Co-proxamol Inconsistent Pricing

James Kelly made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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 Medicines and Healthcare products Regulatory Agency,
Background to my request.

Co-proxamol is continuing to be prescribed today and due to the ridiculous guidelines MHRA stipulate for the importation of unlicensed / off label medications some CCG’s have to pay £5.22 per tablet when they could be imported for approximately £0.05 per tablet if the NHS purchased in bulk!

If the NHS could have purchased in bulk quantities the remaining 60,000 named patients would have continued to benefit from suitable analgesia which had been guaranteed by June Raine (MHRA) and Caroline Flint (Minister for Public Health during 2007)!

Extracts from Openprescribing.net March to December 2019
https://openprescribing.net/national/eng...

NHS South Kent Coast CCG

Price per Tablet / Quantity Ordered

March 2019 £0.46 600
April 2019 £3.26 200
May 2019 £0.74 400
June 2019 £0.91 620
July 2019 £1.17 1200
August 2019 £0.84 400
September 2019 £1.05 600
October 2019 £1.07 700
November 2019 £0.87 400
December 2019 £1.05 700

NHS Enfield CCG
July 2019 £5.22 100
December 2019 £5.22 100

(Dec 2019 Last Available Data)

FOI request:
1. Please name the Importers who charged:
a) South Kent CCG just £0.46 per tablet during March 2019
b) South Kent CCG £3.26 per tablet during April 2019
c) NHS Enfield CCG £5.22 per tablet during July and December 2019

2. Total numbers of Marketing Authorisations issued up to 2005 and the numbers issued
between 2005 and 2019 for:
a) Oxycodone
b) Fentanyl
c) Buprenorphine
d) Tramadol

Yours faithfully,

James Kelly

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 20/159

Dear Mr James Kelly,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 2 April 2020.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 20/159

Dear Mr Kelly,

Thank you for your email of 2 April where you have asked " FOI request:
1. Please name the Importers who charged:
a) South Kent CCG just £0.46 per tablet during March 2019
b) South Kent CCG £3.26 per tablet during April 2019
c) NHS Enfield CCG £5.22 per tablet during July and December 2019

2. Total numbers of Marketing Authorisations issued up to 2005 and the numbers issued
between 2005 and 2019 for:
a) Oxycodone
b) Fentanyl
c) Buprenorphine
d) Tramadol"

A medicinal product must be the subject of a marketing authorisation or product licence before being placed on the market (regulation 46 of the Human Medicines Regulations 2012). Regulation 167 of those 2012 Regulations provides an exemption from the need for a marketing authorisation for a medicinal product. Unlicensed medicines, also referred to as specials, are products which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients.

An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient. Responsibility for deciding whether an individual patient has “special needs” which a licensed product cannot meet should be a matter for the prescriber responsible for the patient’s care. The importation of the product as a special may take place on the understanding that it does not displace that critical role of clinicians and their responsibilities to patients.

The details of the supply of unlicensed medicinal products are explained in the MHRA Guidance Note 14 - The supply of unlicensed medicinal products (“specials”):
https://assets.publishing.service.gov.uk...

The importer of an unlicensed medicinal product into the UK must be suitably licensed. Information is found in the link above.

Pricing of medicinal products is outside the scope of the work of the agency and we do not hold such data. The Department of Health may hold data pertaining to the cost of products – please contact them directly at the following email address: [email address]

If you have questions regarding the pricing of medicines, we advise you to contact the NHS Business Services Authority regarding pricing medication in the NHS:
Email: [email address]

Please find a list below of the number of Marketing Authorisations issued up to 2005 and the numbers issued between 2005 and 2019:

a) Oxycodone Up to beginning of 2005 17
2005-2019 251

b) Fentanyl Up to beginning of 2005 23
2005-2019 125

c) Buprenorphine Up to beginning of 2005 14
2005-2019 118

d) Tramadol Up to beginning of 2005 75
2005-2019 78

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publicatio....

If you have a query about the information provided, please reply to this email.

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

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Dear Medicines and Healthcare products Regulatory Agency,

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

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Co-proxamol Inconsistent Pricing'.

Re your response "If you have questions regarding the pricing of medicines, we advise you to contact the NHS Business Services Authority regarding pricing medication in the NHS:

As the pricing of co-proxamol is so eratic NHS Business Services Authority wouldn't be able to help! The only reason for the eratic pricing is because the recommendations stipulated by MHRA that each CCG has to order Co-proxamol individually resulting with the cost to the NHS reaching an alarming level! Please reference this request for review to the additional email "additional information to FOI 20/159

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

Yours faithfully,

James Kelly

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team
shortly. 

