Recurring concern

Failure to communicate clinically significant medication risks to patients

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First reported 29 Jul 2014•Latest report 2 Feb 2026

Definition

What this concern includes

Includes failures to provide, explain, tailor, document or reinforce clinically significant medication-risk information to patients or their families or carers, including serious psychiatric, overdose, bleeding, toxicity or other medication-related risks where communication is needed for safe use.

Not included

  • Excludes prescriber-only medication guidance, formularies and clinical decision support where patients are not the intended recipients.
  • Excludes medication packaging or product-labelling warnings as a standalone deficiency; those belong to the dedicated product or medication-packaging warning concerns.
  • Excludes failures of prescribing, dispensing, administration, monitoring or treatment where patient-facing medication-risk communication is not the unsafe condition.
  • Excludes generic communication or health-literacy deficiencies without a clinically significant medication-risk context.
Reports
19

Distinct published reports

Individual concerns
21

A report can raise multiple concerns

Date range
2014–2026

First to latest report issue date

Stated actions
40

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.

Betsi Cadwaladr University LHB2
Department of Health and Social Care2
Medicines and Healthcare products Regulatory Agency2
NHS Devon Integrated Care Board2
NHS England2
Bayer plc1
Care Quality Commission1
Clinical Commissioning Group (Devon)1
Devon Partnership NHS Trust1
East Kent Hospitals University NHS Foundation Trust1
Essex Partnership University NHS Foundation Trust1
Farnham Park Health Group1
General Medical Council1
Hampshire and Isle of Wight Healthcare NHS Foundation Trust1
Informa Healthcare1

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. Surrey

    AI-generated summary

    Matthew John Evans · 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

    Matthew John Evans was a 47-year-old man who developed insomnia, anxiety and depression during the third COVID-19 lockdown and died on 16 June 2021 after ending his life. The principal concerns related to the GP’s lack of mental-health assessment, suicide-risk assessment, follow-up and consideration of referral; the general practice’s prescribing, communication and clinical-governance arrangements; and TalkPlus’s lack of clear guidance on referral to secondary mental-health services.

    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 document warnings about Mirtazepine side-effects and increased suicidal ideation risk

    Wider context from the report

    “1. The actions of the General Practitioner The GP was not sufficiently proactive with multiple lost opportunities to provide better care and support for Matthew. The GP did not undertake a mental health assessment to assess the severity of Matthew’s difficulties and to ascertain whether further support or referral to secondary mental health care were indicated in any of the four telephone consultations. He did not ask or document at any time if Matthew had any suicidal ideation or acts of self-harm. The GP did not offer a face-to-face consultation or arrange a follow up appointment. The GP declined to prescribe Zopiclone and whilst he referred Matthew to the benefits of Melatonin he did not offer a prescription. He prescribed Mirtazepine having not done so before for someone in Matthew’s position on a background of having no post graduate qualifications in mental health. Furthermore, he did not document any warning of the possible side-effects of this drug including the possible increased risk of suicidal ideation with commencing the drug. It is unclear whether the GP had read the letters from TalkPlus. He did not ask permission as to whether it was possible to inform or involve Matthew’s partner and family in his on-going care. ”

    Source location

    Matthew John Evans · 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

    Share suicide and self-harm documentation and assessment learning with all Frimley GP practices through bulletins, meetings, clinical leads and prescribing updates.

    Verbatim wording from the response

    “The NHS Frimley ICB will be carrying out a number of actions following the inquest. These include sharing the concerns raised with all GP practices in the Frimley area. The learning will focus particularly on the importance of good documentation in recording risk of suicide or self-harm following a consultation when someone has been assessed as having suicidal ideation or is at risk of acts of self-harm.”

    Source location

    Response from NHS Firmley
    Page 1 · response
    Published 19 May 2022

    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

    Deliver a recorded virtual training session on mental health assessment and documentation, then distribute the recording to all practices.

    Verbatim wording from the response

    “The practices across the ICS will also be reminded of the importance of a good mental health assessment using recognised mental health tools. There are already templates for PHQ9 and GAD on the GP systems for them to use. The learning will be shared with practices in July 2022 in the GP bulletin. In September 2022, there will be a virtual training session, which will be recorded, on mental health assessment, which will also include documentation. The recording will be sent to all practices following the event.”

