Download Lithium for patients over 18 years old including those aged

GMMMG Interface Prescribing
Subgroup
Shared Care Protocol
Shared Care Guideline for
Reference Number
Lithium for patients over 18 years old
including those aged 65 years and older.
Version: 1
Replaces: n/a
Author(s)/Originator(s): (please state author name and
department)
GMMMG Interface Prescribing Subgroup
Based on the shared care guidelines from Pennine Care NHS
Foundation Trust, Manchester Mental Health and Social Care Trust,
and Greater Manchester West Mental Health NHS Foundation Trust
Date approved by Interface Prescribing Group:
08/10/2015
Date approved by Commissioners:
dd/mm/yyyy
Issue date: 19/11/2015
To be read in conjunction
with the following
documents:
Current Summary of Product
characteristics
(http://www.medicines.org.uk)
BNF
NICE CG185
Date approved by Greater Manchester
Medicines Management Group:
19/11/2015
Review Date:
19/11/2017
(Please note Greater Manchester West Mental
Health NHS Foundation Trust use their own
shared care protocol for lithium agreed May 2016
with their CCGs)
Please complete all sections
1. Name of Drug, Brand
Name, Form and
Strength
2. Licensed Indications
3. Criteria for shared
care
Lithium all preparations
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Treatment and prophylaxis of mania, bipolar disorder, and recurrent depression.
Aggressive or self-mutilating behaviour
Treatment and prophylaxis of schizoaffective disorder (unlicensed indication)
Augmentation of antidepressants in patients with treatment resistant depression
(unlicensed indication)
Prescribing responsibility will only be transferred when:

Lithium is prescribed for one of the following conditions:
o
o
Version: 1
Date: 19.11.2015
Review: 19.11.2017
Management of acute manic or hypomanic episodes
Management of episodes of recurrent depressive disorders
where treatment with other antidepressants has been
unsuccessful
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o
o
o
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Prophylaxis against bipolar affective disorders
Control of aggressive behaviour or intentional self-harm
Augmentation of antidepressants as recommended by NICE
(unlicensed indication)
o Prophylaxis of schizoaffective disorder (unlicensed indication)
Treatment has been initiated and established by the secondary care
specialist. This means:
o psychiatric illness has been stabilised
o lithium dose and serum levels are stable
o the side effects from lithium are manageable
The patient’s initial reaction to and progress on the drug is satisfactory.
The GP has agreed in writing in each individual case that shared care is
appropriate.
Concordance is established
The patient’s general physical, mental and social circumstances are
such that he/she would benefit from shared care arrangements
N.B. lithium may be prescribed for other conditions but use outside of the listed
conditions is not covered by this shared care protocol.
4. Therapeutic use &
background
Lithium salts are used in the prophylaxis and treatment of mania, in the prophylaxis and
treatment of bipolar disorder, as concomitant therapy with antidepressant medication in
patients who have had an incomplete response to treatment for acute depression in
bipolar disorder, in the prophylaxis of recurrent unipolar depression, and in the treatment
of aggressive or self-mutilating behaviour.
Lithium may also be used as an adjunct in the treatment and prophylaxis of
schizoaffective disorder, and to augment antidepressants in patients with treatment
resistant depression. (These are unlicensed indications)
Lithium is recommended in NICE guidelines for the Management of Depression in adults
CG90 and Bipolar Disorder CG185 and is considered in the NICE guidelines for
Management of Antenatal and Postnatal Mental Health CG192.
Lithium has a narrow therapeutic range necessitating the maintaining of serum levels at
between 0.4 and 1.0 mmol/litre (BNF). NICE clinical guideline 185 (Bipolar Disorder)
recommends that clinicians should aim for levels of 0.6-0.8 mmol/litre for prophylaxis, up
to 1.0 mmol/litre in acute mania.
If the concentration of lithium in the blood becomes too high, toxic symptoms may occur,
which may lead to acute renal failure, convulsions, coma, and ultimately, death. In
addition, lithium treatment increases the risk of clinical hypothyroidism up to five-fold. As
it is excreted predominantly through the kidneys, plasma levels of lithium can be affected
by fluid balance and renal function. These considerations mean that patients taking
lithium must be subject to a continuous programme of regular blood monitoring.
Additionally, signs and symptoms of neurotoxicity may arise as a result of interaction
with antidepressants, antipsychotics and antiepileptics without a rise in serum levels.
Treatment with lithium is usually initiated and stabilised by consultant psychiatrists. A
consultant psychiatrist should retain responsibility for its overall supervision and periodic
review until the patient is formally discharged from secondary care. However, general
medical practitioners and community pharmacists process most prescriptions for lithium.
It is essential that all prescribers and pharmacists ensure that appropriate and regular
monitoring takes place, and that the results are communicated effectively between
primary and secondary care.
Version: 1
Date: 19.11.2015
Review: 19.11.2017
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The NPSA guidance on safer use of Lithium states that to ensure the safe use of lithium
it is essential that all involved in the patients care ensure that:

