GUIDELINES REFERENCE NUMBER SABP/Executive …

GUIDELINES REFERENCE NUMBER

SABP/Executive Board/0017/Guidelines 01

GUIDELINE NAME

High Dose Antipsychotic Treatment (HDAT)

BRIEF OUTLINE OF THIS GUIDELINE

This guideline aims to improve the safety of people using our services who are

treated with High Dose Antipsychotic Treatment (HDAT). This will involve outlining

responsibilities for professional staff for physical health monitoring,

acknowledgement and records of HDAT treatment and review of medication.

Version Number 5.0

Approving Committee Executive Board

Policy Category Clinical

Executive Lead Chief Pharmacist

Name of Author Deputy Chief Pharmacist

Date Approved 25th January 2019

Date Issued 18th February 2021

Review Date 25th July 2022

Target Audience All registered clinical staff

KEY PRINCIPLES ABOUT THIS POLICY

1. Prescribing High Dose Antipsychotic Treatment (HDAT).

2. Monitoring High Dose Antipsychotic Treatment (HDAT).

3. Reviewing High Dose Antipsychotic Treatment (HDAT).

This policy has been reviewed and is compliant with the most up to date

Code of Practice and NICE Guidelines

Title of Code of Practice NICE Reference Number(s)

Royal College of

Psychiatrists

Consensus statement on

high-dose antipsychotic

medication

CR190

Page 2 of 20

VERSION CONTROL LIST

Version Date Author Status Comment

1.0 October

2009

Fiona

Lockwood Live

1.1 July 2011 Simon

Whitfield Draft

Procedure formal review

date to expire in

November 11. Version 1.1

sent out for consultation.

1.2 29/09/11 Simon

Whitfield

Draft for

October

PAG

2.1 November

2015

Fiona

Lockwood Draft

3.0 January

2016

Fiona

Lockwood Approved

3.1 June 2017 Deborah

Meah Draft

3.2 January

2018 Kate Organ Draft

Appendix 3

Appendix 4

3.3 November

2018 Kate Organ Draft

Reformat into new Trust

format

4.0 January

2019 Kate Organ Approved

5.0 February

2021 Kate Organ Approved

Covid Review extension

agreed

Page 3 of 20

Summary of Changes since Version 3.0

Numbers

(Select the appropriate action)

Page Paragraph Appendix

Original/New/Amendment/Deleted –

Statement

(select the appropriate action)

1.2 A high dose of antipsychotic is defined as a total

daily dose (whether of a single antipsychotic or

more than one prescribed combination) greater

than 100% of the maximum recommended daily

dose as stated in SPC or BNF (Royal College of

Psychiatrists 2014).

Use of “Discretionary” (PRN or “as required”)

antipsychotic medication should also be taken

into account if given on a regular /semi-regular

basis. Please refer to Rapid Tranquilisation

Policy and Procedure (SABP/RISK/0019) if a

stat dose is given which causes the total dose

for that day to exceed BNF maximum.

To calculate the total antipsychotic percentage

dose for an individual, use the Antipsychotic

Dosage Ready Reckoner table to determine the

percentage of the BNF maximum for each

antipsychotic that is prescribed and then the

sum of percentages.

New

1.3 The use of high dose antipsychotics should be

an exceptional clinical practice

New

3.0 GUIDELINE

New

Page 4 of 20

4.0 Monitoring requirements

New

5.0 REFERENCES

New

8 6 Home Treatment Teams and Community

Services

To ensure the policy is implemented, complied

and reviewed within their areas of responsibility.

New

10 9.1 Amendment

Every effort to obtain valid informed consent

should be used to inform the person of the

reason for use of HDAT and the potential side

effects. For people unable to provide informed

consent, and for whom it is clinically appropriate

to treat with HDAT the reason to proceed with

treatment, and the process of reaching that

decision, specifying the legal framework used,

should be documented and recorded in the

Electronic Patient Record (EPR). The risks and

benefits of treatment, and monitoring

requirements must be documented in the EPR.

