted
|
•Compassionate supplies of bacteriostatic to be supplied alongside leptin only •Aim is to reduce required number of vials per day •To be bring back to JDTC once compassionate supplies is no longer available, which is likely to be at the point of leptin being marketed in the UK.
|
|
Benzathine Benzylpencillin (Injection)
|
Restricted
|
ID/Clinic 1a for syphilis. Can be difficult to source, use procaine benzylpencillin in this circumstance.
|
|
Betaine tablets
|
Restricted
|
- For consideration when powder unavailable or patient intolerant to.
- 500mg
|
|
Bisacodyl 2.74mg/ml rectal solution
|
Restricted
|
- Unlicensed
- Approved for use in paeds patients with chronic constipation and ACE formation
|
|
Boric Acid (Pessaries)
|
Restricted
|
Persistent vaginal candidiasis.
|
|
Brincidofovir ((oral tablets, oral solution))
|
Restricted
|
CUHFT:
- Approved clinically for symptomatic Adenovirus infection in immunosuppressed patients including transplant recipients with specified criteria including toxicity experienced by cidofovir subject to agreed supply from manufacturer
- Please contact ChimerixNPP@ubc.com to apply for use if patient likley to be eligible
- 100mg oral tablets and 10mg/ml oral solution (both unlicensed) only available through expanded access/compassionate use programme.Phase III trial product in the US only
- Hospital only via inpatient pharmacy
- Standard dose for >or = to 50kg is 100mg twice weekly and for < 50kg is 2mg/kg twice weekly (max. 100mg twice weekly).
- If a patient is taking ciclosporin then dose of 1.4mg/kg (up to max. of 70mg) twice weekly is recommended for 5 weeks or until Adenovirus cleared.
|
|
Caffeine Citrate
|
Restricted
|
Injection 5mg/ml BASE (10mg/ml caffeine citrate)- licensed Oral Solution 5mg/ml BASE (10mg/ml caffeine citrate)- unlicensed for use in NICU/paeds
|
|
Cannabinoid oral solution (Epidiolex®)
|
Restricted
|
CUHFT only:
- Clinically approved by CUHFT for up to seven children aged 2-8 years with at least one life threatening episodes per month (requiring urgent medical assessment or rescue therapy), with either Dravets or Lennox-Gastaut syndromes causing epilepsy, on the basis of recommendation of RCP and ABPN interim guidance (see document below).
- Current best evidence for the use of cannabis based medicinal products suggests efficacy and short-term safety of Epidiolex® (cannabidiol) in two epileptic encephalopathies (Dravet and Lennox-Gastaut syndromes)
- There is no licensed cannabis based medicinal product available in the UK; Epidiolex® is licensed in the US (but not in the UK or Europe) for Dravet and Lennox-Gastaut syndromes only.
- Access to Epidiolex is limited to a compassionate use programme (max 5 patients allocated to CUHFT)
- Epidiolex® is not currently commissioned; NICE is due to review clinical and cost effectiveness and is expected to publish guidance by the end of 2019.
- Patients will need to be consented in line with current policies on the use of unlicensed medicines and compassionate use.
- Epidiolex® is available in 100mg/ml. The starting dose is 2.5mg/kg twice daily, after a week this can be increased to a maintenance dose of 5mg/kg twice daily and this can be increased further to a max. of 10mg/kg twice daily as tolerated.
|
NHSE: Cannabis-based products for medicinal use
|
Caphosol mouth rinse
|
Restricted
|
Medical device Contains:- Dibasic Sodium Phosphate 0.052, Monobasic Sodium Phosphate 0.009, Calcium Chloride 0.052, Sodium Chloride 0.569, Purified water qs (%w/w). To treat and prevent oral mucositis caused by radiation or high dose chemotherapy Hospital only
|
|
Caplacizumab (Caplivi®)
|
Restricted
|
- JDTC May 2019: clinically approved to trat acquired thrombotic thrombocytopenic purpura (aTTP) via compassionate access scheme only
- Drug is licensed but not yet launched in the UK
- Can be obtained out of hours in emergency from company (they operate 24hrs)
- 10mg powder adn solvent for injection. Normally given as 10mg i/v given with plasma exchange followed by 10mg s/c daily for 30 days
|
|
Cefotaxime Preservative Free (Eye drop)
|
Restricted
|
Severe corneal infections as second line to ofloxacin. Extemporaneous preparation.
|
|
Cemiplimab (Libtayo (proposed)) (Free of charge supply only)
|
Restricted
|
Due to be licensed as Labtayo® in near future
- JDTC/OSTS April 2019. Clinically approved as per compassionate access scheme for cutaneous squamous cell cancer ie.e. free of charge scheme only
- 350mg/7ml solution infusion
|
|
Chlorhexidine 0.02% (Eye drops)
|
Restricted
|
Management of Acanthomeba keratitis. Ophthalmologists only.
|
|
Chorionic gonadotrophin (Gonasi®)
|
Restricted
|
Unlicensed medicine. Available as 2,000IU and 5,000IU Imported from Italy. JDTC Jan ’18:- o Clinically and financially approved o Formulary status: Hospital only via clinic To be used by Cambridge IVF for hypogonadoptrophanism to aid spermatogenesis and
the HCG stimulation test, to determine the Leydig cell responsiveness of the testes.
this replaces Pregnyl which has now been discontinued. Gonasi and Pregnyl are conisdered to be therapeutically equivalent. There is no UK licensed product available in strength required.
