Loss of Co-proxamol Leads To A Life Of Relentless Side Effects And Substandard Pain Relief!

James Kelly made this Freedom of Information request to NHS Blackpool Clinical Commissioning Group

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 NHS Blackpool Clinical Commissioning Group,

When PCT’s were replaced By CCG’s did all common sense leave the Buildings at Seasiders Way and Jubilee House? (CCG answers would indicate this as fact).

I must have been seriously misguided as I genuinely thought that your organisations were there to protect patient’s health and well-being.

Earlier today I submitted a full explanation via LMMG’s Contact form regarding the situation with MHRA and CSM and the dire situation thousands of patients have been left to cope with following their ludicrous decision making. (I will also add this as an annotation)

Do you think the CCG response addressed my request adequately and fairly?

I suggest the information must be available somewhere within the 3 organisations and would appreciate a full reply to my original questions.

1. Does Blackpool CCG operate a process for requesting approval to continue prescribing Black or Grey drugs? If your answer remains No could you explain why this was not considered as a possibility?

2. Re: - http://www.lancsmmg.nhs.uk/medicines/co-... under the heading ‘Background’ you state 'Withdrawn from the UK market because of safety concerns.' "The CSM has stated that there is no identifiable patient group in whom the risk: benefit of co-proxamol may be positive.” Did you arrive at your decision on the grounds of the 2004 CSM recommendations which were seriously outdated by 2015? [Explanation required]

3. Could you supply the following: - A copy of the minutes from any meetings held leading to your decision of a ‘Do Not Prescribe Classification’ for Co-proxamol? [Minutes required]

4. A copy of all the information you reviewed and considered prior to making the decision to stop prescribing Co-proxamol. [Information required]

5. The occupations of all persons who were involved in making this decision.
[Medical or Clerical]

Additional question for LMMG
West Lancashire CCG never listed Co-proxamol a 'Black Drug' Is this being prescribed by GP's within this CCG? How many prescriptions are being filled each month?

This is a copy of the reply to my FOI request 18 April 2016

Dear Mr Kelly 26th April 2016

Re: Request for information under the Freedom of Information Act 2000
Ref no: FOI-01520-Q1H3-BP

Thank you for your correspondence dated 18 April 2016 making a request under the Freedom of Information Act 2000 for access to information which may be held by NHS Blackpool Clinical Commissioning Group (CCG).

Please find detailed below NHS Blackpool CCG’s response to your request, which is formatted as follows:

1. A schedule of all the records covered by your request.
2. Details of NHS Blackpool CCG’s decision in regard to the information requested.
3. Details of how you can appeal this decision should you wish to do so.
4. A statement concerning copyright and re-use of public sector information.

This letter addresses each of these parts in turn:

1. Schedule of records

I have searched ‘Blackpool CCG for 'Request to prescribe Co-proxamol outside of local policy,’ unfortunately no results appeared.

Many other CCG's do recognise and accept that there may be some exceptional patients who may require medication or appliances outside of local policy. e.g. 'Black or Grey listed products'. I would be grateful if you could supply the following information: -

1. Does Blackpool CCG operate a process for requesting approval to continue prescribing Black or Grey drugs?
No

2. Re: - http://www.lancsmmg.nhs.uk/medicines/co-... under the heading ‘Background’ you state 'Withdrawn from the UK market because of safety concerns.' "The CSM has stated that there is no identifiable patient group in whom the risk: benefit of co-proxamol may be positive.” Did you arrive at your decision on the grounds of the 2004 CSM recommendations which were seriously outdated by 2015?
The decision was originally made then and the MHRA has not reinstated the licence for the product.

3. Could you supply the following: - A copy of the minutes from any meetings held leading to your decision of a ‘Do Not Prescribe Classification’ for Co-proxamol?
The CCG does not hold this information; it was prior to the establishment of CCG

4. A copy of all the information you reviewed and considered prior to making the decision to stop prescribing Co-proxamol.
The CCG does not hold this information; it was prior to the establishment of CCG

5. The occupations of all persons who were involved in making this decision.
The CCG does not hold this information, it was prior to the establishment of CCG

6. The results of any voting which may have taken place in arriving at your decision.
The CCG does not hold this information, it was prior to the establishment of CCG

2. Decision

I can confirm that NHS Blackpool CCG does not hold some of the information requested, and this is detailed above:

Yours faithfully,

James Kelly

James Kelly left an annotation ()

Contact Form Sent To LMMG 15/08/2016

I would like to raise my points of view regarding the following page you have published
http://www.lancsmmg.nhs.uk/medicines/co-...

