STANDARD OPERATING PROCEDURE
Supplying Lithium Therapy
Date of Preparation:
Date of next review:
Prepared by:
Signature:
Date review takes
Version number:
place and initials
STANDARD OPERATING PROCEDURE
SUPPLYING LITHIUM THERAPY
This standard operating procedure (SOP) should be read in conjunction with the accompanying guidance
notes and should be tailored to meet your individual circumstances.
SCOPE
This procedure covers the supply of lithium therapy by the pharmacy and includes prescription receipt,
pharmaceutical assessment, interventions and problem solving, assembly and labelling, accuracy
checking and transfer to patient.
PROCEDURE
The order and the way in which you carry out these steps in your pharmacy may vary from the list below.
While professional judgement should prevail, as a principle THERAPY SHOULD NOT BE WITHHELD.
The SOP identifies specific circumstances where the decision to withhold therapy should be considered.
P1 Pharmacy staff authorised to take in prescriptions.
Following procedures outlined in P2 of the SOP, the following pharmacy staff are authorised to take in
prescriptions for lithium.
Name
P2 Prescription receipt [Pharmacy staff authorised to take in prescriptions for lithium]
Follow your existing SOP for taking in a prescription. In addition:



Ask for the lithium therapy record book and permission for the pharmacist to review it.
Alert a member of the pharmacy team if the patient;
 does not have their lithium therapy record book
 declines permission to review (proceed to P4 below)
 has never received a lithium therapy record book.
Check if the patient is taking any OTC medicines, in particular non-steroidal anti-inflammatory
drugs (NSAIDs) and sodium-containing antacids. Inform the pharmacist if the patient is taking
any OTC medicines.
P3 Pharmaceutical assessment, interventions and problem solving
[Pharmacist]
Follow your existing SOP for legal and clinical assessment. In addition:

Where the lithium therapy book is unavailable or the information is missing it is acceptable to:
 verbally confirm the target blood level range and current blood level with the clinic/GP or
patient/carer as appropriate; however a record that this has occurred should then be made in
the PMR and lithium therapy record book. Where no details are available proceed to P4
below.

Ensure the following information is available and recorded in the PMR:
o current brand, formulation and dose of lithium
o lithium target blood level range
o current lithium blood level
o estimated glomerular filtration rate (eGFR)
o thyroid function tests (TFTs, TSH ± FreeT4)
o weight or BMI.
Review this information each time a prescription is dispensed. Retain a record of as many
results as possible to enable changes to be tracked. Verify that the prescription, record book and
PMR are consistent. Reconcile any discrepancies.

Check whether the current lithium blood level is within the patient’s blood level range and whether
the lithium blood level has been checked within the last three months.
 If the current blood level is above 2mmol/L or above 1.5mmol/L and the patient has
symptoms of toxicity refer the patient to Accident and Emergency. It is advisable that you do
not dispense lithium in these circumstances.
 If the current blood level is above the target range and the patient has symptoms of toxicity it
is advisable that you refer the patient immediately to the clinician/consultant/GP or, if the
patient is unlikely to be seen promptly, to Accident and Emergency. It is advisable that you
consider not dispensing lithium in these circumstances.
 If the current blood level is below the target range or above the target range but the patient
has no symptoms of toxicity, inform the clinician/GP at the earliest opportunity.
 If the lithium blood level has not been checked within the last three months, inform the
clinician/consultant/GP as appropriate.

Check whether the TFTs (Thyroid stimulating hormone (TSH), FreeT4) are clinically significant for
comment (refer to clinical information table). Also determine whether the TFTs have been checked
within the last six months.
 Pharmacist to inform clinician/consultant/GP or refer if TSH values imply treatment with
levothyroxine or TFTs are not regularly monitored.

Check whether any changes to the eGFR imply dosing issues and whether the eGFR has been
checked within the last six months.
 Pharmacist to inform clinician/consultant/GP if eGFR results imply dosing adjustments
should be considered, or renal function is not being regularly monitored.

Check whether there have been any gross changes to weight or BMI, the values increase rapidly or
changes represent an issue for patients and whether the weight or BMI has been checked within the
last 12 months.
 Pharmacist to inform clinician/consultant/GP if weight or BMI changes represent an issue or
are not being regularly monitored.

