Depot and long-acting antipsychotic injections (Guidelines)

LAAIs are recommended where a patient has expressed a preference for such a formulation because of its convenience or where avoidance of covert non-adherence is a clinical priority.

Although there is a lack of robust and consistent randomised controlled trial evidence that LAAIs offer better efficacy or tolerability than oral antipsychotic preparations, observational data suggests an overall better global outcome compared with oral antipsychotics with a reduced risk of relapse and rehospitalisation.

Patient choice and consent

Patients and carers should be offered clear and accessible information in a suitable format regarding the risks and benefits of treatment including possible side effects of any injection being considered to assist in informed decision making and ensure that appropriate consent eg T2 has been obtained before commencing treatment.

A record should be made in the patient’s notes/care plan of any information provided and in what format, and also of any information offered but refused.

Where a patient does not consent to treatment and there is a requirement to treat a mental disorder, the decision to prescribe a LAAI must be in accordance with the Mental Health (Care and Treatment) (Scotland) Act 2003. Rationale for commencing treatment to be recorded in the patient’s notes and there is a requirement for a T3.

Patient information

• To aid informed decisions, patient information leaflets on psychotropic medicines are available from www.choiceandmedication.org/nhs24/ which can be found via NHS Inform or via the links provided in appendix 1.
• In particular the handy fact sheet on depot versus oral medication may be useful: https://www.choiceandmedication.org/nhs24/generate/handyfactsheetdepotvsoral.pdf 

It is essential to good patient care that communication between patient settings regarding LAAI prescriptions is robust. This may be between:

• Community teams and mental health in-patient settings
• Community teams and acute medical in-patient settings
• Mental health in-patient settings and acute medical in-patient settings
• Different Mental Health in-patient settings
• Community/ in-patient mental health and care homes

When a patient is transferred between any of these settings the following details must be clearly communicated

• The LAAI preparation prescribed plus the dose and dosage interval.
• Date last given, site of administration and the next due date.

When a patient is admitted to an inpatient setting then the CMHT Kardex must be suspended until IDL information is received on discharge.

A new medication prescription chart (Kardex) for the purpose of community administration should be written following discharge if the dose has changed. To avoid delays in obtaining this, it is important that ward staff prioritise the circulation of IDL information to the relevant CPN.

Communication with Primary Care

Robust systems should be in place to communicate the details of the intended LAAI preparation, dose and dose interval. The GP should also be informed of all changes to dose or frequency of the LAAI medication.

All LAAIs must be prescribed on an appropriate NHS Highland prescribing system and the administration recorded on the corresponding recording system at the time of administration regardless of the setting (ward, home, clinic).

In inpatient settings, prescribing of LAAIs should be done on HEPMA.

In the community setting, the NHS Highland medication prescription chart (Kardex) should be used.

It is the responsibility of the psychiatrist or designated deputy to ensure the LAAI is prescribed on the Kardex to enable administration by nurses in this setting. This prescription is the authority to administer the LAAI for the Community Nurse.

For example, when a patient is admitted to a MH in-patient unit, the community LAAI prescription chart (Kardex) should be suspended and a new community Kardex written when the patient is discharged, if the LAAI/ dose has changed. There should be a robust communication procedure to facilitate the medicines reconciliation process on admission and discharge and confirm accuracy of the community Kardex post discharge even if LAAI/dose and frequency remains the same.

Where a Kardex is used, the prescription must be legibly written and signed and dated by a doctor or non medical prescriber before the LAAI can be administered to the patient. It should be written in BLACK ink.

Prescription details must include:

• The patient’s full name, not an assumed/ abbreviated name or nickname
• The patient’s address 
• The patient’s CHI number
• The patient’s date of birth
• The prescribers’ signature
• Any known allergies or sensitivities . If none, then ‘no known drug allergies’ must be written.
• The drug name, dosage, strength and frequency of administration.
• Site of administration
• If relevant, new prescription may be required on discharge.
• Prescription must be reviewed at least every 12 months by responsible prescriber.
• Special notes, (i.e. only accepts the injection lying down, prefers a particular injection site)

All depot/LAAI must be prescribed on an appropriate NHS Highland prescribing system and administered in accordance with this. The administration must be recorded on the corresponding recording system at the time of administration.