10 9.1.1 Addition – reference to CTO 11 and CTO 12

2 New

3 New

4 New

Page 5 of 20

Contents Page

Section Page

POLICY SECTION

Version Control List 2

Summary of Changes 3

1.0 Policy Purpose 6

2.0 Policy Statement 6

3.0 Related Policies 7

4.0 Glossary of Terms 7

5.0 References 7

PROCEDURE SECTION

6.0 Roles and Responsibilities 9

7.0 Procedure Flow Chart 10

8.0 Procedure Statement 11

9.0 Procedure 11

9.1 Consultant Psychiatrist Role and Responsibilities 11

9.2 Nursing Staff Roles and Responsibilities 14

9.3 Pharmacist Role and Responsibilities 14

10.0 Monitoring 15

11.0 Equality Analysis 15

12.0 Appendices 15

Appendix 1 Royal College of Psychiatrists CR190. Consensus

statement on high-dose antipsychotic medication 15

Appendix 2 POMH-UK Antipsychotic Dosage Ready Reckoner 16

Appendix 3 High Dose Antipsychotic Treatment (HDAT)

Prescribing Form 18

Appendix 4 High Dose Antipsychotic Therapy (HDAT) Monitoring

Form for Initiation 19

Page 6 of 20

POLICY SECTION

1.0 Purpose

This policy aims to outline the key responsibilities for the safe use of high dose

antipsychotic treatment (HDAT) within SABP.

2.0 Policy Statement

In November 2014, the Royal College of Psychiatrists issued a revised

‘Consensus statement on high dose antipsychotic medication’ (Appendix 1).

This document contains important recommendations in relation to the decision

to treat individuals with antipsychotic medication in excess of BNF

recommended dosages. This guideline advises on the implementation of these

recommendations in SABP.

A high dose of antipsychotic is defined as a total daily dose (whether of a

single antipsychotic or more than one prescribed in combination) greater than

100% of the maximum recommended daily dose as stated in SPC or BNF

(Royal College of Psychiatrists 2014).

Use of “Discretionary” (PRN or “as required”) antipsychotic medication should

also be taken into account if given on a regular /semi-regular basis. Please

refer to Rapid Tranquilisation Policy and Procedure (SABP/RISK/0019) if a stat

dose is given which causes the total dose for that day to exceed BNF

maximum.

To calculate the total antipsychotic percentage dose for an individual, use the

POMH-UK Antipsychotic Dosage Ready Reckoner table (appendix 2) to

determine the percentage of the BNF maximum for each antipsychotic that is

prescribed and then the sum of percentages.

The use of high dose antipsychotics (HDAT) should be an exceptional clinical

practice.

Page 7 of 20

If HDAT treatment has been initiated for, the purposes of rapid tranquilisation

please refer to the separate policy and follow its recommendations including

the physical health monitoring during the acute period.

3.0 Related SABP Policies

• The Medicines Policy

• Rapid Tranquilisation Policy

• Physical Healthcare Policy

• Unlicensed Medicines

4.0 Glossary of Terms

BNF British National Formulary

CTO11/CTO12 Forms relating to Community Treatment Orders

ECG Electrocardiogram

EPR Electronic Patient Record

GASS Glasgow Antipsychotic Side-effect Scale

GP General Practitioner

HDAT High Dose Antipsychotic Treatment

MEWS Modified Early Warning Score

MDT Multidisciplinary team

MHA Mental Health Act 1983

MI Myocardial Infarction

POMH-UK Prescribing Observatory for Mental Health

PRN When necessary

SABP Surrey & Borders Partnership NHS Foundation Trust

SPC Summary of Product Characteristics

T2/T3/S62 Statutory MHA consent to treatment forms

5.0 References

• Adapted from Southern Health Guidelines for the use of High Dose

Antipsychotics (HDAT) SHCP134 Version 3 January 2017

• Maudsley Guidelines 12th Edition 2015

• Consensus Statement – high-dose antipsychotic medication, CP190, Nov 2014

Page 8 of 20

• QT Interval and drug therapy, DTB 2016 54:33-36

• Rapid Tranquilisation Policy and Procedure (SABP/RISK/0019)

Page 9 of 20

PROCEDURE SECTION

6.0 Roles and Responsibilities

• The overarching policy for this procedure is the Medicines Policy. To view the

Executive roles and responsibilities please refer to this policy under section 6

on page13.

• Chief Pharmacist

Has responsibility to ensure the policy is regularly reviewed and

communicated to all staff

• Directors

To ensure the policy is implemented within their directorate.

• Professional Roles: to implement and comply with the responsibilities

detailed in the procedure

o Consultant Psychiatrists

o Nurses

o Pharmacists

• Ward Managers and Matrons

To ensure the policy is implemented, complied and reviewed within their

areas of responsibility.

• Home Treatment Teams and Community Services

To ensure the policy is implemented, complied and reviewed within their

areas of responsibility.