|
|
Ciclosporin (Eye ointment)
|
Restricted
|
1st Line: Dr Kerr-Muir and named consultants.
For the management of inflammatory and immune based eye disease in adults intolerant to steriod eye drops or where steroid eye drops are ineffecitve or cause adverse effects.
|
|
Ciclosporin 0.05% Minims (Eye drops)
|
Restricted
|
2nd line. For the management of inflammatory and immune based eye disease in adults intolerant to steroid eye drops or where steroid eye drops are ineffective or cause adverse effects.
|
|
Cidofovir (Vistide®) (Infusion)
|
Restricted
|
Cidofovir infusion approved clinically by JDTC July 2014 for following indications:
• First-line treatment in haemato-oncology patients for Adenovirus viraemia(*please submit IFR for external funding)
• Second or third line treatment in CMV viraemia (routinely commissioned by NSHE- no need for IFR)
• Treatment of BK polyma virus viraemia and/or adenovirus viremia in immunocompromised patients (*please submit IFR for external funding)
*Note internally funding agreed for those cases where an IFR is declined, ahead of decision i.e. treatment should not be delayed
|
|
Cidofovir 1% (Cream)
|
Restricted
|
Clinically approved at JDTC 2004.
Dermatologists for recalcitrant warts & GIN patients.
Cost has increased 8 fold since 2004.
Available via Lloyds Pharmacy.
|
|
Citric acid
|
Restricted
|
Approved for reflex testing on NCCU.
|
|
Clonidine (Liquid)
|
Restricted
|
50micrograms/5mL Routinely used in paediatrics (PICU).
|
|
Diazoxide suspension
|
Restricted
|
250mg/5ml
For chronic hypoglycaemia
* For use when supply issues with tablets
Standard dose is 5mg/kg/day
|
|
Dibotermin Alfa, rhBMP-2 (Bone morphogenetic protein-2 ) (Inductos®) (powder, solvent and matrix for implantation )
|
Restricted
|
- 4mg adnd 12mg kit for implant
- JDTC Sept 2018: Approved as per NHSE CCP
|
Clinical Commissioning Policy: Bone morphogenic protein-2 in spinal fusion Ref NHSE 16063/P
|
Diphencyprone (Solution )
|
Restricted
|
Consultant Dermatologists for alpecia totalis.
|
|
Disodium Edetate 0.37% (EDTA) (Eye drop)
|
Restricted
|
Opthalmology use only.
|
|
Dulwich Mixture
|
Restricted
|
Phosphate Binder renal patients with hypercalcaemia. Nephrologist use only.
|
|
Ethionamide (Tablets)
|
Restricted
|
For multidrug resistant TB, prescribed by ID consultants and respiratory consultants.
|
|
Ferric Chloride (Topical)
|
Restricted
|
Chiropodist only.
|
|
Ferric Subsulfate (Monsel's solution)
|
Restricted
|
Clinic 1A. Rosie Outpatients.
|
|
Flunarizine (Capsules)
|
Restricted
|
JDTC July 2014: Agreed for migraine prophylaxis (incl. in paeds population)
To be prescribed as a 3rd or 4th line for patients with difficult to manage migraine, where other conventional agents and botulinum toxin have not been. Flunarizine is an earlier option for patients with prominent aura or hemiplegic migraine.
|
|
Gentamicin 0.1% (Cream)
|
Restricted
|
For use by nephrology consultants in patients undergoing peritoneal dialysis who develop exit site infections resistant to mupirocin.
|
|
Halothane
|
Restricted
|
Anaesthetists.
|
|
Heparin sulphate/Lidocaine and sodium bicarbonate (Intravesical instillation)
|
Restricted
|
To treat patients with interstitial cystitis and bladder pain.
|
|
Hexamide Disethionate 0.1% (Eye Drops)
|
Restricted
|
Management of acanthomeba keratitis. Ophthalmologists only.
|
|
Idebenone ((Raxone®) )
|
Restricted
|
*Early Access to Medicines Scheme for Duchenne Muscular Dystrophy o Approved for use in line with EAMS scheme for patients >10 years of age with Duchenne’s muscular dystrophy who are not on corticosteroids o BlueTeq application is required o License expected Q3 at which point the EAMS scheme will cease to be operational and no new patients should be started o Supply route is clinical trials pharmacy)
|
|
Indigo carmine
|
Restricted
|
Pancolonic dye spray and endoscopic mucosal resection of colonic adenomas.
|
|
Indometacin 100mg/4ml intramuscular injection (Indotest®)
|
Formulary
|
JDTC Dec 2017: Stat dose of 100mg as challenge (indotest) for responsive headaches; hemichrania continua and paroxysmal hemichrania to be given on R3 day unit If test positive then treatment with po thereafter should continue (unless contra-indicated) as specialist advice except in circumstances where above licensed dose is recommended and GPs may be unhappy to prescribe in which case hospital should conitnue
|
|
Iodoform/bismuth 10% w/w in paraffin base
|
Restricted
|
- CUHFT: Restricted to use in Pre-operative patch testing and ENT
- NWAFT: Restricted to use in ENT
- Non-formulary at all other Trusts and in Primary Care
|
|
Iohexol (Omnipaque®)
|
Restricted
|
Contrast media.
|
|
LAT ((Lidocaine 4%, adrenaline 0.1% and tetracaine 0.5) ) (Gel)
|
Restricted
|
Paediatric A&E only.
For use when cleaning/ suturing wounds.
|
|
Levamisole Tablets 50 mg
|
Restricted
|
Occassional paediatric use.
|
|
Lidocaine 4% colouless topical solution
|
Restricted
|
For paediatric ENT and anaethestitst use only for topicalisation of the airway
|
|
Lidocaine and hydrocortisone mouthwash
|
Restricted
|
CUHFT only
|
|
