Make Co-proxamol A Controlled Drug

Gwrthodwyd y cais gan Home Office.

Dear Home Office,
On the 13th Feb 2013 the “Advisory Council on the Misuse of Drugs” sent a letter to Parliament Re- Tramadol.
Extract from letter; “Prescribing data from the NHS Business Services Authority (NHSBSA) indicate an increase in prescribing, with the number of Daily Defined Doses (England) increasing from approximately 5.9 million in September 2005 to 11.1 million in September 2012. This may be associated with Co-proxamol’s phased withdrawal from 2005. Data from the Office of National Statistics (ONS) for 2011 shows 154 deaths where tramadol had been mentioned on the death certificates; in 2009 there were 87 such mentions and in 2008 this figure was 83. The majority of tramadol related deaths are where it has been obtained through non–prescribed means.” This resulted in the home office issuing an urgent communication rendering tramadol a controlled drug during June 2014.

Because the deaths involving Tramadol in 2014 (240) are almost identical to that of Co-proxamol during 2007 (242) the situation appears to be exactly the same. During October 2006 a ‘Pulse survey’ revealed that 70% of GP’s and 94% of Rheumatologists demanded the MHRA reviewed its decision. That request fell on deaf ears!

The simple fact that Co-proxamol was and is a far superior medication when compared to Tramadol and should be granted the same ‘controlled’ status!

On15th December 2005 the MHRA stated, “I can confirm that the two most useful references which informed the Working Group on different methods of analgesia were the 'Bandolier review' and the 'Australian Acute Musculoskeletal Pain Guideline.'

Example; ‘Bandolier’ tries to find examples of systematic reviews where there is a solid take-home message. After all, we are familiar with uncertainty, and systematic reviews that merely bleat, often inadequately, about inadequacies of research are rather depressing. The trouble is that people use phrases like 'evidence-based medicine', or 'meta-analysis' or 'systematic review' as some form of talisman. Attach one of these phrases to a point of view and an argument is won!

That fails to take into account the fact that reviews can be awful, and even completely wrong. Often systematic reviews try to cover too much ground, and end up giving us too superficial a view of a problem. And even the best of reviews of good studies can leave us in the lurch when there are not enough good studies. Reference: - http://www.medicine.ox.ac.uk/bandolier/b...

The ‘Australian Acute Musculoskeletal Pain Guideline’ was rescinded by National Health and Medical Research Council in 2013.

Australia 2013 The Administrative Appeals Tribunal (AAT) reversed the decision taken in 2011 to ban the drug and concluded that the quality, safety, and efficacy of Di-Gesic and Doloxene (Co-proxamol) were not unacceptable, provided that additional conditions and monitoring arrangements were imposed. The drug is now available for prescribing again. Reference: - http://www.nhmrc.gov.au/_files_nhmrc/pub...

Summery
January 2005 – MHRA announces withdrawal of coproxamol
October 2006 – A Pulse survey reveals 70% of GPs demand the MHRA review its decision
January 2007 – MPs demand a U-turn on withdrawal at special House of Commons debate
October 2007 – 60,000 patients remain on coproxamol
December 2007 – Final withdrawal of coproxamolJanuary 2008 – PCTs panic as price of coproxamol soars
November 2015 patients panic as price of coproxamol soars again to £49.50 and CCG’s enforce an outright ban on prescribing Co-proxamol.
March 2016 the price for coproxamol soars again to a ludicrous price of £125.00. (The best quote I've had for a private prescription was from Boots @ £105.00 / 100 tabs, and then there would be a £20.00 courier fee on top! (This equates to a 46 fold increase in the price it was when it was a licensed drug)!

When MHRA took the disastrous decision to remove the licence for Co-proxamol on the grounds of a report derived from what now appears to be pure guesswork and an Australian study that was later rescinded in 2013 is it possible for the ‘Home Office’ to intervene and put right this catastrophic injustice?

