Formulary Chapter 7: Obstetrics, Gynaecology, and urinary-tract disorders - Full Chapter
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Chapter Links... |
FSRH Clinical Guideline: Contraceptive Choices for Young People |
FSRH: Standards & Guidance |
FSRH: UK Medical Eligibility Criteria for Contraceptive Use (UKMEC) |
LSCMMG: Primary Care Management of Erectile Dysfunction |
LSCMMG: Primary Care Management of Overactive Bladder in Female Adults |
MHRA: Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed? |
NICE CG30: Long-acting reversible contraception |
NICE CG97: Lower urinary tract symptoms in men: management |
NICE NG123: Urinary incontinence and pelvic organ prolapse in women: management |
NICE NG133: Hypertension in pregnancy: diagnosis and management |
NICE NG194: Postnatal care |
NICE NG210: Pelvic floor dysfunction: prevention and non-surgical management |
NICE NG3: Diabetes in pregnancy: management from preconception to the postnatal period |
NICE NG88: Heavy menstrual bleeding: assessment and management |
Details... |
07.01 |
Drugs used in obstetrics |
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Omega-3-acid ethyl esters
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Formulary
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Capsules 1000mg
Preterm birth risk reduction.
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MHRA: Omega-3-acid ethyl ester medicines (Omacor/Teromeg 1000mg capsules): dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors
NHSE: NORTH WEST GUIDELINE PRETERM BIRTH
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07.01.01 |
Prostaglandins and oxytocics |
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Carbetocin
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Formulary
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100 microgram per 1 ml
Prevention of postpartum haemorrhage.
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NICE NG235: Intrapartum care
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Dinoprostone
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Formulary
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Propess VDS 10mg Prostin E2 vaginal gel 1mg, 2mg Prostin E2 vaginal tabs 3mg
Induction of labour.
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NICE NG207: Inducing labour
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Ergometrine Maleate
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Formulary
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Injection 500micrograms/1mL
Postpartum haemorrhage.
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Misoprostol
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Formulary
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Tablets 200micrograms
Induction of abortion. Unlicensed indication
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NICE NG140: Abortion care
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Oxytocin
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Formulary
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Injection 10 units/1mL, 5 units/1mL
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Ergometrine Maleate and Oxytocin (Syntometrine®)
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Formulary
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Injection ergometrine 500micrograms, oxytocin 5 units/1mL
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Carboprost (Hemabate®)
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Formulary
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Injection 250micrograms/1mL
Postpartum haemorrhage.
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07.01.01.01 |
Drugs affecting the ductus arteriosus |
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07.01.01.01 |
Maintenance of patency |
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07.01.01.01 |
Closure of ductus arteriosus |
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Dinoprostone
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Formulary
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Injection 1mg/mL 0.75mL
Maintaining patency of the ductus arteriosus.
Unlicensed indication.
Under expert supervision. This section is not included in the BNF. For the management of ductus arteriosus, see BNF for Children.
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Ibuprofen (Pedea®)
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Formulary
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Injection 10mg/2ml
Closure of ductus arteriosus
Under expert supervision. This section is not included in the BNF. For the management of ductus arteriosus, see BNF for Children.
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07.01.02 |
Progesterone receptor modulators |
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Mifepristone
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Formulary
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Tablets 200mg
Termination of pregnancy.
Follow Trust policy on authorisation to prescribe and prescription requirements.
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NICE NG140: Abortion care
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07.01.03 |
Myometrial relaxants |
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Atosiban
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Formulary
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Injection 6.75 mg/0.9mL, concentrate for infusion 37.5 mg/5mL
Uncomplicated premature labour
Second line option when other options have failed or are unsuitable.
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Nifedipine
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Formulary
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Capsules 10mg
Uncomplicated premature labour unlicensed indication
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Salbutamol injection
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Formulary
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Concentrate for intravenous infusion 5mg/5mL
Uncomplicated premature labour
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Terbutaline injection
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Formulary
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Injection 500micrograms/1mL
Uncomplicated premature labour.
