Download Lithium MonitoringAppendices_Final_Version_1_Feb 2012

Public Health Wales
Lithium Monitoring
Lithium Monitoring
Quality improvement toolkit - Appendices
Author:
Primary Care Quality and Information Service
Date: February 2012
Version: 1
Status: Final
Intended audience:
Public (Internet) / NHS Wales (Intranet) / Public Health Wales (Intranet)
Purpose and summary of document:
This document is for use by general practices to ensure that the delivery of service to
people prescribed Long Term Lithium therapy is evidence based and in line with best
practice.
The audit toolkit will provide the user with a summary of the current evidence directing
the safe provision of service. The toolkit will support practices to review and improve
where necessary by providing information about the care of patients on Lithium
therapy and also suggests appropriate READ codes that the practice is likely to use.
Also included is an evaluation sheet to feedback on the information provided
Publication / distribution:
 Publication in Public Health Wales Document Database (Primary Care Quality
and Information Service)
 Link from Public Health Wales e-Bulletin
Author: Primary Care Quality and
Information Service
Date: February
2012
Status; Final
Lithium Monitoring; Version 1
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Lithium Monitoring
Contents
Appendix
Page
A
Lithium Monitoring
3-12
B
Lithium Shared Care Protocol
13-22
C
Further Information
23 -24
D
READ Codes
25-26
E
Evaluation Sheet
27
F
References
28
© 2012 Public Health Wales
Material contained in this document may be reproduced without prior permission
provided it is done so accurately and is not used in a misleading context.
Acknowledgement to the Public Health Wales to be stated.
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Appendix A – Lithium Monitoring
Lithium Monitoring
1,2,3,4,5,67,8,9,10,11,12
Initial Commencement – Lithium should not be initiated routinely in primary care for
the treatment of bipolar disorder 2
General medical history, physical examination, Full blood count, BP height and weight
1,2,5,9
Advise patients that erratic compliance and discontinuation may increase risk of relape
2
Estimated glomerular filtration rates, thyroid function 1,6, U&E and serum creatinine 2,6
ECG for patients with cardiovascular disease 2,5,6,9
Serum electrolyte levels including serum calcium 6
Full blood count if clinically indicated 2
Shared care protocol with the patient’s GP for prescribing and monitoring lithium and
checking adverse effects 2,3,5
Pregnancy test (women of childbearing age) 1,2
Discus common side effects and toxicity 6
Discuss dose change and the need for continued therapy 6
Discuss adequate fluid intake 12
Aware that patients should take lithium for at least 6 months to establish its
effectiveness as a long-term treatment 2
Prescribing:
Lithium is always prescribed by brand name
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5,9
Lithium is available as two salts:
(i) Lithium Carbonate supplied in tablet form (Camcolit, Liskonum, Priadel).
(ii) Lithium Citrate supplied as a liquid (Priadel and Li-Liquid). 5,9,10
5,9,10
Lithium should be considered for the long-term treatment of bipolar disorder
2
acute mania or hypomanic episodes, 6 recurrent depressive disorder, 6 control of
aggressive behaviour or intentional self harm 6
Serum lithium levels should be checked 1 week after starting and 1 week after every
dose change, and until the levels are stable 2
Ensure lithium serum levels are in therapeutic range 0.5 -1.0 mmol/l
1
Lithium is usually best given as a single dose at night. 1 All blood samples taken for
monitoring of lithium levels should be done approximately 12-16 hours following the
last dose of drug. 2 This is important and failure to do so may result in misleading
results and consequently ill informed clinical action. 6
Lithium is the treatment of choice for relapse prevention for bipolar affective illness.
Lithium should be prescribed at an appropriate dose with a daily dosing regimen.
3
3
The highest dose that produces minimal side effects should be employed. Levels less
than 0.5mmol/l are usually too low. 1 Lithium may be effective in a minority of patients
as a monotherapy. 1
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A serum lithium level of 0.6–0.8 mmol/L is suitable for people who are being prescribed
lithium for the first time. 2,9
Higher serum lithium levels (0.8 – 1.0 mmol/l are suitable for people who have
relapsed previously while taking lithium or who still have sub-threshold symptoms with
functional impairment while receiving lithium a trial of at least 6 months with serum
lithium levels between 0.8 – 1.0 mmol per litre should be considered. 2,9
Titrate dosage further upward if necessary (generally to serum concentrations of 0.5 –
1.0 mmol/l) according to response and side effects. 1
Check lithium level after later dosage increases (steady levels are likely to be reached
approximately 5 days after dosage adjustment). 1
The ‘optimal’ maintenance level is the highest dose tolerated without significant side
effects. It will vary from patient to patient. 1
Older patients, and others with reduced renal function, will require lower doses of
lithium 1 As a group they are more prone to side effects due to increased end organ
sensitivity, reduced circulation and reduced renal clearance. 1
In acute mania, higher serum levels (1.0 – 1.2 mmol/l) are claimed to be more
efficacious, but vigilance is required for adverse effects. 1
The National Patient Safety Agency (NPSA) has asked all healthcare organisations in
the NHS where lithium therapy is initiated , prescribed, dispensed and monitored to
ensure that by 31 December 2010: 4
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Patients prescribed lithium are monitored in accordance with NICE guidance
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There are reliable systems to ensure blood test results are communicated
between laboratories and prescribers 4
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At the start of lithium therapy and throughout their treatment patients receive
appropriate ongoing verbal and written information and a record book to track
lithium blood levels and relevant clinical tests 4
4
The NPSA has developed a patient information booklet, lithium alert card and record
book for tracking blood tests. 4 Copies are available: mailto:[email protected]
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Prescribers and pharmacists check that blood tests are monitored regularly and
that it is safe to issue a repeat prescription and / or dispense the prescribed
lithium. 4
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Systems are in place to identify and deal with medicines that might adversely
interact with lithium therapy. 4
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Monitoring lithium
For patients on long term lithium treatment prescribers should monitor the
following:2,5,6,8,9,11
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Monitor serum levels normally every 3 months 2,5,6,8,11
Monitor older adults carefully for symptoms of lithium toxicity
because they may develop high serum levels of lithium at doses in the normal
range and lithium toxicity is possible at moderate serum lithium levels 2
Monitor weight, especially in patients with rapid weight gain 2,9
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, or diuretics 2
Arrange thyroid and renal function tests every 6 months, and more often if there
is evidence of impaired renal function 2,6,11
Initiate closer monitoring of lithium dose, and blood serum levels if urea and
creatinine levels become elevated, and assess the rate of deterioration of renal
function. 2 Monitor renal function six monthly by checking urea and electrolyte
