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Policy on Pharmacological Therapies Practice Guidance Note
Safer Lithium Therapy - V06
Date issued Issue 1 – Sep 2021
Planned review Sep 2024
PPT-PGN-19 Part of CNTW(C)38 Pharmacological Therapies Policy
Author/Designation Peter Clarke - Lead Pharmacist, South Locality
Aisling Molloy – Advanced Pharmacist Practitioner
Responsible Officer
/ Designation Tim Donaldson – Trust Chief Pharmacist
Contents
Section Description Page No
1 Introduction 1
2 Lithium initiation 1
3 Lithium continuation 4
4 Side effect monitoring 5
5 Lithium level monitoring in the longer term 5
6 Physical health monitoring in the longer term 6
7 Appropriate communication of lithium monitoring results 9
8 Lithium documentation on RiO 10
9 Care planning 10
10 Transfer of care 11
11 Lithium shared care guidelines 11
12 Resources and further information 12
Appendices listed separate to policy
Appendix No:
Description
1 Lithium Level - Guide for Prescribers
2 Lithium Side Effects Rating Scale (LiSERS)
3 Drug Interactions
4 Physical Health Monitoring Requirements for Lithium
5 Lithium Transfer Checklist
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1 Introduction 1.1 Lithium is used for:
Management of acute manic or hypomanic episodes
Prophylaxis against bipolar disorders
Management of treatment resistant depression
Control of aggressive or self-harming behaviours 1.2 Lithium is recommended by NICE as a treatment option in depression and
bipolar disorder. Specific details about treatment of these disorders with lithium can be found in the following guidelines:
CG185 Bipolar disorder
CG90 Depression in Adults
1.3 In December 2009 the National Patient Safety Agency (NPSA) issued a Patient Safety Alert on safer lithium therapy. The alert was in response to reports of harm caused to patients, including fatalities, involving lithium therapy. It was designed to help NHS organisations 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.
2 Lithium initiation
2.1 Patient consultation
2.1.1 Before prescribing lithium, the prescriber should ensure the patient (and/or carer) is involved in the decision to commence lithium and has a good understanding of the treatment including monitoring requirements and potential side effects. This should include the following:
2.1.2 Blood monitoring requirements The importance of regular blood monitoring should be highlighted due to the narrow therapeutic index of the medicine and also potential effect on the kidneys and thyroid.
2.1.3 Concordance
The need to take lithium at the stated time (usually at night) as blood tests required 12 hours post-dose.
Emphasising good compliance and not to double up if they miss a dose
Highlighting the importance of taking the same brand of lithium 2.1.4 The signs and symptoms of toxicity (see section 4)
To advise that medical advice is sought if any symptoms of potential toxicity present.
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Patients should be informed that the following scenarios may increase the risk of toxicity:
Becoming dehydrated (eg hot weather, sickness and diarrhoea, excessive alcohol intake)
Changes in salt intake Taking medications that affect kidney function eg ibuprofen, certain
antibiotics
Patients should also be advised to speak their doctor or pharmacist if they:
Have sickness or diarrhoea for more than a day or two
Develop excessive thirst and are passing significant quantities of urine
Before taking any new medicine (prescribed or bought) to ensure it is safe to take with lithium.
2.1.4 Promoting a healthy lifestyle
Staying hydrated Exercising regularly Eating a balanced diet and avoid sudden dietary changes Avoiding alcohol, smoking and processed foods
2.1.5 Lithium monitoring booklet
An NPSA Lithium Therapy patient pack should be given to the patient/carer by the prescribing team which includes all of the counselling points above. The importance of taking the booklet whenever they visit their GP, clinic or hospital or pharmacy should be highlighted.
2.1.6 Additional points
In the case of patients who lack capacity, the patient’s carer or advocate should be consulted.
Women of childbearing potential should be advised that lithium carries additional risks in pregnancy and is a potential teratogen and therefore appropriate precautions should be taken. Lithium should not be offered to women who are planning a pregnancy or women who are pregnant, unless no other medication is likely to be effective.
