Examination of Witnesses (Questions 220
- 239)
THURSDAY 11 NOVEMBER 2004
DR IONA
HEATH, DR
TIM KENDALL,
MR MATT
GRIFFITHS, MR
JOHN D'ARCY,
MR ROB
DARRACOTT AND
DR RICHARD
NICHOLSON
Q220 Chairman: What might those interests
be, just out of interest, from your point of view? Where could
there be conflicts potentially?
Mr Darracott: It would not be
unusual, but it is not common, for pharmacists to act as consultants
to pharmaceutical companies from time to time. We do not see a
lot of it, but it does happen. The other thing, which again relates
back to a point that you raised earlier with respect to nursing,
is that we are seeing increasing numbers of pharmacists involved
in prescribing activities and we have certainly acknowledged that,
like nurses I guess, pharmacists can be expected to be approached
in greater numbers by representative of the industry.
Q221 Chairman: Is that already happening?
Mr Darracott: Pharmacists have
always been approached by representatives of the industry.
Q222 Chairman: Has the change in
terms of prescribing arrangements meant, as it has with the RCN,
that you have more contact with the industry than previously?
Mr Darracott: I think it is beginning.
The nurses are a few more years down the tracks than we are and
we are only now really getting a few hundred pharmacists through
the accreditation process for being in a position to begin to
prescribe and then local arrangements will need to be made for
that actually to begin to happen in reality. I am sure it is starting,
but these are early days with respect to that in particular. As
an organisation we have produced some guidance for pharmacists
on working with the pharmaceutical industry and that covers everything
and reminds pharmacists of the sorts of skills that they might
have to do in their preparation for initial practice, things like
critical appraisal and evaluation; it covers things like hospitality.
We are very much mirrors, sorts of industry codes, in terms of
what is acceptable and what is not acceptable. It also covers
commercial sponsorship and, again, I guess like a number of other
organisations, we do have protocols for sponsorship of things
like the British Pharmaceutical Conference where we will have
industry involvement in an exhibition at the time. The other thing
I should perhaps also mention is that, as an organisation, we
publish both Martindale which is an enormous reference book to
help professionals and, jointly with the BMA, we publish the British
National Formulary which is purchased by health departments for
all doctors and pharmacists. It is generally regarded as independent
advice for all prescribers.
Q223 Chairman: In relation to the
way your role in prescribing is changing, where a pharmacist will
have a particular relationship with a GP and a local practice,
how aware would you be, where the initial prescription was from
the GP in that practice, of any influences that there might be
on that GP on the initial prescription that you probably would
follow on?
Mr Darracott: I am not sure that
we would be aware that a prescription was particularly influenced.
Q224 Chairman: In terms of how a
practice relates to the drug reps who will visit GPs, would you
be aware of those influences which might have a bearing on the
prescribing practices of a particular doctor, who would link in
with your practice?
Mr Darracott: That very much depends
on the relationship, as you said at the beginning, between the
pharmacist and the local practice and obviously we have encouraged
pharmacists as part of a wider health care team to have good relationships
with local prescribers. If that relationship develops and they
then fundamentally become part of the team, then I guess the pharmacist
would be more likely to know whether the doctor is seeing representatives
or not, because they may well be invited along to the team meeting
in which that sort of thing takes place. That is the level at
which a pharmacist would be aware of the influence, particularly
of a representative of the industry, on a particular practice.
Q225 Chairman: Have any of your members
given examples of where perhaps they have raised a concern about
prescribing which has maybe been influenced in a way that they
were concerned about? This is anecdotal stuff which has come to
one or two of us on the Committee, but is that anything that has
come up through your members?
Mr Darracott: Not to my knowledge,
no.