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07.02 |
Treatment of vaginal and vulval conditions |
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Vaginal dilators (Amielle Comfort)
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Formulary
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Sexual pain-penetration disorder (SPPD) in combination with pychosexual therapy.
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Ospemifene
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Formulary
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Vulvovaginal or vaginal atrophy in postmenopausal women.
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LSCMMG: Ospemifene
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07.02.01 |
Preparations for vaginal and vulval changes |
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07.02.01 |
Topical HRT |
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Transdermal oestrogens are absorbed and should be used in the smallest effective amount and if required long term should be combined with an oral progestogen in women with an intact uterus. For low-dose vaginal oestrogen, a progesterone is not needed for endometrial protection, as systemic absorption of vaginal oestrogen is minimal. |
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Estradiol vaginal 10 microgram tablet
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Formulary
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Vaginal tablets 10microgram
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MHRA: Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping
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Estriol cream
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Formulary
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0.1% vaginal cream, 0.01% vaginal cream
Currently estriol vaginal cream can be prescribed in two forms:
· Estriol 0.1% (Ovestin®) cream which contains 0.5mg estriol per 0.5g application
· Estriol 0.01% (formerly Ortho-Gynest®) cream which contains 0.5mg estriol per 5ml application
Despite Ovestin® 0.1% cream being 10 times stronger, the amount of cream delivered per application is 10 times less than that of Estriol 0.01% cream, meaning that both creams deliver an identical amount of estriol per application, that being 0.5mg.
Contains nuts - contraindicated in patients with hypersensitivity to nuts
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Estriol gel 50mcg/g
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Formulary
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2nd line agent - only to be considered in women who are unable to use estriol pessaries.
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Estriol pessaries
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Formulary
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0.03mg pessaries, 0.5mg pessaries
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Oestrogens, Topical (Estring®)
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Formulary
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Only used in patients who can't use gel or patches.
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Prasterone
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Formulary
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Vulvovaginal or vaginal atrophy in postmenopausal women having moderate to severe symptoms.
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LSCMMG: Prasterone
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07.02.01 |
Non-hormonal preparations |
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07.02.02 |
Vaginal and vulval infections |
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07.02.02 |
Fungal infections |
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Clotrimazole
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Formulary
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Pessary 500mg Vaginal cream 10% Cream 1%
Consider OTC purchase for some conditions.
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LSCMMG: Over the Counter Items that Should not be Routinely Prescribed in Primary Care Policy
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07.02.02 |
Other vaginal infections |
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Clindamycin (Dalacin®)
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Formulary
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Vaginal cream 2%
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07.03 |
Contraceptives |
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Provided that women are fully informed of the small risks of venous thromboembolism and do not have medical contraindications, it should be a matter of clinical judgement and personal choice which type of oral contraceptive should be prescribed. |
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07.03.01 |
Combined hormonal contraceptives |
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First-line options are monophasic preparations containing 30 micrograms of oestrogen, plus either norethisterone or levonorgestrel. However, consider the woman's preference, as any combined oral contraceptive (COC) can be offered first-line depending on patient factors and preferences. |
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Combined Hormonal Contraceptives Evra
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Formulary
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FSRH: Combined Hormonal Contraception
MHRA: Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small
MHRA: St John’s wort: interaction with hormonal contraceptives, including implants
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Combined Hormonal Contraceptives oral
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Formulary
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FSRH: Combined Hormonal Contraception
MHRA: Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small
MHRA: St John’s wort: interaction with hormonal contraceptives, including implants
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07.03.01 |
Emergency contraception |
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07.03.02 |
Progestogen-only contraceptives |
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07.03.02.01 |
Oral progestogen-only contraceptives |
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Desogestrel
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Formulary
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Tablets 75 micrograms
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MHRA: St John’s wort: interaction with hormonal contraceptives, including implants
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Levonorgestrel
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Formulary
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Tablets 30 micrograms
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MHRA: St John’s wort: interaction with hormonal contraceptives, including implants
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Norethisterone
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Formulary
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Tablets 350 micrograms
Menstrual disorders.