• Staff

To follow the relevant procedures outlined within the policy

Page 10 of 20

7.0 Procedure Flow Chart

Consultant Psychiatrist

• Initiates HDAT and signs form, attach to chart

• Record risks vs benefits in EPR

• Complete & record baseline monitoring

• Consent to treatment check

• Complete ongoing physical health monitoring

• Regularly review HDAT prescribing

• Review side effects and physical health of patient regularly

• Patient is informed and provided with information and

opportunity for shared decision making

Nursing Staff • Ensure HDAT is reviewed regularly

• Prompt medical staff to complete physical health monitoring

• Record observations on MEWS chart

• Ensure consent to treatment is valid

• Review side effects and physical health of patient regularly

Pharmacists • Ensure HDAT is reviewed regularly

• Prompt medical staff to complete physical health monitoring

• Ensure consent to treatment is valid

• Identify patients on HDAT

• Annotate prescription charts with HDAT stickers and % BNF

doses

Page 11 of 20

8.0 Procedure Statement

This procedure outlines the key responsibilities for clinical staffing,

monitoring and records to be made for the safe use of HDAT within SABP.

9.0 Procedure/Process

9.1 Consultant Psychiatrist Roles and Responsibilities

9.1.1 Before Starting HDAT

• Complete a medication review of current treatment to ensure sufficient

time has been allowed for response and at least two different

antipsychotics have been tried, within BNF dosing.

• Review the person using our services’ likely compliance

• Consider alternative approaches including adjuvant therapy, first and

second generation antipsychotics including clozapine have been

considered.

• The responsibility to exceed the BNF maximum doses with either a single

antipsychotic or a combination of more than one lies with the person’s

consultant psychiatrist. The decision should be discussed with the

multidisciplinary team and the individual and their carer, where possible.

• Every effort to obtain valid informed consent should be used to inform the

person of the reason for use of HDAT and the potential side effects. For

people unable to provide informed consent, and for whom it is clinically

appropriate to treat with HDAT the reason to proceed with treatment, and

the process of reaching that decision, specifying the legal framework

used, should be documented and recorded in the Electronic Patient

Record (EPR). The risks and benefits of treatment, and monitoring

requirements must be documented in the EPR.

• Check HDAT is on MHA form T2, form T3, form CTO11, form CTO12, or

form S62, if applicable.

Page 12 of 20

9.1.2 Initiation of High-Dose Antipsychotic Treatment (HDAT)

• Complete HDAT form (appendix 3)

• Records need to be made in the person’s clinical notes at initiation of

treatment and at regular treatment reviews, e.g. MDT review. These are

to include risk vs benefit analysis of person having HDAT treatment.

• Indicate in the clinical/medical notes the person’s target symptoms.

• Consider any contra-indications or risk factors such as cardiac

history(particularly MI, arrhythmias and abnormal ECG), hepatic/renal

impairment, epilepsy, diabetes, substance misuse, harmful use of

alcohol, smoking, adults over 65 years, dehydration, being overweight

and diarrhoea and vomiting.

• Consider and minimise potential drug interactions, specifically

concomitant treatment: with other drugs: diuretics, anti-arrhythmics, anti-

hypertensives, tricyclic antidepressants and drugs which may prolong QT

interval, cause electrolyte disturbances or increase antipsychotic blood

levels. Consider recent use of IM medications.

• Where possible increase the dose slowly, ideally over intervals of at least

one week.

• Allow adequate time for response between each dose increase.

Page 13 of 20

9.1.3 Monitoring Requirements

• Complete and assess risk factors.

• Complete physical health monitoring, as stated in table below, and

document on HDAT monitoring form (appendix 4)

• If HDAT is for rapid tranquilisation/ treatment of acute violence and

aggression, follow the separate policy recommendations

Baseline, before

initiation of HDAT

U&Es, FBC, LFTs, prolactin

Blood lipids (cholesterol, triglycerides) – fasting sample

Plasma glucose - fasting sample or HbA1c

ECG, BP, pulse, extra-pyramidal side-effects (EPSE)

Weight, waist circumference and BMI

Weekly for 6 weeks

ECG, BP, Pulse, EPSE, hydration status


At 6 weeks

ECG, BP, EPSE


Side effect scales e.g. GASS

At 3 months

ECG, BP , Pulse, U&Es, FBC, LFTs, prolactin

Side effect scales e.g. GASS

EPSE




6 monthly

U&Es, FBC, LFTs,

Prolactin (not required for aripiprazole, clozapine, olanzapine

<20mg/day, quetiapine, but worth measuring if symptoms arise)



ECG, BP, Pulse, EPSE


Page 14 of 20

9.1.4 Regular Review of HDAT Prescribing

• Review progress, target symptoms and side effects, at least once every 3

months. Continued use of HDAT where there is no clinical response,

should be justified in case notes. Consultants should consider seeking a

second opinion from a colleague. The review should be documented in

the patient’s notes. Recommended rating scales include the BPRS (Brief

Psychiatric Rating Scale) to assess target symptoms and GASS/GASS-C

for side effect review.