In order to check the patient’s understanding a ‘Lithium Knowledge Questionnaire’ form is available on RiO (see section 8).
2.2 Pre-screening 2.2.1 Prescribers should ensure the following baseline checks are made and
reviewed before commencing treatment:
Urea and Electrolytes (U&Es) including calcium and eGFR
Thyroid function tests (TFTs).
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Electrocardiogram (ECG) – if cardiovascular disease or risk factors known to prolong the QT interval are present
Weight or body mass index (BMI) or waist circumference
Full blood count
Blood pressure
Personal and family physical and mental health problems
Lifestyle review (smoking, diet and physical activity)
Lipid profile (fasting if possible)
Fasting plasma glucose (FPG) / HbA1c
Allergies
Note that lithium is contra-indicated in severe renal impairment (eGFR <30ml/min). Caution should be advised if there is mild/moderate renal impairment and nephrology advice may need to be sought before commencing treatment.
2.2.2 Ensure pregnancy has been excluded in women of child bearing potential. Advise women of childbearing potential to use suitable contraception and seek specialist advice if a patient becomes pregnant.
2.2.3 Review other medications prescribed for potential interactions (see appendix 3).
2.2.4 The ‘Pre-Lithium Therapy Checklist’ on RiO should be used to ensure the above screening has been completed (see section 8).
2.3 Prescribing and monitoring levels 2.3.1 The usual starting dose will be specified in the manufacturers Summary of
Product Characteristics (SPC)* (https://www.medicines.org.uk/emc accessed 19.08.2021) and in the BNF. Serum lithium levels should be checked 7 days after initiation. *note there is no current SPC available for Priadel®
2.3.2 Serum lithium levels should be taken 12 hours after the previous dose.
Lithium should be routinely prescribed at night time (where once daily) to allow serum levels to be taken in the morning. In the case of twice daily dosing the level should be taken before the morning dose is administered.
2.3.3. Lithium has a narrow therapeutic range of 0.4 to 1.0mmol/l. When first
prescribing, a range of 0.6 to 0.8mmol/l is advised. The lower end of the range is usually the target for treatment of elderly patients. A higher range of 0.8 to 1.0mmol/l may be required in patients who have previously relapsed whilst taking lithium or those taking lithium who have functional impairment in addition to subthreshold symptoms. The reason for the higher range must be discussed with the patient with appropriate counselling and information given and documented in the notes.
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2.3.4 Lithium preparations vary widely in bioavailability. Therefore, lithium should always be prescribed by brand and form. Priadel® (lithium carbonate) is the first line brand choice in the Trust for tablet formulation.
2.3.5 Caution is required if changing brand or form. Tablets contain lithium
carbonate and the liquid contains lithium citrate. The doses are not equivalent. Refer to the BNF for further information and/or seek advice from pharmacy. Serum lithium levels should also be checked one week after any change.
2.3.6 Serum lithium levels should be checked 7 days after lithium has been
commenced and after each dose change. Levels should continue to be measured every 7 days until a stable therapeutic level and dose is achieved. A stable dose is defined as a minimum of four weeks at the same dose.
2.3.7 Lithium levels should be recorded on the ‘Lithium Initiation and Titration’ form on RiO (see section 8)
2.3.8 For serum levels outside the therapeutic range, the clinical record should
specify what, if any, action has been taken and the rationale clearly recorded in the notes.
2.4 Physical health monitoring during dose titration 2.4.1 Weight/BMI should be measured weekly for the first six weeks and then
measured at week 12. 2.4.2 The following should be measured/completed at week 12:
Lifestyle review
BP
Fasting blood glucose/ HbA1c
Lipid profile 2.4.3 Record the dates of the physical health measurements on the ‘Lithium
Initiation and Titration’ form on RiO (see section 8). 3. Lithium continuation 3.1 Where patients are referred to CNTW services having already been
established on lithium therapy, ensure the following are checked/confirmed before prescribing:
Current lithium dose
Brand and formulation
Indication for lithium therapy
Usual prescriber/monitoring team
Date and reading of most recent serum lithium level
Review results of all relevant investigations (see appendix 4)
Side effects/symptoms (see section 4 below)
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3.2 For women who are thinking about starting a family, offer information to help support an informed decision with regards to continuing lithium. See Section 12: “Lithium & pregnancy - information for patients”.
