Co-proxamol Misinformation Distributed By PrescQipp May 2013 and July 2015

James Kelly made this Freedom of Information request to National Institute for Health and Care Excellence

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

National Institute for Health and Care Excellence did not have the information requested.

Dear National Institute for Health and Care Excellence,

[extraneous material removed]

The information I'm requesting: -

1) A Copy of ‘The PrescQIPP Quality Assurance document (Created: Friday, 12 April 2013)

2) A list of all MMG’s and CCG’s that were issued Bulletin 42 – from May 2013 and Reissued during July 2015 (Reviewing existing co-proxamol patients)

3) A copy of any information PrescQipp considered regarding a balanced view on Co-proxamol ‘Due Diligence.’

4) As the bulletin was prepared by Melitta Mudaly (“Pharmacist Project Manager”) could you supply all medical qualifications held for that position during May 2013?

Yours faithfully,

James Kelly

James Kelly left an annotation ()

My Informal Request For Information

Subject: Copy of: PrescQIPP Enquiry
Date: 13/03/2017 12:15:48 GMT Standard Time
From: admin@prescqipp.info
Reply To: xxxxx@prescqipp.info
To: xxxxx@aol.com

Hello from PrescQIPP
Please read the system message below carefully.

Copy of: This is an enquiry email via PrescQIPP from:
Janes Kelly (xxxxxx@aol.com)

Name: Janes Kelly
Email: xxxxxx@aol.com
Message: My Request

Please could you supply me with a Copy of ‘The PrescQIPP Quality Assurance document (Created: Friday, 12 April 2013)

A list of all MMG’s and CCG’s that were issued Bulletin 42 – from May 2013 and Reissued again during July 2015 (Reviewing existing co-proxamol patients)

A copy of any information you considered regarding a balanced view on Co-proxamol (‘Due Diligence’)

As the bulletin was prepared by Melitta Mudaly ('Pharmacist Project Manager') could you supply all medical qualifications held for that position during May 2013?

My reasons for the requests: -

The PrescQIPP Quality Assurance document (updated Friday, 12 April 2013) States that PrescQIPP initiatives need to be underpinned by a due diligence process.

Bulletin 42 - May 2013 - v 2.0 (Reviewing existing co-proxamol patients) appears to have a total lack of due diligence when Bulletin 42 was first issued to CCG’s. The report is nothing more than a reiteration of the misinformation presented by the CSM /MHRA in 2005!

When CSM / MHRA issued this nonsense there was evidence to prove that most alternate drugs were far more dangerous than Co-proxamol!

There must have been a reason why MHRA deliberately removed a completely safe (when tolerated and used correctly) drug from the market while continuing to grant additional ‘Marketing Authorisations’ for two drugs which were known to have serious consequences for patients. (Tramadol & Oxycodone)

The following Information comes from an American FDA study taken between 1969 and 2005 and would have been available during 2005 when CSM / MHRA made their catastrophic decision to remove the remaining ‘MA’s’ (Licences) for Co-proxamol.

Between 2005 and 2015 MHRA issued an additional 138 ‘Marketing Authorisations’ for Oxycodone. According to the FDA report 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 / PPX (Co-proxamol)!

Oxycodone was prescribed more than a million times in England (2012 – 2013), a rise of 39 per cent since 2010.(The additional 138 ‘Marketing Authorisations’ for Oxycodone issued by MHRA added over two million pounds to their coffers between 2005 and 2015)

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

The price NHS has to pay for Oxycodone (Part VIIIA products).
Drug
Oxycodone 10mg / Naloxone 5mg Modified-release tablets 56 tablets £42.32
Oxycodone 10mg capsules 56 tablets £22.86
Oxycodone 10mg Modified-release tablets 56 tablets £25.04
*The price of Co-proxamol 1n 2005 was £2.70 for 100 tablets.

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 WAS ACHIEVED! Further reductions could have been guaranteed by simply changing the drug classification to ‘controlled’.

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
Total +397
I hope you are able to comply with my request and look forward to an early reply.

Yours Sincerely

James Kelly
Topic: I have a GENERAL question

Monday, 13 March 2017 12:15
_______________________________________________
Reply
Subject: PrescQIPP Enquiry
Date: 14/03/2017 09:43:26 GMT Standard Time
From: help@prescqipp.info
To: xxxxx@aol.com

Good Morning,
As an independent CIC we are not subject to FOI requests however, we can confirm that all our bulletins are made freely available to NHS commissioning organisations four months after publication to our subscribers so all CCGs will have been able to access the resources if they wanted to.