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MHRA: St John’s wort: interaction with hormonal contraceptives, including implants
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07.03.02.02 |
Parenteral progestogen-only contraceptives |
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Etonorgestrel (Nexplanon®)
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Formulary
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Implant 68mg
The doctor or nurse administering (or removing) the system should be fully trained in the technique.
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MHRA: Nexplanon (etonogestrel) contraceptive implants: reports of device in vasculature and lung
MHRA: St John’s wort: interaction with hormonal contraceptives, including implants
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Medroxyprogesterone Acetate
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Formulary
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Injection medroxyprogesterone acetate (Depo-Provera) 150mg/1mL prefilled syringe Injection medroxyprogesterone acetate (Sayana Press) 104mg/0.65mL prefilled syringe
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MHRA: St John’s wort: interaction with hormonal contraceptives, including implants
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07.03.02.03 |
Intra-uterine progestogen-only contraceptive |
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Intrauterine-Progesterone Levonorgestrel IUD (Jaydess®)
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Formulary
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Intra-uterine device system 13.5mg
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LSCMMG: Levonorgestrel
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Intrauterine-Progesterone Levonorgestrel IUD (Kyleena®)
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Formulary
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Intra-uterine device system 19.5mg
Consider in nulliparous patients. Effective for 5 years.
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Intrauterine-Progesterone Levonorgestrel IUD (Mirena® Levosert® Benilexa®)
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Formulary
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Intra-uterine system 20 micrograms/24 hours
Effective for 8 years when used for contraception. Length of effectiveness differs when used for menorrhagia (see BNF).
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07.03.03 |
Spermicidal contraceptives |
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07.03.04 |
Contraceptive devices |
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07.03.04 |
Intra-uterine devices |
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07.03.04 |
Other contraceptive devices |
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07.03.05 |
Emergency Contraception |
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07.03.05 |
Hormonal methods |
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Levonorgestrel
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Formulary
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Tablets 1.5mg
Emergency contraception.
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FSRH: Emergency Contraception
MHRA: Levonorgestrel-containing emergency hormonal contraception: advice on interactions with hepatic enzyme inducers and contraceptive efficacy
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Ulipristal
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Formulary
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Tablets 30 mg
Emergency contraception.
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FSRH: Emergency Contraception
MHRA: Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury
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07.03.05 |
Intra-uterine device |
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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
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Formulary
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M/R capsules 400 microgram
Urinary retention. First line for urinary retention in men.
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Alfuzosin
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Formulary
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Tablets 2.5mg M/R tablets 10mg
Urinary retention.
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Doxazosin
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Formulary
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Tablets 1mg, 2mg, 4mg
Urinary retention.
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LSCMMG: Doxazosin Modified Release
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Solifenacin/Tamsulosin (Vesomni®)
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Formulary
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Modified-release tablets Solifenacin succinate 6 mg, Tamsulosin hydrochloride 400 microgram
Treatment of Storage Symptoms associated with Benign Prostatic Hyperplasia.
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07.04.01 |
Parasympathomimetics |
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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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Urinary incontinence should be categorised at the initial clinical assessment and initial treatment should be started on this basis. During the clinical assessment seek to identify relevant predisposing and precipitating factors and other diagnoses that may require referral for additional investigation and treatment.
Patient’s diagnosed with overactive bladder who are suitable for treatment in primary care should receive non-pharmacological treatment as the first line option.
Anticholinergic medicines can cause problematic adverse effects, especially in those using other medicines that affect total anticholinergic load. |
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Solifenacin
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Formulary
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Tablets 5mg, 10mg
Urinary frequency, urgency, and incontinence.
First line pharmacological therapy for urinary frequency, urgency, incontinence in women.
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Tolterodine
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Formulary
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Tablets 1mg, 2mg, Modified-release capsules 4mg
Urinary frequency, urgency, and incontinence.
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Trospium
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Formulary
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Tablets 20mg, Modified-release capsules 60mg
Urinary frequency, urgency, and incontinence.
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Mirabegron (Betmiga®)
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Formulary
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Modified-release tablets 25mg, 50mg
Urinary frequency, urgency, and incontinence.