With regard to Tramadol I've been informed from the ‘Department of Health’ that the MHRA was not involved in the decision of ‘controlled status’ and if the ACMD considered there to be sufficient evidence, they could make co-proxamol a controlled drug. A medicine does not need to be authorised in order to be classified as controlled, as illicit drugs are also controlled under the same legislation.

Would it be possible for you liaise with the Advisory Council on the Misuse of Drugs (ACMD) to reclassify Co-proxamol as a controlled drug? This would have a profound impact for all the patients that were included on the MHRA’s ‘Named Patient List’ and were still being prescribed Co-proxamol until November 2015. It would also reduce the price of the medication dramatically.

Yours faithfully,

James Kelly

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Dear FOI Requests,
I first contacted the Home Office by Letter to the following address; unfortunately I didn't receive an acknowledgement or reply.

Rt Hon Theresa May MP
Home Secretary
2 Marsham Street
London
SW1P 4DF

I realise this request to the ‘Home Office’ was more of a plea. I only submitted this through FOI because my previous letters to the Home Office, Advisory Council on the Misuse of Drugs, and the All-Party Parliamentary Group on Pharmacy came to naught

I thought if I made my request publicly through 'What Do They Know' FOI there would have been a reasonable chance for an answer to the question in my final paragraph: -

"Would it be possible for you liaise with the Advisory Council on the Misuse of Drugs (ACMD) to reclassify Co-proxamol as a controlled drug? This would have a profound impact for all the patients that were included on the MHRA’s ‘Named Patient List’ and were still being prescribed Co-proxamol until November 2015. It would also reduce the price of the medication dramatically."

I remain hopeful for a reply to my third attempt for an answer via email: -

Subject: Reclassification of Co-proxamol to 'Controlled Drug' Status
Date: 14/04/2016 23:35:33 GMT Daylight Time
From: Send IM to: [email address]
To: [email address]

Yours faithfully,
James Kelly

FOI Requests, Home Office

Thank you for contacting the Home Office FOI Requests mailbox.

The Freedom of Information (FoI) Act 2000 provides public access to
recorded information held by the department.

If you have submitted a valid FoI request, we will acknowledge your
request within 48 hours, and aim to provide the information requested
within 20 working days as specified under the FoI Act

PLEASE NOTE

If you have a general immigration enquiry, or require an update on a
specific case, you should contact UKVI directly, contact information can
be found here:
https://www.gov.uk/government/organisati... and
[1]https://www.gov.uk/visas-immigration

General enquiries should be directed to
[2][email address]  

 

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Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

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FOI Requests, Home Office

Mr Kelly

Thank you for contacting the Home Office with your request.

This has been assigned to a caseworker (case ref 39363). We will aim to send you a full response by 17/05/2016 which is twenty working days from the date we received your request.

If you have any questions then please do not hesitate to contact us.

Thank you,

J Douglas
FOI Requests
Home Office

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Public Enquiries (CD), Home Office

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Mr James Kelly,

 

 

Thank you for your email.

 

Please find a response attached.

 

 

 

Kind regards,

 

 

Public Enquiries

 

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Communications via the GSi may be automatically logged, monitored and/or
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Dear Public Enquiries (CD),
I'm a Patient Not a Pinball!

I find your response (20160419 ResponseT2978 16.doc) entirely unsatisfactory you state “ it is open to the MHRA to consider applications for marketing authorisations whether or not they include drugs controlled under the Misuse of Drugs Act 1971. As such, your suggestion to include co-proxamol as a controlled drug would not change this.”

In my quest for a resolution to this situation I found myself being buffeted (Pinball Effect) from one organisation to the other with no end result. I'm not a person who will sit back and accept this situation I've contacted my MP, MEPs, DOH, MHRA, my local CCG, APPG Secretariat and many of the organisations who originally disputed the MHRA’s decision to remove the licence for Co-proxamol. I've also submitted several ‘Freedom of Information’ requests.

