The
Pharmaceutical Journal Vol 266 No 7132 p110January 27, 2001
The
Pharmaceutical Journal Vol 266 No 7132 p110
January 27, 2001
From Dr A. D. J. Balon, FRPharmS
SIR,—As we are all aware the regulations controlling the sale of levonorgestrel
were amended to allow sale as a pharmacy medicine. The manufacturers introduced
a suitable pack for over-the-counter sale (Levonelle), which is distinguished
from a pack containing exactly the same drug intended for prescription-only
supply (Levonelle-2). The new OTC pack is significantly different from the POM
pack primarily by having a highly modified package insert which complies with
the licensing conditions.
The press and other media sources informed the public that from January 1, 2001,
EHC would be available at pharmacies. They rarely commented on the fact that
the manufacturer had not yet provided pharmacies with the OTC pack. Due to the
timing of the change in regulations (and maybe other factors) the OTC pack has
been slow in reaching many community pharmacies. By January 12, one major wholesaler
quoted an order code but could not supply.
There were some requests for the product as early as the January 2 and pharmacists,
in the main, refused supply as they did not have an appropriate pack.
At about 1.30pm on Wednesday, January 17, a young woman came into the pharmacy
and asked if I could supply the “morning after pill”. I asked a few questions
and the most significant fact elucidated was that unprotected intercourse had
occurred on Sunday night some 65 hours before. She had been in France at the
time but had left early on Monday morning. She was aware of the change in law
regarding the supply of EHC from pharmacies and so did not stop to obtain a
supply in France. Since arriving in England she had visited some 26 community
pharmacies, all of which agreed that they could supply the pills but they did
not have an appropriate pack. I continued my questioning and satisfied myself
that I could legally supply the product. Fortuitously I had received a supply
of three packs in the morning order, so I was in a position to make the supply,
which I did.
Research has shown that the efficacy of the drug in preventing conception reduces
with time after intercourse. I was concerned, because although supply of the
product was within the 72-hour limit, time had indeed passed since the event.
How do the 26 pharmacists (or their public face representatives) feel about
delaying supply of a drug which would be in the patient’s best interest? Surely
these 26 pharmacists could have provided the drug required from their dispensaries.
Principle one of the Royal Pharmaceutical Society’s Code of Ethics states, “A
pharmacist’s prime concern must be for the welfare of both the patient and other
members of the public”. This clearly places the patient’s welfare at the centre
of our profession’s concern. In view of this saga one has to ask whether the
membership has taken this concept on board.
The Code also states, “A pharmacist must do everything reasonably possible to
assist a person in need of . . . (b) emergency supplies of medicines”. I am
aware that supply of the P pack of Levonelle is not an emergency supply as envisaged
in the Code but would argue that the pharmacists approached by this woman did
not do everything reasonably possible to assist. I know that they did not have
the P pack in their pharmacy otherwise many would have made the supply. I am
also aware that the Code states that “a pharmacist must at all times have regard
to the laws and regulations applicable to pharmaceutical practice”.
Part 1 of the Code starts with an introduction to the concept of decision making
in the practice of our profession. It states that “the exercise of professional
judgment requires identification and evaluation of the risks and benefits associated
with possible courses of action; on occasions there may not be a right or wrong
answer. Different people may reach different decisions on a single set of circumstances
and each may be justifiable. . . . When faced with ethical dilemmas, pharmacists
are expected to use their professional judgment in deciding on the most appropriate
course of action.”
The discussion paper by Alan Cribb and Nick Barber (see PJ, May 27, 2000,
p798), “Developing
pharmacy values: stimulating the debate” raises the question of the decision
making process in pharmacy practice. It draws attention to various factors which
need to be addressed by professionals in reaching decisions about their actions
- including scientific factors, the law, ethical, moral, religious considerations,
and many others. The paper also highlights the Society’s position regarding
the fact there are few absolutes, only shades of grey.
So we are now left to consider the actions of these 26 pharmacists. Did they
consider supplying the POM pack and giving the woman all the required information?