Lissamine Green (Stain)
|
Restricted
|
Ophthalmology only.
|
|
Magnesium Glycerophosphate ( Suspension)
|
Restricted
|
JDTC Dec 2017 Magnesium glycerophosphate chewable tablets (licensed) are first-line oral magnesium replacement in paeds and liquid (unlicensed) reserved for paeds who cannot chew- [no change to current practice].
Note only for use in secondary care i.e. Formulary status: Hospital
Suspension 1mmol/ml.
|
|
Magnesium Lactate (Mag-Tab SR) (Modified-release tablet)
|
Restricted
|
Chronic hypomagnasaemia in Gitelman's syndrome
Unlicensed preparation
Hospital clinician should liaise with GP's out of Cambridgeshire CCG to check if they are happy to continue prescription (high-cost), alternatively other arrangemetns may need to be made
Within Cambs prescription should continue from hospital where posible, due to lower acquistion cost
|
|
Magnesium Oxide (Tablet)
|
Restricted
|
Hypomagnesia 500mg = 21 mmol/mg per tablet.
|
|
Megestrol 40mg tablets
|
Restricted
|
- Unlicensed import
- Approved for hot flushes caused by hormonal treatment of breast cancer
- Dose is 20mg once or twice daily for a maximum of 6 months
- Full course dispensed in one episode from Lloyds OP
|
|
Melatonin (Capsules)
|
Restricted
|
Unlicensed immediate-release preparation clinically and financially approved for use in children within CUH but not in primary care.i.e. Hospital only
Unlicensed immediate release capsules are preferred and if needed these can be opened and the contents dispersed in water, milk, yoghurt or fruit juice for administration.
|
|
Methoxypsoralen (Tablets, Liquid)
|
Restricted
|
8-methoxypsoralen 10mg tablets (Puvasoralen®) 5-methoxypsoralen 20mg tablets (Pentaderm®) 0.005% gel.
0.15% emulsion.
1.2% bath lotion.
Dermatology specialist only. Used in photochemotherapy combining long-wave ultraviolet A radiation with a psoralen (PUVA)
|
|
Metreleptin (Myalepta) (Injection)
|
Restricted
|
CUHFT
- Oct 2018,licensed product supersedes leptin that was the previous product available as free of charge and is no longer available
- For use by endocrinologists for lipodystrophy, partial lipodystrophy and congential leptin deficiency
- A compassionate supply of licensed product has been offered for existing pateints who were already receiving leptin until NICE considers this product.
- Applications to use for any patient would need to be via a chairs action
|
|
Natamycin 5% eye drops
|
Formulary
|
JDTC March 2018: Approved for the 1st line treatment for fungal keratitis
Natamycin 5% eye drops are a licensed drug in the U.S
Standard dose: 1 drop every 2 hours during the day between 6 am and 10 pm for 3 days and reduced to 6 times a day for 2 weeks and then 4 times a day for 4-6 weeks
Normal treatment course is 4-6 weeks (1-2 bottles), patient will be regularly reviewed within that time. Hospital only via LLoydsds outpatients
|
|
Nifedipine 20mg/ml oral drops
|
Restricted
|
For paediatrics only
|
|
Nystatin (Pessaries)
|
Restricted
|
For persistent vaginal candidiasis.
|
|
Paromomycin (Tablets)
|
Restricted
|
Leishmaniasis.
|
|
Phenol
|
Restricted
|
MS and spinal cord injury.
|
|
Pipobroman
|
Restricted
|
Haematologist for MPDs.
|
|
Polihexanide (PHMB) 0.02% (Eye Drops)
|
Restricted
|
Ophthalmologists only. Management of acanthomeba keratitis.
|
|
Potassium acetate 20mmol/10mL (Injection)
|
Restricted
|
Standardised TPN regimens.
|
|
Potassium Ascorbate (Ascorbate ) (Eye drops)
|
Restricted
|
Chemical burns to the eye Ophthalmology recommendation.
|
|
Potassium Canreonate (Injection )
|
Restricted
|
- CUH: Neonates and paediatrics.
|
|
Praziquantel (Oral preparation)
|
Restricted
|
ID/Mirco approval required.
|
|
Pridopidine
|
Restricted
|
Huntington’s disease. Free compassionate use supply for 6 months per patient. Each patient has to be approved by JDTC.
|
|
Primatene mist (Adrenaline ) (Inhaler)
|
Restricted
|
Lanryngeal and tongue oedema.
|
|
Procaine benzylpenicillin
|
Restricted
|
ID/Clinic 1a for syphilis.
|
|
Pyremethamine 10mg/5ml liquid
|
Restricted
|
Toxoplasmosis in paeds who cannot swallow tablets
|
|
Pyridoxal Phosphate (Capsules, injection)
|
Restricted
|
- CUH: Paediatric neurologists for epilepsy in children with suspected pyridoxal phosphate sensitive seizures or folinic acid responsive seizures.
|
|
Pyrimethamine 10mg/5ml liquid
|
Restricted
|
For toxoplasmosis in paeds patients unable to swallow tablets
|
|
Remdesivir
|
Restricted
|
Remdesivir in the treatment of COVID-19 is being made available on EAMS (updated 12.06.20)
Indicated for:
The treatment of adults and adolescent patients aged ≥ 12 years and weighing at least 40 kg hospitalised with suspected or laboratory confirmed SARS-CoV-2 infection and severe disease.
Patients with severe disease are those with an SpO2 ≤ 94% on room air or requiring supplemental oxygen, or requiring non-invasive or invasive ventilation or extracorporeal membrane oxygenation (ECMO).
Prescribing clinicians will need to follow the MHRA Treatment Protocol when initiating therapy (https://www.gov.uk/government/publications/early-access-to-medicines-scheme-eams-scientific-opinion-remdesivir-in-the-treatment-of-patients-hospitalised-with-suspected-or-laboratory-confirme)