Mr D'Arcy: To add on that from
a pharmacy committee perspective, taking your original point where
you said other mechanisms were dealing with undesirable activity,
pharmacists are slightly at arm's length from that prescription
pharmaceutical industry in that, although prescribing is coming
on stream, traditionally the main prescribers have been GPs. Where
we do have a problem with industry, where an issue occurs, and
to be honest it occurs very rarely, then what we would do would
be to take it up directly with the company, or to take it up with
the ABPI, or, if it was a very extreme example, perhaps refer
a matter to the code of practice committee. In my time at the
MPA, I am aware of us doing that once on a leaflet some time ago,
something said in a leaflet, but issues like that are very, very
rare. Just to give a little bit of background about changing pharmacy,
because I think prescribing fits into that, a pharmacist's role,
and it is an important role in modern health care, is to ensure
that patients get the right medicine at the right time and with
the information necessary to ensure that they take that medicine
safely and appropriately. Whilst this is the principal role of
pharmacists and in delivering that role medicines are clearly
a principal tool of the trade, the role is changing and pharmacists
are taking on a much wider public health role. This is on the
back of government policy which is aimed at making better use
of the skills of pharmacists and increasing access to pharmacy
services. Indeed we have just negotiated a new contract between
the negotiating body for pharmacy, the Department of Health and
the NHS Confederation. The other thing is that as the role of
pharmacists is changing we are looking more at the pharmacy team
these days: there is the pharmacist but there will also be behind
the pharmacist a range of qualified staff, medicine counter assistants,
who have to do accredited training, dispensary assistants who
will have to do a Level 2 NVQ or equivalent, dispensing technicians
who do a Level 3. As far as pharmacists are concerned, they are
bound by a code of ethics as health care professionals and one
of the key responsibilities of a pharmacist, and this is enshrined
in the code of ethics, is to act at all times in the best interests
of patients. Pharmacists do need to ensure that patients receive
sufficient information and advice to enable them to use their
medicine safely and appropriately. The point was made about CPD
and, similar I think to my colleague from the nursing profession,
pharmacists do their own CPD and are responsible for their own
CPD and will undertake CPD, support their CPD with a range of
materials. As part of that they will from time to time use materials
produced by the industry and I think that is a reasonable thing
to do because a manufacturer who researches and produces the drugs
will be a natural source of that material. However, they are not
influenced in terms of CPD in that it is up to pharmacists individually
to decide how to do that CPD. As far as hospitality is concerned,
there is not a great deal of it in pharmacy, but we do get sponsorship
for meetings. I spoke, for example, at a meeting last night in
Southampton that had industry sponsorship to extent of providing
money to put on a buffet supper. They will have a display and
will tell people about what they are doing, but from a pharmacy
perspective, it is more, I would say, general marketing, to create
awareness about the company and what it is doing, rather than
what you could refer to as straightforward promotion. Finally,
just to say a little bit about pharmacists prescribing, it is
still early days with pharmacy prescribing. No doubt that will
alter and affect the relationship between pharmacy and industry,
but, given that pharmacists are bound by a code of ethics, we
would expect pharmacists to adhere to their code of ethics and
to realise that in any relationship they have with industry, they
do have to keep an arm's-length relationship, professional relationship
and at all times think about what is in the best interests of
patients.
Q226 Mr Jones: I want to come in
on prescribed medicines first and Mr Darracott. You described
in answer to the Chairman the safeguards that your organisation
tries to use to ensure that patients get balanced advice and so
on. Have there ever been any occasions where you, as an organisation,
had to warn one of your members, or perhaps even withdraw the
licence from one of your members where you believed that medicines
were being inappropriately prescribed or a pharmacist had been
inappropriately influenced?
Mr Darracott: Inappropriately
influenced? Not to my knowledge. In a sense the supply of prescription
medicines through a pharmacist is also dependent on one having
receipt of a prescription by another practitioner, so the pharmacist
is acting on the instructions of another health professional.
What we do have instances of, and indeed there are a few cases
which come before our statutory committee, are pharmacists who
have inappropriately supplied quantities of over-the-counter medicines.
We would see one or two cases of those per year. Now whether that
is as a result of an undue influence from the pharmaceutical industry
or the pharmacist getting into a position where they are faced
with the pressure to supply the sort of products which might be
misused, is a moot point. The instances of supplies of large quantities
tend to be around narcotic medicines, rather than other types.
Q227 Mr Jones: But in prescription
medicines, is it just because it is early days, or is it because
the ethical system and code are perfect and there is never any
need for any regulatory mechanism or sanction?
