Will this man benefit when simvastatin
becomes available OTC? |
Making a statin available over the counter seems to be a good
move: improved access to an undoubtedly useful medicine for patients,
a new clinical role for pharmacists and a reduction in workload for GPs.
But
underneath the gloss, is it really such a good idea? Who will benefit
from such a switch? And what are the risks that come with it?
Perhaps the most important question is this: is pharmacy ready for OTC
simvastatin? If the answer is “no”, and the switch goes ahead,
then the result could be shambolic which would do nothing but hinder
the current development of professional roles that pharmacy is enjoying.
If the answer is “yes”, then it represents a significant
move forward in the management of chronic disease in pharmacy. Although
pharmacists — with the new training already proposed as part of
the switch — do have the skills to provide statins over the counter,
the question mark is over the supporting infrastructure.
Records and protocols
The consultation document that outlines the proposed POM to P switch
of 10mg simvastatin (to be called Zocor Heart-Pro) suggests that
it is intended to reduce the risk of a first major coronary event in
people
at moderate risk of coronary heart disease. These groups are all
men aged 55 years and over, and men aged between 45 and 55 years and
women
aged over 55 years with certain risk factors (family history of CHD,
smoker, obese or of South Asian ethnicity).
Provided pharmacists can identify that
patients fit into one of these at-risk groups, the consultation document
states that there is no need for any tests or referral to medical records
before the statin is sold. Instead, it recommends that pharmacists
follow a pharmacy protocol for determining the suitability of the
statin for
the patient. This involves:
• Establishing the likely level of CHD (by assessing risk factors such
as sex and age)
• Checking that there is no pre-existing condition which indicates high
CHD risk and requires management by a doctor
• Checking that simvastatin is not contraindicated
• Checking that the patient is not taking other cholesterol-lowering
drugs and checking for interactions with other prescription medicines
Since the vast majority of pharmacists do not have access to patients’ medical
records, not only can they not check a patient’s medical history
but they cannot add information, either. So it is difficult for the pharmacist
to communicate to the doctor that the patient is buying OTC statins,
and the doctor may not ever know unless the patient chooses to tell him
or her. In addition, the number of purchases the patient makes will not
be recorded so compliance will be difficult to monitor.
This is a concern for the Royal College of General Practitioners: “The
proposed move underlines the need for sharing of relevant clinical information
between pharmacists, GPs and other members of the primary health care
team. Pharmacists currently do not have access to a patient’s medical
records which would help them judge whether statins were necessary. There
would also need to be a system in place for pharmacists to
inform GPs about patients to whom statins have been prescribed.”
The problem could be solved by giving pharmacists access to patients’ records
but IT difficulties have so far prevented this. Contracts to develop
the NHS Care Records Service in England were announced last month, and
pharmacists have been promised access to the NHSnet, but this will not
happen overnight. A push for pharmacists to have access to patient records
has taken place in Wales and also in Scotland, where connection of all
community pharmacies to the NHSnet is under way. Until these IT developments
move forward, pharmacist access to records will remain unusual, although
direct computer access has been achieved
by some pharmacists (PJ, 7 June
2003, p787).
“The Royal Pharmaceutical Society would like pharmacists to have
access to
patients’ medical records and this consultation emphasises the
importance of that access,” says David Pruce, the Society’s
director of practice and quality improvement. In the meantime, he suggests
that pharmacists, with the patient’s permission, make a record
of the sale in the pharmacy and inform the GP that the patient is taking
a statin.
Not everyone believes that access to records is essential. Colette McCreedy,
director of pharmacy practice, National Pharmaceutical Association, says: “Pharmacists
do not need medical records to build up a picture of whether an OTC statin
would be appropriate rather than referral to the doctor. The relevant
information can be obtained by asking appropriate questions.” She
adds: “It is good practice to build up a full picture of a person’s
medication history but this applies to all non prescription medicines
and complementary medicines. There is no need to make a special case
for simvastatin.”
John Blenkinsopp, research fellow at the school of pharmacy, University
of Bradford, and chairman of Johnson & Johnson MSD’s (simvastatin’s
manufacturer) pharmacy advisory panel, says that the company will give
people buying simvastatin a record card to record all the medicines they
take. “The only thing that will work at the moment is a customer-held
record that can be given to whichever health professional they see,” he
explains.