Children aged 12 and under and pregnant mothers are able to access remdesivir through a separate compassionate use scheme.
The supply allocation to individual NHS hospitals will be determined each week.
New registrations to the EAMS in England have now closed. Trusts must retrospectively complete a remdesivir Blueteq form in order to register patients who have received remdesivir and in order to receive further allocated stock.
|
CAS Alert 12.06.20: Update - Early Access to Medicines Scheme for remdesivir in the treatment of COVID-19. Implementation of the scheme and management of supply
COVID-19 Therapeutic Alert: Publication of an interim clinical commissioning policy - Remdesivir for patients hospitalised with COVID-19 (adults and children aged 12 years and older)
CUH Pharmacy SOP
CUH Policy: Remdesivir for COVID-19: clinical management for supply under the Early Access for Medicines Scheme
Early access to medicines scheme (EAMS) scientific opinion: Remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection who meet the clinical criteria
UK Interim Clinical Commissioning Policy: Remdesivir for patients hospitalised with COVID-19 (adults and children 12 years and over)
|
Sea water microdiffusion spray (Sterimar breathe-easy baby®)
|
Restricted
|
Medical device JDTC Jan ’18:- For infants [obligate nasal breather] with blocked nasal passages from secretions second line is N/saline drops ineffective o Clinically and financially approved o Formulary status: Hospital only
|
|
Secretin (Diagnostic)
|
Restricted
|
Enhances diagnostic pancreatic imaging.
|
|
Sildenafil (Revatio®)
|
Restricted
|
- Revatio 10mg/12.5ml solution for injection vials
- JDTC April 2019 -Clinically approved as a 2nd line additional agent for pulmonary hypertension in neonates especially in cases with congenital diaphragmatic hernia (CDH),when nitrous oxide alone ineffective, and patient is NBM so cannot have oral sildenafil
- Suggested dosing 25 mcg/kg/hour (note per HOUR, not per minute) increasing every 6-12 hours by 25 mcg/kg/hour to a maximum of 100 mcg/kg.hour i.e (0.6mg/kg/day- 2.4mg/kg/day), normally fro a max. of 7 days
|
|
Sodium Benzoate (injection, oral solution, tablets) (Injection, oral solution)
|
Restricted
|
- 2g/10ml injection, 500mg/5ml oral solution, 125mg/5ml oral solution (paeds only), 500mg tablets
- For urea cycle disorders, for paediatric use must be specialist advice only
|
|
Sodium Nitroprusside (Injection)
|
Restricted
|
Hypertensive crisis only.
|
|
Sodium Phenybutyrate (oral liquid, injection)
|
Restricted
|
- Urea cycle disorders
- Tablets and granules also allowed and these are licensed
- For paeds metabolic disorders on specilaist advice only
|
|
Sodium thiosulphate anhydrous (STS) 80mg/mL (8%)
|
Restricted
|
- CUHFT only - these will be dispensed from clinical trials dispensary for named patients only (FOC) for prevention of cisplatin-induced hearing loss.
|
|
Spectinomycin (Injection )
|
Restricted
|
Clinic 1A only.
|
|
Spiromycin (Tablet)
|
Restricted
|
Toxoplasmosis in pregnancy.
|
|
Stiripentol (Diacomit®) (Tablet, Sachet, Capsules)
|
Restricted
|
Severe myoclonic epilepsy in infancy.
Shared care in place.
|
|
Sulfadiazine 500mg/5ml liquid
|
Restricted
|
For toxoplasmosis in paeds
|
|
Sulthiame (Tablets)
|
Restricted
|
Benign rolandic epilepsy and other focal epilepsies as per NICE guidance.
50mg and 200mg tablets.
|
|
Tacrolimus (Suppositories)
|
Restricted
|
JDTC Dec 2015
- Tacrolimus suppositories (Licensed drug, unlicensed formulation and indication) clinically and financially approved for use in refractory proctitis unresponsive to first-line agents have been approved for use in up to 20 patients per annum by the gastroenterologists, subject to an audit being completed assessing safety and efficacy at year 1.
- Hospital only.
- Dose 2mg twice daily for weeks (treatment should be discontinued after 4 weeks or one week after a patient enters clinical remission). The anticipation is that a patient may require up to 3 courses per annum
Batch has expiry date of 30 days
|
|
Taliglucerase Alfa (Injection )
|
Restricted
|
200 units Treatment of Gaucher disease until the supply problems with Cerezyme were resolved.
|
|
Tofacitinib
|
Restricted
|
October 2013 JDTC
- FOC supply only.
- Rheumatoid arthritis treatment licensed in the US.Patients to be cesased if compassionate access programme ceased.
JDTC Jan '18 Approved as per NICE TA Bluteq required
Oct 2018 JDTC:-
- Approved for use in ulcerative colitis via free of charge scheme from manufacturer. Full NICE TA is due imminently
|
Letters to healthcare professionals February 2020: Xeljanz▼ (tofacitinib) - increased risk of venous thromboembolism and increased risk of serious and fatal infections
MHRA Drug Safety Update March 2020: Tofacitinib (Xeljanz▼) - new measures to minimise risk of venous thromboembolism and of serious and fatal infections
|
Tolazoline
|
Restricted
|
For use by consultant paediatricians ONLY (neonatal).
|
|
Tranexamic Acid (Oral Solution )
|
Restricted
|
500mg/5mL