Mr Darracott: We would never say
it was perfect, but I think it is early days and it is something
that we will certainly be looking out for as we go on.
Q228 Mr Jones: It is early days,
but Mr D'Arcy in his evidence was saying that of course if there
are no examples of anyone ever having anything withdrawn, then
the conclusions are either that the system is perfect, or that
the regulatory system is inadequate. In terms of the over-the-counter
medicines, Mr D'Arcy, increasing numbers of medicines are available
over the counter. Where do the pharmacists get information about
the new products? Do you think that information is fair and balanced?
The Committee suspended for a two-minute
silence
Mr D'Arcy: Pharmacists will get
the information they need from a variety of sources and the first
thing to say is that by the time the medicine goes over the counter,
it has been used on prescription for quite a while before so pharmacists
will already be familiar with that product. So there will be information
from a variety of sources. We may produce information, the Pharmaceutical
Society may produce information, there will be other information
from other academic, I suppose you could say, sources, the industry
will produce information, the manufacturer of that product will
produce information and it varies. It varies from being credible
robust objective information about the product and its use at
one extreme, to in some cases something which may be no more than
company propaganda. What will happen is that pharmacists will
make their own judgment on materials. The experience we have is
that because they are clinicians with expertise in the actual
use of medicines pharmacists can very readily see what is credible,
objective information and differentiate that from what you might
call company propaganda. The message we give to industry is that
if they are producing training materials, and indeed we would
expect them to produce training materials, if they are not objective,
if they are not balanced and they are not meeting the needs of
pharmacists in their capacity as a clinician with an expertise
in medicine, they will go in the bin. Pharmacists will do that.
In fact one of the areas in which we work with manufacturers is
to help them with their materials, to try to produce what we believe
to be objective materials.
Q229 Mr Jones: May I take you back
to the code of ethics? You quoted some of the code of ethics to
me. What I can remember is that you would wish to ensure that
you do no harm to your patient. Does the code of ethics cover
whether you do any good?
Mr D'Arcy: By implication it does.
It might not specifically say you must do the public good.
Q230 Mr Jones: You exist in order
to sell medicines and it should be the priority to ensure that
the medicines you sell do not do any harm, I can understand that.
But if the medicines you sell do not do any good, you still exist
in order to sell the medicines.
Mr D'Arcy: It is a bit more than
that you just exist to sell medicines. If we look at the way the
regulatory process works, and this applies to prescription medicines
and over-the-counter medicines, medicines are assessed, and there
are regulatory controls for this, against quality, safety and
efficacy. It does not just stop at that point: it is not just
that once you have a product licence that is it, that is the end
of the game. Pharmacists are an important part of the supply chain
and in fact the last link in the supply chain before patients.
So pharmacists are critical evaluators of medicines and their
skill base is about evaluating the safety and efficacy of medicines.
I would expect pharmacists as professionals, and this would be
underpinned by the code of ethics, to assess, as part of the supply
of a medicine, whether it is on a prescription or whether it is
over the counter, whether or not that medicine was appropriate
and actually not put themselves in such a position. In fact the
code of ethics does say you should not supply a medicine where
you doubt its efficacy—I cannot think of the exact wording,
but I am paraphrasing—and we would not expect pharmacists
to do that. In fact in something like 25% of cases pharmacists
do not recommend any product at all. My view would be that we
can rely upon pharmacists and indeed it would be part of their
professional duty, if they do provide a medicine, to provide only
those medicines that work.
Q231 Mr Jones: Since you do not represent
Boots, I can use them as an example. Next time I walk round Boots,
I can be assured that all the medicines I see are efficacious,
can I?
Mr D'Arcy: If it is a medicine,
then yes, I think you can. If it is a medicine, it will have a
product licence and in order to get that product licence it has
passed a regulatory test which satisfies the regulators, in this
case the MHRA, that that product is of sufficient quality, is
sufficiently safe and is efficacious. Yes, you can in the case
of a medicine.
Dr Kendall: Pharmacists like doctors
are absolutely dependent upon a regulatory body which actually
does not look at efficacy in the way that has been described.