appropriate and regular monitoring takes place as stipulated in NICE
guidance

the results are communicated effectively between primary and secondary
care

the patient is aware of the side effects they may experience and the
symptoms of toxicity and that they know what to do if they experience these
symptoms.
It should be noted that the QOF lithium monitoring requirements do not meet the
requirements set out by NICE and the recommendations for monitoring in this shared
care protocol must be followed.
Stable patients may be stepped down to Primary Care in some CCGs where there is
prior agreement to do so with the GP and local commissioning arrangements permit.
This SCP does not apply to these patients.
5. Contraindications
(please note this does
not replace the SPC or
BNF and should be read
in conjunction with it).
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6. Prescribing in
pregnancy and lactation
Hypersensitivity to lithium or to any of the excipients
Clinically significant renal impairment
Untreated hypothyroidism.
Breast-feeding
Patients with low body sodium levels, including for example dehydrated patients
or those on low sodium diets.
Addison's disease
Cautions
 Maintain adequate sodium and fluid intake. This may be of special importance in
hot weather, or during infectious diseases, including influenza, gastro-enteritis or
urinary infections, when dose reduction may be required.
 Reduce dose or omit lithium if diarrhoea and / or vomiting present and in cases
where the patient has an infection and / or profuse sweating.
 May exacerbate psoriasis.
 Use in care in patients with cardiac disease. Higher levels of lithium (usually
above 1.00mmol/L) can be associated with cardiac arrhythmia , mainly
bradycardia, sinus node dysfunction, peripheral circulatory collapse,
hypotension, oedema, ECG changes such as reversible flattening or inversion of
T-waves and QT prolongation, cardiomyopathy.
 Lithium should be discontinued 24 hrs prior to major surgery.
 Lithium should be recommenced post operatively once kidney function and fluidelectrolyte balance are normal.
 Lithium need not be discontinued prior to minor surgery, but careful monitoring
of fluids and electrolytes is needed.
This drug cannot be prescribed in the pregnant and/or breast feeding patient. Under
these circumstances prescribing should be the responsibility of the specialist.
Lithium is a human teratogen. Women of child bearing potential should be advised to
use adequate contraception.
7. Dosage regimen for
continuing care
Route of administration
Preparations available:
Oral
Lithium must be prescribed by brand name.
Version: 1
Date: 19.11.2015
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Brands available are:
Camcolit - (Lithium carbonate 400mg tablets)
Lithium Carbonate Essential Pharma – (Lithium carbonate 250mg tablets) – previously
Camcolit 250mg.
Liskonum – (Lithium carbonate 450mg tablets)
Priadel – (Lithium carbonate 200mg & 400mg tablets + Lithium citrate 520mg/5ml liquid)
Li-Liquid – (Lithium citrate 509mg/5ml liquid, 1.108mg/5ml liquid)
Preparations vary widely in bioavailability therefore changing preparations requires the
same precautions as initiation of treatment (see BNF).
Please prescribe:
Doses will be dictated by serum lithium levels.
The consultant will specify the desired serum lithium range. The usual range for this
would be between 0.4-1.0mmol/l, however, the consultant may recommend a higher or
lower range (i.e. 0.4-0.8mmol/l for a patient more susceptible to side effects, such as in
later life).
Brand Name
Lithium Carbonate
Priadel
Camcolit
Lithium Carbonate
Essential Pharma
(Previously
Camcolit 250mg)
Liskonum
Lithium Citrate
Priadel liquid
Li-Liquid
Version: 1
Date: 19.11.2015
Review: 19.11.2017
Formulation
Modified release
tablets 200mg,
400mg
Initial dose range
Treatment
Prophylaxis
400mg-1.2g daily
as single dose or in
two divided doses
(elderly or patients
<50kg = 200400mg daily
initially)
1g-1.5g daily
(elderly = reduce
initial dose)
1g-1.5g daily
(elderly = reduce
initial dose)
400mg-1.2g daily
as single dose or in
two divided doses
(elderly or patients
<50kg = 200400mg daily
initially)
300mg-400mg
daily
Modified release
tablets 450mg
450mg-675mg
twice daily
(elderly = 225mg
twice daily initially)
450mg twice daily
(elderly = 225mg
twice daily initially)
Sugar free solution
520mg/5ml
1.04g-3.12g daily
(10-30ml) in two
divided doses
(elderly or patients
<50kg = 520mg
daily in 2 divided
doses)
1.108g-3.054g
daily in two divided
doses
1.04g-3.12g daily
(10-30ml) in two
divided doses
(elderly or patients
<50kg = 520mg
daily in 2 divided
doses)
1.108g-3.054g
daily in two divided
doses
Tablets 250mg
Modified release
tablets 400mg
Tablets 250mg
Solution
509mg/5ml
Solution
Shared Care Guideline for Lithium in Adults
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300mg-400mg
daily
Page 4 of 21
1.108mg/5ml
Is titration required
(elderly or patients
<50kg = 509mg
daily in two divided
doses)
(elderly or patients
<50kg = 509mg
daily in two divided
doses)
Yes by specialist or providing information to GP to
prescribe & recommend dose adjustment depending on
local commissioning arrangements.
Adjunctive treatment regime:
Not applicable
Conditions requiring dose reduction:
Age, physical frailty, electrolyte imbalance
Mild to moderate renal impairment – monitor serum lithium concentration closely and
adjust dose accordingly.
Usual response time :
Response time is determined by serum lithium concentration and time taken to reach a
concentration of 0.6 – 0.8mmol/litre for prophylaxis and up to 1mmol/litre for acute mania
(NICE clinical guideline CG185)
Duration of treatment:
Lithium should be taken for at least 6 months to establish its effectiveness as a longterm treatment.
Benefit may not be apparent for up to 1 year. Long-term treatment should be undertaken
only with careful assessment of risk and benefit. The need for continued therapy should
be assessed regularly and patients should be maintained on lithium after 3-5 years only
if benefit persists. Consult specialist to discuss long-term treatment.
Treatment to be terminated by:
Specialist
Abrupt discontinuation of lithium increases the risk of relapse. If lithium is to be
discontinued the dose should be reduced gradually over at least 4 weeks, preferably 3
months.
During dose reduction and for 3 months after lithium treatment is stopped, monitor the
patient closely for early signs of mania and depression.
NB. All dose adjustments will be the responsibility of the initiating
specialist unless directions have been specified in the medical letter to the
GP.
Version: 1
Date: 19.11.2015
Review: 19.11.2017
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8.Drug Interactions
For a comprehensive list
consult the BNF or
Summary of Product
Characteristics
9. Adverse drug
reactions
For a comprehensive list
(including rare and very
rare adverse effects), or if
significance of possible
adverse event uncertain,
consult Summary of
Product Characteristics or
BNF
Version: 1
Date: 19.11.2015
Review: 19.11.2017
The following drugs may be prescribed with caution with appropriate monitoring
of lithium levels as necessary:
Carbamazepine
Clonazepam
Diltiazem
Metronidazole
Phenytoin
Theophylline
Verapamil
ACE Inhibitors
Amiodarone
Angiotensin-II receptor antagonists
Antacids
Antidepressants – seek specialist advice
Antipsychotics – seek specialist advice
Non-steroidal anti-inflammatory drugs
Thiazide and potassium-sparing diuretics.
Loop diuretics
