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COMMON
CAUSES OF CLAIMS
According to http://www.medicalcasenotes.co.uk,
the commonest situations leading to a claim of psychiatric negligence are:
(1)
monitoring of patients in the community;
(2)
discharge and monitoring of patients who later
commit suicide; and
(3)
problems related to side effects of psychiatric
medication.
Oyebode1 says the actual rate
of negligence claims in psychiatry is unknown, but is rising, and that the
areas of practice that commonly lead to negligence claims include:
(1) diagnostic
errors:
(a) error or delay in the diagnosis of
physical illness;
(b) suicide;
(c) failure to investigate properly or
act on results of investigations; and
(2) treatment
errors:
(a) error in administering treatment;
(b) error in the continuing
prescription of treatments that are indicated for brief use; and
(c) prolonged use of anti-psychotic
drugs.
The topic will be considered under three main headings:
(1)
monitoring in the community and suicide;
(2)
monitoring in the community and homicide; and
(3)
medication.
1 Oyebode F,
‘Clinical errors in medical negligence’ Advances in Psychiatric Treatment
(2006) 12: 221-227.
Monitoring in the community and
suicide by people with mental illness
The key evidence here is from the National Confidential Inquiry into Suicide
and Homicide by People with Mental Illness, a continuing national survey. Between 1996 and 2000 there were
4,859 cases of suicide in England and Wales who had been in recent contact with
mental health services.
‘.. 1100 (23 per cent) had been
discharged from psychiatric in-patient care less than 3 months before death.
Post-discharge suicide was most frequent in the first 2 weeks after leaving
hospital; the highest number occurred on the first day…’
‘..Deaths of young patients
were characterised by jumping from a height or in front of a vehicle,
schizophrenia, personality disorder, unemployment and substance misuse. In
older patients, drowning, depression, living alone, physical illness, recent
bereavement and suicide pacts were more common.
‘..Prevention measures likely
to benefit young people include targeting schizophrenia, dual diagnosis and
loss of service contact; those aimed at depression, isolation and physical
ill-health should have more effect on elderly people.’
At the least, however, there should be a
documented risk assessment before discharge, and follow-up of those on enhanced
Care Programme Approach (CPA) within seven days: this should be straightforward
in patients with a clear-cut mental illness such as schizophrenia.
There is more difficulty in deciding what
is appropriate for other patients who have contact with mental health services,
for example ‘young people with personality disorder, unemployment and substance
misuse’, none of which are readily treatable by medical means. In fact such
patients, strictly speaking, would be considered to have ‘mental disorder’,
rather than the ‘mental illness’ in the title of the survey. Most will not be
on enhanced CPA; some may have no fixed address or actively say they want
nothing to do with services. Hard-pressed mental health services have limited
resources to chase such patients, as they are mandated to concentrate on
‘severe and enduring mental illness’ such as schizophrenia.
CPA and ‘care co-ordination’ refer to the
Care Programme Approach, the Government’s stipulated model for delivering
mental health services to patients. It requires that psychiatric patients
should have a named care co-ordinator and a written care plan. For the majority
of mild cases, who are just coming to outpatients, the care-co-ordinator is the
psychiatrist concerned, and the CPA documentation and risk assessment is deemed
to be implicit in the clinical notes and GP letters.
Patients with more severe problems, such
as schizophrenia or other forms of severe and enduring mental illness, will
have complex needs, including, for example, housing, financial and family
problems. They will be allocated a care co-ordinator, such as a community
psychiatric nurse or social worker, in addition to the psychiatrist. The
co-ordinator is responsible for organising patient’s care, for holding regular
review meetings and for providing the patient with a written care plan. The
care co-ordinator will usually work as part of a community mental health team;
they are usually in short supply, and it is frequently difficult to find a care
co-ordinator for patients, whom the psychiatrist considers need one.
Usually, the community mental health team
is not managed by the consultant psychiatrist; allocation of patients to
care-co-ordinators is therefore through a process of discussion and
negotiation. There is something of a grey area in responsibility, where the
patient may be nominally under the care of the consultant psychiatrist of that
particular team, but the psychiatrists may not have actually seen the patient,
as the other team members work with greater or lesser degrees of autonomy.
Monitoring in the community and
homicide by people with mental illness
Oyebode, in a recent review of ‘Clinical
errors and medical negligence’ (see 1 above), quotes the Chief Medical Officer’s report An Organisation with a Memory (Department of Health Expert Group,
2000): ‘in an average year, there are 40 homicides by people in contact with
mental health services in the 12 months prior to the event.’ (To put this in
context, since 1998, ‘offenders on probation have committed more than 1,190
serious crimes, including 211 murders’, according to the Daily Mirror on 11 May 2006, ie, about 48 murders per
annum. Most of the mentally disordered persons who have done homicide
will have either personality disorder or schizophrenia, the latter treatable,
the former not, or at any rate only to a limited extant. The most difficult
cases often exhibit both mental illness and personality disorder.
