GUIDELINES FOR THE USE OF HIGH DOSE VENLAFAXINE AND THE COMBINATION OF VENLAFAXINE AND MIRTAZAPINE IN THE TREATMENT OF DEPRESSION

GUIDELINES FOR THE USE OF HIGH DOSE VENLAFAXINE AND THE COMBINATION OF VENLAFAXINE AND MIRTAZAPINE IN THE TREATMENT OF DEPRESSION Policy Details NHFT...
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GUIDELINES FOR THE USE OF HIGH DOSE VENLAFAXINE AND THE COMBINATION OF VENLAFAXINE AND MIRTAZAPINE IN THE TREATMENT OF DEPRESSION

Policy Details NHFT document reference Version Date Ratified Ratified by Implementation Date Responsible Director Review Date Related Policies & other documents Freedom of Information category

MMG004 Version – 26.06.13 16.07.13 Medicines Management Committee 16.07.13 Medical Director 16.07.15 MMP001 Control of Medicines Guideline

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG004 Guidelines For The Use Of High Dose Venlafaxine Jul13 Jul15

1 of 14

Implementation Date: 16.07.13

TABLE OF CONTENTS

1

DOCUMENT CONTROL SUMMARY ...................................................... 3

2

INTRODUCTION ..................................................................................... 4

3

PURPOSE ............................................................................................... 4

4

DEFINITIONS .......................................................................................... 4

5

DUTIES .................................................................................................... 4

6

PRESCRIBING GUIDELINES ................................................................. 5 6.1 High dose venlafaxine ....................................................................... 5 6.1.1 Practice points for Venlafaxine prescribing:........................ 5 6.2 Venlafaxine and mirtazapine combinations ....................................... 6 6.2.1 Theoretical basis for combination: ...................................... 6 6.2.2 Practice points when prescribing the combination of venlafaxine and mirtazepine: .............................................. 7 6.3 Duloxetine in combination with other antidepressants: ...................... 9

7

TRAINING ............................................................................................... 9 7.1 Mandatory Training ............................................................................ 9 7.2 Specific Training not covered by Mandatory Training ........................ 9

8

MONITORING & REVIEW ....................................................................... 9

9

REFERENCES AND BIBLIOGRAPHY ................................................... 9

10

RELATED TRUST POLICY ................................................................... 10

APPENDIX 1 - ADVICE TO GPS FOR PATIENTS DISCHARGED ON HIGH DOSE VENLAFAXINE (TOTAL DAILY DOSE GREATER THAN 375MG) ................................................................................................. 11 APPENDIX 2 - ADVICE TO GPS FOR PATIENTS DISCHARGED ON A COMBINATION OF VENLAFAXINE AND MIRTAZAPINE .................. 13

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG004 Guidelines For The Use Of High Dose Venlafaxine Jul13 Jul15

2 of 14

Implementation Date: 16.07.13

1

DOCUMENT CONTROL SUMMARY

Document Title

Document Purpose (executive brief)

Guidelines for the use of high dose venlafaxine and the combination of venlafaxine and mirtazapine in the treatment of depression To provide guidance on the use of high dose venlafaxine and the combination of venlafaxine and mirtazapine in the treatment of depression

Status: - New / Update/ Review Areas affected by the policy

Review All patients in the care of NHFT

Policy originators/authors

Jagdeep Nandhra-Senior pharmacist mental health Medicines Management Committee meeting 16.07.13

Consultation and Communication with Stakeholders including public and patient group involvement Archiving Arrangements and register of documents

The Trust Policy Lead is responsible for the archiving of this guideline and will hold archived copies on a central register See MMP001 Control of medicines Policy

Equality Analysis (including Mental Capacity Act 2007) Training Needs Analysis See section 7 Monitoring Compliance and See section 8 Effectiveness Meets national criteria with regard to N/A NHSLA N/A NICE N/A NSF N/A Mental Health Act N/A CQC N/A Other Further comments to be considered at the time of ratification for this policy (i.e. national policy, commissioning requirements, legislation) If this policy requires Trust Board ratification please provide specific details of requirements

2

INTRODUCTION

The majority of patients with depression can be treated with a single antidepressant agent within licensed doses. However there may be a small proportion of treatment resistant depression patients where using above licensed doses of venlafaxine or a combination of Mirtazapine and venlafaxine may be effective / beneficial. 3

PURPOSE

To provide guidance on the use of high dose venlafaxine and the combination of venlafaxine and mirtazapine in the treatment of depression. 4

DEFINITIONS

BP – blood pressure ECG - electrocardiogram NHFT - Northamptonshire Healthcare NHS Foundation Trust SmPC – Summary of Product Characteristics 5

DUTIES

5.1. Medicines Management Committee Will approve and review these guidelines 5.2. Medical Director Is responsible for the dissemination of this guideline to their Clinical Director's and Clinical Tutor's 5.3. Clinical Directors Are responsible for the dissemination and implementation of the guideline in their service areas 5.4. Heads of Service/Hospitals Are responsible for the dissemination and implementation of the guideline in their service areas 5.5. Doctors Are responsible for reviewing the patient and ensuring that the: • rational for use of high dose venlafaxine is documented on EPEX along with the details of BP and ECG monitoring (see also section 6.2 below). •

when it is necessary to use the combination of venlafaxine and mirtazapine clinicians must explain the rational for such prescribing and

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMG004 Guidelines For The Use Of High Dose Venlafaxine Jul13 Jul15

4 of 14

Implementation Date: 16.07.13

any monitoring necessary for an individual patient when asking GP’s to take over prescribing (see also section 6.3 below). 6

PRESCRIBING GUIDELINES

6.1

High dose venlafaxine

The Summary of Product Characteristics (SmPC) for both XL and plain venlafaxine now states a maximum daily dose of 375mg (an increase for the XL preparation from 225mg) 1. A recent survey of the clinicians within NHFT found that very little prescribing of doses above 375mg occurs but clinicians commented that they may consider doses between 225mg and 375mg to be high dose. There is limited available evidence for use of venlafaxine above licensed dosage. There are only a small number of studies. •

One is an open label naturalistic case study of 5 patients, (4 patients received 450mg and 1 patient’s dose was increased to 600mg during the study). All of these patients fitted the criteria for treatment resistant depression but there was no conclusive evidence that using doses above 375mg had additional benefits as the patients were taking a combination of other psychotropic medications.2



Another study by Harrison et al looked at the tolerability of high dose venlafaxine. It did not focus on efficacy. 35 patients received doses ranging from 375mg-600mg a day and 35 patients received low dose

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