Tests and monitoring
Before prescribing a statin, GPs measure a
patient’s cholesterol level. Yet under the new proposals, for someone
buying simvastatin over the counter a cholesterol test is not necessary
before treatment or for monitoring
afterwards. The reason for this, according to the Medicines and Healthcare
products Regulatory Agency, is: “The current evidence suggests
that, for adults in Western societies, it can be beneficial to reduce
cholesterol levels whatever the starting point.”
Dr Blenkinsopp says that a distinction has to be drawn between patients
treated with statins on the NHS according to the National Service Framework
for CHD and those people who buy a statin over the counter. Those who
buy statins will be at moderate risk, falling short of the NSF guidelines,
he explains. “For these people, their cholesterol level is irrelevant.
It is their risk factors that are important so this is why a cholesterol
test is not needed,” he says. Dr Blenkinsopp
expands on this in a letter to the editor (p13).
However, there is another dilemma raised by Professor Sir Charles George,
medical director of the British Heart Foundation. “On one hand,
it is clear that benefits in terms of cholesterol lowering occur whatever
the starting level. But if you really want to determine CHD risk over
the next five or 10 years then you need to know someone’s cholesterol
level,” he says. “My concern is that unless people are given
a proper risk assessment then someone may be deprived the full efficacy
of simvastain [ie, higher doses] because their risk is underestimated.” One
way in which this could be prevented would be for a full screening of
all risk factors, including testing both blood pressure and cholesterol
levels, as well as considering factors such as age, sex, weight, ethnicity
and smoking status.
The consultation document states: “The pharmacy protocol allows
the pharmacist the opportunity to offer a range of supportive
information and/or testing services, including blood pressure and cholesterol
management.” Of course, this is dependent on the pharmacist or
more likely the pharmacy premises being able to provide these services.
The Society will query this in its response to the consultation. “The
consultation document states that people will be offered the opportunity
to have a test but it is unclear how that will be done,” comments
Mr Pruce.
There is also the question of long-term monitoring of people taking a
statin. At the moment, this is carried out by GPs but who this responsibility
will fall to for people who buy a statin is unclear. The NPA says that
responsibility for long-term monitoring of cholesterol levels should
lie with the patient, with encouragement from the pharmacist.
Some of these questions could be ironed out by a pilot study that Johnson & Johnson
MSD began in December in 10 pharmacies to test the feasibility of the
pharmacy protocol. The pharmacist uses the questionnaire that will form
part of the protocol for sale of simvastatin (along with some guidance
for pharmacists) and then makes a recommendation as to whether or not
simvastatin is suitable, or if the patient should be referred to the
GP. Feedback from the customers is collected. The pilot runs until the
end of January and its findings, it is hoped from 100 people, will be
submitted to the MHRA.
In addition to the pilot, Johnson & Johnson MSD is developing a training
package for pharmacists and assistants as part of the proposed switch.
It will include information about CHD, simvastatin (its mode of
action, contraindications, precautions for use and possible adverse effects)
and review other interventions to reduce CHD risk. The Society is also
developing guidance on the sale of OTC statins.
Questions over efficacy
There are other clinical concerns, as well. A question mark exists
over the efficacy of the 10mg dose of simvastatin, for example. There
have
been some suggestions that it is too low and that evidence to support
the 10mg dose in low-risk patients appears to be lacking.
According to the Royal College of General Practitioners: “There
is very little research evidence of statins being beneficial for those
at low risk.” This is backed up by Neal Maskrey, medical director
of the National Prescribing Centre, who comments: “The problem
is that the big trials have almost all used larger doses, in other words
the evidence rests with the 20 and 40mg doses.”
The consultation document states that treatment with simvastatin 10mg
will produce a 27 per cent reduction in low density lipoprotein-cholesterol.
However, it concedes that there are no trial data for this population: “While
no specific clinical trials have been conducted with simvastatin 10mg
in this particular patient population, it is reasonable to assume that
these benefits would also apply to this group of people given that the
effect of lowering LDL-cholesterol by simvastatin is consistent between
populations, and the relation of LDL-cholesterol to risk is linear.”
The NPA is concerned that the proposed indications for use are unclear.
