CHHS13/591

Canberra Hospital and Health ServicesClinical Procedure Treatment for the Initiation, Administration and Monitoring of People on Olanzapine Long-Acting Injection (LAI)Contents

Contents....................................................................................................................................1

Purpose.....................................................................................................................................2

Scope........................................................................................................................................ 2

Section 1 – Olanzapine..............................................................................................................2

Section 2 – Liaison Considerations Prior to Commencing Olanzapine LAI.................................2

Section 3 – Starting Dose of Olanzapine LAI..............................................................................3

Section 4 - Reconstitution.........................................................................................................4

Section 5 - Administration.........................................................................................................4

Section 6 – Adverse Effects.......................................................................................................4

Section 7 – Observation and Monitoring..................................................................................5

Related Policies, Procedures, Guidelines and Legislation.........................................................6

Search Terms............................................................................................................................ 6

Attachments..............................................................................................................................6

Attachment A - Clinical Decision Making Process for use of Olanzapine LAI.........................7

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CHHS13/591

Purpose

The purpose of this Procedure is to provide a framework for Mental Health, Justice Health & Alcohol and Drug Services (MHJHADS) to provide safe and effective treatment in the prescription, administration and monitoring of Olanzapine LAI.

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Scope

This Procedure pertains to all MHJHADS clinical staff involved in the initiation, maintenance and monitoring of people accessing MHJHADS services on Olanzapine LAI.

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Section 1 – Olanzapine

Olanzapine pamoate (Zyprexa Relprevv): Long-acting injectable form of Olanzapine given every 2 or 4 weeks. Indicated for maintenance treatment of Schizophrenia. Is different to Olanzapine IM (Zyprexa IM), which is a short acting intramuscular injection

used for acute agitation and arousal.

Olanzapine LAI is suitable for people who: Are non-adherent to oral medication or who cannot guarantee adherence; Have responded well to and tolerated oral Olanzapine; Are able to agree to a 2 hour supervision/monitoring period (see Observation and

Monitoring); Are being followed up by a clinic that can accommodate a 2 hour observation period;

and Where there is a reasonable expectation that the use of Olanzapine LAI will provide

significant benefit to that individual.

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Section 2 – Liaison Considerations Prior to Commencing Olanzapine LAI

The practical feasibility and governance of Olanzapine LAI use will be negotiated with the appropriate Community Mental Health Service, at an early stage in the decision making process. See Attachment A. Clinical Decision Making Process for use of Olanzapine LAI.

NOTE: When it is planned to start Olanzapine LAI, an email confirming capacity to manage the observation period at BHRC (or Woden) must be sent to the Chief Psychiatrist before the LAI is initiated.

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CHHS13/591

Before starting a person on Olanzapine LAI ensure that:

The person has had a trial of oral Olanzapine. (This will rule out hypersensitivity and confirm efficacy).

Safety precautions and need for the 2 hour observation period after each injection are discussed with the person.

The person has agreed to the observation period as an inpatient and outpatient. The person will be able to receive Olanzapine LAI at their follow-up with clinic/Doctor. It would be expected that benefits and side effects would be explained to the person by

the Doctor. Where there is an identified carer/nominated person the information would also be conveyed and the support of the carer/nominated person would be acknowledged in the treating plan.

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Section 3 – Starting Dose of Olanzapine LAI

The person must be trialled on oral Olanzapine prior to starting treatment with the long-acting injection (LAI).

Establish an effective and tolerable oral dose. Supplementation with oral Olanzapine is not required at the start of treatment. Initiate Olanzapine LAI at a dose recommended in the table below

Total oral olanzapine Dose

Recommended starting dose of olanzapine pamoate

Maintenance dose after 2 months of olanzapine pamoate treatment

10mg/day 210mg/2 weeks or405mg/4 weeks

150mg/2 weeks or 300mg/4 weeks

15mg/day 300mg/2 weeks 210mg/2 weeks or405mg/4 weeks

20mg/day 300mg/2 weeks 300mg/2 weeks

Doses greater than 405mg/4 weeks or 300mg/2 weeks have not been studied in clinical trials.

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Section 4 - Reconstitution

Use only the supplied diluent to reconstitute powder. Each vial strength requires a different amount of diluent to be added, but the result is

always a solution with an Olanzapine concentration 150mg/mL.

