Formulary Chapter 7: Obstetrics, Gynaecology, and urinary-tract disorders - Full Chapter
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Chapter Links... |
County Durham and Darlington Adult Bladder and Bowel formulary First Line Prescribing Guide 2023 |
NICE NG118: Renal and ureteric stones: assessment and management |
NICE NG123: Urinary incontinence and pelvic organ prolapse in women: management |
NICE NG126: Ectopic pregnancy and miscarriage: diagnosis and initial management |
North of Tyne, Gateshead and North Cumbria - Catheter Formulary and Guidance (Sep 2021) |
North of Tyne, Gateshead and North Cumbria - Catheter Info Sheet |
North of Tyne, Gateshead and North Cumbria - Urinary Continence Enablement Products and Devices Formulary 2021 |
North of Tyne, Gateshead and North Cumbria Area Prescribing Committee - Urology Guidelines |
Tees Urinary Continence Formulary February 2020 |
Details... |
07.04 |
Drugs for genito-urinary disorders |
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07.04.01 |
Drugs for urinary retention |
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07.04.01 |
Alpha-blockers |
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Tamsulosin 400microgram MR capsules
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First Choice
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Alfuzosin 2.5mg tablets and 10mg XL tablets
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Alternatives
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Doxazosin 1mg, 2mg and 4mg tablets
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Alternatives
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- MR formulations are not approved
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Prazosin
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Alternatives
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07.04.01 |
Parasympathomimetics |
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07.04.01.02 |
5-Alpha reductase inhibitors |
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Dutasteride
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Formulary
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Finasteride
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Formulary
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07.04.02 |
Drugs for urinary frequency, enuresis, and incontinence |
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07.04.02 |
Urinary incontinence |
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Oxybutynin
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First Choice
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- 2.5mg in 5ml & 1mg/1ml oral solution
- Immediate release oxybutinin is not appropriate for frail elderly people or those with cognitive impairment.
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Solifenacin
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First Choice
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Tolterodine 1mg and 2mg tablets
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First Choice
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Darifenacin
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Formulary
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Duloxetine
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Formulary
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- Capsules: 20mg, 40mg
- Moderate to severe stress incontinence in combination with supervised pelvic floor excercises only
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Fesoterodine
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Formulary
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Propiverine
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Formulary
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Trospium
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Formulary
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Mirabegron
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Alternatives
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- Approved for use when antimuscarinics don’t work, are not suitable or side effects are unacceptable, in line with NICE guidance.
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NICE TA290: Mirabegron for overactive bladder
MHRA Drug Safety Update (Oct 2015): Mirabegron - risk of severe hypertension and associated cerebrovascular and cardiac events
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Oxybutynin Hydrochloride - patch
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Alternatives
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- Oxybutinin patch 36mg (releases approximately 3.6mg in 24 hours).
- Approved for patients in whom two antimuscarinics have proved to be efficacious but the side effects are intolerable, or for patients who cannot swallow tablets.
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Methylphenidate (Giggle incontinence)
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Alternatives
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- Methylphenidate is approved for use as a third line option (after e.g. antimuscarinics, imipramine, and pelvic floor exercises) in the treatment of giggle incontinence in children. Its use should be subject to a therapeutic trial to be reviewed after two months and considered for Shared Care if patients have been shown to respond after the trial period.
- The following methylphenidate formulations are approved for giggle incontinence:
- 5mg & 10mg tablets.
- 10mg, 20mg & 30mg m/r capsules (Equasym XL®).
- 18mg, 27mg & 36mg m/r tablets (Xaggitin® XL)
- Existing patients who are prescribed Concerta® XL should be reviewed and switched to Xaggitin® XL as appropriate
- Xaggitin® XL is bioequivalent to Concerta® XL
- The effects of Equasym® XL last for about 8 hours compared with about 12 hours for Xaggitin® XL.
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MHRA Drug Safety Update (Sep 2022): Methylphenidate long-acting (modified-release) preparations: caution if switching between products due to differences in formulations
North of Tyne, Gateshead and North Cumbria: Giggle Incontinence in children & young people aged 8 to 18 years
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Vaginal Devices
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Alternatives
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- Vaginal Devices for female stress urinary incontinence (e.g. Diveen, Contiform, Efemia)
- Approved for use in line with NTAG / NICE
- Product should only be initiated by a specialist pelvic health physiotherapists and specialist nurses
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NICE NG210: Pelvic floor dysfunction: prevention and non-surgical management
NTAG: Vaginal devices for female urinary stress incontinence
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07.04.02 |
Nocturnal enuresis |
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Amitriptyline
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Formulary
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- 10mg, 25mg and 50mg tablets
- 25mg in 5ml sugar-free oral solution is also approved for use.
- Green plus for the treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products.Should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis
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Desmopressin
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Formulary
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- The following formulations are approved:
- 100microgram and 200 microgram tablets;
- 120 microgram sublingual tablets.
- Note: nasal formulations no longer licensed for treating nocturnal
enuresis (see section 6.5.2 for other formulations).
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Desmopressin (Noqdirna®)
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Formulary
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- Oral lyophilisates: 25microgram, 50 microgram
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Information leaflet for primary care: Noqdirna (desmopressin oral lyophilisate)
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Imipramine
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Formulary
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- 10mg and 25mg tablets
- 25mg in 5ml syrup is also approved. unlicensed.
