Pharmacy law and ethics
This year’s Pharmacy Law and Ethics Association
session, held on 17 September, focused on the delivery of
mental health care. The session was well attended, with a strong presence of
pharmacists working in the
prison service and in nursing homes, as well as those working in National Health
Service. Lin-Nam Wang (on the staff of The Journal) reports
Applying the Code of Ethics to psychiatric pharmacy practice
John Donoghue: psychiatry requires expert pharmacists |
Therapeutics in mental health treatment is fraught with risks, John
Donoghue, founder member of the College of Mental Health Pharmacists,
declared at the start of his presentation on mental health issues and
ethical dilemmas in practice. These include risks for patients if they
are not treated and risks when they are treated, risks for members of
staff involved in patient care and, in some cases, risks to the general
public if treatment is not fully effective.
Mr Donoghue described an incident in a hospital where a large male patient
threw an armchair through a window. It took six male psychiatric nurses
to restrain him and giving him huge doses of a benzodiazepine and an
antipsychotic did not calm him. “What do you do next,” he
asked. Input into individual clinical decisions is where the expertise
of mental health pharmacists lies but, in order to give good advice,
these pharmacists need to be aware of all the issues and risks and weigh
these up quickly.
Although psychiatric disorders make decision-making processes more complex, “you
won’t go far wrong if you apply the Royal Pharmaceutical Society’s
principles and ethics”, Mr Donoghue told the audience. However,
in practice, this is not always easy. For example, a pharmacist’s
key responsibility is to provide the “best possible care”,
but this cannot happen when he or she is told that a drug is too expensive,
he explained.
Evidence base
Clinical governance demands evidence-based practice, but in psychiatry
the evidence base is not ideal. Mr Donoghue said that there are many
randomised controlled trials (RCTs) for newer medicines (because they
are required by licensing authorities), but these tend to be in narrow
areas. For example, an atypical antipsychotic will have lots of RCTs
in schizophrenia, but none in obsessive compulsive disorder or mania,
so “we do not have the evidence base once we step outside that
indication”. In the same vein, Mr Donoghue expressed concern
over unlicensed treatments, which are used
widely in mental health.
Adequate experience
The Code of Ethics states that pharmacists must “ensure that they
only accept work where they have the requisite skills”. In addition,
the Society’s practice guidance on the care of people with mental
health problems clearly states that “pharmaceutical
services to mental health units should be provided by specialist mental
health pharmacists”. It is therefore worrying, said Mr Donoghue,
that pharmacists with no knowledge whatsoever in psychiatry are being
sent to cover a psychiatry ward when someone is off sick. “This
puts them at risk and the patient at risk, but it does happen with some
frequency — we should not work in conditions that do not enable
us to perform our duties appropriately,” he warned.
Another issue Mr Donoghue raised is the job titles given to junior
pharmacists. He said that on many occasions he has come across pharmacists
taking the United Kingdom Psychiatric Pharmacy Group course in basic
psychiatry, with titles like “senior pharmacist in psychiatry”.
Yet these pharmacists have only been working in psychiatry for two or
three weeks. “What are the managers thinking of, giving a
person with little knowledge, competence or experience in psychiatry
a title like that,” he asked.
Guidance from the National Institute for Clinical Excellence says that
rapid
tranquillisation of a patient is the last resort in a behavioural emergency.
If the unit
is having to use rapid tranquillisation
frequently, preventive measures, including reducing overcrowding on wards
and providing more activities, need to be addressed. Junior pharmacists
will often not have the experience or clout with the ward manager to
get things changed and that is just one reason why it is so important
for pharmacy in mental health to be provided by specialist pharmacists,
Mr Donoghue explained.
Information and informed consent
The Code of Ethics says that pharmacists must “respect the patient’s
right to be involved in treatment decisions”. However, genuine
involvement can only be achieved if the patient has been given understandable
information. In addition, said Mr Donoghue, the treatment and recovery
process in mental disorder is fluid so
providing information is not something that can be done at a single point
in time. Patients’ needs should be addressed at all the stages
of treatment and recovery.
Informed consent is “the biggest gaping hole in mental health care”,
Mr Donoghue said. In terms of giving adequate information, he said that
little had changed since 1991 when a survey (commissioned by the mental
health charity Mind) found that the vast majority of mental health service
users were completely dissatisfied with the information about medicines
that they received. The recent National Service Framework for Mental
Health also notes that inadequate information is a common complaint. “It
is now 13 years later and the same complaints come through with monotonous
regularity — we are simply not getting this right,” he commented.