Background
Withdrawn from the UK market because of safety concerns. The CSM has stated that there is no identifiable patient group in whom the risk: benefit of co-proxamol may be positive.
THIS STATEMENT IS TOTALLY INCORRECT

BACKGROUND
* June 2004, MHRA sent out approximately 350 letters to organisations seeking opinions of Co- proxamol. The deadline for replies was September 2004.

* January 2005, MHRA published the outcome of the review.
Following “The Call for Evidence” (a 12-week exercise to gather further information on the risks and benefits of the pain killer co-proxamol), UK Ministers had decided to accept the advice of the Committee on Safety of Medicines (CSM) that co-proxamol should be withdrawn from the market. This report had such a low response (Just 14.7%) No Credible or Useful information could have been gained!

Many of the organisations contacted from the ‘Request for Information List’ wouldn’t have had much knowledge or interest regarding the subject: - All Party Pro-life Group, ACEVO, Ambulance Services Association, Association of British Dispensing Opticians, Association of Chief Police Officers, Association of Chief Police Officers Scotland, And the Association of Head Teachers.
This only covers an alphabetical start with ‘A’ I feel sure that if I had continued searching ‘B’ through ‘Z’ I would have found many more!

* MHRA reported to the CSM with their version of the content of the responses received from 'their opinion seeking exercise.

* The CSM, after considering the responses (did CSM have sight of the original responses, or merely rely on the MHRA's summary report? I cannot say with any certainty but, it would seem that the CSM relied solely upon the MHRA's evaluation of the responses) advised that co-proxamol be withdrawn from the market "on the grounds that the benefits of taking co-proxamol are not considered to outweigh the risks." [Para.3 Outcome of the Review of Risks and Benefits]

* January 2005, it was announced on the BBC lunchtime news that co-proxamol was to be withdrawn from the market. Originally the withdrawal period was to be 6-12 months to enable patients to have alternatives prescribed; this withdrawal period has been extended to -December 2007, after which licences will be revoked.

* Unlicensed co-proxamol will be available on a named patient basis after December 2007. Briefly, the reasons given for withdrawing co-proxamol were: co-proxamol was implicated in between 300-400 deaths per year (either intentional unintentional overdose), and, there was little evidence that co-proxamol any more effective than full dose paracetamol alone. Another interested co-proxamol user spent several months researching all the issues surrounding co-proxamol use and this culminated in a 40 page document being written and sent to the MHRA pointing out why the majority of patients thought their decision was wrong. The document: (A Critique of the MHRA's Decision to Withdraw Co-proxamol from the Market) addressed each issue which the MHRA had put forward for the withdrawing of co-proxamol, and highlighted the discrepancies in their reasoning and, what I believe to be a gross misrepresentations, of their evaluations of the responses received from their opinion seeking exercise.

Examples of why I think the MHRA decision was wrong: -

1) The figure of between 300-400 deaths per year is difficult to establish when using Office of National Statistic figures: often alcohol and other drugs were used in conjunction with co-proxamol. At the time of stating this figure, there were approximately 1.7 million patients taking co-proxamol; the death rate, even if correct, equated to just 0.02% of patients affected. The vast majority of patients had taken co-proxamol responsibly and, in normal use, co-proxamol posed no threat to life and had considerably fewer side effects than other pain killing drugs.

2) The effectiveness of co-proxamol, in chronic pain conditions, and this is what it is mostly prescribed for, has never been tested, therefore, the lack of evidence for its effectiveness lies not in research to prove its ineffectiveness, but rather in the fact that there is no research to prove this point.

3) The MHRA stated that the Royal Colleges were 'unanimously in favour of withdrawing co-proxamol’1 (document: "Outcome of the public request for information on the risks and benefits of the painkiller co-proxamol"). This is blatantly untrue; I have read the actual responses and while many opinions were forwarded, there was no unanimous favouring of withdrawing the drug. This is not the first- time that the MHRA have misrepresented the outcome of a public request for information. In June 2005, the MHRA were criticised for publishing the wrong facts about a consultation exercise. The drug concerned was Zocor Heart Pro – a simvastatin, and the issue involved the transition of the drug from prescription only to over the counter availability. The editor of the Drugs and Therapeutics Bulletin, Ike Iheanacho, stated:

"The MHRA has stated that it has made an 'administrative error1 but there must be concerns that it dressed up the consultation responses to support its own decision to make simvastatin available over the counter."