levels and eGFR 6
The decision whether to continue lithium depends on clinical efficacy, and degree
of renal impairment: prescribers should consider seeking advice from a renal
specialist and a clinician with expertise in the management of bipolar disorder on
this 2
Serum calcium annually 5,6
Full blood count annually and as clinically required 2
Consider ECG monitoring for patients at high risk of cardiovascular disease 2,11
Monitor for symptoms of neurotoxicity, including paraesthesia, ataxia, tremor
and cognitive impairment, which can occur at therapeutic levels 2
Monitoring of laboratory values
Lithium levels are normally measured 1 week after starting therapy, 1 week after every
dose change and weekly thereafter until the levels are stable. The aim should be to
maintain serum lithium levels between 0.6 and 0.8 mmol/l in patients being prescribed
lithium for the first time. 2
Lithium blood levels should be measured 12 hours post-dose
4,9
Baseline renal function tests, thyroid function tests, and a full blood count are normally
measured at the start of treatment. Thereafter thyroid and renal function tests should
be monitored every 6 months (or more often if there is evidence of impaired renal
function). 2,9
Initiate closer monitoring of lithium dose and blood serum levels if urea and creatinine
levels become elevated, and assess the rate of deterioration of renal function. 2
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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. 2
Renal and thyroid function should be checked every 12 months in stable patients or
whenever the clinical status changes. 1
Compliance
Lithium discontinuation by patients is extremely common and is associated with
admission to hospital. This association will be due in large part to manic relapse which
is provoked by abrupt lithium discontinuation. Unless patients are adherent to lithium
for a minimum of 2 years, these withdrawal effects will nullify any potential
prophylactic effect. 1
Pregnancy
Lithium should not routinely be prescribed for pregnant women with bi-polar disease
because of risk of harm to the fetus, such as cardiac problems. 2,6
Women of childbearing age should use reliable contraception. Lithium is contraindicated in the 1st trimester of pregnancy and breast feeding.
If the pregnancy is confirmed in the 1st trimester, and the woman is stable, lithium
should be stopped gradually over 4 weeks, and the woman informed that this may not
remove the risk of cardiac defects in the fetus. 2
Women with bi-polar disease considering pregnancy should normally be advised to stop
lithium therapy and an alternative considered. 2
Women with severe bipolar disorder, who are maintained on lithium, can be continued
on lithium during pregnancy if clinically indicated. 3
Options to consider for women taking lithium and considering pregnancy:
2
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If the patient is well and not at high risk of relapse gradually stopping lithium.
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If the patient is unwell or at high risk of relapse:
Switching gradually to alternative or
Stopping lithium and starting in second trimester if not planning to breastfeed.
Continuing with lithium and discussing risks.
If the woman decides to stay on lithium during pregnancy: 2,6
Serum lithium levels should be monitored every 4 weeks
Weekly from 36th week
24hrs after childbirth
Dose adjusted to keep serum levels within therapeutic range
Maintain adequate fluid levels
The newborn should have a full paediatric assessment with social and medical help.
2
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Women should be advised not to breastfeed if taking lithium 2,3,6 This is particularly if
the infant is not full-term and healthy. If a decision is made to proceed, close
monitoring of the infant, including serum lithium levels, should be undertaken. 3
Relapse
Relapse rates on lithium over a year or so were 40% compared with about 60% on
placebo. That means, in general, one would need to treat about four patients for a year
with lithium to avoid one relapse. There are fewer relapses at times beyond a year: the
patients who do well on Lithium continue to do well on it. 1 Abrupt discontinuation
increases the risk of relapse. 10
For people who have relapsed previously while taking lithium or who still have subthreshold symptoms with functional impairment while receiving lithium, a trial of at
least 6 months with serum lithium levels between 0.8 and 1.0 mmol per litre should be
considered. 2
Lithium mono-therapy is probably effective against both manic and depressive relapse,
although it is more effective in preventing mania 1
Erratic compliance or rapid discontinuation may increase risk of manic relapse.
Overdose
2
7
If an acute overdose has been taken by a patient on chronic lithium therapy, this can
lead to serious toxicity occurring even after a modest overdose as the extravascular
tissues are already saturated with lithium.
Lithium toxicity can also occur in chronic accumulation for the following reasons: 7
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Acute or chronic overdosage.
Dehydration e.g. due to intercurrent illness.
Deteriorating renal function.
Drug interactions, most commonly involving a thiazide diuretic or a non-steroidal
anti-inflammatory drug (NSAID).
In patients with a raised lithium concentration, the risk of toxicity is greater in those
with the following underlying medical conditions: hypertension; diabetes; congestive
heart failure; chronic renal failure; schizophrenia; Addison's disease. 7
Most patients experience toxic effects with levels above 1.5 mEq/L; levels above 2.0
mEq/L are associated with life-threatening side effects and require urgent treatment:
haemodialysis may be needed to minimize toxicity. 1,10
Lithium toxicity should also be suspected at ‘therapeutic’ levels in compromised
patients with relevant symptoms. 1
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Contraindications
Cardiac disease 9
Renal impairment 9
Untreated hypothyroidism 9
1st Timester of pregnancy 9
Breastfeeding 9,12
Low body sodium levels, patients on low sodium diets and those who are
dehydrated 9
Addison’s disease 9
Side effects
Side effects include tremor, polyuria, polydipsia, hypothyroidism, 3,4 weight gain,
cognitive problems, sedation or lethargy, impaired co-ordination, gastrointestinal
distress 3,4,10, hair loss, benign leukocytosis, acne and oedema Lithium can precipitate
and exacerbate psoriasis 1 The common side effects can usually be reduced or
eliminated by lowering the lithium dose or changing the dosage schedule. 1
With long term lithium treatment (>10 years), 10% - 20% of patients display
morphological kidney changes. These changes are not generally associated with renal
failure, although there are case reports of renal insufficiency attributed to lithium. 1
Drug Interactions (Refer to interaction section of BNF)
10
There must be effective communication between all healthcare practitioners involved
with patients on lithium therapy. This will ensure the impact of interacting medicines is
considered when clinical decisions are made. 4
While many medications have been reported as interacting with lithium monitoring
must highlight as a minimum the potential for lithium’s interactions with the following
commonly prescribed therapies and OTC medicines: 4,6
1. thiazides and related diuretic;
2. ACE inhibitors
3. non-steroidal anti-inflammatory drugs (NSAIDS);
4. sodium bicarbonate containing, non-prescription antacids or urinary alkalinising
agents 4
Concomitant use may cause lithium toxicity or with sodium containing antacids subtherapeutic levels. 4
Diuretics
Thiazide diuretics can increase serum lithium levels by reducing clearance of lithium.