Ms McCreedy says that the definition used of moderate risk does not tally
with the definition in the Joint British Societies Coronary Risk Prediction
Chart. This might lead to confusion over how appropriate a 10mg dose
is for some patients.
Perhaps the dose comes down to a question of balance. Sir Charles says
that although higher doses are more effective, choice is about safety
and efficacy. “The 10mg dose is unlikely to have significant adverse
effects,” he points out.
Safety concerns
One of the biggest concerns of the anti-OTC lobby is over the safety
of statins. Overall, the safety profile of simvastatin is excellent.
However, there are some potential adverse
effects of concern. In particular, they are muscular effects (myopathy
and rhabdomyolisis) and liver function abnormalities.
The consultation document states that the contraindications and cautions
listed in the pharmacy protocol and product labelling address the concerns
about myopathy. It says that modest elevations of liver enzymes are common
with statin use and do not reflect hepatotoxicity. It adds that hepatic
injury is extremely rare so routine testing of liver function tests before
and during treatment with OTC simvastatin is not required.
If liver function tests are not necessary for patients taking statins,
why do GPs carry them out? Sir Charles suggests that the reasons for
GPs continuing to monitor liver
enzymes are historical. Although conducting liver function tests had
been reasonable when statins were first launched, the usefulness of monitoring
is no longer clear, he says.
Ms McCreedy comments: “The NPA is confident that pharmacists will
be able to handle non prescription supply of simvastatin safely. They
have been supplying it on prescription for many years and are well aware
of the drug’s side effects.”
Perhaps the most difficult question is the fact that it is not possible
to predict accurately who will fall into the small minority of people
who develop these adverse events. This is of concern for two particular
pharmacists.
Pamela Brompton, a community pharmacist in Yorkshire whose father suffered
a severe adverse reaction to a statin, is concerned about their safety. “If
statins are to be made available over the counter then patient registration
is needed at the pharmacy not only to prevent people shopping around
for statins but also to keep track of potential or developing problems,” she
says.
A year ago, an academic
pharmacist wrote to The Journal about his disappointment
with suggestions that statins might become OTC medicines. His opposition
to the proposed POM to P switch was prompted by the
adverse effects he had experienced as a result of taking statins (PJ,
16 November 2002, p711). This week, he told The Journal that he remains
opposed to the switch. “I am not sure that the general public knows
enough about statins and their side effects to make reasoned, intelligent
decisions about buying them,” he comments. “I am more than
happy for GPs to prescribe statins on the basis of a patient’s
risk category but not for people to be able to turn up and buy them.”
According to researchers (PDF 85K) writing in this week’s Journal, many adverse
effects associated with statin use can be explained by coenzyme Q10 depletion
caused by statins (p23).
Costs and inequalities
Some people believe that making statins available over the counter
is no more than the Government avoiding paying for treatment for this
group. Simvastatin accounted for 3.75 per cent of the drugs budget
in England in 2002. Shifting some of this cost to patients’ pockets
will certainly save the Government money in terms of the drugs budget.
Whether or not it will lead to other costs, through encouraging more
people to go to the GP for a cholesterol test or even to request a
statin, is not known.
However, as the Royal College of General Pracitioners points out, having
an OTC statin “raises the issue as to whether we, as a society,
want health care costs to be financed by society as a whole or if we
want some health care costs moved to patients as individuals”.
And this in turn leads to health inequalities. If it is decided that
some health care costs for treating chronic conditions should be moved
to individuals then some people with low incomes will be denied treatment.
Is this acceptable? Another issue is advertising and a debate over advertisements
for simvastatin, as an OTC medicine, is likely.
Then there are ethical issues. Will easier access to statins mean that
people use them instead of making lifestyle changes? After all, given
a choice between losing weight, giving up smoking and taking exercise
or popping a pill, many people are likely to be tempted by the easiest
option.
Even the POM to P consultation document admits: “It is recognised
that there are uncertainties about the effect of taking a statin on compliance
with behavioural risk-modifications (such as healthy eating, exercise
and smoking cessation).” But if the choice was between people doing
nothing at all or taking a statin, then how detrimental is it for people
to take a statin?
If the switch takes place, simvastatin will be available over the counter
in the spring. |