I am aware that this could be deemed as breaking the law. I am also aware that
such a supply would be outside the product licence. However, I would suggest
that the patient’s welfare should be placed before the law, which does not bar
the supply of the drug without a prescription; only the product licence of the
pack supplied would not support such action. What is more important? The spirit
of the law or the law itself?
Derek Balon
Edgware, Middlesex
From Mrs J. Loch, MRPharmS
SIR,—I am writing in connection with the recent publicity surrounding
MMR vaccination.
Many experts in the field of autism agree that classically autistic children
can be identified from as young as two or three months of age. At 14 months
of age, my youngest son was considered by all health professionals known to
him to be both physically and developmentally normal. He received his MMR vaccination
and within a few weeks showed signs of developmental and behavioural regression,
and symptoms suggestive of a serious bowel disorder began to manifest. At two
years of age, he was assessed and found to have “autistic tendencies”. At two
and a half years of age he received a diagnosis of autism. He has recently been
extensively reassessed by a clinical neuropsychologist who is internationally
aclaimed in the field of autism. At four and a half years of age, he now significantly
exceeds the cut-off point for a diagnosis of autism in all core areas. In other
words, the development of his condition has been regressional. His bowel problems
continue and a biopsy result shows the presence of measles virus in his bowel
tissue, even though he has never been exposed to wild measles.
I strongly believe that his problems are a direct result of an adverse reaction
to MMR vaccination. Many parents are having identical experiences with their
children and are reaching the same conclusion. But the Department of Health
continues to assure the public that MMR vaccination is both safe and effective.
Clearly, something is going badly wrong with these children. I feel that the
Department of Health should take responsibilty for finding out exactly what
has caused so many children to develop regressional autism and bowel disorders,
if it was not MMR. Appropriate treatment for the bowel dysfunction could significantly
improve their long-term prognosis.
Dr Fiona Scott of the Autism Research Centre at Cambridge university was commissioned
by the Government to carry out epidemiological studies into autism. She studied
the population of boys aged between five and 12 year in Cambridgeshire. Her
results demonstrated that one in 175 children in this population has a diagnosis
of autistic spectrum disorder. A similar study carried out in East Surrey showed
an incidence of autism of one in 69 boys under seven years of age.
This pattern of regressive presentation was historically rare, with some 65
cases appearing in the clinical literature between 1908 and 1988. Presently
in the United Kingdom alone, there are at least 2,000 families describing children
with regressional autism.
I think that it is grossly unfair to dismiss these observations as merely anecdotal,
as parents generally do not have the opportunity to have peer-reviewed reports
published in medical journals.
If the Department of Health is committed to reassuring the public about the
safety of MMR vaccination, then I feel it will need to demonstrate clearly the
mechanism by which all of these children have fallen ill.
If anyone would care to share similar experiences or receive more information,
I can be contacted by e-mail at peteraloch@hotmail.com.
Julie Loch
Marshfield, Cardiff
From Mr C. R. Cleverly, MRPharmS
SIR,—Following the publication of the National Health Service plan for
pharmacy, including improved out-of-hours services, I have no doubt that faceless
clerks at the Department of Health are even now preparing their latest “Howdah
Decree” that we are expected to provide this “compulsorily” on a “voluntary”
(ie, unremunerated) basis.
Perhaps if we act now we can avoid yet another imposition on a sadly abused
profession by stating that we are not prepared to surrender our freedom of movement
in what little leisure time remains to us unless we are properly remunerated
for it. We need to state a minimum fee, certainly no less than £5 an hour, and
a realistic response time, perhaps 90 minutes, dependent upon circumstances.
To those who would consider it professional to provide this service free I would
make two comments. First, the major distinction between professionalism and
amateurism is that professionals are paid for their services, hence to provide
it unremunerated is rank amateurism. Second, if it is thought that pharmacists
will earn some unspecified kudos with other health care professionals or the
public for providing the service free, rest assured that they will see only
a divided profession whose negotiators are too spineless to stand up to a bunch
of administrative clerks.
In the past we have been so naive as to expect that services provided voluntarily
will eventually be remunerated; we should now have learnt our lesson.