People who are stabilized on lithium and begin taking thiazide diuretics are at
significant risk of developing lithium toxicity. Toxic lithium concentrations may be seen
within 3 –5 days. Loop diuretics also cause lithium retention but are less likely to result
in lithium toxicity 9,12
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Ace Inhibitors
Decrease the excretion of lithium. They can also precipitate renal failure. If these two
drugs are prescribed together, extra care is required in monitoring both serum
creatinine and lithium 9
Non steroidal anti-inflammatory drugs (NSAIDs)
Patients taking lithium should be warned not to take over-the-counter NSAIDs.
Prescribing NSAIDs for such patients should be avoided if possible, and if they are
prescribed the patient should be closely monitored.2
Reduce lithium excretion – avoid if possible 12
May increase serum lithium levels by up to 40%. The mechanism of this interaction is
thought to be related to the effects of NSAIDs on fluid balance. This is particularly
important if NSAIDs are added to a long-standing prescription of lithium. 9
Haloperidol
Although severe neurotoxicity has been reported with this combination, if lithium levels
are maintained in the therapeutic range (0.6–1.0 mmol/L) and the haloperidol dose is
not increased rapidly above the recommended maximum, the chance of inducing a
toxic state is very low 9
Carbamazepine
In combination with lithium has been reported to cause neurotoxic reactions. Higher
(greater than 1 mmol/L) plasma lithium levels were involved than are now thought
acceptable, so a neurotoxic reaction to lithium alone was a risk factor. Carbamazepine
and lithium may therefore be usefully co-prescribed 9
Antidepressants
With a serotonergic action (such as selective serotonin reuptake inhibitors, tricyclic
antidepressants, venlafaxine, duloxetine) have rarely been linked to an increased
incidence of central nervous system toxicity when used with lithium. The mechanism of
this interaction is not well understood. Prescribers should check lithium levels soon
after starting treatment with a serotonergic antidepressant, although there are some
reports of neurotoxic reactions in the absence of raised lithium levels 9,12
Signs / Symptoms and Management of Toxicity
Most patients experience toxic effects with levels above1.5 mmol/l; 6,9,12
Levels above 2.0mmol/l are associated with life-threatening side effects and require
urgent treatment: haemodialysis may be needed to minimise toxicity. 6,9 Lithium
toxicity should also be suspected at ‘therapeutic’ levels in compromised patients with
relevant symptoms 9
Signs / Symptoms
Management
10
Nausea & vomiting
Anorexia, diarrhoea 12
Blurred Vision6
Coarse tremor10
Muscle weakness10
Lack of co-ordination10
Lithium toxicity is a medical
emergency, 9,10 because it can result in
permanent neurological damage and
death. It is treated by the withdrawal
of lithium treatment, fluid replacement
and sometimes haemodialysis. 9
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Mild drowsiness 6
Sluggishness 10
Progressive giddiness10
Ataxia 6
Dysarthia 12
Levels above 2.0mmol/l
Hyperreflexia, hyperextension of the
limbs, toxic psychoses, convulsions,
syncope, oliguria, circulatory failure,
coma and death 6,9,10,12
Levels are monitored every 6-12 hours
9
The risk of toxicity is greater in people
with hypertension, diabetes, congestive
heart failure, chronic renal failure,
schizophrenia or Addison’s disease. 9
Guidance to Patients
Patients taking lithium should be advised to:
 Carry a lithium card
 Regular blood tests are important and the results should be recorded in their
lithium record booklet
 Adverse effects to expect. Monitor weight if rapid weight gain
 How to recognize the symptoms of lithium toxicity
 Not to take over the counter Non-steroidal anti inflammatory drugs
 Seek medical attention if they develop diarrhoea and/or vomiting or any form of
dehydration, will lead to sodium depletion and therefore increase plasma lithium
levels 2
 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 2
 If a dose is missed they should take it as soon as possible; but should not double
the dose
 Do not stop taking lithium abruptly, and that non compliance may lead to relapse
 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 2
 Women of childbearing age should use reliable contraception. If the pregnancy
is confirmed in the 1st trimester, and the woman is stable, lithium should be
stopped gradually over 4 weeks, and the woman informed that this may not
remove the risk of cardiac defects in the fetus. 2 If a woman remains on lithium
during pregnancy more frequent monitoring is required, and good fluid intake is
essential 2
Long term adverse effect
Long term treatment with lithium may be associated with persistent parathyroidism and
hypercalcaemia, weight gain, changes in glucose tolerance, nephrogenic diabetes
insipidus, nephritic syndrome. In some patients goitre can be induced as lithium can
inhibit thyroid hormone release. Hypothyroidism can be successfully managed with
thyroxine. Lithium is also teratogenic 12
Hypothyroidism
There is a small risk that people taking lithium at therapeutic doses may develop
clinical goitre, hypothyroidism, or both; the risk appears to be greatest in the first
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2 years of treatment. Although this may occur, it should not be a reason for stopping
lithium treatment. Levothyroxine replacement is usually indicated. Thyroxine function
tests usually return to normal when
lithium is discontinued. 9
Lithium treatment increases the risk of clinical hypothyroidism up to five-fold, the risk
being particularly high in women who are 40-59 years old.9 The clinical symptoms of
hypothyroidism overlap with those of depression and may therefore remain
undiagnosed and untreated unless specific screening tests are undertaken. 4
Hyperthyroidism
Lithium-associated thyrotoxicosis is rare and occurs mainly after long-term use. It
should not constitute an absolute contraindication to lithium treatment. Specialist
advice should be sought regarding management. 9
Hyperparathyroidism
Lithium use has been associated with hypercalcaemia accompanied by elevations in
circulating parathyroid hormone (PTH). The coexistence of hypercalcaemia and
elevated PTH levels suggests primary hyperparathyroidism. However, significantly
greater serum levels of calcium are probably required to inhibit PTH secretion during
lithium therapy. The presence of mild hypercalcaemia with elevated PTH is consistent
with lithium-induced hyperparathyroidism. Parathyroid surgery is not indicated in this
situation, and withdrawal of lithium will result in prompt normalization of serum calcium
and PTH levels. 9
Nephrotoxicity
A small reduction in glomerular filtration rate is seen in 20% of people taking lithium.
