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
Executive non-departmental public body9
NHS trust5
Medicines and medical devices regulator4
Healthcare site3
Type not available3
Integrated care board2
Private limited company2
Clinical commissioning group1
Executive agency1
Health professional body1
Health professional committee1
Health-sector membership body1
Independent healthcare provider1
Ministerial department1
Sub-organisation1
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.
Hertfordshire
Concerns raised1
Lack of warnings to prescribing doctors about tramadol-warfarin interactions
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
West Yorkshire Eastern
Concerns raised2
Failure to highlight the preferred ARB recommendation for patients of Black African or African Caribbean origin in the BNF
Failure to publish the increased ACE inhibitor angioedema risk for people of Black African or African Caribbean origin in the BNF
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
Cornwall and Isles of Scilly
Concerns raised1
Failure of prednisolone guidance to reflect bowel perforation risk in diverticular disease
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.2
Action
Assess BNF information and review literature on bowel perforation risk in patients with diverticular disease.
Stated by BNF PublicationsStated completedThe respondent said that this action was complete when they made their response on 3 May 2023.
Action
Add diverticular disease and increased risk of diverticular perforation to the Cautions section of all corticosteroid monographs in the August online update.
Stated by BNF PublicationsStated plannedThe respondent said that this action was planned when they made their response on 3 May 2023.
County Durham and Darlington
Concerns raised1
Failure of nitrofurantoin prescribing guidance to provide advice on monitoring for sudden pulmonary deterioration during short-term treatment in elderly patients
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.7
Action
Review evidence on nitrofurantoin pulmonary adverse reactions and obtain expert advice on whether product information should be amended.
Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 8 March 2022.
Action
Request marketing authorisation holders to strengthen and prominently emphasise respiratory warnings in nitrofurantoin product information for healthcare professionals and patients.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
Action
Communicate nitrofurantoin product-information updates to the BNF so its monograph can be revised as needed.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
Action
Publish an MHRA Drug Safety Update article informing UK healthcare professionals about nitrofurantoin pulmonary risks, respiratory symptoms, investigation and prompt reporting.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
Action
Alert prescribing clinicians to nitrofurantoin’s serious breathlessness side effects and the need for prompt patient reporting.
Stated by Claypath and University Medical GroupStated completedThe respondent said that this action was complete when they made their response on 8 March 2022.
Action
Write to the Local Medicine Management Team highlighting nitrofurantoin’s life-threatening side effect.
Stated by Claypath and University Medical GroupStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
Action
Update the nitrofurantoin monograph with highlighted information on acute pulmonary reactions, including patient counselling and prompt symptom reporting.
Stated by Royal Pharmaceutical SocietyStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.4
Position
The BNF is outside the MHRA’s responsibility, so the MHRA will not directly amend its monograph.
Stated by Medicines and Healthcare products Regulatory AgencyOutside remitThe respondent said that this matter was outside its role or authority.
Position
The BNF is expected to further revise its nitrofurantoin monograph as needed after receiving updated product information.
Stated by Medicines and Healthcare products Regulatory AgencyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Responsibility for BNF content remains with its publishers, so the matter is outside NICE’s authority to comment on or amend.
Stated by National Institute for Health and Care ExcellenceOutside remitThe respondent said that this matter was outside its role or authority.
Position
The Royal Pharmaceutical Society is better placed to respond to concerns about the BNF entry for nitrofurantoin.
Stated by National Institute for Health and Care ExcellenceRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
County Durham and Darlington
Concerns raised1
Omission of Lamotrigine self-harm or suicide risk from pharmacological information resources
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.4
Action
Add suicidal ideation as a side effect to the lamotrigine monograph.
Stated by Royal Pharmaceutical SocietyStated plannedThe respondent said that this action was planned when they made their response on 26 October 2020.
Action
Add information about suicidal ideation to the lamotrigine monograph’s important safety section.
Stated by Royal Pharmaceutical SocietyStated plannedThe respondent said that this action was planned when they made their response on 26 October 2020.
Action
Update the epilepsy guideline and consider incorporating the coroner’s concerns, including moving the suicidal-thoughts footnote into the recommendation.
Stated by National Institute for Health and Care ExcellenceStated plannedThe respondent said that this action was planned when they made their response on 26 October 2020.
Action
Develop and obtain approval for a Medication Safety Series document on prescribing resources and patient information sources.
Stated by Tees, Esk and Wear Valleys NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 26 October 2020.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3
Position
No longer involved in the Maudsley Prescribing Guidelines and therefore cannot influence their future content.
Stated by Oxleas NHS Foundation TrustUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
Position
Reviewing the content of the British National Formulary is outside NICE’s role and authority.
