1.
From:
Date: 15 January 2007
Copy: Dr June Raine VRMM MHRA
Shirley Norton VRMM MHRA
Sarah Branch VRMM MHRA
Sarah Wark VRMM MHRA
Shaun Gallagher Policy MHRA
Paul Brice Policy MHRA
Aidan McIvor Policy MHRA
Matthew Garland Policy MHRA
Scott Sinclair Parly
ADJOURNMENT DEBATE (WESTMINSTER HALL): WEDNESDAY 17
JANUARY 2007 – WITHDRAWAL OF CO-PROXAMOL
As requested, attached is briefing for the above adjournment debate on Wednesday 17
January. Officials will be available for the box if required.
Adj Debate co-proxamol 17 January 2007
1
ADJOURNMENT DEBATE WEDNESDAY 17 JANUARY 2007
AVAILABILITY OF CO-PROXAMOL
CONTENTS
Speech
Pg 3
Bullet points
Pg 15
Q&A
Why has co-proxamol been licensed for so long Pg 16
When will co-proxamol be withdrawn from the market? Pg 17
What about patients who can’t find alternatives?
Pg 18
Is it fair for the MHRA to shift this responsibility on to
the prescriber?
Pg 19
What if a doctor is not willing to prescribe unlicensed
co-proxamol?
Pg 20
Can the Government insure GP’s against claims?
Pg 21
How can you ignore the Pulse survey?
Pg 22
In the consultation some people wanted co-proxamol
withdrawn and some didn’t. How did you weigh one
set of views against another?
Pg 23
Background material
Pg 24
Information on Anne Begg MP
Pg 26
Previous Parliamentary Questions
Pg 27
Previous Private Office Cases
Pg 29
Adj Debate co-proxamol 17 January 2007
2
ADJOURNMENT DEBATE 17 JANUARY 2007
WITHDRAWAL OF CO-PROXAMOL
I would like to congratulate my Honourable Friend the
member for Aberdeen South, in her success in securing
another debate on this important issue, which I know is stil
causing a great deal of concern to some people.
I want to start by saying that I am sorry that the
Government’s decision to withdraw co-proxamol is causing
concern and inconvenience to some patients.
I have the greatest of sympathy for patients, who are
affected in this way.
History of co-proxamol
First let me bring my colleagues up to date with how we
have come to where we are today. Co-proxamol is a
Adj Debate co-proxamol 17 January 2007
3
combination product consisting of paracetamol at a lower
than recommended dose, and a weak opiate,
dextropropoxyphene.
In 2003 there was growing concern about the safety of co-
proxamol prompted by UK research showing that co-
proxamol alone accounts for almost one-fifth of drug related
suicides and is second only to tricyclic antidepressants as an
agent of fatal drug overdose. Furthermore, co-proxamol is
involved in 300-400 self-poisoning deaths each year. Many
deaths involve people taking co-proxamol that had not been
prescribed to them such as troubled teenagers coming
across tablets in their granny’s medicine cabinet. Co-
proxamol is potentially very toxic, and toxic overdose can
occur with only a few tablets more than the recommended
daily dose. Unlike paracetamol there is very limited
opportunity for effective treatment of co-proxamol poisoning
and sadly victims often die before they reach hospital.
Adj Debate co-proxamol 17 January 2007
4
As a result of these concerns, in 2004 the Committee on
Safety of Medicines (CSM) conducted a rigorous review of
all the available evidence regarding the risks and benefits of
co-proxamol. The review highlighted that there is a lack of
evidence that co-proxamol is any more effective than full
dose paracetamol, either for short term use or for chronic
conditions.
During the review a public call for evidence on the risks and
benefits of co-proxamol was also conducted. The Medicines
and Healthcare products Regulatory Agency (MHRA) wrote
to a large number of organisations representing healthcare
professionals, patient groups and other stakeholders.
Comments from patients and members of the public, as well
as healthcare professionals were welcomed.
Adj Debate co-proxamol 17 January 2007
5
The information gathered provided no new objective
evidence concerning the risk and benefits. The CSM noted
that previously strengthened warnings to doctors and
patients on the hazards of co-proxamol had proved
ineffective. After considering all the available evidence the
CSM determined that the risks of co-proxamol outweigh the
benefits of allowing the medicine to remain on the market.