Roger Cleverly
Sherborne, Dorset
From Mr P. I. Herman, MRPharmS
SIR,—Comment has been made as to the lack of response to the so-called NHS plan for pharmacy, prepared during a period when there was not even a chief pharmacist. Perhaps the lack of response is a stunned silence due to the absolute cheek of it all. I should like to make the following comments:
The above comments are by no means comprehensive and I think the whole plan could be summarised by the phrase “real threats, illusory promises”.
Peter I. Herman
London W1
From Mr B. G. Spencer, MRPharmS
SIR,—Mr Robert Blyth, a former editor of The Pharmaceutical Journal,
although not omniscient, is not usually far from getting the facts right and
succinctly distilling them. His assumption that many of the current ailments
of the Royal Pharmaceutical Society stem from the implementation of the Banks
report and the Society’s new ways of working administratively is most probably
correct (PJ, January 20, p80).
The Veterinary Pharmacists Group (VPG), too, has suffered the ignominy of having
its recently established newsletter summarily withdrawn, without notice and
given no chance to seek alternative channels of funding. Steven Kayne, in his
last editorial, expressed his despair at the decision, having spent three years
working up the publication. To see it jettisoned in this way is particularly
galling for all concerned.
The past three years has witnessed a steady degradation of the service which
the membership groups have been receiving from Lambeth. The onus has been moved
from the Officers and employees of the Society to the elected members of the
group committees. Whereas in the past we in the VPG had the services of a dedicated
pharmacist staff member willing, able and enthusiastically involved in all matters
veterinary, we now have an overworked non-pharmacist trying her best to cope
with ever- increasing responsibilities. Our committee can no longer submit new
policy strategies direct to the Council as in the past, we are shunted there
at the whim of an intermediate (it could be called interfering) committee with
no veterinary interest and very little veterinary knowledge.
The VPG, although a minority interest group within pharmacy, represents a huge
industry which is essential for the feeding and ultimate well-being of the population
as a whole. Its influence within the Society is minimal and is being eroded
by other interests with other agendas. Many products used in veterinary medicine
are derivatives of human medicines, and in some cases the reverse is true. We
ignore or diminish the importance of this aspect of pharmacy at our peril. There
are lots of animals out there in the pharmaceutical wilds, waiting like jackals
to feed off anything we are foolish enough to leave unattended.
As Mr Blyth suggested, it would be a big improvement to return to the previous
status. We are being run by non-pharmacist administrators who, like their civil
servant equivalents at Westminster, will be there when all the pharmacists have
long since departed from Lambeth. If the reasons for all these problems are
financial, as has been suggested, perhaps it is time the hush hush brigade was
headed by a Pied Piper who could pipe all of them into the Thames so we could
make a fresh start?
Brian Spencer
Sutton Coldfield, West Midlands
From Mr I. M Caldwell, FRPharmS
SIR,—Your heading, “Some changes are inevitable”, on the letter from
Cox and Fox (PJ, December 9, 2000, p855)
was both pithy and accurate but there are at least two circumstances under which
change should not be welcomed: first, when it is change for the sake of change
and, second, when it is change without clear evidence of the benefits which
will flow from it. Pharmacy is a science-based profession and pharmacists are
expected to use evidence-based practice. Where is the evidence that the public
would be better served if the Royal Pharmaceutical Society abrogated its regulatory
function? It was suggested that Sue Norman (chief executive, United Kingdom
Centreal Council for Nursing Midwifery and heath Visiting) had answered that
at the British Pharmaceutical Conference 2000 (PJ, September 23, 2000,
p453), the first BPC
I have missed in 30 years. It is possible to read the report of that session
as a defence of her particular “status quo” rather than the presentation of
an irresistable alternative.
It is proposed that the “statutory function” be handed over to some sort of
regulatory committee, which may or may not be composed of a majority of the
profession and which may or may not be elected, without even spelling out what
that function is. Let me give a broad view. Regulation is only necessary to
control entry to and participation in a profession. The first involves controlling
the means and standards of entry which normally requires outlining undergraduate
course content, student progression protocols, monitoring university delivery
of these standards and ensuring good postgraduate, preregistration performance.