However, Mr Donoghue admitted that there are some limitations to what
pharmacists can do and called the minimum requirement in the Mental Health
Act Code of Practice a “tall order”. The minimum required
is that, in all cases, the patient must be informed of the nature of
the treatment planned and that the information must be sufficient for
the patient to understand its purpose, likely effects and risks. He or
she should also be told of the chances of the treatment being a success
and of any alternative treatments. Mr Donoghue said that although pharmacists
are giving patients information about the treatments they are receiving,
or are about to receive, they are not giving enough information about
all the alternatives available. “Frankly, it is too time consuming — we
have got ward rounds and are needed in the dispensary — but that
is an important issue that we need to address. If left for pharmacists
alone to do, we would not be able to do it because there are not enough
of us. In this situation we have
to work with other professionals,” he
suggested.
The Mental Health Act 1983
Although only a minority of patients are treated under the Mental Health
Act 1983, pharmacists need to know what the Act contains and how it
works. However, training is not widely available, Mr Donoghue said.
Capacity and consent
• Mental incapacity remains under the remit of common law but,
in 1995, the Law Commission made recommendations for reform of
the law in this area. The Government recently introduced a draft
Mental Incapacity Bill, intended to address consent and mental
incapacity. It is expected that there will be an Incapacity Act
in the next year or two. The new legislation is discussed in an
article (PDF 110K) by Professor Joy Wingfield on p463.
• Consent of people with capacity was covered in a recent
article in The Pharmaceutical Journal (23 August, pp240–2). |
* PDF files on PJ Online require Acrobat Reader 4 or later. |
Robert Robinson, a legal member of the Mental Health Act Commission
and the Mental Health Review Tribunal, gave an overview of capacity,
consent
and the Mental Health Act. In normal circumstances, if a person has “capacity” he
or she has the right to refuse treatment, even if the treatment is life-saving,
and to treat that person against his or her wishes would constitute an
assault. Incapacity means the inability to make a genuine choice. The
law says that people lack capacity if they have some impairment or disturbance
in mental functioning that renders them unable to make a decision. In
turn, this requires the ability to comprehend and retain information
material to the decision and the ability to use the information and weigh
it in the balance. According to Mr Robinson, for most practical purposes,
pharmacists can rely on the presumption that most adults have capacity,
but if anything undermines this presumption there is a need to ask questions
to dispel any doubt.
In cases where people lack capacity consent is insignificant. Treatment
can be
given, even where it is refused, if it is in the person’s “best
interest”, which has been interpreted as a wide variety of care
situations (eg, dressing a person) — it is not limited to emergency
situations. In other words, the clinician has a common law (un-enacted
law) “power to treat”, which makes lawful what would otherwise
be an assault.
The exception lies where treatment involves admission to a psychiatric
hospital. Unless an admission is rated as an urgent necessity (where
a patient who is a danger to himself and others can be temporarily restrained),
a patient lacking capacity and who objects to being treated in a psychiatric
hospital can only be treated if formally detained under the Mental Health
Act, ie, clinicians have no common law power to treat. If the patient
does not object to treatment, he or she can be treated under common law
and the Act is unnecessary. The Mental Health Act Code of Practice gives
guidance on what constitutes objection.
The Act is a safeguard for the patient. It divides treatment into three
categories.
Psychosurgery and implantation of hormones to reduce male sex drive can
only be given to a patient who is capable of understanding the nature
of the treatment and has consented to it. The second category of treatments,
electroconvulsive therapy and the administration of psychiatric medicines
for more than three months, can only be lawfully given if a “responsible
medical
officer” has certified that the patient understands the treatment
and has consented to it; or if a “second opinion appointed doctor” (SOAD)
has certified that the patient has capacity and is consenting; or that
the patient lacks capacity or consent but the treatment should be given
to alleviate the condition or prevent it from deteriorating. This means
that in a psychiatric unit, there must be a formal record of capacity
at three months. Before giving a certificate, the SOAD must consult two
other people professionally concerned with the patient’s treatment
and one of these could be a pharmacist. The third category covers treatments
for mental disorders not in the other two categories, and no consent
is needed.
Mr Donoghue commented that there is a common misconception that the Mental
Health Act is about detaining and treating patients. He said that instead,
it could be looked at as a piece of empowering legislation that preserves
patients’ rights to have effective treatment when they would otherwise
not accept it. Looking at the Act in this way makes mental health pharmacists’ jobs
a great deal easier because it protects patients’ rights, he added.
Moreover, just because patients are detained under the Act, it does not
mean that pharmacists’ obligations under the Code of Ethics are
any less. For example, just because patients lack capacity, this does
not mean that we should not provide them with information, Mr Donoghue
said.
Since the Human Rights Act 1998 came into force in 2000, there have been
significant challenges to the treatment of non-consenting patients detained
under the Mental Health Act, under the articles
stating that no one should be subjected to inhuman and degrading treatment
and declaring the right to respect for privacy and family life. So far,
these have failed, but there is scope for further challenge. |
