“No case to answer” ruling for Shipman pharmacist
A Statutory Committee inquiry into a complaint by the Council of the
Royal Pharmaceutical Society against the pharmacist named in the fourth
report of the Shipman Inquiry has been halted by the committee’s
acceptance of a submission that there is no case to answer.
The Council’s complaint was against Ghislaine Brant (registration
number 70438), who at the material times was a pharmacist employed at
Battersby’s Chemist, 23 Market Street, Hyde, Cheshire, next door
to Harold Shipman’s surgery.
The Council alleged that on 13 or 14 occasions between 22 February and
27 August 1993, Mrs Brant dispensed or was involved in dispensing prescriptions
for single 30mg ampoules of diamorphine in the names of 13 different
patients, each prescription being written by Shipman.
It was alleged that a competent pharmacist would have known that a single
30mg ampoule is an unusual amount to prescribe, that 30mg would be a
lethal dose for someone not accustomed to the drug, that 30mg ampoules
were usually prescribed as part of a course of treatment for cancer patients
and that repeated prescribing of a single 30mg ampoule would be unusual.
A competent pharmacist would also have known the doses set out in the
British National Formulary for its use in acute pain, in myocardial infarction,
in acute pulmonary oedema and in chronic pain.
The Council further alleged that, by repeatedly dispensing single 30mg
ampoules on the prescription of one doctor, Mrs Brant had failed to:
(i) take steps to satisfy herself that an unnecessary or excessive dose
was not being prescribed; and/or (ii) appreciate that Shipman’s
repeated collection of the ampoules himself meant that there was a need
to investigate this prescribing and collecting pattern further; and/or
(iii) take steps to satisfy herself that there was no abuse of diamorphine
in relation to the prescribing; and/or (iv) identify any discernable
and/or unusual pattern in Shipman’s prescribing of diamorphine;
and/or (v) take steps to report the clear and unusual pattern of prescribing
either to her superintendent pharmacist or to the Home Office, either
directly or through the police chemist inspection officer (CIO), or to
the Society.
It was alleged that Mrs Brant had failed to order supplies of 5mg or
10mg ampoules before about June 1993 even though she apparently understood
that one reason why Shipman prescribed 30mg ampoules was that the pharmacy
did not have smaller doses in stock.
In summary, the Council alleged that, in the course of exercising her
role of pharmacist between 22 February and 27 August 1993, Mrs Brant
had (a) failed to exercise the professional judgment and/or the objectivity
of a reasonably careful and competent pharmacist, (b) failed to exercise
sufficient scrutiny of Shipman’s prescriptions for single 30mg
doses of diamorphine, (c) not acted towards Shipman in a way which was
to the benefit and welfare of the public and patients, (d) failed to
discharge her obligations as a pharmacist to patients, (e) not in any
way exercised sufficient control over the product supplied by means of
enquiring, of the doctor or any other person, into the repeated prescription
by the same doctor of large amounts of a CD, and that those matters individually
or cumulatively may amount to such misconduct as to render her unfit
to have her name on the Register of Pharmaceutical Chemists.
The inquiry took place on 21 and 22 February and was adjourned to 24
February, when David Aaronberg, QC, for Mrs Brant, submitted that there
was no case to answer. The case was then adjourned for a month.
Submission allowable
Giving the committee’s determination on 21 March, the chairman,
Lord Fraser of Carmyllie, QC, said that the rules governing the Statutory
Committee — The Pharmaceutical Society (Statutory Committee) Order
in Council 1978 — make no specific provision for a “no case
to answer” submission. “But,” he said, “in our
view there is no prohibition on such an argument being advanced and it
is implicit in the rules that such a submission can be made. It can only
be in the interests of justice that is should be allowed to be made.
Accordingly we have not disallowed Mr Aaronberg from making his submission.
“In an elegant counter-argument, [Alison] Foster, QC, [for the Council]
urged that whatever view we took of the evidence, we should, in the public
interest, allow the case to run its full course. There would have been
some force in that argument if we were in the inquisitorial position
of being able to require Mrs Brant to give evidence and subject herself
to examination and cross-examination and questions from the Statutory
Committee. The Regulations that presently govern us, however, give us
no such authority. We are not in the role of a French juge d’instruction,
free to roam and free to question at large. . . . It is not for us to
fashion a complaint against an allegedly errant pharmacist. Our task
is to determine whether the complaint set out in the notice of inquiry — nowadays
invariably by the Council of the Royal Pharmaceutical Society — has
been made out.
“The pharmacists on the committee do
of course bring to bear their professional expertise on the issues raised
and, time after time, it is welcome and invaluable. However, repeatedly
as the legally qualified chairman I counsel them that their expertise
is to be exercised only in relation to the matters in the notice of inquiry
and in relation to the evidence before us. To pursue some failing the
Council of the Society has not identified in the notice of inquiry is
not their role if compatibility with the European Convention of Human
Rights is to be secured. We are the independent and impartial tribunal,
not the aides to the complainer.
