Items which should not be routinely prescribed in primary care MLCSU Consultation Report

James Kelly made this Freedom of Information request to Midlands and Lancashire Commissioning Support Unit

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was partially successful.

Dear Midlands and Lancashire Commissioning Support Unit,

My FOI request relates to a report you prepared for NHS / NHSCC "Items which should not be routinely prescribed in primary care Consultation Report'

Background to My Request

**THE UK HAD SUCESSFULY IMPORTED CO-PROXAMOL FROM MHRA’s APPROVED MANUFACTURERS FROM THE TWO COUNTRY’S THAT OVERTURNED THE LUDICROUS
BAN ON CO-PROXAMOL!

I have no doubt that Co-proxamol could have been imported from any of the Indian Manufacturers from February 2017 (nine months before your report was first published) for approximately £5.00 per 100 tablets and would have saved the ‘Named Patient Facility’ for the patients that relied on it, and the NHS millions of pounds!

Clinical evidence, Re: - Effectiveness of Co-proxamol
***Dr Munir Pirmohamed, Professor of Molecular, and Clinical Pharmacology at the University of Liverpool, in reply to an enquiry:-

“Codeine is a pro-drug and it is converted in the body to morphine which is what leads to the pain relief. This conversion is undertaken by an enzyme called CYP2D6, which is absent in about 7-8% of the UK population. Thus, if you lack the enzyme, you cannot convert codeine to morphine, you do not get pain relief.
In relation to dextropropoxyphene:
(a) It is not a pro-drug and is supposed to act directly;
(b) It is not broken down by the same enzyme as codeine (CYP2D6) and thus will not be liable to the same issues as codeine; and
(c) It is broken down by another enzyme called CYP3A4, which varies in the body, but all people have the enzyme.”
In other words, if you are genetically unable to produce the enzyme to metabolise it, codeine will do nothing for you. We have to make clear Co-proxamol, being easily metabolised and direct acting, is a valuable treatment or we will lose it!
MHRA were fully aware of the Hanks / Forbes report and the problem with enzyme CYP2D6, at the time they announced the removal of the MA’s for Co-proxamol which resulted with 122,500 patients without any appropriate pain relief! (7% of 1.75 Million patients being prescribed Co-proxamol in 2005)!

FOI Questions

1) The report states that there were 2638 responses received from patients over the
eighteen products you researched.
1a) How many of the patient responses were there regarding Co-proxamol
alone?
1b) How did the patients become aware of your report in order for them to
respond?
1c) How many ‘Named Patients’ did you contact for a response?
1d) If the answer to c) is none please could explain why not?

2) The second highest responses came from members of the public (1200)
2a) How many of the public responses were there regarding Co-proxamol alone?
2b) How did the public become aware of your report in order for them to respond?
2c) How many members of the public who responded did you contact for a
response regarding Co-proxamol?
3) When you prepared this report for NHSCC / NHS were you aware that the Indian
Government had reversed their decision to ban the use and production of
Dextropropoxyphene Combination based products following the collapse of their
Palliative Care regime?
3a) Were you aware that Co-proxamol was available for import from India
for approximately £5.00 per 100 tablets from February 2017?
3b) Were you aware that most of the Co-proxamol prescribed to the ‘Named
Patients’ during the period May 2008 to January 2016 was supplied by Indian
Company’s?

4) Were you aware of the report produced by Dr Munir Pirmohamed which would
have left approximately 122,500 patients without any appropriate pain relief from the
time of the first announcement of the ban during 2005? MHRA were certainly aware
of the problems with enzyme CYP2D6 at that time (7% of 1.75 Million patients being
prescribed Co-proxamol during 2005)
5) ****Why is NHS Chorley and South Ribble CCG continuing to pay over £100 .00 per
box for Co-proxamol?
I look forward to your response within the next 20 working day's.

Yours faithfully,

James Kelly

CONTACTUS, England (NHS ENGLAND), Midlands and Lancashire Commissioning Support Unit

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FOI, England (NHS ENGLAND), Midlands and Lancashire Commissioning Support Unit

Dear James Kelly,

 

Freedom of Information Request Acknowledgement (Our Ref: FOI-058121)

 

Thank you for your communication dated 21 December 2018.

 

NHS England has assessed your communication as a request under the Freedom
of Information (FOI) Act 2000. As such, please be assured that your
request is being dealt with under the terms of the FOI Act and will be
answered within twenty working days.

 

For further information regarding the FOI Act, please refer to the
Information Commissioner’s Office (ICO) website. For further information
regarding NHS England and the information it publishes please visit our
website here.

 

If you have any queries about this request or wish to contact us again,
please email [1][Midlands and Lancashire Commissioning Support Unit request email] and the message will be
forwarded appropriately. Please remember to quote the above reference
number in any future communications.

 

Please do not reply to this email. This message has been sent from a
central mailbox. To communicate with NHS England regarding Freedom of
Information (FOI) requests, enquiries or complaints we ask these are sent
directly to NHS England’s customer contact centre. This is to ensure all
communications are progressed correctly. Their postal address, telephone
number and email details are as follows:- PO Box 16738, Redditch, B97 9PT;
0300 3 11 22 33, [2][Midlands and Lancashire Commissioning Support Unit request email].

 

Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [3][Midlands and Lancashire Commissioning Support Unit request email]

 

‘Health and High quality care for all, now and for future generations’

show quoted sections

Dear FOI, England (NHS ENGLAND),
Copy of your email: -

Re: NHS England correspondence
Mon, 14 Jan 2019 16:30
FOI, England (NHS ENGLAND) [email address]
To [email address]

Dear James Kelly,

Re: NHS England correspondence

Thank you for your correspondence dated 24 December 2018.
Your correspondence read:

My FOI request relates to a report prepared by* Midlands and Lancashire Commissioning Support Unit, for NHS / NHSCC "Items which should not be routinely prescribed in primary care

FOI Questions

1) The report states that there were 2638 responses received from patients over the eighteen products you researched.

1a) How many of the patient responses were there regarding Co-proxamol alone?
1b) How did the patients become aware of your report in order for them to respond
1c) How many ‘Named Patients’ did you contact for a response?
1d) If the answer to c) is none please could explain why not?