Please note that we are currently experiencing an unusually high number of
queries due to Covid-19, which may mean that it takes slightly longer for
us to respond than usual, please bear with us.

For information on how MHRA is responding to Covid-19, please [1]visit our
website.

You can expect a reply from us within a few days for a straightforward
request. Where a more detailed response or contribution from a specialist
is required this is likely to take longer but we will inform you of this.

If your request is urgent, please call us on 020 3080 6000

Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade,

Canary Wharf,

London

E14 4PU

gov.uk/mhra

Stay connected

References

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1. https://www.gov.uk/government/collection...

James Kelly left an annotation ()

RE: - Co-proxamol is continuing to be prescribed today and due to the ridiculous guidelines MHRA stipulate for the importation of unlicensed / off label medications some CCG’s have to pay £9.40 per tablet (NHS Swale Below) when they could be imported for approximately £0.05 per tablet if the NHS were able to purchase in bulk!
The details of the supply of unlicensed medicinal products are explained in the MHRA Guidance Note 14 - The supply of unlicensed medicinal products (“specials”):
https://assets.publishing.service.gov.uk...
It's because these recommendations stipulated by MHRA that each CCG has to order Co-proxamol individually resulting with the cost to the NHS reaching an alarming level!
During July 2019 NHS Enfield CCG paid £522.00 for 100 tablets and during
September 2019 NHS Swale CCG Paid £564.00 for 60 tablets
https://openprescribing.net/all-england/... (July 2019)
https://openprescribing.net/all-england/... (September 2019)
_______________________
MHRA have behaved in a despicable manner since recommending the ban on co-proxamol during 2005, a drug that had been used effectively for over 50 years without causing any serious side effects! This caused hundreds of thousands of patients living with uncontrolled pain and suffering with horrendous side effects!

MHRA refused to consider any of the sensible suggestions raised by parliament e.g. extract from Hansard "Howard Stoate Labour, Dartford 4:40 pm, 17th January 2007”

A more sensible way forward, as my hon. Friend said, is to make co-proxamol a controlled drug under schedule 3 of the Misuse of Drugs Act 1971. The advantage of doing that is that the potential risks involved in prescribing would be flagged up, but GPs could still prescribe the drug when necessary, and it would be clearly acknowledged in doctors' minds that extra precautions and closer monitoring of patients would be advisable.

Schedule 3 status would also send a clear message that co-proxamol is not a first-line drug and that it should be used only after careful consideration of all the available alternatives. It would also give pharmacists the opportunity to reinforce guidance to patients who are on the drug and to ensure that they fully understand the risks and benefits of taking it. The MHRA must trust GPs—who are, of course, in dialogue with their patients—to exercise clinical judgment when it comes to the prescription of Co-proxamol. In view of the potential risks, the decision will not be easy for GPs to make, but we should not forget that they are highly trained, and well paid, to make decisions on a daily basis that require them to tread the fine line between therapeutic benefits and the disadvantages and side effects of drugs.

The MHRA should have the courage to rethink its decision to withdraw coproxamol."

MHRA blundered on regardless issuing many more ‘Marketing Authorisations’ for the more dangerous and addictive drugs until 13th February 2013 when ACMD advised the Government that tramadol be controlled as a class C substance under the Misuse of Drugs Act 1971 and listed in Schedule III of the Misuse of Drugs Regulations 2001, which it considers would provide the correct controls to prevent diversion and misuse.

ACMD advice “Prescribing data from the NHS Business Services Authority (NHSBSA) indicate an increase in prescribing, with the number of Daily Defined Doses (England)1 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. (I have no doubts it was a direct result)

This is exactly the recommendation MP ‘Howard Stoate’ suggested for co-proxamol during 2007, his suggestion would have saved many lives, Hospital admissions, and millions of pounds for the NHS throughout this period while 1.75 million patients could have continued to receive the most effective pain relief!

As MHRA are totally responsible for the additional MA’s issued for Oxycodone, Fentanyl, Fentanyl analogues, and Buprenorphine since 2005, MHRA must accept full responsibility for the opioid epidemic the UK has today and the fact that co-proxamol remains an essential and effective drug.

MHRA should urgently review the supply of unlicensed medicinal products (“specials”):
https://assets.publishing.service.gov.uk...