4. Side effect monitoring 4.1 Patients, carers and staff involved in the patient’s care should all be familiar
with the common side effects of lithium. 4.2 The following symptoms are indicative of toxicity and should warrant an
immediate referral to a doctor:
o Severe tremor
o Diarrhoea +/or vomiting
o Blurred vision
o Muscle weakness
o Unsteadiness, lack of co-ordination
o Muscle twitches
o Slurring of words
o Confusion
o Excessive drowsiness
It is important to note that signs of toxicity may occur with lithium levels within the therapeutic range.
4.3 Lithium should be STOPPED if symptoms of toxicity are present and an urgent level taken or transfer to A&E (depending upon clinical presentation) should be arranged.
4.4 Monitor for signs of neurotoxicity, including paraesthesia, ataxia, tremor
and cognitive impairment, which can occur at therapeutic levels. 4.5 Excessive thirst (polydipsia) and an increase in urinary frequency may
indicate the development of diabetes insipidus and would require further investigation.
4.6 A formal assessment of side effects should be carried out annually. See
appendix 2 and the ‘Lithium Side Effects Rating Scale (LiSERS)’ on RiO (see section 8).
5. Lithium serum level monitoring in the longer term 5.1 Serum lithium levels should be carried out every 3 months for the first 12
months as a minimum requirement.
5.2 More frequent monitoring may be required in the following circumstances:
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people with any disturbance of fluid balance/sodium intake (e.g. diarrhoea)
following any change in lithium dose or brand (see 2.3.5 and 2.3.6)
raised urea/creatinine levels or reduced eGFR over at least 2 readings. Ensure renal function assessed in these circumstances
5.3 After one year of treatment, serum lithium level monitoring can be reduced to a minimum of 6 monthly if the patient is stable and in the absence of any of the risk factors below:
older people
people taking drugs that interact with lithium
people who are at risk of impaired renal or thyroid function, raised calcium levels or other complications
people who have poor symptom control
people with poor adherence
people whose last serum lithium level was 0.8 mmol per litre or higher
5.4 The ‘Lithium Maintenance’ form should be updated on RiO for each monitoring episode (see section 8)
5.5 Levels should be followed up with appropriate actions. Appendix 1 offers guidance for prescribers within the Trust. There is usually a linear relationship between serum level and dose.
5.6 Patients should take lithium for at least 6 months to establish its
effectiveness as a long-term treatment. If the decision is made to discontinue lithium then this should be done as slowly as possible, taking into account any clinical risk and the mental state of the patient and alternative treatment should be considered.
5.7 The BNF and NICE recommend reducing the dose gradually over at
least 4 weeks, preferably over 3 months, even if the patient has started taking another antimanic drug. Clinical experience suggests that to prevent relapse, this dose reduction should be more gradual than the national recommendations.
5.8 If lithium has been stopped, this should also be recorded on RiO,
documenting the date and reason. 5.9 During dose reduction and for 3 months after lithium treatment is stopped,
monitor the patient closely for early signs of mania or depression. 6 Physical Health monitoring in the longer term 6.1 Please refer to Appendix 4 – Monitoring requirements for patients
prescribed lithium.
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6.2 Renal Function 6.2.1 Lithium, nephrotoxicity and association with chronic kidney disease
Lithium has direct nephrotoxic effects on the kidney and is associated with the development of chronic kidney disease, manifesting as interstitial nephritis, glomerulonephritis and formation of renal cysts.
It is therefore essential that renal function is closely monitored and that steps are taken to address modifiable risk factors for chronic kidney disease (examples are given in Table 1, below). Where chronic kidney disease is already established, progression may be slowed by such measures.