2) The second highest responses came from members of the public (1200)

2a) How many of the public responses were there regarding Co-proxamol alone?
2b) How did the public become aware of your report in order for them to respond?
2c) How many members of the public who responded did you contact for a response regarding Co-proxamol?

3) When you prepared this report for NHSCC / NHS were you aware that the Indian Government had reversed their decision to ban the use and production of Dextropropoxyphene Combination based products following the collapse of their Palliative Care regime?

3a) Were you aware that Co-proxamol was available for import from India for approximately £5.00 per 100 tablets from February 2017?
3b) Were you aware that most of the Co-proxamol prescribed to the ‘Named Patients’ during the period May 2008 to January 2016 was supplied by Indian Company’s?

4) Were you aware of the report produced by Dr Munir Pirmohamed which would have left approximately 122,500 patients without any appropriate pain relief from the time of the first announcement of the ban during 2005? MHRA were certainly aware of the problems with enzyme CYP2D6 at that time (7% of 1.75 Million patients being prescribed Co-proxamol during 2005)

5) ****Why is NHS Chorley and South Ribble CCG continuing to pay over £100.00 per box for Co-proxamol?

NHS England is not, at this stage, able to proceed with your enquiry under the (FOI) Act, as your request is unclear.

We would be grateful if you could clarify the following points in relation to questions one and two of your request.

• Please clarify whether you are asking for information in respect of the number of respondents which answered the co-proxamol questions or whether you are requesting information about responses where the respondents provided responses regarding co-proxamol alone (i.e did not answer questions on the other medicines in the consultation).

As set out at Section 1(3) of the FOI Act, when further information is required in order to identify and locate the information requested, and the applicant has been informed, no further action is required until the additional information has been received.

Please send your clarified request to [email address].

Once received, NHS England will write to acknowledge receipt of your request and to provide you with a reference number. Please note that the 20 working day timeframe for complying with an FOI request does not commence until the above information is provided.

It may assist you to know that information in relation to the report, including the breakdown of responses to the closed questions for each of the products, including Co-Proxamol, is published within Annex 7, page 57 of the Items which should not be routinely prescribed in primary care: Consultation Report of Findings (Nov 2017) which can be viewed here.

Please note that CSUs are NHS England hosted bodies, and as such all FOI requests for CSU information should be directed [email address] in the first instance. This is to ensure efficient processing of your request.

Please do not reply to this email. This message has been sent from a central mailbox. To communicate with NHS England regarding Freedom of Information (FOI) requests, enquiries or complaints we ask these are sent directly to NHS England’s customer contact centre. This is to ensure all communications are progressed correctly. Their postal address, telephone number and email details are as follows:- PO Box 16738, Redditch, B97 9PT; 0300 3 11 22 33, [email address].

Yours sincerely,

Freedom of Information
Corporate Communications Team
Patients and Information Directorate

NHS England
PO Box 16738
REDDITCH
B97 9PT

Tel: 0300 311 22 33
Email: [email address]
_____________________________________________

I thought my questions were succinct and I’m left wondering if your response is merely a delaying tactic.

Regarding "Please clarify whether you are asking for information in respect of the number of respondents which answered the co-proxamol questions" I have been able to find the numbers on page 57 Annexe 7.

Re: Items which should not be routinely prescribed in primary care Consultation Report of Findings (Nov 2017) Annex 7, page 57

Q3. That in exceptional circumstances if there is a clinical need for Co-proxamol to be prescribed in primary care this should be undertaken in cooperation arrangement with a multidisciplinary team and/or other healthcare professional

491 Patients responded 63% were in favour of retaining Co-proxamol in exceptional circumstances. I would think that ‘Named Patients’ would fall into this Category.

318 Members of the public responded 59% were in favour of retaining Co-proxamol in exceptional circumstances.
Questions 1b, 1c, 1d, 2b, 2c, 3, 3a, 3b, 4 and 5 remain unanswered. I would appreciate a full response by January 24 in line with my original request

Yours sincerely,

James Kelly

FOI, England (NHS ENGLAND), Midlands and Lancashire Commissioning Support Unit

Dear James Kelly,

 

Freedom of Information Request Acknowledgement (Our Ref: FOI-058283)

 

Thank you for your communication dated 15 January 2019.

 

NHS England has assessed your communication as a request under the Freedom
of Information (FOI) Act 2000. As such, please be assured that your
request is being dealt with under the terms of the FOI Act and will be
answered within twenty working days.

 

For further information regarding the FOI Act, please refer to the
Information Commissioner’s Office (ICO) website. For further information
regarding NHS England and the information it publishes please visit our
website here.

 

If you have any queries about this request or wish to contact us again,
please email [1][Midlands and Lancashire Commissioning Support Unit request email] and the message will be
forwarded appropriately. Please remember to quote the above reference
number in any future communications.

 

Please do not reply to this email. This message has been sent from a
central mailbox. To communicate with NHS England regarding Freedom of
Information (FOI) requests, enquiries or complaints we ask these are sent
directly to NHS England’s customer contact centre. This is to ensure all
communications are progressed correctly. Their postal address, telephone
number and email details are as follows:- PO Box 16738, Redditch, B97 9PT;
0300 3 11 22 33, [2][Midlands and Lancashire Commissioning Support Unit request email].

 

Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [3][Midlands and Lancashire Commissioning Support Unit request email]

 

‘Health and High quality care for all, now and for future generations’

show quoted sections

FOI, England (NHS ENGLAND), Midlands and Lancashire Commissioning Support Unit

Dear James Kelly,

 

Re:      Freedom of Information request (Our Ref: FOI-058283)

 

Thank you for your clarified Freedom of Information (FOI) request dated 14
January 2019

 

Your exact request was:-

 

“Clarified Request:

 

Regarding "Please clarify whether you are asking for information in
respect of the number of respondents which answered the co-proxamol
questions" I have been able to find the numbers on page 57 Annexe 7.

