Lithium monitoring via nurse led clinic policy

1 Introduction

1.1 The importance of lithium monitoring

Lithium therapy is indicated for use in:

the acute treatment of mania
prophylaxis in bipolar disorder
to augment antidepressants in treatment of refractory recurrent depression

(National Institute for Health and Care Excellence)

Lithium has a narrow therapeutic index and recognised adverse effects on the kidneys and thyroid. Therefore, regular blood tests are important to ensure that the dosage is adjusted to be both safe and effective when changes occur. Clinical guidelines for the management of bipolar disorder published by The National Institute for Health and Clinical Excellence (NICE, 2014) and more recently in the patient safety alert published by the National Patient Safety Agency (NPSA, 2009) recommend protocols to establish safer lithium therapy.

Initiation onto lithium will be organised by the lead clinician or care coordinator in conjunction where appropriate with their consultant This policy does not deal specifically with the initiation of lithium which will need to be addressed elsewhere. The ongoing monitoring of those patients following this will be completed in nurse led lithium clinics.

2 Purpose

The purpose of this policy is to outline an approved framework to facilitate a structured approach within nurse led lithium clinics.
This policy will:

provide staff with up to date guidance on the processes involved with the monitoring of patients on lithium therapy
allow for the development of standardised practice where possible within the different locations of the lithium clinics, and link to or overarch the individual standard operating procedures for each location
facilitate the monitoring of the compliance to lithium therapy monitoring within Rotherham, Doncaster and South Humber NHS Foundation Trust (RDASH) as outlined by the NPSA (2009) and NICE Guidance CG 185 (opens in new window)

3 Scope

This policy applies to the nurse led lithium clinics within RDaSH which are located in Doncaster, Rotherham and North Lincolnshire. It will also provide guidance for clinicians who are monitoring patients within their teams prior to referral to a nurse led lithium clinic. There may be some patients who prefer not to attend lithium clinic and this policy will provide advice to the services who are managing their care.

4 Responsibilities, accountabilities and duties

Within each locality there will be a clear line of accountability within the management structure, which will be identified in more detail within the standard operating procedure for each area which are held at each clinic.

4.1 The lithium clinic nurse

The lead nurse for a lithium clinic; this may be more than one nurse in situations where different staff are involved, for example, Rotherham, is responsible for:

the routine monitoring of each patient on lithium therapy in accordance with both the NICE (2020) and NPSA (2009) guidelines
maintaining accurate patient records
following the processes that are in place to inform primary care of the results of any investigations in a timely manner
monitoring compliance with the standards as set out in this policy
reporting any patterns or trends of non-compliance with the policy to the relevant service manager
identifying and arranging any required staff training in relation this policy
adherence with the process of audit within the standards as set out in this policy
supervision of all staff working within the clinic setting

4.2 Clinical staff working in the clinic

These staff will work under the supervision of the Lead nurse and are responsible for:

maintaining accurate clinical records
completion of the physical health check screening
dealing with any urgent concerns regarding blood results in a quick and effective manner as identified in the local area standard operating procedure
documenting and taking action as required for the continued safe prescribing of lithium therapy as indicated in the local area standard operating procedure in the case of any patient’s non-attendance at the nurse led lithium clinic
providing information to patients regarding blood test results (in the record book supplied by the NPSA), and possible interactions with other medications, side effects and the signs of toxicity
reporting on the trust electronic IR1 system any untoward incidents which occur in the clinic
carrying out their roles in accordance with the standards as set out in both this policy, and the locally agreed standard operating procedures
liaising with care coordinators, lead professionals, responsible clinicians and general practitioners (GPs) when concerns are raised including non-attendance at clinic
referring any situations which require an urgent response to the local Access team for immediate action
reporting any breaches in compliance with this policy to the lead nurse

4.3 The locality service manager

The locality service manager is responsible for the overall management of the service including issues relating to safety, training, and competence of staff and audit processes.

4.4 The prescriber

Lithium will be routinely prescribed in primary care. The prescriber has a responsibility as outlined in NICE guidance (2020) and NPSA (2009) guidelines.
Act on local guidelines.
In the case of urgent prescriptions or alterations to the dose, both primary and secondary care have a responsibility to inform each other of such changes in order to maintain accurate records in accordance with NPSA guidance, and a further additional lithium blood level is required in the week following a dose alteration.

4.5 The care coordinator, lead professionals and responsible clinicians

The care coordinator and clinicians involved in the management of patients taking lithium must be aware of the patient’s need for lithium monitoring and encourage or support them in attending the clinic.
A care coordinator or lead professional must be aware of the possible drug interactions and signs of toxicity in order to provide ongoing education to the patient.
A care coordinator or lead professional is required to contact the nurse led lithium clinic to discuss any possible complications or concerns regarding the monitoring. They must also report any breaches of this policy with the lead nurse.

