Does Blackpool CCG operate a process for requesting approval to continue prescribing Black or Grey drugs?

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

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The request was partially successful.

Dear NHS Blackpool Clinical Commissioning Group,

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?
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 under the heading ‘Background’ you state 'Withdrawn from the UK market because of safety concerns.'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 Did you arrive at your decision on the grounds of the 2004 CSM recommendations which were seriously outdated by 2015?
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?
4. A copy of all the information you reviewed and considered prior to making the decision to stop prescribing Co-proxamol.
5. The occupations of all persons who were involved in making this decision.
6. The results of any voting which may have taken place in arriving at your decision.

Yours faithfully,

James Kelly

James Kelly left an annotation ()

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

On 15th 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 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. The Administrative Appeals Tribunal (AAT) reversed the decision took 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 inept decisions taken by the MHRA in 2005 has caused worldwide disruption in the manufacture of Dextropropoxyphene which is the main cause of the spiralling costs of Co-proxamol. 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 have been at best speculative and possibly just plain guesswork. With the fact the ‘Australian Acute Musculoskeletal Pain Guideline’ was rescinded in 2013 It surely has to be time for all the updated information regarding Co-proxamol to be thoroughly studied again by the NHS and a rethink of the positive effects that Co-proxamol has on patients well-being.

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.

A controlled status would have a positive impact for all the patients that were included on the MHRA’s ‘Named Patient List’ who were still being prescribed Co-proxamol until November 2015. It would also reduce the price of the medication dramatically.

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

PLEASE DO NOT MAKE ANY AMENDMENTS TO THE SUBJECT LINE

Thank you for your request for information. Your request was received on
Monday 18 April 2016 and I am dealing with it under the terms of the
Freedom of Information Act 2000.

Your request was received for the following CCGs:

FOI-01520-Q1H3-BP Blackpool CCG

 
In some circumstances a fee may be payable and if that is the case, I will
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If you have any queries about this letter, please contact me. Please
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Yours sincerely
 
Freedom of Information Officer
01772 214 227
[1][email address]

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

1 Attachment

Re: Request for information under the Freedom of Information Act 2000

 

Ref: FOI-01520-Q1H3-BP

 

Please find attached response to your freedom of information request, for
Blackpool CCG.

 

Yours sincerely

                                           

Freedom of Information Officer

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Dear Glover Chantelle (NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT),

Re: - http://www.lancsmmg.nhs.uk/medicines/co-... under the heading ‘Background’ LMMG states, “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.

Re: -Your reply 1 “NO”
Colour classification for medicines http://www.lancsmmg.nhs.uk/medicines/co-...
Black medicines
o NOT recommended for use by the NHS in Lancashire.
o Includes medicines that NICE has not recommended for use and terminated technology appraisals, UNLESS THERE IS A LOCAL NEED.

Since I had received a regular supply of Co-proxamol for the previous seven years while this was an unlicensed drug should have Proved There Was A Local Need For The Continuation Of Supply!

Re: -Your reply 2 “The decision was originally made then, and the MHRA has not reinstated the licence for the product.”

I find this response entirely unsatisfactory, 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.”
During 2005 I was taken off Coproxamol 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 with his decision 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 following 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.
A recent reply from my FOI request to MHRA states: - “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.
I now strongly believe that it is the decision taken by BLACKPOOL CCG ALONE that has caused my GP to stop prescribing Co-proxamol.
If you follow the link http://www.lancsmmg.nhs.uk/medicines/co-... it seems to me that out of the six CCG’s that make up the LMMG five have chosen to categorise Co-proxamol as ‘Black’ however West Lancashire appears to be free to continue prescribing. At this point I can only assume that meetings within individual CCG’s in Lancashire must have taken place.
Re: -Your reply 3, 4, 5, and 6 “The CCG does not hold this information; it was prior to the establishment of CCG.”
I feel that your answer refers to decisions taken by the CSM during 2004-2007, when I was asking the questions directly to Blackpool CCG on how they came to their decision to ban Co-proxamol. My questions need answers.

Yours sincerely,

James Kelly

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

Dear Mr Kelly

Thank you for your email.

I have forwarded this to the CCG for a response. Once we receive a response back we will forward back to yourself.