Inquiries into such events often record
extremely difficult patients, perhaps with mental illness and personality
disorder and substance misuse, who may have moved around the country, with
various contacts with mental health services, as well with as the criminal
justice system. Imperfections in mental health care are often documented in
reports from enquiries, but these are usually obvious as just one problem
amongst many others, and, perhaps for that reason, these cases are not usually
the subject of clinical negligence claims.
The current government controversially
proposed in its Mental Health Bill that ‘dangerous and severe personality
disorder’ should be liable to preventive detention, but this proposal was
abandoned in the 2007 Act.
Medication
Medication will be covered under three
headings: Oyebode indicates three types of case where medication use can be
criticised:
(1)
problems in medication monitoring;
(2)
wrongly continued prescription of
benzodiazepines; and
(3)
Prolonged use of anti-psychotic drugs.
Problems in medication
monitoring
Problems in medication monitoring might
include, for example, failure to monitor properly the blood level of lithium (a
mood stabiliser). This would be one of the classic examples. In modern use,
with moderate doses and regular blood tests, lithium is safe, but some patients
who have taken lithium in high doses for many years without adequate monitoring
did go on to develop kidney damage. This is now largely a historical problem.
More acute problems with lithium toxicity
still occur, however. To be safe, lithium has to be monitored by regular blood
tests. There needs to be a clear understanding between psychiatrist and general
practitioner as to who is going to be responsible for this. Monitoring may need
to be weekly, when the drug is first started, but patients who are stable on it
may only need 6 or 12 monthly tests.
Kidney and thyroid function should also be
checked, as underactivity of the thyroid gland can occur (hypothyroidism). The
level will need to be checked more frequently, however, if the brand of lithium
changes, if the patient develops an acute illness, particularly one involving
the risk of dehydration, for example vomiting, or if other medications are
changed, for example, diuretics. Signs of lithium toxicity include reduction in
conscious level (drowsiness), diarrhoea and vomiting, and muscular tremor
proceeding to involuntary movements or even convulsions. Patients should be
provided with a lithium card, as set out in the British National Formulary.
The topical drug at the time of writing is
olanzepine, one of the newer types of antipsychotic medication. It has been
touted as having fewer side-effects than the traditional antipsychotics, and in
respect of stiffness and shakiness (referred to as extrapyramidal side effects,
EPSEs), this is undoubtedly true. However, after it has been in use for
something of the order of 10 years, it has become apparent that it is
frequently associated with weight gain. This can proceed to the extent of causing
diabetes, and there are associated metabolic problems including raised
cholesterol. It is therefore incumbent on those prescribing olanzepine for
long-term use – and because it is used in patients with psychosis, which is
often a chronic condition, this can often be the case – to monitor the weight
of the patient at the very least. There are those who advocate regular blood
tests for blood sugar and blood lipids in addition. Similar considerations
apply to other atypical antipsychotic drugs.
Clozapine is recommended for use in
treatment resistant schizophrenia. It can cause serious blood abnormalities, in
particular, reduction in a type of white blood cell, neutrophils, essential for
fighting infection. However, there is a system in place where regular blood
tests are monitored by a central Monitoring Service, and the prescription
cannot be issued unless a satisfactory current blood test is available. Even
though the drug is associated with a very small number of fatalities every
year, these are not usually the subject of negligence actions because of the
‘failsafe’ link between continued supply of the drug and the requirement for
satisfactory blood test results.
Mood stabilisers such as sodium valproate are associated with a very small risk of malformations,
including spina bifida, in the baby, if they are taken by the mother during
pregnancy. The same also applies to lithium. The risk is greatest in the first
three months of pregnancy, as it is during this period that the fertilised egg
transforms into a fully developed foetus. After that time, the baby has got, as
it were, ‘all its arms and legs’, and is essentially just growing, so that the
risk of malformations is greatest in the first trimester and almost absent
subsequently.
If these drugs are prescribed to young
women, these risks need to be explained to them. The risks of continuing with
these drugs during conception and the first trimester, have to be balanced
against the benefits, for example, the newborn baby needs his mother to be in
good mental health when he is born. The key point is to make sure that the
mother is in possession of the full information, said that she is in a position
to be able to give her informed consent to the use of these medications.
