7.0 Obstetrics, gynaecology & urinary-tract disorders

7.1.1 Prostaglandins and oxytocics

Dinoprostone 10mg vaginal delivery system (Propess®)

Propess® (dinoprostone) 10mg vaginal delivery system is licensed and now locally approved for the initiation of cervical ripening in patients, at term (from 38th week of gestation). It has a number of advantages over dinoprostone gel (Prostin®) and is expected to become the product of choice for this indication where appropriate. This is in line with recommendations from NICE in its Clinical Guideline advice on Induction of Labour which stated use of Propess® is expected to deliver downstream savings from its preferential use over Prostin® gel.

RED           Dinoprostone vaginal pessaries 10mg

7.1.1.1 Ductus arteriosus

7.1.2 Mifepristone

RED           Mifepristone tablets 200mg

7.1.3 Myometrial relaxants

7.2.1 Preparations for vaginal atrophy

Refer also to HRT section 6.4.1.1.

GREEN      Clotrimazole
                  cream 1% , vaginal cream 10%,   vaginal tablet 500mg  

7.3.1 Combined hormonal contraceptives

CSM advice - 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.

Interactions with liver enzyme inducing drugs

Faculty advice relating to a long term course of an enzyme inducing drug in women unable to use an alternative method of contraception is to use two low dose COCs providing a total daily dose of 50-60 micrograms of ethinyloestradiol (for example two Microgynon 30® daily - unlicensed). Women are advised to use additional contraception, such as condoms during use of a liver enzyme inducing drug and for 28 days after the liver enzyme-inducer is stopped.

7.3.2 Progestogen-only contraceptives

These are useful for women in whom oestrogen is contraindicated or if breastfeeding.

7.3.2.2 Parenteral progestogen-only contraceptives

For IUS/IUD and Implanon fitting special training is required (primary care -see nGMS enhanced services contract for details and contact local CCG for further information as necessary). NICE guidance states that these methods together with Depo-Provera® are the most cost effective option and that their use should be encouraged.

The CSM have also advised that; 

• In adolescents, medroxyprogesterone acetate (Depo-Provera®) be used only when other methods of contraception are inappropriate 
  
• In all women, benefits of using medroxyprogesterone acetate beyond 2 years should be evaluated against risks;
  
• In women with risk factors for osteoporosis an alternative method of contraception instead of medroxyprogesterone acetate should be considered 

7.3.5 Emergency contraception

7.4.1 Drugs for urinary retention

Alpha-blockers relax smooth muscle in benign prostatic hyperplasia producing an increase in urinary flow rate and an improvement in obstructive symptoms.  Watchful waiting may be preferable to treatment in men with mild to moderate symptoms. Alpha-blockers are the treatment of choice for benign prostatic obstruction, and are likely to provide symptom relief in men with prostates of any size. The effect should be noticed within several days, with full response after 4-6 weeks.  They appear to be equally effective but there are differences in tolerability. All alpha-blockers reduce blood pressure, and first doses may cause drowsiness and dizziness. Modified release preparations may reduce these effects. Patients also receiving antihypertensives may need lower doses and supervision. 

Tamsulosin capsules m/r should be used first line, but some patients may experience a higher incidence of adverse sexual dysfunction, so alfuzosin m/r is often preferable for those in whom this is an issue.

Mirabegron is recommended by NICE TA290 as an option for treating the symptoms of overactive bladder only for people in whom antimuscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects. The dose needs to be reduced in renal/hepatic impairment. Patient’s should be reviewed 4 weeks after initiating.

Following a review by the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency (MHRA), there are now new recommendations for the use of Betmiga▼ (mirabegron).     

The new recommendations follow a review by the European Medicines Agency of cumulative data associated with mirabegron and increased blood pressure. Serious cases of hypertension and increased blood pressure have been reported in patients on mirabegron treatment.

In addition, there have been some reports of hypertensive crisis and cerebrovascular and cardiac events associated with hypertension with a clear temporal relationship with the use of mirabegron.

Its use in patients with severe uncontrolled high blood pressure is now contraindicated. Blood pressure should be measured at the start of treatment and monitored regularly, especially in patients with hypertension.

GREEN      Mirabegron tablets 25mg, 50mg

Oxybutyin patches are not routinely recommended and should be reserved only for individuals who are unable to tolerate oral medication.

A guideline for the management of the condition can be found here      

7.4.3 Drugs used in urological pain

7.4.4 Bladder instillations and urological surgery

7.4.5 Drugs for erectile dysfunction

An amendment to the SLS regulations, effective from the 1 August 2014 means that prescribers will no longer be required to annotate prescriptions for the generic erectile dysfunction tablet sildenafil with the letters "SLS".

Following consultation the Department of Health (DH) selected to remove sildenafil from the list of medicines that may only be prescribed where they meet the selected list scheme requirements.

Whilst generically written prescriptions for sildenafil no longer require the prescriber to annotate the prescription with the letters “SLS”  the branded version of the drug -  Viagra s should be annotated “SLS” in order to be valid for NHS prescribing. Viagra is black lighted in East Lancashire.

The regulation amendment applies only to generic sildenafil.  Other oral PDE5 for erectile dysfunction remain subject to the “SLS” requirements.

Prescribers should make clear to any patients prescribed sildenafil outside the selected list scheme that they will not be eligible for other treatment options for erectile dysfunction on NHS prescription, unless they met the appropriate “SLS” criteria.  If treatment with sildenafil proves unsuccessful and patients do not meet SLS criteria then any alternative treatment for erectile dysfunction should be offered on a private prescription.

Prescribing of other PDE5  preparations should be in line with the Health Service Circular Guidelines (HSC 1999/115). NHS prescriptions (endorsed "SLS") can be issued for alprostadil, tadalafil, vardenafil and certain vacuum tumescence devices to men suffering from erectile dysfunction who have these medical conditions: diabetes, prostate cancer or prostatectomy, spinal cord injury, radical pelvic surgery or severe pelvic injury, parkinson's disease, renal failure requiring dialysis or following transplant, multiple sclerosis, spina bifida, poliomyelitis, single gene neurological disease, plus men who were receiving treatment for erectile dysfunction who was a member of the EU before 14th september 1998. GPs can issue private prescriptions for the above drugs and devices for patients on their list who do not meet these criteria, but cannot charge patients for issuing a private prescription.

In cases where erectile dysfunction is causing severe distress ALL prescribing should only be carried out from specialist services.

Vardenafil remains available on formulary for any patients started on this drug prior to July 2012