They are primarily concerned with safety and the same is true
in the United States with the FDA. You only have to have two trials
that show efficacy for a drug to be regulated. I also wanted to
say that all of us are dependent on what is published and drug
companies do not always publish their trials. So when we say that
something is efficacious, we can only say it is efficacious according
to what we have seen.
Chairman: We might get onto that point
a bit later on.
Q232 Dr Naysmith: I want to ask Mr
D'Arcy a question really. If, as has just been pointed out by
Dr Kendall, what the regulatory bodies look at is safety rather
than efficacy, and that is almost certainly true, do you have
any mechanism for feeding back problems you might observe or your
members might observe in terms of safety? There is the yellow
card scheme for GPs. What is there for pharmacists?
Mr D'Arcy: Pharmacists now are
included in the adverse drug reporting scheme, that is the yellow
card scheme and pharmacists can and indeed do report instances
where they experience problems with drugs; they report that back
on the mechanism. There is proportionately less reporting from
pharmacists than GPs, and I think that is probably in part due
to the fact that pharmacists do not carry out the diagnosis, but
where they do see a problem with medicines—and indeed identifying
problems with medicines is part of their core role—then
they can and do report through the yellow card scheme.
Q233 Dr Naysmith: Is it working?
As you say, it did not always apply to pharmacists but it does
now.
Mr D'Arcy: As far as I am aware
it is working and it is working well.
Mr Darracott: The latest figures
I saw about the yellow card scheme, and yes of course, there could
always be more reports, was that around a quarter of all reports
are now submitted by pharmacists, in particular by hospital pharmacists.
I think 24% of reports are submitted by hospital pharmacists and
there is a small proportion submitted by community pharmacists.
I would agree with John that one of the issues around that is
about access to the information required to provide a full report
within the yellow card scheme. What we would certainly argue very
strongly for as we go forward is that pharmacists have access
to more information, the sort of information that is going to
be put on the national care record, and allowing us to see that
information means that we are going to have more of the information
that is needed for a yellow card report. It is working reasonably
well, but I am sure we could always have more reports.
Q234 John Austin: We put this to
other witnesses before. The yellow card scheme is voluntary rather
than mandatory. Do you think it is right that it should be?
Mr D'Arcy: I have no problem with
it being voluntary. Perhaps the question to be asked in terms
of a mandatory scheme is: how would you mandate that, how would
you prioritise what needs to be reported on? In the case of pharmacy,
and I can only speak for pharmacy, it is relatively early days
and we are still seeing it bed down. Certainly our view initially
would be that we would like to see a voluntary scheme to see how
it works and learn lessons. I do not have a particularly strong
view one way or the other on that.
Dr Heath: The people with the
most interest in reporting are of course patients themselves and
I do not know why we do not have a system of allowing patients
to feed back their experience directly. I think that would be
much more effective than trying to mandate people around something
which is actually a continuum, from the most minor side effect
to a very serious side effect and the way you draw the line in
that range. I would really like to see a system that invited feedback
from patients about their own experience of using medicines.
Q235 Chairman: May I turn to a slightly
different area? In one of our earlier sessions we had a GP who
came to the Committee and was arguing very strongly on the issue
of so-called disease-mongering about some of the concerns he had,
and I quote. He said "One of the issues that I feel very
strongly about as a day-to-day general practitioner is the amount
of health anxiety and health neurosis that has been generated,
often through things like disease awareness campaigns. We certainly
feel that is undermining people's sense of health and wellbeing.
To put it bluntly, the reasons for that is because it is in the
commercial interests of the pharmaceutical industry to promote
new conditions and different conditions". I notice in your
organisation's evidence Dr Heath, you refer to certain disease
conditions and say it is very much in the interests of the industry
to draw a line which includes as large a proportion as possible
within the range of abnormality. Could you expand on that and
your comments about the over-consumption of pharmaceuticals being
a serious and growing health problem? Are we taking too many drugs
and if we are, are you people not in a prime position to do something
about it? I do not often go to the doctors, I do not know how
many years it has been since I saw a doctor, but certainly going
back to my experience, and the experience of most people as patients,
it is interesting that when you go in front of the doctor you
will see that the prescription pad has your name and address written
on it before you have even said what is wrong with you. So there
is an assumption that there is going to be something on that prescription
pad before you even sit down.