    Source location

    Response from NHS Firmley
    Page 1 · response
    Published 19 May 2022

    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 local formulary to highlight national guidance on increased suicidal behaviour risk after antidepressant initiation.

    Verbatim wording from the response

    “Across Frimley there is an evidence-based formulary the production of which is supported by a multidisciplinary team and this details prescribing practices that are routinely used in the area. After reviewing this case, we have considered that although there are also a number of national publications that highlight the increased risk of suicidal behaviour for a patient initiated on antidepressants (for example, the BNF, MHRA and NICE) the risks should be further highlighted on the local formulary. Action will be taken to ensure that the local formulary highlights the national guidance more acutely, in addition to the currently available information. Furthermore, the development of a point of prescribing alert will be undertaken to ensure that prescribers are reminded about the national guidance relating to potential increased risk in young people.”

    Source location

    Response from NHS Firmley
    Page 2 · response
    Published 19 May 2022

    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

    Develop a point-of-prescribing alert reminding prescribers about national guidance on increased risk in young people.

    Verbatim wording from the response

    “Across Frimley there is an evidence-based formulary the production of which is supported by a multidisciplinary team and this details prescribing practices that are routinely used in the area. After reviewing this case, we have considered that although there are also a number of national publications that highlight the increased risk of suicidal behaviour for a patient initiated on antidepressants (for example, the BNF, MHRA and NICE) the risks should be further highlighted on the local formulary. Action will be taken to ensure that the local formulary highlights the national guidance more acutely, in addition to the currently available information. Furthermore, the development of a point of prescribing alert will be undertaken to ensure that prescribers are reminded about the national guidance relating to potential increased risk in young people.”

    Source location

    Response from NHS Firmley
    Page 2 · response
    Published 19 May 2022

    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

    Add clearer initiation advice requiring discussion of possible worsening depression and increased suicidal thoughts for relevant patients receiving new antidepressants.

    Verbatim wording from the response

    “The prescribing choices undertaken by the GP were in line with guidance: prioritising non-pharmacological support for people with insomnia, providing a short course of zopiclone when essential; and prescribing mirtazapine for depression where there is also significant insomnia. However, we are undertaking additional steps to provide clearer advice at initiation of a new antidepressant. This will state that highlighting the potential for worsening depressive symptoms and increasing suicidal ideas is a key step that should be undertaken in every relevant case. This will happen on 12th July 2022 following approval from the medicine optimisation committee. Local prescribers will be reminded of this via our communication channels. This is happening through July and August 2022.”

    Source location

    Response from NHS Firmley
    Page 2 · response
    Published 19 May 2022

    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

    Remind local prescribers about the clearer antidepressant-initiation advice through ICB communication channels.

    Verbatim wording from the response

    “The prescribing choices undertaken by the GP were in line with guidance: prioritising non-pharmacological support for people with insomnia, providing a short course of zopiclone when essential; and prescribing mirtazapine for depression where there is also significant insomnia. However, we are undertaking additional steps to provide clearer advice at initiation of a new antidepressant. This will state that highlighting the potential for worsening depressive symptoms and increasing suicidal ideas is a key step that should be undertaken in every relevant case. This will happen on 12th July 2022 following approval from the medicine optimisation committee. Local prescribers will be reminded of this via our communication channels. This is happening through July and August 2022.”

    Source location

    Response from NHS Firmley
    Page 2 · response
    Published 19 May 2022

    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

    Audit patient use of the specified medication, present the results, and identify any required patient-safety actions.

    Verbatim wording from the response

    “38. The Practice will conduct an Audit of patient ████████ use by August 2022. To present audit results and identify if there is/are action/s required in relation to patient safety i.e. patient education regarding the use of the drug, follow-up to check patient remained safe in taking this drug, and does or has the patient required secondary referral to be supported by the community mental health team.”

    Source location

    Response from Farnham Practice
    Page 5 · response
    Published 19 May 2022

    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 circumstances were a specific case, not widespread poor care, and the care provided was not unsafe.