In the vast majority of these people this effect is benign. A very small number of
people taking lithium may develop interstitial nephritis. Lithium can also cause a
reduction in urinary concentrating capacity (nephrogenic diabetes insipidus, with
symptoms of thirst and polyuria) which is reversible in the short-to-medium term, but
may be irreversible after long-term treatment (greater than 15 years). 9
Stopping Lithium
Lithium should be stopped gradually over at least 4 weeks 1, and preferably over a
period of up to 3 months, particularly if the patient has a history of manic relapse (even
if they have been started on another antimanic agent). 2,3,6
When lithium treatment is stopped or is about to be stopped abruptly, prescribers
should consider changing to monotherapy with an atypical antipsychotic or valproate,
and then monitor closely for early signs of mania and depression. 2
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Appendix B – Lithium Shared Care Protocol
Abertawe Bro Morgannwg (ABM) Health Authority
DRUG: LITHIUM CARBONATE (Priadel tablets, Camcolit tablets, Liskonum
tablets) LITHIUM CITRATE (Li-liquid, Priadel liquid)
This document should be read in conjunction with the current Summary of Product
Characteristics (SPC) http://www.medicines.org.uk/
This protocol is part of an enhanced service.
INDICATIONS FOR LITHIUM THERAPY
Treatment and prophylaxis of mania, bipolar disorder, and recurrent depression,
aggressive or self-mutilating behaviour
GENERAL GUIDANCE
This protocol sets out details for the monitoring of patients requiring lithium and should
be read in conjunction with the Lithium Monitoring Service Specification. Sharing of
monitoring requires communication between the specialist, GP and patient. The
intention to share monitoring of lithium treatment should be explained to the patient by
the doctor initiating treatment. The doctor who prescribes the medication legally
assumes responsibility for the drug and the consequences of its use. The prescriber has
a duty to keep themselves informed about the medicines they prescribe, their
appropriateness, effectiveness and cost. They should also keep up to date with the
relevant guidance on the use of the medicines and on the management of the patient’s
condition.
BACKGROUND
Lithium is licensed for use in the management of acute manic or hypomanic episodes,
the prophylaxis of bipolar affective disorder, and the management of episodes of
recurrent depressive disorders where treatment with other antidepressants has been
unsuccessful. It is also licensed for control of aggressive behaviour or intentional selfharm.
Lithium has small therapeutic index and plasma levels may be affected by many
factors. Lithium toxicity is potentially fatal. For this reason regular monitoring of lithium
levels is required.
CRITERIA FOR SHARED CARE
Prescribing responsibility will only be transferred when:
 Treatment is for a specified indication and duration;
 Treatment has been initiated and stabilised by the secondary care specialist;
 The patient’s initial reaction to and response on the drug is satisfactory;
 The GP has agreed in writing in each individual case that primary care lithium
monitoring is appropriate;
 The patient’s general physical, mental and social circumstances are such that
he/she would benefit from this arrangement.
RESPONSIBILITIES OF INITIATING CONSULTANT
 Confirm diagnosis, and assess baseline mental state;
 Ensure all baseline monitoring is undertaken;
 Initiate lithium treatment if patient deemed suitable in terms of diagnosis and
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Lithium Monitoring
fitness for medication;
Review and Stabilisation of patient on Lithium. Until stable (lithium level and dose
both stable for 4 weeks), prescribing should be confined to secondary care.
Monitor patient’s initial reaction to and progress on the drug;
Request for monitoring to be shared with GP. Once stable, prescribing and
monitoring of lithium will be via General Practitioner (for this reason it is
imperative all lithium monitoring results are shared in writing between
Health Board Mental Health department and General Practitioner);
Contact the GP to invite participation in monitoring of lithium by sending the
Lithium Monitoring Agreement. The Health Board recognises that the GP has the
right to refuse to participate in sharing of care. In such an event the total clinical
responsibility for the patient for the diagnosed condition will remain with the
consultant;
Secondary care will provide patient with:
o NPSA patient information booklet or other relevant drug information to enable
informed consent to therapy, understanding of potential side effects &
appropriate action, & an understanding of the role of monitoring;
o Completed NPSA record book & Lithium card1 on initiation of treatment;
o Record book must be given to patient to take to all appointments;
Arrange for hospital supply of medication until in the opinion of the consultant the
patient's condition is stable;
Ensure that the patient has an adequate supply of medication until GP supply can
be arranged;
Monitor patient’s initial reaction to and progress on the drug;
Ensure that serum lithium monitoring is carried out during initial titration and
during periods of instability either in secondary care or by arrangement with GP;
On receipt of the GP's agreement the consultant will supply a complete patient
summary. The summary will provide the information specified in the appropriate
protocol. Full details of all other drugs will be given. An original pack supply of the
drug will be dispensed by the hospital (unless a smaller quantity is appropriate).
