Reporting of adverse events or adverse reaction to medication by Trusts in the UK

The request was successful.

Dear NHS Improvement,

I recently sent a freedom of information request to Southern Health NHS Foundation Trust about this topic.

This is the reply I received from them

FOI2245- Concerning additional incident reporting to the MHRA.

We can confirm that Southern Health NHS Foundation Trust can advise as follows in response to your Freedom of Information request.

Please can you confirm if there are any other internal methods used by Health Care Professionals at Southern Health to report side effects or adverse reactions to medication to the MHRA?

If there are internal methods of reporting such events please can you supply the number of reports each year that have been recorded by this manner?

As per the cover email, kindly refer to the additional information provided in our revised response to your previous request (FOI2082) alongside the information below.

There are no other internal methods used by Southern Health staff to report side effects or adverse reactions to medications to the MHRA other than the yellow card system.

That said, all the incidents that the Trust reports on Ulysses (which will include adverse reactions to medications) are uploaded to the National Reporting and Learning System (NRLS) which is managed by NHS Improvement, who may, in accordance with their own reporting protocols, provide incident data to the MHRA.

The Trust is not sighted on whether this is part of their function or not and we do not hold any information concerning possible reports from NRLS to the MHRA. You may wish to submit a Freedom of Information request to NHS Improvement, to establish whether there is any reporting done by them in this way.

.....................................................................................................................................................

Please can you confirm if NHS Improvement do hold information about the reporting of side effects or adverse drug reactions on the NRLS from Southern Health and do you report this information to the MHRA or the European Medicines Agency as part of your protocols.

If you hold information about Southern Health reports for side effects and adverse drug reactions on the NRLS system please can you supply details of number of reports, severity of side effects or drug reactions. Were these events passed to the NRLS or the EMA.

Thanks

Yours faithfully,

R West

FOI (NHS IMPROVEMENT - T1520), NHS Improvement

Dear Ms West

 

Thank you for your email dated 9 September 2018.

 

You have forwarded to us a response you received from Southern Health NHS
Foundation Trust. Please can you outline as clearly as possible the
information you are requesting from NHS Improvement?

 

This will ensure it gets handled by the appropriate teams and in a timely
manner.

 

We look forward to hearing from you.

 

Yours sincerely

 

NHS Improvement

T 0203 747 0000
W [1]improvement.nhs.uk
Wellington House, 133-155 Waterloo Road, London SE1 8UG

 

Follow us on: [2]Twitter | [3]LinkedIn

 

NHS Improvement is responsible for overseeing foundation trusts, NHS
trusts and independent providers. We offer the support these providers
need to give patients consistently safe, high quality, compassionate care
within local health systems that are financially sustainable. By holding
providers to account and, where necessary, intervening, we help the NHS to
meet its short-term challenges and secure its future.

 

NHS Improvement is the operational name for the organisation that brings
together Monitor, NHS Trust Development Authority, Patient Safety, the
National Reporting and Learning System, the Advancing Change team and the
Intensive Support Teams.

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FOI (NHS IMPROVEMENT - T1520), NHS Improvement

Dear Ms West

 

Please can you confirm the information you are requesting rom NHS
Improvement so we are able to process your request.

 

We look forward to hearing from you.

 

Yours sincerely

 

NHS Improvement

T 0203 747 0000
W [1]improvement.nhs.uk
Wellington House, 133-155 Waterloo Road, London SE1 8UG

 

Follow us on: [2]Twitter | [3]LinkedIn

 

NHS Improvement is responsible for overseeing foundation trusts, NHS
trusts and independent providers. We offer the support these providers
need to give patients consistently safe, high quality, compassionate care
within local health systems that are financially sustainable. By holding
providers to account and, where necessary, intervening, we help the NHS to
meet its short-term challenges and secure its future.

 

NHS Improvement is the operational name for the organisation that brings
together Monitor, NHS Trust Development Authority, Patient Safety, the
National Reporting and Learning System, the Advancing Change team and the
Intensive Support Teams.