During the review, the CSM also considered a number of
alternative regulatory options to withdrawing the product
from the market such as:
• strengthening warnings in the product information,
• restricting the pack size,
• an education and communication programme to alter
prescribing behaviours,
• restricting the indication to the treatment of chronic
pain,
Adj Debate co-proxamol 17 January 2007
6
• restricting prescriptions for second line use,
• restricting prescriptions for specialist use only, and
finally
• rescheduling co-proxamol as a controlled drug.
The CSM advised that none of these measures were
capable of effectively minimising the risks.
Public Health gain from the withdrawal
The Government takes the prevention of suicide very
seriously. Around 4,500 people take their own life in
England every year. A National Suicide Prevention Strategy
was launched in 2002, which sets the target of reducing the
death rate by suicide by at least one-fifth by 2010. An
important aspect of the strategy is to reduce the number of
suicides as a result of self-poisoning.
Adj Debate co-proxamol 17 January 2007
7
It was extremely encouraging in April 2006 to see that
progress is being made towards our national suicide targets.
The third annual report of the National Suicide Prevention
Strategy showed that the most recent suicide rate for the 3
years 2002 to 2004 had been reduced by 6.6 percent from
the 1995 to 1997 baseline. The report outlined areas where
progress was being made including the phased withdrawal
of co-proxamol.
Co-proxamol is a cause of accidental as well as deliberate
harm, because only a few tablets more than the
recommended dose may cause toxicity. It is estimated that
that one fifth of the co-proxamol self poisoning deaths each
year have been unintentional. On this basis alone we can
assume that over 100 lives have been saved to date as a
result of the action taken to withdraw co-proxamol.
Phased withdrawal
Adj Debate co-proxamol 17 January 2007
8
There are many alternatives to co-proxamol and this is
reflected in the steady fall in prescribing of this medicine.
Over the phased withdrawal period we were expecting to
see the prescribing decline as patients move to suitable
alternatives and available data shows that in England, Co-
proxamol prescriptions have fallen from over 7.2 mil ion in
2004 to approximately 1.5 mil ion in 2006 – which is around
an 80 percent drop in usage over the last 2 years.
Importantly many local formularies including Northern Ireland
have already phased out co-proxamol altogether.
The steady decline in usage has no doubt been supported
by Pain Management guidance from the CSM and the
National Prescribing Centre, and demonstrates that
healthcare professionals and patients are making informed
choices about appropriate pain relief.
Flexibility of the system
Adj Debate co-proxamol 17 January 2007
9
We recognise, however, that there is a small group of
patients who are finding it very difficult to change from co-
proxamol or when alternatives appear not to be effective or
suitable. Before the CSM started the review, co-proxamol
was widely used. As I have said, there were 7.2 mil ion
prescriptions in England in 2004. In comparison, the 367
letters that have been received in the last 2 years from
patients concerned by the decision, highlights the small
minority that are having difficulty changing.
For these patients, continued provision of co-proxamol
through normal prescribing may continue until the
cancellation of the licences at the end of 2007. After this
time there wil be continued manufacture of co-proxamol.
The main manufacturer has informed us that it is their firm
intention to continue to manufacture co-proxamol following
cancellation of the licences. So supply wil be assured.
Adj Debate co-proxamol 17 January 2007
10
There wil be scope as there always is for the prescription of
unlicensed co-proxamol. There is clear provision in
legislation which gives the right to the prescriber to prescribe
off-label or unlicensed medicines when this is judged to be in
the best interests of the patient.
So where there is a clear clinical need, it wil stil be possible
to prescribe co-proxamol but in a way that is more targeted,
with a stronger focus on the risk:benefit judgment for the
particular patient, and involvement of the patient in the
decision.
Conclusion
I hope I have demonstrated to my honourable friend that the
Government understands that there are a minority of
patients who wil find the change difficult and may ultimately
continue to be prescribed co-proxamol.
Adj Debate co-proxamol 17 January 2007
11
The decision to withdraw co-proxamol from the market has
tested medicines regulation to the extreme.