Check the patient’s PMR to see if there have been any changes to the patient’s other medication or if
you have been informed that they are taking medicines OTC.
 Check for drugs which may alter lithium levels, in particular ACE inhibitors, NSAIDs, thiazide
diuretics or sodium containing antacids. Refer to the latest BNF or the latest edition of
Stockley’s Drug Interactions where available and the ‘Drug interactions’ section in the
guidance notes for more detail. If a patient is prescribed these drugs, pharmacist to assess
and consult the clinician/consultant/GP as appropriate.
P4 Pharmaceutical assessment when lithium therapy record details unavailable [Pharmacist]

If you are unable to verify any details of a patient’s lithium therapy;
 Check for signs of lithium toxicity and refer where appropriate.
 If the patient does not have symptoms of toxicity, explain the importance of the pharmacist
reviewing the lithium therapy record book on each occasion and ask them to bring it next
time.


If the patient does not bring their lithium therapy record book with them repeatedly,
pharmacist to inform the clinician/consultant/GP or PCT as appropriate that they are unable
to comply with Patient Safety Alert – Safer lithium therapy (NPSA 2009/PSA 005)
or if the patient refuses consent to review their therapy, ask permission to inform the
clinician/consultant/GP that you are unable to review their lithium therapy. If the patient
refuses consent to inform the clinician/consultant/GP, record this on the PMR and consider
the appropriateness of disclosure without patient consent.
P5 Assembly and labelling
[Pharmacy staff authorised to assemble and label prescriptions]
Follow your existing SOP for assembly, labelling and dispensing. In addition:
 Confirm the brand of lithium which the patient takes by checking the PMR or lithium therapy
record book.
 Assemble the prescription using the correct brand of lithium.
 Where possible, avoid instructions such as ‘as directed’ on the label. It would be acceptable to
label as ‘take as directed in your lithium record book’
 Ensure a Patient Information Leaflet is included.
 Attach the ‘Li’ prescription alert sticker to the bagged up package.
 Lithium may be included in monitored dosage systems following risk assessment.
P6 Accuracy checking [Pharmacy staff authorised to accuracy check or pharmacist]
Follow your existing SOP for checking and bagging a prescription. In addition:
 Double check that the correct brand has been selected.
 Double check that the correct strength(s) have been selected.
 Double check that the dosage on the label(s) is correct.
 Double check that the labels for different strengths have not been transposed.
P7 Pharmacy staff authorised to transfer lithium prescriptions to a patient
Following procedures outlined in P8 of the SOP the following staff are authorised to transfer prescriptions
for lithium to a patient.
Name
P8 Transfer to patient
[Pharmacy staff authorised to transfer prescriptions for lithium to a patient]
Follow your existing SOP for giving out a prescription. In addition:
 Check the expected dose, formulation and brand of lithium with the patient or representative and
ascertain that this is what was expected.
 Check that the patient and/or carer understand how to take the correct dose in relation to the
number of mg and the number of tablets and explain the importance of remembering to take
every dose as prescribed.
 If the dosage instructions are ‘as directed’, check that the patient knows what their dose should
be and check that this information is in their lithium therapy record book. Make a note in the
PMR that a dosage was not on the prescription but was verbally reinforced.
 Check for and respond appropriately to any questions the patient might have.
 Ask the patient if they have noticed any side-effects from their treatment. Refer such patients to
the pharmacist.
 Pharmacist to check if adverse effects could be side-effects and advise accordingly.
When signs of lithium toxicity are suspected refer to the clinician/consultant/GP/out of
hours/Accident and Emergency as appropriate.
Side effects of lithium
Upset stomach – particularly at the start of
treatment
Signs of lithium toxicity
Severe hand shake (‘tremor’)
Stomach ache along with nausea and diarrhoea
Find shake (‘tremor’) of hands
Muscle weakness
Metallic taste in mouth
Being unsteady on feet
Weight gain
Muscle twitches
Swelling of ankles
Slurring of words
Feeling of thirst and passing a lot of urine
Blurred vision
Reduction in thyroid activity
Confusion
Alteration of renal function
Feeling sleepy



Remind the patient that they need to maintain a consistent intake of fluid and specifically not to
become dehydrated.
Ensure the patient is aware of the potential for lithium to interact with other medicines, including
those bought over-the-counter, and that they understand the need to consult with a pharmacist or
the prescriber before taking other medicines.
Return the lithium therapy record book to the patient.
APPENDIX 1
I have read and understood this standard operating procedure.
Date
Name
Signature
GUIDANCE NOTES
SUPPLYING LITHIUM THERAPY
In December 2009 the National Patient Safety Agency (NPSA) issued a Patient Safety Alert on
safer lithium therapy: NPSA Patient Safety Alert – Safer lithium therapy (NPSA 2009/PSA005).
The alert was in response to reports of harm caused to patients, including fatalities, involving
lithium therapy. The alert was developed in collaboration with the Prescribing Observatory for
Mental Health (POMH-UK) of the Royal College of Psychiatrists, the National Pharmacy
Association (NPA), other organisations, clinicians and patients. It was designed to help NHS
organisations, including community pharmacies, in England and Wales to take steps to
minimise the risks associated with lithium therapy and to ensure that potential harm to patients
is minimised. The deadline for action is 31 December 2010.
The NPSA Patient Safety Alert includes actions which are relevant to community pharmacy.
This resource aims to help you review your dispensing procedures and prepare a written
standard operating procedure (SOP) to ensure that you are complying with the Patient Safety
Alert when lithium is supplied in your pharmacy.
While all NPSA Patient Safety Alert actions may apply to your practice, those in italics are
particularly relevant for the majority of community pharmacies:

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;

systems are in place to identify and deal with medicines that might adversely interact
with lithium therapy;

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;

patients prescribed lithium are monitored in accordance with NICE guidance;

there are reliable systems to ensure blood tests results are communicated between
laboratories and prescribers;
Administration of lithium in social care settings such as care homes and the use of monitored
dosage systems are outside the scope of the Patient Safety Alert. However, it would be good
practice to review lithium blood levels and health checks of patients in care homes. Lithium
may be included in monitored dosage systems following risk assessment.
A pharmacist is allowed to write in the patient’s lithium therapy record book. A pharmacist can
make notes in the patient’s information booklet, lithium alert card and record book as
appropriate. Signing and dating the entry will maintain an audit trail.
When reviewing a patient’s lithium therapy it may be appropriate for the pharmacist to discuss
observations with the patient. The pharmacist should use their professional judgement to
determine if discussion with the clinician/consultant/GP is in the patients’ interest.
If you are aware that tests are not being conducted in accordance with the Patient Safety Alert
this SOP directs that you contact the prescriber making them aware of the issues. You must
document this communication.
Use
Lithium:

is the gold standard used alone or in combination for mania and prophylaxis in bipolar
disorder

is an option for Treatment Resistant Depression (TRD)

has anti-suicidal effects.
Different brands
The BNF states that lithium preparations vary widely in bioavailability. The brand or formulation
should not be changed without appropriate communication and monitoring.
Drug interactions
Many drugs have been found to interact with lithium, in particular thiazide diuretics, NSAIDs,
ACE inhibitors and sodium containing antacids. In principle if a drug acts on or through the
kidney, an interaction is possible. When assessing potentially interacting medication consider:

if lithium levels are being monitored more frequently.

if the use of the drugs is occasional. 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.