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MHRA: Mirabegron (Betmiga▼): risk of severe hypertension and associated cerebrovascular and cardiac events
NICE TA290: Mirabegron for treating symptoms of overactive bladder
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Oxybutynin
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Formulary
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Tablets 2.5mg, 5mg Liquid 2.5mg/5mL M/R tablets 5mg, 10mg
Urinary frequency, urgency, and incontinence.
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Darifenacin
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Formulary
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Modified-release tablets 7.5mg, 15mg
Urinary frequency, urgency, and incontinence.
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Duloxetine (Yentreve®)
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Formulary
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Capsules 20mg, 40mg Moderate to severe stress urinary incontinence.
There can be variation in the licensing of different medicines containing the same drug therefore prescribe by brand name.
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MHRA: Duloxetine: marketed as Cymbalta▼ and Yentreve▼ for different disorders
MHRA: SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
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Fesoterodine
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Formulary
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Modified-release tablets 4mg, 8mg
Urinary frequency, urgency, and incontinence.
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Vibegron
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Formulary
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NICE TA999: Vibegron for treating symptoms of overactive bladder syndrome
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Oxybutynin
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Formulary
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Transdermal patches 3.9mg/24h
Urinary frequency, urgency & incontinence.
Restricted to use in patients who are unable to take/tolerate oral anticholinergics, in line with LSCMMG guidance.
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07.04.02 |
Nocturnal enuresis |
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07.04.03 |
Drugs used in urological pain |
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Pentosan polysulfate sodium
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Formulary
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Capsules 100mg
Bladder pain syndrome.
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MHRA: Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathy
NICE TA610: Pentosan polysulfate sodium for treating bladder pain syndrome
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07.04.03 |
Alkalinisation of urine |
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Potassium Citrate
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Formulary
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Effervescent tablets, 30% mixture BP
Alkalinisation of urine.
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Sodium Bicarbonate
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Formulary
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Capsules 500mg, Oral powder
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07.04.03 |
Acidification of urine |
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07.04.03 |
Other preparations for urinary disorders |
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Tiopronin
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Formulary
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Prescribing restricted to consultant urologists only. Unlicensed
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07.04.04 |
Bladder instillations and urological surgery |
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For bladder cancer see sections 8.1.2 (mitomycin) and 8.2.4 (BCG) |
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Chondroitin sulphate 0.2% (Gepan® instil)
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Formulary
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Bladder instillation
Interstitial cystitis.
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Dimethyl sulfoxide (DMSO) installation
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Formulary
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Bladder instillation 50% 50mL
Interstitial cystitis. Unlicensed
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Sodium Hyaluronate (Hyacyst®)
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Formulary
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Bladder instillation 40mg/50ml
Consultant urologist only
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Sodium hyaluronate & Sodium chondroitin sulphate bladder instillation (iAluRil)
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Formulary
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Pain due to interstitial cystitis.
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07.04.04 |
Urological surgery |
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Glycine
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Formulary
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Irrigation solution 1.5%
Bladder irrigation.
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Sodium chloride 0.9% irrigation solution
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Formulary
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Irrigation solution 3L
Bladder irrigation.
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07.04.04 |
Maintenance of indwelling urinary catheters |
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Sodium Chloride 0.9%
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Formulary
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Catheter maintenance solution.
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Solution G
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Formulary
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Catheter maintenance solution.
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Solution R
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Formulary
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Catheter maintenance solution.
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07.04.05 |
Drugs for erectile dysfunction |
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Generic sildenafil can be prescribed without restriction on the NHS.
The following drugs for the treatment of erectile dysfunction -Alprostadil, Avanafil, Tadalafil, Vardenafil, Viagra are not prescribable on an NHS prescription unless the prescription is endorsed "SLS" for men who: • Have diabetes, multiple sclerosis, Parkinson's disease, poliomyelitis, prostate cancer, severe pelvic injury, single-gene neurological disease (for example Huntington's disease), spina bifida, or spinal cord injury.
• Are receiving renal dialysis for renal failure.
