Examination of Witnesses (Questions 80
- 86)
THURSDAY 9 SEPTEMBER 2004
DR FELICITY
HARVEY, DR
JIM SMITH,
PROFESSOR SALLY
DAVIES, PROFESSOR
KENT WOODS
Q80 Dr Naysmith: Is it possible you
could provide the figures?
Dr Harvey: We could certainly
provide further information about that, but before the work programme
is given to NICE ministers also consult on the scope and remit
of each issue on the work programme. When they formally go to
NICE, in terms of an appraisal it takes about 18 months from the
start of the work on that appraisal by NICE to a product actually
being put out on their website and sent out to NHS professionals.
For appraisal it is about 18 months; for a clinical guideline
it is more like about two years, but when NICE are developing
their products, be they the appraisals or indeed the clinical
guidelines, they go through quite a lot of formal public consultations
during that process, so the draft product as it were is actually
on their website during that time, but it does take 18 months
to two years once they actually have the work programme until
the products actually come out the other end.
Q81 Dr Naysmith: I believe that drug
firms are sometimes a bit critical of the length of time it takes.
Do you think that is a balanced criticism?
Dr Harvey: I think in terms of
the processes that NICE has—in fact those were recently
looked at by WHO in terms of the quality of the processes that
are used—they would say it would be very, very difficult
to actually get those time lines down in terms of the amount of
evidence that they are using as a basis for either the clinical
guideline or the development of the appraisal. There is therefore
a gap, obviously, for many new innovations, from them coming to
market to actually coming out as a product for NICE, although
it may be fair to say that we are trying to get things into the
work programme earlier in their development, so that we get the
best information for NHS professionals as soon as is possible.
Q82 Dr Naysmith: Thank you. The last
question is about the idea of automatic generic substitution,
the idea that if doctors do not prescribe a particular brand of
drug then automatically the generic substitute is prescribed.
That would save quite a lot of money for the National Health Service;
is there any estimate of how much it would save and what is the
policy on it?
Dr Harvey: In terms of the generic
substitution, as you know we have very high rates, the highest
in Europe. In terms of an estimate of how much more we might save
if that was legislated for as against using the mechanisms that
we have outlined through the prescribing advisers etc, we might
save somewhere in the region of about £16.5 million for,
say, the top 20 selling drugs; generic prescribing is actually
the policy of the Department and the policy of the NHS. I think
that one of the issues where there may be more savings for the
NHS drugs budget is actually in relation to waste, and that is
one of the areas that we are looking at very carefully at the
moment, and it is one of the issues that we have also been looking
at when negotiating the new pharmacy contract. That is an area
where there are fairly major potential savings for the NHS, patient
compliance and things like that.
Dr Naysmith: Thank you. Jim?
Q83 Mr Dowd: A couple of quick questions
on waste. Does the Department have any calculation on the amount
of drugs that are prescribed and just not used?
Dr Harvey: Can I suggest Dr Smith
might answer that?
Dr Smith: I can try. It is a very
difficult area, and the figure that we use and has been used since
before I came to the Department is that there is £100 million
worth of medicines wasted every year. If you bear in mind that
is out of possibly now a £10 billion annual spend, that sounds
remarkably low and I would be prepared to accept that it may be
higher than that but it is very difficult to measure. It is waste
for various reasons: it is waste because of unnecessary prescribing,
most often around repeat prescriptions, where there is a package
of medicines and they are not all needed. That is how some people
end up with a bathroom cabinet full of things because they just
do not tell the doctor that they do not need a particular medicine.
Q84 Mr Dowd: Or they do not complete
the course.
Dr Smith: Or they do not complete
the course, but 80% of prescriptions are repeat medication for
long term conditions, so if you have blood pressure tablets, tablets
for diabetes and something you only use intermittently like an
antacid, the bottles of antacid can pile up in the cupboard. We
are tackling that through much closer management of the repeat
prescribing and dispensing process. I take your point absolutely,
there is waste, we are working very hard to root it out of the
system and, going back to Dr Harvey's point, we think that is
more productive in terms of saving money than going down the road
of legislating to compel particular generic prescribing behaviours.
Q85 Mr Dowd: Finally, finally, in
the absence of generic prescribing procedures, substitution procedures,
what in your estimation—and I will be putting this question
to the pharmaceutical companies themselves in the course of time,
if we can get some before us—is the value of drug representatives
extolling the virtue of prescription drugs to pharmacists who
are not the prescribers?
Dr Smith: I suppose I had better
answer that. You will find that most of the promotional effort
of companies is directed towards prescribers, but it is true that
increasingly it is targeted towards pharmacists. There are two
reasons for that: pharmacists do need to be familiar with products;
if a GP is going to start using a product they need to be familiar
with it and, actually, it is quite useful to have had a presentation
and learn something about it, but also I think pharmacists are
increasingly influential in the prescribing process and very many
community pharmacists are now doing sessional work in GP surgeries,
helping them with formulary development and managing their prescribing.