The second demands the creation of professional standards, the registration
of members and that instances of unprofessional behaviour by members be dealt
with in a clear, efficient, transparent and equitable manner in the interest
of both the profession and of the public which we serve. Since long before the
days of political correctness we have had public disciplinary hearings and “minorities”
have been at the heart of our processes for over half a century. As a result
of conscious decision rather than legislative requirement, we started a gender
shift when Mrs Anne Marsden was appointed to the Statutory Committee and now
we have moved to the inclusion of lay members other than the Chairman of the
Statutory Committee. I cannot resist the temptation to use the adage, “If it
ain’t broke, don’t fix it”. Here we have a Society which is either ahead of,
or keeping up with, public requirement and yet it is proposed that its core
being be given away to some undefined body which must, by definition, be answerable
to the same higher authorities, in the form of the courts and the government,
as the Society currently is. Removal of the present functions would certainly
do something dramatic to our Society and you may choose from a host of words
other than “mutilated”, “savaged” or “eviscerated”, for example, leaving only
a rump (not stump) with, at best, an advisory voice from a reduced and voluntary
membership.
No system can ever be perfect, but our very record of willing evolution would
suggest that revolution is not the way forward. We could perhaps enlarge the
Statutory Committee with more lay members and operate it as a series of panels.
Lay members may have a role in the referral process. In the Council, the Privy
Council nominees have almost universally been productive, involved, independent
and capable of punching above their weight, and a modest increase in their numbers
could well benefit both the profession and the public. Improvement need not
involve babies and bathwater!
On the question of democratic representation, only 20 per cent of the membership
choose to exercise their voting rights at present, be it due to apathy, contentment,
disillusionment or persistent mystification with the single transferable vote
system. If that is the response to a Society which the members own, then I cannot
see a greater degree of involvement in a body which is imposed upon them. Looking
at non-registering societies overseas, Australia does particularly well with
80 per cent of pharmacists, in a country where pharmacies are pharmacist-owned,
joining the Pharmaceutical Society of Australia. Our Australian colleagues are
pre-eminent in continuing education, using every mode of communication except
smoke signals, and they frame professional standards, but the implementation
is in the hands of the state boards. Some other pharmaceutical societies fare
less well in terms of membership and I am unaware of any comparative studies
which demonstrate that other populations are better served by the board model
than the British public are by the Society’s structure.
The correspondence to date has concentrated on concepts but has not mentioned
the choices and costs devolving on the individual. Obviously there would be
a substantial annual registration fee to allow one to practise - a fee which,
by reference to other bodies, is extremely unlikely to be lower than the Society’s
retention fee. Thereafter it is up to the individual. Join the Society - a fee.
Join the Pharmaceutical Services Negotiating Committee or the Scottish Pharmaceutical
General Council - a fee. Join National Pharmaceutical Association or the Scottish
Pharmaceutical Federation - a fee. Join the union - a fee. Join the College
of Pharmacy Practice - a fee. Yes, I know this series was predicated by all
sorts of fanciful proposals of amalgamations and mergers but I am prepared to
be amazed if the PSNC/SPGC and the NPA/SPF and the College and the Society find
grounds to reverse their original respective decisions to split.
Finally, Sir, as well as apologising for another lengthy epistle, may I return
to semantics. Contrary to the implication in the letter of December 9, 2000,
I can find no evidence among the contributions of the use of the word “reactionary”.
In addition, a skim through a few dictionaries published over the past century
confirms my understanding that the word “radical” conveys a complementary meaning.
Ian Caldwell
Larkhall, Lanarkshire
From Mr A. G. Shaw, FRPharmS
SIR,—I write to support the criticisms published in the columns of The
Pharmaceutical Journal about the decision of the Royal Pharmaceutical Society’s
Council to discontinue publication of The Industrial Pharmacist.
Information about this unwelcome decision first appeared in reports from the
chairman of the Industrial Pharmacists Group (Mr Mel Smith) and the managing
editor of the publication (Mr Jonathan Buisson) printed in the December issue.
Both reports stated the decision had been taken at a Council meeting held in
December to review the Society’s finances. The Society’s financial affairs have
been the subject of considerable comment and there appears to be general agreement
that they are not in a satisfactory state. The true facts of the situation,
however, must have been known to Officers and senior staff for some time. Thus
the decision to discontinue the publication of The Industrial Pharmacist
without consulting those concerned must be regarded as a lack of common courtesy
and a knee-jerk reaction demonstrating a failure in forward planning.
