Co-proxamol, Why Are They Scrapping The the "Named Patient Safety Net"?

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When the MHRA delicensed 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.

In Summary,

During 2015 The NHS RAG list (Red, Amber, Green) categorised Co-proxamol as a BLACK DRUG which in turn prevented GP's from prescribing the drug. This decision has again resulted in another price increase to £49.50 a 17 fold increase on the licensed price for Co-proxamol, 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.” 

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

The MHRA's decision to remove the licence for Co-proxamol was on the grounds of the number of suicides in the UK. However the suicide rate 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 RELICENCED IMMEDIATELY!

FACTS!

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. 

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.”

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?

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 PATIENTS & CLINICIANS WOULD HAVE WELCOMED “CONTROLLED STATUS” FOR CO-PROXAMOL BACK IN 2007!  

What Can Patients Do?

Check for any petitions or blogs on the subject and sign or comment.

Contact your MP,  local Press and CCG. 

 

3 likes, 145 replies

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  • Posted

    I am sure there are people like myself who will be in constand pain with the withdrawal of Co-proxamol for the rest of there lives.  That could mean more suicides In the UK.  There is no other painkiller that works for me after many many years with comparatively low pain threshhold that Co-proxamol gave me. I am 78 years old and not so many years in front of me now, all I have to look forward to is pain for the rest of my life.  No one wants to use the human rights act method of solving problems but the MHRA have condemed through there thoughtlessness many people to a life of complete misery.
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    • Posted

      hi Colin - I've been thinking along the same lines: unrelieved pain is, by definition, torture and that is outlawed under the U.N. Convention on human rights.  So we have a valid case to put, it's just knowing to whom, and how, that is the problem.
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  • Posted

    I agree entirely with your anger, I was incandescent for years ! Basically, doctors do not have the time to read in full medical papers & respond to them if they disagree,& they WERE overprescribing for years & didn't listen to the MRHA warnings ! SOME doctors are arrogant & don't like to be told what to do !!

    They trust the summaries of medical papers to be correct ! They believed the paper that Coprox was a dangerous drug, which is true & it SHOULD have been restricted (NOT withdrawn) but they also believed the summary of the Wang Po paper that coproxamol was NO BETTER than paracetamol, which was flawed because it was conducted with young healthy patients with short term pain & dosage !! Pain specialists have explained that Coproxamol works better because of it's different metabolism & accumulative effect when taken for chronic pain !

    What's all this about 'stopping' the named patient prescription ? I presently do have Coproxamol prescribed PRIVATELY by my GP who has eventually listened to my evidence & argument & now trusts me not to abuse it & to store it safely, which, because she kindly does not charge me, costs me £4.90/56tabs. Because I take only 1 Coproxamol+1 Paracetamol 3 times a day to give me adequate analgesia with minimal side effects that lasts me approx. one month.

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    • Posted

      MHRA “Named Patient Safety Net.” I was placed in this group in 2008 and received a regular supply until November 2015 when I received a call from my surgery telling me they were no longer able to supply me. The only explanation given was “it is a highly toxic and dangerous drug and no longer safe to prescribe.” (This was the reason given by MHRA in 2005)

      This new NHS advice is being given on totally discredited information originally supplied by the MHRA during 2004 – 2007!  

      There are six CCG’s operating in Lancashire (Clinical Commissioning Groups). Five have followed this advice and only one hasn’t responded at this time.

      Co-proxamol

      Decisions of Lancashire local decision making groups:

      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.

      Recommendation

      LMMG (Lancashire Medicines Management Group) recommendation:                   Black

      Reason for decision:  Not recommended for prescribing on the NHS in Lancashire

      Supporting documents:                                     None                                                                     NHS Blackburn with Darwen

      CCG and NHS East Lancashire CCG               Black

      NHS Blackpool CCG                                         Black              

      NHS Chorley and South Ribble CCG                Black

      NHS Greater Preston CCG                                Black              

      NHS Fylde and Wyre CCG                                Black

      NHS Lancashire North CCG                              Black              

      NHS West Lancashire CCG                              (No Response)

      This situation will be occurring throughout every county.

