Inside Health – co proxamol/ meningitis B vaccination 23/2/16

Current issue: spending lots on coproxamol

“NHS Nene Valley CCG and NHS Basildon and Brentwood CCGs have told their members 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 drug has had to be sourced as an unlicensed ‘special’, increasing its costs…. after the removal from the Drug Tariff, from £21.38 for 100 tablets to £49.50 now.

Over 100,000 prescriptions for co-proxamol were still being issued in England in 2014, despite the drug being withdrawn from the market in 2005 over safety concerns.”

2011 – FDA withdraws products containing same from USA 

“New clinical data from the USA show that (dextro)propoxyphene can have serious effects on the electrical activity of the heart (resulting in prolongation of the P-R and Q-T intervals, and widened QRS complexes), even at normal therapeutic doses. As a result, products that contain this active, either alone or in combination with acetaminophen (paracetamol), are being withdrawn from the US market, and the Food and Drug Administration (FDA) is advising healthcare professionals to stop prescribing (dextro)propoxyphene to their patients:

Since 2005, most patients have found an acceptable alternative to co-proxamol, after consultation with their healthcare professional. We recognise that there is a small group of patients who have found it very difficult to change from co-proxamol, when alternatives appear to be ineffective or unsuitable. As with any unlicensed medicine there is a provision for the supply of unlicensed co-proxamol, on the responsibility of the prescriber, who can judge the risks and benefits in consultation with the patient. When making this judgment, prescribers will wish to bear in mind the new evidence of cardiotoxicity.Why originally withdrawn”

In a study of local suicides between 1993 and 1997 Keith Hawton and his colleagues noticed that co-proxamol was involved in approximately 20% of overdose deaths. The team followed this up with a larger study using national and local data leading to a ground-breaking paper published in the British Medical Journal in 2003. This showed that co-proxamol was the most common drug used for suicide in England and Wales, accounting for 18% of fatalities. They also found that co-proxamol overdoses were 28 times more likely to lead to death than those involving paracetamol.”

Parliamentary debate

“During the 6 years following the withdrawal of co-proxamol in the UK, there was a major reduction in poisoning deaths involving this drug, without apparent significant increase in deaths involving other analgesics.

The reduction in prescribing of co-proxamol following its withdrawal in 2005 was accompanied by increases in prescribing of several other analgesics (co-codamol, paracetamol, codeine, co-dydramol, tramadol, oxycodone, and morphine) during 2005–2010 compared with 1998–2004. These changes were associated with major reductions in deaths due to poisoning with co-proxamol receiving verdicts of suicide and undetermined cause of −21 deaths (95% CI −34 to −8) per quarter, equating to approximately 500 fewer suicide deaths (−61%) over the 6 years 2005–2010, and −25 deaths (95% CI −38 to −12) per quarter, equating to 600 fewer deaths (−62%) when accidental poisoning deaths were included. ”

“The impact of the policy appears to have reduced nonfatal self-poisoning with co-proxamol without significant substitution with other analgesics. This finding is in keeping with that for suicide.”


evidence for coproxamol  being better than paracetamol was not robust “few studies’ had looked at effects beyond  a week 

MHRA in 2007 

advice in 2007 about rare supply

“We recognise that there is a small group of patients who are finding it difficult to change, or where there is an identified clinical need when alternatives seem to be ineffective or unsuitable. For this small group of patients, continued provision of coproxamol through normal prescribing may continue until the cancellation of the licences at the end of 2007. After this time, a provision will remain for the supply of unlicensed co-proxamol on the responsibility of the prescriber, and the Marketing Authorisation holder for the brand leader (Distalgesic) has indicated that they will continue to manufacture co-proxamol to meet clinical demand.”

Ethics around unlicensed medicines 

Prescribing unlicensed medicines may be necessary where:
a. There is no suitably licensed medicine that will meet the patient’s need. Examples include (but are not limited to), for example, where :26
i there is no licensed medicine applicable to the particular patient. For example, if the patient is a child and a medicine licensed only for adult patients would meet the needs of the child; or
ii a medicine licensed to treat a condition or symptom in children would nonetheless not meet the specific assessed needs of the particular child patient, but a medicine licensed for the same condition or symptom in adults would do so; or
iii the dosage specified for a licensed medicine would not meet the patient’s need; or
iv the patient needs a medicine in a formulation that is not specified in an applicable licence.
b. Or where a suitably licensed medicine that would meet the patient’s need is not available. This may arise where, for example, there is a temporary shortage in supply; or
c. The prescribing forms part of a properly approved research project.
70. When prescribing an unlicensed medicine you must:
a. be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy
b. take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so
c. make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing an unlicensed medicine.



“The BNF includes unlicensed use of medicines when the clinical need cannot be met by licensed medicines; such use should be supported by appropriate evidence and experience. When the BNF recommends an unlicensed medicine or the ‘off-label’ use of a licensed medicine, this is shown in the appropriate place by ‘[unlicensed]’.”

“Co-proxamol tablets (dextropropoxyphene in combination with paracetamol) are no longer licensed because of safety concerns, particularly toxicity in overdose. Co-proxamol tablets [unlicensed] may still be prescribed for patients who find it difficult to change, because alternatives are not effective or suitable.”


Association antibiotics and patient satisfaction


Lancet on antibiotics and information  

BMJ on meningitis b vaccine cost effectiveness 

JCVI statement 

The Joint Committee on Vaccination and Immunisation (JCVI) published a position statement in March 2014 which concluded that, on the basis of the latest available evidence, Bexsero was likely to be effective in preventing a proportion of cases of invasive meningococcal disease, and given the likely strain coverage of the vaccine a national implementation in infants in the UK would be likely to prevent a significant number of cases of the disease in that age group

vaccination company data

are different cost/value calculations needed 

interesting other views from the SMC

Comments are closed.