Recurring concern

Unreliable guidance for medication continuation and discontinuation decisions

Pin Get email alerts Request correction

First reported 14 Jul 2016•Latest report 7 Jan 2025

Definition

What this concern includes

Includes failures of clinical guidance, decision criteria or supporting processes specifically governing whether medication should be continued, paused or discontinued, including guidance on treatment duration, remission-related discontinuation and medication-specific risk considerations.

Not included

  • Excludes general medication prescribing, administration, monitoring or supply failures where continuation or discontinuation guidance is not the unsafe condition.
  • Excludes guidance deficiencies concerning a single named clinical condition or treatment pathway when that condition or pathway provides the more specific supported boundary.
  • Excludes generic clinical-policy updating, training or evidence-review failures unless they directly impair guidance for medication continuation or discontinuation decisions.
  • Excludes decisions to continue or discontinue medication that are clinically disputed but not linked to unclear, absent or inconsistently applied guidance.
Reports
6

Distinct published reports

Individual concerns
6

A report can raise multiple concerns

Date range
2016–2025

First to latest report issue date

Stated actions
6

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

National Institute for Health and Care Excellence4
NHS England3
Department of Health and Social Care1
Greater Manchester1
Medical Centre1
Medicines and Healthcare products Regulatory Agency1
Royal College of General Practitioners1
Warwick Hospital1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. Gloucestershire

    AI-generated summary

    Thomas Henry Robin Kingston · 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 Henry Robin Kingston, a 45-year-old man, died after sustaining a self-inflicted shotgun wound to the head at his parents’ property on 25 February 2024. The report raises concerns about communication of suicide risks associated with SSRI medication and whether guidance to continue or switch SSRI medication is appropriate when there is no benefit or adverse side effects are experienced.

    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

    Inadequate guidance on persisting with or switching SSRI medication when there is no benefit or adverse side effects

    Wider context from the report

    “2. Whether the current guidance to persist with SSRI medication or switch to an alternative SSRI medication is appropriate when no benefit has been achieved and/ or especially when any adverse side effects are being experienced. ”

    Source location

    Thomas Henry Robin Kingston · 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

    Provide a Mental Health toolkit containing evidence-based guidance on medical and psychological treatments for depression and anxiety.

    Verbatim wording from the response

    “It is however usual to switch to a different class if there has not been a benefit or side effects and there are recommendations in the guidance on how to switch drugs safely between classes due to interactions and different bioavailability. It is also important to be clear on the indication for an SSRI and use of diagnostic criteria for both anxiety as well as depression, as the conditions can be separate or combined this can guide various treatment options. The RCGP also has a Mental Health toolkit which provides evidence-based guidelines for medical and psychological treatments for both depression and anxiety.”

    Source location

    Response from Royal College of GPs
    Page 3 · response
    Published 9 January 2025

    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

    Medication side-effect and SSRI safety concerns are best addressed initially by the MHRA, with NICE considering action after collaborative work concludes.

    Verbatim wording from the response

    “Given that the matters of concern relate to the side effects and safety of medication, specifically selective serotonin reuptake inhibitors (SSRIs), we believe that the key issues raised are best addressed in the first instance by the Medicines and Healthcare products Regulatory Agency (MHRA), and I note that your report has also been sent to them.”

    Source location

    Response from NICE
    Page 1 · response
    Published 9 January 2025

    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

    Existing NICE guidance addresses suicide-risk warnings, treatment review and switching antidepressants when SSRIs are ineffective or cause side effects.

    Verbatim wording from the response

    “There are specific guidelines for Depression produced by NICE and most GPs shall follow NICE CKS (Clinical Knowledge Summaries). The guidance specifically covers the consideration of antidepressant drug treatment (using shared decision making to agree an appropriate treatment plan). The guidance includes advising that symptoms of anxiety, agitation, hopelessness, or suicidal ideas may increase when starting treatment, and advise when to seek urgent review. Advice is also given regarding review and switching antidepressant medication. This does mention considering a switch to a drug that the person has previously found helpful or prefers. In this case it is not clear whether there was a previous preference for a particular SSRI.”