 

Re: Items which should not be routinely prescribed in primary care
Consultation Report of Findings (Nov 2017) Annex 7, page 57

 

Q3. That in exceptional circumstances if there is a clinical need for
Co-proxamol to be prescribed in primary care this should be undertaken in
cooperation arrangement with a multidisciplinary team and/or other
healthcare professional

 

491 Patients responded 63% were in favour of retaining Co-proxamol in
exceptional circumstances. I would think that ‘Named Patients’ would fall
into this Category.

 

318 Members of the public responded 59% were in favour of retaining
Co-proxamol in exceptional circumstances.

Questions 1b, 1c, 1d, 2b, 2c, 3, 3a, 3b, 4 and 5 remain unanswered. I
would appreciate a full response by January 24 in line with my original
request

 

Original request:

 

1) The report states that there were 2638 responses received from patients
over the eighteen products you researched.

 

1a) How many of the patient responses were there regarding Co-proxamol
alone?

1b) How did the patients become aware of your report in order for them to
respond

1c) How many ‘Named Patients’ did you contact for a response?

1d) If the answer to c) is none please could explain why not?

 

2) The second highest responses came from members of the public (1200)

2a) How many of the public responses were there regarding Co-proxamol
alone?

2b) How did the public become aware of your report in order for them to
respond?

2c) How many members of the public who responded did you contact for a
response regarding Co-proxamol?

 

3) When you prepared this report for NHSCC / NHS were you aware that the
Indian Government had reversed their decision to ban the use and
production of Dextropropoxyphene Combination based products following the
collapse of their Palliative Care regime?

3a) Were you aware that Co-proxamol was available for import from India
for approximately £5.00 per 100 tablets from February 2017?

3b) Were you aware that most of the Co-proxamol prescribed to the ‘Named
Patients’ during the period May 2008 to January 2016 was supplied by
Indian Company’s?

 

4) Were you aware of the report produced by Dr Munir Pirmohamed which
would have left approximately 122,500 patients without any appropriate
pain relief from the time of the first announcement of the ban during
2005? MHRA were certainly aware of the problems with enzyme CYP2D6 at that
time (7% of 1.75 Million patients being prescribed Co-proxamol during
2005)

 

5) ****Why is NHS Chorley and South Ribble CCG continuing to pay over
£100.00 per box for Co-proxamol?”

NHS England holds some recorded information in relation to this request.

 

1b) How did the patients become aware of your report in order for them to
respond

 

Patients were informed of the consultation through general and targeted
communications and engagement with relevant stakeholders via a variety of
mechanisms e.g. emails, newsletters, bulletins, social media and face to
face meetings. Patients had an opportunity to feedback through an online
survey, written correspondence, face to face and online meetings. Patients
were also able to email or post written responses.

 

1c) How many ‘Named Patients’ did you contact for a response?

 

NHS England did not directly contact any named patients for a response.

 

1d) If the answer to c) is none please could explain why not?

 

The communication and engagement plan ensured that appropriate stakeholder
groups were aware and able to share the consultation with patients e.g.
pain charities, national and local Healthwatch. Clinical Commissioning
groups were also encouraged to send in results of local patient
engagement.

 

2) The second highest responses came from members of the public (1200)

2b) How did the public become aware of your report in order for them to
respond?

 

A communications and engagement plan was delivered to ensure that the
consultation was effectively promoted with the public. Members of the
public had an opportunity to feedback via an online survey, written
correspondence, face to face and online meetings. Patients were also able
to email or post a written response.

 

2c) How many members of the public who responded did you contact for a
response regarding Co-proxamol?

 

NHS England did not follow up any members of the public who responded to
the consultation on co-proxamol.

 

3) When you prepared this report for NHSCC / NHS were you aware that the
Indian Government had reversed their decision to ban the use and
production of Dextropropoxyphene Combination based products following the
collapse of their Palliative Care regime?

 

In reaching its recommendations for the 18 products listed in the CCG
guidance (including co-proxamol), the group considered recommendations
from NICE. Where NICE guidance was not available the group considered
evidence from a range of sources, for example; the Medicines and
Healthcare products Regulatory Agency (MHRA), the British National
Formulary, the Specialist Pharmacist Service and PrescQIPP Community
Interest Company (CIC) evidence reviews. Further information on how the
recommendations in this guidance been developed can be found in the CCG
guidance which is available on the NHS England website:

 

[1]https://www.england.nhs.uk/wp-content/up...

 

3a) Were you aware that Co-proxamol was available for import from India
for approximately £5.00 per 100 tablets from February 2017?

3b) Were you aware that most of the Co-proxamol prescribed to the ‘Named
Patients’ during the period May 2008 to January 2016 was supplied by
Indian Company’s?

 

This information was not considered as the recommendations on co-proxamol
were based on the safety of the medicine.

 

4) Were you aware of the report produced by Dr Munir Pirmohamed which
would have left approximately 122,500 patients without any appropriate
pain relief from the time of the first announcement of the ban during
2005? MHRA were certainly aware of the problems with enzyme CYP2D6 at that
time (7% of 1.75 Million patients being prescribed Co-proxamol during
2005)

 

This report was not considered in development of the recommendations on
co-proxamol.

 

5) ****Why is NHS Chorley and South Ribble CCG continuing to pay over
£100.00 per box for Co-proxamol?”

 

NHS England does not hold information in relation to this question.
Information may be held by NHS Chorley and South Ribble CCG, we have
provided their contact details below for your convenience;

 

By Email:       [2][email address]

 

By Writing:     Customer Care Team - Chorley and South Ribble CCG
Chorley House
Lancashire Business Park
Centurion Way
Leyland
Lancashire
PR26 6TT

 

Copyright:- NHS England operates under the terms of the open government
licence. Please see the NHS England Terms and conditions on the following
link [3]http://www.england.nhs.uk/terms-and-cond...

 

We hope this information is helpful. However, if you are dissatisfied, you
have the right to ask for an internal review. This should be requested in
writing within two months of the date of this letter. Your correspondence
should be labelled “Internal Review” and should outline your concerns
and/or the area(s) you would like the review to consider. Internal Review
requests should be sent to:

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Email: [4][Midlands and Lancashire Commissioning Support Unit request email]

 

Please quote the reference number FOI-058283 in any future communications.

