POLICY DOCUMENT
Document Title / Continuing Care Guideline for Lithium Therapy
Reference Number
Policy Type / Continuing Care Guidelines
Electronic File / Location / N:\Pharmacy\Intranet
Intranep Location /
Status / FINAL
Version No / Date / Version 2.0 –June 2016
Author(s) Responsible for Writing and Monitoring / Dr R Gupta, Consultant Psychiatrist
R Parekh, AD for Pharmacy
C Banham, Pharmacy Manager
J Dattani, Lead Pharmacist for Mid Essex
Approved By and Date / Medicines Management Group, July 2016
Implementation Date / 6 July 2016
Review Date / 6 July 2019
Copyright / ©North Essex Partnership University NHS Foundation Trust (2016). 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 ( 07768 873 701), Mark Kidd (), Mark Trevallion, LCFS Lead ( 07800 718 680) or the National Fraud and Corruption Line on 0800 028 40 60

CONTENTS

Item No / Item / Page No
1 / Introduction / 3
2 / Aim / 3
3 / Scope / 4
4 / Referenceto other standards, policies or procedures / 4
5 / Responsibilities / 5
5.1 / Consultant / 5 & 6
5.2 / General Practitioner / 6 & 7
5.3 / Patient / Carer / 8
6 / Procedure / 8
6.1 / Indications and licensing / 8
6.2 / Administration / 8
6.3 / Brand prescribing / 8 & 9
6.4 / Monitoring standards / 9
6.5 / Monitoring guidance / 10 & 11
7 / Prescribing in specialist groups / 12
7.1 / Pregnancy / 12
7.2 / Children / 13
7.3 / Elderly / 13
7.4 / Renal impairment / 13 & 14
8 / Side effects / 14
8.1 / Toxicity / 14 & 15
8.2 / Cautions / 15
8.3 / Interactions / 15
8.4 / Contraindications / 15 & 16
7 / SummaryofChanges / 16

APPENDICES

App. No / Appendix / Page No
1 / Lithium monitoring form / 17
2 / Initial letter to GP / 18
3 / Second letter to GP to start continuing care / 19
4 / NEP Algorithm for Prescribing & monitoring Calcium / 20

CONTINUING CARE GUIDELINE PROCESS FOR LITHIUM

1.INTRODUCTION

This is a document that provides information allowing patients to be managed safely across primary care, secondary care and across the interface.

It is a partnership /agreement between Secondary care, Primary care and the patient which sets out responsibilities for each party.

The patients should be clearly explained about the intentions for shared care and should give their agreement.

There should be good communication and cooperation between the parties involved in ensuring patient safety and management.

The doctor who is prescribing the medication should have clinical responsibility for the drug and the consequence of its use.

2.AIM

The aims and objectives of these continuing care guidelines are to ensure that lithium therapy is initiated, prescribed, dispensed and monitored appropriately and according to the National Patient Safety Alert (NPSA) guidelines and NICE guidance.

This is to ensure that patients on lithium therapy are managed safely across the interface of primary and secondary care.

Arrangements should be put in place to ensure that:

  1. Patients who are prescribed lithium are monitored in accordance with NICE guidance
  1. There are reliable systems to ensure blood test results are communicated between laboratories and prescribers
  1. At the start of lithium therapy and throughout their treatment patients receive appropriate on-going verbal and written information and a record book to track lithium blood levels and relevant clinical tests.
  1. Prescribers and pharmacists (hospital and community) check that blood tests are monitored regularly and that it is safe to issue a repeat prescription and/or dispense the prescribed lithium.
  1. Systems are in place to identify and deal with medicines that might adversely interact with lithium therapy.

3.SCOPE

All practitionerswithin NEP andthirdparties dealing with Lithium therapy in respect to NEP patients.

4.REFERENCES TOOTHER STANDARDS,POLICIES ORPROCEDURES

NICE guidance on Bipolar Affective disorder [Nice Guidance CG185 published in Sept 2014]

NICE guidance on Antenatal and Postnatal mental health [Nice Guidance CG192 published in December 2014]

The Maudsley Prescribing Guidelines.12th edition.

British National Formulary.

Close monitoring of patients prescribed Lithium NSPA Dec. 2009

Lithium monitoring app, available on the App Store.