Given that the medicines side of the MHRA's responsibilities is funded 100% by the pharmaceutical industry, I have to question whose interests are being met by withdrawing a drug which was absolutely safe in normal use. It certainly does not appear to be the patient with chronic pain who has taken co-proxamol, sometimes for years, and has experienced good pain relief without unwanted side effects.

The organisations, Arthritis Care, fibromyalgia, and the British Society for Rheumatology had continued with ongoing campaigns. The magazine: Pulse, which is read and contributed to by GP's, had been publishing letters from concerned GP's who wish to see the decision to withdraw co-proxamol reversed. Admittedly, some GP's do favour withdrawing co-proxamol, but they are in the minority.

I sincerely believe the MHRA has misguided/misinformed the government and other regulatory bodies as to the true nature of the issues surrounding co-proxamol. The decision to withdraw licences for co-proxamol has left thousands of patients in the UK and millions globally to suffer a life of relentless debilitating pain with horrendous side effects from alternative analgesia.

Decisions of Lancashire local decision making groups:

Of the six Local CCG’s you represent ‘NHS West Lancashire CCG’ still appear to be prescribing Co-proxamol. Could you advise me on how many prescriptions have been dispensed by this CCG?

FOITeam (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT), NHS Blackpool Clinical Commissioning Group

Dear Mr Kelly

Additional question for LMMG
West Lancashire CCG never listed Co-proxamol a 'Black Drug' Is this being prescribed by GP's within this CCG? How many prescriptions are being filled each month?

This would need to be sent to West Lancashire CCG for a response as Blackpool CCG cannot respond on their behalf.

Kind regards

Donna Bamber
Freedom Of Information Manager

Midlands and Lancashire CSU

Tel: 01772 214227
[mobile number]
Email: [email address]
www.midlandsandlancashirecsu.nhs.uk

Jubilee House, Centurion Way, Leyland, Preston, PR26 6TR

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Bamber Donna (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT), NHS Blackpool Clinical Commissioning Group

 

 

Dear Mr Kelly

 

Having revisited your request and the information provided please see
below in bold the response to your internal review.

 

Kind regards

 

Dear NHS Blackpool Clinical Commissioning Group,

 

When PCT’s were replaced By CCG’s did all common sense leave the Buildings
at Seasiders Way and Jubilee House? (CCG answers would indicate this as
fact).

 

I must have been seriously misguided as I genuinely thought that your
organisations were there to protect patient’s health and well-being.

 

Earlier today I submitted a full explanation via LMMG’s Contact form
regarding the situation with MHRA and CSM and the dire situation thousands
of patients have been left to cope with following their ludicrous decision
making. (I will also add this as an annotation)

 

Do you think the CCG response addressed my request adequately and fairly?

 

I suggest the information must be available somewhere within the 3
organisations and would appreciate a full reply to my original questions.

 

Information prior to April 2013 is not held by the CCG as it pre-dates our
legal existence and as such is exempted under “Legacy” regulations within
the FOI Act and guidance from the Information Commissioner’s Office: i.e.
public bodies are not liable to disclose information before they became
public bodies. The CCG was legally formed on 1^st April 2013 and is only
subject to FOI requests after this date. Therefore pre-April 1^st calendar
year information should be requested from the Department of Health instead
- email requests should be sent to
[1]Reviews&[email address], writing “Freedom of Information”
in the subject line.

 

 

1.         Does Blackpool CCG operate a process for requesting approval to
continue prescribing Black or Grey drugs? If your answer remains No could
you explain why this was not considered as a possibility?

The colour classification of all drugs may be reviewed where there is new
evidence available. Drugs allocated a ‘Grey’ status are yet to be
reviewed.