JDTC clinically approved May 2016 for short-term use in paediatrics only (estimated 15 patients per annum), subject to division approving cost pressure.
If continued at discharge for short-term use hospital to supply- not available in primary care.
|
|
Tranexamic Acid (Liquid)
|
Restricted
|
Bleeding disorders - approved for short term usage of no more than 7 dys. Long term use needs to be re-reviewed at JDTC.
|
|
Triamcinolone + 5-fluorouracil (Injection)
|
Restricted
|
Adcortyl® 10mg/mL Kenalog® 40mg/mL For keloid scarring when triamcinolone alone is ineffective. Extemporaneous preparation, liaise with Cytos Pharmacy regarding patient scheduling and product availability. 5-FU prepared in Cytos Pharmacy - Paper prescription available in clinic.
|
|
Triflurothymidine 1% (Eye Drops)
|
Restricted
|
Ophthalmology only Herpes Simplex cornealinfection (2nd line to aciclovir)
|
|
Trometamol (THAM)
|
Restricted
|
C2 SCBU TH8
Use in NICU as alternative to sodium bicarbonate for acidosis management.
|
|
|
20.01 |
Off-Label Use of Medicines |
|
|
|
Medicines that are licensed but being used for an indication that is not licensed. |
|
Acetylcysteine (Injection )
|
Restricted
|
- Injection given orally.
- Limited evidence.
- Dr Fitzgerald for gastroendoscopy. The use of acetylcysteine provided better visual examination of the GI tract, stomach and oesophagus, therefore enhancing early diagnosis.
- Off-label for meconium ileus in neonates (often these neonates go on to be diagnoses with CF) and Distal Intestinal Obstructive syndrome in CF
|
|
Alemtuzumab
|
Restricted
|
Oncologists for BMT and CLL patients. Vasculitis. Kidney and kidney/pancreas transplant. Available via PAS.
|
|
Aprotinin
|
Restricted
|
Patients undergoing liver transplantation: 1. 2nd line when not responding to tranexamic acid. 2. With fulminant hepatic failure.
|
|
Basiliximab (Injection)
|
Restricted
|
Maintenance of immunosuppression following intestinal transplant for small cohort of patients being treated by Dr Massey.
|
|
Belatacept (Nulojix®) (Injection)
|
Restricted
|
Clinically approved for organ transplant recipients who are: • EBV seropositive AND • Intolerant of first-line immunosuppressive therapy (for example thrombotic microangiopathy with tacrolimus/ciclosporin, acute tubular necrosis with tacrolimus/ciclosporin, ymphocele with sirolimus) AND • In whom maintenance immunosuppression with an anti-proliferative agent (mycophenolate mofetil or mycophenolate sodium) and steroids alone is insufficient. NOT ROUTINELY FUNDED. NEW PATIENTS REQUIRE FUNDING APPROVAL BEFORE INITIATING.
|
|
Bevacizumab (Avastin®) (Intravitreal injection)
|
Restricted
|
Off-label intravitreal use (pre-filled syringes obtainable from Moorfields) for the following indications: • Neovascular glaucoma • For non-age related wet AMD • Anterior progressive ROP in neonates
|
|
Botulinum Toxin Type A (Injection)
|
Restricted
|
Consultant recommendation only
li>Warning: Units are not equivalent to Botox units.
Choice of botulinum toxin A across the Trust is under review (currently Dysport).
Indications on Formulary for hospital use only in accordance to prior approval documents(Dysport unless otherwise indicated - under review)
1) Severe Blepharospasm in Adults
2) Dysphagia caused by Achalasia
3)Focal Spasticity after Brain or Spinal Lesions or neurodegenerative Conditions
4)Torsion dystonias and other involuntary movements
5)Low compliance/low capacity bladders in paediatrics
6)Hyperhidrosis (axillae only
7)Prophylaxis of migraine as per NICE TA 260 (administered through headache clinic)
8)Musculoskeletal spasticity in cerebral palsy
9)Spasticity in multiple sclerosis
10)Contracture of the joint in multiple sclerosis
11)Detrusor Overactivity
12)Anal outlet obstruction in patient with internal anal sphincter achalasia and Hirschsprung disease
13)Anal fissure
14) Open abdomen following laparotomy surgery (funded by division)
*PLEASE SEE CPJPG DRUG CLASSIFICATION DOCUMENT FOR LINKS TO PRIOR APPROVAL DOCUMENTS AND SUPPORTING INFORMATION*
|
Group Prior Approval Forms for CCG Commissioned Indications
|
Cabergoline (Tablet)
|
Restricted
|
April 2013 JDTC: Prevention of ovary hyper stimulation syndrome due to IVF complications.
|
|
Calcium Folinate
|
Restricted
|
Paediatric neurologists for epilepsy in children with suspected folinic acid responsive seizures.
|
|
Carvedilol (Tablet)
|
Restricted
|
Prophylaxis of variceal bleeding.
|
|
Deferasirox (Tablet)
|
Restricted
|
Via homecare in up to 15 patients per year, currently funded through the Trust.
Not routinely commissioned by either NHSE or CCG for: - Iron chelation in Myelodysplastic Syndrome - Clinically approved at JDTC December 2016. - CCG reviewing January 2017.
*Note as of June 2017, the dispersible tablets will be discontinued and a film-coated alternative will be available. The film-coated tablet is formulated in different strengths and the bioavailbility is different.case of switching from dispersible tablets to film-coated tablets, the dose of the film-coated tablets should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole tablet.Please refer to SPC for furtehr details
|
|
Desferrioxamine (Subcutaneous injection )