5.RESPONSIBILITIES

5.1 Initiation of Lithium Therapy - Consultants’ Responsibilities
Lithium therapy will usually be initiated by a consultant psychiatrist. A GP may consider restarting lithium (preferably in consultation with a psychiatrist) for the same diagnosis if the patient has previously benefited but has relapsed since discontinuation.
Baseline investigation will be undertaken before initiating lithium (Table 1).
A lithium monitoring book will be provided containing a lithium alert card complete with relevant details e.g. baseline checks, current dose, target lithium level.
Appropriate on-going verbal and written information will be provided to the patient.
Clinicians are to update the lithium monitoring booklet where appropriate.
It must be ensured that the first blood test is done and checked.
Monitoring of side effects is to be agreed by both parties.
A comprehensive referral letter to the GP is to be provided also indicating when the patient should be referred back to the consultant (see Appendices 1 and 2).
Conditions of assuming responsibility by the GP agreed and a continuing care document is to be sent.
Patients on CPA (Care Programme Approach) should remain with Secondary Care unless agreed by GP and stated on the CPA.
Both parties should ensure that results are shared by both sectors and means of doing this should be agreed.
Criteria for transferring prescribing and/or discharging to GP
Prescribing responsibility will only be transferred when the consultant and the GP are in agreement that the patient’s condition is stable or predictable.
The patients will only be referred to the GP once the GP has agreed each individual case and the hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined below.
The hospital will provide the patient with a minimum initial supply of 2 weeks therapy on discharge.
Areas of responsibility
In general the various responsibilities will be shared as outlined below, but for an individual patient there may be some variation in the detail (e.g. on who does which blood tests) but this must be clearly agreed between the consultant and the GP.
It should be clearly explained to patients about the intentions for continuing care and their consent given.
There should be good communication and cooperation between the parties involved to ensure patients are safely managed.
  • All patients to have been counselled and have an up to date lithium monitoring book.
  • All patients will continue with hospital prescribing until the patient has stable dose and only routine monitoring required (Table 1).
  • The consultant/specialist will send a full referral letter giving details of patient’s response to therapy.
  • The letter will list any drugs or investigations recommended by the consultant and previous test results.
  • The consultant will request that the GP consider taking over the monitoring requirements as per continuing care guidelines, which is considered safer than splitting the prescribing and monitoring across care sectors.
  • The patient will continue to be monitored until deemed stable to be discharged from mental health services.

5.2 Lithium Therapy - General Practitioner Responsibilities
  • Reply to the request for continuing care within 2 weeks and clarify with the hospital specialist who is to take responsibility for issuing the blood tests and monitoring. Whoever issues the blood requests must act upon the results.
  • Ensure patient brings their monitoring book with them, whenever requesting a further supply of lithium.
  • Check lithium dose and blood results prior to deciding if safe to continue to prescribe.
  • Update patient’s monitoring book where appropriate. Check with the relevant pathology lab if patient has been tested but no results are available.
  • Prescribe lithium by brand.
  • Ensure patient understands that branded product is lithium.
  • Use of phrases such as 'as directed' should be avoided and should state specific instructions, for example, ‘take one tablet (400mg) at night’.
  • Prescriptions are recommended to be provided as acute prescription or with appropriate safeguarding.
  • Where repeat prescriptions are necessary, it is recommended that 28-day prescription is adopted unless not deemed appropriate.
  • Ensure patients are aware of their blood testing requirements. Measure lithium plasma levels every 3 months (see below for further information regarding lithium levels) and check they are within desired therapeutic range as advised by the consultant. Samples should be taken 12 hours post dose (trough). Patients should be encouraged to know acceptable levels and their most recent results.
  • Respond to out of range results as outlined in the guidance.
  • Measure thyroid function and renal function every 6 months.
  • Provide appropriate on-going verbal and written information to patient.
  • Monitor for drug interactions.
  • Monitor for side-effects or adverse effects as specified later.
  • Perform/request additional tests and investigations during maintenance therapy if abnormal results obtained or as stated by the consultant.
  • Consider referral back to consultants for review of stable patients on lithium for 3 years.
  • Lithium patients discharged from Mental Health Services can be referred urgently to the Access and Assessment teams /Community Mental Health Teams.
Response to results:
  • If Lithium levels are above or below the range, confirm with patients the timing of the blood test and adherencewith lithium.
  • Lithium levels below the range should be discussed with the specialist services contact and consideration given to increasing the dosage.
  • Levels above the range should also be discussed urgently with the specialist service contact and consideration given to referring patients to A&E or stopping the lithium for a period of time and restarting at a lower dose once the lithium level is within the normal range.
  • All lithium levels abovethe range should be rechecked urgently and consider urgent medical review.
  • Review patient and look for signs of toxicity and side-effects.
The patient lithium monitoring booklet must be updated at each visit. If the hospital has the monitoring responsibility, the hospital is responsible for contacting the patient if any action is required. If the GP has the monitoring responsibility, the GP is responsible for contacting the patient if any action is required.
5.3 Patient/ Carer Responsibilities
  • Report any adverse effects to their GP and/or specialist.
  • Ensure that they have a clear understanding of their treatment.
  • Report any changes in disease symptoms to GP and/or specialist.
  • Alert GP and/or specialist of any changes of circumstance which could affect management of disease e.g. plans for pregnancy.
  • Take/ administer the medication as prescribed.
  • Undertake any monitoring as requested by the GP and/or specialist.
  • Ensure that their monitoring booklet is kept up to date and taken to all appointments.
  • Inform their GP in sufficient time to obtain repeat prescriptions.
  • Keep monitoring booklet safe and bring to hospital/GP appointments.
  • Show monitoring booklet to pharmacist when collecting medication.