There is a National Teratology Centre,
which will advise on risk benefit analysis regarding individual patients;
consulting the centre would be regarded as good practice, and would provide
comfort for the mother and the prescriber.
This is a convenient point to mention the SSRI
antidepressants, the best known of which is of course fluoxetine, trade name
Prozac. There have been two main concerns expressed about this group of
medications, which have of course been very widely prescribed.
First, it has been suggested that they can
increase the risk of suicide. There has been litigation about this in the US.
It is at present unclear whether there is a proven statistical increase in risk
overall, but if so, it is likely to be small. The drugs are commonly seen to cause
agitation in a proportion of patients in everyday clinical use, and this could
potentially cause a patient with suicidal ideas to be tipped over into carrying
them out. Hence, it is essential that patients being prescribed this type of
antidepressants should be risk assessed for suicide and the risk monitored.
It is unclear whether these risks are just
for SSRIs, or possibly for all antidepressants. It has always been known that
in a severely depressed person, once the depression starts to lift, there can
be an increase in suicide risk, before it resolves, and it is thought to be
because patients’ energy and motivation may increase before their mood lifts.
What is different about the SSRIs as compared with, for example, tricyclic
antidepressants, is the propensity to cause agitation in some patients in the
early days of treatment. It has even been suggested that SSRIs have caused homicide,
for similar reasons. The whole area is highly disputed; Dr David Healy well
articulates the case for the critics of these drugs – see http://www.healyprozac.com/.
Addiction to SSRIs, although it has been
suggested by their critics, does not occur, in the sense that there is no
development of ‘tolerance’: that is, it is not found necessary to keep
increasing the dose of the drug in order to produce the same effect. Perhaps
most tellingly, the drugs have no black market value. It has become clear
however, that a proportion of patients, probably especially those on long-term
treatment, can develop symptoms such as anxiety if the drug is suddenly
stopped. As with the benzodiazepine story, it is not clear that the so-called
‘withdrawal symptoms’ are qualitatively different from the symptoms for which
the drug was prescribed in the first place. Nevertheless, it is now regarded as
appropriate that patients who have been on high doses of these drugs for a long
time should have the dose reduced gradually with appropriate monitoring of
their condition.
Wrongly continued prescription
of benzodiazepines
For a time after their introduction in the
1960s, it was as if the pharmaceutical industry had found the Holy Grail with
the benzodiazepines: a tranquilising and sleep-inducing drug class which
(unlike its predecessors the barbiturates, such as phenobarbitone) was so safe
even in overdose that one could, as it were, only die from the benzodiazepines
by drowning in a vat of the substance. Initially, they were promoted as being
non-addictive and free of side effects, though subsequently they were found to
be addictive. Leo Sternbach, the developer of benzodiazepines, received the
ultimate tribute by his drug being the unidentified subject of the Rolling
Stones’ 1967 ‘Mother’s little helper’. Jagger’s genius for lyric summed it up:
‘And though she’s not really ill, there’s a little yellow pill...’, reflecting
the medicalisation of normal anxiety two decades before the benzodiazepine
group litigation. In these cases, the drugs were blamed for various
non-specific symptoms, which were remarkably similar to the symptoms for which
they were prescribed, and the litigation did not succeed in the UK.
Current guidance is that these drugs are
for short-term use only, and should not be used if there is a risk of
addiction. These stipulations seem to be widely observed, indeed, these useful
drugs are now possibly somewhat under prescribed.
Antipsychotic drugs and
movement problems
Patients on antipsychotic medication,
especially the older kinds (such as chlorpromazine and haloperidol), can
develop movement disorders, such as involuntary jerking or writhing of the face
or limbs. Now it is known that similar abnormal movements did occur in
psychiatric patients long before antipsychotic drugs were invented, so it
cannot necessarily be assumed that all abnormal movements are due to this
category of drug.
Nevertheless, there is no doubt that it
has been a major problem over the years, particularly in the asylums, where
patients shuffling along the corridors with parkinsonian gait, with obviously
abnormal jerking and writhing movements of the limbs and face were a common
sight. Historically, what seems to have happened is that the introduction of
such drugs as chlorpromazine and haloperidol had the effect of emptying many
asylum beds, so dramatic were the effects in the early years (1950s onwards),
when they tended to be used in moderate doses. Patients who remained in
hospital were by and large, therefore, the more severely affected cases, and
during the 1960s and 70s there was a tendency to increase the dose of these
drugs in a vain attempt to produce improvements in these most severely affected
cases. However, the high doses employed produced the well-known side-effects,
but did not increase the therapeutic effect. This was how these drugs acquired
a bad name for side effects. If used
in small doses, for example, haloperidol 5 mg daily, they have a favourable
side effect profile, and it is likely that such drugs will stage a gradual
comeback in coming years.