|
Restricted
|
Not routinely commissioned by either NHSE or CCG for: - Iron chelation in Myelodysplastic Syndrome - Clinically approved at JDTC December 2016. - CCG reviewing January 2017.
|
|
Diamorphine (Intanasally)
|
Restricted
|
The injection may be used intranasally in children on AED only.
|
|
Dornase/Alteplase
|
Restricted
|
Empyema (for patient who have not responded to intercostal drainage).
|
|
Doxycycline
|
Restricted
|
Percutaneous sclerotherapy in 5-10 children per year.
|
|
Foscarnet (Intra-vitreal)
|
Restricted
|
- CUHFT: Approved for use as a stat dose (rarely repeated once) for severe cases of acute retinal necrosis. Hospital only via inpatient pharmacy.
- NWAFT: Approved for severe acute retinal necrosis. Hospital only.
|
|
Fosfomycin (Injection)
|
Restricted
|
Clinically approved by JDTC for mutli-drug resistant organisms: carbapenemase-producing Enterobacteriaceae (CPE. Microbiology input needed) High cost drug. Funding approved by investment review board subject to usage reports being maintained and provided to JDTC at 6 months and then 9 months to ensure usage remains within scope.
|
|
Glycopyrronium Bromide 0.05% (Solution)
|
Restricted
|
For patients with excessive sweating. Endocrinologists and dermatologists.
|
|
Iloprost (Injection)
|
Restricted
|
Iv ( unlicensed product)
Vasculitis - for limb ischaemia. Rheumatologists - for peripheral vascular disease.
|
|
Indocyanine Green
|
Restricted
|
Used for staging in breast cancer.
|
|
Infliximab (Injection)
|
Restricted
|
*Inflectra® as brand of choice. If you require any support with prescribing please contact biologics pharmacy team on distribution list ‘pharmacy biologics’.*
1.All new Infliximab patients to be prescribed Inflectra.
2.All infliximab prescriptions to be prescribed using a therapy plan in EPIC.
- Ipilimumab associated Immune-related diarrhoea.
|
|
Ketamine (Oral solution)
|
Restricted
|
Palliative Care - ketamine oral solution for neuropathic pain. Local pain pathway in place (primary care)- secondary care in development.
|
|
Ketamine (Preservative Free Injection)
|
Restricted
|
Paediatric anaesthesia.
|
|
Lidocaine 5% (Versatis®) (Patches)
|
Restricted
|
See section 15.02
|
|
Mecasermin (Injection)
|
Restricted
|
Severe insulin resistance national service.
Not agreed and commisisoned for growth failure in Addenbrookes.
|
|
Mepivacaine (Injection)
|
Restricted
|
Chiropodists only.
|
|
Mitomycin C
|
Restricted
|
Non-oncology indications on Formulary Off-Label: 1) Ophthalmologists - to prevent scarring following trabeculectomy. 2) Airway stenosis (in adults)
|
|
Neomycin (Nivemycin®) 500mg tablets/Metronidazole 400mg tablets/Macrogols (Moviprep®) sachets
|
Restricted
|
JDTC July 2018: Moviprep, neomycin and metronidazole combination ( mechanical bowel preparation and antibiotics) for elective bowel cancer resections in adults approved for use on day prior to surgery as follows;
Macrogol (2 x sachet and 2 sachet B- given as A +B) twice daily
Neomycin 1g three times daily
Metronidazole 400mg three times daily
To be prescribed by surgeon in clinic, dispensed from Lloyds
|
|
Pyridoxal phosphate (Capsule)
|
Restricted
|
- CUH: Paediatric neurologists for epilepsy in children with suspected pyridoxal phosphate sensitive seizures or folinic acid responsive seizures.
|
|
Ribavirin (Copegus®) (Tablet)
|
Restricted
|
Hepatitis E in immunocompromised haemato-oncology patients.
Chronic hepatitis C treatment in children age 3+ (in combination with pegylated interferon).
|
|
Rivaroxaban (Tablet)
|
Restricted
|
- JDTC April 2015 approved for thromboembolism prophylaxis in lower limb injury requiring immobilisation started in ED only in 16 years and over (off label use).
- JDTC May 2016 Clinically approved for VTE prophylaxis in acetabular and pelvic fracture for 3 months by Orthopaedic team. Funding/tariff now agreed.Full 12 weeks to be supplied from Lloyds (off label use).
- JDTC February 2019 approved for superficial thrombophlebitis - 10mg daily for 6 - 12 weeks. Hospital only via Lloyds OP (off label use).
|
MHRA Drug Safety Update July 2019: Rivaroxaban (Xarelto▼) - Reminder that 15 mg and 20 mg tablets should be taken with food
|
Sarilumab (Injection)
|
Restricted
|
- Interim Position Statement: Interleukin-6 inhibitors (tocilizumab or sarilumab) for patients admitted to ICU with COVID-19 pneumonia (adults): Clinicians should consider prescribing intravenous tocilizumab following the criteria defined in the interim position statement for patients in intensive care. Intravenous sarilumab could be considered as an alternative (if available).
|
Interim Position Statement: Interleukin-6 inhibitors (tocilizumab or sarilumab) for patients admitted to ICU with COVID-19 pneumonia (adults)
|
Sirolimus (Tablet)
|
Restricted
|
Polycystic liver disease.
|
|
Sodium thiosulphate injection for solution 25%(12.5g/50mls)
|
Restricted
|
JDTC Dec 17:
Approved for use off-label to treat calciphylaxis in dialysis patient in patients with End Stage Renal Failure (CKD 5)
|
|
Sulfadiazine (Tablet)
|
Restricted
|
Clinic 1A/ID only for toxoplasmosis.
|
|
Tocilizumab (Injection)
|
Restricted