Kind regards

Chantelle Glover
Freedom of Information Communications Officer

Midlands and Lancashire CSU

Tel: 01772 214037
Email: : [email address]
Web: www.midlandsandlancashirecsu.nhs.uk

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

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

Dear Mr Kelly

 

I have received the below statement from the CCG with regards to your
further enquiry.

 

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 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:

 

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

 

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

 

 

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James Kelly left an annotation ()

Following another unsatisfactory response from my local CCG I have sent the following information to: - healthwatch@empowermentcharity.org.uk

I must stress that I have received exceptional care from my GP and the Rheumatology department at Blackpool over the years. Unfortunately my GP had to stop prescribing Co-proxamol in 2015.

Background

During 2005 I was taken off Coproxamol 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 with the advice given to him from his insurers and made his decision not to prescribe Co-proxamol at that time. When he realised how distressed I was becoming he 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 following 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.

Despite my repeated attempts to gain answers from my local CCG (via emails and FOI requests) none have been forthcoming.

My latest response from my FOI request simply states “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 decisions/recommendations previously made by Blackpool Primary Care Trust. Since the MHRA recommendation regarding Coproxamol still stands the CCGs position remains the same.”

FOI Request
https://www.whatdotheyknow.com/request/d...

As a direct result of their actions the CCG have deprived me of a tolerable existence by denying me effective pain relief without suffering the severe side effects of the alternate drugs

Despite my best efforts there appears to be no cohesion at all between the NHS departments. MMG’s, CCG’s, DOH, MHRA, ACMD, or the Home Office.

I've previously contacted these departments the APPG Secretariat and many of the organisations who originally disputed the MHRA’s decision to remove the licence for Co-proxamol at the end of 2007. I've also submitted several ‘Freedom of Information’ requests.

Facts on the efficacy of Co-proxamol!

The ‘Australian Acute Musculoskeletal Pain Guideline’ Which the MHRA relied on when making their decision to remove the licence for co-proxamol was actually rescinded by the Australian National Health and Medical Research Council in 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...

It had taken less than two years for the Australian Government to realise there was a major impact for patients and immediately reversed their decision on co-proxamol!

It is my strong opinion the inept decisions taken by the MHRA in 2005 has caused the worldwide disruption in the manufacture of Dextropropoxyphene which is the main cause for the spiralling costs of Co-proxamol. Search ‘Dextropropoxyphene’ today for the manufacturer the only result available is ‘no supplier information found for this compound’.

WHY HAS THE NHS ALLOWED THIS SITUATION TO OCCUR? WHO IS RESPONSIBLE?

The MHRA stated (and continues to do so via NHS RAG list, PrescQIPP, LAT’s, and CCG’s) “There is no robust evidence that efficacy of this combination product is superior to full strength paracetamol alone in either acute or chronic use.”

The following BMJ article was published on 27th June 1998 and was readily available to MHRA long before their recommendations were made!

Reference: - http://www.ncbi.nlm.nih.gov/pmc/articles...
Editor—Lawn Po and Zhang's review substantiates the widely held view that paracetamol is as effective as co­proxamol in single dose for acute pain.

1 We agree with their message; indeed, another recent systematic review comes to the same conclusion.
2 The authors dismiss comments we have made about the use of co­proxamol.
3 However, our remarks related to the treatment of chronic pain, which cannot and should not be managed with single doses of analgesics. Co­proxamol is recommended and has been extensively used at step 2 of the World Health Organisation analgesic ladder for managing chronic pain in cancer, when it is used in repeated doses. We are concerned that Li Wan Po and Zhang fail to make sufficiently clear that their analysis was of single dose studies only. It may therefore be taken out of context and dissuade doctors from implementing this good practice.
As we and others have suggested, the analgesic efficacy of single and repeated doses of co­proxamol is likely to differ, a lesson learnt 20 years ago with other morphine like opioid analgesics.
(4) Because of the extensive first pass metabolism of dextropropoxyphene which is dose dependent.
(5) Plasma concentrations after a single dose may be four times lower than those found in steady state after regular six hourly administrations. In addition, the active metabolite, norpropoxyphene, has a longer elimination half-life than the parent compound and will accumulate to some extent on regular dosing. Thus there is a strong pharmacokinetic basis for believing that repeated doses of co­proxamol are likely to be more effective than single doses.

