assistant - GreenCross Publishing

Transcription

issue 3 volume 10 • march 2008
The independenT monThly for irish pharmacisTs
the interview
Pharmacist of
the Year
Professor
Caitriona O’Driscoll
the coalface
David Jordan expresses
his gratitude to
Professor Drumm
Q&a
ronan Quirke
Short StorY
an inSpector callS
Julian Judge
claSh of cultureS
fintan moore
n
duci
o
r
t
in
g
t
n
a
t
assis
pharm
acy
pluS TraInInG
CD
Back, muscle
and joint pain.
special reporT
Special General
Meeting of the IPU
Full text of Aidan O’Shea’s statement
to the meeting.
news
news
STATEMENT TO THE AGM OF
THE IRISH PHARMACY UNION
FROM AIDAN O’SHEA, FPSI.
(This statement was read on behalf of Aidan
O’Shea by Marie Hogan, Past President of the
IPU, at the Special General Meeting held on
the 5th March.)
Despite having recently retired from
community pharmacy for family
reasons, I have been closely following
the turmoil created by the decision of
the HSE of September last to reduce
the reimbursement price for dispensed
drugs under state schemes by 8.2%. The
HSE claims that this reduction, taken
directly from the revenue of community
pharmacies, would effect a budgetary
saving of €100 million per annum.
The substance and the manner of
this decision breaches a number of
fundamental principles underlying
the relationship between community
pharmacists and the state.
The decision was taken without prior
consultation with the IPU.
Contractor pharmacists believe that it
is prima facie a breach of the pharmacy
contract.
The HSE has compounded this turmoil by
claiming that The Competition Act prevents
it henceforth from negotiating terms and
conditions of contract with the IPU.
This claim has led to disengagement and
the collapse of substantive direct dialogue
with the IPU, the responsible Union which
has acted for pharmacists for over 35 years.
Consequent to this collapse of dialogue,
the vacuum has been filled by a series of
legal actions taken by the IPU itself and by
individual members against the unilateral
decision of the HSE. These actions put the
parties in a sub judice mode, creating an
even higher barrier to resolving the issues.
The substantial amounts of money, time
and energy spent on these legal actions
should be channelled towards direct
dialogue and resolution rather than legal
confrontation.
The Minister for Health and Children
Mary Harney TD has recently set up an
independent arbitration committee to
urgently examine the professional and
economic elements of the pharmacy
contract, but the HSE obdurately insists on
its price reductions as a non-negotiable
precondition of the process. This
precondition emasculates the scope of the
arbitration, since the negative impact of the
price reductions will intensify over time.
Community pharmacists are struggling
with the ethical dilemma of maintaining
professional services at an economic loss,
or degrading the quality of those services
by cutting staff numbers and hours of
service. At its most extreme, this process
will ultimately lead to the closure of smaller
independent pharmacies in communities
with a high number of medical card
holders.
Marie Hogan, Past President,
reading Aidan O’Shea’s
statement to the packed
Special General Meeting.
This vexed and volatile situation calls for leadership
and vision of a high order from our Government
and the HSE who are our servants and not our masters, and
from the IPU and PSI representing the profession. We must
avoid personal abuse and protect patient care, in spite of the
dangerous and provocative sequence of events. Ultimately
everything is negotiable and competent of resolution in
order to maintain and indeed enhance community pharmacy
services.
Parity of esteem, engagement and dialogue are the
cornerstones of resolution.
Irish Pharmacist is grateful to Mr Aidan O’Shea for permission
to publish this statement.
Issue 3 Vol 10 March 2008
3
The independenT monThly for irish pharmacisTs
conTenTs
ediTorial
Stuck between a rock and a hard place?
Firstly, we would like to apologise for the late arrival of this issue of Irish
Pharmacist, but we felt it was important to cover the historic meeting of
pharmacists which took place on Wednesday last.
Anyone attending the Special General Meeting in the Ballsbridge Inn can have
been in no doubt that pharmacists are angry.
It remains to be seen if the mood of solidarity, and determination to take the
fight to the HSE, which was shown in the morning session will hold up in the
weeks and months ahead.
Prior to the meeting, the union issued a statement saying it has left it up to
individual pharmacists to choose their own particular course of action, taking
into account their own circumstances and business arrangements.