5 Procedure or implementation

5.1 Monitoring

Monitoring is required for all patients on lithium therapy, and as recommended in the NICE guidelines (2020) the following routine monitoring should be completed for all patients on lithium therapy.

That lithium blood levels are checked and recorded every 3 months during the first year (following the initiation period, when lithium levels should be done weekly until stable).
After the first-year monitoring may be done at least every six months unless the patient falls into one of the following groups. Should they fall into one of these groups monitoring should take place every three months:
- older patients
- people on drugs which interact with lithium
- people at risk of impaired renal or thyroid function, raised calcium or other complications3b (eGFR 30 to 45)
Monitoring advice:
- monitor lithium and eGFR 3 monthly
- monitor ACR annually (early morning sample)
- bone biochemistry annually
- consider medical referral if renal function declining
- refer for medical advice re renal function
- review risks and benefits of continuing lithium

CKD stage, 4-5 (eGFR less than 30)
Monitoring advice:
- discontinue lithium
- refer to consultant

5.2 Record keeping and communication with primary care

A record of the above assessments must be documented in the patient’s shared care records and “in a timely manner” conveyed to primary care. Primary care will continue to prescribe the lithium once a patient has been initiated and will need the information to continue to do so safely. It should also be recorded in the patients Record Book (NPSA, 2009) so that the pharmacist can check the lithium levels when dispensing the lithium prescription.

5.2.1 Where shared care is in place this must be followed

If levels are too high or low or there are concerns raised regarding renal or thyroid function, there must be a local process in place on the standard operating procedure to make sure the patient is assessed by a medic within 48 hours and any alterations to the lithium dosage made. Primary care must be informed of the outcome of such an assessment and any changes made to medication.

If a patient and GP request that monitoring is completed in primary care, then it must be confirmed in writing to the lithium clinic that the GP in primary care accepts responsibility and that secondary care will no longer be involved in the monitoring for lithium. If at any point this arrangement is no longer suitable the GP can write to the lithium clinic and request that monitoring be completed in secondary care. Blood tests may be taken at a GP practice, it is important to not assume that all of the other monitoring is completed unless informed in writing. In such cases confirmation must be sought from the GP and, until it has been given, the patient should be monitored in lithium clinic.

If adjustments of dose or prescription are considered in clinic then the prescriber must make contact with the patient’s GP before issuing a prescription to reconcile any other medication that the Patient might be taking.

5.3 The range of lithium levels and indications of toxicity

Although the therapeutic range for lithium is 0.4 to 1.2mmol/L it is suggested that the lower end of this is only used for the elderly and infirm patients and the upper end for younger patients, particularly those with predominantly manic symptoms.

The NICE guidance (2020) suggests clinicians aim for levels of 0.6 to 0.8mmol/L in the main, but to aim for levels of 0.8 to 1.0mmol/L if the patient has relapsed previously on lithium or has prodromal symptoms.
Patients should be assessed for and reminded of the symptoms of toxicity:

blurred vision
muscle weakness
course tremor
slurred speech
confusion
seizures
renal damage

In the event toxicity is suspected (even within the therapeutic range of blood lithium levels) a medic must be contacted immediately, and advice sought regarding the appropriate course of action. The patient must be seen by a doctor within 48 hours.

Primary Care should inform the nurse led lithium clinic of any changes to medication and these should be checked with the patient during their appointment.

Monitoring must highlight to the patient the possible interaction between medications and lithium therapy, in particular the following medications:

thiazides and related diuretics
non-steroidal anti-inflammatory drugs (NSAIDS)
sodium bicarbonate containing non-prescription antacids or urinary alkalinising agents

It may be appropriate for primary care to commence patients on the above medications, but they and the nurse led lithium clinic must be aware of the possible effects on the lithium levels and be prepared to adjust the dosage or monitoring as required.

Please refer to appendix A, guidance for interpreting common results.

5.4 Patients who do not attend clinic for monitoring

If a patient fails to attend two consecutive appointments within a month the clinic nurse is to contact the care coordinator and request an urgent review to ascertain why the patient is not complying with the monitoring requirements.

Any patients who do not have a care coordinator are to be re-referred to the appropriate multidisciplinary team, who can carry out an assessment, where necessary led by a consultant.

In the event that the patient fails to keep this appointment continuation of Lithium treatment is not safe and the patient and their GP is to be informed in writing that the treatment is being stopped and the patient discharged from clinic.

5.5. Discharge from lithium clinic

Where lithium is covered by formal shared care agreement patients should not be discharged back to primary care. In the event of the patient specifically requesting this then the patients GP must be contacted, and the risks and benefits discussed, and only then discharged if the GP agrees in writing to take on the monitoring, using the shared care or policy document for guidance

6 Training implications

There are no specific training needs in relation to this policy, but the following staff will need to be familiar with its contents: Nurse led clinic coordinators, nurse led clinic support workers, and covering staff for nurse led clinic within RDASH. Responsible clinicians should be aware of the role of lithium clinic and the process of referral to the nurse led lithium clinics as outlined in the standard operating procedures.