Li Wan Po and Zhang's systematic review is therefore not directly relevant to the discussion of the efficacy of co­proxamol as it is usually used—in repeated doses. We agree that there is a lack of data from randomised controlled trials relevant to this situation. Such trials are required to settle the argument but are difficult to accomplish. In the absence of this evidence we abide by our view that extensive anecdotal experience cannot be disregarded. It is worth listening to patients when they report that pain not controlled by regular paracetamol alone is relieved by repeated doses of co­proxamol.

Reference: - G W Hanks Macmillan professor of palliative medicine
Karen Forbes Macmillan senior lecturer in palliative medicine
Department of Palliative Medicine, Bristol Oncology Centre, University of Bristol, Bristol BS2 8ED

19th October 2006 GPs demanded a U-turn on co-proxamol ban 70 per cent of GPs,
and 94 per cent of Rheumatologists demanded the MHRA revisit their decision.

Reference: -
http://www.pulsetoday.co.uk/gps-demand-u...

• GPC prescribing spokesman Dr Peter Fellows denounced the MHRA's position as 'absolute and utter nonsense'. He said the GPC was opposed to co-proxamol's withdrawal and it was inappropriate to expect GPs to prescribe it on a named-patient basis.
• Dr George Kassianos, a GP in Bracknell, Berkshire, said the withdrawal was a 'backwards step in pain management'.
• Dr Roger Henderson, a GP in Newport, Shropshire, said: 'The grounds on which this ridiculous decision has been reached are spurious. This drug is a lifeline for some of my arthritic patients.'
• Dr Andrew Bamji, president of the British Society for Rheumatology, said: 'My view is that it is unreasonable to withdraw a drug from those who understand the risk.'

13th July 2005 MP Caroline Flint (Parliamentary Under-Secretary Department of Health)
stated in Parliament: -
1. “At the end of the phased withdrawal, and following the cancellation or withdrawal of licences for existing products, provision will remain for the supply of unlicensed preparations. I understand that the drug will continue to be available on a named patient basis, and that the MHRA will communicate that fact clearly. Its doing so should deal with the question of supply, but I will check this point for my hon. Friend and I am happy to write to her about it.”

2. 17th January 2007 “Before the CSM review, co-proxamol was widely used. As I have said, there were 7.2 million prescriptions in England in 2004. We received 367 letters during the past two years from patients concerned by the decision. However, that number of letters represents a small minority given the overall benefits that we think will be gained by the withdrawal of co-proxamol. For those patients, the continued provision of co-proxamol through normal prescribing may continue until the end of 2007. We have confirmed with manufacturers that the manufacture of co-proxamol will continue after that date. The main manufacturer has informed us that it is its firm intention to continue to manufacture co-proxamol following the cancellation of the licences, so supplies will be assured.

Despite the withdrawal, we legislation gives the right to prescribers to prescribe off-label or unlicensed medicines if it is judged to be in the best interests of the patient. If there is clear clinical need, it will still be possible to prescribe co-proxamol, but in a more targeted way
legislation gives the right to prescribers to prescribe off-label or unlicensed medicines if it is judged to be in the best interests of the patient. If there is clear clinical need, it will still be possible to prescribe co-proxamol, but in a more targeted way with a stronger focus on the risk-benefit judgment for the patient—and the patient will be involved in the decision.

“I shall write to my hon. Friend about some of the issues that she has raised, and particularly about the question of stocks. Clearly, it is important to determine what the future holds for those people for whom co-proxamol is the only drug that can give them the relief that they need.”

December 18, 2007 MHRA clarifies co-proxamol position
“For a very small number of patients unlicensed co-proxamol can be supplied, on the responsibility of the prescriber.”

October 2008 Statement For Patient Organisations Co-proxamol (Distalgesic) available from Clinigen

Following a decision by the Medicines Healthcare and Regulatory Authority (MHRA) the licence for Co-proxamol was withdrawn from the market at the end of 2007. However, it is still available on a named patient basis to those who were unable to find a suitable alternative. From calls to our helpline we know that some people had difficulty in obtaining supplies.
In order to clarify the situation in regard to the UK market we recently met with Clinigen who have the licence to supply ‘unlicensed’ Co-proxamol.