    Source location

    Response from Royal College of GPs
    Page 3 · response
    Published 9 January 2025

    Open published response
  2. Manchester South

    AI-generated summary

    Audrey Margaret Lambert · 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

    Audrey Margaret Lambert suffered an accidental fall at home on 25 March 2024, fractured her right proximal femur, underwent surgery and subsequently had significantly reduced mobility while receiving care at Brinnington Hall. She was found unresponsive on 28 May 2024 and died from pulmonary thromboembolism due to deep vein thrombosis. The concern was that there was no national guidance to help primary care clinicians assess whether anticoagulation should be prolonged for elderly, immobile patients after the standard post-operative course.

    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 guidance for primary care clinicians on assessing whether to prolong anticoagulation for elderly immobile patients

    Wider context from the report

    “The inquest heard evidence that prior to the fall and fracture Mrs Lambert had been mobile. Following the operation her mobility was very limited. She was prescribed the standard heparin treatment post operatively. The inquest was told that it was recognised in her case that she had become very immobile since her fall. However the inquest was told that there was no national guidance that would assist clinicians in primary care in assessing whether they should consider prolonging the course of anti-coagulation prescribed in secondary care to reduce the ongoing risk of elderly immobile patients such as Mrs Lambert developing a fatal DVT in the community. ”

    Source location

    Audrey Margaret Lambert · 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

    Review guidance on stopping and starting VTE prophylaxis to determine whether an update is warranted.

    Verbatim wording from the response

    “I can confirm that we will review our guidance on stopping and starting VTE prophylaxis to see if an update is warranted. The potential scope of this work is to be confirmed but it may cover the management of people with immobility, if there is sufficient good quality evidence on which to base recommendations.”

    Source location

    Response from NICE
    Page 2 · response
    Published 5 November 2024

    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

    Existing national guidance addresses discharge VTE risk assessment and prophylaxis decisions, although it does not advise starting prophylaxis de novo in the community.

    Verbatim wording from the response

    “In the circumstances outlined in your report we believe that an assessment of the venous thromboembolism (VTE) risk, balanced against the prophylaxis risk, should have been made at discharge. Although our VTE guideline [NG89] does not give advice on starting VTE prophylaxis de novo in the community, it does give advice on starting and continuing pharmacological VTE prophylaxis after surgery (recommendation 1.11) and having a clear discharge plan. Decisions on prophylaxis should be driven by the needs of the individual, balancing the person’s individual risk of VTE against their risk of bleeding when deciding whether to offer pharmacological thromboprophylaxis to surgical and trauma patients (recommendation 1.1.6).”

    Source location

    Response from NICE
    Page 1 · response
    Published 5 November 2024

    Open published response
  3. Manchester South

    AI-generated summary

    Linda MCLAUGHLIN · 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

    Linda McLaughlin was treated for chronic myeloid leukaemia with nilotinib and later developed interstitial lung disease, probably as a consequence of the treatment. She was admitted with bronchopneumonia and died at Tameside General Hospital on 27 October 2023. Concerns included limited awareness of this rare complication, consent processes that may not mention it, and a lack of clear guidance on stopping treatment when patients are in remission.

    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 clear guidance on discontinuing nilotinib or similar drugs when patients are in remission

    Wider context from the report

    “3. In this case the inquest was told that a decision was taken to continue with nilotinib despite being in remission. The inquest was told that there is growing evidence that some people do not need to stay on these drugs for life if in remission but there is no clear guidance for the approach to take. As a consequence patients may remain on the drug longer than necessary. ”

    Source location

    Linda MCLAUGHLIN · 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

    The MHRA is considered more appropriate to comment on guidance concerning continued tyrosine kinase inhibitor treatment after remission.