• Have had radical pelvic surgery, prostatectomy (including transurethral resection of the prostrate), or a kidney transplant.
• Were receiving Caverject®, Erecnos®, MUSE®, Uprima®, Viagra®, Cialis®, or Viridal®at the expense of the NHS on 14 September 1998. |
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Phentolamine/ Aviptadil (Invicorp®)
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Formulary
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Injection, phentolamine 2 mg/0.35 ml; aviptadil 25 micrograms/0.35 ml
Symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology.
Reserved for patients not responding or intolerant to Alprostadil, as an option before referral for surgical procedure.
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07.04.05 |
Prostaglandins and analogues |
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Alprostadil 3mg/g cream (Vitaros®)
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Formulary
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Alprostadil 3 mg per 1 gram Erectile Dysfunction in patients who have not responded to at least 2 other PDE5 inhibitors Erectile Dysfunction in patients who are intolerant to or have a contra-indication to PDE5 inhibitors
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Alprostadil intracavernosal injection (Caverject®)
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Formulary
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Injection 10 microgram, 20 microgram
Erectile Dysfunction.
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Alprostadil Urethral application (MUSE®)
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Formulary
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Urethral sticks 500microgram, 1000microgram
Erectile Dysfunction.
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07.04.05 |
Phosphodiesterase type 5 inhibitors |
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Sildenafil
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Formulary
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Tablets 25mg, 50mg, 100mg
Erectile dysfunction.
First line pharmacological therapy for erectile dysfunction.
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Tadalafil
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Formulary
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Tablets 10mg, 20mg
Erectile dysfunction
When required preparation
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Tadalafil once daily
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Formulary
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5mg Tablets
For the treatment of erectile dysfunction. 2.5mg tablets are restricted for when the 5mg daily dose is not tolerated.
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Tadalafil (all preparations)
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Formulary
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Benign prostatic hyperplasia
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NICE TA273: Tadalafil for the treatment of symptoms associated with benign prostatic hyperplasia (terminated appraisal)
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Avanafil (Spedra®)
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Formulary
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Tablets 50mg, 100mg, 200mg
Erectile Dysfunction.
Treatment of erectile dysfunction in adult men who are unable to tolerate sildenafil and tadalafil.
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Vardenafil
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Formulary
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Erectile Dysfunction.
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07.04.05 |
Papaverine and phentolamine |
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07.04.06 |
Drugs for premature ejaculation |
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Citalopram
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Formulary
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Tablets 10mg, 20mg
Premature ejaculation.
Unlicensed indication
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MHRA: Citalopram and escitalopram: QT interval prolongation
MHRA: Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use
MHRA: SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
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Fluoxetine
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Formulary
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Capsules 20mg
Premature ejaculation.
Unlicensed indication
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MHRA: SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
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Lidocaine/Prilocaine
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Formulary
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Primary premature ejaculation in men.
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LSCMMG: Lidocaine/Prilocaine Cutaneous Spray
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07.04.06 |
Dapoxetine |
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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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Cancer Drugs Fund
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NHS England |
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Homecare |
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CCG |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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Traffic Light Status Information
Status |
Description |
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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |
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Green (Restricted):
Appropriate for initiation and ongoing prescribing in both primary and secondary care provided:
Additional criteria specific to the medicine or device are met, or
The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway.
Generally, little or no routine drug monitoring is required.
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Red medicines:
Medicine is supplied by the hospital for the duration of the treatment course.
Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP.
Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this.
Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care. |
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Amber level 0:
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Little or no specific monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Brief prescribing document or information sheet may be required.
Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information.
When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe. |
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Amber level 1 (with shared care):
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Minimal monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care. |
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Amber level 2 (with shared care and enhanced service):
Initiated by specialist and transferred to primary care following a successful initiation period.
Significant monitoring required on an on-going basis.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Suitable for enhanced service.
These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements). |
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Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria.
Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need. |
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Grey medicines:
Medicines which have not yet been reviewed or are under the review process.
GPs and specialists are recommended not to prescribe these drugs.
This category includes drugs where funding has not yet been agreed.
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Refer to local guidance. |
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