So, even though the meeting called for unity and collective action, the union
has not chosen to impose its views on its members. How this will play out is
difficult to predict.
It would seem, however, that the HSE appears to think it knows pharmacists
better than pharmacists know themselves; it looks as if the HSE is banking on the
assumption that pharmacists will find it deeply unsettling to turn away the old
and the chronically sick. A compunction, from which the HSE does not appear to
suffer.
But then as a number of speakers attested, the HSE seems to have decided
that everything, even the health of the nation, must be sacrificed to the God of
competition.
It’s hard to believe that even Mary Harney and Brendan Drumm can be so
ideologically driven that they believe competition rules must be obeyed in every
circumstance.
Despite the show of strength, there was a general feeling of weariness from
many of the members at lunchtime on the day. Partly this must stem from the
fact that pharmacists appear to be stuck between a rock and a hard place.
However, they have been left with little option but to repress their
professional instincts this time if they are going to bring the HSE to the table. As
President of the IPU, Michael Guckian, made clear at the meeting: if pharmacists
roll over this time, next time they will have nowhere else to go.
GreenCross Publishing is a recently established publishing house which is
jointly owned by Graham Cooke and Maura Henderson. Between them Graham
and Maura have over 25 years experience working in healthcare publishing.
Their stated aim is to publish titles which are incisive, vibrant and pertinent to
their readership. GreenCross was recently appointed by the Irish Practice Nurses
Association to publish their new title Nursing in General Practice. GreenCross will
be introducing new titles over the coming months.
sandyford industrial estate, dublin
© copyright
disclaimer
Greencross publishing
irish pharmacist endeavours to ensure accuracy
2008
of information given and of claims made in
no part of this
articles and advertisements. nevertheless, no
publication may be reproduced, stored in a
responsibility is accepted in respect of such
retrieval system, or transmitted in any form by any
information or claims. any opinions expressed
means – electronic, mechanical or photocopy
by contributors are entirely their own and do not
recording or otherwise – whole or in part, in any
purport to be the views of irish pharmacist.
the publishers.
report from the Special General Meeting of the IPU.
3 newS
Statement of Aidan o’Shea to the Special General Meeting
15 ContraCt law
What it means for pharmacists.
Cormac o’Neill
18 the CoalFaCe
David Jordan gives thanks to Professor Drumm.
20 Short Story
An Inspector Calls
Julian Judge
22 the interview
Professor Caitriona o’Driscoll, Pharmacist of the year, talks to Irish
Pharmacist.
24 FinanCe
Paul A overy asks if all the predictions of doom and gloom amount to a
hill of beans.
25 a view From above
The role of the pharmacist in prevention is being taken seriously by our
near neighbours.
Terry Maguire
27 hoSpital pharmaCy
Breast cancer: an overview
In this article the authors outline the pathology of breast cancer and the
role pharmacists can play in prevention and patient support.
33 meeting report
The manufacture and use of biopharmaceuticals.
Stephen Meyler
epharmaCy
37 health in your hand
Pharmacists can now use SMS to let patients know when their
prescription is ready for collection.
39 weird and wonderFul world oF the web
We go in search of the best web sites so that you don’t have to.
Jay Curtis
41 produCt newS
45 travel
Introducing Zara’s Planet – a travel company for the more discerning
traveller.
42 Q&a
our new feature provides a snapshot of the interests likes and dislikes of
our readers and contributors. This month: ronan Quirke.
46 CroSSword
46 reCruitment
Clash of cultures
Fintan Moore says the HSE has completely failed to understand the
mindset of pharmacists.
publishing, unit 6, st Kieran’s enterprise centre,
purposes without the prior written permission of
6 Cover Feature and SpeCial report
48 outSide edge
irish pharmacist is published by Greencross
form whatsoever for advertising or promotional
issue 3 volume 10 • march 2008
EDITor: Maura Henderson
PUBlISHEr: Graham Cooke
CoNSUlTING EDITor: Stephen Meyler
rEPorTEr: Jay Curtis
SUB EDITor: Fran McDonagh
CoNTrIBUTorS: David Jordan, Fintan
Moore, Paul Shalvey, Terry Maguire,
Niamh McSweeney, Cormac o’Neill,
ronan Quirke.