Ensure that the patient has an adequate supply of medication until GP supply can
be arranged;
Secondary care will arrange regular out-patient assessment depending on clinical
circumstances and will see the patient at the GP's request. The assessments will
include clinical monitoring as set out in this protocol, consideration of potential drug
interactions, assessment of compliance & response, and evaluation of any adverse
events noted by the patient/carer or GP;
Communication - Secondary care will provide GP with:
o Diagnosis, relevant clinical information and baseline results, treatment to date
and treatment plan, intervals for consultant review, and any change in the
patient's status including the dose, target blood range, frequency and form of
the drugs currently prescribed;
o 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;
o Advice on when to stop this drug including urgent advice in response to
abnormal blood results identified during monitoring.
http://www.nrls.npsa.nhs.uk/resources/?entryid45=65426&q=0%c2%aclithium%c2%ac
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RESPONSIBILITIES OF PRIMARY CARE
 Complete the “Lithium Monitoring Agreement Form”;
 Following receipt of the “Lithium Monitoring Agreement Form” and reference to the
Lithium Monitoring Protocol the GP should ensure they have the information and
knowledge to understand the therapeutic issues relating to the patients medical
condition and the facilities to comply with the protocol;
 Return the completed “Lithium Monitoring Agreement Form” within one week of
receipt of the request to indicate whether the GP is willing to undertake lithium
monitoring
 Prescribe the maintenance therapy in accordance with the consultant request,
whilst also considering potential drug interactions. This may include changing the
dose of medication as advised by hospital specialist team;
 Monitor and record the therapy in accordance with the lithium monitoring protocol;
 To ensure that the lithium record book is kept up to date;
 Record and communicate with secondary care all symptoms or results that are
appropriate;
 Report any adverse events in the treatment of the patient to the consultant, as well
as to the usual bodies- including the locality clinical governance lead (e.g. yellow
card reporting to CSM);
 Monitor the patient for signs of toxicity and take immediate action as appropriate
(see below).
RESPONSIBILITIES OF PATIENT / SERVICE USER
 Attend hospital and GP clinic appointments, bringing lithium record booklet (once
issued);
 Failure to attend will result in referral back into secondary care management and
potentially medication being stopped (on specialist advice);
 Report adverse effects to their specialist or GP, urgently if any of the following
occur: ataxia, coarse tremor, dysarthria , confusion, lack of co-ordination.
ADDITIONAL CONSIDERATIONS
 There may be a very gradual increase in serum lithium level over time, probably
because of progressive reduction in renal function with age;
 Renal disease can reduce elimination of lithium and doses may need to be reduced;
 Renal lithium concentration is usually constant, however, when plasma
concentration is low, or the patient is dehydrated, lithium clearance falls and blood
levels rise relative to glomerular filtration rate. Accordingly lithium levels are likely
to be increased in a patient with a low salt diet, on a drug which reduces lithium
excretion, e.g. NSAID (including COX-2s), ACE inhibitor, diuretic, or who has
diarrhoea, vomiting or excessive sweating;
 Patients should maintain an adequate fluid intake and should avoid dietary changes
which might reduce or increase sodium intake;
 The ABMU Health Board “Early Intervention Project” strongly advises patients
admitted to Medical and Surgical wards to be referred for senior psychiatric opinion
with patient’s consent, at earliest opportunity.
CONTRAINDICATIONS
 Hypersensitivity to lithium or to any of the excipients.
 Lithium is not recommended in pregnancy or breast-feeding. Women of
childbearing age should be advised to use reliable contraception.
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See current Summary of Product Characteristics for full list.
DOSAGE REGIMEN
For full prescribing information please consultant the Summary of Product
Characteristics for the requested product. These can be found at:
http://www.medicines.org.uk/emc/
Route: ORAL
Lithium should be started at a low dose and titrated up to achieve therapeutic levels as
indicated by serum level monitoring. The normal starting dose in 400mg at night2 of
the modified release preparation, lower in the elderly or in renal impairment. The dose
should then be adjusted according to serum levels of lithium. The recommended
therapeutic range is 0.4-1.0mmol/L. See BNF for dosing regimens specific to different
formulations.
Lithium has linear pharmacokinetics therefore, assuming stable renal function, an
increase in dose of 25% will result in an increase of serum lithium concentration of
25%.
Conditions requiring dose reduction
Elderly patients OR those below 50kg in weight, often require lower lithium dosage to
achieve therapeutic serum levels. Starting doses of 200mg to 400mg are
recommended. Dosage increments of 200 to 400mg every 3 to 5 days are usual.3
Formulations: As bioavailability varies from product to product (particularly with
regard to retard or slow release preparations) a change of product should be regarded
as initiation of new treatment. Lithium is available as the carbonate salt (tablet
formulations) and citrate salt (liquid preparation). As a general guide lithium carbonate
200mg = lithium citrate 509mg, however, changing preparation requires the same
precaution as initiation of therapy.
The default product for all patients newly commenced on lithium within ABMU HB is
Priadel unless stated otherwise. Priadel is available in 200mg (5.4mmol Li+) & 400mg
modified release scored lithium carbonate tablets and 520mg/5ml (5.4mmol Li+)
lithium citrate liquid.
Lithium citrate liquid & Liskonium® tablets should be administered twice daily. Other
lithium preparations are normally prescribed as a single dose at night.
All dose adjustments will be done by secondary care unless directions have been
specified in the medical letter to the GP.
BASELINE MONITORING
Mental state.
Smoking status and alcohol intake.
Baseline investigations (Pre-treatment) - to be undertaken by secondary care4:
Thyroid function tests (TSH & T4);
Taylor D, Paton C, Kerwin R. The Maudsley Prescribing Guidelines. 9 th Ed. London: Informa Uk Ltd; 2007.
p148
3 Sanofi Aventis. SPC Priadel 200mg & 400mg prolonged release tablets.[Online]. Available from:
http://emc.medicines.org.uk/document.aspx?documentId=6983 [Accessed 27th October 2009].
4 National Institute for Clinical Excellence. Bipolar Disorder. The management of bipolar disorder in adults, children & adolescents, in
primary & secondary care. Clinical Guideline 38. htt:p//www.nice.org.uk. 2006.
2
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Renal function (U&Es, eGFR5, serum creatinine);
Full Blood Count;
Liver Function Tests (LFTs) & Bone Profile;
Body mass index (BMI);
Blood pressure;
Lipid profile;
Blood (plasma) glucose;
ECG (for those with existing cardiac disease or risk factors)6.
When indicated by the clinical picture or co-morbidity
Drug screening, CXR, EEG,MRI, CT.