 

If you are not content with the outcome of the internal review, you have
the right to apply directly to the Information Commissioner for a
decision. The Information Commissioner’s Office (ICO) can be contacted at:

 

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

Telephone: 0303 123 1113

Email: [5][email address]  

Website: [6]www.ico.org.uk

 

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Please be aware that in line with the Information Commissioner’s directive
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Please do not reply to this email. This message has been sent from a
central mailbox. To communicate with NHS England regarding Freedom of
Information (FOI) requests, enquiries or complaints we ask these are sent
directly to NHS England’s customer contact centre. This is to ensure all
communications are progressed correctly. Their postal address, telephone
number and email details are as follows:- PO Box 16738, Redditch, B97 9PT;
0300 3 11 22 33, [7][Midlands and Lancashire Commissioning Support Unit request email].

 

Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [8][Midlands and Lancashire Commissioning Support Unit request email]

 

‘Health and high quality care for all, now and for future generations’

 

show quoted sections

Dear Midlands and Lancashire Commissioning Support Unit,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Midlands and Lancashire Commissioning Support Unit's handling of my FOI request 'Items which should not be routinely prescribed in primary care MLCSU Consultation Report'.

I'm applying for an internal review for the following reasons: - There Has Been A Total Lack of Due Diligence In Your Research and Response!

1b) How did the patients become aware of your report in order for them to respond

Patients were informed of the consultation through general and targeted communications and engagement with relevant stakeholders via a variety of mechanisms e.g. emails, newsletters, bulletins, social media and face to face meetings. Patients had an opportunity to feedback through an online survey, written correspondence, face to face and online meetings. Patients were also able to email or post written responses.

I'm probably the most involved person in the UK regarding Co-proxamol and I certainly wasn't aware of this consultation until the date your findings were published!

1.75 million Patients have suffered through the totally unnecessary ban on co-proxamol I doubt any of these patients were aware of your consultation!

1c) How many ‘Named Patients’ did you contact for a response?

NHS England did not directly contact any named patients for a response.

As this group of patients would be the most affected group, your decision not to invite their views was absolutely negligent on your part!

2) The second highest responses came from members of the public (1200)

2b) How did the public become aware of your report in order for them to respond?

A communications and engagement plan was delivered to ensure that the consultation was effectively promoted with the public. Members of the public had an opportunity to feedback via an online survey, written correspondence, face to face and online meetings. Patients were also able to email or post a written response.

2c) How many members of the public who responded did you contact for a response regarding Co-proxamol?

NHS England did not follow up any members of the public who responded to the consultation on co-proxamol.

My question was regarding the members of the public you may have initially contacted, not followed up. Again I certainly wasn't aware of the consultation until the date your findings were published!

3) When you prepared this report for NHSCC / NHS were you aware that the Indian Government had reversed their decision to ban the use and production of Dextropropoxyphene Combination based products following the collapse of their Palliative Care regime?

In reaching its recommendations for the 18 products listed in the CCG guidance (including co-proxamol), the group considered recommendations from NICE. Where NICE guidance was not available the group considered evidence from a range of sources, for example; the Medicines and Healthcare products Regulatory Agency (MHRA), the British National Formulary, the Specialist Pharmacist Service, and PrescQIPP Community Interest Company (CIC) evidence reviews. Further information on how the recommendations in this guidance had been developed can be found in the CCG guidance which is available on the NHS England website:

NICE website states: - NICE evidence summaries
Summaries of the best available evidence to inform local NHS planning and decision-making, for selected new medicines, off-label use of licensed medicines and unlicensed medicines.

I maintain NICE took MHRA's initial reasoning for the ban at face value! They never took into consideration the pro Co-proxamol evidence or challanged MHRA's reasoning. (See attachment) [Reply to NICE Reference No: EH79182]

My opinion is there was a complete lack of 'due diligence' by your committee completely ignoring the fact that Co-proxamol could have been imported for approximately £5.00 for 100 tablets since February 2017 and the very important report by Dr Munir Pirmohamed. You will see in the attached file [Reply to NICE [Reference No: EH79182] NHS, NHSCC, PrescQipp, and all CCG's have failed to question the acceptability of the Co-proxamol ban!

Effectiveness: -
Co-proxamol is effective in chronic pain!

https://www.ncbi.nlm.nih.gov/pmc/article...

Hanks Forbes report published during 1998, stated “Co-proxamol was very effective in ‘Palliative Care.” If it was proved that it was effective for end of life pain, it would be an exceptionally effective drug for arthritic pain! (Which it was)

The situation in India during 2013 corroborates beyond any doubt that the Hanks Forbes report was 100% correct on the efficacy of Co-proxamol, and MHRA was completely wrong in its recommendation’s!

India was the last country to ban Co- proxamol and its production during 2013. It wasn’t a surprise when this resulted in the collapse of their palliative care system and the decision was overturned very quickly! Co-proxamol was the most effective analgesic in the UK for over 50 years prior to 2005.

The following refers to the attached file [Reply to NICE Reference No: EH79182] (Please read in full)

Page17
The UK suicide rates were already declining for Co-proxamol while the drug was classed as a POM prior to the ban. Suicide/Open reports had reduced from 296 in 2000 to just 204 in 2004 A 7% REDUCTIONS HAD BEEN ACHEIVED! Further reductions could have been guaranteed by simply changing the drug classification to ‘Shedule 3 controlled’. I feel sure if the classification had been changed Co-proxamol would have remained on the market today at a very completive price for the NHS! (2000 - 2004) the chart below clearly shows a 7% reduction in Co-proxamol Suicides prior to the ban being announced! This fact contradicts MHRA's reasoning!

Page 2
According to a FDA report [Page 16 Fig 1] produced between 1969 and 2005 there were; 10671 more adverse event reports, 3256 more overdose reports, 437 more suicide reports, 5041 more abuse & dependence reports, and the total number of death reports increased by 5059 when Oxycodone was compared with Propoxyphene (Co-proxamol)!

Between 2005 and 2015 MHRA issued an additional 138 ‘Marketing Authorisations’ for Oxycodone.