6.PROCEDURE

6.1 Indications and Licensing

  • Management of acute mania or hypomanic episodes.
  • Management of refractory depressive disorders where Lithium is used for augmentation of antidepressants.
  • Prophylaxis of Bipolar Affective disorder.

6.2 Administration

The usual starting dose is 400mg at night (200mg in the elderly). Once daily dosing at night is preferred due to monitoring of plasma lithium levels. The dose of lithium is adjusted to achieve a lithium concentration of 0.4-1mmol/litre.

6.3 Brand Prescribing

Lithium should be prescribed by brand name because of its narrow therapeutic range and difference in product bioavailability. Not all products are modified release (MR).

The brand Priadel® is recommended within NEP and is available as 200mg and 400mg tablets. Priadel contains lithium carbonate and are scored tablets which can be halved. Particular care is needed with Priadel 520mg / 5ml sugar free liquid, which actually contains lithium citrate where 5ml = 200mg lithium carbonate (=5.4mmol Lithium). Using a single brand (Priadel) throughout the locality should help to reduce medication errors.

Camcolit® tablets are film coated immediate release. (Note from 1st October 2015 Camcolit 250mg tablets changed name to Lithium Carbonate Essential Pharma 250mg film-coated tablets. The name of Camcolit 400mg modified release tablets remains unchanged).

Care should be taken, including additional monitoring, when changing brands for formulations. Tablets contain lithium carbonate 200mg  lithium citrate 520mg.

6.4 Monitoring Standards

When starting lithium

Advise patients that poor adherence or rapid discontinuation may increase risk of relapse.

  • Ensure that the patient is given appropriate information on taking lithium safely, including monitoring booklet which is to be requested and issued from NEP Pharmacy with the medication.
  • Establish a continuing care arrangement with the patient’s GP for prescribing and monitoring adverse effects.

When stopping lithium

  • Gradually reduce the dose over at least 4 weeks and preferably up to 3 months, even if the person has started taking another anti-manic drug.
  • During dose reduction and for 3 months after stopping Lithium, monitor closely for early signs of mania or depression.

6.5 Monitoring Guidance

The safe and effective use of lithium requires regular general physical monitoring (see Table 1) and lithium levels (see Table 2).

Table 1 - General Checks

Checks / Baseline (Pre- Treatment) / After Treatment Commenced
Weight / BMI /  / Every 6 months
Urea & Electrolytes /  / Every 6 months (more frequent in renal impairment – see 6.6.4 below)
eGFR /  / Every 6 months (more frequent in renal impairment - eGFR<50ml/min)
Calcium /  / Every 6 months
(more frequent if raised)
Thyroid Functions /  / Every 6 months (more frequent if impairment)
FBC /  / Every 6 months
ECG / People with cardiovascular risk factors. / Repeat only if appropriate.
Pulse /  / Annual
Blood pressure /  / Annual

Table 2 Lithium Checks

Blood samples for lithium levels should be taken 10-14 hours (ideally 12 hours) post dose. For patients on liquid preparations taking it twice daily, patients should be advised to delay the morning dose until after the blood sample and taken 12 hours post the night time dose.