As you can see from my correspondence below no individual organisation will accept responsibility and that changes to this situation MUST BE AGREED.

Subject: RE: GCEP-00110012: Co-proxamol "Named Patient Safety Net"
Date: 25/04/2016 16:32:34 GMT Daylight Time
From: [email address]
To: Send IM to: @aol.com
CC: [email address], [email address]

Dear Mr Kelly,
Thank you for your email and sincere apologies for the delay in responding to your questions regarding the supply of co-proxamol.
As you are aware the Medicines and Healthcare products Regulatory Agency (MHRA) has responsibility for the regulation of medicines and medical devices. The MHRA together with independent expert advice from the Commission on Human Medicines (CHM) is responsible for ensuring that the overall balance of benefits in terms of effectiveness and risks of medicines is positive at the time of licensing and remains so thereafter.
Co-proxamol is a combination of paracetamol and dextropropoxyphene which was licensed for the treatment of pain. In 2005, it was established that co-proxamol was associated with an unacceptable risk of fatal overdose. It was concluded that the benefits of the continued availability of co-proxamol did not outweigh the risks and that co-proxamol should be withdrawn from the market. All licences were cancelled by the end of 2007.

In June 2010, the European Commission recommended that due to the safety concerns co-proxamol should no longer be available across Europe.
(I Believe Their Decision Was Based On the MHRA’s Original Research)

In 2011, the USA’s Food and Drug Administration (FDA) advised healthcare professionals to stop prescribing co-proxamol due to serious effects on the electrical activity of the heart.
(I have been led to believe the Xanodyne trial, commissioned by the FDA in late 2009- 2010 to ascertain the possible consequences of increasing doses of dextropropoxyphene on cardiac function. This followed the FDA’s refusal to accept the Public Plea to ban it.
They gave healthy 25 - 45yr old volunteers daily doses of 600mg (2.31 times the max UK dose) & 900mg. (3.46 times the max UK dose). After 11 days they had to stop the trial as some of the volunteers developed serious & potentially fatal cardiac arrhythmias.
The FDA's / Xanodyne Pharmaceuticals cardiac conduction testing was performed with extremely high daily doses of Dextropropoxyphene! While Co-proxamol, contains only 32,mg/maximum 8 tabs/day which only amounts to 260mg/day!

http://www.fda.gov/downloads/AdvisoryCom...

The USA equivalent ‘Darvon’ has a usual dosage of one 65 mg propoxyphene hydrochloride capsule every 4 hours 6 tablets per day. The maximum daily dose is 390mg which is significantly higher than the UK maximum dose.)

The MHRA has always acknowledged that there may be a small group of patients who would find it very difficult to change from co-proxamol to an alternative analgesic.

The MHRA is not in a position to guarantee the supply of co-proxamol but has referred to the provisions within the legislation regarding the supply of unlicensed medicines such as co-proxamol, on the responsibility of the prescriber, who can judge the risks and benefits in consultation with the patient. Under this provision prescriber's, must consider whether the medicine is the best option for their patient and subsequently take on personal responsibility for any adverse effects the patient may experience. This provision was not introduced by the MHRA specifically for co-proxamol and applies to all unlicensed medicines.
(This is exactly why Co-proxamol should have been classified as controlled. The price of Tramadol has remained constant despite its reclassification to controlled).