Specialist to detail below the action to be taken upon occurrence of a particular
adverse event as appropriate. Most serious toxicity is seen with long-term use
and may therefore present first to GPs.
Adverse event
System – symptom/sign
Toxicity
Signs of toxicity:
 blurred vision
 nystagmus
 diarrhoea and
vomiting muscle
weakness
 coarse tremor
 sedation, confusion,
drowsiness
 slurring of words
 convulsions
 ataxia
 renal impairment
Action to be taken
Include
whether drug should be stopped
prior to contacting secondary care
specialist
Treatment should be
stopped for 48 hours and
advice sought from a
Consultant if serum
levels exceed 1.5
mmol/litre and/or the
patient shows signs of
toxicity.
By whom
GP/Consultant
Serum levels of 2.0
mmol/litre and over
require urgent treatment
at an Accident and
Emergency department.
Treatment details can be
found in the BNF under
‘Emergency
Treatment of Poisoning.’
Fine Tremor/
Polydipsia/Polyuria
Serum Lithium
concentration to be
measured (Dose may
need reducing)
GP/Consultant
Hypothyroidism
Monitor and replace with
levothyroxine
GP
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The patient should be advised to report any of the following signs or symptoms to
their GP without delay:
Signs of toxicity - symptoms of neurotoxicity, including paraesthesia, ataxia, tremor and
cognitive impairment; stomachache, nausea, diarrhoea; blurred vision; increased fluid
intake; increased urine production.
Seek medical attention if they develop diarrhoea or vomiting or become acutely ill for any
reason
Other important co morbidities (e.g. Chickenpox exposure). Include advice on
management and prevention and who will be responsible for this in each case:
Infections including influenza, gastroenteritis and urinary infections may result in the
need for dose reduction. Careful monitoring of serum lithium concentration is required in
these conditions and dosage should be adjusted if necessary by the GP/Consultant.
Any adverse reaction to a black triangle drug or serious reaction to an established
drug should be reported to the MHRA via the “Yellow Card” scheme.
10.Baseline
 Height, weight and BMI
investigations
 urea and electrolytes and serum creatinine, eGFR
(Local
commissioning
arrangements
may
vary
between
CCGs)
 thyroid function
 lipids
 Fast blood glucose or Hba1c
 LFTs
 FBC
 Blood pressure
 Pulse
 ECG for patients with cardiovascular disease or risk factors for it
 Smoking status
 Alcohol status
 Pregnancy test in women of child bearing age
 Calcium levels if indicated (e.g. in women aged 60 years or older, patients with
renal failure)
11. Ongoing monitoring
requirements to be
undertaken by GP
(Local commissioning
arrangements may vary
between CCGs)
Version: 1
Date: 19.11.2015
Review: 19.11.2017
Is monitoring required?
Yes
Prescribers should check local commissioning
arrangements prior to implementing shared care as
there may be variation in who is responsible for the
physical health checks due to differences in local
commissioning arrangements.
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Monitoring
Lithium level
(level to be taken
12 hours post
dose)
Thyroid function
Renal function
Urea, electrolytes
and calcium
Version: 1
Date: 19.11.2015
Review: 19.11.2017
Frequency
Results
3 monthly
Usual range =
0.4-1.0mmol/l
(more frequent
monitoring is
required if
levels fall
outside of
patients target
range, the dose
is changed,
interacting drug
prescribed or
change to
physical health.
Following a
change in dose,
levels should be
taken 7 days
after the change
then weekly
until levels have
been stable for
1 month)
6 monthly
Consultant will
specify range
TSH 0.274.2mU/l
(more frequent
monitoring
required if TSH
elevated or an
increase in
mood
symptoms that
might be related
to impaired
thyroid function)
6 monthly
(more frequent
monitoring
required if
evidence of
impaired renal
function and
more often if on
ACEI’s,
diuretics or
NSAIDs)
6 monthly
(more frequent
monitoring
required if
evidence of
impaired renal
function or
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Action
If low – contact consultant/
specialist nurse for advice
If high – withhold lithium and
contact consultant/ specialist
nurse for advice
If over 2.0mmol/l - send patient
to A&E and inform consultant
If normal but signs of lithium
toxicity - contact consultant/
specialist for advice
TSH > 2 times upper limit of
normal - high risk of progression
to overt hypothyroidism and
levothyroxine should be
prescribed.
TSH 1-2 x upper limit of normal
- more frequent monitoring is
indicated and a trial of
levothyroxine may be
appropriate particularly if the
patient is symptomatic.
If eGFR< 45ml/min, a rapidly
falling eGFR, or results suggest
a gradual decline in renal
function contact consultant/
specialist for advice.
Page 8 of 21
raised Ca
levels)
Weight and BMI
ECG
Physical Health:
lipid levels (incl.
cholesterol
in
patients > 40 yr)
plasma glucose
levels
weight
smoking
status
and alcohol use
blood pressure
pulse
Side effects/signs
of toxicity
12. Pharmaceutical
aspects
13. Patients excluded
from shared care
14. Responsibilities of
initiating/supervising
specialist
(Local commissioning
arrangements may vary
between CCGs)
Diet can be considered for
increased weight.
Annually if high
CVD risk or
otherwise
clinically
indicated.
Consultant to
advise if ECG
monitoring
required.
Annually
Please contact the consultant
urgently if any ECG changes
such as reversible flattening or
inversion of T-waves and QT
prolongation.
(weight should
be monitored
more frequently
in patients with
rapid weight
gain)
Every
consultation
Any physical health problems
identified through monitoring in
primary care should be treated
by the appropriate primary care
health professional and should
be communicated to the
initiating consultant within 14
days.
If lithium toxicity is identified or
suspected lithium should be
stopped and an urgent lithium
level taken (see above for
details of action to be taken
regarding lithium results).
NB: Toxicity can
occur
even
when the lithium
serum
levels
are within the
recommended
therapeutic
range
Abrupt discontinuation of lithium increases the risk of relapse. If lithium is to be
discontinued the dose should be reduced gradually over at least 4 weeks, preferably 3
months.
 Unstable disease state
 Patient does not consent
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Version: 1
Date: 19.11.2015
Review: 19.11.2017
Every 6 months
Initial diagnosis
Appropriateness of lithium treatment considering co-morbidities, concurrent
medication effect of any past treatment, patient choice and treatment guidelines.
Initiate treatment and prescribe until dose is stable OR provide information to GP
to prescribe & recommend dose adjustment depending on local commissioning
arrangements.
Undertake baseline monitoring.
Dose adjustments.
Ensure the patient/carer is counselled about the use and indication of lithium
including:
o How long it will take to have an effect including that lithium should be
taken for at least 6 months to establish its effectiveness as a long-term
treatment
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o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
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Ensure that the patient has an NPSA purple lithium pack. Complete all details in
the NPSA purple lithium pack (information, alert card and record book) and give
to the patient/carer, emphasising that the alert card is carried at all times and all
the occasions that the record book must be shown and updated with information.