We can confirm that Co-proxamol will continue to be available on a named patient basis as an unlicensed product. To clarify the situation Clinigen have given us the following statement:

Co-proxamol (Distalgesic), used for pain relief, is available from Clinigen on a ‘named patient’ or unlicensed basis. This follows restrictions placed on the supply of co-proxamol at the end of December 2007 by the Department of Health’s regulatory body, the Medicines, and Healthcare products Regulatory Agency (MHRA).

Clinigen is a specialist provider of unlicensed/specialist medicines and it has the required licenses and processes approved by the MHRA to provide co-proxamol to patients through local pharmacies.

If a doctor decides that there is no appropriate licensed pain relief medicine suitable for a patient, then he/she can issue a prescription for co-proxamol. A pharmacist can order co-proxamol directly from Clinigen and will explain to the patient that the medicine is being provided as an unlicensed product.

The MHRA is encouraging the controlled provision of co-proxamol to ensure that patients who need the medicine are provided with verified, quality product from an approved company.

THESE ASSURANCES HAVE BEEN DESTROYED DURING 2015! WHO IS RESPONSIBLE?

Before the ban it was estimated that 1.7 million GP patients per year received 7.5 million prescriptions for co-proxamol at an approximate cost of £2.70 per 100 tablets. Immediately after the licence was removed the price increased to over £23.00.

Prior to the ban I believe that 17 licences were held for the production of co-proxamol this had been reduced to just 1 Meda the manufacturer and Clinigen was the chosen MHRA Supplier at that time.
This decision removed all the competition from the market hence the price increase!

Co-Proxamol Update February 2016:

Please note, the contract for the supply of Co-Proxamol on a named-patient, or unlicensed, basis is no longer being produced by Clinigen. Here are the names of the companies currently supplying this drug (as of February 2016):

Supplies are still available
Creo Pharma: 0844 879 3188 E-mail sent 09/05/2015
Ennogen: 01322 629220 E-mail sent 09/05/2015 (No Response)

During 2015 CCGs were sending letters to GPs telling them to switch prescriptions for co-proxamol to paracetamol because of escalating costs for the drug since it was removed from the Drug Tariff in October.

GP practices have been told to switch patients to alternative medication after fears that the annual spend will far outreach the £3.2 million spent in 2014 on co-proxamol.

THE IRONY OF THIS CATASTROPHIC SITUATION!

THERE HAS BEEN NO SIGNIFICANT IMPROVEMENT IN SUICIDE RATES SINCE THE CO-PROXAMOL BAN BEGAN!

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.

The deaths involving Tramadol in 2014 are almost identical as it was with Co-proxamol during 2007 the NHS/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 CONTINUES TO BE A FAR SUPERIOR MEDICATION WHEN COMPARED WITH TRAMADOL, CO-CODAMOL, OR DIHYDROCODEINE.

The figures in the box below shows the data referred to in the judgment (the UK ban was phased in over the 3 years 2005–2007). The reduction in all drug suicides (362 fewer in 2008 than 2004) was greater than that from fatal poisonings attributed solely to dextropropoxyphene (196 fewer), suggesting that there may also have been a large additional reduction in mixed-drug overdoses. The frequency of other analgesic poisonings did not change significantly over 13 years (the rate varied between 209 and 287, but the linear trend was horizontal [− 0.5 deaths/year] and the 2010 data are equal to the long-term median [257]). Scientific thinking understands that minor year-to-year fluctuations are expected and are simply statistical noise rather than signals.

In another example, the manufacturer (Australian) and the AAT have also made much of the fact that there were more deaths recorded in the past decade in New South Wales coronial inquiries from codeine, paracetamol and tramadol than from dextropropoxyphene; however, no attempt was made to put that into perspective by adjusting for the vastly different rates of use.

The removal of Co-proxamol from the market can only be described as a failed experiment; someone needs to admit that genuine mistakes may have been made in the past, and have a complete reassessment of what was the most effective and low cost pain relieving drug for patients!