 

2.         Re: - [2]http://www.lancsmmg.nhs.uk/medicines/co-...
under the heading ‘Background’ you state 'Withdrawn from the UK market
because of safety concerns.' "The CSM has stated that there is no
identifiable patient group in whom the risk: benefit of co-proxamol may be
positive.” Did you arrive at your decision on the grounds of the 2004 CSM
recommendations which were seriously outdated by 2015? [Explanation
required]

The decision was made following the 2004 recommendations.

 

3.            Could you supply the following: - A copy of the minutes from
any meetings held leading to your decision of a ‘Do Not Prescribe
Classification’ for Co-proxamol? [Minutes required]

                The CCG does not hold this information; it was prior to
the establishment of CCG

 

4.            A copy of all the information you reviewed and considered
prior to making the decision to stop prescribing Co-proxamol. [Information
required]

                The CCG does not hold this information; it was prior to
the establishment of CCG

 

5.            The occupations of all persons who were involved in making
this decision.

[Medical or Clerical]

The CCG does not hold this information; it was prior to the establishment
of CCG

 

The CCG adopted the decisions/recommendations previously made by Blackpool
Primary Care Trust. Since the MHRA recommendation regarding Coproxamol
still stands the CCGs position remains the same.

 

We are unable to resolve your individual concerns through the FOI process
and suggest if you wish to pursue the matter you have the right to make a
formal complaint.

 

The details for making a complaint are available on our website:

 

[3]http://blackpoolccg.nhs.uk/contact-us/co...

 

Alternatively please see your GP for a discussion on your personal
clinical circumstances

 

Kind regards

 

Donna Bamber

 

Donna Bamber
Freedom Of Information Manager
 
Midlands and Lancashire CSU
 
Tel: 01772 214227

[mobile number]
Email: [4][email address]

[5]www.midlandsandlancashirecsu.nhs.uk

 

Jubilee House, Centurion Way, Leyland, Preston, PR26 6TR

 

 

 

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References

Visible links
1. mailto:Reviews&[email address]
2. http://www.lancsmmg.nhs.uk/medicines/co-...
3. http://blackpoolccg.nhs.uk/contact-us/co...
4. mailto:[email address]
5. http://www.midlandsandlancashirecsu.nhs....

Dear Donna Bamber (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT),

I CAN ONLY ASSUME THERE HAS BEEN A DELIBERATE ATTEMPT TO MISLEAD ME WITH YOUR ANSWERS TO MY FOI REQUEST.

The information I'm requesting relates from the period October 2014 to November 2015

Re: - Your response
“Information prior to April 2013 is not held by the CCG as it pre-dates our legal existence and as such is exempted under “Legacy” regulations within the FOI Act and guidance from the Information Commissioner’s Office: i.e.. public bodies are not liable to disclose information before they became public bodies. The CCG was legally formed on 1st April 2013 and is only subject to FOI requests after this date. Therefore pre-April 1st calendar year information should be requested from the Department of Health instead.”

MY REQUEST FOR INFORMATION RELATES TO DECISIONS TAKEN BY BLACKPOOL CCG AND LANCASHIRE MEDICINES MANAGEMENT GROUP BETWEEN OCTOBER 2014 AND NOVEMBER 2015.

FIVE OF THE SIX CCG’s THAT MAKE UP LMMG CLASSIFIED CO-PROXAMOL BLACK DURING THIS PERIOD.
It wasn’t the previous PCT that made the decision to stop my prescription during November 2015. It was Blackpool CCG one of the 6 CCG’s that make up LMMG!

Q1. Does Blackpool CCG operate a process for requesting approval to continue prescribing Black or Grey drugs? If your answer remains No could you explain why this was not considered as a possibility?
[No Explanation Given]

Q2
“The decision was made following the 2004 CSM recommendations.”
NO! THE DECISIONS WERE MADE BETWEEN 2014 AND 2015 WHEN PRESCQIPP ADVISED ‘MEMBER CCG’s’ TO STOP PRESCRIBING DUE TO INCREASING COSTS!

Q3. Could you supply the following: - A copy of the minutes from any meetings held leading to your decision of a ‘Do Not Prescribe Classification’ for Co-proxamol? [Minutes required]
The CCG does not hold this information; it was prior to the establishment of CCG.
[YES YOU DO!]