    Verbatim wording from the response

    “We are satisfied, at this point, that the circumstances surrounding Mr Evans’ death were a specific case and not indicative of widespread poor care on the part of the provider. Whilst we have concluded that improvements could have been made in the care and treatment provided to Mr Evans, this was not unsafe. We are pleased to see the provider has identified areas of improvement in its care and treatment, and we are assured that the actions taken will protect others using the service from harm. At this stage we have decided not to instigate any further action. However, we will continue to regularly monitor the provider and, where”

    Source location

    Response from Care Quality Commisson
    Page 1 · response
    Published 19 May 2022

    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

    No further action is currently considered necessary because the provider’s actions are expected to protect service users from harm.

    Verbatim wording from the response

    “We are satisfied, at this point, that the circumstances surrounding Mr Evans’ death were a specific case and not indicative of widespread poor care on the part of the provider. Whilst we have concluded that improvements could have been made in the care and treatment provided to Mr Evans, this was not unsafe. We are pleased to see the provider has identified areas of improvement in its care and treatment, and we are assured that the actions taken will protect others using the service from harm. At this stage we have decided not to instigate any further action. However, we will continue to regularly monitor the provider and, where”

    Source location

    Response from Care Quality Commisson
    Page 1 · response
    Published 19 May 2022

    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

    Regulatory action can target registered managers or providers, but not failings attributed solely to individuals.

    Verbatim wording from the response

    “As you may be aware, CQC can only take regulatory action against a registered manager or a registered provider, but not when failings of an individual have been identified.”

    Source location

    Response from Care Quality Commisson
    Page 2 · response
    Published 19 May 2022

    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 clinical guidance, professional standards, revalidation and training arrangements are considered sufficient to support appropriate prescribing and diagnosis.

    Verbatim wording from the response

    “As noted by NHS England, there are several educational resources and guidance documents relating to the assessment and treatment of depression that are regularly reviewed and accessible to clinicians. These include National Institute for Health and Care Excellence (NICE) guidance, which details possible adverse effects of prescribing mirtazapine, Clinical Knowledge Summaries and the British National Formulary.”

    Source location

    Response from Department of Health and Social Care
    Page 1 · response
    Published 19 May 2022

    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 GP’s prescribing choices were in line with guidance, despite identified risks associated with antidepressants.

    Verbatim wording from the response

    “The prescribing choices undertaken by the GP were in line with guidance: prioritising non-pharmacological support for people with insomnia, providing a short course of zopiclone when essential; and prescribing mirtazapine for depression where there is also significant insomnia. However, we are undertaking additional steps to provide clearer advice at initiation of a new antidepressant. This will state that highlighting the potential for worsening depressive symptoms and increasing suicidal ideas is a key step that should be undertaken in every relevant case. This will happen on 12th July 2022 following approval from the medicine optimisation committee. Local prescribers will be reminded of this via our communication channels. This is happening through July and August 2022.”

    Source location

    Response from NHS Firmley
    Page 2 · response
    Published 19 May 2022

    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 concerns do not indicate that the doctor poses a patient risk or undermines public confidence in doctors.

    Verbatim wording from the response

    “The AR is assured that the matters contained in your complaint do not raise concerns that ████████ poses either a risk to patients or undermines the public’s confidence in doctors. Although we do not need to investigate further, we will share your concerns with the doctor’s responsible officer and ask the doctor to discuss it with their appraiser as part of their revalidation.”

    Source location

    Response from General Medical Council(2)
    Page 1 · response
    Published 19 May 2022

    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

    No further investigation is considered necessary, although the concerns will be shared for discussion during revalidation.

    Verbatim wording from the response

    “The AR is assured that the matters contained in your complaint do not raise concerns that ████████ poses either a risk to patients or undermines the public’s confidence in doctors. Although we do not need to investigate further, we will share your concerns with the doctor’s responsible officer and ask the doctor to discuss it with their appraiser as part of their revalidation.”