Inform GP of diagnosis, that lithium therapy has commenced (specify brand) and
being supplied, the patients desired therapeutic range, relevant clinical
information, baseline results, treatment to date and treatment plan, duration of
treatment before consultant review.
Assess the patient regularly and titrate upwards using lithium serum levels
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Version: 1
Date: 19.11.2015
Review: 19.11.2017
What are the signs of a high lithium level and what to do
How long lithium therapy needs to be taken for
The importance of compliance and not suddenly stopping lithium therapy
including that erratic compliance or rapid discontinuation may increase
the risk of manic relapse
The differences between the different brands and the need to remain on
the same brand
Dosage instructions (including when to take it in regards to lithium level
monitoring)
Side effects of lithium
How to stop the lithium level getting too high
Ensure they maintain their fluid intake, particularly after sweating (for
example, after exercise, in hot climates, or if they have a fever), if they
are immobile for long periods or – in the case of older people – develop
a chest infection or pneumonia
Interactions (including with OTC medications - patients should be
warned not to take over-the-counter non-steroidal anti-inflammatory
drugs)
Other monitoring requirements (e.g. renal function and thyroid function)
What to do if a dose is forgotten
Management of lithium in hot weather (effect of sweating)
Effect of alcohol on lithium use/serum concentrations
Effect of caffeine (diuretic) on lithium use/serum concentrations
The need to seek medical attention if they develop diarrhoea or vomiting
or become acutely ill for any reason
For women of childbearing age pregnancy and contraception;
contraindication to breast feeding and action to take if they become
pregnant while taking lithium.
Driving implications - effect of lithium and mental health on driving –
impact on DVLA driving licences
Arrangements for further supplies

Monitor serum level weekly and adjust dose as required until steady state is
obtained within target range depending on local commissioning in arrangements.
In some CCGs this may be done by GPs with support and advice from the
specialist - optimum target range needs to be set and recorded in purple lithium
pack for each individual patient and varies dependent on age, physical frailty,
kidney function and condition to be treated. Normal target range 0.4-1.0 mmol/l
(0.5-0.8 mmol/l for twice daily dosage)