This drug has been withdrawn by the MHRA and therefore we cannot recommend prescribing of it, our guidance is designed to help commissioners to understand and implement national guidance and policies. Any concerns regarding the MHRA/CSM should be addressed to them directly.

Kind regards,
Carol
Carol Roberts FRPharmS
Chief Executive
PrescQIPP CIC

NICE Mail, National Institute for Health and Care Excellence

Dear Mr Kelly,

 

Reference No: EH79182

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on 13 March 2017, in which
you asked NICE for the following information regarding PrescQIPP:

1) A Copy of ‘The PrescQIPP Quality Assurance document (Created: Friday,
12 April 2013)

2) A list of all MMG’s and CCG’s that were issued Bulletin 42 – from May
2013 and Reissued during July 2015 (Reviewing existing co-proxamol
patients)

3) A copy of any information PrescQipp considered regarding a balanced
view on Co-proxamol ‘Due Diligence.’

4) As the bulletin was prepared by Melitta Mudaly (“Pharmacist Project
Manager”) could you supply all medical qualifications held for that
position during May 2013?

 

Your request will now be considered and you will receive a response within
the statutory timescale of 20 working days as defined by the Act, subject
to the information not being exempt or containing a reference to a third
party. In some circumstances we may be unable to achieve this deadline. If
this is likely you will be informed and given a revised time-scale at the
earliest opportunity.

 

There may be a fee payable for the retrieval, collation and provision of
the information you request. If this is the case you will be informed and
the 20 working day timescale will be suspended until we receive payment
from you. If you chose not to make a payment then your request will remain
unanswered.

 

Some requests may also require either full or partial transference to
another public authority in order to answer your query in the fullest
possible way. Again, you will be informed if this is the case.

 

I would like to take this opportunity to thank you for your interest in
NICE.

 

Yours sincerely,

Natalie

 

Communications Executive

Corporate Communications

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149
Web: [1]http://nice.org.uk

 

 

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NICE Mail, National Institute for Health and Care Excellence

Dear Mr Kelly,

 

Reference No: EH79182

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on 13 March 2017, in which
you asked NICE for the following information regarding PrescQIPP:

1) A Copy of ‘The PrescQIPP Quality Assurance document (Created: Friday,
12 April 2013)
2) A list of all MMG’s and CCG’s that were issued Bulletin 42 – from May
2013 and Reissued during July 2015 (Reviewing existing co-proxamol
patients)
3) A copy of any information PrescQipp considered regarding a balanced
view on Co-proxamol ‘Due Diligence.’
4) As the bulletin was prepared by Melitta Mudaly (“Pharmacist Project
Manager”) could you supply all medical qualifications held for that
position during May 2013?

 

Following a search of our records please find below our responses to your
questions. 

 

1.      A Copy of ‘The PrescQIPP Quality Assurance document (Created:
Friday, 12 April 2013)

We do not hold this document. NICE was not responsible for this document.

 

2.      A list of all MMG’s and CCG’s that were issued Bulletin 42 – from
May 2013 and Reissued during July 2015 (Reviewing existing co-proxamol
patients)

We do not hold this information. NICE had no role in issuing or reissuing
this document (Bulletin 42) to MMGs and CCGs.

 

3.      A copy of any information PrescQipp considered regarding a
balanced view on Co-proxamol ‘Due Diligence.’

We do not hold information relating to this request. NICE was not involved
in the development of PrescQipp documents.

 

4.      As the bulletin was prepared by Melitta Mudaly (“Pharmacist
Project Manager”) could you supply all medical qualifications held for
that position during May 2013?

We do not hold this information.

 

 

You’ve said in your correspondence: “As I'm unable to Request FOI from
PrescQipp directly I believe your organisation would be responsible for
the behaviour of MHRA and PrescQipp”. 

 

NICE is not responsible for the work of the MHRA or PrescQipp. We are a
separate organisation, and information about what we do and how we work
can be found on [1]our website.

 

Any questions or complaints about [2]PrescQipp should be sent to the
organisation directly. 