    Source location

    Response from General Medical Council(2)
    Page 1 · response
    Published 19 May 2022

    Open published response
  2. County Durham and Darlington

    AI-generated summary

    Viktor John Anthony Scott-Brown · 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

    Viktor John Anthony Scott-Brown, aged 23, was found hanging at his home overnight on 14/15 December 2018 and pronounced dead at the scene; the inquest concluded that his death was suicide. He had been prescribed Lamotrigine without being warned about its potential association with thoughts of self-harm or suicide, and concerns were raised that reputable prescribing resources were inconsistent or silent about this potential side effect.

    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 provide patients with information about Lamotrigine side effects

    Wider context from the report

    “Mr Scott-Brown was prescribed Lamotrigine by an NHS Foundation Trust Consultant Psychiatrist. The prescribing consultant did not give Mr Scott-Brown a Trust information sheet about Lamotrigine and a Patient Information Leaflet about Lamotrigine from the drug manufacturer, GlaxoSmithKline. It was common ground that the consultant should have done so. Both documents record as a side effect of using Lamotrigine a risk that the patient may begin to experience thoughts of self-harm or suicide. Mr Scott-Brown was never given that information. The consultant gave evidence that he was not aware of that particular side effect of Lamotrigine, and that his prescribing practice was informed by the British National Formulary and The Maudsley Prescribing Guidelines. Neither the online BNF viewable via the NICE website nor the 10th Edition of The Maudsley Guidelines (to which the court was referred) refer to that side effect in their respective entries for Lamotrigine. Subsequent to the conclusion of the Inquest, I have learned from the Oxleas NHS Foundation Trust that when Mr Scott-Brown was prescribed Lamotrigine, then the current edition of the Maudsley Guidelines was the 13th Edition. The Inquest heard no evidence about the 13th Edition of the Maudsley Guidelines and information therein concerning Lamotrigine. Quite apart from any issue regarding the consultant’s knowledge about Lamotrigine (and the existence of the 13th Edition of the Maudsley Guidelines) and his not having given Mr Scott-Brown the Trust’s prepared information about the drug and its side effects, I am concerned that two obviously reputable sources of pharmacological information are apparently silent, or have been silent, on a potentially significant side effect of this particular drug. From a lay perspective, there is apparent potential for harm to patients depending upon which resources a prescriber consults before prescribing Lamotrigine. That potential for harm might be ameliorated were the advice about Lamotrigine consistent across all such resources. ”

    Source location

    Viktor John Anthony Scott-Brown · 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

    Develop and obtain approval for a Medication Safety Series document on prescribing resources and patient information sources.

    Verbatim wording from the response

    “I would like to reassure you that as an organisation we have taken your concerns seriously. As a consequence we have committed to develop a Medication Safety Series document regarding prescribing resources and sources of patient information. This will be made available to all prescribers. We are aiming to have a draft ready for approval at our Drugs and Therapeutics Committee on 24th September 2020. The final document will then be provided to all prescribers and other relevant staff within the Trust. This is expected to be completed by 2nd October 2020. In addition further communication on this will be provided widely through our Trust Ebulletin. It will also be available on the Trust intranet.”

    Source location

    2020-0163-Response-from-Tees-Esk-and-Wear-Valleys-NHS-Foundation-Trust_Redacted-1.pdf
    Page 1 · response
    Published 26 October 2020

    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

    Provide the approved Medication Safety Series document and related communications to prescribers and relevant staff through Trust communications and the intranet.

    Verbatim wording from the response

    “I would like to reassure you that as an organisation we have taken your concerns seriously. As a consequence we have committed to develop a Medication Safety Series document regarding prescribing resources and sources of patient information. This will be made available to all prescribers. We are aiming to have a draft ready for approval at our Drugs and Therapeutics Committee on 24th September 2020. The final document will then be provided to all prescribers and other relevant staff within the Trust. This is expected to be completed by 2nd October 2020. In addition further communication on this will be provided widely through our Trust Ebulletin. It will also be available on the Trust intranet.”

    Source location

    2020-0163-Response-from-Tees-Esk-and-Wear-Valleys-NHS-Foundation-Trust_Redacted-1.pdf
    Page 1 · response
    Published 26 October 2020

    Open published response
  3. Inner North London

    AI-generated summary

    Doreen Elma STAPLETON · 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

    Doreen Stapleton died at Whittington Hospital on 15 September 2016 from a pulmonary thromboembolism, after previously being diagnosed with pulmonary emboli. Following discharge, district nurses were intended to administer daily tinzaparin injections, but the referral was not received because an obsolete email address was used. The principal concern was that Doreen and her sons were not given sufficiently explicit advice about the potentially fatal consequences of missed medication and were not given the district nursing team’s telephone number or told to call if nurses did not attend.