The December Council meeting was reported in part by The Journal but
there was no reference to a discussion on financial affairs or the discontinuance
of journals. I have waited, but in vain, for the report to be concluded so that
members of the Society might be better informed about the issues at stake and
the views of Council members.
My advice to Mel Smith and his colleagues is to arrange a special meeting of
the group committee (to be attended by elected members only) and perhaps away
from the constraining influence of Lambeth. The remit for the meeting should
be to review all aspects of the relationship between the IPG and the Society
and examine whether the interests of those who work in the industry might not
be best served by a degree of disengagement between the two parties — a course
advocated by some correspondents in your columns.
A. G. Shaw
St Albans, Hertfordshire
From Mr M. J. D. Gamlen, MRPharmS
SIR,—The only benefit I have received from the Royal Pharmaceutical Society over my 20 years in industry is through the Industrial Pharmacists Group and, principally, The Industrial Pharmacist. Now it is clear that the Society has no interest in its industrial membership there seems little point in retaining membership. It is a sad day, indeed.
Michael Gamlen
Beckenham, Kent
From Miss J. A. Valente, MRPharmS
SIR,—I am writing to express my disappointment and anger that The Agricultural and Veterinary Pharmacist is being temporarily suspended. It is a valuable source of information, and I wish it had been around when I started practising pharmacy as I have had many inquiries from pet owners over the years. I hope that the Royal Pharmaceutical Society will reconsider its decision. It also makes me wonder what the Society spends our fees on, as we pay a considerable amount each year, to find they are axing the veterinary and industrial journals. Whenever I contact the Society I find staff to be unhelpful and lacking in knowledge, so what are we paying our subscriptions for?
Julie Valente
Glasgow
From Mr A. J. T. Low, MRPharmS
SIR,—The article on community pharmacy’s 100-year role in sexual health
was interesting and informative (PJ, January 6, p23).
The author concludes that pharmacy can afford to be more modest in its aspirations
for the future than the exalted place history gave it in 1980. This exalted,
important place stemmed from the AIDS crisis in the early 1980s. The open display
of condoms in pharmacies was one result of this crisis.
Although the AIDS crisis has not developed into the horrific epidemic it was
once feared it might, the threat to public health is still very much a fact
of life and pharmacies play an important role in making condoms available and
accessible. It is a supply function and pharmacists could surely do worse than
make sure these important items are in stock and easily purchased in a way that
is comfortable and not embarrassing for the customer. With the advent of over-the-counter
emergency hormonal contraception, we ought to hear more of the humble and unassuming
condom, a prophylactic that might save a lot of bother later.
We ought to be careful which takes the most exalted position: the “morning after
pill” or the condom? We should not forget the less glamorous article in favour
of something that certainly extends the role of the pharmacist, but which does
not promote safe sex and forethought.
Andrew
Low
South Harrow,
Middlesex
From Dr J. K. Cross, MRPharmS
SIR,—Pharmacists may be interested to know that dental surgeons are being paid a £100 one off sum and 10p per form for checking the validity of patient exemption claims of NHS charges. I do not believe that they are being tested either to check that the proper procedure is carried out.
J. K. Cross
Skipton, North Yorkshire
| Mr STEPHEN R. AXON (general secretary, Pharmaceutical Services Negotiating
Committee) replies: In comparing the payments made to dentists and pharmacists we are not comparing like with like. Initially, pharmacists received payments in respect of training amounting to £1.85m (equivalent to £180 per contractor). This sum was offset against over-payments in the balance sheet at the time. On an ongoing basis, pharmacy contractors had a sum of money added to the balance sheet equivalent to 2.3p for every prescription (exempt and non-exempt). The current position is that they still receive 2.3p for each prescription in respect of point of dispensing checks as the volume increase over the period has matched the remuneration increase. As patients receive on average nine prescriptions per annum this amounts to a payment which is equivalent of approximately 20p per patient per annum. Patients generally receive considerably more prescriptions than claims are made for dental treatment under the NHS particularly bearing in mind the fewer and fewer patients who now receive dental treatment under the NHS. As regards checks being made on dentists carrying out exemption checking I cannot comment other than to say that I would surprised if this escapes the attention of the Directorate of Counter Fraud Services for very long! |
From Mr A. F. Huntley, MRPharmS
SIR,—“Onlooker” (PJ, January 20, p66)
writes of the concoction of make-believe blood and tattoos in evidence of a
“joie de vivre” of a bygone era.