    Verbatim wording from the response

    “Your Report also raises that there is growing evidence that some people do not need to stay on tyrosine kinase inhibitor drugs for life once in remission, but that there is no clear guidance on this and that consequently patients may remain on the drug longer than necessary. Again, you may wish to direct this concern to the MHRA who would be more appropriate to comment. However, specialist cancer colleagues have advised that this is an issue that currently remains in evolution. A proportion of patients can stop taking the drugs once they achieve a durable molecular remission, and this is normally discussed with patients after a certain length of time, weighing the potential toxicity of ongoing treatment against the risk of recurrence. The British Society for Haematology has an extensive guideline addressing this issue.”

    Source location

    Response from NHS England
    Page 2 · response
    Published 14 June 2024

    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

    Clinical practice issues, including prescribing and treatment decisions, are outside the medicines regulator’s remit.

    Verbatim wording from the response

    “The MHRA recognises that as the medicines’ regulator, it is not within our remit to comment on clinical practice issues. It is a healthcare professional’s responsibility to prescribe a drug based on the information contained within the SmPC and to obtain appropriate consent after counselling the patient on their individual benefits and risks with use.”

    Source location

    Response from MHRA
    Page 3 · response
    Published 14 June 2024

    Open published response
  4. Warwickshire

    AI-generated summary

    David RILEY · 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

    David Riley developed a pericardial effusion after atrial fibrillation ablation and later suffered a stroke before dying on 10 June 2023. Concerns included inconsistent decisions about pausing Apixaban, delays in restarting it, inadequate communication and continuity of care, and difficulties using computerised clinical records.

    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 clear guidance for clinicians on pausing DOACs

    Wider context from the report

    “1. Decisions regarding pausing of DOACs. It was not clear if there is national guidance available to clinicians regarding the pausing of DOACs and the considerations to be applied in making that decision. If there is such guidance, it is not widely understood or on the evidence given, followed consistently from hospital to hospital or within different teams. The inconsistency of approach appears from the evidence to increase the risk of misunderstanding and to put patients with atrial fibrillation at risk. ”

    Source location

    David RILEY · Prevention of Future Deaths report
    Page 3 · 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

    Further consider the issues raised through guideline surveillance to determine whether the VTE guideline requires updating.

    Verbatim wording from the response

    “Our guideline on venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism [NG89] covers VTE risk assessment but does not specifically cover pausing of DOACs such as apixaban. It is not possible to cover all clinical circumstances in our guidelines. Nevertheless, NICE will further consider the issues raised through our guideline surveillance process to see if an update to the guideline is required.”

    Source location

    Response from NICE
    Page 1 · response
    Published 8 August 2024

    Open published response

    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

    Update the Oral Anticoagulant Guideline with a link to the UK Clinical Pharmacy Association perioperative medicines guidance.

    Verbatim wording from the response

    “This guideline has now been updated to include a link to the UK Clinical Pharmacy Association’s Handbook of Perioperative Medicines which provides national guidance re perioperative medicine.”

    Source location

    Response from S. Warwickshire NHS
    Page 3 · response
    Published 8 August 2024

    Open published response

    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

    Further update the Oral Anticoagulant Guideline to provide clearer guidance on DOAC management.

    Verbatim wording from the response

    “The Trust’s haematology lead advised the Working Group that, despite guidance and resources being available to staff, there has been a tendency to ask the haematology department for case-by-case advice. Whilst this will remain an important resource we intend to further update our Oral Anticoagulant Guideline to provide clearer guidance.”

    Source location

    Response from S. Warwickshire NHS
    Page 3 · response
    Published 8 August 2024

    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

    Responsibility for responding to concerns about national DOAC guidance lies with NICE, which develops evidence-based NHS guidelines.