“While Mr Aaronberg opened, advising us that he was advancing a ‘no
case to answer’ submission and Miss Foster responded in like manner,
it was not a classic ‘no case to answer’ submission and response
in that at various points in their respective arguments we were invited
to consider not only what was set forth on the part of the Royal Pharmaceutical
Society but parts of Mrs Brant’s case which had been admitted and
accepted.
“Be that as it may, what we have to consider is whether, on the basis
of the complaint focused within the notice of inquiry, there is substance
in the complaint against her taken at its highest without regard at this
stage to the credibility of witnesses, which would allow us to conclude
disciplinary action should be taken against her.
“For the reasons I shall set out (and this is not a criticism of
the Society) at the end of the Society’s case we could not discern
a case requiring her response. The witnesses for the Society were admirably
frank, professional
and clear in their evidence. That we are entitled to expect from witnesses
of a senior regulatory body and we would wish to place on record our
appreciation of their evidence but taking that evidence at its highest
at the end of the day we cannot see what it is that is being alleged
Mrs Brant did unprofessionally to cause us to conclude that her name
should be removed from the Register.
“As the courts have remarked more than once, that is the test we
are bound to apply even if our subsequent conclusion is that we can restrict
our
sanction to the lesser penalty of an admonition or reprimand.
“There is a context to be set here. Our sponsoring minister, Lord
Warner, described Dr Shipman at a meeting of the Council for Healthcare
Regulatory
Excellence on 8 March 2005 as ‘uniquely evil’. Although Dr
Shipman committed suicide in prison without ever explaining his motivation
in killing so many of his patients, we would respectfully endorse Lord
Warner’s description. We are, of necessity, unsure about the number
of patients he murdered but we would recognise, as did Dame Janet Smith
[chairman of the Shipman Inquiry], that the figure probably significantly
exceeded the number in respect of whom he was convicted of murdering
in a criminal court.
“We would only observe in passing that long before Dr Shipman encountered
Mrs Brant he had been murdering his patients and long after she was no
longer in the picture his criminality continued.
“Dame Janet Smith assessed that over the relevant period Dr Shipman
had from a variety of sources amassed 24,000mg of diamorphine and had used
that to kill off his patients, not just accelerating the deaths of elderly
patients whose demise was imminent and inevitable in order to shorten
their pain but others who were younger, those who had prospects of recovery
or those who could have expected at least an extended period of life
before them.
“Out of this massive quantity of 24,000mg of diamorphine the complaint
against Mrs Brant is that against wholly lawful and modest prescriptions
over a period of six months she dispensed at maximum 390mg of diamorphine,
ie, at most about 1.6 per cent of what he accumulated and used.
“No evidence was led before us that she wilfully or recklessly dispensed
quantities of diamorphine which she knew or ought to have known were
excessive. On the contrary, the complaint against her is only that she
failed to spot a pattern of prescriptions for relatively modest quantities
of diamorphine. There is and can be no suggestion that she had any knowledge
of the use to which he might put it.
“As we understand the situation, for someone wholly unused to diamorphine
the appropriate dosage may be as little as 2.5mg. However, at the other
end of the scale for a patient used to diamorphine and in acute pain
a dosage of no less than 250mg might be appropriate. As I have indicated,
the complaint against Mrs Brant is that she failed to notice an unusual
pattern of prescribing at 30mg. That is higher than the minimum dosage
that might be called for but it is more than 200mg below the top figure
that a careful and considerate GP might wish to use to alleviate severe
pain and which would have excited no attention at all.
“The key witnesses for the Society before us were David Young, who
has been an inspector for the Society since 1985, and Robert Hallworth,
who
has exceptional qualifications in pharmacy and was probably adduced before
us as an expert witness.
“Dealing with Mr Young first, he is an able and conscientious inspector
of the Society. Had he been slapdash and transparently irresponsible
that might have coloured our judgement but he is neither. On a number
of occasions he had visited the Hyde pharmacy for which Mrs Brant had
been responsible but with regard to Controlled Drugs he had noticed
nothing untoward although it was part of his responsibility to check the Register
of Controlled Drugs. Interestingly, … he acknowledged that ‘I
do consider it to be part of my job to observe and report on unusual
prescribing practices of prescribing
doctors’, and he gave an insightful example of just such a pattern
which he had pursued and which revealed the prescribing doctor was
personally abusing the drug.
“However, his examination of Mrs Brant’s meticulously kept
records had aroused no suspicions on his behalf. Nor, incidentally, had
it caused
another pharmacist who made an entry in the self-same register to voice
her suspicions. It was only when Dame Janet Smith at a later part of
her inquiry had sent to him a ‘Salmon letter’ [a letter
that the Shipman Inquiry is required to write to those who have contributed
to the inquiry, to outline areas of potential criticism of their evidence]
that he slightly changed his tune. Then it became his argument that
pharmacy
staff were better placed than he was as an inspector to spot unusual
prescribing practices. We are not persuaded by this argument.