Table 1: Slowing the progression of lithium-induced chronic kidney disease
Modifiable risk factors for chronic kidney disease
Suggested intervention
Smoking Smoking cessation support
Polypharmacy (multiple medications)
Medication review Stop other directly nephrotoxic drugs eg
NSAIDs Reduce anticholinergic burden
Consider reviewing lithium dose (Table 2)
Poor glycaemic control (diabetes mellitus) Medication & lifestyle review
Poor blood pressure control (hypertension) Medication & lifestyle review
The above is not an exhaustive list, please refer to NICE guidance CG182: Chronic kidney disease in adults: assessment and management for further information.
Lithium is almost entirely renally excreted. Thus, any decline in renal function may lead to accumulation of lithium, increased sensitivity to lithium-related side-effects and further damage to the kidneys.
It is therefore essential that prompt action is taken when a progressive decline in renal function is observed. This may entail adjusting the dose of lithium, addressing reversible causes of renal impairment and consultation with renal colleagues.
Table 2: Lithium-related monitoring and dosing in renal impairment
Renal function Suggested Action
eGFR > 90ml/min Standard titration & dosing
eGFR < 90ml/min
Be vigilant for the development of chronic renal impairment (two or more consecutive reduced eGFR readings
during routine monitoring (6.2.2) )
All patients with eGFR 30-60ml/min
Consider whether lithium therapy is still appropriate. Address concomitant risk factors to slow progression (Table 1). Dose reduction to 50-75% of standard
dose may be required, along with increased monitoring. Seek advice
from Renal specialist.
eGFR < 30 mL/min Lithium contra-indicated
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6.2.2 Monitoring of renal function
Urea and electrolytes including calcium and estimated glomerular filtration rate (eGFR) should be tested every 6 months and more often if there is evidence of impaired renal function. Monitor lithium dose and serum 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. The decision to continue lithium when eGFR falls below 60 should involve a multidisciplinary discussion of the risks and benefits including opinion from a renal specialist and that of the patient or their representative.
For further information, see NICE guidance on chronic kidney disease or seek advice from a renal specialist.
6.2.3 A recent Drug Safety Update (October 2019) (accessed 19.08.2021) has
re-emphasised advice in the BNF that creatinine clearance (CrCl) provides a better estimate of renal function than eGFR in patients with extremes of muscle mass or those aged 75 years and over who are prescribed medications which are extensively renally excreted.
6.2.4 The standard calculation uses the Cockcroft-Gault equation which can be
found easily online e.g. CG Calculator (accessed 19.08.2021). The full MHRA Article can be found here MHRA: Estimates of Renal Function (accessed 19.08.2021)
6.3 Thyroid Function 6.3.1 Lithium therapy can cause hypothyroidism or rarely hyperthyroidism. Thyroid function should be checked every 6 months. If hypothyroidism is suspected then TFTs need to be monitored more frequently. In many cases changes in TFTs are temporary and resolve without intervention however patients should be monitored closely for symptoms of hypothyroidism. If biochemical hypothyroidism persists then treatment with levothyroxine may be indicated. If needed, seek advice from an endocrinologist. 6.4 Hypercalcaemia 6.4.1 Lithium increases the risk of hyperparathyroidism. Raised calcium levels may indicate hyperparathyroidism therefore calcium levels should be checked every 6 months. In cases of mild and moderate hypercalcaemia, the patient should be referred to an endocrinologist for further investigation. In cases of severe hypercalcemia, the patient should be admitted to hospital immediately.
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6.5 Weight or BMI 6.5.1 Measure the patient’s weight or BMI every 6 months. This should be
recorded in the Core Height and Weight Form on RiO, and lithium booklet. Waist circumference should also be measured annually.
6.6 Other routine monitoring 6.6.1 Blood pressure, lifestyle review, lipid profile and fasting plasma glucose/
HbA1c should be carried out annually.
7 Appropriate communication of lithium monitoring results 7.1 There must be effective communication between all healthcare practitioners involved with patients on lithium therapy. 7.2 Lithium monitoring results should be communicated from pathology laboratories to the requesting prescriber without delay. This is particularly important when lithium levels are above the normal therapeutic range (>1.0mmol/l).
