Medicines Optimisation Team Standard Operating Procedure Audit: Doxazosin MR to Doxazosin IR - South Staffordshire Joint ...

 
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Cannock Chase Clinical Commissioning Group
   South East Staffordshire and Seisdon Peninsula Clinical Commissioning Group
   Stafford and Surrounds Clinical Commissioning Group

                            Medicines Optimisation Team
                         Standard Operating Procedure Audit:
                            Doxazosin MR to Doxazosin IR
Aim
The aim of this project is to review all patients currently prescribed Doxazosin XL formulations with
the intention to convert to the standard release formulations in line with the NHS England “items
which should not be routinely prescribed in primary care” guidance.

Rationale

There is no good evidence of additional benefit over immediate release doxazosin. Both formulations
provide effective blood pressure control (doxazosin is recommended only as a fourth-line
antihypertensive) and are effective at controlling the symptoms of BPH and improving maximum
urinary flow rate. The long half-life of immediate release doxazosin allows once daily dosing.
Suggested action: current prescription for doxazosin MR to be changed to normal-release doxazosin
tablets.

Doxazosin has a half-life of 22 hours making it suitable for once daily dosing both for immediate
release and modified release preparations. A modified release version of Doxazosin therefore offers
no advantage in terms of patient compliance.

There are three possible ways of converting patients from modified release to standard doxazosin.
All of these ways require follow up monitoring of the blood pressure and patient tolerability.
Doxazosin immediate release tablets come as 1mg, 2mg and 4mg tablets.
    1. Give the standard release at half the dose of doxazosin XL i.e 4mg XL switched to 2mg
         standard release. There may be some patients who require a higher dose and subsequent
         dose titration may need to be done.
    2. Give the standard release at the same dose as doxazosin XL but there may be some patients
         who suffer orthostatic hypotension and need a lower dose and subsequent dose titration.
    3. Discontinue the modified release doxazosin and comply with the licensed dosing
         recommendations for standard release doxazosin and initiate therapy at 1mg daily, increasing
         at weekly/fortnightly intervals.

For patients at risk of hypotension it is most appropriate to switch to half dose, and increase if
necessary. If switching to the same dose, bear in mind that the dose may need to be decreased.
Whichever dose is chosen, it is important to monitor blood pressure closely and adjust the dose if
necessary.

Audit criteria

       Inclusion criteria :
           1. All patients currently prescribed Doxazosin MR tablets (brand or generic)

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         Version 1.0 Developed by Kirandeep Sangha April 2018      To be revised: April 2020
                        Approved By Medicine Optimisation Group: April 2018
Exclusion criteria:
          1. No patients to be excluded (Although patients may have previously been prescribed
             the IR preparation it is still relevant to include them to review why they were initiated
             on the MR preparation).

Method
      1. Prior to commencing work, familiarise yourself with current BNF section on these
          products. It is also worthwhile to look at the reference resources to support the switches.
      2. Check the practice has agreed to the protocol and a signed copy is in place.
      3. Check for any extra exclusions or amendments to the protocol made by the practice.
      4. Check prescribing support software prompts are in place where relevant.
      5. Run a computer search to identify all patients who are currently receiving prescriptions
          for doxazosin MR tablets (brand and generic).
      6. Complete audit sheet with the required fields and include and information that you feel
          may be of relevance.
      7. Agree with practice how they would like this information communicated with the patient
          (GP review, telephone review, letter- appendix 1).
      8. Agree with the clinical lead which dosing option they want to choose. This is likely to be
          patient specific. Some patients may require a BP check prior to any changes being made
          if they do not have a more recent BP recorded.
      9. Advised practice to repeat BP after 4 weeks (or as agreed) and review accordingly.
      10. Record on patient records the changes made.
      11. Problem link drug to disease (where possible).
      12. Inform relevant practice staff.

Notes for Practice Pharmacist/ nurse/GP:
Points to discuss with practice
   1. Who is the contact in the practice for project?
   2. Agree whether the patients are to be contacted via letter, phone call or another means.
   3. Agree content of patient letter – suggested letter attached.
   4. Any practice additions, deletions or amendments to the protocol.