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    • Posted

      Do you think perhaps that you may be concentrating too much on the NHS prescriptions of coproxamol, JK ? Now that the price has rocketed, I'm afraid we shall have to convince the powers that be that there is a proportion of the society who will not be at risk of taking this drug in prolonged disage, because they are responsible, are not of a susceptible genotype & benefit from the accumulative & metabolic properties of the drug in therapeutic doses. We have to somehow convince the UK powers AND the manufacturers that the demand WILL continue only if the prices come down, otherwise it will inevitably dry up because it will be no longer profitable for the pharaceutical rogues !! It's hard to know where to start, if it isn't already too late !
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  • Posted

    You are talking about NHS prescriptions which have to have the blessing of the CCG !!! I am talking about a PRIVATE PRESCRIPTION which a GP can legally give to a patient for whom they consider it  benefitial, appropriate & medically safe, with the patient, GP & pharmacist taking legal responsibilty for the possible consequences in the event of an accidental or intentional harm/ death leading to a court case !

    We HAVE to accept that Coproxamol IS a dangerous drug ! It is metabolised & acts quickly, one does not have to take many to cause death, AND there is NO known antidote. It is highly unlikely that any pharmaceutical co. will, now that there is little 'demand', spend £thousands on finding an antidote, there's no profit in it !!

    Prof. Hawton NEVER recommended licence withdrawal in his original paper, only further restriction, i.e. making it a Controlled Drug like morphine e.g.

    HOWEVER, it wouldn't surprise me if Prof. Hawton was in some way involved in the investigation into the death of David Kelly, the 'weapons of mass destruction' Inspector ! David Kelly, as you know, was 'said' to have committed suicide with the aid of Coproxamol, tho' there was no medical evidence of the drug in sufficient quantities in his body to have caused his death !! ??

    IF a GP trusts his/her patient to use & store the drug responsibly & safely, & the pharmaceutical company is prepared to continue to make it, & the distributors are still prepared to supply it & pharmacy owners & pharmacists are prepared to dispense & sell it, then Coproxamol IS legally obtainable in the UK, ON PRIVATE PRESCRIPTION !!

     

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    • Posted

      The supply of Co-Proxamol on a named-patient, or unlicensed basis was provided by Clinigen until 2013. The contract then moved to “Creo Pharma” who continued to supply the drug in the same way. As far as I know this is the only company that can supply this drug in the UK.

      On November 16th 2015 NHS business services authority announced that the following price amendments would apply for Co-proxamol the reimbursement prices for 100 - 32.5mg/325mg tablets would increase to £49.50.

      Assuming all GP’s who had placed their patients on the MHRA’s “Named Patient Safety Net” and trusted their patients to use, and store, the drug responsibly would be content to carry on prescribing on a private prescription. I would be very interested in finding out how your pharmacist can source Co-proxamol for the price you pay for your private prescription when the cost to the NHS would be £49.50 for 100 tablets. 

      My GP was fully prepared to prescribe it on a free NHS prescription right up to the date that individual CCG’s changed its status to “Black” during November 2015.

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  • Posted

    You are quite right, the tablets I am dispensed are made by Creo. I'm afraid the details of how much Creo charges the NHS are not my primary concern. Where did you get this information from, & exactly what is the 'reimbursment price'  ? I am more concerned with how few people AND GPs know that it IS possible to safely & legally obtain Coproxamol on private prescription at a reasonable price ! It is an outrage that so many people's lives are made such a misery because of ignorance & unnecessary confusion & fear. I recently attended a follow-up appt. with a delightful, caring Rheumatology Consultant who was SO excited & thrilled to know that, not only it was POSSIBLE but that my GP was actually prescribing them for me privately. Her intention was to ask ALL her patients' GPs to consider doing the same as pain relief without horrendous side effects was a major problem for them since withdrawal of the licence !!! Doctors don't know the facts ( they have more pressing priorities in today's struggling NHS !) let alone their patients ! However, I am a little concerned that too much rocking the boat could even lead to peevish closure of the 'private prescription' option if we are not careful ! Exactly WHAT are you campaigning for yourself, apart from information ? Have you, by chance, been recently chasing information via the 'freedom of information' path ?? Are you JK? Are you concerned for your own well being amongst the thousands of pain sufferers, or is it an academic well meaning cause you are pursuing ?
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    • Posted

      My situation; (JK)

      January 2005 I was taken off Co-proxamol and prescribed several alternatives which proved to be entirely ineffective. Towards the end of 2005 I was placed back on Co-proxamol however at the end of December 2007 the licence was revoked. This meant that once again I had to suffer the unbearable side effects of Co-codamol, Tramadol, and Dihydrocodeine for the next eighteen months. Eventually I was placed within the MHRA’s ‘Named Patient Safety Net.’