DISPITE THIS STUDY BEING COMPLETED BY 2005 THE UK GOVERNMENT SHOWED A TOTAL DISRESPECT FOR PATIENT SAFETY AND WELLBEING BY SIMPLY ACCEPTING THE RESULTS OF THE FLAWED CSM / MHRA CALL FOR EVIDENCE REPORT WHICH HAD BEEN TOTALLY DEVOID OF ANY DUE DILIGENCE!’ THE TOTAL RESPONSE FOR THIS REPORT WAS JUST A MEAGRE 14.7%!

Deaths in the UK from all of the alternate analgesia have increased alarmingly since the MA’s for Co-proxamol were removed!

• Deaths from Tramadol rose from 53 in 2005 to 240 in 2014 +187
• Deaths from Oxycodone rose from 11 in 2005 to 53 in 2014 + 42
• Deaths from Codeine rose from 44 in 2005 to 136 in 2014 + 92
• Deaths from Fentanyl rose from 3 in 2005 to 40 in 2014 + 37
• Deaths from Buprenorphine rose from 5 in 2005 to 24 in 2014 + 19
+397

Oxycodone was prescribed more than a million times in England (2012 – 2013), a rise of 39 per cent since 2010.

OXYCODONE PRESCRIPTIONS 2009/2010 - 788,607 2010/2011 919,177 2011/2012 - 1.01million 2012/2013 - 1.09million

The UK government were forced to impose a ‘controlled status’ on Tramadol during June 2014 as a result of the ever increasing death toll!

Pages 3&4
Shows the most likely reason MHRA wanted to ban Co-proxamol was for Monetry Gain!

THE UK HAD SUCESSFULY IMPORTED CO-PROXAMOL FROM MHRA’s APPROVED MANUFACTURERS FROM THE
TWO COUNTRY’S THAT OVERTURNED THE LUDICROUS BAN ON CO-PROXAMOL!

Dextropropoxyphene was banned in India during 2013 the Drugs Technical Advisory Board (DTAB) revoked the ban on the manufacture and sale of Dextropropoxyphene based products. Production began again during 2016 following the collapse of their palliative care system

As all ‘Marketing Authorisations’ had been cancelled since 1st January 2008 I assume that MHRA, NHS, and DOH were perfectly content for Co-proxamol to be imported from India in order for the Named Patient Facility to continue.

The following Indian manufacturers had previously supplied Co-proxamol to the UK throughout the period of the ‘Named Patient Facility’. Obviously they must have met MHRA’s exacting standards!

MEDREICH LIMITED, STRIDES SHASUN LIMITED, INTAS PHARMACEUTICALS, AUROBINDO PHARMA LIMITED.

I have no doubt that Co-proxamol could have been imported from any of the Indian Manufacturers who continued to supply the UK importers during the ‘Named Patient era for approximately £5.00 per 100 tablets since February 2017! (nine months before your report was first published). Thiswould have saved the ‘Named Patient Facility’ for the patients who relied on it, and the NHS millions of pounds per year!

[Medindia Drug Price] https://www.medindia.net/drug-price/dext...

THE QUESTION’S THAT MUST BE ANSWERED

As the NHS were prepared to pay up to £300.00 for 100 tablets to enable the ‘Named Patient’ to continue, why are they not prepared to continue purchasing the drugfor £5.00 in order for the 'Named Patient' facility which was Guaranteed By Caroline Flint and MHRA to continue?

Why is MHRA continuing to protect importers identity who have obviously been overcharging the NHS?

Why was it necessary for my GP to apply for an IFR when the drug could have been imported for a mere £5-00 per 100 tablets at the time the application was made?

Why has no section of the NHS or DOHSC confronted MHRA regarding their decision to ban Co-proxamol? when there has been so much evidence that their decision was flawed?

MHRA is a corrupt organisation with abdsolute power to do anything without the fear of being challanged! (Power Corrupts, and Absolute Power Corrupts Absolutely)!

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/i...

Yours faithfully,

James Kelly
[This Request Has Been Sent By Seperate Email with Attachment]

CONTACTUS, England (NHS ENGLAND), Midlands and Lancashire Commissioning Support Unit

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Thank you for your email. **Please read the important information below**

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FOI, England (NHS ENGLAND), Midlands and Lancashire Commissioning Support Unit

Dear James Kelly,

 

Thank you for email of 18 February 2019. Please see this email as
acknowledgement of your Internal Review request.

 

We endeavour to respond to Internal Reviews within 20 working days.
However, please be aware that on some occasions this has been extended to
40 working days. An officer will be allocated to handle your Internal
Review and will update you accordingly where necessary.

 

If you have any queries about this request or wish to contact us again,
please email [1][Midlands and Lancashire Commissioning Support Unit request email] and the message will be
forwarded appropriately. Please remember to quote the above reference
number in any future communications.

 

To communicate with NHS England regarding Freedom of Information (FOI)
requests, enquiries or complaints we ask these are sent directly to NHS
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are progressed correctly. Their postal address, telephone number and email
details are as follows:- PO Box 16738, Redditch, B97 9PT; 0300 3 11 22 33,
[2][Midlands and Lancashire Commissioning Support Unit request email].

 

Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [3][Midlands and Lancashire Commissioning Support Unit request email]

 

‘Health and high quality care for all, now and for future generations’

show quoted sections

FOI, England (NHS ENGLAND), Midlands and Lancashire Commissioning Support Unit

Dear James Kelly,

 

Re:      Freedom of Information Internal Review outcome (Our Ref:
FOI-058283 IR)

 

Thank you for your Freedom of Information (FOI) Internal Review request
dated 18 February 2019.

 

Your original FOI request was received by NHS England on 14 January 2019,
and read:-

 

Clarified Request:

 

Regarding "Please clarify whether you are asking for information in
respect of the number of respondents which answered the co-proxamol
questions" I have been able to find the numbers on page 57 Annexe 7.

 

Re: Items which should not be routinely prescribed in primary care
Consultation Report of Findings (Nov 2017) Annex 7, page 57

 

Q3. That in exceptional circumstances if there is a clinical need for
Co-proxamol to be prescribed in primary care this should be undertaken in
cooperation arrangement with a multidisciplinary team and/or other
healthcare professional

 

491 Patients responded 63% were in favour of retaining Co-proxamol in
exceptional circumstances. I would think that ‘Named Patients’ would fall
into this Category.