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Dose Zyprexa Relprevv Vial Strength

Volume of Diluent to add

150mg 210mg 1.3ml210mg 210mg 1.3ml300mg 300mg 1.8ml405mg 405mg 2.3ml

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Section 5 - Administration

Olanzapine LAI is for deep gluteal intramuscular use. DO NOT administer into the deltoid muscle. DO NOT administer intravenously or subcutaneously.

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Section 6 – Adverse Effects

Potential inadvertent intravascular injection events have occurred with Olanzapine LAI, leading to symptoms of overdose (referred to as Post-Injection Syndrome).

All other adverse effects occurred at a similar incidence as oral Olanzapine.

Post-Injection Syndrome (PIS) Appears to occur due to intravascular administration of a portion of the dose. Symptoms are consistent with Olanzapine overdose – sedation, dizziness, confusion,

slurred speech, altered gait, weakness or unconsciousness. Most reports were classified as mild, however rarely it can result in coma. PIS has occurred in 0.07% of injections, can occur in a person more than once and with

any injection. Approximately 80% of events occur within 1 hour of injection; one case was reported to

have occurred more than 3 hours after injection

Precautions to take: Prior to administering the injection observe and note if the person is alert and

orientated. Aspirate the syringe prior to injection – if blood is visible discard syringe and inject in

different site.

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Section 7 – Observation and Monitoring

All people on Olanzapine LAI must be observed for 2 hours post injection, with 30 mins observation and transported home.

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The observation period is coordinated through the Team Manager of Brian Hennessey Rehabilitation Centre (BHRC). A discussion MUST occur prior to administration to arrange logistics.

A community option for observation can be arranged subject to operational capacity, and the commitment from the clinical manager to be with the person throughout the observational period to ensure policy compliance.

Managing 2 hour observation period: The person MUST be observed for 2 HOURS after each injection. Observation to be conducted by appropriately trained staff. Actively monitor person for alertness every 30 minutes to confirm the person is alert,

oriented and signs and symptoms of overdose are absent. In the wards, the person is to remain on ward and is NOT to be given leave or ground

access during this 2 hour period. In community mental health clinics, the person is to remain in the clinic during this 2

hour period. Ideally transport should be arranged for the person’s return home but accompaniment

by a health professional is no longer required after 2 hour period of observation. If an overdose is suspected, close medical supervision and monitoring is recommended

until symptoms have resolved. For the remainder of the day the person must be vigilant for symptoms of PIS, be able to

obtain medical assistance and cannot drive a car or operate machinery. Should the person leave the clinic prior to the end of the monitoring period or refuse to

return to the clinic after leaving, an assessment must be made by the treating Consultant Psychiatrist (or if not available, another Consultant Psychiatrist/Psychiatry Registrar) regarding the follow-up plan required. This includes but is not limited to phone contact with the person or home visiting the person after administration.

Review of the person’s suitability for Olanzapine LAI must occur where a person repeatedly leaves the clinic prior to the conclusion of the 2 hour observation period.

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Related Policies, Procedures, Guidelines and Legislation

Legislation Health Practitioner Regulation National Law (ACT) 2009 Health Records (Privacy and Access) Act 1997 Human Rights Act (2004) Medicines, Poisons and Therapeutic Goods Act (ACT) 2008 Mental Health Act 2015

Policies Medication Handling Policy

Standards National Mental Health Standards 2010 ACHS EQuIP 5. Clinical 1.5.1 & Corporate 3.1.1

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Search Terms

Olanzapine, Long Acting Injection, LAI, MHJHADS, Chief Psychiatrist

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Attachments

Attachment A - Clinical Decision Making Process for use of Olanzapine LAI

Disclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Service specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

Date Amended Section Amended Approved ByEg: 17 August 2014 Section 1 ED/CHHSPC Chair

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CHHS13/591

Attachment A - Clinical Decision Making Process for use of Olanzapine LAI

NOTE: As of March 2013 the observation period has been reduced to 2 hours (from 3) and there is no longer a requirement to be transported home by a health professional after 2 hour observation period.

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Psychiatrist to discuss with DOCS or CDASRe availability of observation period

Case Manager liaises with BHRC or Community team to affirm logistics of observation period

BHRCCase Manager to arrange

Consumer’s transport to/from BHRC for 2 or 4 week injection

2 hour Observation period 30 Min observations provided by

nursing staff at BHRC

If concern – actions as per Treatment guidelines and advise

DOCS/CDAS

Community (to be initiated in Q4 of 2012)

Home team to arrange transport to /from observation centre

Observation period30 Min observations provided by

Community staff

If concern – actions as per Treatment guidelines and advise

DOCS/CDAS