Abnormal movements, due to antipsychotic
drugs, are a much less common clinical problem these days. It is probably
because the older antipsychotics are now less used, or at any rate in lower
doses, and it also seems to be the case that the main condition for which there
are prescribed, schizophrenia, has gradually become somewhat less common and
less severe.
It would be expected that in a newly
arising case in recent years, there should be a clear diagnosis, with some
attempt at least to ameliorate the problem, such as prescription of
anticholinergic medication to combat side-effects, and consideration of change
of medication from an older to a newer drug. It will be appropriate for the
matter to have been discussed properly with the patient; in particular, the pros
and cons of the various treatment alternatives, so that they can be seen to
have made a reasonably informed decision.
Other types of psychiatric
negligence
Brief mention will now be made of other psychiatric circumstances, which can
give rise to negligence claims.
Physical disease
Physical disease always lies in wait to
trip up the unwary psychiatrist. If the patient is an inpatient, it is
important to exclude physical causes for the presentation, and this is the
responsibility of the hospital. Examples would be a patient presenting with
depression, who actually has an underactive thyroid, or a patient presenting
with dementia, who actually has vitamin B12 deficiency. Therefore, routine
physical examination, and baseline blood tests are generally accepted as
mandatory. Appropriate referral to general hospital physicians and surgeons
must not be neglected.
In outpatients, the responsibility to
exclude physical disease ultimately lies with the referring doctor, usually the
general practitioner. Nevertheless, the psychiatrist does have a duty to make
sure that appropriate consideration has been given to the possibility of
physical disease and to recommend appropriate referrals and investigations if
necessary.
Other psychiatric claims
Other types of psychiatric claim are now
mainly of historical interest. Incredible as it now seems, LSD was used as a
treatment during the 1960s and 1970s, notably at Powick Hospital near Worcester
(where Elgar had been bandmaster). Claims later resulted, though it was
obviously very difficult to evaluate the effects of the substance so long
afterwards.
ECT now rarely gives rise to claims. It is still used,
occasionally, for severe depression, particularly in the elderly, where the
response in patients who are for example refusing to eat and drink undoubtedly
saves lives. The days of very large numbers of applications being used are now
over; in practice, the treatment has few adverse effects, the commonest being
some mental confusion for a few hours afterwards, which resolves naturally.
There is no evidence that ECT causes continuing memory problems in modern use.
RELATION BETWEEN COMPLAINTS
PROCESS AND NEGLIGENCE
This is something of a double-edged sword.
On one hand, a speedy and informal response to patients or relatives who are
dissatisfied can resolve matters, and help to prevent a formal complaint being
put in. On the other hand, NHS Trusts frequently have elaborate procedures to
investigate themselves in the event of any adverse event. These internal
inquiries can seem excessive to the staff involved. Often they have to be made
within a short time, for example seven days. They frequently seem to be
proceeded with by the Trust in an assumption that the staff involved with the
patient involved in the adverse event are innocent until proved guilty.
Doubtless, this is from laudable motives of the employer, for example, that an
adverse event should be an opportunity for learning and improvement. However,
documents arising from such inquiries are likely disclosable in the event of a
clinical negligence action, and could potentially make it more difficult to
defend.
GROUP LITIGATION
Recent years have seen group litigation in
respect of benzodiazepines and SSRIs. Theses are essentially product liability
claims, whether in negligence or under the Consumer Protection Act 1987, since
the allegations are directed at the medication and its accompanying warnings
rather than the treating doctor. The allegations of breach of duty or defect
are reasonably discrete; it is the issue of individual causation which gives
rise to difficulty.
The alleged injuries (ie, side effects of
psychotropic medication) were generally psychological or psychiatric in nature
occurring in patients with longstanding psychiatric illnesses. It is quite
impossible practically and conceptually to distinguish between the underlying
illness breaking through because of tolerance/loss of efficacy, recrudescence
or rebound of the intrinsic illness on cessation of medication, and genuine
side effects. Is it possible to distinguish between dependence based on
therapeutic benefit due to the efficacy of medication, and dependence due to a
non-therapeutic emotional crutch?
The benzodiazepine litigation involved
thousands of cases and stands as a monument to the generosity of our legal aid
system. It cost over £40million in public funding and not a penny was recovered
in compensation. Since the benzodiazepine fiasco there have been other legally
aided group actions costing millions where the only beneficiaries have been
lawyers.
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