• If there are any abnormalities in the test results review treatment and

refer, where necessary.

• Where patients are discharged on HDAT the GP should be contacted and

monitoring agreed.

9.2 Nursing Staff Roles and Responsibilities

• Check for clinical signs of dehydration.

• Record monitoring on MEWS

• Document “High dose” status in progress notes.

• Assist completing the recommended physical health monitoring outlined

above

• Check the monitoring sheet is being completed and bring it to the

attention of medical staff if checks have not been completed.

• Ensure the high-dose status is discussed and recorded at review.

• Ensure that consent to treatment includes the use of HDAT, if applicable

9.3 Pharmacist Role and Responsibilities

• Identify that a patient is on high-dose antipsychotics.

• Complete HDAT form including: high-dose details and total % of BNF

maximum dose, Interacting medications

• Attach “High Dose” label to prescription card and complete total % of BNF

dose

• Endorse each antipsychotic with % of BNF maximum dose

• Check HDAT is included on consent to treatment documentation

T2/T3/CTO11/CTO12/Section 62

Page 15 of 20

10.0 MONITORING TABLE

The monitoring table for this procedure can be located in the Medicines

Policy which is the overarching policy for this document.

11.0 EQUALITY ANALYSIS

The equality analysis for this procedure can be located in the Medicines

Policy which is the overarching policy for this document

12.0 APPENDICES

Appendix One:

Royal College of Psychiatrists CR190. Consensus statement on high-dose

antipsychotic medication

Available from:

http://www.rcpsych.ac.uk/usefulresources/publications/collegereports/cr/cr19

0.aspx

Appendix Two:

POMH-UK Antipsychotic Dosage Ready Reckoner:

Page 17 of 20

http://nww.sabp.nhs.uk/services/pharmacyservices/audit/pomhuk/generalinfo/readyreckoner/view

Appendix Three

HIGH DOSE ANTIPSYCHOTIC TREATMENT (HDAT) PRESCRIBING FORM

• This form is to be completed by the person who uses services consultant psychiatrist

• Patients need to be made aware of the HDAT and associated risks

• Follow SABP HDAT Guidelines

• SABP HDAT Monitoring Form to be attached to the drug chart and completed

according to the guidelines

• Review at every opportunity the need for HDAT

• A copy of this form to be uploaded to the EPR and attached to the drug chart

CONSULTANT TO COMPLETE

Patient Name

NHS Number

Ward or Team

Rationale for HDAT, including consideration for clozapine

Total BNF dose of regular antipsychotics prescribed (oral and depot)

Total BNF dose of all antipsychotic’s including PRN

Specify drug(s) and dose(s)

Expected duration of treatment

Next review of HDAT prescribing

Date of HDAT monitoring form initiated

Information and consent gained by patient or SOAD

• I am aware of the additional risks associated with High Dose Antipsychotic Treatment

• I take responsibility for the additional physical health monitoring requirements in

accordance with Trust guidelines

• I am aware of the unlicensed use of a single medication above BNF maximum doses

• I have informed the person receiving HDAT of its use, including and risks and benefits

Name of Consultant GMC Number Signature Date

Appendix 4: High Dose Antipsychotic Therapy (HDAT) Monitoring Form for Initiation (record result values in progress notes)

Patient Name Consultant MHA consent? Rationale

NHS Number Ward Patient consent?

Co-Morbid Condition (please circle)

• Cardiovascular, hepatic/renal impairment, epilepsy, diabetes

• Substance/alcohol misuse, high-dose methadone

• Overweight, smoking status

What additional actions need to be taken?

High Dose Antipsychotic Therapy (HDAT) Monitoring Date Dose details

Specify % Drug(s) & dose(s)

Monitoring Baseline Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 At 3 mths At 6mths 6 mthly

ECG (date and QTc msec)

BP (√ & date if OK)

Pulse (√ & date if OK)

Weight

BMI

Waist circumference

EPSE (√ & date if assessed)

GASS (√ & date completed)

U&E’s (√ & date if OK)

Page 20 of 20

Monitoring Baseline Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 At 3 mths At 6mths 6 mthly

FBC (√ & date if OK)

LFTs (√ & date if OK)

Prolactin (date and value)

Fasting Lipids (√ & date if OK)

Fasting glucose or HbA1c (√ & date if OK)

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GUIDELINES REFERENCE NUMBER SABP/Executive …