“The premise on which inspectors operate on behalf of the Society
must be that they know best and communicate on behalf of the Society
not only
what is required of pharmacists under the Code [of Ethics] but what
they ought to be doing to match best practice. Of course it is for the individual
pharmacist to keep the Controlled Drug register up to date and show
in
chronological order supplies in and dispensing out but the role of
the inspector is not only to observe patent errors in the discharge of those
duties but, as Mr Young acknowledged himself, it was his duty to report
upon unusual prescribing practices by doctors.
“In this case he did not suggest that there were any unusual prescribing
practices until threatened with criticism by Dame Janet Smith’s
inquiry and even then his criticism was in the muted form that it was
the pharmacy staff who were better placed than himself to spot the
unusual practices.
“In our view, if there were patently obvious unusual prescribing
practices, Mr Young, the other qualified dispenser and the police should
have picked
up these irregularities. None of them did and it would be grossly unfair
to single out Mrs Brant as culpable.
“
The reality is that the unusual character of Dr Shipman’s prescribing
pattern only emerged with 20/20 perfect hindsight vision after his conviction
as a mass-murderer. In 2005 we might expect pharmacists to query a GP’s
prescribing, suspecting that patients were being hastened to their
death, but in 1993 it was unthinkable that pharmacists who matched
the high
standards Mrs Brant set herself would harbour worries that a GP was
set on murdering his patients.
“ Post-Shipman the profession will have to be on guard and ever-vigilant
but that is a long way from their pre-Shipman state of alert requiring
them only to watch for slipshod GPs, the incompetents, the self-abusers
or the indecipherable. All these types of queries over prescriptions
were well recognised by the profession and any falling below those
professional standards has been fiercely penalised by this committee. “Guilt by association” unacceptable
“Guilt by association is a wholly unacceptable jurisprudential
concept and forms no part of the approach of the Statutory Committee.
Miss Foster,
one of the most assiduous and skilled pleaders in London, never sought
to rely on this odious concept but I fear that in a wider world, because
the luckless Mrs Brant had a professional association with the ‘uniquely
evil’ Dr Shipman, she is regarded as being in some way tainted.
We reject that entirely. She is more to be praised than pilloried. Had
it not been for her meticulous record-keeping retained long after the
law required it of her, much of what the police uncovered about Dr Shipman
would have been lost for ever. From what I have commented upon thus far
it will be obvious that we have some sympathy with Mrs Brant, who has
hitherto been a pharmacist of unimpeachable integrity.
“
However, it would not be unusual for us to turn on a pharmacist like
her where we regarded the falling away from professional standards as
so grave as to warrant removal from the Register. In this case we cannot
do so and we conclude that she has no case to answer.”
The chairman said that, in a “spirited and eloquent” conclusion,
Miss Foster had urged the committee to reject the submission and allow
the case to continue to its conclusion. For the reasons already outlined,
that did not appear to be an option if the committee was not to be oppressive.
While not suggesting that the Society should not have pursued
the case, the committee saw no purpose in unnecessarily protracting it.
In the committee’s view, Miss Foster had an intractable problem
in the balanced evidence of her expert Mr Hallworth, who was well experienced
in the profession. The committee had listened to his evidence keenly.
However, when asked whether people who held the view that it was not
necessary to challenge unusual-looking prescribing such as Shipman’s,
he had replied that such people were “perfectly reasonable”.
“In summary,” continued the chairman, “what then is the case
for the Society? Mr Young sort of wants to pass the responsibilities
back to the pharmacy staff. While acknowledging his scrutiny of the particular
register did not put him on alert and although they were not called before
us, the entry in the register gave neither another pharmacist nor the
police any cause for concern. Then, as Mr Aaronberg teased out at the
very end of his further cross-examination, Mr Hallworth conceded in his
balanced evidence that anyone who took a contrary view that these entries
did not require to be challenged or queried was ‘perfectly reasonable’.
We were pointed to no provision in the Code [of Ethics] requiring a challenge
to Dr Shipman’s prescribing pattern.”
Early in the inquiry, Miss Foster had “with admirable brevity” set
out the Society’s case: “It is the Society’s case that
Mrs Brant failed in her duty in not recognising that the repeated doses
of 30mg of diamorphine gave rise to queries about its use that Mrs Brant
should have raised with the doctor, and reported, if not logically and
adequately resolved, to her supervising chemist, the Society inspector
or to the relevant police officer, the CIO, all of whom were available
to her.”
“That was an impressively precise opening,” said the chairman. “Her
misfortune was that the Society’s inspector on whom she relied
did not support that bald assertion. Nor did the expert witness she adduced.”
“In such circumstances we would regard it as both proper and inevitable
that we should sustain the submission of ‘no case to answer’ made
by Mr Aaronberg. Neither the Society nor Miss Foster should reflect that
this complaint should not have been brought. There was a serious professional
issue to be explored. That has been done but our conclusion on the evidence
is that there is no case to answer.”
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