Once stable dosing and serum level achieved move to long term blood
monitoring arrangements (3 monthly), record results in the purple book and copy
results to primary care
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15. Responsibilities of
the GP
(Local commissioning
arrangements may vary
between CCGs)
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Version: 1
Date: 19.11.2015
Review: 19.11.2017
Ensure that the patient has an adequate supply of medication until GP supply
can be arranged.
Continue to monitor and supervise the patient according to this protocol, while
the patient remains on this drug, and agree to review the patient promptly if
contacted by the GP.
Review patient at 12 monthly intervals or less for overall monitoring of mental
health, efficacy and continued need for treatment and monitoring results since
the last review. For some patients it may be appropriate to discharge the patient
from mental health services in these cases the consultant may agree this with
the GP and no longer provide annual reviews. In these cases there must be a
system in place to allow the GP to rapidly refer a patient if problems with lithium
therapy are experienced.
Provide GP with details of outpatient consultations, ideally within 14 days of
seeing the patient or inform GP if the patient does not attend appointment.
Provide GP with advice on when to stop this drug.
Act upon communication from the GP in a timely manner.
Be available to provide patient specific advice and support to GPs as necessary.
Patients initiated on lithium during an inpatient admission should be recounselled immediately prior to discharge.
To exclusively prescribe lithium by the brand name and at the dose and
frequency advised by the consultant once shared care has been agreed. (NB
lithium must be prescribed by brand name).
Ensure monitoring requirements are carried out and recorded in the patient’s
NPSA purple lithium pack as detailed in the table above.
To carry out serum lithium level monitoring if not being undertaken by mental
health services in accordance with the agreed frequency (minimum three
monthly) if advised and agreed with the GP.
To communicate results of lithium level monitoring to specialist.
If the lithium level is outside the therapeutic range, the specialist should be
informed as soon as possible.
If not undertaken by mental health service to facilitate physical monitoring of TFT
and U&E every six months and inform the Psychiatrist of the results.
Undertake more frequent tests if there is evidence of clinical deterioration,
abnormal results, a change in sodium intake, or symptoms suggesting abnormal
renal or thyroid function such as unexplained fatigue, or other risk factors, for
example, if the patient is starting medication such as ACE inhibitors, nonsteroidal anti-inflammatory drugs, thiazides and related diuretics or sodium
bicarbonate containing, non-prescription antacids or urinary alkalinising agents’.
Contact consultant/specialist for advice on monitoring if required.
Check all monitoring results prior to issuing a repeat prescription to ensure it is
safe to issue. If a patient fails to attend for monitoring:
o Only issue a 28 day prescription and send them the next available
appointment for a blood test.
o If they fail to attend the second appointment, contact the consultant
team for advice and to discuss suitability for continued shared care
before supplying further prescriptions.
Ensure that potential interactions with lithium are considered when
starting/stopping/altering medication. Particular caution is required with ACE
inhibitors, non-steroidal anti-inflammatory drugs and diuretics. Inform the
consultant and ensure appropriate action is taken where appropriate.
Reinforce the importance of continued contraception with women of child
bearing age as necessary.
Consider the side effects of lithium in consultations; especially signs of toxicity
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(see side effects/signs of toxicity in table above).
Consider stopping lithium for up to 7 days if the patient becomes acutely and
severely ill with a metabolic or respiratory disturbance from whatever cause.
 Provide on-going counselling regarding lithium treatment where appropriate.
 Inform the consultant immediately if a patient has become pregnant or is
planning to become pregnant for treatment options to be considered.
 Report any adverse effects of treatment to the consultant.
 Act upon communication from the specialist in a timely manner.
 To formally reply to the request for shared care from the specialist depending on
local commissioning arrangements in each CCG.
 To monitor and prescribe in collaboration with the specialist according to this
protocol.
 Symptoms or results are appropriately actioned, recorded and communicated to
secondary care when necessary.
 If lithium serum levels are received from Mental Health Services GP practices
should input this level into their clinical records as soon as possible to allow safe
dispensing when requested by the community pharmacist.
 Enter a READ code (e.g. 8BM5.00) on to the patient record to highlight the
existence of shared care for the patient.
 Seek urgent advice from secondary care if:
 Toxicity is suspected
 The patient becomes pregnant whilst taking lithium (but do not stop the lithium)
 Non-compliance is suspected
 The GP feels a dose change is required
 There is marked deterioration in mental health
 The GP feels the patient is not benefiting from the treatment

16. Responsibilities of
the patient





17.Additional
Responsibilities
e.g. Failure of patient to
attend for monitoring,
Intolerance
of
drugs,
Monitoring
parameters
outside acceptable range,
Treatment
failure,
Communication failure
To take medication as directed by the prescriber, or to contact the GP if not
taking medication
To attend for blood monitoring
To attend hospital and GP clinic appointments, bring monitoring booklet
Failure to attend will result in medication being stopped (on specialist advice).
To report adverse effects to their Specialist or GP.
List any special
considerations
Action required
Failure of patient to
attend for monitoring
Encouragement to
GP
[insert]
attend, if still fails
then to advise
consultant
Serum lithium level
GP with advice
[insert]
needed urgently
from specialist as
and dose
required
adjustment
considered
 To follow local SOP within their organisation for the
dispensing of lithium.
 To follow the following good practices when dispensing
lithium:
 To facilitate appropriate supply of lithium (keep to
same brand), after reconciling patients’ test results with
lithium dose and assured of safety of the dispensing.
 To communicate with the prescriber immediately if
lithium is supplied without availability of blood test data.
Development of signs
of toxicity
Responsibilities of
dispensing pharmacist
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
18. Supporting
documentation
To communicate with the prescriber immediately if
there are any concerns with patients’ lithium therapy.
 To check if any relevant drug interactions including
OTC medicines and advise prescriber and service
user.
The SCG must be accompanied by a patient information leaflet. (Available from
http://www.medicines.org.uk/emc OR http://www.mhra.gov.uk/spc-pil/)