 

318 Members of the public responded 59% were in favour of retaining
Co-proxamol in exceptional circumstances.

Questions 1b, 1c, 1d, 2b, 2c, 3, 3a, 3b, 4 and 5 remain unanswered. I
would appreciate a full response by January 24 in line with my original
request

 

Original request:

 

1) The report states that there were 2638 responses received from patients
over the eighteen products you researched.

 

1a) How many of the patient responses were there regarding Co-proxamol
alone?

1b) How did the patients become aware of your report in order for them to
respond

1c) How many ‘Named Patients’ did you contact for a response?

1d) If the answer to c) is none please could explain why not?

 

2) The second highest responses came from members of the public (1200)

2a) How many of the public responses were there regarding Co-proxamol
alone?

2b) How did the public become aware of your report in order for them to
respond?

2c) How many members of the public who responded did you contact for a
response regarding Co-proxamol?

 

3) When you prepared this report for NHSCC / NHS were you aware that the
Indian Government had reversed their decision to ban the use and
production of Dextropropoxyphene Combination based products following the
collapse of their Palliative Care regime?

3a) Were you aware that Co-proxamol was available for import from India
for approximately £5.00 per 100 tablets from February 2017?

3b) Were you aware that most of the Co-proxamol prescribed to the ‘Named
Patients’ during the period May 2008 to January 2016 was supplied by
Indian Company’s?

 

4) Were you aware of the report produced by Dr Munir Pirmohamed which
would have left approximately 122,500 patients without any appropriate
pain relief from the time of the first announcement of the ban during
2005? MHRA were certainly aware of the problems with enzyme CYP2D6 at that
time (7% of 1.75 Million patients being prescribed Co-proxamol during
2005)

 

5) ****Why is NHS Chorley and South Ribble CCG continuing to pay over
£100.00 per box for Co-proxamol?

 

Your Internal Review request was received by NHS England on 18 February
2019, and read:-

 

I'm applying for an internal review for the following reasons: - There Has
Been A Total Lack of Due Diligence In Your Research and Response!

1b) How did the patients become aware of your report in order for them to
respond

Patients were informed of the consultation through general and targeted
communications and engagement with relevant stakeholders via a variety of
mechanisms e.g. emails, newsletters, bulletins, social media and face to
face meetings. Patients had an opportunity to feedback through an online
survey, written correspondence, face to face and online meetings. Patients
were also able to email or post written responses.

I'm probably the most involved person in the UK regarding Co-proxamol and
I certainly wasn't aware of this consultation until the date your findings
were published!

1.75 million Patients have suffered through the totally unnecessary ban on
co-proxamol I doubt any of these patients were aware of your consultation!

1c) How many ‘Named Patients’ did you contact for a response?

NHS England did not directly contact any named patients for a response.

As this group of patients would be the most affected group, your decision
not to invite their views was absolutely negligent on your part!

2) The second highest responses came from members of the public (1200)

2b) How did the public become aware of your report in order for them to
respond?

A communications and engagement plan was delivered to ensure that the
consultation was effectively promoted with the public. Members of the
public had an opportunity to feedback via an online survey, written
correspondence, face to face and online meetings. Patients were also able
to email or post a written response.

2c) How many members of the public who responded did you contact for a
response regarding Co-proxamol?

NHS England did not follow up any members of the public who responded to
the consultation on co-proxamol.

My question was regarding the members of the public you may have initially
contacted, not followed up. Again I certainly wasn't aware of the
consultation until the date your findings were published!

3) When you prepared this report for NHSCC / NHS were you aware that the
Indian Government had reversed their decision to ban the use and
production of Dextropropoxyphene Combination based products following the
collapse of their Palliative Care regime?

In reaching its recommendations for the 18 products listed in the CCG
guidance (including co-proxamol), the group considered recommendations
from NICE. Where NICE guidance was not available the group considered
evidence from a range of sources, for example; the Medicines and
Healthcare products Regulatory Agency (MHRA), the British National
Formulary, the Specialist Pharmacist Service, and PrescQIPP Community
Interest Company (CIC) evidence reviews. Further information on how the
recommendations in this guidance had been developed can be found in the
CCG guidance which is available on the NHS England website:

 

NICE website states: - NICE evidence summaries

Summaries of the best available evidence to inform local NHS planning and
decision-making, for selected new medicines, off-label use of licensed
medicines and unlicensed medicines.

 

I maintain NICE took MHRA's initial reasoning for the ban at face value!
They never took into consideration the pro Co-proxamol evidence or
challanged MHRA's reasoning. (See attachment) [Reply to NICE Reference No:
EH79182]

 

My opinion is there was a complete lack of 'due diligence' by your
committee completely ignoring the fact that Co-proxamol could have been
imported for approximately £5.00 for 100 tablets since February 2017 and
the very important report by Dr Munir Pirmohamed. You will see in the
attached file [Reply to NICE [Reference No: EH79182] NHS, NHSCC,
PrescQipp, and all CCG's have failed to question the acceptability of the
Co-proxamol ban!

Effectiveness: -

Co-proxamol is effective in chronic pain!

[1]https://www.ncbi.nlm.nih.gov/pmc/article...

Hanks Forbes report published during 1998, stated “Co-proxamol was very
effective in ‘Palliative Care.” If it was proved that it was effective for
end of life pain, it would be an exceptionally effective drug for
arthritic pain! (Which it was)

The situation in India during 2013 corroborates beyond any doubt that the
Hanks Forbes report was 100% correct on the efficacy of Co-proxamol, and
MHRA was completely wrong in its recommendation’s!

India was the last country to ban Co- proxamol and its production during
2013. It wasn’t a surprise when this resulted in the collapse of their
palliative care system and the decision was overturned very quickly!
Co-proxamol was the most effective analgesic in the UK for over 50 years
prior to 2005.

