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There should be national processes to measure and improve the quality and safety of lithium treatment for bipolar disorder, the Health Services Safety Investigations Body (HSSIB) has said.
The recommendation comes in a patient safety investigation published by the HSSIB on 12 November 2026, which explores the reasons behind a decline in lithium prescribing, despite the National Institute for Health and Care Excellence (NICE) recommending it as a first-line medication for the long-term treatment of bipolar disorder.
More than one million people in the UK have bipolar disorder, according to the charity Bipolar UK.
The results of a study, published in Pharmacoepidemiology and Drug Safety in 2021, revealed that lithium prescribing in the UK declined by 14.58% between 2001 and 2018 — although, diagnoses had increased in that same time period.
Lithium is a mood stabiliser, which has the “largest evidence base for efficacy in bipolar disorder compared to any other treatment”, the HSSIB report noted.
However, in its investigation, the HSSIB found that some patients were not offered lithium as a first-line medication and tried several other medications first.
The investigation heard evidence that the risks, monitoring and potential side effects of lithium were often the first things discussed between clinicians and patients, rather than the potential effectiveness of the medicine. This approach could put people off wanting to try the drug, the report said.
The report also highlighted that prescribers’ decisions could be influenced by the availability and visibility of other medications, even if those medications may not be as effective as lithium.
Clinicians also reported concerns about the practical requirements of lithium monitoring, which includes blood testing, dose adjustment and annual health checks. This issue was particularly noted with patients being treated in the community, where monitoring and follow-up was sometimes seen as “adding complexity to treatment initiation”, the report said.
The report underscored variation in primary care monitoring under shared care agreements, with some GP practices having specialist roles to support people taking medications considered to be more high risk, including lithium. In these cases, the clinician would arrange the monitoring schedule, it added.
However, the report also said that in other practices, patients described being “left to it”, including arranging their own blood tests.
The Community Pharmacy Quality Scheme did include lithium monitoring in 2019/2020, which found that 95% of patients were being monitored as per NICE guidelines, the report said, adding that “this audit has not been repeated and so the current effectiveness of monitoring in primary care is unknown”.
According to the report, in secondary care, some clinicians said that monitoring felt like a “huge individual responsibility on the prescribing clinician”, especially compared with clozapine monitoring, which “has an established infrastructure which requires patient monitoring to be managed in a specific clinic”.
NHS England and the Department of Health and Social Care should establish “national oversight and assurance processes to measure and improve the quality and safety of lithium treatment across care settings”, the report recommended.
It also suggested that the Royal College of Psychiatrists — together with other relevant stakeholders — should publish a position statement and protocol on the use of lithium for bipolar disorder.
Subodh Dave, president of the Royal College of Psychiatrists, said that the royal college is developing a broader position statement on bipolar disorder with Bipolar UK and had appointed a presidential lead for clinical effectiveness “to help ensure that effective treatments, such as lithium, are used consistently across services”.
“Lithium remains one of the most effective treatments available for preventing relapse and supporting long-term recovery for many people with bipolar disorder. We welcome HSSIB’s report and its focus on ensuring that people who may benefit from lithium are able to access it safely, supported by appropriate monitoring and follow-up care,” he added.
Steve Bazire, honorary professor at the University of East Anglia School of Pharmacy and content consultant for Choice and Medication, told The Pharmaceutical Journal that “faced with the problem of erratic lithium”, he had been involved in setting up a lithium register, with reminders for monitoring and shared care agreements, run by a part-time pharmacy administrator for the whole county.
“This was set up in April 2002 and is still running successfully, with no reports of lithium toxicity in registered patients (as opposed to people who move into Norfolk) since,” he said.
“Norfolk has one of the highest lithium prescribing levels in the east [of England]. That has come from prescribers having the confidence to know that once they have initiated lithium, it will be monitored fully and correctly, there is no confusion as to who should act should a level be too high, and the prescriber can be identified and contacted.”
