Olanzapine Embonate injection (ZypAdhera)



|Clinical Guideline |

|Document Title |Olanzapine Embonate Injection (ZypAdhera®) |

| |Procedure for Prescribing and Administration |

|Reference Number |CG/Olanzapine Depot/12/14 |

|Policy Type |Clinical Guideline |

|Electronic File/Location |N:\Pharmacy\Intranet |

|Intranet Location | |

|Status |Final |

|Version No/Date |Version 2 |

|Author(s) Responsible for |Pharmacist North East |

|Writing and Monitoring | |

|Approved By and Date |Medicines Management Group November 2014 |

|Implementation Date |December 2014 |

|Review Date |December 2017 |

|Copyright |© North Essex Partnership University NHS |

| |Foundation Trust (2014). All rights reserved. Not to |

| |be reproduced in whole or in part without the permission of the copyright owner. |

|All matters or concerns regarding fraud or corruption should be reported to: Chris Rising, Senior Manager |

|(Chris.Rising@bakertilly.co.uk 07768 873701), Hannah Wenlock, LCFS Lead (Hannah.Wenlock@bakertilly.co.uk 07972 004257) Mark|

|Trevallion, LCFS Lead (Mark.Trevallion@bakertilly.co.uk 07800 718680) OR the National Fraud and Corruption Line 0800 028 40|

|60 |

Olanzapine Embonate Injection (ZypAdhera®)

Procedure for Prescribing and Administration

Introduction

Olanzapine embonate long acting injection (Zypadhera®) is licensed for maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.

This injection is non-formulary and has significant restrictions on its licence. It is not funded by the commissioners and is expensive both in staff time and drug cost.

Scope

This guideline gives advice to prescribers and other healthcare professionals on the use of Olanzapine Embonate Long Acting Injection and appropriate monitoring of patients following administration of the injection.

Before prescribing

• The current cost of care and quality of life must be assessed, and Olanzapine only prescribed if significant benefits can be anticipated.

• Concordance of the patient must be a key consideration.

• A medication history should be completed by pharmacy to ensure the patient meets the criteria for use of Olanzapine Embonate Long Acting Injection i.e. the patient must require treatment with depot medication and previous trials of formulary depots must have been considered ( See “antipsychotic long acting injections” guidance).

• The patient MUST be advised of the risk of post-injection syndrome.

• Due to the risk of post injection syndrome the patient MUST be advised for the need to be observed in a healthcare facility for 3 hours after each injection.

• The community team and the local inpatient unit must have the capacity to provide the ongoing monitoring required and this must be agreed beforehand. A healthcare professional must be designated to undertake the follow-up the day after the injection.

• For wards with inpatient consultants, this must be discussed with the patient’s community consultant before applying to the Medicines Management Group (MMG).

• The consultant must complete a form B for the patient and send to the AD for pharmacy for consideration by the MMG. Approval should be obtained before the prescription is written.

• Ensure that the prescriber and the people who are to administer the injection have undertaken the training. zypadhera.co.uk.

• Ensure the patient is given a leaflet about ZypAdhera (from Lilly or from .

• Write the prescription on an inpatient card (PMAC) or a Long-acting injection form and fax to NEPFT pharmacy.

• Pharmacy will only supply when the form B has been approved.

Prescribing

• Ensure the patient has a recent history of response and tolerability to oral olanzapine.

When transferring patients from oral olanzapine to long acting injection the following schedule is recommended:

|Target oral olanzapine dose |Recommended starting dose of Zypadhera |Maintenance dose after 2 months of Zypadhera|

| | |treatment |

|10mg/day |210 mg/2 weeks or 405 mg/4 weeks |150 mg/2 weeks or 300 mg/4 weeks |

|15 mg/day |300 mg/2 weeks |210 mg/2 weeks or 405 mg/4 weeks |

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

Before administering

• Complete the checklist provided (Appendix 1).

• Ensure you have done the olanzapine training and that it has been entered on the OLM record. Retain a copy of the certificate in your personal file and send one to the NEP Pharmacy.

• Consider what the patient is going to do during their 3 hours on the unit each time. They should not do vigorous exercise (not gym) and they must not leave the unit.

• Ensure that staff are available to cover the 3 hours and follow-up.

Administration

• For intramuscular use only, do not administer intravenously or subcutaneously.

• Zypadhera® should only be administered by deep intramuscular gluteal injection by a registered healthcare professional (doctor or registered nurse) trained in the appropriate injection technique and in locations where post-injection observation and access to appropriate medical care in the case of overdose can be assured.

• Observation must be carried out by a registered nurse for the first hour, then a qualified healthcare professional (OT, HCA, social worker).

• After each injection, observation as shown in table below:

|Time |Staff |Frequency of observations |Observation |

|Before 0 |REGISTERED NURSE | |Baseline observations (track and trigger form). |

| | | |Check patient is alert and not showing signs of |

| | | |intoxication |

|0- 60 minutes |REGISTERED NURSE |Every 10 minutes |Ensure patient is fully alert and ambulatory |

| | | |Observe for signs of sedation or delirium and complete |

| | | |the observation form(Appendix2) |

| | | |There is no need to measure physical parameters |

|1-3 hours |HCA, SOCIAL WORKER, |Every 30 minutes | |

| |OT | | |

|3 hours |REGISTERED NURSE | |Prior to the patient leaving the unit it must be |

| | | |confirmed that the patient is alert, orientated and |

| | | |absent of any signs and symptoms of olanzapine overdose. |

|Next day |HEALTHCARE |Within 30 hours of injection |Contact to check they are OK |

| |PROFESSIONAL | | |

|Ongoing | |At least 6-monthly |Physical healthcare checks, particularly weight gain, |

| | | |cholesterol, cardiac problems |

Before the patient leaves:

• All observations must be documented on the provided form (Appendix 2).