Experienced pharmaceutical hands of the present era would be hard pressed to
find the wherewithal with which to make such nostrums. More pertinently, such
concoctions would be unlicensed and possibly thought to be a health hazard -
Ignorantia juris neminem excusat.
A. F. Huntley
Bristol
From Mr K. D. Leivers, MRPharmS
SIR,—I was astonished to read that the House of Lords Select Committee
on Science and Technology has categorised anthroposophic medicine as “indifferent
to conventional scientific principles”.
While I applaud the select committee for this first step towards regulation
and integration of complementary and alternative medicine, I believe that the
decision to categorise anthroposophic medicine in Group 3a has been taken without
sufficient consultation.
Anthroposophic medicine is well established with 30,000 doctors worldwide and
currently over 100 clinical and developmental studies in progress.
Such a well established complementary medicine, which is investing significantly
in research, is utilising conventional science rather than ignoring its principles.
Kevin Leivers
Chief Pharmacist,
Weleda (UK) Ltd
From Mr B. I. Stroh, MRPharmS
SIR,—Recently, during a busy morning dispensing period, I received a
prescription calling for an “elastic band truss - inguinal single” (no size
stated) for a frail, 84-year-old man.
I had to ask him to call back that afternoon when I knew I would have sufficient
time to take his measurements.
When he returned to be measured, he was rather embarrassed and worried because
many female staff were present. I had to take him up a flight of stairs into
a stock room to take his measurements. I assured him that the staff would remain
downstairs.
Why on earth did this man’s general practitioner not measure him for the truss
while he was undressed and on the examination couch? It would have taken only
an extra minute or two. Community pharmacies are not suitable establishments
for truss measuring and fitting.
Brian Stroh
London NW11
From Mr A. Tanna, MRPharmS
SIR,—Can the manufacturer of the following products give a logical explanation as to why the prices of the products are the same, even though the strengths are different:
Ashwin Tanna
London SE26
| A spokesman for MSD responds: MSD’s policy of “flat pricing” is designed
with the best interests of the patient in mind. It has been adopted across
a number of MSD lines to help ensure that the appropriate indicated doses
are prescribed and not compromised. For example, the results of a major clinical study (the Scandinavian Simvastatin Survival Study) indicated that Zocor (simvastatin) offers unique benefits to patients through its unsurpassed survival data, efficacy across all lipid parameters, proven long-term benefits and ability to deliver nine ot of 10 patients to their cholesterol target. While many patients can reach their target cholesterol levels on a 20mg dose of Zocor, others may need titration to a higher dose. MSD’s flat pricing ensures that physicians can increase the dose without worrying about short-term cost pressures, which could otherwise lead to inappropriate switches of therapy to products without the proven efficacy of Zocor Vioxx 12.5mg is the starting and maintenance dose for osteoarthritis. Some patients will receive additional relief from Vioxx 25mg once daily. Vioxx is flat priced so that the cost is the same regardless of the dose, giving doctors the flexibility they need in prescribing. |
From Mr J. V. Wilson, MRPharmS
SIR,—Colleagues need no longer worry about whether there will or will
not be a pharmacist as the editor of The Journal. The post is now occupied
by an engineer and aviator - the ghost of Edward A. Murphy (1918–90)!
My recent “Broad Spectrum” article on Murphy’s law (PJ, January 20, p84)
was originally titled “Odd socks . . .” but became “Old socks . . .” during
the editing process. As it so happens, my collection of odd socks is old, but
this has no bearing on the message in my article, which was to issue a warning
about thinking through the consequences (all of them, even the unthinkable ones)
before making radical and perhaps irrevocable changes to the way in which we
practise our profession.
John Wilson
Arnold, Nottinghamshire