Recurring concern

Unreliable medication-specific blood-level monitoring

First to latest report 25 Jun 2014 — 14 Jan 2026

Reports that mention this concern
16
Times this concern has been raised
22
Stated actions linked to this concern
39

What this concern includes

Includes failures of controls specifically dedicated to monitoring blood levels associated with a prescribed medicine, including guidance on testing thresholds or timing, arrangements for obtaining tests, interpretation of results and review of prescribing or monitoring practice. Includes the anchor's tinzaparin prescribing and blood-level monitoring concern and comparable failures concerning fluoxetine or clozapine levels.

What is not included
  • Excludes routine blood tests or biochemical monitoring where the assertion is not specifically about a medication-associated blood level.
  • Excludes generic medication prescribing, administration, reconciliation, long-term review or medication-risk recognition failures when medication-specific blood-level monitoring is not the unsafe condition.
  • Excludes failures concerning a clinical test performed for diagnosis or general disease monitoring rather than to monitor a medicine's level or medication-related toxicity.
  • Excludes deficiencies limited to treatment response or clinical action after a medication level was reliably obtained, unless the monitoring process itself was also deficient.

Reports and published responses 16 reports

See individual reports that have raised this concern, and the actions taken in response

  1. Staffordshire South

    AI-generated summary

    Thomas Paul Arthur JACKSON · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Thomas Paul Arthur Jackson was found in a poorly state in his room at a secure unit within St George’s Hospital, Stafford, in the early hours of 25 August 2016 and was certified dead at 02.25 hours. The inquest recorded clozapine toxicity and pneumonia as causes of death, with treatment-resistant schizophrenia also noted; the substantive concern was the lack of a national policy for regular blood plasma monitoring of patients receiving clozapine.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of national policy for regular clozapine blood plasma-level testing

    Wider context from the report

    “It is well known that Clozapine is a potentially dangerous drug which needs to be carefully monitored. Monitoring is for both whole blood to look at infection markers and for blood plasma to cheek on Clozapine levels. Since this death the Trust involves has established a policy for the regular checking of blood plasma levels for patients in receipt of Clozapine. However it appears that this is a local policy and that there is no national policy for these checks to be carried out. I wonder if there should be a direction for all trusts to carryout blood plasma tests on patients receiving Clozapine on a regular basis perhaps at least six monthly or yearly. ”

    Source location

    Thomas Paul Arthur JACKSON · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The MHRA is responsible for medicine safety and will assess whether therapeutic drug monitoring supports safer clozapine use.

    Verbatim wording from the response

    “As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for the safety of medicines and medical devices. The MHRA seeks independent advice from the Commission on Human Medicines (CHM) which advises on whether the overall balance of benefits and risks of medicines is favourable at the time of licensing and remains so thereafter.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 12 April 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The NICE guideline surveillance team will consider whether guidance on clozapine plasma-level monitoring requires updating.

    Verbatim wording from the response

    “I am informed that clinical guideline CG178 is to undergo a surveillance review to check whether it needs to be updated and given the concerns you raise, the issue of monitoring blood plasma levels in people taking clozapine (or other antipsychotics) has been logged for the consideration of the guideline surveillance team undertaking the review process.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 12 April 2019

    Open published response

  2. Cornwall and Isles of Scilly

    AI-generated summary

    Pauline May Pryor · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Pauline May Pryor, a resident of Trevornor Nursing Home receiving lithium treatment, was found unwell on 9 July 2015 and died in hospital on 13 July 2015. The report identified concerns that required quarterly blood tests were not carried out because of unclear communication between the nursing home and GP surgery, and that psychiatric advice to reduce and stop lithium was not seen or followed up.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to complete quarterly kidney function and lithium-level monitoring

    Wider context from the report

    “• Mrs Pryor suffered from bipolar affective disorder and was on Lithium treatment which had been successful for many years in controlling her mood. Patients on Lithium are required to have quarterly blood tests to check kidney function and lithium levels. This was not carried out for a number of reasons do to with unclear communication between the Nursing Home and GP surgery. The practice did have in place a computer system to highlight test/reviews for certain groups of patients based on “Quality Outcome Framework Targets” (QOF) guidelines and were unaware these did not necessarily mirror the NICE Guidelines or Local Prescribing /Care Guidelines such as in the case of Lithium Toxicity • A blood test on 29th April 2015 showed Mrs Pryor’s kidney function dropped (eGFR 25) despite a lithium test being requested by Nursing Home and GP it did not occurred. As a result of the kidney function test result the GP wrote to Mrs Pryor’s Consultant Psychiatrist for advice on medication. The Psychiatrist replied by e-mail on the 15.6.15 and advised the GP to reduce and stop the Lithium medication. The E-mail was sent to the GP Practice e-mail but was not seen by the GP for reasons unknown nor was the reply chased up ”

    Source location

    Pauline May Pryor · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Highlight lithium monitoring requirements to GPs and practices and remind them that current BNF and local CCG prescribing guidance is available.

    Verbatim wording from the response

    “2. Lithium monitoring. Thank you for pointing out that the QOF framework which is designed to reward GPs for quality, is not the mirror of lithium monitoring guidelines. We will ensure that this is highlighted to GPs and practices and a reminder that up to date guidance is available from the latest BNF, and also local CCG prescribing guidelines.”

    Source location

    2018-0008-Response-by-NHS-England
    Page 1 · response
    Published 7 March 2018

    Open published response

  3. South Wales Central

    AI-generated summary

    Deidre Harvey · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Deidre Harvey died on 19 April 2017 after attaching a dressing gown cord to her neck in a mental health unit bathroom; the cause of death was recorded as hanging. The report raised concerns about coordination between mental-health and outside consultants, management of ligature risks and dangerous items, risk-assessment communication, and the potential toxicity and monitoring of hydroxychloroquine.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of routine clinical monitoring of Hydroxychloroquine levels

    Wider context from the report

    “Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

    Source location

    Deidre Harvey · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    MHRA and NHS Improvement are responding separately to concerns about monitoring patients prescribed hydroxychloroquine.