When it is anticipated that a lithium level may be in the toxic range the sample should be marked ‘urgent’ and sent immediately to the pathology laboratory. If the lithium level is found subsequently to be ≥1.5mmol/l, the result will be communicated by telephone, to the prescriber, by pathology laboratory staff. For all suspected toxic lithium levels the lithium level result should have been received and any appropriate action taken within 24 hours of the sample being taken from the patient. This communication and action should be recorded in the patient’s Progress Notes in RiO.
A non-urgent lithium level which is subsequently found to be ≥1.5mmol/l will be communicated by telephone, to the prescriber, by pathology laboratory staff and any appropriate action taken within 24 hours of the lithium result being analysed. This communication and action should be recorded in the patient’s Progress Notes in RiO.
Non-urgent lithium levels within the normal therapeutic range should be seen by the prescriber and any appropriate action taken within 1 week.
7.3 Pharmacists must check that blood results are being monitored regularly and that it is safe to dispense lithium. A standard operating procedure has been written for use within CNTW pharmacy services. This covers all NPSA requirements for safe handling of lithium prescriptions: The pharmacist will check on point of receipt of prescription:
Current brand, formulation and dose of lithium
Current lithium blood level and last blood test date
Last blood test date for U&Es, eGFR ,TFTs and calcium
Any clinically significant drug interactions
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Note that LloydsPharmacy provide pharmacy services in North Cumbria and will have their own procedures.
8. Lithium documentation on RiO 8.1 The following forms are available on RiO (under Service Specific Files >
Physical Treatment > Lithium Documentation) and should be used where indicated:
Pre-Lithium Therapy checklist
Lithium Initiation and Titration
Lithium Maintenance form
Lithium Side Effects Rating Scale (LiSERS)
Lithium Knowledge Questionnaire 9 Care planning
When patients are prescribed Lithium, possible physical health issues should be considered within their individualised care plan
Common side-effects that should be monitored include an upset
stomach, fine tremor, polydipsia (thirst), polyuria (passing more urine
than usual), weight gain and hypothyroidism (underactive thyroid)
Lithium has a narrow therapeutic range, that is, there is a small margin
between an effective dose and a toxic one. The therapeutic range is
generally accepted to be 0.4-1.0mmol/L. If the concentration of lithium
in the blood is too high, blurred vision, muscle weakness, coarse
tremor, slurred speech, confusion, seizures and renal damage may all
occur. All patients who take lithium should have regular blood
tests to ensure that the amount of lithium in their blood is within
the therapeutic range along with observation for clinical
symptoms
Lithium is not metabolised by the liver; it is almost wholly excreted in the
urine. Any changes in kidney (renal) function, fluid balance (such as
dehydration) or electrolyte levels (such as a low level of sodium in the
blood - hyponatraemia), can potentially lead to lithium accumulation
which in turn can lead to renal damage and toxicity. All patients who
receive treatment with lithium should have their renal function
(electrolytes and creatinine/e-GFR) checked regularly along with
observation for clinical symptoms
Lithium treatment increases the risk of clinical hypothyroidism up to 5-
fold by interfering with iodine uptake. The clinical symptoms of
hypothyroidism overlap with those of depression and may therefore
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remain undiagnosed and untreated unless specific screening tests are
undertaken. All patients who receive treatment with lithium should
have their thyroid function tests (TFTs) checked regularly along
with observation for clinical symptoms.
10 Transfer of care 10.1 When transferring care from inpatient or community services it is important
to ensure that all appropriate actions have been taken and that all required information has been communicated. The Lithium Transfer Checklist (see Appendix 5) is available as an aid to ensure required information is communicated.
11 Lithium shared care guidelines 11.1 Before considering shared care arrangements it is important to discuss with
the patient/carer and gain consent for the arrangement. This should be clearly documented on RiO.
11.2 The shared care status of lithium is ‘amber’ in all CNTW localities. ‘Amber’
drugs are initiated by the hospital specialist, but continuing treatment by GPs may be appropriate under a shared care arrangement. Lithium must be prescribed within its licensed dose and for licensed indications to be eligible for shared care.