Weighed against the difficulty for individual users is the clear
public health gain from the removal of a medicine which has
been widely implicated in accidental and non accidental
overdose.
Sometimes regulation has to balance the needs of the
individual against the benefits at a population level.
In this case the removal of marketing authorisations, with
continued unlicensed use possible in exceptional
circumstances, is the best balance that could be achieved.
There are already real signs of an impact on our national
suicide targets and the withdrawal of co-proxamol may be
playing a key part.
1220 words
Adj Debate co-proxamol 17 January 2007
12
Bullet points
• There is growing concern prompted by UK research which shows
that in England and Wales, co-proxamol alone is implicated in 300-
400 deaths from overdose a year, almost one fifth of drug related
suicides and is second only to tricyclic antidepressants as an agent
of fatal overdoses. In response, the MHRA/CSM conducted a
review of the risks and benefits of co-proxamol.
• During this review the CSM noted that previously strengthened
warnings to doctors and patients on the hazards of co-proxamol
have unfortunately proved ineffective.
• The CSM considered all the available data for co-proxamol and
advised that it should be withdrawn from the market on the
grounds that the benefits of taking co-proxamol are not considered
to outweigh the risks. The Licensing Authority accepted this advice
and co-proxamol will be phased out of the market place gradually
to give patients time to discuss their treatment with their doctor and
change to a suitable alternative.
• There are a number of alternatives to co-proxamol and the CSM
pain management guidance has been provided to help doctors in
the process of transferring their patients to suitable alternatives.
• It has been agreed with the manufacturers to withdraw co-
proxamol over an extended period of time in order to allow long
term users an opportunity to adopt suitable alternative pain
management strategies. At the end of the phased withdrawal and
following the cancellation or withdrawal of the licences for
existing products, the provision would remain for the supply of
unlicensed preparations to individual patients on the clinical
responsibility primarily of a patient's doctor.
• The decision to withdraw co-proxamol from the market has tested
medicines regulation to the extreme, as weighed against the
difficulty for individual users is the clear public health gain from
the removal of a medicine which has been widely implicated in
accidental and non accidental overdose.
B/Adj debate 17 January 2007
13
Q&A on issues likely to be raised:
Q1 Why has co-proxamol been licensed for so long if there is doubt
over whether the risks and benefits are favourable - and how
long has the MHRA known about the dangers?
Co-proxamol has been marketed since the 1960's, and was widely
used as a treatment for mild to moderate pain long before modern
standards of clinical research. The CSM reviewed the risks of fatal
self-poisoning with co-proxamol in 1985, and prescribers were
advised how to reduce these risks and stronger warnings were
introduced into the product information. Current evidence is that
previous action in 1985 to strengthen warnings about co-proxamol
overdose and to educate prescribers on the risk has not been
effective in reducing deaths.
Adj debate 17 January 2007
14
Q2 When will co-proxamol be withdrawn from the market?
Co-proxamol will be phased out of the market place gradually to
give patients time to discuss their treatment with their doctor and
change to a suitable alternative. The Committee on Safety of
Medicines (CSM) advised that the withdrawal of co-proxamol
should be phased over a period up to 36 months or to an earlier
timetable to be agreed with manufacturers. Some manufacturers
have already cancelled their licences and a few will defer the
withdrawal until the end of 2007. Over the phased withdrawal
period the prescribing of co-proxamol has declined steadily as
patients are transferred to suitable alternatives.
Adj debate 17 January 2007
15
Q3 What about patients who can’t find alternatives?
We recognise that there is a small group of patients who are
finding it very difficult to change or when alternatives appear not
to be effective or suitable. For patients in this situation, continued
provision of co-proxamol through normal prescribing may continue
until the cancellation of the licences at the end of 2007. After this
time there is a provision for the supply of unlicensed co-proxamol
on the NHS. This is not an unusual arrangement and medicines
may be supplied on this basis, but the responsibility for deciding
whether or not to make use of that provision lies with the
prescriber. The risks and benefits of the continued supply of an
unlicensed medicine for individual patients must be weighed up by
the prescriber in consultation with the patient.