      My GP stopped prescribing Co-proxamol in November 2015. This situation now leaves me in complete dread of the side effects I will have to endure in the future

      I assume the 'reimbursement price' is the cost paid by the NHS to the pharmacist who dispenses the drug.

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    • Posted

      Hi Jun and Whogivesastuff1 - my Co-Prox are manufactured by Ennogen Healthcare Ltd., Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, so it would appear that at least 2 companies are still producing them, unless Ennogen are part of Creo.   The last time a price was quoted to me was a couple of years back, when I was told C-P now cost £20 per 100, before licence was withdrawn £0.20 per 100 - I don't know if those numbers are correct though.
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    • Posted

      Yes, it's only recently dawned on me that there is more than ONE supplier in England, I think they are ALL distributors importing the tabs but licensed to distribute by the Licensing Authority branch of the MHRA. Till your post I thought perhaps that Creo were used by the NHS, but obviously not as YOURS on NHS prescription come from Ennogen & MINE on a private prescription come from Creo !! All very confusing but it accounts for the different prices being asked by not only distributors but pharmacies !!! They are ALL taking their bite of the cherry & ripping off either the NHS or the patient !!

      June

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    • Posted

      Hi, I'm new to this group but have been following your thread about coprox tonight... My situation sounds so similar to yours and I'm going to have face being without coprox soon too.

      My GP originally took it off me totally when the ban first came in.. I was given cocodamol (with total nightmare side effects and no pain reduction at all), I was then given tramadol plus dihydrocodene, then eventually bupronorphine.. (All over a 2 yr period).. After nearly collapsing on bupronorphine after 3 days I demanded coprox back and was given it on named patient basis - but feeling guilty every time I ordered a repeat! Anyway, I was then on tramadol too and other higher medications I couldn't get off. I managed to get off tramadol, but I'm now on fentanyl, robaxin and gavapentin too, in addition to anti-inflammatory drugs... I swear that if coprox hadn't been taken off me all those years ago I'd not have had my meds all messed up! Anyway, I recently had a phone call from my GP - they want me to stop taking coprox thus year. But how? What do I do? What's the alternative? Of course I wish there was a drug to swap to, but all the hassle I had trying to find alternatives for over 10yrs since the initial ban has been a nightmare!

      A pain consultant is suggesting a drug called tapentadol - has anyone heard of that? I gues I got to try it but I'm not looking forward to it sad

      Thank you for listening x

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    • Posted

      Dear Hope, What a very appropriate name ! Welcome to our exchange of ideas & support ! If you've read all the posts, you'll know that the coproxamol situation throughout the world is pretty dire. Presently there is a worldwide shortage of the active ingredient (dextropropoxyphene - Sorry !) because of the multi-country ban on any medication containing it. To my knowledge, Australia is now the only country where it can be prescribed apart from the UK, but I'm not sure of the drug's regulations there.

      You don't mention what the source of your pain is ? A lot depends on that for different drugs seem to work better for different typres of pain. I'm afraid I'm not familiar with Tapentadol, but I don't think you will be alone in being denied coproxamol tablets, sadly. because the price to the NHS & private patients has rocketed recently to more than £130 for 100 tablets ! So it is understandable that the CCGs are putting pressure on GPs to find alternatives for their patients. Both Whogivesastuff & I, & I hope many others are writing to lots of people to try to get coproxamol relicensed with stricter regulations on its availability so that it is not used by people who are not responsible.

      I'm afraid that's not much hope for you, I'm sorry.

      It sounds as if you have a very compassionate & enlightened GP, because he has been willing to put his career on the line for you for a long time !