DESIGN: Donal larkin
CArTooNIST/IllUSTrATor:
John Corrigan
PHoToGrAPHy: Audrey Hanley
PrINTErS: Bairds
lETTErS To THE EDITor:
[email protected]
Advertising: graham@
greencrosspublishing.ie
or 0872222221
special report
news
Special General Meeting
of the IPU
Pharmacists urged to resist attack on
their fundamental human rights
Michael Guckian, President of the
IPU, Marie Hogan, Past President,
John Chave, Secretary General,
PGEU, and Dr Martin Daly, Vice
President of the IMO, in buoyant
mood prior to the meeting.
Marie Hogan, Past President, told the
packed auditorium, that what is being
missed in all the media coverage;
“is that this isn’t a dispute about the
issues, this is a dispute about the fact
that one side will not talk.”
T
hey were expecting 500 but last Wednesday saw the
largest gathering of pharmacists in the history of the
state – more than 1000 – packed into the Conference
Room of the Ballsbridge Inn.
As well as past and current office holders of the IPU,
the historic meeting was addressed by representatives
from General Practice, Dentistry, the NUJ, and the PGEU.
After a brief history of the dispute to date, Liz Hoctor, Chair of the
meeting, said that the HSE, by their own admission, are taking 100
million from community pharmacists, thereby reducing the income
of pharmacies by 30%. “They seem to think they can confiscate this
money with impunity and without any consequences for patients or
for pharmacy services,” she said.
Ms Hoctor stated: “So today is very much about the rights of
pharmacists to belong to this union in the face of unprecedented
attacks by the HSE. Their new strategy is to try to divide and conquer.
They will not succeed. The unity and solidarity within the profession is
stronger than ever and will be more so after today.”
Presidential address
The President of the IPU, Michael Guckian, took up where Ms Hoctor
left off: “For the past six months the pharmacy profession has been
subjected to abuse, misinformation, innuendo and bullying by the
HSE. However your presence here today sends a very strong signal that
we will not roll over in the face of this unreasonable attitude.
“We are not unreasonable people” he continued, “but we demand
fair play and we demand respect. And we demand to be dealt with
the same as all other organisations. We should expect it all the more
when we are dealing with a state institution charged with delivering
healthcare services.”
Addressing the issue of patients Mr Guckian said: “We also have a
duty to patients to ensure that they get the services that they deserve.
And equally, we have a duty to tell them when these services are being
threatened by the unreasonable behaviour of the HSE, and we make
no apologies for doing so.”
6
Liz Hoctor,
Vice President,
chaired the
historic meeting.
Seamus Dooley,
Secretary of the
NUJ, said: “the
Competition Act has
been interpreted
to mean that
certain workers
cannot exercise
their constitutional
right to freedom of
association…without
fear of civil or criminal
prosecution.”
news
special report
“The HSE are forcing change on the sector without any
regard to patient care and they ignore the advice of their
own consultants about the need to implement changes in
a reasonable and gradual manner. If they won’t listen to the
consultants that they themselves employed out of taxpayers
money what hope have we got of doing business with them?”
Support from the Imo
Dr Martin Daly, Chairman of the National GP Committee of the
IMO and Vice President of the IMO, opened by remarking on
the huge turnout, saying it reflected the critical nature of the
crisis.
“It is timely for all of us to reflect, in our respective
representative organisations, on the situation in which
community pharmacists find themselves placed.
“In their haste to be seen to prevail – and remember this is
all about optics – to prevail over community pharmacists, they
are actively undermining a contract that has been entered
into freely by the state.”
Dr Daly stated that the competition law is being used as a
tool to break pharmacists. He says the IMO has studied this
area and has found that other countries in Europe have sought
derogation from the competition law when it came to health
services.
However he continued “The HSE [are] the archetypal bean
counters who know the cost of everything but the value of
nothing.”
Paraphrasing Thomas Paine, Dr Daly said: “If you don’t hang together, you will
surely hang separately.” He told members that solidarity was the only option if
they were to counter the HSE.
‘partnerShIp’ IS dead
Marie Hogan, past president of the IPU, said she has watched in amazement and
disbelief over the past 18 months as the relationship between the union and the
HSE have disintegrated.
“The thing that gets lost in all the media coverage is that this isn’t a dispute
about the issues, – if we could get to talk about the issues we might have some
hope – this is a dispute is about the fact that one side wont talk, they simply are
not prepared to talk to our union.