Adj debate 17 January 2007
16
Q4 Is it fair for the MHRA to shift this responsibility on to the
prescriber?
The supply of unlicensed medicines on the responsibility of a
prescriber is not an unusual arrangement and medicines may be
supplied on this basis. The risks and benefits of the continued
supply of an unlicensed medicine for individual patients must be
weighed up by the prescriber in consultation with the patient.
Adj debate 17 January 2007
17
Q5 What if a doctor is not willing to prescribe unlicensed co-
proxamol?
There is clear provision for doctors to prescribe unlicensed
medicines when this is in the patient’s best interests. The National
Prescribing Centre has distributed guidance to assist in therapeutic
management of co-proxamol.
Adj debate 17 January 2007
18
Q6 Can the Government insure GP’s against claims based on their
recommendations, thus allowing GP’s to use their judgement
over whom to prescribe co-proxamol to?
The Government does not provide indemnity cover for healthcare
professionals. It is the responsibility of each professional to ensure
that they have adequate cover. G.P’s and other health
professionals currently have their own medical defence
organisations, such as the Medical Defence Union and the Medical
Protection Society. These provide indemnity in respect of private
practice and independent G.P practice.
Adj debate 17 January 2007
19
Q7 The Pulse survey showed that some 70% of GPs and 94% of
rheumatologists want the MHRA to revisit this decision. How
can you ignore that?
The avoidable death toll from co-proxamol overdose cannot be
ignored. Sometimes regulation has to balance the needs of the
individual against the benefits at a population level. In this case
the removal of marketing authorisations with continued use
possible in exceptional circumstances is the best balance that could
be achieved. The public health gain is already becoming apparent.
Adj debate 17 January 2007
20
Q8 In the consultation some people wanted co-proxamol
withdrawn and some didn’t. How did you weigh one set of
views against another?
It is important to remember that a consultation exercise is not a
vote and in the case of co-proxamol specific evidence was asked
for on the risks and benefits. Unfortunately the information
gathered during this exercise provided no new objective evidence
about the relationship between the risks and benefits of co-
proxamol in the light of known safety hazards.
Adj debate 17 January 2007
21
Background
1. Co-proxamol is indicated for 'mild to moderate pain' with a maximum
daily dose of 8 tablets. It contains dextropropoxyphene (32.5mg), a weak
opioid analgesic that is known to be toxic in overdose and a dose of
paracetamol (325mg) that would on its own be considered sub-
therapeutic. Concomitant ingestion of alcohol or other central nervous
system depressants significantly increases risk of toxicity.
2. Each year there are 300-400 fatalities following deliberate or
accidental drug overdose involving co-proxamol in England and Wales.
Approximately one-fifth of these deaths are considered to be accidental.
There was growing concern prompted by published UK research showing
that co-proxamol alone is involved in almost one-fifth of drug-related
suicides and is second only to tricyclic antidepressants as an agent of fatal
drug overdose. In response, the MHRA conducted a review of the risks
and benefits of co-proxamol.
3. On 30 June 2004 the MHRA issued a public request for information
which ended on 22 September 2004. The MHRA asked for further
information, which may have a bearing on the risks and benefits of co-
proxamol products. A total of 52 responses were received. No new
objective information was provided concerning the risk:benefit of co-
proxamol, and opinion was broadly divided between evidence based
prescribing advisers and front line clinicians, mainly GPs,
rheumatologists and pain or palliative care specialists together with
patients currently using co-proxamol. Prescribing advisers (including the
Royal College of General Practitioners) were unanimously in favour of
withdrawing co-proxamol, whilst current prescribers and patients tended
to favour its continued availability.
4. A Working Group of the Committee on Safety of Medicines (CSM)
(now the Commission on Human Medicines) on Pain Management was
set up to consider alternative pain management treatment options
available and to consider the advice to be offered to healthcare
professionals for specific patient groups or clinical situations. This
Group gave guidance on various treatment strategies for different patient
groups.