The MHRA are aware that the costs associated with the production of smaller quantities of co-proxamol have increased and some Clinical Commissioning Groups (CCGs) have issued guidance that prescriber's should review patients receiving co-proxamol to establish whether those patients can be prescribed alternatives which offer better value for the NHS. The MHRA does not have any role in the regulation of clinical practice, the cost of prescribing or the advice issued by CCGs.
(During 2005 all patients were taken off Co-proxamol and forced to trial the alternatives. Some patients who couldn't tolerate the drugs were placed on the ‘Named Patient safeguard.’ All patients who were able to be placed in this group had all proved beyond any doubt that all alternative pain relief had been useless. Why should they be forced to go through this process again? The MHRA are certainly responsible for this situation by insisting the licence was removed)

You have raised questions regarding the classification of Tramadol as a controlled drug and whether this classification could have been applied to co-proxamol. The MHRA were not involved in the decision of the Advisory Council on the Misuse of Drugs (ACMD) to reclassify Tramadol as a controlled drug.
As mentioned in your correspondence, the majority of tramadol related deaths occurred in individuals who had not been prescribed tramadol – illicit use of a prescription only medicine. If the ACMD considered there to be sufficient evidence, they could make co-proxamol a controlled drug. A medicine does not need to be authorised in order to be classified as a controlled drug, as illicit drugs are also controlled under the same legislation.
(Illicit use of Co-proxamol was a concern of MHRA when the decision was taken to remove the licence Re: - Dr David Kelly & others)

In order for co-proxamol to be made available again as a licensed medicine in the UK, an application would need to be submitted to the MHRA for a new marketing authorisation for co-proxamol. The application would need to meet the current standards required in terms of the safety, quality, and efficacy of the product regardless of the controlled drug status.

I hope this information is useful.

Kind Regards,

Ronke Omotayo (Mrs)
Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [email address]
Stay connected: mhra.gov.uk/stayconnected
__________________________________________________________________________________________
From: @aol.com [mailto: @aol.com]
Sent: 11 February 2016 19:45
To: MHRA Customer Services
Cc: [email address]; [email address]
Subject: Co-proxamol "Named Patient Safety Net"

Dear MHRA,
Following the advice given below from Blackpool NHS I'm requesting a reasonable response to my points put to my local CCG on the 4th February 2016.

Following your review of Tramadol you granted a licence to “Bristol Laboratories Limited” on 27th June 2006.

On the 13th Feb 2013 the “Advisory Council on the Misuse of Drugs” sent a letter to Parliament Regarding the misuse of Tramadol. This resulted in the home office issuing an urgent communication rendering tramadol a controlled drug in June 2014. Most patients and clinicians would have welcomed “controlled status” for co-proxamol back in 2007!

Because the deaths involving Tramadol in 2014 (240) are almost identical to death rate of Co-proxamol (242) during 2007 the MHRA now appears to be in the exact same situation again.
The fact that Co-proxamol was and is a far superior medication when compared to Tramadol do you now think it would be prudent to re-license Co-proxamol in order to give patients a better quality of life, and a more cost effective drug?

Yours sincerely

James Kelly

Blackpool Clinical Commissioning Group
Blackpool Stadium
Seasiders Way
Blackpool
Lancashire
FY1 6JX
Telephone: 01253 951200

Email: [email address] Contact Form sent 04/02/2016 @23:04

[email address] Email sent 10/02/2016 14:26

When the MHRA de licensed the product at the end of December 2007 they admitted in published documentation that there would be “some” patients left without suitable alternate pain management, and guaranteed that these patients would be protected and their well-being made safe by their “Named Patient safety Net.” Simultaneously they introduced a policy that the “RESPONSIBILITY FOR THE PRESCRIBING OF CO-PROXAMOL BY UK DOCTORS WOULD FALL ON THEM. This resulted in their insurers refusing to insure the doctors and the medical unions such as MDDUS who advised a blanket ban on any prescription for Co-proxamol. Subsequently this left their “Named Patient Safety Net” in tatters, and ultimately resulted in thousands of patients being left to live without suitable pain management, or left to cope with unmedicated pain.