Stated by National Institute for Health and Care ExcellenceOutside remitThe respondent said that this matter was outside its role or authority.
Position
Responsibility for considering and acting on the BNF content concerns rests with its publishers.
Stated by National Institute for Health and Care ExcellenceRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Inner North London
Concerns raised1
Failure to advise prescribers to reconsider adrenaline auto injector dose after a device switch
This report raised 20 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.8
Action
Disseminate prescribing, dosing, device-change and training guidance for adrenaline auto-injectors through safety bulletins, newsletters, intranet updates, scriptswitch messages and practice events.
Stated by NHS Enfield Clinical Commissioning GroupStated completedThe respondent said that this action was complete when they made their response on 13 August 2020.
Action
Require senior pharmacist approval of scriptswitch messages and GP Clinical Lead approval of newsletters before distribution.
Stated by NHS Enfield Clinical Commissioning GroupStated completedThe respondent said that this action was complete when they made their response on 13 August 2020.
Action
Establish an NCL primary care group to review local formulary and scriptswitch messaging and standardize messages across CCGs.
Stated by NHS Enfield Clinical Commissioning GroupStated completedThe respondent said that this action was complete when they made their response on 13 August 2020.
Action
Implement a post-incident review, produce a report, and submit it to the Quality and Safety Committee to oversee recommendations and implementation.
Stated by NHS Enfield Clinical Commissioning GroupStated plannedThe respondent said that this action was planned when they made their response on 13 August 2020.
Action
Share learning with the CCG medicines management team to support safer AAI prescribing.
Stated by the three G.Ps that were interested persons in the above matterStated completedThe respondent said that this action was complete when they made their response on 13 August 2020.
Action
Amend the ScriptSwitch message with AAI availability, prescribing, dose-checking, counselling, training and allergy-action-plan requirements.
Stated by the three G.Ps that were interested persons in the above matterStated completedThe respondent said that this action was complete when they made their response on 13 August 2020.
Action
Have commissioning teams liaise with relevant organisations to facilitate uptake of new guidance and resources supporting management of severe allergies.
Stated by NHS EnglandStated plannedThe respondent said that this action was planned when they made their response on 13 August 2020.
Action
Consider whether communication routes or commissioning levers can support uptake and embedding of new allergy guidance and resources.
Stated by NHS EnglandStated plannedThe respondent said that this action was planned when they made their response on 13 August 2020.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Position
Matters of concern 1–14 and 20 do not concern NHS Pathways and fall outside its remit.
Stated by NHS EnglandOutside remitThe respondent said that this matter was outside its role or authority.
Position
Information about specific adrenaline auto-injector doses is a prescriber’s responsibility, not the call handler’s.
Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
West Sussex
Concerns raised1
Insufficient BNF clarity about clozapine side effects
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
Bedfordshire and Luton
Concerns raised1
Failure of the BNF to provide caution and monitoring guidance for simultaneous amitriptyline and oxycodone prescribing
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Position
Not all opioid–tricyclic combinations should be stopped because low-dose combinations may be clinically appropriate; risks should be reviewed individually.
Stated by NHS Central East Integrated Care BoardDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
Inner South London
Concerns raised1
Lack of definitive cardiac-monitoring requirements in Carfilzomib prescribing information
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.3
Action
Review the statutory safety information for carfilzomib, cyclophosphamide and dexamethasone and seek pharmacovigilance expert advice on cardiac-arrest risk controls.
Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 8 May 2019.
Action
Publish a Drug Safety Update article reminding prescribers and cardiologists to monitor patients for cardiac disorders before and during carfilzomib treatment.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 8 May 2019.
Action
Continue evaluating SmPC guidance on cardiac monitoring for Kyprolis.
Stated by Amgen LimitedStated in progressThe respondent said that this action was in progress when they made their response on 8 May 2019.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3
Position
Existing statutory product information adequately highlights serious cardiac disorder risks for the medicines concerned.
Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
Existing prescribing information definitively outlines cardiac monitoring guidance, so no further SmPC revisions are required.
Stated by Amgen LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
A unilateral SmPC update based on one case is not possible because extensive medical evidence and stakeholder examination are required.
Stated by Amgen LimitedUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
Birmingham and Solihull
Concerns raised1
Lack of doctors’ awareness of the BNF mobile device app for identifying potential drug interactions
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Publish and circulate a Medicines Newsletter alert promoting use of the BNF App to check drug interactions when clinical-system checking is unavailable.
Stated by NHS Birmingham and Solihull Integrated Care BoardStated completedThe respondent said that this action was complete when they made their response on 19 September 2018.
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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.