“There is no way we can accept going into a review with preconditions and a
predetermined outcome, and where they have taken away a third of our income,
and then they want us to discuss it!
“The real reason they are doing this is that, like all bullies, they are cowards at
heart. The HSE are behaving like this because they know their own arguments
will not stand up. They know that any rational, really independent review will
find against them and will not give them the result they want. They believe that
might is right.”
the CompetItIon aCt
Seamus Dooley of the NUJ informed the assembly that the strict interpretation
of the Competition Act has already been used to take away the fundamental
human rights of Irish freelance journalists, photographers and Equity members.
“The Act has been interpreted to mean that certain…workers cannot exercise
their constitutional right to freedom of association, collective bargaining, nor
can they conduct or comply with a collective agreement without fear of civil or
criminal prosecution.”
He concluded: “In our democratic society we must ensure that the creatures
Dr Martin Daly, Vice President of the
IMO, told the assembly: “What we
have with the HSE is the archetypal
bean counters who know the cost of
everything but the value of nothing.”
The packed auditorium gives John Burke
a standing ovation after he speech urging
members to unite and resist the HSE.
of statute are kept under control. We must guard against the unintended
consequences of the actions of creatures of statute.”
european Support
John Chave, Secretary General of the PGEU, whose organisation represents
community pharmacists in 30 countries said that never in the history of the
PGEU have pharmacist representatives, in any European country, been put into
the position in which the IPU currently finds itself.
“I’m amused by the HSE talking about the European average for this and
the European norm for that, I have to tell [the HSE] that there is no European
norm for trampling on collective rights. There is no European norm for putting
pharmacists out of business, there’s no European norm for pharmacists to
dispense at a loss, and there’s no European norm for having your lawyers
running around finding excuses because you have made a political decision not
to negotiate.
“There are good reasons why these rights are called fundamental. They are
fundamental because they can’t be disregarded for simple reasons of political
expediency. They can’t be thrown in the bin because some bright spark lawyer
cannot tell the difference between the letter of the law and the spirit of it,” said
Mr Chave.
Concluding the meeting, John Burke, founder member of the IPU, said that
the only part of the health service which worked, and which was respected by
the general public, was now under attack by the HSE and the Minister. If this
service implodes, he warned, it will be “laid at the feet of Minister Harney.”
He also cautioned members about attempts to divide pharmacists and
predicted that things will worsen over the coming months. He said the best way
to counteract this was to stay united, keep all lines of communication open and
to talk regularly to fellow pharmacists.
“Walk tall and be not afraid,” he urged, as the biggest gathering of
pharmacists in the history of the state rose to their feet to give him a sustained
round of applause.
John Burke, founder member and
Trustee of the IPU, and Seamus
Feely, General Secretary.
7
news
news
“Start planning for an imminent
flu pandemic”
Speaking at a breakfast briefing attended by some of
Ireland’s leading CEOs, Willie Walsh, CEO of British Airways
said: “The threat of a flu pandemic is very real, so it is vital
that businesses put the necessary controls in place now
through proper continuity planning. As with all major
adverse events, this planning means they will be prepared
in advance and will help them to avoid major financial
losses when it does happen. British Airways (BA) has taken
this threat seriously by creating a business continuity plan
for pandemic influenza, and I would recommend that Irish
businesses do the same.”
Mr Walsh was keynote speaker at a breakfast briefing
entitled ‘The economic impact of an influenza pandemic
– is your business prepared?’ which was held in the
Shelbourne Hotel, Dublin, to discuss the importance of
business continuity planning for adverse events. The event
also heard a contribution from Dr Mary Horgan, Consultant
in Infectious Diseases, Cork University Hospital, and was
chaired by economist, David McWilliams.
Dr Horgan updated briefing attendees on the current
status of influenza and the need to stockpile antivirals. “The
World Health Organisation has been monitoring the H5N1
strain of influenza (bird flu) for a number of years. This virus
already has the ability to transfer from birds to humans, and
we feel that it is only a matter of time before it, or a variant,
can be transmitted easily from human-to-human,” Dr
Horgan said. “I believe it’s important for businesses to have
a pandemic preparedness plan which includes stockpiling
antivirals, as these will play a key role in safeguarding the
Irish population’s health during a pandemic before a vaccine
is developed. Tamiflu is the antiviral of choice of the WHO.