11.3 A shared care request form must be completed by the secondary care
specialist and the GP ensuring all parties have accepted their responsibilities under the arrangement. The completed form must be received before prescribing and monitoring responsibilities can be transferred to the GP. Until confirmation of acceptance is received from the GP, CNTW are responsible for the prescribing and monitoring of lithium.
11.4 The patient must remain under CNTW services and cannot be discharged,
unless under exceptional circumstances as documented in the shared care guidelines. The shared care guidelines and request forms for lithium can be found at the following links:
North of Tyne, Gateshead and North Cumbria
http://www.northoftyneapc.nhs.uk/guidance/ (Accessed on 05.08.21)
South Tyneside and Sunderland
https://www.sunderlandccg.nhs.uk/about-us/prescribing/shared-care-green-plus/ (Accessed on 05.08.21)
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12 Resources and further information
NPSA Patient Safety Alerts
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 from: https://webarchive.nationalarchives.gov.uk/20171030130945/http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=65426&p=2 (Accessed on 05.08.21)
Supplies of the patient information booklet, lithium alert card and record book are available from the Admin Team, Pharmacy Department, St Nicholas Hospital
Lithium and Pregnancy: information for patients
The “BUMPS” [Best Use of Medicines in Pregnancy] resource offered by the National Teratology Information Service provides detailed information for patients on outcomes for babies born to mothers prescribed lithium at various stages of pregnancy.
The Choice and Medication resource includes a guide for expectant mothers or women wishing to start a family which describes the potential risks vs benefits of continuing lithium throughout the first and second trimester and perinatal period, including delivery and breastfeeding.
References
1. NICE. The assessment and management of bipolar disorder in adults,
children and young people in primary and secondary care. Clinical guideline (CG185). Last updated February 2020. Accessed at: https://www.nice.org.uk/guidance/cg185 (Accessed on 05.08.21)
2. NICE. Depression in adults: recognition and management. Clinical
guideline (CG90). October 2009. Accessed at: https://www.nice.org.uk/guidance/cg90 (Accessed on 05.08.21)
3. National Patient Safety Agency (NPSA) Alerts Summary Lithium Dec 2009.
Accessed at: https://webarchive.nationalarchives.gov.uk/20171030130945/http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=65426&p=2 (Accessed on 05.08.21)
4. British National Formulary (BNF) (updated 29/04/21). Accessed at:
https://bnf.nice.org.uk/
5. NICE. Chronic kidney disease in adults: assessment and management. Clinical guideline (CG182). Last updated January 2015. Accessed at: https://www.nice.org.uk/guidance/cg182
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6. Taylor DM, Barnes TRE, Young AH. The Maudsley Prescribing Guidelines
in Psychiatry. 13th edition, 2018, pg 205-213
7. Stockley’s Drug Interactions accessed via http://www.medicinescomplete.com (Accessed on 05.08.21)
8. Goodwin et al. Evidence-based guidelines for treating bipolar disorder:
Revised third edition recommendations from the British Association for Psychopharmacology. J Psychopharmacology 2016. Vol 30(6) 495-553
9. MHRA. Drug Safety Update: Prescribing medicines in renal impairment:
using the appropriate estimate of renal function to avoid the risk of adverse drug reactions. Published 18th October 2019. Accessed at: https://www.gov.uk/drug-safety-update/prescribing-medicines-in-renal-impairment-using-the-appropriate-estimate-of-renal-function-to-avoid-the-risk-of-adverse-drug-reactions (Accessed on 05.08.21)
10. Cockcroft DW and Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976. 16(1) 30-41 http://www.ncbi.nlm.nih.gov/pubmed/1244564 (Accessed on 05.08.21)
11. UK Teratology Information Service. Lithium in Pregnancy monograph. Last
updated May 2015. Accessed at: https://www.toxbase.org/poisons-index-a-z/l-products/lithium-in-pregnancy/ (Accessed on 05.08.21)
12. Taylor DM, Gaughran, F, Pillinger T. The Maudsley Practice Guidelines for Physical Health Conditions in Psychiatry. 1st edition, 2021, pg 292-294
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