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From: FOI (NHS IMPROVEMENT - T1520)
Sent: 10 September 2018 16:52
To: 'R West' <[FOI #518730 email]>
Subject: RE: Freedom of Information request - Reporting of adverse events
or adverse reaction to medication by Trusts in the UK

 

Dear Ms West

 

Thank you for your email dated 9 September 2018.

 

You have forwarded to us a response you received from Southern Health NHS
Foundation Trust. Please can you outline as clearly as possible the
information you are requesting from NHS Improvement?

 

This will ensure it gets handled by the appropriate teams and in a timely
manner.

 

We look forward to hearing from you.

 

Yours sincerely

 

NHS Improvement

T 0203 747 0000
W [4]improvement.nhs.uk
Wellington House, 133-155 Waterloo Road, London SE1 8UG

 

Follow us on: [5]Twitter | [6]LinkedIn

 

NHS Improvement is responsible for overseeing foundation trusts, NHS
trusts and independent providers. We offer the support these providers
need to give patients consistently safe, high quality, compassionate care
within local health systems that are financially sustainable. By holding
providers to account and, where necessary, intervening, we help the NHS to
meet its short-term challenges and secure its future.

 

NHS Improvement is the operational name for the organisation that brings
together Monitor, NHS Trust Development Authority, Patient Safety, the
National Reporting and Learning System, the Advancing Change team and the
Intensive Support Teams.

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Dear FOI (NHS IMPROVEMENT - T1520),

I thought the request was simple enough but here is what I am asking please.

Please can you confirm if NHS Improvement do hold information about the reporting of side effects or adverse drug reactions on the NRLS system from NHS Trusts and do you report this information to the MHRA or the European Medicines Agency as part of your protocols or what you do with these reports.

Southern Health NHS Trust have indicated that they report side effects and adverse drug reactions via the NRLS system to you when these occur.

If you hold information about Southern Health reports for side effects and adverse drug reactions on the NRLS system please can you supply details of number of reports, severity of side effects or drug reactions you have received from them for each of the last 5 years. Were these events passed to the MHRA or the European Medicines Agency.

Yours sincerely,

R West

FOI (NHS IMPROVEMENT - T1520), NHS Improvement

Dear Ms West,

 

Receipt of your request for information by email dated 14 September 2018
is acknowledged.

 

NHS Improvement will respond promptly to your request within 20 working
days following the date of receipt, so by 12 October 2018.

 

Yours sincerely,

 

NHS Improvement

 

Follow us on: [1]Twitter | [2]LinkedIn

 

NHS Improvement is responsible for overseeing foundation trusts, NHS
trusts and independent providers. We offer the support these providers
need to give patients consistently safe, high quality, compassionate care
within local health systems that are financially sustainable. By holding
providers to account and, where necessary, intervening, we help the NHS to
meet its short-term challenges and secure its future.

 

NHS Improvement is the operational name for the organisation that brings
together Monitor, NHS Trust Development Authority, Patient Safety, the
National Reporting and Learning System, the Advancing Change team and the
Intensive Support Teams.

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FOI (NHS IMPROVEMENT - T1520), NHS Improvement

2 Attachments

Dear R West,

 

Please see the attached decision letter dated 10 October 2018.

 

Yours sincerely

 

NHS Improvement

T 0203 747 0000
W [1]improvement.nhs.uk
Wellington House, 133-155 Waterloo Road, London SE1 8UG

 

Follow us on: [2]Twitter | [3]LinkedIn

 

NHS Improvement is responsible for overseeing foundation trusts, NHS
trusts and independent providers. We offer the support these providers
need to give patients consistently safe, high quality, compassionate care
within local health systems that are financially sustainable. By holding
providers to account and, where necessary, intervening, we help the NHS to
meet its short-term challenges and secure its future.

 

NHS Improvement is the operational name for the organisation that brings
together Monitor, NHS Trust Development Authority, Patient Safety, the
National Reporting and Learning System, the Advancing Change team and the
Intensive Support Teams.

show quoted sections

 

 

 

 

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Dear FOI (NHS IMPROVEMENT - T1520),

Thank you very much for the information you have provided. It is very useful

King Regards

Yours sincerely,

R West

Dear FOI (NHS IMPROVEMENT - T1520),

Thanks for all the info

Yours sincerely,

R West