MONITORING
This monitoring protocol is based upon a principle of minimum regular 3 monthly
lithium levels carried out in primary care for all patients prescribed lithium by their GP.
Additional Monitoring by Secondary Care: It is recognised that the frequency of
testing may need to be increased depending on individual patient risk, however,
additional testing above and beyond the 3 monthly lithium levels monitored in primary
care should be undertaken by secondary care. In such cases it is imperative that
secondary care checks results of primary care testing to avoid duplication of
monitoring. It is imperative that GP maintains baseline monitoring of lithium levels
every 3 months.
5
6
Kripalani M, Shawcross J, Reilly J, Main J. Lithium and chronic kidney disease. BMJ 2009;339:166-9
Taylor D, Paton C, Kerwin R. The Maudsley Prescribing Guidelines. 9th Ed. London: Informa Uk Ltd; 2007. p148
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This monitoring protocol requires minimum regular 3 monthly lithium levels
carried out in primary care for all patients prescribed lithium by their GP
Monitoring
Frequency
Action
Responsibility
Serum lithium
levels (initial)
Serum lithium
levels (once stable)
Thyroid function
tests (TSH &T4)
Renal function
(U&Es, eGFR,
serum creatinine)
Full Blood Count
Liver Function
Tests & bone
profile
BMI
Blood Pressure
Lipid profile (over
40s only)
Blood (plasma)
glucose
Review of mental
health & monitoring
5-7 days after
initiation then
weekly until dose
and serum lithium
levels stable
(Stable defined as
steady for 4 weeks)
Once stable, every
three months
minimum
Six monthly (three
monthly if evidence
of deterioration)
Six monthly (more
often if evidence of
deterioration or
other medication
changed e.g.
nsaid/diuretic/ACE)
Only if clinically
indicated
Only if clinically
indicated
Secondary Care /
Consultant Psychiatrist
Primary Care / GP
All requests to
pathology must
state the secondary
care consultant or
team to be copied
into results, for
interpretation and
dosing advice
Primary Care / GP
Primary Care / GP
Primary Care / GP
Primary Care / GP
Annually – more
frequently if patient
gains weight
rapidly
Annually
Annually
Primary Care / GP
Primary Care / GP
Primary Care / GP
Annually
Primary Care / GP
Annually
Secondary Care /
Consultant Psychiatirst
Where it is not possible/ appropriate in certain patients to perform regular additional
blood tests within secondary care lithium clinic, the GP may be asked to participate in
carrying out these recommended blood tests.
Therapeutic Drug Monitoring: Blood samples for lithium should be taken 12 hours
after the last dose. There can be diurnal variation, so ideally the sample should be
taken at the same time on each occasion. Therapeutic levels should be 0.4-1.0mmol/L.
Whoever initiates blood tests for lithium blood levels is responsible for acting
on abnormal lithium results.
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ADVERSE EFFECTS
In addition to carrying out the regular recommended blood test monitoring, it is
important to note that it is also the prescriber’s responsibility to ensure that patients
are monitored for signs and symptoms of toxicity and potential adverse effects
according to the summary of product characteristics.
Side effects are usually related to serum lithium concentration and are less common in
patients with plasma lithium concentrations below 1.0 mmol/l. Long term treatment
with lithium may result in permanent changes in the kidney and impairment of renal
function. High serum concentrations of lithium, including episodes of acute lithium
toxicity may enhance these changes.
See SPC for full list of reported adverse reactions.
Clinical condition
(Where possible indicate if common, rare or serious)
Initial therapy
fine tremor of the hands, dry mouth, metallic taste in mouth polyuria and
thirst may occur
Dermatology
alopecia, acne, folliculitis, pruritus, aggravation or occurrence of
psoriasis, allergic rashes, acneiform eruptions, papular skin disorders,
cutaneous ulcers.
Endocrine
euthyroid goitre, hypothyroidism, hyperthyroidism and thyrotoxicosis.
Lithium-induced hypothyroidism may be managed successfully with
concurrent levothyroxine. Hypercalcaemia, hypermagnesaemia,
hyperparathyroidism have been reported
Gastrointestinal
anorexia, nausea, vomiting, diarrhoea, excessive salivation, dry mouth,
abdominal discomfort, taste disorder, gastritis
Haematological
leucocytosis
Metabolic &
weight gain, hyperglycaemia
Nutritional
Renal
polydipsia and/or polyuria, symptoms of nephrogenic diabetes insipidus,
histological renal changes with interstitial fibrosis after long term
treatment.
High serum concentrations of lithium including episodes of acute lithium
toxicity may aggravate these changes. The minimum clinically effective
dose of lithium should always be used. In patients who develop polyuria
and/or polydipsia, renal function should be monitored, e.g. with
measurement of blood urea, serum creatinine and urinary protein levels
in addition to the routine serum lithium assessment
Reproductive
sexual dysfunction
Senses
dysgeusia, blurred vision, scotomata
Cardiovascular
Effects of lithium are rare and often benign. Reported effects are
arrhythmia, oedema and sinus node dysfunction. QT interval
prolongation, ventricular arrhythmias – ventricular fibrillation, ventricular
tachycardia (rare), sudden unexplained death, cardiac arrest and
Torsade de pointes have been reported, Any signs of cardiac disturbance
e.g. syncope, heart rhythm or rate disturbances should be investigated
further
Rare cases
Nephritic syndrome, speech disorder, confusion, impaired
consciousness, myoclonus and abnormal reflex have been reported.
If any of the above symptoms appear, treatment should be stopped
immediately & arrangements made for serum lithium measurement
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Serious toxicity may present first to GPs.
IF YOU SUSPECT LITHIUM TOXICITY, STOP THE DRUG AND CONTACT THE
CONSULTANT PSYCHIATRIST/ SECONDARY CARE MENTAL HEALTH TEAM. IF
CLINICAL CONDITION WARRANTS REFER TO NEAREST ACCIDENT &
EMERGENCY DEPARTMENT.
IF YOU SUSPECT AN ADVERSE REACTION HAS OCCURRED, PLEASE CONTACT
THE CONSULTANT PSYCHIATRIST/ SECONDARY CARE MENTAL HEALTH TEAM.