19. Patient monitoring
booklet
20. Shared care
agreement form
21. Contact details
Version: 1
Date: 19.11.2015
Review: 19.11.2017
Bipolar disorder; the assessment and management of bipolar disorder in
adults, children and young people in primary and secondary care CG185
(Sept 14) https://www.nice.org.uk/guidance/cg185
 Depression in adults: The treatment and management of depression in
adults CG90 (Oct 09) https://www.nice.org.uk/guidance/cg90
 Antenatal and postnatal mental health: clinical management and service
guidance CG192 (Dec 14) https://www.nice.org.uk/guidance/cg192
 Patient Safety Alert NPSA 2009/PSA005 available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=65426
 NPA/NPSA Standard operating Procedure “Supplying Lithium therapy”
available at http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=65426
A lithium treatment pack should be given to patients on initiation of treatment with
lithium. The pack consists of a patient information booklet, lithium alert card, and a
record book for tracking serum-lithium concentration.
Packs may be purchased from 3M:
Tel: 0845 610 1112 OR Email: [email protected]
The patient must bring this booklet to all specialist and GP appointments where it will
be updated by the health professional conducting the appointment. The patient must
also produce the booklet to any health professional involved in other aspects of their
care e.g. pharmacists and dentists.
Attached below
See Appendix 1
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Appendix 1 – Local Contact Details
Lead author contact
information
Name: [insert text here]
Email: [insert text here]
Contact number: [insert text here]
Organisation: [insert text here]
Commissioner contact
information
Name: [insert text here]
Email: [insert text here]
Contact number: [insert text here]
Organisation: [insert text here]
Secondary care contact
information
If stopping medication or needing advice please contact:
Dr [insert text here]
Contact number: [insert text here]
Fax:[insert text here]
Hospital: [insert text here]
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Appendix – Information to be provided to the patient
(Taken from Greater Manchester West Mental health NHS Foundation Trust SHARED CARE
GUIDELINE for Prescribing of Lithium, monitoring of clinical state, presence of side effects
and serum levels – Salford Version).
The initiating prescriber should ensure that the recommended NPSA Lithium information and
record books are supplied to the patient.
 Lithium Therapy’ Record Book
 Lithium Therapy’ Important information for patients or
 Lithium alert cards
 Patient information leaflets should be given to the patient.
Advise people taking lithium to:
 Seek medical attention if they develop diarrhoea or vomiting or become acutely ill for any
reason
 Ensure they maintain their fluid intake, particularly after sweating (for example, after
exercise, in hot climates or if they have a fever), if they are immobile for long periods or if
they develop a chest infection or pneumonia.
 Talk to their doctor as soon as possible if they become pregnant or are planning a
pregnancy
Warn people taking lithium not to take over the counter non-steroidal anti-inflammatory drugs and
avoid prescribing these drugs for people with bipolar disorder if possible. If they are prescribed,
this should be on a regular (not prn) basis and the person should be monitored monthly until a
stable lithium level is reached and then every 3 months.
Procedures should be created for the updating and reconciliation of the information regarding
blood tests in the booklets and patient card provided. A note should be made on the patient’s
records that such information has been given to the patient.
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Appendix – Prescribing of Lithium in renal impairment
(Taken from Greater Manchester West Mental health NHS Foundation Trust SHARED CARE GUIDELINE for
Prescribing of Lithium, monitoring of clinical state, presence of side effects and serum levels – Salford Version).
Changes in renal function and prescribing lithium in patients with Chronic Kidney Disease
Stage G3 – G5
Renal function and guidance for prescribing lithium
*Note this guidance is based on consensus and expert opinion and is not all evidence based.
Monitor lithium dose and plasma lithium levels more frequently if urea levels and creatinine levels
become elevated, or eGFR falls over 2 or more tests, and assess the rate of deterioration of renal
function. For further information on monitoring frequency and classification see link to NICE’s
guidance on chronic kidney disease and acute kidney injury.
Introduction to eGFR
Estimated glomerular filtration rate (eGFR) is routinely used to assess renal function and is a
more sensitive measure of renal impairment than serum creatinine or urea alone. The eGFR is
calculated in the laboratory from the serum creatinine, age, sex and ethnicity of the patient using
the abbreviated MDRD formula. However the laboratory will generally not know the ethnicity of a
patient and for that reason the eGFR will always be calculated for a non Afro-Caribbean patient. If
the patient is Afro-Caribbean then multiply the value by 1.21. NICE classifies CKD according to
eGFR and Albumin Creatinine Ration (ACR) using ’G’ to denote GFR category and ‘A’ for the
ACR category.
Interpreting eGFR values
 If eGFR >90 use an increase in serum creatinine of more than 20% to infer significant
reduction in kidney function.
 If eGFR >60 interpret values with caution bearing in mind that estimates of GFR become
less accurate as the true GFR increases.
 If eGFR <60 if person not previously tested confirm the result by repeating the test within
2 weeks. Allow for biological and analytical variability of serum creatinine (+/-5%) when
interpreting changes in eGFR .
 eGFR 45-59 sustained for at least 90 days and no protein urea or other marker of kidney
disease, refer to guidelines re cystatin c-based estimates of GFR.
Prescribing Lithium
If patients have an eGFR of > 60 ml/min it is usually safe to start lithium treatment.