As a trust policy, all clinical staff need to be aware of the key points that the policy covers. Staff can be made aware by local induction, if planning to work within the nurse led clinics, and by the Team brief on publication of the policy or any further amendments.

7 Monitoring arrangements

7.1 Compliance with the patient monitoring requirements as detailed in section 5.1 of this procedure

How: Clinical record audit.
who by: Care coordinator.
Reported to: Care group, governance group.
Frequency: Annual.

7.2 Patient satisfaction with the lithium clinic services

How: Monitoring of complaints.
Who by: Trust complaints manager.
Reported to: Care group governance group.
Frequency: Quarterly.
7.3 Patient satisfaction with the lithium clinic services

How: Patient satisfaction surveys.
Who by: Care coordinator.
Reported to: Care group governance group.
Frequency: Annual.

8 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.2 How this will be met

No additional requirements with regards to privacy, dignity, and respect have been identified in relation to this procedure.

8.2 Mental Capacity Act 2005

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005)to ensure that the rights of individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act (2005) (section 1).

Where English is not the preferred language of the patient or service user, using an interpreting service should enhance the assessment of Mental Capacity.

9 Links to any other associated documents

The contents of this policy are to be read in conjunction with the following trust policies,

10 References

National Institute for Health and Clinical Excellence (2020). Bipolar Disorder: The management of bipolar disorder in adults, children and adolescents, in primary and secondary care. NICE; London.
National Patient Safety Agency (2009). Patient Safety Alert NPSA 2009/PSA005, Safer Lithium Therapy. NPSA; London.

11 Appendices

11.1 Appendix A Guidance for interpreting common results

11.1.1 Lithium blood level test

Clinical reason: 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 greater than or equal to 1.2 mmol/L, but it is very dependent on renal function. In elderly renally compromised patients, levels less than 1 mmol/L have been toxic.
Frequency of test: 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. A change in formulation should be treated as initiation of therapy for monitoring, for example, weekly until stable.
Normal range: Determined by prescriber and documented in the patient’s lithium therapy record book. Potential range between 0.4mmol/L to 1mmol/L. NICE suggests 0.6 to 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.

11.1.1.1 What to check for?

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.

11.1.1.2 What to do?

Reassure the patient if tests are unremarkable.
Inform clinician or GP or refer if appropriate.
Document your actions in the patient medical record or dedicated record.
Patients with levels above 2mmol/L should be referred to accident and emergency.

11.1.2 Thyroid function test (TFTs)

Clinical reason: Lithium is associated with long-term risk of hypothyroidism.
Frequency of test: Every 6 months.
Thyroid stimulating hormone (TSH) 0.5 to 5.5mU/L
Free thyroxine (FT4) 9 to 26pmol/l FreeT4 is depressed with hypothyroidism. Normal range, Laboratories vary in the method of testing and in the units of reporting, thus the ‘normal’ range may vary. Approximate normal reference ranges are:

11.1.2.1 People may need to be treated with L-Thyroxine, what to check for?

TSH values which are increasing and, or free T4 values that are decreasing

11.1.2.2 People may need to be treated with L-Thyroxine, What to do?

Reassure the patient if tests are unremarkable.
Inform clinician or GP or refer if appropriate.
Document your actions in the patient medical record or dedicated record.

11.1.3 Estimated glomerular filtration rate (eGFR) test

Clinical reason: Measures the level of kidney function. Lithium associated with long term risk of chronic renal impairment.
Frequency of test: Every 6 months, but see guidance in policy for those with impaired renal function.
Normal range: 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.

11.1.3.1 What to check for?

An eGFR which is decreasing or results imply dosing adjustments should be considered.

11.1.3.2 What to do?

Reassure the patient if tests are unremarkable.
Inform clinician or 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 patient medical record or dedicated record.

11.1.4 Weight or BMI

Clinical reason: 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 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: Varies between patients

11.1.4.1 What to check for?

Trends in change in weight, or sudden changes in weight, in particular rapid weight gain.

11.1.4.2 What to do?

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.
To calculate BMI, use the formula weight (kilograms) divided by the height (metres) squared.
Document your actions in the patient’s medical record or dedicated record.

Document control

Version: 5.
Unique reference number: 108.
Ratified by: Clinical policy review and approvals group.
Date ratified: 14 March 2022.
Name of responsible individual: Medicines management committee.
Date issued: 23 March 2022.
Review date: March 2025.
Target audience: Clinical staff working in the lithium clinics.
Description of change: Review.

Page last reviewed: April 30, 2024
Next review due: April 30, 2025

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