Dr Heath: There is not. There
certainly is not a system like that.
Q236 Chairman: Perhaps there are
different procedures, but I have certainly seen many doctors and
talked to people who have made the same point, that you go in
front of a GP and the receptionist will have already ensured that
your name and details are on that prescription pad so the doctor
only has to write the actual prescription to give to you at the
end of the consultation. The assumption I have from that is that
automatically we are straight into me coming out with a piece
of paper, which may not necessarily be the best thing from my
point of view.
Dr Heath: Oh, absolutely not.
That is not my experience. Obviously computers are changing all
that; the vast majority of prescriptions are now computer generated
and there would be no point putting your name on it beforehand.
I do not have the data about how many consultations end with a
prescription, but it is nowhere near 100% General practitioners
regard part of their role as defending patients against the healthcare
system in general and the pharmaceutical industry in particular,
because medicines are as dangerous as they are beneficial. According
to the government's own medicines partnership—what is it
called? -the one working on concordance and compliance, 70% of
the UK population are taking medications regularly every day,
either over-the-counter ones or other. We are healthier than we
have ever been before in history and is it appropriate that 70%
of the population are taking medications? I think the data from
Norway, which is an even healthier population, which we put in
our report, is about the new guidance putting 90% of over-50-year
olds in a sort of disease category. The problem I really wanted
to emphasise today is the difference between treatment and preventive
technologies. When you are treating someone with a condition,
you have some chance to assess whether the treatment you are giving
is having an impact, is efficacious, is more beneficial than harmful,
you have a framework within which to work. However, the pharmaceutical
industry is now investing much more in developing preventive technologies
than treatment technologies because humanity seems to have this
constant illusion that you can prevent all ill health. It has
been a very costly struggle to realise the limits of that approach.
Q237 Chairman: Can you get up to
the point which was the key point in my question in a sense that?
Are people presenting to you and your colleagues assuming there
is something wrong with them as a consequence of what has been
termed disease-mongering by certain people in the industry which
is the argument which has been put to us by other witnesses?
Dr Heath: Absolutely. I see women
worrying about osteoporosis every day of my working life. I see
people inappropriately worried about cholesterol every day of
my working life. We are including an ever greater proportion of
the population within a group who considers themselves to have
some sort of health problem and that has huge psychological and
social implications for them and it has huge financial implications
for society.
Q238 Chairman: What can we do about
the issue you have just described?
Dr Heath: We need a huge public
debate. We have to have a really adult conversation within society
about the limits of medicine, about the limits of pharmaceuticals,
about how much gain. I am sure you have been informed about numbers
needed to treat. Some of these preventive technologies have huge
numbers needed to treat. There are people who will take drugs
for years with no tangible benefit whatsoever and others who gain
a very, very small amount. The cost per gain is becoming increasingly
huge and it is a sort of collision of different strands: the fact
that we now have preventive technologies, but we now also have
this kind of computer surveillance of the population where we
know where everybody is and we can target everybody. Those two
working together seem to me to be increasingly malign. I am supposed
to be able to make people feel better and I spend my life working
in a situation which seems hell-bent on making everybody feel
worse.
Q239 Chairman: Do you find yourself
as a GP in a situation where patients come with a particular expectation
of an outcome from a consultation with you and go away disappointed
if the outcome is not a prescription of some sort which can offer
them some sort of instant cure, when you might say that there
are other means of dealing with their condition, or you might
say that they do not have a condition? Is that increasingly a
problem?
Dr Heath: It is certainly a problem.
I hope people do not go away disappointed. I have to work very
hard to make sure they do not go away disappointed. I think what
has happened about antibiotic prescribing over recent years shows
that GPs have been successful in having that sort of conversation
about treatment therapeutics. It is much more difficult in preventive
therapeutics because of the global fear about early death. It
is very hard.
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