      I do hope that the medication your GP suggests will help. In the meantime do keep in touch, I'm sure everyone on this discussion will be very supportive & lend a listening ear.

      Kind regards

      June

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    • Posted

      hi!  So sorry to hear what you're going through: be firm with your GP; tell him what hell the pain is in without co-proxamol (pain isn't visible, you have to give them a picture): then present him (or her) with a letter for the Local Area Team saying that you had been taking co-proxamol safely for several years, that NO OTHER medication alleviates your pain and you were able to take co-proxamol without the nasty side effects of the other meds.  Accept full responsibility for continuing to take it as prescribed and explain that without it you will no longer have any quality of life.  

      It is still available, but that availability is going to be further and further restricted if doctors think they have found a satisfactory alternative.  So please, make it clear they have not, that you are suffering as a result and that there have been severe consequences for your physical and mental health. 

      We all need you to succeed and hope you will!  Helenx

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  • Posted

    Thanks JK ! you've unearthed some sterling info ! However, I really am not optimistic that all your hard work will bear fruit, I fear your namesake's plight is at the root of it all & the myth has gone too far now & spread to too many countries  to change in our lifetime. Perhaps it is better to concentrate one's energies on what IS achievable ! WHY do you think your GP won't give you a private prescription ? What reason does he/she give ? Or is it a matter of principle to you, or can you not afford it ? I think I understand something of what determines the price to me, e.g. How many other patients the pharmacy is ordering for, how much is the postage, & even whether you have a good relationship with the pharmacist, the more tabs he orders the cheaper it will be to the patients ! etc.etc. I am a socialist, retired midwifery tutor & health visitor - but there comes a time in one's life when one HAS to concentrate on one's own well being without harming anyone else, &, at 85, that time has come for me. I repeatedly sent my GP evidence from the internet of why it was morally & factually wrong to deny patients like myself a life enhancing drug which would neither do me nor anyone else any harm & how she could do it legally without the CCG's blessing. It took me about 4-5 years, but eventually, three months ago, she changed her mind & believed me that Coproxamol WAS a better analgesic than Paracetamol (!) & safer than the proposed alternatives, Wang Po's paper was flawed & many eminent pain specialists & rheumatologists & gastroenterologists  & ME ( & thousands of folks like me) were right AND she trusted me !! Look after yourself JK, use your energy to fight for YOUR rights & leave others to fight for theirs armed with your valuable information. I wish you good luck & a relatively pain free & enjoyable future, either with the present GP or another more intelligent & compassionate one !
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    • Posted

      Why it is important to fight to have Co-proxamol relicensed.

      I had always thought that the decision to withdraw the license for Coproxamol was seriously flawed and the views of patients and healthcare professionals had been completely ignored by MHRA in 2005.

      When Co-proxamol was a licenced drug there were approximately 1.7 million patients being issued with a total of 7.5 million prescriptions for Coproxamol each year.

      The MHRA’s shambolic “Named Patient Safety Net” reduced the number of patients to a derisory 150,000. This resulted in the price for Co-proxamol increasing from £2.70 per box of 100 to £21.38 plus additional expenses, (quote from prescQipp) bulletin “co-proxamol is now an unlicensed medicine, it has to be obtained from specific suppliers, and this incurs out-of-pocket expenses e.g. posting, packaging, and courier costs.

      November 2015 the NHS contacted local CCG’s to inform GP’s to stop prescribing Co-proxamol resulting in another price increase to £49.50.

      The price increase is directly linked to the number of prescriptions issued, so it would only be a matter of months before Co-proxamol became uneconomical for “Creo”to produce. This is why the “Black category” has to be removed by the NHS & CCG’s immediately!

      The MHRA’s catastrophic decisions have resulted in worldwide misery! The UK and EU initiative prompted the US Food and Drug Administration to take action in 2010 to withdraw dextropropoxyphene in the USA. This resulted in Canada, Singapore, Taiwan, and New Zealand to follow the same route.

      In December 2011 Australia also announced a decision to withdraw all analgesics containing dextropropoxyphene (Co-proxamol). However in April 2013 the AAT 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. This decision taken by the Australian Government proves that common sense can prevail!

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