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07.04.02 |
antimuscarinics |
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07.04.02 |
beta3-adrenoceptor agonists |
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07.04.02 |
botulinum toxin |
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07.04.03 |
Drugs used in urological pain |
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Sodium Hyaluronate (Hyacyst® 120)
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Formulary
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- Prefilled syringe: 120mg/50ml
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07.04.03 |
Alkalinisation of urine |
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Potassium Citrate Mixture
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Formulary
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- potassium citrate 3g & citric acid 500mg in 10ml
Note: for the treatment of mild cystitis potassium citrate mixture is suitable for self-care.
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Conditions for which over the counter items should not routinely be prescribed in primary care: Guidance for CCGs
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07.04.03 |
Treatment of interstitial cystitis |
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Pentosan Polysulphate Sodium (Elmiron®)
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Formulary
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- Approved for treating bladder pain in line with NICE
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NICE TA610: Pentosan polysulfate sodium for treating bladder pain syndrome
MHRA Drug Safety Update (Sept 2019): Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathy
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07.04.03 |
Other preparations for urinary disorders |
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07.04.04 |
Bladder instillations and urological surgery |
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Sodium hyaluronate 40mg in 50ml solution (Cystistat®)
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Formulary
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- For instillation into the bladder.
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Sodium hyaluronate (1.6%)/sodium chondroitinsulphate (2%) (Ialuril® )
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Formulary
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- Ialuril® is a 50ml solution for instillation into the bladder approved as second line treatment in patients who have failed Cystistat.
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Chondroitin sulfate (Gepan Instill®) (Bladder Installation)
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Formulary
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- Approved the treatment of:
- Interstitial cystitis/painful bladder syndrome
- Radiation cystitis
- Recurring bacterial cystitis
- Overactive bladder
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Glycine 1.5% solution
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Formulary
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- 1.5% large volume solutions (up to 3 litres).
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Sodium chloride 0.9% solution
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Formulary
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- Large volume solutions (up to 3 litres).
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Sodium Hyaluronate (Hyacyst®)
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Formulary
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Water
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Formulary
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- Large volumes - up tp 3 litres.
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Whitmore cocktail
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Unlicensed
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- Whitmore cocktail is a 60ml bladder installation containing hydrocortisone 100mg, heparin Sodium 10,000units, and bupivacaine 50mg in Sodium Chloride 0.9%.
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07.04.04 |
Urological surgery |
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07.04.04 |
Maintenance of indwelling urinary catheters |
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Catheter Patency Solutions (Chlorhexidine 0.02%)
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Formulary
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- Chlorhexidine 0.02% (1 in 5,000) solution in 100ml sachets.
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Catheter Patency Solutions (Sodium chloride 0.9%)
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Formulary
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- Sodium chloride 0.9% solution in 100ml sachets.
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Catheter Patency Solutions (Urotainer Twin Solution R®) (Solution R)
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Formulary
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- Solution R 2 x 30ml sachets (citric acid 6%, gluconolactone 0.6%, magnesium carbonate 2.8%, disodium edetate 0.01%)
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Catheter Patency Solutions (Urotainer Twin Suby G®) (Solution G)
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Formulary
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- Solution G 2 x 30ml sachets (citric acid 3.23%, magnesium oxide 0.38%,
sodium bicarbonate 0.7%, disodium edetate 0.01%)
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07.04.05 |
Drugs for erectile dysfunction |
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Sildenafil
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First Choice
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- Approved for the treatment of erectile dysfunction
- Also approved for specialist use in treating:
- Pulmonary hypertension (see section 2.5.1a)
- Secondary Raynaud’s disease.
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MHRA Drug Safety Update (Nov 2018): Sildenafil (Revatio and Viagra): reports of persistent pulmonary hypertension of the newborn (PPHN) following in-utero exposure in a clinical trial on intrauterine growth restriction
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Tadalafil
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Second Choice
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- 10mg and 20mg tablets
- Approved for the treatment of erectile dysfunction
- Also approved for specialist use in treating secondary Raynaud's disease.
- 5mg tablets (once daily)
- Approved for the treatment of erectile dysfunction (in accordance with SLS criteria)
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NTAG: Daily vs on-demand phosphodiesterase-5 (PDE-5) inhibitors for the management of erectile dysfunction following treatment for prostate cancer
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Vardenafil
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Formulary
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- 5mg, 10mg and 20mg tablets
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Alprostadil (Vitaros® & Muse® )
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Alternatives
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- Vitaros® 3mg/g cream
- Muse® 500microgram, and 1mg.
Treatment with alprostadil cream (Vitaros®) is NOT approved for use in County Durham and Tees Valley
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Aviptadil 25microgram/phentolamine 2mg solution for injection (Invicorp®)
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Alternatives
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- 25microgram/phentolamine 2mg solution for injection.
- Approved as first choice intracavernosal injection option.
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Alprostadil (Caverject® & Viridal Duo®)
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Alternatives
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- Approved as the second choice intracavernosal injection option.
- Caverject® 10 & 20 microgram injections (Caverject® dual chamber injections are easier to use and less expensive than the vials).
- Viridal Duo® 10, 20 and 40 microg starter pack and dual chamber injection (approved for use whilst supply issues surrounding Caverject® are ongoing).
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07.04.06 |
Drugs for premature ejaculation |
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Description |
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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. |
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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. |
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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. |
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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. |
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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. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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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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