Fig1 LMMG website clearly shows Co-proxamol was discussed during October 2014. (Fig 2 Shows That Melanie Preston from Blackpool CCG was present at that meeting)
Q4. A copy of all the information you reviewed and considered prior to making the decision to stop prescribing Co-proxamol. [Information required]
Ans; The CCG does not hold this information; it was prior to the establishment of CCG
[NO IT WASN’T] It was between October 2014 and November 2015

Fig 1
Medicine Recommendations
http://www.lancsmmg.nhs.uk/recommendatio...
Medicine Brand Indication Disease Category Date Considered by LMMG
Co-proxamol Pain Central Nervous System October 2014

Fig 2
Minutes of the Lancashire Medicines Management Group Meeting Held on Thursday
9th October 2014 at Preston Business Centre
http://www.lancsmmg.nhs.uk/download/minu...

PRESENT:
Melanie Preston (MP) Assistant Director - Medicines Optimisation NHS Blackpool CCG

Date considered by LMMG October 2014 (I have read through the published minutes for October 2014 on the LMMG website, unfortunately I wasn't able to find any information relating to Co-proxamol.

Please can you answer my questions from the period 1st April 2013 to November 2015

Yours sincerely,

James Kelly

Bamber Donna (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT), NHS Blackpool Clinical Commissioning Group

I am currently away from the office and will be back in on Wednesday 28th
September 2016. During this period my emails will not be monitored so if
your query needs immediate attention please contact the FOI Team on 01772
214227

 

 

 

 

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Glover Chantelle (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT), NHS Blackpool Clinical Commissioning Group

2 Attachments

Dear Mr Kelly

 

Following on from our telephone conversation on Thursday evening I have
now received the below/attached information from the CCG with regards to
your further enquiry detailed below.

 

The status of Coproxamol was part of an annual review by LMMG in October
2014. A list of drugs which included Coproxamol, was circulated with a
covering paper. Coproxamol was not highlighted as needing a change of RAG
status i.e. it would remain as black. Therefore no specific comments were
made relating to it in the minutes, which are on the LMMG website. The
December minutes highlight only those that CCGs wished to review. There
has not been any further review of Coproxamol.

 

"We have supplied all the information available to us on this matter and
feel this now brings our correspondence to a conclusion."

 

If you are dissatisfied with the service you have received in relation to
your request and wish to make a complaint or request a review of our
decision, you are entitled to complain in the following way:

 

Initially you should complain in writing to the freedom of information
officer, either by email on [1][email address] or post to Jubilee House,
Lancashire Business Park, Leyland, PR26 6TR, specifying why you feel you
have been wrongly denied access to the information requested.  The freedom
of information officer will ensure your complain is investigated under NHS
Blackpool CCG’s internal processes and provide you with a written response
within 20 working days.

 

If you are not content with the outcome of your complaint, you may apply
directly to the Information Commissioner’s Office (ICO) for a decision.
Generally, the ICO cannot make a decision unless you have exhausted the
complaints procedure provided by NHS Blackpool CCG.

 

 

Kind regards

Chantelle Glover

Freedom of Information Communications Officer

 
Midlands and Lancashire CSU
 

Email: : [2][email address]

Web: [3]www.midlandsandlancashirecsu.nhs.uk

 

Jubilee House, Lancashire Business Park,  Leyland, PR26 6TR

________________________________________
From: James Kelly <[4][FOI #352119 email]>
Sent: 20 September 2016 02:14
To: Bamber Donna (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT
UNIT)
Subject: Re: FW: Freedom of Information request - Loss of Co-proxamol
Leads To A Life Of Relentless Side Effects And Substandard Pain Relief!

Dear Donna Bamber  (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT
UNIT),

I CAN ONLY ASSUME THERE HAS BEEN A DELIBERATE ATTEMPT TO MISLEAD ME WITH
YOUR ANSWERS TO MY FOI REQUEST.

The information I'm requesting relates from the period October 2014 to
November 2015

Re: - Your response
“Information prior to April 2013 is not held by the CCG as it pre-dates
our legal existence and as such is exempted under “Legacy” regulations
within the FOI Act and guidance from the Information Commissioner’s
Office: i.e.. public bodies are not liable to disclose information
before they became public bodies. The CCG was legally formed on 1st
April 2013 and is only subject to FOI requests after this date.
Therefore pre-April 1st calendar year information should be requested
from the Department of Health instead.”