Note, patient’s renal function will naturally deteriorate with age and a decline of approximately
1ml/min year is expected in patients over the age of 40.
Patients under 65 years of age who are found to have an eGFR of less than 60mls/min may
require investigation for a cause of underlying kidney disease. Such patients should be entered
on the QoF CKD register and managed according to renal network guidelines.
eGFR between 45 and 60mls/min
Young fit adults with eGFR of 45 to 60mls/min may be commenced on 200-400mg daily.
Older patients with significant co-morbidities, and patients known to have an eGFR of 4560mls/min should be commenced on a maximum of 200mg lithium carbonate daily
eGFR between 30 and 44mls/min
Patients with an eGFR of <45mls/min, patients who are concomitantly prescribed known
nephrotoxic drugs or drugs that may interact to increase levels and patients who have additional
risk factors for kidney disease should be started on 100mg lithium carbonate daily
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Monitoring of lithium in patients with Chronic Kidney Disease Stage G3-G5
Following initiation of lithium:
 Lithium levels should be checked weekly
 Renal function should be monitored by checking the eGFR in 2 weeks.
 If the eGFR is stable following initiation of lithium, continue lithium and recheck the renal
function every 3 months.
Lithium levels should be taken 12 hours post dose and checked weekly until stable and within the
range of 0.4-1mmol/L
For patients already taking lithium
Monitor eGFR every 3 months and consider maintaining lithium level at the lower end of the
range providing the dose remains therapeutic.
Monitoring eGFR over time.
Patients identified with an eGFR of 30-59mls/min require routine monitoring to consider the rate
of decline in renal function.
If the rate of decline is >5mls/min/12 months, a repeat blood test should be taken in 2 weeks and
if consistent follow guidelines for referral to specialist renal services.
eGFR 15-29mls/min & eGFR <15mls/min and/or receiving renal replacement therapy:
Any patients identified with an eGFR of less than <30mls/min and not known to renal services
may require referral to secondary care.
If the patient is taking lithium, and renal function deteriorates contact the renal specialist team for
advice. If the cause of the renal failure is thought to be due to lithium, careful consideration of
risks of stopping lithium must be discussed with the patient and /or carer and recorded in the case
notes. It may be possible to continue lithium with additional monitoring and reduction of lithium
dosage.
Note that lithium toxicity can occur in patients with therapeutic levels. It is important to monitor
clinical signs and symptoms of toxicity especially in patients with Chronic Kidney Disease Stage
G3-G5.
Patients known to have CKD G4 – G5 and already taking lithium will require careful monitoring
and should have lithium levels and renal function checked every 1-2 months with adjustment of
dose as renal function deteriorates.
Additional caution
Starting or adjusting doses of any diuretics or ACE inhibitors /Angiotensin 2 receptor blockers in
patients taking lithium should only be done after careful consideration and on specialist advice
from a nephrologist or pharmacist.
General Advisory Notes:
Interpret eGFR with caution in those with extremes of muscle mass.
Make an allowance for biological and analytical variability of serum creatinine plus or minus 5%
when interpreting changes in eGFR
Patients who are diabetic should have albumin or /protein excretion measured.
General risk factors for in patients with Chronic Kidney Disease Stage G3-G5:
Cardiovascular disease, proteinuria, hypertension, diabetes, smoking, black, Asian, SLE, heart
failure, hereditary genetic conditions eg polycystic kidney disease.
Regular use of known nephrotoxic drugs such as NSAIDs, mesalazine, ciclosporin, ACE
inhibitors, Angiotensin Receptor Blockers (ARBs)
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Shared Care Agreement Form
Specialist request
*IMPORTANT: ACTION NEEDED
Dear Dr
[insert Doctors name here]
Patient name: [insert Patients name here]
Date of birth: [insert date of birth]
NHS Number: [insert NHS Number]
Diagnosis:
[insert diagnosis here]
This patient is suitable for treatment with [insert drug name] for the treatment of
[insert indication]
This drug has been accepted for Shared Care according to the enclosed protocol
(as agreed by Trust / CCG / GMMMG). I am therefore requesting your agreement
to share the care of this patient.
The patient has been fully counselled on the medication.
Treatment was started on [insert date started] [insert dose].
If you are in agreement, please undertake monitoring and treatment from [insert
date]
NB: date must be at least 1 month from initiation of treatment.
Baseline tests:
[insert information]
Next review with this department:
[insert date]
You will be sent a written summary within 14 days. The medical staff of the
department are available at all times to give you advice. The patient will not be
discharged from out-patient follow-up while taking [insert text here].
Please use the reply slip overleaf and return it as soon as possible.
Thank you.
Yours
[insert Specialist name]
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Shared Care Agreement Form
GP Response
Dear Dr [insert Doctors name]
Patient
[insert Patients name]
NHS Number [insert NHS Number]
Identifier
[insert patient date of birth/address]
I have received your request for shared care of this patient who has been
advised to start [insert text here]
A
I am willing to undertake shared care for this patient as set out in the
protocol
B
I wish to discuss this request with you
C
I am unable to undertake shared care of this patient.
My reasons for not accepting are:
(Please complete this section)
GP signature
Date
GP address/practice stamp
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Shared Care Guideline Summary:
LITHIUM FOR PATIENTS OVER 18 YEARS OLD INCLUDING
THOSE AGED 65 YEARS AND OLDER
Lithium must be prescribed by brand name.
Brands available are:

