Microsoft word - vardenafil and pde inhibitor audit.doc
1. To clarify the indications for erectile dysfunction.
2. To prescribe the formulary choice vardenafil (Levitra®).
Vardenafil, sildenafil (Viagra®) and tadalafil (Cialis®) are phosphodiesterase type-5 (PDE5) inhibitors and are licensed for the treatment of erectile dysfunction. Sildenafil was first introduced in the UK in 1998 and since then, the treatment options have expanded by the introduction of vardenafil and tadalafil. PDE5 inhibitors work by increasing penile arterial blood flow leading to muscle relaxation and vasodilation. They are not initiators of penile erection and therefore require sexual stimulation to be effective. These drugs differ mainly in their pharmacokinetic properties; see Table 1.
The table above shows that both sildenafil and vardenafil have similar characteristics and are considered quicker acting whereas tadalafil is a long acting agent. The disadvantages of longer acting drugs particularly in patients who are eligible for treatment with a PDE5 inhibitor, are that many of these patients may have underlying cardiac issues and are at increased risk of developing side effects. At the present time, there is no data available for the ‘head to head’ comparison of the three PDE5 inhibitors on the market. Largely, prescriber choice will come down to patient preference/experience, drug properties and cost. PDE5 inhibitors should initially be prescribed at lower doses and titrated up according to patient response.
PDE5 inhibitors are not prescribable on the NHS unless the patient is suffering from one of the following criteria;
Diabetes, multiple sclerosis, Parkinson’s disease, poliomyelitis, prostate cancer, severe pelvic injury, single gene neurological disease, spina bifida or spinal cord injury.
Are receiving dialysis for renal failure
Have had radical pelvic surgery, prostatectomy (including transurethral resection of the prostate) or kidney transplant
Were receiving Caverject®, Erecnos®, MUSE®, Viagra® or Viridal® for erectile dysfunction, at the expense of the NHS, on 14th Sept ’96
Are suffering severe distress as a result of impotence (to be prescribed in specialist centres only, i.e. not in primary care, see below)
If an NHS prescription is deemed appropriate, it should be endorsed ‘SLS’. Historically, there has been some confusion around the term ‘severe distress’ as an indication for treatment. The BNF uses the following as a guideline for assessing distress;
There is significant disruption to normal social and occupational activities
There is a marked effect on mood, behaviour, social and environmental awareness
There is a marked effect on interpersonal relationships.
The table below shows the relative costs of the most commonly used strengths of PDE5 inhibitors;
Vardenafil is the drug of choice for the treatment of erectile dysfunction in NHS Dumfries and Galloway, based on patient tolerability and its cost-effectiveness. There is no clinical reason why a patient may not be transferred from one PDE5 inhibitor to another and therefore, it is of significant financial benefit to switch patients currently prescribed either tadalafil or sildenafil to vardenafil. PRISMS data from April ‘09 to April ‘10 shows that less than 24% of the total amount of PDE5 inhibitors prescribed during this period is attributable to vardenafil. If a 100% switch were made (matching equivalent doses of PDE5 inhibitors), a potential saving in excess of £50,000 annually could be achieved.
This audit is divided into two parts; to clarify the indications for treatment with a PDE5 inhibitor
(Part 1) and to switch eligible patients to vardenafil from another PDE5 inhibitor (Part 2). As part of this, it may be prudent to discontinue treatment where appropriate. 1. For GPs; the indications for treatment with a PDE5 inhibitor are listed above. Any patient who is not eligible for the prescribing of a PDE5 inhibitor on the NHS should be reviewed with the aim of discontinuing treatment. We would recommend that this is carried out as a face to face intervention due to the potentially sensitive nature of this topic, but a discontinuation letter is included should the practice wish to use it (Appendix 2).
2. For pharmacy technicians; for patients who are eligible to switch from sildenafil/tadalafil to vardenafil or have treatment discontinued;
Search for those patients having been prescribed sildenafil/Viagra®) or tadalfil/Cialis®) (with a view to switching/stopping) or vardenafil/Levitra® (with a view to stopping) in the last 12 months.
If possible and where medical notes allow, check that these patients are eligible for treatment with a PDE5 inhibitor. If not eligible for treatment, refer to GP.