The healthcare professional who administers the depot/LAAI should NOT be the same person who has prescribed it on the prescription chart.

Licensed injection sites

The following table details the licensed site of administration for each long-acting antipsychotic injection. The information has been taken from the current Summary of Product Characteristics for each drug

Principles

• The principles of administration are outlined in the Policy on the Administration of Medicines in NHS Highland(NHS Highland intranet access required)
• The following links include diagrammatic information on injection sites:
  • Administering drugs via the intramuscular route Nursing Times August 2018
  • Guidance on the Administration to Adults of Oil-based Depot and other Long-Acting Intramuscular Antipsychotic Injections 7^th edition

Practical issues with administration

Nodule formation and site rotation

With repeated injections of depots/LAIs over years, there is a risk of hard lumpy nodule formation. It is important that sites of administration are rotated to minimise this risk, using all licensed sites of administration that the patient consents to and to use the smallest volume to deliver the prescribed dose. Ultimately, nodule formation may necessitate a change in treatment if the patient suffers significant pain/ distress or if there is concern regarding reliable administration and/or absorption of the LAAI.

Extremes of weight

Needles need to be long enough to allow injection to the intended depth of muscle.

• An assessment of the size of needle required to reach the muscle must be made taking into account any subcutaneous fat especially in obese patients.
• 3 commonly available needle sizes for IM administration are:
  • 1-inch blue
  • 1.5-inch green
  • 2-inch yellow
• Where needles are supplied with the injection e.g. SGA LAIs, these should be used

Record keeping

Proper record keeping (hard copy and/or electronic) is essential to patient safety. Medication incidents have occurred because of poor record keeping and should be reported via Datix e.g.

• Doses being given before or after the next due date in error.
• Wrong medication or dose being dispensed or administered.
• Doses missed completely

The reasons for an LAAI not being administered, administered at a different time or any other relevant information related to the administration of a depot, must be recorded in the patient’s notes, in addition to recording on the administration record. Discontinued or old Kardexes must be retained in the patient’s notes.

Wards and CMHTs must have a local system in place for tracking the next due dates for all patients prescribed an LAAI to minimise the risk of missed doses.

In addition, CMHTs must have a procedure in place for patients who have failed to attend their scheduled LAAI appointment, describing actions to be taken to reschedule, communication systems and documentation.

Pre-treatment workup

General

• Patient consent to treatment must be obtained and documented, or relevant legal paperwork in place, prior to initiation of Long Acting Antipsychotic treatment.
• Patients should be given the relevant medication information leaflet available via the link in appendix 1 as part of the pre-treatment discussion.

Rationale of ensuring tolerance before first administration

LAAI are long-acting medications that take a long period to be fully eliminated from the body. Therefore adverse effects, which may result from the injection, are likely to be long-lived. In addition there is a theoretical risk of anaphylaxis from the oil component of first generation depots.

The licensed recommendations specified in the manufacturer’s summary of product characteristics (SPC) for each individual product should be followed. These recommendations usually involve assessing patient’s tolerability to the drug before giving the full therapeutic LAAI dose to reduce the risks of severe and prolonged adverse effects.

For first generation antipsychotic depots, a small dose of the injection is given to assess tolerance to the antipsychotic and sensitivity to the oil component. This is traditionally referred to as a ‘Test Dose’. Where possible it is also good practice to trial the oral form of a first generation depot for response and tolerability.

For the second generation antipsychotic LAAI, the patient should be tolerant and responsive to the oral form of the drug prior to initiating the LAAI. Refer to the manufacturer’s SPC for each individual product

Test Dose Logistics 

Test doses of First generation LAAIs should be given in a healthcare facility with access to emergency equipment (disposable ambu-bag, airways, laerdal pocket mask, and medicines) should anaphylaxis occur in reaction to the oily base.

Olanzapine LAI

Olanzapine LAI has additional monitoring requirements following every IM injection. Olanzapine LAAI is not SMC approved and requires an IPTR for authorisation.

Olanzapine LAI must always be given in a healthcare facility and patients must remain there for at least 3 hours post dose. Guidance on prescribing, administration and post-injection monitoring is included in the local protocol: Olanzapine LAI protocol and care plan 2020 (NHS Highland intranet access required)

Side effect monitoring

General

People with severe and enduring mental illness are more likely to have a shortened lifespan compared to those without. This has led to the development of Physical Health Guidelines to highlight the need for routine monitoring.