All serious adverse drug reactions should be reported to the CSM via “Yellow Card”
scheme
IMMEDIATELY. Blood sample should be taken immediately to determine serum lithium
levels, renal function, FBC, & LFTs. The GP may also refer to the nearest accident and
emergency department if the clinical condition warrants it.
Lithium toxicity can occur at any serum lithium level but particularly at levels
>1.5mmol/L.
It is particularly important for GPs to check for ataxia, dysarthria &/or lack of
coordination as these have been found to be clinically useful symptoms indicating
lithium toxicity7
Symptoms of lithium toxicity include; anorexia, diarrhoea, vomiting, muscle weakness,
muscle twitching, tinnitus, blurred vision, ataxia, coarse tremor, dysarthria, confusion,
lack of co-ordination and in severe toxicity, stupor, coma, renal impairment, cardiac
arrhythmias and death. If features of lithium toxicity occur stop lithium immediately,
check serum lithium levels, creatinine, urea and electrolytes and discuss with a doctor
from mental health services.
Refer to the nearest accident and emergency department if the clinical condition
warrants it.
INTERACTIONS
Caution is advised when any patient is co-prescribed interacting medications with
lithium and specialist advice should be sought if needed. The following are important
drug interactions:
 Diuretics, loop & especially thiazides reduce lithium excretion, and increase serum
levels leading to toxicity. Refer to secondary care for specialist advice and dose
reduction prior to initiating a diuretic. Re-stabilisation will be required;
 NSAIDs (including COX-2s) reduce lithium excretion, increasing lithium serum levels
which can lead to toxicity. Avoid PRN (when required) use of NSAIDS.
 SSRIs - increased risk of CNS toxicity;
 ACE inhibitors - may alter lithium excretion;
 Sodium containing antacids - reduce lithium levels. To compensate, the patient’s
dose may have been increased. If the patient then stops taking the antacid toxicity
may occur.
Please see SPC for full details before initiating any new medication
In principle if a drug acts on or through the kidney, or affects sodium levels, an
interaction is possible. When assessing potentially interacting medication consider:
7
Colgate R. Ranking of therapeutic and toxic side-effects of lithium carbonate. Psychiatric Bulletin 1992;16:473-475
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 if lithium levels are being monitored more frequently.
 if the use of the drugs is occasional (PRN). You may need to advise a patient of the
potential harm of using an interacting drug occasionally.
 if lithium dosing has been altered to compensate for interacting drugs.
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Lithium Monitoring Agreement Form
CONSULTANT REQUEST TO GP - *IMPORTANT: ACTION NEEDED
To: Dr.
Name of patient___________________________________________ Date of birth _________________
Diagnosed condition ____________________________________________________________________
This patient has been accepted as suitable for Lithium monitoring in accordance with the attached protocol.
I am requesting your agreement to share the lithium monitoring of this patient. The preliminary tests set
out in the protocol have been carried out.
I am currently prescribing the stabilising treatment.
I would like you to undertake treatment from (date): __________________________________________
The initial treatment will be: ______________________________________________________________
_____________________________________________________________________________________
The baseline tests are: __________________________________________________________________
_____________________________________________________________________________________
If you undertake treatment I will reassess the patient in __ weeks. You will be sent a written summary
within 14 days. I will accept referral for reassessment at your request.
The medical staff of the department are available at all times to give you advice.
Contact Telephone No. __________________________________________________________________
Consultant Name_______________________________________________________________________
Signature ____________________________________________________________________________
Department ________________________________________________ Date _____________________
Hospital ______________________________________________________________________________
GP RESPONSE
A. I am willing to undertake Lithium shared care as set out in the protocol for this patient.
B. I wish to discuss this request with you.
C. I am unable to undertake shared care for this patient.
G.P. signature______________________________________________________ Date ______________
Practice Address/Stamp
_____________________________________________________________________________________
(Please return whole completed form or a photocopy to the consultant requesting shared care prescribing
within one week).
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Appendix C- Further Information
Lithium Therapy: Manic depression fellowship Wales
Monitoring patients on lithium – a good practice guideline 2002
General Practice Notebook - Lithium
How safe is lithium prescribing? The Psychiatrist 2005
Scottish shared care guidance for GP’s 2009
MIND Making sense of Lithium and other mood stabilisers
Lithium in breast milk and nursing mothers: Clinical implications
electronic Medicines Compendium (eMC) Priadel
Clinical effectiveness group (ceg); Severe Long-term Mental Health Problems 2003
The primary care guide to managing severe mental illness 2004
Adult Mental Health Services in Primary Healthcare Settings in Wales Welsh Health
Circular WHC (2006) 053
NHS Primary Care guidelines; Bipolar Disorder F31 2004
Lithium: Shared care Protocol and Information for GP’s; Scotland 2009
Better testing: Lithium safety monitoring 2005
Lithium for maintenance treatment of bipolar disorders: bipolar foundation
Long term lithium therapy for bipolar disorder: Systematic review and metaanalysis of randomised controlled trials 2004
Lithium for maintenance treatment of mood disorders; Cochrane systematic review
2001
Lithium verses antidepressants in the long term treatment of unipolar affective
disorder: Cochrane systematic review 2006
Suicidal risks during treatment of bipolar disorder patients with lithium verses
anticonvulsants: DARE review 2010
Prescribing Observatory for Mental Health (POMH-UK)
Monitoring patients on lithium in the primary care setting 2004
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Using Lithium Safely DTB Vol 37 No 3 March 1999
GPC acts over lithium quality confusion 2005
Lithium treatment and thyroid abnormalities 2006
Wales Mental Health in Primary Care Network
Primary Care guide to Managing Severe Mental Illness 2004
Long-term Lithium Therapy Leading to Hyperparathyroidism: A Case Report 2009
eMC Medicine Guide SPC Priadel 2011
Lithium-induced Hypercalcemia and Parathyroid Dysfunction 2001
Reversible hypercalcemia and hyperparathyroidism associated with lithium therapy: a case
report and review of the literature 2006
Lithium: a review of its metabolic adverse effects 2006
Requesting patterns for serum calcium concentration in patients on long-term lithium therapy
2009
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Appendix D - READ Codes
These suggested read codes may be of help when completing this audit. Please note
that the Read Codes below are from Read Code Version 2 (5 Byte) and that the ‘%’
indicates that the code and its children should be included within the search.