MY REQUEST FOR INFORMATION RELATES TO DECISIONS TAKEN BY BLACKPOOL CCG
AND LANCASHIRE MEDICINES MANAGEMENT GROUP BETWEEN OCTOBER 2014 AND
NOVEMBER 2015.

FIVE OF THE SIX CCG’s THAT MAKE UP LMMG CLASSIFIED CO-PROXAMOL BLACK
DURING THIS PERIOD.
It wasn’t the previous PCT that made the decision to stop my
prescription during November 2015. It was Blackpool CCG one of the 6
CCG’s that make up LMMG!

Q1. Does Blackpool CCG operate a process for requesting approval to
continue prescribing Black or Grey drugs? If your answer remains No
could you explain why this was not considered as a possibility?
[No Explanation Given]

Q2
“The decision was made following the 2004 CSM recommendations.”
NO! THE DECISIONS WERE MADE BETWEEN 2014 AND 2015 WHEN PRESCQIPP ADVISED
‘MEMBER CCG’s’ TO STOP PRESCRIBING DUE TO INCREASING COSTS!

Q3. Could you supply the following: - A copy of the minutes from any
meetings held leading to your decision of a ‘Do Not Prescribe
Classification’ for Co-proxamol? [Minutes required]
The CCG does not hold this information; it was prior to the
establishment of CCG.
[YES YOU DO!]

Fig1 LMMG website clearly shows Co-proxamol was discussed during October
2014. (Fig 2 Shows That Melanie Preston from Blackpool CCG was present
at that meeting)
Q4. A copy of all the information you reviewed and considered prior to
making the decision to stop prescribing Co-proxamol. [Information
required]
Ans; The CCG does not hold this information; it was prior to the
establishment of CCG
[NO IT WASN’T] It was between October 2014 and November 2015

Fig 1
Medicine Recommendations
[5]http://www.lancsmmg.nhs.uk/recommendatio...
Medicine                Brand           Indication           Disease
Category                   Date Considered by LMMG
Co-proxamol                             Pain                 Central
Nervous System             October 2014

Fig 2
Minutes of the Lancashire Medicines Management Group Meeting Held on
Thursday
9th October 2014 at Preston Business Centre
[6]http://www.lancsmmg.nhs.uk/download/minu...

PRESENT:
Melanie Preston (MP) Assistant Director - Medicines Optimisation NHS
Blackpool CCG

Date considered by LMMG October 2014 (I have read through the published
minutes for October 2014 on the LMMG website, unfortunately I wasn't
able to find any information relating to Co-proxamol.

Please can you answer my questions from the period 1st April  2013 to
November 2015

Yours sincerely,

James Kelly

show quoted sections

Dear NHS Blackpool Clinical Commissioning Group,

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

I am writing to request an internal review of NHS Blackpool Clinical Commissioning Group's handling of my FOI request 'Loss of Co-proxamol Leads To A Life Of Relentless Side Effects And Substandard Pain Relief!'.

I CAN ONLY ASSUME THERE HAS BEEN A DELIBERATE ATTEMPT TO MISLEAD ME WITH YOUR ANSWERS TO MY FOI REQUEST.
The information I'm requesting relates from the period October 2014 to November 2015

Your response:-
“Information prior to April 2013 is not held by the CCG as it pre-dates our legal existence and as such is exempted under “Legacy” regulations within the FOI Act and guidance from the Information Commissioner’s Office: i.e.. Public bodies are not liable to disclose information before they became public bodies. The CCG was legally formed on 1st April 2013 and is only subject to FOI requests after this date. Therefore pre-April 1st calendar year information should be requested from the Department of Health instead.”

MY REQUEST FOR INFORMATION RELATES TO DECISIONS TAKEN BY BLACKPOOL CCG AND LANCASHIRE MEDICINES MANAGEMENT GROUP BETWEEN OCTOBER 2014 AND NOVEMBER 2015. FIVE OF THE SIX CCG’s THAT MAKE UP LMMG CLASSIFIED CO-PROXAMOL BLACK DURING THIS PERIOD. It wasn't the previous PCT that made the decision to stop my prescription during November 2015. It was Blackpool CCG one of the 6 CCG’s that make up LMMG!