The following refers to the attached file [Reply to NICE Reference No:
EH79182] (Please read in full)

Page17

The UK suicide rates were already declining for Co-proxamol while the drug
was classed as a POM prior to the ban. Suicide/Open reports had reduced
from 296 in 2000 to just 204 in 2004 A 7% REDUCTIONS HAD BEEN ACHEIVED!
Further reductions could have been guaranteed by simply changing the drug
classification to ‘Shedule 3 controlled’. I feel sure if the
classification had been changed Co-proxamol would have remained on the
market today at a very completive price for the NHS! (2000 - 2004) the
chart below clearly shows a 7% reduction in Co-proxamol Suicides prior to
the ban being announced! This fact contradicts MHRA's reasoning!

Year Co-proxamol †
Suicide, open Suicide, open, accidental
1998 298 (21) 354 (16)
1999 298 (21) 359 (16)
2000 296 (23) * 345 (16)
2001 268 (21) 322 (15)
2002 217 (18) 265 (13)
2003 196 (16) 226 (12)
2004 204 (16 ) * 249 (12)

Page 2

According to a FDA report [Page 16 Fig 1] produced between 1969 and 2005
there were; 10671 more adverse event reports, 3256 more overdose reports,
437 more suicide reports, 5041 more abuse & dependence reports, and the
total number of death reports increased by 5059 when Oxycodone was
compared with Propoxyphene (Co-proxamol)!

Between 2005 and 2015 MHRA issued an additional 138 ‘Marketing
Authorisations’ for Oxycodone.

DISPITE THIS STUDY BEING COMPLETED BY 2005 THE UK GOVERNMENT SHOWED A
TOTAL DISRESPECT FOR PATIENT SAFETY AND WELLBEING BY SIMPLY ACCEPTING THE
RESULTS OF THE FLAWED CSM / MHRA CALL FOR EVIDENCE REPORT WHICH HAD BEEN
TOTALLY DEVOID OF ANY DUE DILIGENCE!’ THE TOTAL RESPONSE FOR THIS REPORT
WAS JUST A MEAGRE 14.7%!

Deaths in the UK from all of the alternate analgesia have increased
alarmingly since the MA’s for Co-proxamol were removed!

• Deaths from Tramadol rose from 53 in 2005 to 240 in 2014 +187

• Deaths from Oxycodone rose from 11 in 2005 to 53 in 2014 + 42

• Deaths from Codeine rose from 44 in 2005 to 136 in 2014 + 92

• Deaths from Fentanyl rose from 3 in 2005 to 40 in 2014 + 37

• Deaths from Buprenorphine rose from 5 in 2005 to 24 in 2014 + 19

+397

Oxycodone was prescribed more than a million times in England (2012 –
2013), a rise of 39 per cent since 2010.

 

OXYCODONE PRESCRIPTIONS 2009/2010 - 788,607 2010/2011 919,177 2011/2012 -
1.01million 2012/2013 - 1.09million

 

The UK government were forced to impose a ‘controlled status’ on Tramadol
during June 2014 as a result of the ever increasing death toll!

 

Pages 3&4

Shows the most likely reason MHRA wanted to ban Co-proxamol was for
Monetry Gain!

 

THE UK HAD SUCESSFULY IMPORTED CO-PROXAMOL FROM MHRA’s APPROVED
MANUFACTURERS FROM THE

TWO COUNTRY’S THAT OVERTURNED THE LUDICROUS BAN ON CO-PROXAMOL!