So whether it is a good thing or not, I think it happens. If we
are going to allow promotion by pharmaceutical companies, which
I think we must in a free society, I think it is proper that they
visit pharmacists. We would expect the primary care trusts to
regulate and manage that in the same way as they would manage
all other promotional activities and relationships with the industry,
and those pharmacists would be bound by the local codes of conduct
which we expect them all to have.
Q86 Dr Taylor: Just a very quick
request for more information about the yellow card scheme. In
the Department's memorandum you do say "under-reporting of
adverse drug reactions is an inherent feature of spontaneous reporting
schemes". Could we have, in due course, a record of annual
numbers of yellow cards that are filled in, whether they are going
up or down? I gather the electronic yellow card scheme was instituted
recently, has that made a difference?
Professor Woods: Perhaps I can
very briefly answer that. To the first question the answer is
we receive about 19,000 yellow card reports a year from the UK
and we receive probably twice that many adverse spontaneous reports
from outside the UK, passed on to us from other agencies. The
figure of 19,000-20,000 or thereabouts has been pretty steady
for several years, with one very atypical year. The electronic
card over the internet has been available now for a year or so.
It is not widely used, we have seen a few hundred reports through
that route, but we do intend to communicate more widely the availability
of that route. I should mention that we recently had receipt of
an independent review of the yellow card system, which Dr Jeremy
Messers led, which has made a number of recommendations about
the wider publicity as it were of spontaneous reporting, and that
is one of the things I shall be expecting our new communications
directorate to get into quite quickly.
Dr Naysmith: If there are no further
questions from any of my colleagues and nothing from any of you
that you think you want to tell us, thank you all five, very much
indeed, for getting us off to a really good start on this inquiry.
Thank you for coming.
Letter from Head, Medicines, Pharmacy
and Industry Group, Department of Health to the Clerk of the Committee
(PI 1A)
HEALTH COMMITTEE INQUIRY: INFLUENCE OF THE
PHARMACEUTICAL INDUSTRY
I am writing following the oral evidence provided
by the Government officials to the Health Committee on 9 September.
During the hearing the Government team agreed to come back to
the Committee on a couple of points: the detail of how long it
takes a medicine to go through the NICE process; and on the Yellow
Card Scheme. Having now seen the uncorrected transcript I thought
it would be helpful to clarify a couple of other points.
NICE GUIDANCE TIMELINES
I agreed that I would let the Committee know
how long it takes a medicine that comes to market to have a NICE
guideline published. Before a topic is referred to NICE it goes
through an internal Department of Health process to ensure that
any referral to NICE is line with current priorities. The Department
refers new topics to NICE twice a year. Depending on when a topic
enters the Departmental process it could take at the most 12 months,
or if entered early it could be referred within eight months.
It can then take NICE 15 months to publish a technology appraisal
or 20-26 months for a clinical guideline. There are formal processes
and timescales clearly set which the Department of Health and
NICE adhere to when going through these procedures. These are
set out in Annex A to this letter.
YELLOW CARD
SCHEME
Professor Woods agreed to let you have information
on the Yellow Card Scheme and the number of reports of suspected
adverse drug reactions it has received. This is attached at Annex
B. This covers the Yellow Card Scheme, and the introduction of
electronic reporting. It also refers to the independent Review
of the Scheme, which was led by Dr Jeremy Metters, a former Deputy
Chief Medical Officer. A copy of the final report entitled "Report
of an Independent Review of Access to the Yellow Card Scheme"
is enclosed.[1]
COMPLAINTS MADE
ON ADVERTISEMENTS
During the hearing, Professor Woods was asked
about the determination by the MHRA on the complaints they had
received on advertisements. At the time Professor Woods did not
have that detail to hand but referred to the MHRA website where
the information is publicly available. We thought it would help
to provide this data in this letter. Of the 16 reports published
on the MHRA website from 1 December 2003 to the end of June 2004,
the complaint was upheld in 12 cases, and appropriate action was
taken.
MEETINGS WITH
THE INDUSTRY
The Committee asked how often the Government
team met representatives from the industry in the last six months.
When I replied I said that I had curtailed my meetings with industry
as I co-chaired the confidential PPRS negotiations. While this
is the case I do have a wide range of responsibilities outside
of the PPRS, and as part of these I have met industry representatives
on four other occasions. I met them twice to discuss the Government
proposals on improving the implementation of NICE guidance. I
attended the Ministerial Industry Strategy Group with Lord Warner
in April, and I also chaired the Industry Strategy Group in July.
These were all meetings with the ABPI and not individual companies.
28 September 2004
1 Not printed. Back
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