AB/Adj debate 17 January 2007
22
5. The CSM considered all the available evidence including the results of
the public request for information and advised that co-proxamol should
be withdrawn from the market on the grounds that the benefits of taking
co-proxamol are not considered to outweigh the risks. The Licensing
Authority has accepted this advice and a public announcement on the
decision to withdraw co-proxamol was made on Monday 31 January
2005. This message together with the CSM’s overview of alternative
analgesic options was communicated though the Chief Medical Officer's
Public Health Link to all health care professionals.
Adj debate 17 January 2007
23
Background information on Anne Begg MP
Anne Begg was born (in 1955) with the degenerative genetic condition,
Gaucher's Disease, an inherited, enzyme deficiency disorder. She has
been confined to a wheelchair since 1984. She is Patron of the National
Federation of Shopmobility, the Scottish Motor Neurone Disease Society,
and Angus Special Playscheme. She was a founder member of Angus
Access Panel, which campaigns for improved access for disabled people
to the built environment in the Scottish county of Angus, and is President
of the Blue Badge Network, which aims to assist disabled people and
their families. Ms Begg was named Disabled Scot of the Year in 1988.
She has campaigned with Arthritis Care to have the withdrawal of Co-
proxamol overturned. She also secured a previous adjournment debate on
this issue in July 2005. Ms Begg was the first full-time user of a
wheelchair elected to the House of Commons and is currently a member
of the Work and Pensions Select Committee. She has been the Member
for Aberdeen South since 1 May 1997.
Adj debate 17 January 2007
24
Parliamentary Questions
22 February 2005
Paul Flynn: To ask the Secretary of State for Health what alternative
drugs will be available for prescription in place of co-proxamol
following its withdrawal by the Medicines and Healthcare Products
Regulatory Agency.
Ms Rosie Winterton: There are a number of alternatives for managing
painful conditions and the committee on safety of medicines (CSM) has
issued advice on pain management options to assist prescribers, together
with individual patients, in choosing appropriate pain management
strategies. This guidance also refers to a number of sources of additional
advice, including the British National Formulary, which is sent to all
doctors and pharmacists.
The CSM's overview of alternative analgesic options was communicated
through the Chief Medical Officer's Public Health Link to all health care
professionals accompanying the communication on the withdrawal of co-
proxamol and is available on the Medicines and Healthcare products
Regulatory Agency's website
www.mhra.gov.uk. Copies have been
placed in the Library.
2 March 2005
Mr Brady: To ask the Secretary of State for Health whether his
Department will maintain approval for Co-proxamol for those
patients who have intolerance to other painkillers.
Ms Rosie Winterton: There are a number of alternatives for managing
painful conditions and the Committee on Safety of Medicines (CSM) has
issued advice on pain management options to assist prescribers together
with individual patients, in choosing appropriate pain management
strategies. This guidance also refers to a number of sources of additional
advice including the British National Formulary, which is sent to all
doctors and pharmacists.
The CSM's overview of alternative analgesic options was communicated
though the Chief Medical Officer's public health link to all health care
professionals, accompanying the communication on the withdrawal of co-
proxamol and is available on the Medicines and Healthcare products
Adj debate 17 January 2007
25
Regulatory Agency's website www.mhra.gov.uk. Copies have been
placed in the Library.
It has been agreed with the manufacturers to withdraw co-proxamol over
an extended period of time in order to allow long term users an
opportunity to adopt suitable alternative pain management strategies. At
the end of the phased withdrawal and following the cancellation or
withdrawal of the Marketing Authorisations for existing products, the
provision would remain for the supply of unlicensed preparations to
individual patients on the clinical responsibility primarily of a patient's
doctor.
7 March 2005
Dr. Pugh: To ask the Secretary of State for Health what advice is
given to general practitioners who are unwilling or discouraged from
re-issuing prescriptions for distalgesic and Co-proxamol; what
advice his Department gives with regard to the prescription of
distalgesic and Co-proxamol.
Ms Rosie Winterton: The Committee on Safety of Medicines (CSM)
having considered all the available evidence, including the results of a
public request for information, has advised that co-proxamol should be
withdrawn from the market on the grounds that the benefits of co-
proxamol are not considered to outweigh the risks. The Licensing
Authority has accepted this advice and a public announcement on the
decision to withdraw co-proxamol was made on Monday 31 January. The
Marketing Authorisation holders have agreed to withdraw co-proxamol
over an extended period of time in order to allow long term users an
opportunity to adopt suitable alternative pain management strategies.