1. For GPs; the following lists patients who should not be prescribed PDE5 inhibitors (as per BNF);
Those receiving a nitrate drug (isosorbide mono/dinitrate, glyceryl trinitrate), nicorandil, or alpha blockers. Additionally, sildenafil and vardenafil should not be
prescribed with antivirals. Vardenafil should not be prescribed with antifungals or grapefruit juice (see BNF Appendix 1 for more drug interactions).
Those in whom vasodilation and sexual activity are inadvisable
Those with a previous history of non-arteritic anterior ischaemic optic neuropathy
Those with hypotension (avoid if systolic BP <90mmHg), recently suffered stroke, unstable angina and myocardial infarction.
Any patient not conforming to the above ‘inclusion criteria’
Previous switch to an alternative product which caused distress
Any individual patient exclusions deemed necessary by the GP (e.g. patients who are deemed to be not open to change as judged by GP)
Implementation of the audit in selected GP practices by the Prescribing Support Team is as follows:
Protocol to be discussed with all GPs in the practice to ensure that agreement to proceed is reached
Computer search of all patients according to the inclusion criteria
Review of patients medical notes and repeat prescribing records
For GPs; a list produced of those patients who are not eligible for supply of PDE5 inhibitors on the NHS.
For Pharmacy technicians; a list produced of patients on sildenafil/tadalafil tablets.
List of eligible patients to be checked by GP/GPs
Letters to be sent to eligible patients and the ‘switch’ (Appendix 1) or ‘discontinuation’(Appendix 2) to be undertaken on the computer system.
Letters written to all patients outlining the reasons for switching/stopping their medication to ensure they are fully informed and given an opportunity to discuss this with either their GP or Prescribing Support Pharmacist. (Appendices 1 and 2)
Admin. staff in practices to be made aware of change to repeat medication.
Report for practices will include number of switches/stops made by the pharmacist/technician and projected cost savings as a result of the recommendations.
Written by Dr Jennifer Dillet, October 2010
Appendix 1: Patient letter if switching to vardenafil (Levitra®) tablets. Patient name Address
As part of a review, NHS Dumfries and Galloway are currently looking at all patients being prescribed tadalafil (Cialis®) or sildenafil (Viagra®).with a view to changing to another drug Levitra® (vardenafil), which is used to treat erectile dysfunction in the same way. We know that this drug is well tolerated by patients; it works quickly and has less chance of causing troublesome side effects. It is also the most cost-effective drug treatment and for these reasons, it is the drug of choice in NHS Dumfries and Galloway.
The timing of your dose may change slightly from your previous treatment; you should take a tablet 25-60 minutes prior to sexual activity with a maximum of one dose in 24hrs. There should be no difference in the effectiveness of your treatment, but you are advised to contact your GP if you are aware of any changes. This switch has been made to ensure that patients are using the most appropriate treatment and it also helps GPs make the most effective use of available resources.
Should you have any queries, please contact your GP Surgery on the number above or, alternatively, you can contact a member of the Prescribing Support Team on xxxxxx.
Prescribing Support Technician On behalf of the Doctors
Appendix 2: Patient letter if discontinuing treatment.
As part of a review, NHS Dumfries and Galloway are currently looking at all patients being prescribed either sildenafil (Viagra®), tadalafil (Cialis®) or vardenafil (Levitra®) for erectile dysfunction.
Due to the nature and cost of these medicines, there are specific medical criteria that a patient must meet in order to be eligible for treatment with these drugs on the NHS. In recent years, there has been increased scrutiny in the prescribing of these drugs to ensure that guidelines are followed and criteria met. For this reason, we have been reviewing patients who currently receive repeat prescriptions for these drugs in order to make sure that we are meeting national prescribing guidelines. In your case, we have found that you do not meet NHS prescribable criteria and therefore will no longer be prescribed X (drug name) by your GP. We hope now to have clarified the situation and apologise for any confusion.
These drugs remain prescribable on a ‘private’ prescription if deemed appropriate by your GP, to which you would incur the cost of treatment.
Please be assured that this has been done to optimise the resources that GPs have available to them. If you have any questions regarding this, please contact Paul Beardon or the (Prescribing Support Team) on xxxxxx
Prescribing Support Technician, on behalf of your doctor
Appendix 3; Vardenafil Switch Project - Audit Data Collection Sheet
Appendix 4; PDE5 Inhibitor Discontinuation - Audit Data Collection Sheet
(for patients who do not meet SLS criteria)
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