Like all drugs, LAAI may be associated with side effects. A full list of possible side effects can be found in the manufacturer’s SPC for each drug. The following are some important points to remember.

• Pain, erythema, swelling and nodules can occur at the injection site. Discuss with prescriber if this develops or seek advice from New Craigs Pharmacy.
• Apart from local reactions and the theoretical risk of anaphylaxis, LAAI are unlikely to produce significant side effects, including extra-pyramidal side effects, at the time of administration. They are more likely to occur after several days and particularly around the time of peak plasma levels.
• Rarer adverse effects such as rashes and agranulocytosis are well documented with antipsychotics, however anaphylaxis is not.

Patient subjective side effects should be assessed using GASS (Glasgow antipsychotic side effect scale).

This should be offered routinely at least every 6 months, ideally prior to the prescription review, and approximately six weeks after initiation or a dose change of a LAAI .

Baseline monitoring prior to first dose/test dose of a LAAI

• FBC
• Plasma glucose or HbA1c
• Lipid profile
• Liver function
• Renal function
• U&Es
• ECG
• NEWS
• Weight/BMI
• Prolactin

Routine Physical Health Monitoring

 As a minimum, monitoring as per baseline should be carried out on an annual basis

It is recognised that on occasion, for various reasons, it may not be possible to administer a long acting antipsychotic injection/depot (LAAI) to a patient on the scheduled date.

When prescribing LAAI on the medication prescription chart (Kardex) refer to table below and consider including a degree of lee-way either side of the due date.

eg If LAAI is to be administered every 2 weeks, consider prescribing this as “every 2 weeks +/- 2 days.

*pragmatic advice not based on clinical evidence: This advice was extrapolated from a number of sources:

• Bazire S.,Psychotropic Drug Directory, 2020/21; Choice and Medication website
  
• http://www.choiceandmedication.org/generate.php?sid=113&fname=handyfactsheetdepotvsoral.pdf
  
• https://www.medicines.org.uk/emc/medicine/9939 
  
• https://www.medicines.org.uk/emc/product/7653/smpc

1. If timescale since last depot dose is within the parameters detailed in the table and the Kardex is prescribed as such – administer the LAAI. Record date of administration on the Kardex and document in the patient notes and on the Kardex the reason why it was not possible to administer the LAAI on the due date.
   Calculate the “date next due” from the day the LAAI should have been given and record in the patient notes and on the Kardex.
2. If outwith the parameters detailed in the table or the Kardex is not prescribed with any flexibility, contact the prescriber or psychiatrist to agree a revised plan and new prescription. Factors for consideration include:-
   • Risk of relapse
   • Number of days before or after the due date
   • Need for oral supplementation
     
     In circumstances where the LAAI has previously been prescribed but where changes are necessary and the prescriber is not on site, a remote prescription should be sought. Email is the preferred method of authorising the change followed by a new written prescription confirming the changes as soon as practicable, within a maximum of 5 working days. The prescriber should copy the relevant medical secretary into the email and request that this is printed off and filed in the patient notes.
     
     Once authority to administer the LAAI has been received, administer the LAAI. Record date of administration on the Kardex. Document in the patient notes and on the Kardex the reason why it was not possible to administer the LAAI on the due date. File copy of authorising email in community nursing notes.
     
     Calculate the “date next due” from the revised prescription date and record in the patient notes and on the Kardex
     
     Where unable to contact prescriber or psychiatrist, contact Pharmacy, New Craigs Hospital for advice (telephone 01463 704663 or via generic mailbox: nhsh.pharmacydepartmentnewcraigshospital@nhs.scot))
3. It is recognised that there are individual patients who consistently present for administration of LAAI medication outwith the parameters detailed table. For these patients an individualised risk assessment and management plan must be agreed with the prescriber and include parameters within which the LAAI may be administered.

• Basic life support/ Immediate life support: annually
• Anaphylaxis: Recognition and Management: annually (available on TURAS)
• Medicines management for nurses working in hospitals/registered community nurses: every 2 years (available on TURAS).

In-Patients:

• LAAI are ordered from the hospital pharmacy.