On 27th June 2006 MHRA; Based on the review of the data on quality, safety and efficacy the UK granted a marketing authorisation for the medicinal product Tramadol 50mg Capsules (PL 17907/0110) to Bristol Laboratories Limited. Tramadol 50mg Capsules is a prescription only medicine. Was this another mistake made by MHRA? Because on the 13th Feb 2013 the “Advisory Council on the Misuse of Drugs” sent a letter to Parliament Re- Tramadol (Dear Home Secretary and Secretary of State for Health)

Extract from letter;
“Prescribing data from the NHS Business Services Authority (NHSBSA) indicate an increase in prescribing, with the number of Daily Defined Doses (England) increasing from approximately 5.9 million in September 2005 to 11.1 million in September 2012. This may be associated with Co-proxamol’s phased withdrawal from 2005. Data from the Office of National Statistics (ONS) for 2011 shows 154 deaths where tramadol had been mentioned on the death certificates; in 2009 there were 87 such mentions and in 2008 this figure was 83. The majority of tramadol related deaths are where it has been obtained through non–prescribed means.”

Tramadol presents interesting data in the UK; in 1996, England and Wales reported one death with the drug mentioned, but by 2011 there were 154 deaths. (Rising to 240 in 2014) In Scotland, tramadol-related deaths increased from eight in 2001 to 34 deaths in 2011. The increase in tramadol-related deaths may reflect a rise in tramadol prescriptions, thus availability, but also points to the need to monitor closely any increase in deaths caused by opioid analgesics because it may signal an emerging problem in the UK.

Deaths involving Co-codamol (paracetamol and codeine) increased by 21% in 2014 to a new high of 63 deaths.
Deaths involving Codeine increased from 130 in 2013 to 136 (2014)
Deaths involving other specified opiate increased From 93 in 2013 to 129 (2014)
JUNE 2014 THE HOME OFFICE ISSUED AN URGENT COMMUNICATION (RENDERING TRAMADOL A CONTROLLED DRUG.)
MOST CLINICIANS WOULD HAVE WELCOMED “CONTROLLED STATUS” FOR CO-PROXAMOL BACK IN 2007!

In Summary,
2007 DEATHS WHERE CO-PROXAMOL WAS MENTIONED ON DEATH CERTIFICATES 242
2014 DEATHS WHERE TRAMADOL WAS MENTIONED ON DEATH CERTIFICATES 240
WHAT WAS THE POINT OF BANNING CO-PROXAMOL?

16th November 2015 CCG’s informed GP’s to stop prescribing Co-proxamol as the price had increased again to £49.50. (THIS WAS NOT THE PATIENTS FAULT) This now appears to have put the final nail in the coffin of the MHRA’s shambolic “named patients safeguard.” The NHS RAG list (Red, Amber, and Green) categorised Co-proxamol as a BLACK DRUG.

This decision has left thousands of patients who couldn't tolerate any of the alternate medications in a dire and deteriorating situation!

The number of suicides in UK continues to increase, with male rate at its highest since 2001. The male suicide rate has increased significantly since 2007, the ONS said, while female rates have stayed relatively constant and were consistently lower than those for men. UK deaths from alternate pain killers have also increased since the ban.

Because the deaths involving Tramadol in 2014 are almost identical as it was with Co-proxamol during 2007 the MHRA appears to be in the exact same situation they were in 2004. Surely it’s now time to reconsider the fact that Co-proxamol was and is a far superior medication when compared to Tramadol and Co-proxamol SHOULD BE RE-LICENCED IMMEDIATELY!

• Was your decision on Co-proxamol based on the MHRA findings made during 2004 to 2007?
• If not was it based on the recent price increase to £49.50?
• As I had been placed within the “Named Patient Safety Net” guaranteed by MHRA since 2007 I would assume there was a “local need” for me to continue with this drug.