• All patients should be fully informed of the symptoms of post-injection syndrome and be advised to be vigilant for signs and symptoms of olanzapine overdose (secondary to post-injection adverse reactions) for the remainder of the day.

• Assurance must be sought that the patient will remain in a position to obtain assistance if needed.

• Patients must be advised not to drive or operate machinery for the remainder of the day.

• Make sure the date for the next injection is written up on the card and tell the patient.

• Order the injection from NEP pharmacy in good time.

•

• The 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose

• 80% post-injection symptoms are seen within 1 hour of the injection

• The median time to onset of post-injection syndrome symptoms is 25 minutes.

• Probably caused by unintended partial intravascular injection. This occurs in a small number of people, even with appropriate injection technique.

• The risk is 0.07% (about 1 in 1400 injections).

If post-injection syndrome occurs

• Immediately call for medical assistance

• Dial 999

• Give supportive care

• Review the future treatment for this patient.

• Report suspected post injection syndrome to MHRA using the yellow card scheme

• Complete a Datix form

Action if patient leaves before 3 hours, cannot be contacted at follow-up

• Consider welfare check by the police if within first hour of injection.

• Next of kin to be informed.

• Contact care co-ordinator.

• Datix form to be completed.

Follow-up

• When the patient is discharged from the ward ensure a new prescription is written up on the long-acting injection form

• Clarify the date of the next injection, who will be ordering the injection, and where it is to be delivered

• Olanzapine embonate is non-formulary, so outcomes are important. Please inform the MMG of the outcome of treatment using the report form (Appendix 3) sent to the consultant when the treatment was approved by the Medicines Management Group. This includes discontinuation, adverse effects, concordance, efficacy, reduced length of stay or reduced admissions

Summary Of Changes

|Date |Page Number(s) |Summary of Changes |

|Nov 2014 |throughout |Recommendations on monitoring revised. |

| | | |

Appendix 1

Checklist before Olanzapine Embonate (Zypadhera®) can be administered

Patient Name:

Patient DOB:

|Action |Completed/ Signed |Date |

|Ensure valid prescription is present | | |

| | | |

|Ensure service user is in agreement to three hours | | |

|observations. | | |

|Patient is aware and agrees to not drive or operate any | | |

|machinery for the remainder of the day | | |

|Base line physical observation prior to injection. | | |

|(Track and trigger form) | | |

|To check patient or care co-ordinator has organised | | |

|alternative methods of transport home post 3 hour | | |

|observation as patient is unable to drive themselves | | |

|Persons administering must have undergone specific | | |

|training for administration zypadhera.co.uk | | |

|Persons observing must have undergone specific training | | |

|on the identification and management of post-injection | | |

|syndrome. zypadhera.co.uk | | |

This checklist must be completed before each administration of Zypadhera®

Appendix 2

Monitoring Record for Patients Treated with Olanzapine Embonate Long-Acting Injection

Patient name ………………………………. Patient’s DOB……………………………….

Dose administered…………………………. Administered by…………………………….

Date and time of administration………………………………………

0-1 hour post injection observations:

| |0 min |10min |20min |30min |

|Any signs of PIS (Y/N) | | | | |

|If yes please state nature of symptom(s) | | | | |

|NB: Call for medical assistance | | | | |

| | | | | |

|Completed by (sig/initials/designation) | | | | |

1-3 hour post injection observations:

To be scanned into remedy and filed into patient’s notes

Appendix 3

FORM C Non-formulary* medicines or usage – outcome report for the Medicines Management Group following a Form B approval

|Medicine name |Strength/dose |Frequency |

|Olanzapine embonate long-acting injection | | |

|Consultant(s) |Unit/address |Tel. |

|Patient NHS number |Carebase no. |

|Indication |

|Date of approval by MMG |Date of MMG for this outcome report |

|Date treatment started |Length of trial period |Obtained from: |

| | |Hospital pharmacy |

|Date(s) of follow-up | | |

| | |

|Outcome at (date) ……………… |Concordance |

|Efficacy |

| |

| |

| |

|Adverse effects |

| |

| |

| |

| |

|Other |

| |

| |

| |

|To be continued |Discontinued on (date) |

|Comments |Reasons for discontinuation |

| | |

| | |

| | |

| | |

| | |

|Medicines Management Group |Next outcome report requested for (date) |

|Comments | |

| | |

| | |

|Considered for inclusion in formulary Y/N |PCT approval given (date) |

Please complete this form and fax it to the A.D for Pharmacy two weeks before the MMG meeting that the outcome will be on the agenda. 01245 256826 or 01245 256853

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Post-injection syndrome signs and symptoms

Delirium (disorientation and cognitive impairment)

Dysathria (slurred speech)

Sedation, which can become profound

Agitation

Confusion

Ataxia

Anxiety

Dizziness

Aggression

Post-injection syndrome (PIS) signs and symptoms

Delirium (disorientation and cognitive impairment)

Dysathria (slurred speech)

Sedation, which can become profound

Agitation

Confusion

Ataxia

Anxiety

Dizziness

Aggression

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