Camcolit – (Lithium carbonate 250mg tablets, 400mg tablets)

Lithium Carbonate Essential Pharma – (Lithium carbonate 250mg tablets) – previously
Camcolit 250mg.

Liskonum – (Lithium carbonate 450mg tablets)

Priadel – (Lithium carbonate 200mg & 400mg tablets + Lithium citrate 520mg/5ml liquid)

Liskonum – (Lithium carbonate 450mg tablets)

Li-Liquid – (Lithium citrate 509mg/5ml liquid, 1.018g/5ml liquid)
Preparations vary widely in bioavailability therefore changing preparations requires the same
precautions as initiation of treatment (see BNF).
Drug
Indication




Treatment and prophylaxis of mania, bipolar disorder, and recurrent depression.
Aggressive or self-mutilating behaviour
Treatment and prophylaxis of schizoaffective disorder (unlicensed indication)
Augmentation of antidepressants in patients with treatment resistant depression (unlicensed
indication)
Overview
Lithium is recommended in NICE guidelines for the Management of Depression in adults CG90 and
Bipolar Disorder CG185 and is considered in the NICE guidelines for Management of Antenatal and
Postnatal Mental Health CG192.
Specialist’s
Responsibilities
Initial investigations: Assessment & diagnosis of patient. Assess suitability of patient for treatment.
Discuss benefits and side-effects of treatment with the patient. Baseline investigations as
recommended by NICE.
(Local
commissioning
arrangements may
vary between
CCGs)
Initial regimen: Depends on the brand chosen (see BNF and SPC). Doses will be dictated by serum
lithium levels (usual range between 0.4-1.0mmol/l).
Clinical monitoring: Review patient at 12 monthly intervals or less for overall monitoring of mental
health, efficacy and continued need for treatment and monitoring results since the last review.
Safety monitoring: Monitoring for response and adverse drug reactions (ADRs) during initiation
period. Evaluating ADRs raised by the GP and evaluating any concerns arising from reviews
undertaken by GP.
Prescribing details: Specialist initiated. Transferred to GP once stabilised. To stop the drug or
provide GP with advice on when to stop this drug.
Documentation: Patients will only be transferred to the GP once the GP has agreed via signing
copies of the Shared Care Agreement Form unless other commissioning arrangements exist. Provide
GP with diagnosis, relevant clinical information, treatment plan, duration of treatment within 14 days of
seeing the patient or inform GP if the patient does not attend appointment
GP’s
Responsibilities
(Local
commissioning
arrangements may
vary between
CCGs)
Maintenance prescription: Prescribe lithium in accordance with the specialist’s recommendations.
Doses will be dictated by serum lithium levels & the brand chosen.
The consultant will specify the desired serum lithium range. The usual range for this would be between
0.4-1.0mmol/l however, the consultant may recommend a higher or lower range (i.e. 0.4-0.8mmol/l for
a patient more susceptible to side effects, such as in later life).
Clinical & Safety monitoring: To report to and seek advice from the specialist on any aspect of
patient care which is of concern to the GP and may affect treatment.
Lithium level (level to be taken 12
3 monthly
hours post dose)
(more frequent monitoring is required if levels fall
outside of patients target range, the dose is
changed, interacting drug prescribed or change to
physical health. Following a change in dose, levels
should be taken 7 days after the change then
weekly until levels have been stable for 1 month)
Thyroid function
Renal function
Version: 1
Date: 19.11.2015
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6 monthly
(more frequent monitoring required if TSH elevated or an
increase in mood symptoms that might be related to
impaired thyroid function)
6 monthly
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Urea, electrolytes and calcium
Weight and BMI
ECG
Physical Health:
lipid levels (incl. cholesterol in patients
> 40 yr)
plasma glucose levels
weight
smoking status and alcohol use
blood pressure
pulse
Side effects/signs of toxicity
(more frequent monitoring required if evidence of
impaired renal function and more often if on ACEI’s,
diuretics or NSAIDs)
6 monthly
(more frequent monitoring required if evidence of
impaired renal function or raised Ca levels)
Every 6 months
Annually if high CVD risk or otherwise clinically indicated.
Consultant to advise if ECG monitoring required.
Annually
(weight should be monitored more frequently in patients
with rapid weight gain)
Every consultation
NB: Toxicity can occur even when the lithium serum
levels are within the recommended therapeutic range
Duration of treatment: Lithium should be taken for at least 6 months to establish its effectiveness as
a long-term treatment. Benefit may not be apparent for up to 1 year. Long-term treatment should be
undertaken only with careful assessment of risk and benefit. The need for continued therapy should
assessed regularly and patients should be maintained on lithium after 3-5 years only if benefit persists.
Consult specialist to discuss long-term treatment.
Re-referral criteria: Seek urgent advice from secondary care if:
 Toxicity is suspected
 The patient becomes pregnant whilst taking lithium (but do not stop the lithium)
 Non-compliance is suspected
 The GP feels a dose change is required
 There is marked deterioration in mental health
 The GP feels the patient is not benefiting from the treatment
Documentation: Depending on local commissioning arrangements formally reply to the consultant’s
request to shared care within 14 days of receipt, using the shared care agreement forms.
Adverse Events
Adverse events
Toxicity
Signs of toxicity: blurred vision,
nystagmus, diarrhoea vomiting,
muscle weakness,
coarse tremor, sedation,
confusion, drowsiness, slurring
of words, convulsions, ataxia,
renal impairment
Fine Tremor/ Polydipsia/Polyuria
Hypothyroidism
Action
Treatment should be stopped for 48 hours and advice sought
from a Consultant if serum levels exceed 1.5 mmol/litre and/or
the patient shows signs of toxicity.
Serum levels of 2.0 mmol/litre and over require urgent treatment
at an Accident and Emergency department. Treatment details
can be found in the BNF under ‘Emergency Treatment of
Poisoning.’
Serum Lithium concentration to be measured (Dose may need
reducing)
Monitor and replace with levothyroxine
Contraindications
Cautions
Drug
Interactions
Please refer to the BNF and/or SPC for information.
Other
Information
A lithium treatment pack should be given to patients on initiation of treatment with lithium. The pack
consists of a patient information booklet, lithium alert card, and a record book for tracking serumlithium concentration.
Abrupt discontinuation of lithium increases the risk of relapse. If lithium is to be discontinued the dose
should be reduced gradually over at least 4 weeks, preferably 3 months.
Contact Details
Name: [insert text here]
Address: [insert text here]
Telephone: [insert text here]
Lithium is a human teratogen. Women of child bearing potential should be advised to use adequate
contraception.
Conditions requiring dose reduction:
Age, physical frailty, electrolyte imbalance
Mild to moderate renal impairment – monitor serum lithium concentration closely and adjust dose
accordingly.
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