    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 provide explicit discharge advice about the fatal consequences of district nursing visits and medication administration not taking place

    Wider context from the report

    “When she was discharged, although the plan of daily district nursing visits was made clear to her, no member of the team had another very explicit conversation with her or with her two sons, about the potential consequence (i.e. death) of the visits and medication administration not taking place. She and her sons were not given the telephone number of the district nursing team and were not told to ring if nurses failed to attend the following day. I understand that patients are now all given a leaflet with the district nursing team telephone number, but I am concerned that there is still a lack of emphasis on this aspect of discharge advice. I heard from one witness that this is a whole team responsibility. Any member of the team – consultant physician, consultant psychiatrist, discharge nurse – could have had this very direct conversation with Ms Stapleton and her family, but nobody did. I appreciate that there may be a reluctance to be so blunt because of a fear of scaring patients, but any reluctance must be overcome in certain situations if patients are to be supported in the best way possible. Indeed, it had already been overcome by one consultant earlier in Ms Stapleton’s admission. ”

    Source location

    Doreen Elma STAPLETON · 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

    Write to doctors, senior nurses and pharmacists highlighting learning points for embedding in clinical practice.

    Verbatim wording from the response

    “1) ████████ and I, as Director of Nursing and Patient Experience and Executive Medical Director respectively, will write to our doctors and senior nurses and pharmacists to highlight what we think are the key learning points that arise out of your concerns, so that they can consider how to embed these in their clinical practice from now on.”

    Source location

    Doreen-Stapleton-Response-by-Whittington-Health-NHS_Redacted
    Page 1 · response
    Published 5 March 2017

    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

    Share learning with inpatient pharmacists to support patients’ understanding of medication significance at discharge.

    Verbatim wording from the response

    “5) I have asked our Chief Pharmacist to share this learning with all pharmacists on our inpatient wards so that they can make an important contribution to ensuring that patients understand the significance of their medication on discharge.”

    Source location

    Doreen-Stapleton-Response-by-Whittington-Health-NHS_Redacted
    Page 2 · response
    Published 5 March 2017

    Open published response
  4. Berkshire

    AI-generated summary

    Charles Hugh Rendell · 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

    Charles Hugh Rendell, aged 76, underwent a prostate biopsy and was prescribed Ciprofloxacin before being found hanging in a garage on 24 September 2016. The Inquest concluded that he took his own life. The report raises concern that Ciprofloxacin’s potential psychiatric and suicide-related risks, and the symptoms requiring attention, may not be sufficiently communicated to patients and prescribing clinicians.

    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 clearly communicate ciprofloxacin’s potential psychiatric and suicidal effects to patients

    Wider context from the report

    “(2) Ciprofloxacin carries warnings/precautions that, in rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. However, it is unclear how clearly this is made known to Ciprofloxacin users. (3) The literature suggests that this type of side effect can occur even soon after commencing Ciprofloxacin at a comparatively low dose. As it is an antibiotic, there is no compelling reason why patients should expect to have this effect unless this fact, and potential symptoms, are brought clearly to their attention by prescribing clinicians. (4) One of Mr Rendell’s family members is a general practitioner in New Zealand. At the Inquest, she advised that she had no knowledge of the potential effect of Ciprofloxacin and, in conversation with her colleagues, nor did they. I am therefore concerned that this potential risk has not been given sufficient emphasis and that consideration should be given to prescribing clinicians highlighting the symptoms and suggesting to patients that they are alert of the possibility and react appropriately. ”

    Source location

    Charles Hugh Rendell · 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

    Review all UK package leaflets for generic ciprofloxacin products for consistent presentation of the identified safety information.

    Verbatim wording from the response

    “We will review all the UK Package Leaflets for generic ciprofloxacin products to ensure that the information mentioned above is consistently presented across these products.”