There are a number of alternatives to co-proxamol for managing pain and
the CSM has issued advice on pain management options to assist
prescribers together with their individual patients, in choosing appropriate
pain management strategies. This guidance also refers to a number of
sources of additional advice including the British National Formulary,
which is sent to all doctors and pharmacists.
The CSM's overview of alternative analgesic options was communicated
though the Chief Medical Officer's public health link to all health care
professionals, accompanying the communication on the withdrawal of co-
proxamol and is available on the Medicines and Healthcare products
Regulatory Agency's website (www.mhra.gov.uk). Copies have been
placed in the Library.
Adj debate 17 January 2007
26
Private Office cases from Anne Begg MP
Adj debate 17 January 2007
27
PO 5017296
Anne Begg MP
Thank you for your letter of 20 June 2005, about your constituent Mr Russell,
of 3 Springbank Place, Aberdeen and the withdrawal of the pain killer co-
proxamol.
I am sorry that the withdrawal of co-proxamol is causing concern and
inconvenience to some patients who, like your constituent, have been taking
co-proxamol without experiencing any problems and do not consider
themselves to be at risk of deliberate or accidental overdose. This was not an
easy decision to make and follows an extensive risk:benefit assessment, a
wide consultation and advice from the Committee on Safety of Medicines
(CSM) - the Government’s independent scientific advisory committee on
medicine safety - and other experts.
The problem with co-proxamol (a combination of the weak opiate painkiller
dextropropoxyphene with a relatively low dose of paracetamol) is two-fold; its
dextropropoxyphene component is extremely hazardous in overdose and
there is little, if any, evidence that it offers an advantage over full strength
paracetamol. Co-proxamol is involved in 300-400 self-poisoning deaths each
year, of which around a fifth are accidental. Many deaths involve people
taking co-proxamol that had not been prescribed to them. Co-proxamol can
be very toxic, and overdose can occur with only a few tablets more than the
recommended daily dose especially if taken in combination with alcohol or
other CNS depressants. Death from co-proxamol overdose is extremely rapid
compared with other pain relieving medicines so that victims often die before
they reach hospital. Unlike paracetamol, there is no effective ‘antidote’ to co-
proxamol poisoning. Whilst the dangers of co-proxamol are well-established,
there is very little objective evidence that co-proxamol is any more effective in
treating pain than normal paracetamol in the recommended dose.
Furthermore, paracetamol is considered to have a comparatively good safety
profile; onset of toxic effects is slow, allowing more time for rescue and a
larger quantity of tablets is required to cause serious harm.
The CSM noted that previously strengthened warnings to doctors and patients
on the hazards of co-proxamol have proved ineffective. After considering the
wide range of available evidence and the options for action to reduce the risk
of overdose (e.g. prescriber and patient education, smaller pack sizes and
restricted indications) the CSM determined that the risks of co-proxamol
clearly outweigh the benefits of allowing the medicine to remain on the
market.
It has been agreed with the manufacturers to withdraw co-proxamol over an
extended period of time in order to allow long term users an opportunity to
adopt suitable alternative pain management strategies. The Medicines and
Healthcare products Regulatory Agency (MHRA) has issued CSM pain
management guidance to help doctors find the best options for individual
Adj debate 17 January 2007
28
patients. May I suggest that your constituent discusses suitable alternatives
with his doctor.
At the end of the phased withdrawal and following the cancellation or
withdrawal of the Marketing Authorisations for existing products, the provision
would remain for the supply of unlicensed preparations. Individual patient use
of preparations of co-proxamol could continue with responsibility for that use
falling primarily on the prescriber. If your constituent wishes to go down this
route may I suggest that he discusses this possibility with his doctor.
The Government takes the prevention of suicide very seriously. Suicide is a
major public health issue. Around 4,500 people take their own life in England
every year. A national suicide prevention strategy was launched in 2002,
which sets the target of reducing the death rate by suicide by at least one-fifth
by 2010. An important aspect of the strategy is to reduce the number of
suicides as a result of self-poisoning.