Reply from contact form

Subject: RE: New submission from CCG Contact Form
Date: 11/02/2016 13:33:17 GMT Standard Time
From: [email address]
Reply To: @aol.com
CC: [email address]
Sent from the Internet (Details)

Dear Mr Kelly
Thank you for your email, I can understand your concerns relating to the use of pain killers and their potential consequences. The MHRA are the organisation that grant a licence for a product, (or not) and they do review these decisions based on evidence presented to them around safety concerns.
The MHRA provides CCGs and prescriber's with their recommendations regarding any cautions or licence changes and we are expected to act on these. I would advise that you submit your concerns to the MHRA for consideration since they will be able to respond directly around their process and actions relating to those painkillers.
I have attached a link to their website to enable you to contact them.

https://www.gov.uk/government/organisati...

Kind regards
Melanie
_________________________________________________________________________________

During 2005 I was taken off Co-proxamol and was forced to trial the alternatives, after almost two years of suffering the unbearable side effects from Co-codamol, Dihydrocodeine, and Tramadol. My GP continued not to prescribe Co-proxamol at that time, although when he realised how distressed I was becoming he eventually put me in touch with a GP within the practice who was continuing to prescribe.

My new GP certainly made my life tolerable over the next seven years and I appreciate there must have been a valid reason for his decision to stop prescribing. I received my final prescription for Co-proxamol on 11th November 2015, and have used them sparingly since then.

This situation now leaves me in complete dread of the side effects and lack of pain relief I will have to endure in the future.

The NHS via local CCG’s now appear to be determined to stamp out the ‘Named Patient safeguard.’ All patients who were able to be placed in this group had all proved beyond any doubt that all alternative pain relief had been useless. This decision will result in thousands of patients living with horrendous side effects or in unmedicated pain for the rest of their lives.

Fortunately I remain optimistic that someone will eventually raise their head above the parapet and seek justice for patients regarding Co-proxamol as they did in Australia.

The ‘Australian Acute Musculoskeletal Pain Guideline’ which was one of the two main documents the MHRA originally based its decision on was rescinded by National Health and Medical Research Council in 2013
Australia 2013 The Administrative Appeals Tribunal (AAT) reversed the decision taken in 2011 to ban the drug and concluded that the quality, safety, and efficacy of Di-Gesic and Doloxene (Co-proxamol) were not unacceptable, provided that additional conditions and monitoring arrangements were imposed. The drug is now available for prescribing again. Reference http://www.nhmrc.gov.au/_files_nhmrc/pub...
The situation in Australia was resolved in less than two years from the original banning order!

In my quest for a resolution to this situation I found myself being buffeted from one organisation to the other with no end result. I'm not a person who will sit back and accept this situation I’ve contacted my MP, MEPs, DOH, MHRA, my local CCG, APPG Secretariat and many of the organisations who originally disputed the MHRA’s decision to remove the licence for Co-proxamol. I’ve also submitted several ‘Freedom of Information’ requests.

As a responsible adult I think I'm more than capable of making decisions regarding my long term health needs!

Do I want to suffer the unbearable side effects of the alternative medication, or live with reduced medication and less pain relief for the rest of my life? CERTAINLY NOT!

Would I accept any long term problems that could occur with the continuation of Co-proxamol? ABSOLUTELY!

My Remaining Questions
• Is it the fact that it was the UK who started the ban on Co-proxamol initially that successive Governments are reluctant to admit that mistakes may have been made?
• Cardiac conduction testing, has there been any testing carried out using the UK's recommended dose?
• Is it possible for the Home Office to liaise with the Advisory Council on the Misuse of Drugs, MHRA, and the NHS in order to end this dreadful game of pinball?
• The Australian Government took less than two years to admit they got things wrong regarding Co-proxamol. Isn't it time for the UK Government to do the same?

Yours sincerely,

James Kelly

FOI Responses, Home Office

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Please see attached in response to your enquiry.

P. Zebedee
Knowledge and Information Management Unit
Performance and Risk Directorate
Home Office | 4th Floor | Peel | 2 Marsham Street |  London SW1P 4DF
www.gov.uk/home-office

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Public Enquiries (CD), Home Office

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