Recurring concern
Unreliable dissemination of safety alerts to relevant recipients
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Request correctionFirst reported 10 Jun 2014•Latest report 17 Feb 2021
What this concern includes
Includes failures in arrangements for identifying recipients, circulating, transmitting, receiving or confirming receipt of safety alerts about medicines, medical devices or comparable patient-safety risks, including national distribution routes and dissemination to pharmacies, private care providers, inspectors and other responsible functions.
Not included
- Excludes failures to act on or implement an alert after it has been reliably received; those concern downstream alert response or safety-action implementation.
- Excludes generic communication, policy dissemination or organisational-learning deficiencies where no safety-alert dissemination process is identified.
- Excludes the substantive content, accuracy or clinical adequacy of an alert unless the deficiency directly prevents reliable dissemination of the alert.
- Excludes ordinary clinical record alerts, system-generated warnings and patient-specific flags where the concern is the operation of that separate alerting system rather than dissemination of safety alerts to relevant organisations or functions.
- Reports
- 5
- Individual concerns
- 5
- Date range
- 2014–2021
- Stated actions
- 7
Distinct published reports
A report can raise multiple concerns
First to latest report issue date
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.
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.
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Concerns raised1
Lack of an effective national procedure for circulating Patient Alerts to pharmacies
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach 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
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Position
NHSEI is responsible for systems oversight of controlled-drug management and use, including the alert system’s operation.
Stated by Department of Health and Social Care
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Concerns raised1
Failure to sustain and nationally reinforce the button-battery safety alert
This report raised 10 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
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Concerns raised1
Failure to provide private community-care companies with alerts about relevant medicines and medical devices
This report raised 8 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach 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
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Action
Continue reviewing methods for communicating important healthcare information to healthcare professionals and the public.
Stated by Medicines and Healthcare products Regulatory Agency
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Concerns raised1
Failure to alert the wider medical community to potential cardiovascular problems with intravenous Buscopan
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach 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
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Action
Revise the Buscopan Ampoules Summary of Product Characteristics to strengthen warnings about serious adverse reactions in patients with cardiac disease.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Communicate the revised Buscopan safety recommendations to healthcare professionals through the MHRA Drug Safety Update newsletter.
Stated by Medicines and Healthcare products Regulatory Agency -
Action
Analyse reported UK deaths suspected to involve Buscopan Ampoules and review the current product information to determine necessary regulatory action.
Stated by Medicines and Healthcare products Regulatory Agency
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Action
Request the Buscopan Ampoules licence holder to revise product information to clarify cardiac risks and recommend monitoring and readily available emergency equipment and trained personnel.
Stated by Medicines and Healthcare products Regulatory Agency
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Concerns raised1
Failure to ensure that CQC inspectors are properly aware of relevant Department of Health alerts
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach 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
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Action
Undertake a detailed review to ensure Regulation 28 reports and other information systematically feed into intelligence monitoring, inspection and registration processes.
Stated by Care Quality Commission -
Action
Discussed the report with the CQC and considered how to ensure Safety Alerts reach appropriate teams.
Stated by Department of Health and Social Care
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
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Position
Primary responsibility for managing patient safety and implementing safety alerts rests with health and social care providers.
Stated by Care Quality Commission
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Position
Providers, rather than the Department or CQC, are responsible for managing patient safety, actioning alerts, and selecting suitable window restrictors.
Stated by Department of Health and Social Care
Data last updated 7 September 2026