    Source location

    2017-0006-Response-by-MHRA
    Page 2 · response
    Published 19 February 2017

    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

    Examine New Zealand Ciproxin product information to verify warnings about possible suicidal behaviour for prescribers and patients.

    Verbatim wording from the response

    “Following receipt of your report however we have examined the New Zealand Data Sheet and CMI for Ciproxin and can confirm that they both contain warnings about the possible risk of suicidal behaviour, directed towards prescribing healthcare professionals and patients respectively.”

    Source location

    2017-0006-Response-by-Bayer-PLC
    Page 6 · response
    Published 19 February 2017

    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

    Review UK product information issued by generic ciprofloxacin manufacturers for adequacy of warnings about suicidal behaviour.

    Verbatim wording from the response

    “In summary, Bayer keeps the product information for its medicines under constant review and, while the data relating to a risk of suicidal behaviour following use of ciprofloxacin are very limited, the UK product information for Ciproxin (both the SmPC and the PIL) includes an appropriate and sufficiently prominent warning to advise prescribers and patients. We recognise that this information is important, but do not believe greater prominence is appropriate, based on the available data and our concern not to detract from other information regarding use of ciprofloxacin. For completeness, we have carried out a review of the UK product information issued by manufacturers of generic formulations of ciprofloxacin and believe that all such information adequately warns prescribers and patients regarding the risk of suicidal behaviour.”

    Source location

    2017-0006-Response-by-Bayer-PLC
    Page 7 · response
    Published 19 February 2017

    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

    Keep Bayer’s product information for its medicines under constant review.

    Verbatim wording from the response

    “In summary, Bayer keeps the product information for its medicines under constant review and, while the data relating to a risk of suicidal behaviour following use of ciprofloxacin are very limited, the UK product information for Ciproxin (both the SmPC and the PIL) includes an appropriate and sufficiently prominent warning to advise prescribers and patients. We recognise that this information is important, but do not believe greater prominence is appropriate, based on the available data and our concern not to detract from other information regarding use of ciprofloxacin. For completeness, we have carried out a review of the UK product information issued by manufacturers of generic formulations of ciprofloxacin and believe that all such information adequately warns prescribers and patients regarding the risk of suicidal behaviour.”

    Source location

    2017-0006-Response-by-Bayer-PLC
    Page 7 · response
    Published 19 February 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

    Existing Ciproxin product information is comprehensive and up to date on psychiatric risks and advises immediate contact with the prescriber.

    Verbatim wording from the response

    “In light of the above, we consider that the product information for Ciproxin provides comprehensive, up-to-date information on the risk of mental disturbances including agitation, confusion, psychosis, depression, suicidal ideation and the possibility of completed suicide. In addition, there is clear advice on the need for immediate contact with the prescribing doctor, should these undesirable effects occur whilst taking Ciproxin.”

    Source location

    2017-0006-Response-by-MHRA
    Page 2 · response
    Published 19 February 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

    Existing UK and New Zealand product information adequately warns prescribers and patients about suicidal behaviour risks, so greater prominence is not appropriate.

    Verbatim wording from the response

    “In summary, Bayer keeps the product information for its medicines under constant review and, while the data relating to a risk of suicidal behaviour following use of ciprofloxacin are very limited, the UK product information for Ciproxin (both the SmPC and the PIL) includes an appropriate and sufficiently prominent warning to advise prescribers and patients. We recognise that this information is important, but do not believe greater prominence is appropriate, based on the available data and our concern not to detract from other information regarding use of ciprofloxacin. For completeness, we have carried out a review of the UK product information issued by manufacturers of generic formulations of ciprofloxacin and believe that all such information adequately warns prescribers and patients regarding the risk of suicidal behaviour.”

    Source location

    2017-0006-Response-by-Bayer-PLC
    Page 7 · response
    Published 19 February 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 content of a generic New Zealand ciprofloxacin product's information cannot be altered because it is controlled by another manufacturer.

