Recurring concern

Incomplete medication safety guidance for prescribers

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First reported 29 Apr 2014•Latest report 20 Nov 2023

Definition

What this concern includes

Includes failures of national formularies, prescribing guidelines or clinical decision-support guidance to include, maintain or clearly communicate material medication safety risks, interactions, contraindications or monitoring requirements to prescribers.

Not included

  • Excludes patient-facing product packaging, consumer warnings and general medication information where the deficient recipient is not a prescriber.
  • Excludes unsafe prescribing decisions where applicable medication safety guidance was available and the problem was failure to follow it.
  • Excludes medication administration, dispensing, supply, monitoring or reconciliation failures unless the asserted deficiency is the omission of prescriber-facing medication safety guidance.
  • Excludes guidance for a separately named medication-specific system or hazard where that narrower concern provides the more faithful boundary.
Reports
14

Distinct published reports

Individual concerns
15

A report can raise multiple concerns

Date range
2014–2023

First to latest report issue date

Stated actions
25

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 Excellence6
Medicines and Healthcare products Regulatory Agency4
NHS England4
Advanced Health And Care Limited1
Amgen Limited1
Association of Ambulance Chief Executives1
Bausch & Lomb U.K. Limited1
BNF Publications1
Claypath and University Medical Group1
Department of Health and Social Care1
Informa Healthcare1
King's College Hospital1
King'S College Hospital NHS Foundation Trust1
Lincolnshire Community Health Services NHS Trust1
London Ambulance Service NHS Trust1

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. South Lincolnshire

    AI-generated summary

    Lynn POYSER · 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

    Lynn POYSER had impaired kidney function and was prescribed Lisinopril while already taking Spironolactone. She was admitted to hospital with severe hyperkalaemia and suffered a cardiac arrest from which she could not be resuscitated. The principal concern was whether guidance on co-prescribing these medicines sufficiently emphasised caution, review, and monitoring of renal function and electrolytes.

    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

    Insufficient guidance on care and caution when co-prescribing ACEI drugs and Spironolactone

    Wider context from the report

    “1: Evidence was presented at the inquest to the effect that the interaction between Lisinopril and Spironolactone is well known, and that Lisinopril can precipitate deterioration in a patient's renal function. NICE published guidelines on initiation of Angiotensin converting enzyme inhibitor therapy indicates that patients should be reviewed one to two weeks after initiation of therapy and have their renal function and electrolyte status checked 10 – 14 days after initiation of ACEI therapy. This is re-iterated in LCHS guidance. The expert evidence at the inquest pointed out that, following a report of a trial in 1999 "The Randomised Aldactone Evaluation Study", there was an increase in the co-prescription of Spironolactone and Lisinopril in heart failure, immediately followed by an increase in hospital admissions and subsequent deaths associated with hyperkalaemia. Those to whom I make this report may wish to consider whether or not the current guidance relating to the co-prescription of ACEI drugs, such as Lisinopril, and Spironolactone draws sufficient attention to the need for care and caution and the need to take a holistic view of the best interests of the patient. ”

    Source location

    Lynn POYSER · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

  2. 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 prompt prescribers to seek a history of substance 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

  3. Portsmouth and South East Hampshire

    AI-generated summary

    George Stone · 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

    George Stone suffered from long-term depressive illness and ended his own life on 19 November 2012 after a grand mal seizure following treatment with Venlafaxine. The concern was that severe seizures are a rare side effect of Venlafaxine and similar antidepressants, but the national warning guidelines did not then include the risk of severe seizures.

    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 inclusion of the risk of severe seizures in prescribing warnings for venlafaxine and similar antidepressants

    Wider context from the report

    “I was told in evidence at the Inquest that a side effect of Venlafaxine and similar antidepressants is seizures and that although this is rare, these seizures can be very severe - as was the case with George Stone. I was also told that the NPSA issues national guidelines for the warnings practitioners must give their patients who are prescribed these sorts of antidepressants but the risk of patients suffering a severe seizure is not included in the guidelines at the present time. ”

    Source location

    George Stone · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

  4. Avon

    AI-generated summary

    Dafydd Rhys WATTS · 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

    Dafydd Rhys WATTS died of eosinophilic pericarditis and DRESS syndrome following treatment with levetiracetam for epilepsy. The report raised concern that the possibility of this exceptionally rare reaction and death was not drawn to physicians’ attention in the drug literature or BNF entry.

    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 draw physicians’ attention to the possibility of such an occurrence in drug literature or BNF entries

    Wider context from the report

    “Although the evidence suggests that this is only the fourth such death documented it appears that the possibility (albeit remote) of such an occurrence is not drawn to physicians attention in the drug literature or in the BNF entry. ”

    Source location

    Dafydd Rhys WATTS · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report
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Data last updated 7 September 2026