    Verbatim wording from the response

    “Finally, I am aware that the MHRA and NHS Improvement are responding separately to your matter of concern on the monitoring of patients who are prescribed Hydroxychloroquine. I hope that response is helpful.”

    Source location

    2018-0266-Response-by-Department-of-Health-Social-Care
    Page 3 · response
    Published 20 July 2017

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The MHRA has primary responsibility for monitoring Hydroxychloroquine toxicity and will provide the substantive response on this issue.

    Verbatim wording from the response

    “The issue of monitoring for toxicity that you raised is primarily in the remit of the MHRA, and they will provide the substantive reply to you on this issue. We have supported their work through undertaking a search of the National Reporting and Learning System. This did not identify any additional cases where systematic toxicity from Hydroxychloroquine had been identified, but did reinforce the importance of annual eye screening for patients on long-term Hydroxychloroquine, as set out in current guidance from the British Society for Rheumatology and British health Professionals in Rheumatology ‘Guideline for the prescription and monitoring of non-biologic disease-modifying anti rheumatic drugs (see https://cks.nice.org.uk/dmards#!scenario:8)”

    Source location

    2018-0266-Response-by-NHS-Improvement
    Page 2 · response
    Published 20 July 2017

    Open published response

  4. South Yorkshire (Western)

    AI-generated summary

    Captain James Michael Bedford · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Captain James Michael Bedford, a senior long-haul airline pilot, developed a left-leg deep vein thrombosis and later collapsed after a flight from China. He suffered a pulmonary embolus and cerebral events, followed by an acute cerebral haemorrhage after treatment with heparin, and died on 30 June 2015. Concerns included differing hospital practices regarding lower-leg scanning for DVT and whether a full-leg scan at his first attendance might have provided an opportunity for treatment.

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    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Delays in Heparin-level testing and result availability

    Wider context from the report

    “5. There was no criticism of the use of 50mg Alteplase but there was a lack of clarity as to whether this was followed by an infusion. A further expert witness (a haematologist) criticised the subsequent use of unfractionated Heparin and a test of Heparin level seems to have taken a long time from sampling to delivery to the laboratory and later result. The evidence was strongly suggestive of over-anticoagulation by Heparin. ”

    Source location

    Captain James Michael Bedford · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The apparent 2-hour-37-minute APTT delay was actually 1 hour 20 minutes because the form was pre-prepared.

    Verbatim wording from the response

    ““The sample for APTT testing was timed as being collected from ICU at 19.58hrs, but the sample was not taken until 21.15hrs and not received by pathology until 21.24. The results were reported to ICU at 22.35hrs, so an apparent delay of 2 hours and 37 minutes seemed to have occurred.”

    Source location

    2016-0368-Barnsley-Hospital-NHS-Trust
    Page 2 · response
    Published 18 October 2016

    Open published response

  5. Carmarthenshire and Pembrokeshire

    AI-generated summary

    Margaret Hions · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Margaret Hions was admitted to Glangwili Hospital on 1 July 2013 and later transferred to Prince Philip Hospital, where she died on 27 August 2013. During her admission, a large bruise rapidly expanded after warfarin was replaced with tinzaparin. Concerns were raised about tinzaparin prescribing, monitoring of blood levels, and monitoring creatinine clearance, with the inquest identifying shortcomings in the management of her care at Glangwili Hospital.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to ensure safe tinzaparin prescribing and blood-level monitoring

    Wider context from the report

    “(1) That there should be a review of the current Health Board practice in the prescribing of tinzaparin medication and the monitoring of blood levels. (2) That the importance of monitoring creatinine clearance as per Health Board clinical pharmacy policy to be reiterated to medical team and pharmacists. These matters were identified by a Root Cause Analysis Investigation report but it was unclear at the inquest whether these recommendations have yet been acted upon. ”

    Source location

    Margaret Hions · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Complete consultation and obtain approval for the revised guideline on low molecular weight heparin prescribing and creatinine monitoring.

    Verbatim wording from the response

    “In relation to the recommendation to review Health Board practice in the prescribing of tinzaparin medication and monitoring of blood levels, I can confirm that this has been reviewed and a revised guideline for prescribing and monitoring low molecular weight heparin had been produced. This is currently subject to consultation within the Health Board and will be presented to the next scheduled meetings of both the Medicines Management Group and Clinical Policy Review Group for approval.”

    Source location

    Margaret-Hions-Response
    Page 1 · response
    Published 12 February 2016

    Open published response

  6. Inner North London

    AI-generated summary

    Ralph Stephen Goslin · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Ralph Stephen Goslin, an inpatient detained under Section 3 of the Mental Health Act, was found unresponsive in a bath on 21 June 2014 and died later that day in hospital. A concern was raised that a junior doctor did not recognise his sodium valproate level as subtherapeutic because of the reference range shown, delaying recognition of his failure to take anti-epilepsy medication.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of sodium valproate blood test reference ranges to clearly indicate the therapeutic range

    Wider context from the report

    “1. The junior doctor at St Pancras Hospital who first reviewed the UCH blood test result giving Mr Goslin’s sodium valproate level as less than 3, did not realise that this was sub therapeutic, because the reference range was given as less than 100, rather than 50-100 as it is in some other hospitals. This meant that Mr Goslin’s failure to take his anti epilepsy medication was not recognised as quickly as it could have been. ”

    Source location

    Ralph Stephen Goslin · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026