    Verbatim wording from the response

    “In contrast, the document which you provided and which was, seemingly, supplied to you by the relative of Mr Rendello who is a general practitioner in New Zealand, is a Data Sheet for a generic version of ciprofloxacin supplied in New Zealand by Multichem NZ Limited (i.e. a formulation of ciprofloxacin that is not manufactured or supplied by Bayer). Bayer does not control the content of the information produced by Multichem. It is relevant that the information contained in this document is less detailed than that in the product information supplied by Bayer in relation to Ciproxin (whether in”

    Source location

    2017-0006-Response-by-Bayer-PLC
    Page 6 · response
    Published 19 February 2017

    Open published response
  5. East London

    AI-generated summary

    EMMA LOUISE BRAY · 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

    Emma Louise Bray had a history of problems with mood and was assessed by mental health services in January 2015 after her mood deteriorated. Her family reported worsening symptoms, hopelessness, suicidal research and concerns about her medication, but several planned referrals, follow-up actions and communication of information did not occur. She hanged herself on 25 February 2015. Concerns included incomplete medication and treatment histories, failures in follow-up and referral, inadequate response to family information, failures to record emails, unclear medication-risk communication, and wider deficiencies in service guidance and monitoring.

    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 communicate medication risks to patients and families

    Wider context from the report

    “During the evidence I was told that a number of things had not happened that ought to have done: (a) A proper medication history was not taken on assessment (b) EB’s treatment and medication history were not obtained from either public or private sector providers. (c) Had EB’s history been obtained she should have been referred to a psychiatrist following assessment, to be seen and assessed within 14 days. (d) ████████ felt that there was an underestimate of the level and complexity of EB’s condition. (e) EB remained with the Intake team for the whole period of her contact with the service. This appears to have occurred because of a failure to make a referral rather than because of any positive decision to retain her within the team. (f) EB should have been referred to an appropriate service, probably initially the BIT. This would have provided her with better support and regular monitoring. (g) Even within the IT there was a failure to follow EB up. Telephone contact should have been made with her by seven days after the initial assessment. (h) There should have been regular contact with EB thereafter, initiated by IT. (i) Important information was provided by EB’s family about the changes in her presentation, most notably on 19 January, 22 January and then from 19 February 2015 onwards. Nothing happened in response to these reports. The information should have been placed before the Intake Team MDT to discuss her care. (j) Had the information been provided EB should have been seen by the team and, in response to the information of 19 February 2015 at the latest, had a psychiatric assessment. (k) The emails sent by EB’s family were not placed on her notes; accordingly other members of staff looking at her care were not aware of the family’s concerns. (l) Risks associated with the drug Sertraline do not appear to have been communicated to EB and her family. Were the drug was recommended by a psychiatrist who had not seen or assessed EB it was unclear where responsibility for advising about risk lay. On a systemic level, the following issues are of concern: (a) Absence of guidelines about what information must be obtained on assessment, including the medication history. (b) Absence of guidance about where that information should be obtained from: the patient / primary sources. (c) A lack of clarity amongst staff about when to retain patients under the IT and when to refer out of it intake to other services. (d) Lack of clarity about who should be the person between patients and the IT. (e) Lack of guidance about what to do when patients are not engaging directly with the IT but there is reason for concern about them. (f) A lack of monitoring / auditing of the passage of patients through the service to see whether cases are being managed and progressed as they ought to be. (g) An absence of guidelines giving staff timescales within which referrals should take place. (h) A lack of appreciation of the need to create a plan with timescales for further treatment / referral to take place. (i) A lack of clear information about the circumstances in which it is appropriate for a psychiatrist to make recommendations about the medication without a full medical history. (j) A lack of clear information about the circumstances in which it is appropriate for a psychiatrist to make recommendations about the medication without seeing the patient in person. (k) A lack of clarity about whose responsibility it is to communicate risks about medication to the individual when the medication is recommended by the WFAAT psychiatrist but prescribed by the GP. This was particularly the case with the Sertraline prescribed to EB, which apparently does have specific associated risks that must be warned of. (l) The lack of apparent process or procedure to ensure that emails sent to staff directly are placed on an individual’s notes. (m) Any proper understanding by staff of risk assessment in the context of self-harm. The risk assessment tool in use appeared very basic and not one that provided any real assistance to staff. ”

    Source location

    EMMA LOUISE BRAY · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  6. West Sussex

    AI-generated summary

    John Hills · 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

    John Hills, a resident of a nursing home, suffered fatal burns after his clothing and blankets caught fire while he was smoking in the conservatory. The report raised concerns about the failure to ensure he was wearing his fire-retardant apron and about insufficient awareness, communication and prevention of the fire risks associated with paraffin-based emollient creams such as Cetraben, particularly in community care settings.