Checks / Stabilising Treatment / Maintenance
Lithium Levels / 5-7 days after starting treatment
One week after every dose change
Then monitor weekly until dose and level is stable to 4 weeks. / GENERAL
Once stable:
Every 3 months in first year, then
Every 6 months thereafter
SPECIAL GROUPS
Every 3 months in following groups:
  1. Older adults
  2. Risk of impaired renal or thyroid function
  3. Raised calcium levels
  4. Poor symptom control
  5. Poor adherence
  6. Last plasma level 0.8 mmol /l or higher
  7. Taking interacting drugs
PREGNANCY
(see advice below on prescribing in pregnancy)
Every 4 weeks up to 36 weeks of pregnancy then weekly till labour starts.
Do not give lithium during labour.
After delivery measure levels 12 hours after last dose. Lithium to be given after receipt of blood assay results and dose adjusted according to lithium levels (minimum of 24h after last dose).
Target Levels / Levels <0.4mmol/l subtherapeutic
Aim for 0.6mmol/l-0.8mmol/l (first time treated with lithium)
0.8-1.0mmol/l previously on lithium who have relapsed

6.6 Lithium Prescribing in Special Groups

6.6.1 Pregnancy

Do not offer lithium to women who are planning a pregnancy or pregnant, unless antipsychotic medication has not been effective.

If antipsychotic medication has not been effective and lithium is offered to a woman who is planning a pregnancy or is pregnant, ensure:

  • The woman knows that there is a risk of foetal heart malformations when lithium is taken in the first trimester, but the size of the risk is uncertain
  • The woman knows that lithium levels may be high in breast milk with a risk of toxicity for the baby
  • Lithium levels are monitored more frequently throughout pregnancy and the postnatal period (see table 2 lithium level monitoring)
  • If a woman taking lithium becomes pregnant, consider stopping the drug gradually over 4 weeks if she is well. Explain to her that:

Stopping medication may not remove the risk of foetal heart malformations

There is a risk of relapse, particularly in the postnatal period, if she has bipolar disorder.

  • If a woman taking lithium becomes pregnant and is not well or is at high risk of relapse, consider:

Switching gradually to an antipsychotic or

Stopping lithium and restarting it in the second trimester (if the woman is not planning to breastfeed and her symptoms have responded better to lithium than to other drugs in the past) or

Continuing with lithium if she is at high risk of relapse and an antipsychotic is unlikely to be effective.

  • If a woman continues taking lithium during pregnancy:

Check plasma lithium levels as above ( Table 2)

Adjust the dose to keep plasma lithium levels in the woman's therapeutic range

Ensure the woman maintains an adequate fluid balance

Ensure the woman gives birth in hospital

Ensure monitoring by the obstetric team when labour starts, including checking plasma lithium levels and fluid balance because of the risk of dehydration and lithium toxicity

Stop lithium during labour and check plasma lithium levels 12 hours after her last dose. Restart lithium at least 24 hours after last dose and only after reviewing the blood assay results (as dose may need to be readjusted).

6.6.2 Children

The use in children is not recommended.

The decision to give prophylactic lithium requires specialist advice, and must be based on careful consideration of the likelihood of recurrence in the individual child, and the benefit of treatment weighed against the risks.

Serum- lithium concentration needs to be monitored and should therefore not be prescribed unless facilities for monitoring serum-lithium concentration are available.

Lithium is approved to treat mania in children 12-17 yrs. However adherence to treatment and regular blood tests may be challenging in adolescents.

Although Lithium can be used to treat severe aggressive behaviour in conduct disorder, it is not licensed for this purpose.

6.6.3 Elderly Patients

Elderly patients are particularly liable to lithium toxicity and may exhibit adverse reactions at serum levels ordinarily tolerated by younger patients.

Caution is also advised since lithium excretion may be reduced in the elderly due to age related decrease in renal function (see also Renal Impairment section).

Elderly patients or those below 50kg in weight, often require lower lithium dosage to achieve therapeutic serum lithium levels and serum concentrations of lithium need to be reduced in the elderly population and particularly so in the very old and frail elderly. The summary of product characteristics (SPC) for Priadel tablets states that for prophylaxis, the dosage needed to reach a blood lithium level of 0.4-0.8mmol/L is generally in the range 600mg – 1200mg/day.