Lithium
Read Code
LITHIUM SALTS
d6... %
Long term drug therapy
8B3G.
Diagnosis
Read Code
[X]Mania NOS
Eu30z
Affective psychoses
E11.. %
[X]Bipolar affective disorder
Eu31. %
Recurrent depression
E1137
[X]Mood - affective disorders
Eu3.. %
Neurotic, personality and other nonpsychotic disorders
E2... %
Monitoring
Read Code
Lithium monitoring
6657.
Lithium level checked at 3 monthly intervals
665J.
Lithium annual review
8BM00
Disorders of thyroid gland
C0...
Renal function monitoring
8A6..
Body Mass Index
22K..
O/E - BP reading
246.. %
Smoker - amount smoked
137.. %
Alcohol consumption
136.. %
ECG
32... %
Pregnancy advice
67A.. %
Advice given about lithium side-effects and toxicity
8Cd5.
Patient held care plan
9366.
Lithium patient information booklet given
8CE90
Lithium therapy record book completed
665K.
Psychiatric monitoring
8A2Z.
Seen in psychiatric clinic
9N1T.
Medication review
8B3S.
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Management
Read Code
Drug compliance good
8B3E.
Drug compliance poor
8B3i.
Prescription dose change
66R5.
Medication change to branded
8BP4.
Shared care prescribing
8BM5.
Prescription by GP
8B2F.
Blood Tests
Read Code
Renal function tests
451.. %
Thyroid function tests
442..%
Thyroid function tests normal
442H.
Thyroid function tests abnormal
442I.
Serum creatinine
44J3. %
Serum calcium
44I8. %
Glomerular filtration rate
451F.
Glomerular filtration rate calculated by abbreviated Modification of
Diet
Renal
Disease Study Group calculation
Urea in
and
electrolytes
451E.
Urea and electrolytes normal
44120
Urea and electrolytes abnormal
44121
Blood Levels
44JB.
Read Code
Serum lithium level
44W8. %
Lithium level therapeutic
44vE.
[D]Lithium, blood level abnormal
R1053
Lithium level high - toxic
44W81
Interactions
Read Code
Non-steroidal anti-inflammatory drugs contraindicated
8I2T.
Angiotensin converting enzyme inhibitors contraindicated
8I28.
[X] Adverse reaction to other diuretics
U60E5
[X]Fluoxetine adverse reaction
U609A
Advice regarding symptoms on discontinuation of selective
serotonin re-uptake inhibitor
8CAh.
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Appendix E - Quality improvement toolkit – evaluation form
Quality improvement toolkit - evaluation form
The Primary Care Quality and Information Service would like to ensure
that the information and suggested tools help practices to monitor and
audit their practice data, therefore please could you take a moment and
provide your comments on the quality improvement toolkit.
1)
Did you find the introduction, aims and methodology to be clear and easy to
understand?
YES
NO
If No, please comment _______________________________________
2)
Did you find the Audit Criteria to be clear and easy to understand?
YES
NO
If No, please comment _______________________________________
3)
Did you find the data collection easy to use?
YES
NO
If No, please comment _______________________________________
4)
Did you find the data summary easy to usel?
YES
NO
N/A
If No, please comment _______________________________________
5)
Did you find the practice review template useful?
YES
NO
N/A
If No, please comment _______________________________________
6)
Did you find the information within the appendices helpful?
YES
NO
If No, please comment ______________________________________
7)
Do you have any suggestions on how we should improve our quality improvement
toolkits?
__________________________________________________________
__________________________________________________________
__________________________________________________________
Please send to: Laura Jones PCQIS
Public Health Wales
36, Orchard Street, Swansea. SA1 5AQ
e-mail [email protected]
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Appendix F - References
1.
British Association of Psychopharmacology: Evidence bases guidelines
for treating bipolar disorder: revised second edition recommendations
2009 http://www.bap.org.uk/pdfs/Bipolar_guidelines.pdf
2.
NICE Bipolar disorder Clinical guideline 38 2006
http://www.nice.org.uk/nicemedia/live/10990/30193/30193.pdf
3.
SIGN Bipolar affective disorder: 82; May 2005
http://www.sign.ac.uk/pdf/sign82.pdf
4.
NPSA Safer lithium therapy 2009
http://www.nrls.npsa.nhs.uk/resources/?EntryId45=65426
5.
Drug Monitoring Toolkit PCQIS page 58 Lithium 2008
http://nww2.nphs.wales.nhs.uk:8080/primarycareqitdocs.nsf/1f8687d
8da97650980256fa30051b0be/3e75f1384cd148a7802575050033306a
/$FILE/2009%20Drug%20Monitoring%20LoRes%20for%20Web.pdf
6.
Gwent Healthcare NHS Trust Policy for the Use and Administration of
Lithium
http://www.wales.nhs.uk/sites3/Documents/814/Lithium%2DGwentTr
ustPolicyJune2009.pdf
7.
MHRA Lithium Overdose
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicin
es/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/
Genericoverdosesections/Lithium/CON026247
8.
GMS Contract Lithium indicators page 78
Quality & Outcome Framework guidance for GMS contract 2009/10
http://www.wales.nhs.uk/sites3/Documents/480/QOF%5FGuidance%5
F2009%2D10%5FFINAL.pdf
9.
CKS Bipolar Disorder – Management - Lithium 2009
http://www.cks.nhs.uk/bipolar_disorder/management/prescribing_info
rmation/lithium/monitoring
10.
BNF 60 September 2010 Lithium: 4.2.3 Antimanic drugs; page 223
http://bnf.org/bnf/bnf/current/3281.htm?q=Lithium&t=search&ss=text
&p=2#_hit
11.
NICE The treatment and management of depression in adults: Update
2009 http://www.nice.org.uk/nicemedia/live/12329/45888/45888.pdf
12.
Lithium: Cardiff and Vale Shared Care Policy CV12 2010
http://www.wmic.wales.nhs.uk/pdfs/shared_care_protocols/lithium_sc
_cv12_v4.0_nov2010.pdf
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