|
- As per NHSE Commissioning policy for Takayasu arteritis.
- JDTC July 2018: Approved for use as per NICE TA 518 criteria
- Interim Position Statement: Interleukin-6 inhibitors (tocilizumab or sarilumab) for patients admitted to ICU with COVID-19 pneumonia (adults): Clinicians should consider prescribing intravenous tocilizumab following the criteria defined in the interim position statement for patients in intensive care. Intravenous sarilumab could be considered as an alternative (if available).
|
Interim Position Statement: Interleukin-6 inhibitors (tocilizumab or sarilumab) for patients admitted to ICU with COVID-19 pneumonia (adults)
MHRA Drug Safety Update July 2019: Tocilizumab (RoActemra) - rare risk of serious liver injury including cases requiring transplantation
|
Valaciclovir (Valtrex®) (Tablets)
|
Restricted
|
- CUHFT: Hospital only via Lloyds for acute retinal necrosis. Usual dosage 2g three times daily for 3 weeks followed by 1g three times daily for 3 months.
June 2020 - Supply issues with valaciclovir 500mg tablets
- Ranbaxy and Aurobindo the generic suppliers are both out of stock with resupply dates to be confirmed.
- GSK, the supplier of the brand Valtrex, has confirmed sufficient supplies are available to meet normal UK demand.
|
|
Zuclopenthixol (Clopixol®) (Tablet)
|
Restricted
|
For Gauchers Disease.
|
|
20.02 |
CUH Dermatolgy Specials |
|
|
|
This is a selection of dermatology products approved for use on the CUH formulary that appear on the British Association of Dermatology (BAD) List. Note many of these are 'specials' and unlicensed |
|
Cade oil ointment (Ointment)
|
Restricted
|
12%:6% 6%:3% Only for severe scalp psoriasis.
|
|
Cidofovir cream (in Unguentum M) (Cream)
|
Restricted
|
1%. Not in BAD list.
|
|
Coal tar in yellow soft paraffin (Ointment)
|
Restricted
|
1% 2% 5% 10% 20% May be long-term or repeated treatment.
|
|
Coal Tar solution in Betnovate (Ointment)
|
Restricted
|
5% and 10%.
|
|
Crude coal tar, salicylic acid 2% in emulsifying ointment (Ointment)
|
Restricted
|
1% 2% 5% 10% 20% May be long-term or repeated treatment.
|
|
Diphenylcyclopropanone in acetone
|
Restricted
|
Alopecia arreata.
|
|
Dithranol in Lassar’s Paste (Paste)
|
Restricted
|
0.1% 0.25% 0.5% 1% 2% 4% 8% 12% Occasionally longer term treatment is required.
|
|
Formaldehyde (Formalin) (Solution )
|
Restricted
|
- 40% diluted to 4% soak.
- For soaking warts.
|
|
Glycopyrrolate in cetimacrogol cream (Cream)
|
Restricted
|
0.5% and 1%.
|
|
Hydroquinone 5%, hydrocortisone 1% and Retin A cream (Pigmanorm) (Cream)
|
Restricted
|
|
|
Hydroquinone in aqueous cream (Cream)
|
Restricted
|
4%
|
|
Podophyllum in Tinct Benz Co Paint (Paint)
|
Restricted
|
Not in BAD list.
|
|
Propylene glycol in aqueous cream (Cream)
|
Restricted
|
20% and 40% Short term use.
|
|
Propylene glycol in dermovate (Cream)
|
Restricted
|
20% and 40%.
|
|
Salicylic acid and sulphur cream (Cream)
|
Restricted
|
2%:2% May be long-term or repeated treatment. Not used very often.
|
|
Salicylic acid in aqueous cream (Cream)
|
Restricted
|
2% May be long-term or a repeated treatment.
|
|
Salicylic acid in Arachis oil (Oil)
|
Restricted
|
2% Safe combination. Very useful for very thick scaling in the scalp. Washes out easily (compared to Sebco etc) and does not smell.
|
|
Sunscreen (Dundee Formula) (Ointment)
|
Restricted
|
|
|
Trichloroacetic acid
|
Restricted
|
50% 90% 100%
|
|
Urea in half strength Lassar’s Paste (Paste)
|
Restricted
|
20% and 40%. For hair removal.
|
|
.... |
Non Formulary Items |
3, 4 Diaminopyridine