The Royal College of General Practitioners (RCGPs) and the National
Institute for Mental Health in England (NIMHE) are supportive of the decision
to withdraw co-proxamol from the market. NIMHE advise that reducing
access to lethal methods of self-harm is known to be an effective way of
preventing suicide. One reason is that suicidal behaviour is sometimes
impulsive, so that if a lethal method is not immediately available a suicidal act
can be delayed or prevented altogether. Although “method substitution” does
occur, a number of people will not go on to use another method and lives can
therefore be saved. In light of this evidence, the withdrawal of co-proxamol
represents an important move towards reducing the number of suicide deaths
each year.
JANE KENNEDY
Adj debate 17 January 2007
29
Adj debate 17 January 2007
30
PO5018843
Anne Begg MP
Thank you for your letter of 4 August 2005 about the withdrawal of co-
proxamol. I was glad to hear that your constituent Jonathan Russell is feeling
much better.
While prescribers can and do prescribe to patients on their own responsibility
on the basis of the particular balance of risks and benefits, the Medicines and
Healthcare products Regulatory Agency (MHRA) is considering what further
steps, if any could be taken to give prescribers some additional reassurance if
they continue to prescribe co-proxamol following cancellation of the Marketing
Authorisations (MAs).
JANE KENNEDY
Adj debate 17 January 2007
31
Adj debate 17 January 2007
32
PO 00000140993
Anne Begg MP
Thank you for your letter of 12 September 2006 about the withdrawal of the
pain killer co-proxamol.
It was decided to withdraw co-proxamol over an extended period of time in
order to allow long term users an opportunity to move to suitable alternatives.
The withdrawal will be phased over a period of up to 36 months. Some
manufacturers have already withdrawn co-proxamol and a few will phase the
withdrawal until the end of 2007.
We recognise, however, that there is a small group of patients who are likely
to find it very difficult to change or where there is an identified clinical need;
when alternatives appear not to be effective or suitable. For these patients,
continued provision of co-proxamol through normal prescribing may continue
until the cancellation of the licences at the end of 2007. Although data
suggests that the number of prescriptions for co-proxamol is steadily dropping
as patients are moved to alternatives, the data we have from the
manufacturers shows that stocks of co-proxamol are still available and will be
until the end of 2007. After this time there is a provision for the supply of
unlicensed co-proxamol, on the responsibility of the prescriber.
ANDY BURNHAM
Adj debate 17 January 2007
33
Dear Ms Begg
You raised the issue of the withdrawal of the pain killer co-proxamol, during
Business Questions on 23 June 2005. I am writing to set out the
Government’s position.
The decision to withdraw co-proxamol from the market was not easy to make
and followed an extensive risk:benefit assessment, a wide consultation and
advice from the Committee on Safety of Medicines (CSM) and other experts.
The problem with co-proxamol (a combination of the weak opiate painkiller
dextropropoxyphene with a relatively low dose of paracetamol) is two-fold; its
dextropropoxyphene component is extremely hazardous in overdose and
there is little, if any, evidence that it offers an advantage over full strength
paracetamol. Co-proxamol is involved in 300-400 self-poisoning deaths each
year, of which around a fifth are accidental. Many deaths involve people
taking co-proxamol that had not been prescribed to them. Co-proxamol can
be very toxic, and overdose can occur with only a few tablets more than the
recommended daily dose especially if taken in combination with alcohol or
other CNS depressants. Death from co-proxamol overdose is extremely rapid
compared with other pain relieving medicines so that victims often die before
they reach hospital. Unlike paracetamol, there is no effective ‘antidote’ to co-
proxamol poisoning. Whilst the dangers of co-proxamol are well-established,
there is very little objective evidence that co-proxamol is any more effective in
treating pain than normal paracetamol in the recommended dose.
Furthermore, paracetamol is considered to have a comparatively good safety
profile; onset of toxic effects is slow, allowing more time for rescue and a
larger quantity of tablets is required to cause serious harm.