Noti

Notification Importer Bulk Importer Exporting Manufacturer Pack
Month/Year Name Code Country Size
May/08 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
May/08 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
Oct/08 REDACTED CO INDIA MEDREICH LIMITED 100
Oct/08 REDACTED CO INDIA MEDREICH LIMITED 100
Oct/08 REDACTED CO INDIA MEDREICH LIMITED 100
Oct/08 REDACTED CO INDIA MEDREICH LIMITED 100
Nov/08 REDACTED CO INDIA MEDREICH LIMITED 100
Mar/09 REDACTED CO INDIA MEDREICH LIMITED 100
Apr/09 REDACTED CO INDIA MEDREICH LIMITED 100
Apr/09 REDACTED PAR547 AUSTRALIA ASPEN 20
May/09 REDACTED PAR547 AUSTRALIA ASPEN 20
Jul/09 REDACTED CO-PROX INDIA MEDREICH LIMITED 100
Jul/09 REDACTED PAR547 AUSTRALIA ASPEN 20
Aug/09 REDACTED PAR547 AUSTRALIA ASPEN 20
Sep/09 REDACTED CO INDIA MEDREICH LIMITED 100
Sep/09 REDACTED PAR547 AUSTRALIA ASPEN 20
Oct/09 REDACTED PAR547 AUSTRALIA ASPEN 20
Nov/09 REDACTED PAR547 AUSTRALIA ASPEN 20
Dec/09 REDACTED CO INDIA MEDREICH LIMITED 100
Jan/10 REDACTED CO INDIA MEDREICH LIMITED 100
Jan/10 REDACTED PAR547 AUSTRALIA ASPEN 20
Jan/10 REDACTED INDIA AUROBINDO PHARMA 100
LIMITED
Feb/10 REDACTED PAR547 AUSTRALIA ASPEN 20
Feb/10 REDACTED S24100 INDIA AUROBINDO PHARMA 100
LIMITED
Feb/10 REDACTED INDIA AUROBINDO PHARMA 100
LIMITED
Mar/10 REDACTED S24100 INDIA AUROBINDO PHARMA 100
LIMITED
Apr/10 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
Apr/10 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
Apr/10 REDACTED PAR547 AUSTRALIA ASPEN 20
Apr/10 REDACTED S24100 INDIA AUROBINDO PHARMA 100
LIMITED
May/10 REDACTED COP INDIA MEDREICH LIMITED 100
May/10 REDACTED PAR547 AUSTRALIA ASPEN 20
Aug/10 REDACTED COP INDIA MEDREICH LIMITED 100
Sep/10 REDACTED COP INDIA MEDREICH LIMITED 100
Oct/10 REDACTED COP INDIA MEDREICH LIMITED 100
Nov/10 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
Dec/10 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
Dec/10 REDACTED AUSTRALIA SIGMA 25
PHARMACEUTICALS
Jan/11 REDACTED COL INDIA AUROBINDO PHARMA 100
LIMITED
Jan/11 REDACTED COP INDIA MEDREICH LIMITED 100
Jan/11 REDACTED PAR547 AUSTRALIA ASPEN 20
Feb/11 REDACTED PAR547 AUSTRALIA ASPEN 20
Mar/11 REDACTED PAR547 AUSTRALIA ASPEN 20
May/11 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
Sep/11 REDACTED PAR547 AUSTRALIA ASPEN 20
Oct/11 REDACTED CAPA AUSTRALIA FAWNS & MCALLEN 20
Nov/11 REDACTED CO INDIA INTAS 100
PHARMACEUTICALS
Nov/11 REDACTED COP100 INDIA MEDREICH LIMITED 100
Nov/11 REDACTED INDIA MEDREICH LIMITED 100
Feb/12 REDACTED COP100 INDIA MEDREICH LIMITED 100
May/12 REDACTED GCOP100OV INDIA MEDREICH LIMITED 100
Jun/12 REDACTED Q-CO-PROXTABSAL1 INDIA STRIDES SHASUN 100
LIMITED
Nov/12 REDACTED COP INDIA MEDREICH LIMITED 100
Mar/13 REDACTED Q-CO-PROXTABSAL2 INDIA STRIDES SHASUN 100
LIMITED
Apr/13 REDACTED COP INDIA MEDREICH LIMITED 100
Oct/13 REDACTED COP/32.5/325/100 INDIA INTAS 100
PHARMACEUTICALS
May/14 REDACTED GCOP100OV INDIA MEDREICH LIMITED 100
Apr/15 REDACTED DIG523 AUSTRALIA ASPEN 20
Oct/15 REDACTED 722-2599 AUSTRALIA ASPEN 20
Oct/15 REDACTED DIG/32.5/325/20 AUSTRALIA ASPEN 20
Dec/15 REDACTED DIG/32.5/325/20 AUSTRALIA ASPEN 20
Jan/16 REDACTED COP534 INDIA MEDREICH LIMITED 100
Feb/16 REDACTED DIG523 AUSTRALIA ASPEN 20
Mar/16 REDACTED DEX/20 AUSTRALIA ASPEN 20
Mar/16 REDACTED DIG523 AUSTRALIA ASPEN 20
Apr/16 REDACTED DIG523 AUSTRALIA ASPEN 20
Apr/16 REDACTED DIG523 AUSTRALIA ASPEN 20
May/16 REDACTED DIG523 AUSTRALIA ASPEN 20
Dec/17 REDACTED DIG523 AUSTRALIA ASPEN 20
Feb/18 REDACTED DIG523 AUSTRALIA ASPEN 20

Dextropropoxyphene was banned in India during 2013 the Drugs Technical
Advisory Board (DTAB) revoked the ban on the manufacture and sale of
Dextropropoxyphene based products. Production began again during 2016
following the collapse of their palliative care system

 

As all ‘Marketing Authorisations’ had been cancelled since 1st January
2008 I assume that MHRA, NHS, and DOH were perfectly content for
Co-proxamol to be imported from India in order for the Named Patient
Facility to continue.

 

The following Indian manufacturers had previously supplied Co-proxamol to
the UK throughout the period of the ‘Named Patient Facility’. Obviously
they must have met MHRA’s exacting standards!

 

MEDREICH LIMITED, STRIDES SHASUN LIMITED, INTAS PHARMACEUTICALS, AUROBINDO
PHARMA LIMITED.

.

I have no doubt that Co-proxamol could have been imported from any of the
Indian Manufacturers who continued to supply the UK importers during the
‘Named Patient era for approximately £5.00 per 100 tablets since February
2017! (nine months before your report was first published). Thiswould have
saved the ‘Named Patient Facility’ for the patients who relied on it, and
the NHS millions of pounds per year!

 

[Medindia Drug Price]
[2]https://www.medindia.net/drug-price/dext...

 

THE QUESTION’S THAT MUST BE ANSWERED

 

As the NHS were prepared to pay up to £300.00 for 100 tablets to enable
the ‘Named Patient’ to continue, why are they not prepared to continue
purchasing the drugfor £5.00 in order for the 'Named Patient' facility
which was Guaranteed By Caroline Flint and MHRA to continue?

 

Why is MHRA continuing to protect importers identity who have obviously
been overcharging the NHS?

Why was it necessary for my GP to apply for an IFR when the drug could
have been imported for a mere £5-00 per 100 tablets at the time the
application was made?

 

Why has no section of the NHS or DOHSC confronted MHRA regarding their
decision to ban Co-proxamol? when there has been so much evidence that
their decision was flawed?

 

MHRA is a corrupt organisation with abdsolute power to do anything without
the fear of being challanged! (Power Corrupts, and Absolute Power Corrupts
Absolutely)!

 

The FOI Management team have reviewed your request and this letter
provides the outcome of this review. It may be helpful if we first explain
that an Internal Review looks at the handling of, and response given to, a
Freedom of Information request which has previously been made. The scope
of an Internal Review is therefore limited to considering whether the
request(s) was appropriately handled and whether the response given was
accurate and appropriate. An Internal Review cannot consider any new
queries not originally included in the relevant FOI request(s); these
should be submitted as new FOI requests via our Contact Centre.

 

It was noted that your original response was issued within the statutory
guidelines of 20 working.

 

We have also assessed whether you received an appropriate response to your
request and considered the comments you have set out in your Internal
Review email.

 

It is the conclusion of this review that NHS England’s original response
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The FOI Act gives you the right to ask any public sector organisation for
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As such it is an opinion of the FOI management team that a response was
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In line with the above, our original response is upheld.

 

We hope that this addresses your concerns. However, if you are not content
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Commissioner’s Office (ICO) can be contacted at:

 

The Information Commissioner’s Office

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Please do not reply to this email. This message has been sent from a
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Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [6][Midlands and Lancashire Commissioning Support Unit request email]

 

‘Health and high quality care for all, now and for future generations’

 

show quoted sections