New rights bring new responsibilities
Views on why pharmacists should prescribe, what training
they should receive, how supplementary prescribing will work in practice
and what
legal responsibilites prescribing brings were all presented at the seventh
annual Hospital Pharmacist conference held in London on 30 October. Gareth
Jones and
Rachel Graham (on the staff of Hospital Pharmacist) report
Christopher Newdick: introducing new systems of working is challenging from a legal viewpoint |
Some of the legal issues associated with prescribing were
set out by CHRISTOPHER NEWDICK, barrister and reader in health care law
at the University of Reading. Mr Newdick hoped to give reassurance to
pharmacists about their new prescribing role by providing a legal framework,
based on general aspects of the law of clinical negligence. In presenting
the framework, Mr Newdick set out some of the issues for individual pharmacists
associated with obtaining patient consent and performing to an acceptable
standard of care. For pharmacy managers in particular, he reviewed the
quality of systems and clinical governance arrangements that need to
be in place to avoid potential liability.
Mr Newdick introduced the topic of informed consent by explaining that
the burden on clinicians to inform patients of the pros and cons of treatments
has increased markedly over the past ten years or so. Patients have a
right to choose, regardless of their reasons for making a particular
decision, he said. For example, it was decided in a case in 1992 that “the
[competent] patient’s right of choice exists whether the reasons
for making that choice are rational, irrational, unknown or even non-existent.
That his choice is contrary to what is expected of the vast majority
of adults is only relevant if there are other reasons for doubting his
capacity to decide.”
It is in this environment that new pharmacist prescribers will be working,
Mr Newdick explained. He advised pharmacists that the best way to approach
the issue of how much information they need to divulge about the treatments
they prescribe is to put themselves in the patient’s position and
ask “knowing what [I] know, would [I] want to know about that”.
This is better than relying on statistics from case law, he said, particularly
since the decisions on the point are inconsistent. For example, one case
suggests that a one per cent risk of paralysis does not need to be disclosed
to a patient, whereas another (an Australian case) suggests that a one
in 14,000 risk of blindness does. For purely elective treatments, it
will be appropriate to point out many more risks than for life saving
treatments, Mr Newdick added.
Deciding whether a patient is competent to consent to treatment involves
a three part test, Mr Newdick advised; whether the patient is able to
(1) take in and retain treatment information; (2) to believe the information
and; (3) weigh up that information, balancing risks and needs. Mr Newdick
stressed that just because a patient is, for example, suffering from
delusions, does not mean that he or she cannot make a decision about
anything. There may be some issues (for example, whether or not they
want their foot amputated) on which they are capable of withholding consent.
If a patient is not competent to consent to a particular treatment, the
next step is to use the “best interests” test. This is an
imprecise test, Mr Newdick pointed out. If pharmacist prescribers find
themselves in this situation, they are advised to consult with their
independent prescribers and other professional colleagues, he added.
For children (ie, under 16s), whether or not they can give consent depends
on the individual child and on the treatment proposed. Case law suggests,
for example, that while children can in some circumstances decide for
themselves to take the contraceptive pill, no child has the capacity
to refuse a potentially life saving transplant operation.
Regarding the general standard of care to which pharmacist prescribers
should operate, Mr Newdick pointed out that case law recognises the legitimacy
of differences between professional opinions. The law is clear that it
is not negligent to follow a course of action, for example, prescribe
a particular treatment, just because the majority of professionals would
not have done the same thing. But the professionals’ actions must
be on spectrum of reasonable opinion – they must be “logical,
defensible and reasonable”. It is not adequate for a professional
to say that they did what they did because they were told to do so, or
taught that way some time ago, Mr Newdick added. They must exercise independent
judgement and assert their professional expertise.
During his presentation, Mr Newdick discussed the requirements for supplementary
prescribing, looking at the regulations and pointing out some interesting
legal aspects. For example, the regulation technically requires the supplementary
prescriber to have access to just “patient records”, but
to avoid potential liability for negligence, these should be common records,
Mr Newdick advised. Mr Newdick also suggested that, where patients have
agreed to a clinical management plan, it would be advisable for them
be given a copy of the plan and their agreement should be recorded in
the notes.
In response to a question from the audience, he pointed out that it might
be difficult for supplementary prescribing to go ahead when, for example,
a patient has dementia, because the regulations specifically require
the patient to agree to the clinical management plan. This overrides
the “common law” approach (ie, the body of law that has built
up through judges’ decisions during cases) that would allow, for
example, patients’ carers to make decisions in circumstances where
the patient cannot. [Gul Root, from the Department of Health, noted this
issue and said she would investigate.]
For pharmacy managers in particular, Mr Newdick addressed the standard
of systems and clinical governance arrangements that need to be in place.
When in “new terri-tory”, managers need to be able to “show
that [they] have made reasonable efforts to look into the future and
try and develop systems.” As far as they can, managers need to
deal with potential problems before they arise, and not just wait and
see what happens.
Mr Newdick demonstrated what can go wrong when adequate systems are not
in place by discussing some of the cases on system and managerial negligence
in the health care service. In one case, inadequate managerial systems
meant that a consultant obstetrician was physically supposed to be at
more than one hospital site at the same time, and could not be available
to supervise the birth of twins, one of whom was ultimately born brain-damaged.
In another case, a communication breakdown meant that although clear
messages were left by a staff member finishing her shift that a baby
was distressed in the womb, the information was not read and was therefore
not acted upon.
Ensuring effective communication is also a key factor for individual
prescribers, as well as managers, in avoiding negligence, Mr Newdick
said. He urged supplementary prescribers to ensure that they have the
clearest lines of communication between themselves and the independent
prescriber. They must not find themselves in a position where they do
not have enough information on which to make a decision, he said. “There
are circumstances when you must make a decision. Making no decision is
a decision.”
Mr Newdick concluded his presentation by pointing out that, of the topics
he discussed, ensuring safe systems and good clinical governance arrangements
would be the biggest challenge.
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