The CSM noted that previously strengthened warnings to doctors and patients
on the hazards of co-proxamol have proved ineffective. After considering the
wide range of available evidence and the options for action to reduce the risk
of overdose (e.g. prescriber and patient education, smaller pack sizes and
restricted indications) the CSM determined that the risks of co-proxamol
clearly outweigh the benefits of allowing the medicine to remain on the
market.
It has been agreed with the manufacturers to withdraw co-proxamol over an
extended period of time in order to allow long term users an opportunity to
adopt suitable alternative pain management strategies. The Medicines and
Healthcare products Regulatory Agency (MHRA) has issued CSM pain
management guidance to help doctors find the best options for individual
patients.
At the end of the phased withdrawal and following the cancellation or
withdrawal of the Marketing Authorisations for existing products, the provision
would remain for the supply of unlicensed preparations. Exceptionally, a
prescriber might consider that it is in the best interests of a patient to continue
to use co-proxamol, which could be prescribed on the NHS.
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The Government takes the prevention of suicide very seriously. Suicide is a
major public health issue. Around 4,500 people take their own life in England
every year. A national suicide prevention strategy was launched in 2002,
which sets the target of reducing the death rate by suicide by at least one-fifth
by 2010. An important aspect of the strategy is to reduce the number of
suicides as a result of self-poisoning.
The Royal College of General Practitioners (RCGPs) and the National
Institute for Mental Health in England (NIMHE) are supportive of the decision
to withdraw co-proxamol from the market. NIMHE advise that reducing
access to lethal methods of self-harm is known to be an effective way of
preventing suicide. One reason is that suicidal behaviour is sometimes
impulsive, so that if a lethal method is not immediately available a suicidal act
can be delayed or prevented altogether. Although “method substitution” does
occur, a number of people will not go on to use another method and lives can
therefore be saved. In light of this evidence, the withdrawal of co-proxamol
represents an important move towards reducing the number of suicide deaths
each year.
PATRICIA HEWITT
Adj debate 17 January 2007
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Letter to Anne Begg MP following the adjournment debate in July 2005
Anne Begg MP
166 Market Street
Aberdeen
AB11 5PP
Dear Anne
During the debate in the House on 13 July 2005 about co-proxamol, I
promised to write to you with further details about the possibility of the
ongoing supply of co-proxamol where there is a clinical need, following
withdrawal of the licences.
As I said in the House, I understand that there are a minority of patients who
will find it difficult to move to an alternative and for these patients, at the end
of the phased withdrawal period when the licences are cancelled, the
provision would remain for the supply of unlicensed preparations. Individual
patient use of preparations of co-proxamol could continue with the
responsibility for that use falling primarily on the prescriber.
Most manufacturers have indicated they intend to withdraw co-proxamol over
a period of 6-12 months. A few have indicated that they wish to phase the
withdrawal until the end of 2007. At the end of the withdrawal period, to
enable supply to continue in this way, the marketing authorisation (MA)
holders must of course be willing to continue manufacturing co-proxamol.
Ultimately, this will be a commercial decision, which will depend on the
demand for the product. The brand leader has, however, indicated that their
intention is to continue to manufacture co-proxamol after the product is
withdrawn from the market, if there is a clinical demand.
I also promised to reflect on the point you raised about the potential social
impact on individuals resulting from the withdrawal of co-proxamol. As I said
during the debate, while there are those for whom there may be no effective
alternative to co-proxamol, it is also all to easy for prescribers to use what
they have traditionally prescribed rather than working through with the patient
the best option for them. Taken together, the fact that there will continue to
be a provision to prescribe co-proxamol, and the driver that withdrawal of the
licences provides for medication review, the risk of the negative impact on
quality of life you describe should be avoided. We have now built medication
reviews for individuals into the GP contract. Under the Quality and Outcomes
Framework, which is part of the new GP contract, there are two medicine
management indicators which reward practices for undertaking these reviews.
This should encourage prescribers to involve patients in decisions about their
treatment and support good joint decision making around pain management
where, as you pointed out, quality of life as an outcome is so important.
CAROLINE FLINT
Adj debate 17 January 2007
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Adj debate 17 January 2007
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