 

If you have any questions on this response you are welcome to call me on
the enquiry handling team number: 0300 323 0141 (weekdays 09:00 – 17:00).

 

If you are unhappy with this response and want an internal review of how
we handled your request, you must write to us within 20 working days of
our response. Send your request to: Associate Director, Corporate Office,
National Institute for Health and Care Excellence, 10 Spring Gardens,
London SW1A 2BU or email: [3][email address]. When we receive your
request we will send you an acknowledgement within 5 working days.

 

The Associate Director, Corporate Office, will review your complaint and
send you a full reply within 20 working days. If you are dissatisfied
with the outcome of this review, you can apply directly to the Information
Commissioner for a decision at: The Information Commissioner’s Office,
Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.

 

Kind regards

Natalie

 

Natalie Whelan

Communications Executive

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149
Web: [4]http://nice.org.uk 

 

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Dear National Institute for Health and Care Excellence,

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

I am writing to request an internal review of National Institute for Health and Care Excellence's handling of my FOI request 'Co-proxamol Misinformation Distributed by PrescQipp May 2013 and July 2015'.

Considering there is a 20 working days’ time constraint for a request for an internal review of your response I feel it would be unwise to wait for a response to my last query.

Your website states: - "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.”

"The PrescQIPP Drop-List is an accumulation of drugs that NICE have comprehensively reviewed and produced do not dos’ for, or where PrescQIPP CCG members consider them to be low priority, poor value and can safely be considered for self-care or where safer alternatives are available."

This last statement would indicate it could only be NICE or the CCG’s who are responsible for the dire situation I have been left with!

My local CCG is Blackpool my GP's CCG Fylde & Wyre. In a separate FOI request Both Blackpool and Fylde and Wyre CCG’s have denied any responsibility and laid all blame on the previous PCTs who were in charge up to April 2013. (Ref no: FOI-02317-P0B8-FW)

09/02/2017 I requested an internal review; this was refused on 27/02/2017.

28/02/2017 I submitted a further request for internal review which has not been answered.

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

Yours faithfully,

James Kelly

David Coombs, National Institute for Health and Care Excellence

Dear Mr Kelly

I write to confirm receipt of your request below for an internal review. This will be considered in accordance with NICE’s Freedom of Information Policy and Complaints Procedure and you should usually receive a response with 20 working days.

Should there be a delay, I will let you know as soon as possible of any revised timescale.

Kind regards

David

David Coombs
Associate Director – Corporate Office
National Institute for Health and Care Excellence
10 Spring Gardens | London | SW1A 2BU | United Kingdom

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David Coombs, National Institute for Health and Care Excellence

Dear Mr Kelly

 

Our reference: EH79182

Response to internal review of request under the Freedom of Information
Act 2000

 

Background

 

I write to set out the National Institute for Health and Care Excellence
(NICE)'s response to your request for an internal review of its decision
regarding your request under the Freedom of Information Act 2000 (the
‘Act’), made on 13 March 2017, for information on Co-proxamol.

 

NICE responded to your request on 15 March 2017 and explained it did not
hold the information you requested.

 

On 4 April 2017 you requested an internal review of NICE's decision.

 

NICE's response

 

Under the Act, NICE has two duties to individuals requesting information:
firstly to confirm whether or not it holds the information requested and
secondly to provide a copy of that information, if held and not otherwise
exempt from disclosure.  NICE must comply with both of these duties.

 

I have carried out the internal review on behalf of NICE. Having
reconsidered your request, I can confirm that NICE does not hold the
information requested. I have also considered whether you were provided
with appropriate advice and assistance in the handling of your request as
required under section 16 of the Act and I confirm that you have. NICE has
explained why we do not hold the information requested and you have been
directed to PrescQipp and the Medicines and Healthcare products Regulatory
Agency (MHRA) where you may pursue your enquiries.

 

I therefore conclude that NICE has fulfilled its obligations in compliance
with the Act and I do not uphold your complaint.

 

External review

 

If you remain dissatisfied with the handling of your request following an
internal review, you have a right to appeal to the Information
Commissioner at:

 

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

[1]www.ico.org.uk

 

 

Kind regards

David

 

 

David Coombs

Associate Director – Corporate Office

National Institute for Health and Care Excellence

10 Spring Gardens | London | SW1A 2BU | United Kingdom

 

 

 

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