_______________________

Problems with the Alternate Analgesia

https://www.ons.gov.uk/peoplepopulationa...
2018 2005
All drug poisonings 4,359 2,762
Any opiate Any opiate
(inc unspecified opiates, excl paracetamol
compounds) 2,208 1,311
Heroin and Morphine 1,336 842
Methadone 419 220
Tramadol 220 53
Codeine not from
compound formulation 169 44
Dihydrocodeine not from
compound formulation 97 106
Oxycodone 79 11
Fentanyl 74 3
Fentanyl analogues 31 0
Buprenorphine 26 5
Other specified opiate 12 12
Unspecified opiate 181152

Data from 2018/2019, published on 28 November 2019, show that 18,053 people in England were admitted to hospital for poisoning related to drug misuse that year; the primary diagnosis in 9,486 of those cases was poisoning from opioids other than heroin, including codeine and morphine.

The number of patients admitted for opioid poisoning have risen year on year since 2005, there were 4,891 admissions in 2005-06, reaching 12,254 in 2013, 7363 additional admissions!

The number of patients admitted for opioid poisoning 30,409

Deaths from Tramadol rose from 53 in 2005 to 220 in 2018
Codeine not from compound formulation 44 in 2005 to 169 in 2018
Deaths from Oxycodone rose from 11 in 2005 to 79 in 2018
Deaths from Fentanyl rose from 3 in 2005 to 74 in 2018
Deaths from Buprenorphine rose from 5 in 2005 to 26 in 2018

Parliamentary Under-Secretary for health Caroline Flint accepted the assurance given by June Raine that patients could be classed as a ‘named patients’ if their GP agreed that co-proxamol was the best analgesic for the patient.

I remained a ‘named patient’ from 2008 until November 2015 when my GP succumbed to increasing pressure from my CCG regarding the ever increasing price of co-proxamol and stopped prescribing. This has left me with uncontrolled pain, and severe gastrointestinal side effects

Co-proxamol supply will be guaranteed The Pharmaceutical Journal 27th JAN2007
https://www.pharmaceutical-journal.com/n...
supply-will-be-guaranteed/10003130.fullarticle?firstPass=false
Manufacturers of co-proxamol (paracetamol 325mg with dextropropoxyphene hydrochloride 32.5mg) have promised that the product will continue to be available after all UK marketing authorisations are cancelled at the end of the year. This was revealed by health minister Caroline Flint during a Westminster Hall debate on the withdrawal last week.

Responding to claims by Anne Begg (Lab, Aberdeen South) and Howard Stoate (Lab, Dartford) that there are no satisfactory alternative painkillers for some arthritis patients, the minister said that doctors will be able to continue to prescribe co-proxamol on a named-patient basis after the licences are cancelled.
_____________________

Data from NHS Digital, published on 31 August 2017, showed that in England the number of patients admitted to hospital for overdosing on opioid painkillers almost doubled in the last decade, from 4,312 in 2005–2006 to 8,219 in 2016. Poisoning from other synthetic narcotics also increased more than four-fold from 579 in 2005–2006 to 2,780 in 2016–2017.
OpenPrescribing January 2020
https://openprescribing.net/national/eng...
CCG Price per Tablet Quantity Ordered
NHS Kernow CCG £0.99 2,504
NHS East Lancashire
CCG £0.98 1,717
NHS Knowsley CCG £0.94 840
NHS Greater
Huddersfield CCG £0.88 2,064
NHS Portsmouth CCG £0.75 1,392
NHS Warwickshire
North CCG £0.67 1,000
NHS Swale CCG £5.64 60
NHS Brent CCG £4.68 400
NHS Havering CCG £4.64 200
NHS Bolton CCG £3.20 300
NHS Redbridge
CCG £3.15 500
NHS Redditch and
Bromsgrove CCG £3.04 100

Least Expensive NHS Warwickshire North CCG @ £0.67per tablet
Most Expensive NHS Swale CCG @ £5.64 per tablet

It’s essential that MHRA should urgently review the supply of unlicensed medicinal products (“specials”) for co-proxamo.

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Kelly,

Thank you for your email.

We confirm that an internal review is being carried out on FOI 20/159.

Please note the deadline for reply for Internal Reviews is 20 working days and for this Internal Review the deadline will be 26 May 2020.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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    Internal Review co proxamol inconsistent pricing response for delivery.pdf

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Dear Mr Kelly,

Thank you for your email.

Please find attached the response to your Internal Review.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

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