Community Patients:

• In general this is done via primary care via a GP10 prescription and supply via community pharmacy.
• For patients who have their LAAI medication dispensed via a community pharmacy, the LAAI is the property of the patient and can be stored in their home. This is the preferred option. The patient should be advised on how to store their LAAI medicine appropriately.
• In very exceptional circumstances, such as if a patient is not registered with a GP practice, the psychiatrist or designated deputy writes an out-patient prescription which is dispensed by New Craigs Pharmacy and collected by the CPN. In this situation the responsibility of storage remains with the CMHT.

Within New Craigs hospital

Follow the Policy for the Storage and Security of Medication For Nurses and Midwives in Clinical Areas in NHS Highland (NHS Highland intranet access required)

Within the CMHT

• Medication should be stored in a locked cupboard.
• Access to keys should be limited to nursing staff only.
• Risperidone long-acting injections can only be stored at the CMHT base if there is a locked drugs fridge with the temperature maintained between 2 and 8 ^oc. A daily log of the fridge temperature should be recorded and if necessary remedial action should be taken to ensure medication is stored as per manufacturers’ guidance. If the cold chain is broken, risperidone LAAI should be stored at room temperature and used within 7 days.  

Patient's own medication

For patients who have their LAAI dispensed via a community pharmacy, the dispensed medication is their property and may be stored in their own home. Occasionally it may be more appropriate, or the patient may ask, for the LAAI to be stored by the CMHT. This agreement may help ease of access or be a way of reducing safety concerns. Even though this medicine is stored within the appropriate locked cupboard it still remains the property of the individual to whom it is prescribed and must NOT be used for any other patient.

There is a need for LAAIs to be transported by authorised healthcare professionals when injections are to be administered in patients’ homes.

• The medicines should be transported in a non-identifiable manner.
• If transportation is by car, any medicines, equipment and documentation must be kept in the locked boot of the car when they are not under personal control.
• The key of the vehicle must be in possession of the healthcare professional.
• If applicable, the LAAI should be collected from the pharmacy as near to the time of administration as practically possible.
• The healthcare professional needs to be aware of any specific manufacturer or pharmacy guidelines regarding the storage of medication during transportation.
• Medication should be transported in a safe, secure bag that can be carried on home visits. It should be spacious enough to hold all the items necessary for the safe administration of the LAAI in the patient’s home (see below). 
• Only the LAAIs to be administered on the day should be carried.

Recommended contents of medication case: 

• Laminated poster: Anaphylactic reactions – Initial treatment
• Adrenaline injection 1:1000 (1mg/1mL)
  May be administered without a prescription in an emergency for the purpose of saving a life. See section 5.3 of the Policy on the Administration of Medicines in NHS Highland (NHS Highland intranet access required)
• Pocket mask
• Hand wash/gel
• Gloves
• Blunt fill needles
  In order to minimise the likelihood of drawing up small slivers of glass from glass vials, a filter needle may be used to draw up the injection. However, the viscosity of the oil in some oil-based depot injections may make this impractical
• Blue needles (23 gauge)
• Green needles (21 gauge)
• Yellow needles
• 2mL syringes
• Cotton wool balls
• Sterets/ Chloraprep
• Sharps box
• Orange contaminated waste bags
• Black ink pen
• Plasters

Patient information leaflets on psychotropic medicines can be found at: Choiceandmedication: NHS 24 Home

Links to LAAI information leaflets:

• Extrapyramidal side effects
• Aripiprazole long-acting injection
• Haloperidol decanoate
• Flupentixol decanonate
• Paliperidone palmitate
• Risperidone long-acting injection
• Zuclopenthixol decanoate

There should be regular self and peer audits of compliance with these guidelines

• BMI: Body mass index
• CMHT: Community Mental Health Team
• FBC: Full blood count
• ECG: Electrocardiogram
• GASS: Glasgow antipsychotic side effect scale
• HbA1c: Haemoglobin A1c test
• IM: Intramuscular
• IPTR: Individual patient treatment request
• LAI or LAAI: Long-acting antipsychotic intramuscular injection
• MH: Mental Health
• NEWS: National early warning score
• SMC: Scottish Medicines Consortium
• SPC: Summary of Product Characteristics
• T3: Treatment Order, Section 3 of the Mental Health Act
• U&Es: Urine and electrolytes