Q1. (Partial Answer) Does Blackpool CCG operate a process for requesting approval to continue prescribing Black or Grey drugs? If your answer remains No could you explain why this was not considered as a possibility? [No Explanation Given] (Many other CCG’s discussed this situation and put plans in place for patients Re:- Stockport CCG Request to prescribe from the Black or Grey list)

Q2 “The decision was made following the 2004 CSM recommendations.”
NO! THE DECISIONS WERE MADE BETWEEN 2014 AND 2015 WHEN PRESCQIPP ADVISED ‘MEMBER CCG’s’ TO STOP PRESCRIBING DUE TO INCREASING COSTS!

Q3. Could you supply the following: - A copy of the minutes from any meetings held leading to your decision of a ‘Do Not Prescribe Classification’ for Co-proxamol? [Minutes required]
The CCG does not hold this information; it was prior to the establishment of CCG.
[YES YOU DO!]

LMMG website clearly shows Co-proxamol was discussed during October 2014 and Melanie Preston from Blackpool CCG was present at that meeting.

Q4. A copy of all the information you reviewed and considered prior to making the decision to stop prescribing Co-proxamol. [Information required]
Ans; The CCG does not hold this information; it was prior to the establishment of CCG [NO IT WASN’T] It was between October 2014 and November 2015 (I honestly believe Blackpool CCG didn’t consider patient well-being & safety concerns prior to making their decision)

Every government department I have contacted reiterates the nonsense given by MHRA during the period 2004 - 2007.

The Facts are:-

Approximately 1.7 million patients were taking co-proxamol prior to the ban which equated to just 0.02% of patients being at risk from suicide (intended or not). Many of the deaths had been caused by the unauthorised use of the drug by others.
The vast majority of patients used Co-proxamol responsibly and in normal use the drug posed no threat to life and had considerably fewer side effects than any of the other pain killing drugs.
MHRA refused to accept any of the positive responses they received from ‘Medical Professionals’, MP’s, or Patients.
January 2005, MHRA published the outcome of the review. UK Ministers had decided to accept the advice of the Committee on Safety of Medicines (CSM) that co-proxamol should be withdrawn from the market. This report had such a low response (Just 14.7%) no credible or useful information could have been gained from the exercise!
MHRA AND DEPARTMENT OF HEALTH HAVE HAD A COMPLETE DISREGARD FOR PATIENT’S SAFETY AND WELLBEING THROUGHOUT THIS PERIOD!

November 2015
CCGs informed their members to switch patients to alternative medication after fears that the annual spend would far outreach the £3.2 million spent in 2014 on Co-proxamol. This decision was based on financial savings NOT MEDICAL NEED!
Within a month of this decision the recommended alternatives were once again causing increasing unpleasant gastrointestinal side effects and not providing me with adequate pain relief resulting again in me having to lead a life of increased side effects, lack of sleep, and relentless debilitating pain.

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.
The following Information comes from an American FDA study taken between 1969 and 2005 and would have been available during 2005 when MHRA made their decision to remove the MA (Licence) for Co-proxamol.
KEY
(AER’s) Total Number of Adverse Event Reports
(POR) Proportion of Overdose Reports
(NSR) (Number of Suicide Reports
Total Number of Death Reports (NDR)
AER’s POR NSR NDR
Oxycodone 15,941 28.4% 982 6,625
Tramadol 7,548 7.9% 264 963
Propoxyphene
(Co-proxamol) 5,270 24.2% 437 1,566

You can clearly see Oxycodone is a far more dangerous drug for patients than Co-proxamol in all categories yet MHRA have issued an additional 138 'Marketing Authorisations' for Oxycodone since the removal of Co-proxamol, adding approximately £1,550,000 to their income. This was the total they received in application fees for the new marketing authorisations and does not include any subsequent licence variations or service fees. (They don’t want to disclose this amount)

If you didn't discuss or consider patients well-being and safety you should consider this subject again.

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

Yours faithfully,

James Kelly

Foiteam (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT), NHS Blackpool Clinical Commissioning Group

1 Attachment

Dear Mr Kelly

 

Please find attached the response to your review of your Freedom of
Information request. Please accept my sincere apologies for the delay in
responding to you  and I would like to thank you for your continued
patience.

 

Kind regards

 

Louise Booker

FOI/SARS Manager
 
Midlands and Lancashire CSU 
 
[1]www.midlandsandlancashirecsu.nhs.uk

 

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References

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1. http://www.midlandsandlancashirecsu.nhs....