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.
CLINICAL INFORMATION
Test
Clinical reason
Frequency of test
Lithium blood
level
Blood levels are an indication
of clinical efficacy or potential
toxicity.
Levels should be within target
range, not sub therapeutic or
toxic. Toxicity has been seen
at levels ≥1.2 mmol/L, but it is
very dependent on renal
function. In elderly renally
compromised patients, levels
<1 mmol/L have been toxic.
Once blood levels are
stable, ‘normally’ every
3 months. Monitoring
should be increased
with potential drug –
drug interactions, such
as the introduction of
thiazide diuretics.
Thyroid
function tests
(TFTs)
Lithium is associated with
long-term risk of
hypothyroidism.
A change in
formulation should be
treated as initiation of
therapy for monitoring
i.e weekly until stable.
Every 6 months.
Normal range
Determined by prescriber and
documented in the patient’s
lithium therapy record book.
Potential range between
0.4mmol/L – 1mmol/L. NICE
suggests 0.6-0.8 mmol/L as
the optimum range.
However, some patients who
are young with excellent renal
function may require up to
1.2mmol/L.
Higher levels are required for
patients with acute
exacerbations of mania.
Laboratories vary in the
method of testing and in the
units of reporting, thus the
‘normal’ range may vary.
Approximate normal reference
ranges are:
Thyroid-stimulating hormone
(TSH) 0.5 – 5.5mU/L
Free thyroxine (FT4) 926pmol/l FreeT4 is depressed
with hypothyroidism.
Patients with a sustained
increase in TSH of greater
than twice the upper limit of
‘normal’ (~10 mU/L) which is
confirmed by repeat testing
after 2 weeks should be
treated with levothyroxine.
What to check for
What to do
Levels below or above the
patient’s target blood level
range. Also, the trend in blood
levels. Progressively increasing
lithium levels are a
consequence of deteriorating
renal function. Be more vigilant
with elderly patients, or
patients experiencing side
effects which could be signs of
toxicity.
Reassure the patient if
tests are unremarkable.
Inform clinician/GP or
refer if appropriate.
TSH values which are
increasing and/or free T4
values that are decreasing.
Reassure the patient if
tests are unremarkable.
Inform clinician/GP or
refer if appropriate.
Document your actions in
the PMR or dedicated
record.
Patients with levels
above 2mmol/L should
be referred to Accident
and Emergency.
Document your actions in
the PMR or dedicated
record.
Test
Estimated
glomerular
filtration rate
(eGFR)
Weight/BMI
Clinical reason
Measures the level of kidney
function. Lithium associated
with long-term risk of chronic
renal impairment.
Commonly patients do gain
weight; however, loss of
weight is linked to worsening
depression.
Weight gain may be linked to
hypothyroidism and viewed
as a complication of lithium
therapy.
Frequency of test
Every 6 months
Every 12 months as
part of a general
health check. Every 6
months when
prescribing medication
for children,
adolescents or during
an acute manic
episode.
Normal range
A patient with a TSH which is
around double the normal
upper limit (~10 mU/L) or
between the upper normal limit
and double the normal upper
limit (~5.5mU/L - ~10mU/L)
may require additional
monitoring and possible
treatment with levothyroxine.
Assays vary between
laboratories.
Values below 60 ml/min/1.73
m2 are noteworthy, >90
ml/min/1.73 m2 is considered
normal. Renal function
deteriorates with age.
Varies between patients
What to check for
An eGFR which is decreasing
and/or results imply dosing
adjustments should be
considered.
Trends in change in weight, or
sudden changes in weight, in
particular rapid weight gain.
What to do
Reassure the patient if
tests are unremarkable.
Inform clinician/GP or
refer if you have
concerns that renal
function is deteriorating
and no dose adjustments
appear to have been
made.
Document your actions in
the PMR or dedicated
record.
Monitoring and achieving
goals for weight should
be encouraged. May be
viewed as an indicator of
health status.
Rapid weight gain should
be referred.
The absence of a weight
check is not a reason for
withholding therapy.
Document your actions in
the PMR or dedicated
record.
RESOURCES AND FURTHER INFORMATION
NPSA
The Patient Safety Alert, supporting documentation and PDFs of a Lithium Therapy Record
book, Lithium Therapy – Important information for patients booklet and Lithium Alert Card can
be accessed and downloaded from the NPSA website at http://www.npsa.nhs.uk. You are
advised to read this material and store a copy for reference in your pharmacy.
Supplies of the patient information booklet, lithium alert card and record book are available from
the current NHS Non-Secure Contract held by 3M. Orders should be sent to:
Telephone 0845 610 1112
Email: nhsforms@spsl.uk.com
The contact for the Alert is:
Dr David Gerrett
Senior Pharmacist
National Patient Safety Agency
4-8 Maple St
London
W1T 5HD
david.gerrett@NPSA.NHS.UK
NPA resources
The following items can be obtained from NPA Sales on 01727 800401:

Prescription alert stickers

Medicine care cards – can be used to provide further information and/or reminders to
help patients remember to take their medicines correctly.
NHS resources
Lithium therapy record books and the booklet Lithium therapy important information for patients
are available to purchase from NHS forms (0845 6101112).
Please note that some clinics may have produced their own lithium therapy record book based
on the NPSA version.
The clinician/consultant initiating therapy or GP for patients being maintained in the community
are primarily responsible for providing the lithium therapy record book, the Lithium therapy important information for patients booklet and the lithium alert card. However, repeats of the
record book may be made available from clinicians/consultants, GP or community pharmacists.
CPPE
Training materials on bipolar disorder are available on the CPPE website www.cppe.ac.uk/
NICE guidance
NICE guidance on the management of bipolar disorder can be found at:
http://guidance.nice.org.uk/CG38/Guidance/pdf/English
Further References
 Ward ME, et al. Clinical pharmacokinetics of lithium. J Clin Pharmacol 1994;34:280–5.





Reiss RA, et al. Lithium pharmacokinetics in the obese. Clin Pharmacol Ther
1994;55:392–8.
Thomsen K, Schou M. Avoidance of lithium intoxication: advice based on knowledge
about the renal lithium clearance under various circumstances. Pharmacopsychiatry
1999;32:83–6.
Sproule BA, et al. Differential pharmacokinetics of lithium in elderly patients. Drugs
Aging 2000;16:165–77.
Kripalani M, Shawcross J, Reilly J, Main J. Lithium and chronic kidney disease. BMJ
2009;339:b2452
Livingstone C, Rampes J. Lithium: a review of its metabolic adverse effects.
Psychopharmacol 2006;20(3):347-55.