References:

   1. Summary of Product Characteristics. Cardura XL 4mg tablets. Pfizer Limited. Last updated
      August 2017. Available at https://www.medicines.org.uk/emc/product/1310
   2. NICE Clinical Guideline 127. Hypertension in adults: diagnosis and management. August
      2011 updated November 2016 Available at https://www.nice.org.uk/guidance/cg127
   3. https://www.sps.nhs.uk/wp-content/uploads/2013/12/QA-22_6_FINAL_Jan16.doc
   4. Summary of Product Characteristics. Cardura tablet 2mg. Pfizer Limited. Last updated June
      2017. Available at https://www.medicines.org.uk/emc/product/6957
   5. UK Medicines Information (UKMi). How should conversion between doxazosin formulations
      be carried out in patients with hypertension? 2015. Available at
      https://www.sps.nhs.uk/articles/how-should-conversion-between-doxazosin-formulations-be-
      carried-out-in-patients-with-hypertension/

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         Version 1.0 Developed by Kirandeep Sangha April 2018      To be revised: April 2020
                        Approved By Medicine Optimisation Group: April 2018
Appendix 1 – data collection form
    Data Collection Form

      Patient        Age     Name,             Indication   Recent    Date of most   Compliant    Reason for stopping   Additional   Proposed Action
      identifier:            strength, dose                 BP        recent BP      with         IR preparation (if    Comments
                             and quantity of                                         medication   patient has had in
                             drug                                                    Yes/No?      the past)

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                                  Version 1.0 Developed by Kirandeep Sangha April 2018      To be revised: April 2020
                                                 Approved By Medicine Optimisation Group: April 2018
Appendix 2 – Patient letter

                                 [Please amend accordingly as practice wishes]
                                                                                           [Practice Name]
                                                                                         [Practice Address]

                                                                                                     [Date]
[Patient Name]
[Patient Address]

Dear Patient,

   IMPORTANT INFORMATION REGARDING A CHANGE IN YOUR REPEAT MEDICATION

As a practice, we regularly review the medicines that we prescribe to check that they work as well
as possible and are good value for money for the NHS.

We are writing to let you know that your GP has reviewed your current prescription for doxazosin
modified-release, a drug usually used in hypertension.

Doxazosin modified-release tablets offer no clinical advantages over normal doxazosin tablets and
they are more expensive for the NHS. Usually modified-release drug preparations are prescribed
to enable a patient to take one tablet, once a day rather than a number of tablets throughout the
day – they are in essence a long-acting version of the base drug. With doxazosin, once a dose is
taken, all formulations exert the same blood pressure lowering effect lasting up to 24 hours in the
body and therefore there is no advantage in taking a modified-release product.

Due to this, Clinical Commissioning Groups within South Staffordshire do not support the
prescribing of doxazosin modified-release on NHS prescriptions. Your prescription has therefore
been changed to normal release doxazosin at an equivalent dose.

Please continue to use your current supplies of medications and ensure you check your next batch
of prescription items carefully. There has been a change in the dosage of your doxazosin
prescription and it will now appear on your repeat prescription as:
                           Doxazosin Xmg tablets – One to be taken daily.

As this is a change to your anti-hypertension medication, the practice would like you to make an
appointment to have your blood pressure checked in XX weeks time. Please make this
appointment in the usual way.

If you have any queries regarding this change please do not hesitate to discuss with your local
pharmacist. Alternatively you can contact the Patient Advice and Liaison Service (PALS) as they
deal with any patient complaint on behalf of the CCG.

PALS can be contacted via:
•     Freephone: 0800 030 4563
•     Email: MLCSU.PatientServices@nhs.net
Yours sincerely

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              Version 1.0 Developed by Kirandeep Sangha April 2018      To be revised: April 2020
                             Approved By Medicine Optimisation Group: April 2018
[Name]
[Position]

Document Change History
Version                 Date                              Editor                     Details of significant
                                                                                     changes
1.0                           25/04/18                    Kiran Sangha               New Standard Template

      Head of Medicine Optimisation        Sam Buckingham                              Date 21/05/18
      Cannock Chase, South East
      Staffordshire and Seisdon Peninsula
      and Stafford and Surrounds Clinical
      Commissioning Group
      GP Prescribing Lead                  Claire Pilkington                           Date 21/05/18
      Cannock Chase Clinical Commissioning
      Group

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               Version 1.0 Developed by Kirandeep Sangha April 2018      To be revised: April 2020
                              Approved By Medicine Optimisation Group: April 2018
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