    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 communicate paraffin-emollient fire risk to patients

    Wider context from the report

    “(4) Mr Hills was clearly recorded (in his medical notes) as being a chronic smoker with acute bronchitis. He was also recorded as being a pipe smoker (in his medical records on 13/10/14) yet had a repeat prescription for Cetraben 500 gram being recorded on 11/09/14. There is nothing to evidence that any risk was considered or communicated by either the GP surgery or the prescribing pharmacy. ”

    Source location

    John Hills · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report
  7. South Lincolnshire

    AI-generated summary

    Andre Roderick Stewart MICKLEY · 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

    Andre Roderick Stewart MICKLEY used heroin and cocaine on 17 February 2015, then collapsed with a massive subarachnoid haemorrhage and died on 23 February 2015 despite neurosurgical intervention. The report raised concern about potentially adverse interactions between cocaine and SSRI drugs, and that prescribing information may not prompt consideration of substance misuse or caution about interactions with drugs of misuse.

    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 medicines information to instruct patients to exercise caution and seek advice before using medicines with potential interactions with drugs of misuse

    Wider context from the report

    “1. There are clear potentially adverse pharmacokinetic interactions between Cocaine and the SSRI group of drugs, as well as case reports. (e.g. FU K et al. ). Journal of Analytical Toxicology. 24C7:648-50, 2000). In general, the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL) do not suggest prescribers seek a history of substance misuse or patients exert caution and seek advice before prescribing or using medicines that have the potential to interact adversely with drugs of misuse. This includes adverse interactions other than just those between SSRI and cocaine ”

    Source location

    Andre Roderick Stewart MICKLEY · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  8. North Wales (East and Central)

    AI-generated summary

    Christopher Paul Davies · 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

    Christopher Paul Davies was found unresponsive at home on 5 February 2014 and was verified dead that day; the inquest recorded accidental death, with the cause stated as clozapine poisoning. Concerns were raised that information about possible interactions between clozapine, caffeine and changes in smoking, and about warning signs of toxicity, had not been communicated to the deceased or Community Mental Health Team staff.

    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 communicate the warning signs of clozapine toxicity

    Wider context from the report

    “He stated that although his son’s clozapine levels were being regularly monitored, at no point was he ever made aware of the possible interaction between caffeine or the cessation/reduction of smoking in relation to clozapine levels, nor was he made aware of the possible warning signs of toxicity. It was therefore felt that there should be greater emphasis placed on the sharing of this knowledge with users and with staff within the Community Mental Health Team. It was also felt that due to memory issues, patients should be regularly reminded of this information. ”

    Source location

    Christopher Paul Davies · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report
  9. Exeter and Greater Devon

    AI-generated summary

    Andrew john Hooper · 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

    Andrew John Hooper died after taking methadone prescribed to his girlfriend, with the stated cause of death being respiratory failure, hypoxic brain injury and methadone toxicity. The concerns were that the medication was not secured, was available in a quantity sufficient for a fatal dose, and that the person prescribed it appeared unaware of the risks to others and unable to keep it safe.

    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 awareness of medication dangers when ingested by others

    Wider context from the report

    “(1) The medication was not secured, and was prescribed in sufficient quantity for a fatal dose to be taken by a user un-used to this medication. (bottle 420ml) (2) the person to whom was prescribed appeared to be unaware of the dangers of this medication, when taken by another in large quantities. (3) Consideration should be given to the appropriateness of prescribing to an individual who is not able or prepared to keep the medication safe and secure, or is not aware of the dangers of ingestion, (deliberate or otherwise), for others. If this means daily prescription, the balance of inconvenience versus the safety of others should be carefully weighed on an individual basis, and evidence recorded in this regard. ”

    Source location

    Andrew john Hooper · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report
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Data last updated 7 September 2026