|
Non Formulary
|
- Commissioned by NHSE for LEMS
- Not approved on formulary until a full business case is received and considered. Applications in the itnerim via a chairs action request
- If clinically approved, clinician required to submit a request/disclaimer to manufacturer to request they supply
|
|
5 hydroxytryptophan

|
Non Formulary
|
- Dihydropteridine reductase deficiency
|
|
Amitriptyline 25mg suppositories

|
Non Formulary
|
*Note 25mg suppositories are unlicensed and non formulary* |
|
Ammonium chloride 500mg capsules

|
Non Formulary
|
|
|
Anakinra

|
Non Formulary
|
December 2012 JDTC: Inpatient gout flares. Compassionate supply - FOC. JDTC requested a report of the experience with these patients before it could be added to the formulary. |
|
Benzatropine (Injection)

|
Non Formulary
|
- For extrapyramidal symptoms / acute dystonic reactions.
- See section 4.9.2
- See Toxbase for guidance and dosing information.
|
|
Botulinum Toxin Type A (Injection)

|
Non Formulary
|
Reviewed by the Prescribing Authority Committee and not recommedned for:
-massateric hypertrophy
-dysphagia nto cuased by Achalasia
-Facial palsy or following stroke or head trauma
-Hidradenitis Suppurativa
-Mechanical Neck Disorders
-Raynauds disease |
|
Ciprofloxacin 0.2% (Eye drops)

|
Non Formulary
|
Has be replaced with levofloxacin preservative free. |
|
Dehydroepiandrosterone (DHEA) (Tablets)

|
Non Formulary
|
Also know as prasterone. |
|
Dibotermin alfa (recombinant human (Bone Morphogenetic Protein-2; rhBMP-2) (InductOs® 1.5 mg/ml powder, solvent and matrix for implantation matrix)

|
Non Formulary
|
One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa. After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa.
CUHFT: Approved Sept 2018 as per NHSE clinical commissioning policy |
|
Ergocalciferol 3,000units/1ml (Oral Solution )

|
Non Formulary
|
Tend to use colecalciferol liquid, but if not available then ergocalciferol would be used.
|
|
Esketamine (Injection)

|
Non Formulary
|
25mg/5mL Would be used if ketamine is unavailable. |
|
Gusperimus

|
Non Formulary
|
May 2013 JDTC: Refractory vasculitis. Clinically approved but funding needs to be clarified. |
|
Iopanoic Acid (Oral preparation)

|
Non Formulary
|
Commercial production of this product was discontinued in 2009. Professor Chatterjee obtains a laboratory grade product from a laboratory in Japan. Individual chairman’s actions are requested per patient - ongoing. |
|
Muromonab (OKT3)

|
Non Formulary
|
|
|
Neomycin (Nivemycin®) 400mg tablets/Metronidazole 500mg tablets/Macrogols (Moviprep®) sachets

|
Non Formulary
|
JDTC July 2018: Moviprep, neomycin and metronidazole combination ( mechanical bowel preparation and antibiotics) for elective bowel cancer resections in adults approved for use on day prior to surgery as follows;
Macrogol (2 x sachet and 2 sachet B- given as A +B) twice daily
Neomycin 1g three times daily
Metronidazole 400mg three times daily
To be prescribed by surgeon in clinic, dispensed from Lloyds. Patient will still also receive stat dose of i/v antibiotic on day of surgery |
|
Nitazoxanide
|
Non Formulary
|
On recommendation of microbiology or infectious diseases.
Chairman's action required. |
|
Sodium hyaluronate (Cystistat®) (bladder instillation)

|
Non Formulary
|
Second line treatment for cystitis |
|
Sulfapyridine (Capsules)

|
Non Formulary
|
|
|
Sulphamethoxypyridazine (Tablets)

|
Non Formulary
|
Discontinued, and imported supplies do not appear to be available. |
|
Triiodothyroacetic acid (TRIAC)

|
Non Formulary
|
February 2014 JDTC for resitnace to thyroid hormone. Clinically approved subject to: a) Confirmation that there would be a written agreement from the reffering Trusts that they would accept the patient back b) Clarification of funding for drug and pick up prescribing costs.
|
|
|
Key |
|
|
Cytotoxic Drug
|
|
Controlled Drug
|
|
High Cost Medicine
|
|
Cancer Drugs Fund
|
|
NHS England |
|
Homecare |
|
CCG |
|
Traffic Light Status Information
Status |
Description |

|
Available Over the Counter. Consider Self Care |

|
Formulary - Can be prescribed in both secondary and primary care. |

|
Formulary - Specialist Advice, secondary care advice provided for primary care initiation. |

|
Formulary - Specialist initiation without shared care guidance. |

|
Formulary - Specialist initiation with shared care guidance. |

|
Restricted - Prescribing (and monitoring where applicable) to remain with the hospital or specialist service. Not to be prescribed in Primary Care |

|
Not recommended for prescribing. Switch to alternative cost-effective option. |

|
Not recommended for prescribing in primary or secondary care. |

|
Not recommended as no formal application made for addition to the formulary. Contact relevant pharmacy team for further information.
|

|
Non-Formulary (category under review). |
|
|
|