    Verbatim wording from the response

    “NICE will be responding directly to your concern about national guidance on DOACs. As you will be aware, the National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body, sponsored by the DHSC. It is the independent body responsible for developing evidence-based guidelines for the National Health Service, following a rigorous process and extensive engagement with stakeholders and expert input to develop the scope of the guidelines. However, it is important to note that NICE guidelines do not override a clinician’s responsibility to make decisions appropriate to individual patients. NICE guidelines describe best practice, and the Government expects NHS commissioners to take them into account in designing services that meet the needs of their local populations.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 8 August 2024

    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

    Publishing national clinical guidance on pausing direct oral anticoagulants is outside NHS England’s remit.

    Verbatim wording from the response

    “It is not within NHS England’s remit to publish the relevant clinical guidance on this matter. We would refer you to the National Institute for Health and Care Excellence (NICE), who we note you have also addressed your Report to, and who have published national guidance on the use of Apixaban, which was last updated in April 2024. The guidance states that patients may need to temporarily stop taking Apixaban if they require surgery or any other invasive procedure, and this depends on the patient’s risk of having a thromboembolic event along with the bleeding risk associated with the procedure. For “procedures with a high bleeding risk, the last dose of apixaban should be taken 3 days before the procedure”.”

    Source location

    Response from NHS England
    Page 1 · response
    Published 8 August 2024

    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

    NICE is responsible for relevant national guidance on pausing Apixaban and direct oral anticoagulants.

    Verbatim wording from the response

    “It is not within NHS England’s remit to publish the relevant clinical guidance on this matter. We would refer you to the National Institute for Health and Care Excellence (NICE), who we note you have also addressed your Report to, and who have published national guidance on the use of Apixaban, which was last updated in April 2024. The guidance states that patients may need to temporarily stop taking Apixaban if they require surgery or any other invasive procedure, and this depends on the patient’s risk of having a thromboembolic event along with the bleeding risk associated with the procedure. For “procedures with a high bleeding risk, the last dose of apixaban should be taken 3 days before the procedure”.”

    Source location

    Response from NHS England
    Page 1 · response
    Published 8 August 2024

    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

    Guidelines cannot cover all clinical circumstances and do not specifically address pausing direct oral anticoagulants.

    Verbatim wording from the response

    “Our guideline on venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism [NG89] covers VTE risk assessment but does not specifically cover pausing of DOACs such as apixaban. It is not possible to cover all clinical circumstances in our guidelines. Nevertheless, NICE will further consider the issues raised through our guideline surveillance process to see if an update to the guideline is required.”

    Source location

    Response from NICE
    Page 1 · response
    Published 8 August 2024

    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

    National guidance on perioperative DOAC management is available, although the Trust considers its own guidance requires greater clarity.

    Verbatim wording from the response

    “Decisions regarding pausing of Direct Oral Anticoagulants (DOAC). It was not clear if there is national guidance available to clinicians regarding the pausing of DOACs and the considerations to be applied in making that decision. If there is such guidance, it is not widely understood or on the evidence given, followed consistently from hospital to hospital or within different teams. The inconsistency of approach appears from the evidence to increase the risk of misunderstanding and to put patients with atrial fibrillation at risk.”

    Source location

    Response from S. Warwickshire NHS
    Page 2 · response
    Published 8 August 2024

    Open published response
  5. Milton Keynes

    AI-generated summary

    Frederick Squires · 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

    Frederick Squires was involved in a low-impact road traffic collision, sustained a head injury, and was discharged home after his warfarin and other medications were stopped. He was later found unwell, diagnosed with an acute ischaemic stroke, and died on 30 December 2014. The principal concern was the lack of guidance for clinicians on when warfarin should be recommenced after a head injury.

    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 guidance on when to recommence Warfarin after head injury

    Wider context from the report

    “(1) That there is no guidance available to clinicians as to when Warfarin should be recommenced for a patient who has suffered a head injury. If clear guidance is not available it will lead to confusion amongst clinicians and the patient with the result that it is commenced too soon and the patient develops a bleed or too late and the patient suffers a stroke. ”

    Source location

    Frederick Squires · 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

    Consider extending the head-injury guideline’s scope to examine evidence and develop recommendations on restarting warfarin during the 2017 update.

    Verbatim wording from the response

    “We have a guideline on the assessment and early management of head injury (accessible from our website: www.nice.org.uk/cg176), which includes recommendations regarding discharging patients. However, we believe that to examine the available evidence and make specific recommendations on when to restart Warfarin would require the guideline’s scope to be extended. We will consider the case for doing so, when we consider the guideline for updating in 2017.”

    Source location

    Response from National Institute for Health and Care Excellence
    Page 1 · response
    Published 31 October 2016

    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

    Specific recommendations on restarting Warfarin after head injury cannot be made without extending the guideline’s scope.

    Verbatim wording from the response

    “We have a guideline on the assessment and early management of head injury (accessible from our website: www.nice.org.uk/cg176), which includes recommendations regarding discharging patients. However, we believe that to examine the available evidence and make specific recommendations on when to restart Warfarin would require the guideline’s scope to be extended. We will consider the case for doing so, when we consider the guideline for updating in 2017.”

    Source location

    Response from National Institute for Health and Care Excellence
    Page 1 · response
    Published 31 October 2016

    Open published response
  6. Manchester South

    AI-generated summary

    Fred Whittaker · 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

    Fred Whittaker, who had schizophrenia and was known to abuse drugs and alcohol, attended hospital with chest pains and drowsiness after taking codeine, alcohol and methadone, but self-discharged and went home. He was found dead in his flat the following morning; the inquest concluded that he died from developing bronchopneumonia and combined codeine, methadone and alcohol toxicity. A principal concern was that Clonazepam was restarted in error after his psychiatrist had requested that it be stopped, reflecting inadequate recording and procedures for discontinued prescriptions.

    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 standard directions for managing requests to restart a discontinued medication

    Wider context from the report

    “An important issue in the Inquest was the continued prescription of Clonazepam by the Heaton Moor Medical Centre despite the written request on 17th August 2015, from Mr Whittaker’s treating psychiatrist, ████████ that this medication be stopped. The evidence given to me by ████████ a partner at the Heaton Moor Medical Centre, suggests that although the prescription was stopped it was started again in error. ████████ advised that, a) On receipt of ████████ request the drug was moved from the Repeat Prescription list to the Past Prescription list, without any reference in the records of the reason as to why the Clonazepam was being stopped. b) On or about the 19th August 2015 the pharmacy which administered Mr Whittaker’s medication requested a repeat prescription. c) It was likely that upon receiving that request Clonazepam was simply moved back on to the repeat prescription by one of the doctors at the Practice on being advised by an administrator of the Pharmacy’s request. This is clearly an unacceptable error. I accept that, on this occasion, this error played no part in Mr Whittaker’s demise but it is not difficult to imagine a completely different set of circumstances where such an error would give rise to a risk of death. ████████ evidence was that there were no standard directions as to how to manage this as a situation and that other practices may adopt the same simple policy of transferring the drug from one list to another. 1. That Heaton Moor Medical Centre does not have a mechanism whereby the reasons or requests or decisions that a patient is no longer to be prescribed a particular drug are recorded in the clinical records. 2. That this poor practice may not be limited to Heaton Moor Medical Centre and is replicated in many GP practices in the Northwest and indeed, nationally. ”

    Source location

    Fred Whittaker · 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

    Legal responsibility for prescribing lies with the doctor who signs the prescription.

    Verbatim wording from the response

    “In the guidance published by the Department of Health, Responsibility for prescribing between hospitals and GPs EL (91) 127, 1991 (enclosed) makes it clear that the legal responsibility for prescribing lies with the doctor who signs the prescription. The issue of any prescription and the subsequent doctor’s signature is to assure the dispensing pharmacist that the doctor considers the medication to be appropriate and necessary to treat that patient, giving due regard to dose,”

    Source location

    2016-0249-Response-by-NHS-England
    Page 1 · response
    Published 14 July 2016

    Open published response
Back to top

Data last updated 7 September 2026