Waiting until an outbreak occurs to acquire antivirals is illadvised, as it will be impossible to stockpile after an outbreak
occurs due to production and supply chain constraints.”
A new economic impact assessment, commissioned by
Roche Products (Ireland) Limited, was briefly discussed at
the meeting prior to its official launch. The study estimates
the cost of productivity loss to employers due to the effects
of pandemic influenza on the Irish working population. This
assessment shows a potential loss to the economy of e2
billion during a severe influenza pandemic.
The new economic impact assessment was conducted
from the perspective of employers in Ireland under two
different scenarios – a moderate influenza pandemic and
a severe pandemic. It is expected to be launched in late
February/early March 2008.
Expert PSI group to consider expansion of
pharmacy services
At its Council Meeting at the end of February the
Pharmaceutical Society of Ireland, established a new
group to look at how pharmacy services in Ireland can be
expanded. The group is to be chaired by Mr Brendan Hayes,
President of the PSI. The other PSI Council members on the
Group are: Ms Cathriona Hallihan, the Managing Director,
Europe, Middle East and Africa of Operations at Microsoft,
Professor Peter Weedle, a lecturer in pharmacy at University
College Cork, and Ms Ita Kelleher, a former nurse and a
public interest nominee of the Minister for Health and
Children, to the Council of the PSI.
The Group will report to the Council of the PSI within
three months and the PSI will then forward its advisory
report to the Minister Harney.
Announcing the composition of the group, the Registrar
of the PSI, Dr Ambrose McLoughlin, said its work was
timely. “The role of pharmacy in public healthcare is
growing internationally. We need to focus more on what
pharmacists can bring to patient value, especially in health
promotion and prevention.”
“This group will examine if pharmacy can deal more
effectively than other parts of the health system with
many patients’ concerns through health promotion and
screening for certain chronic conditions, e.g. fingerprick
testing for diabetes with referral to GPs when indicated;
managing patients with stable long-term conditions, e.g.
cardiac patients and patients suffering from respiratory
diseases; advising patients on managing medications;
managing minor ailments to reduce unnecessary visits
to GPs and outpatient services; obesity and weight
management; and to deliver a broader range of diagnostic
and screening services, such as cholesterol testing.”
He said such services were already available in the UK
and there has to be a shift here towards rewards for quality
and range of services provided. “Pharmacists are a highlyeducated profession with a widely dispersed network
of pharmacies across the country. In our view, this has
enormous potential to assist with bottlenecks and to be an
effective weapon in improving the health of the population.”
The group was appointed at the Council meeting
today which for the first time was held at a school of
pharmacy. The meeting took place at the Pharmacy
School of the Royal College of Surgeons and was followed
by a courtesy call by the Council on the Lord Mayor of
Dublin. The PSI is to hold meetings at the other two schools
of pharmacy, UCC and TCD, later this year.
research update
G spot spotted!
The good news is that doctors
in Italy have at last located the
G spot; the bad news is that not
all women appear to have one.
Doctors at the University of
L’Aquila in Italy claim to have
located the whereabouts
of the G spot. They say that
scans show clear anatomical
differences between women
who say they experienced
vaginal orgasms and a group
of women who do not. The
ultrasound scans identified a
region of thicker tissue where
scientists suspect the holy
grail of the vaginal orgasm is
thought to reside. This thicker
tissue was not visible in the
women who say they have
never had a vaginal orgasm.
The G spot is only thought
to affect a woman’s ability to
have vaginal orgasms, so if
women do not have one they
can still have a normal orgasm
through stimulation of the
clitoris, according to the Italian
researchers.
Lung cancer risk from
Vitamin E
People who take daily
supplements of vitamin E have
a greater risk of developing
lung cancer, according to study
carried out at the University of
Washington in Seattle
The researchers monitored
77,000 men and women over
a four-year period and found
that a number of vitamins failed
to protect against lung cancer,
but that daily vitamin E intake
slightly increased the risk of
developing the disease. The
study suggested that taking
400mg of vitamin E for 10 years
increases the risk of lung cancer
by 28%.
NE
W
55937.02_ActAd_245x340-IrePharm:Layout 1
28/1/08
16:55
Page 1
In established postmenopausal osteoporosis
Actonel 35mg
Plus 1000mg Calcium
Plus 880 IU Vitamin D3
3 in 1 packaging
convenience1
In postmenopausal osteoporosis where 1000mg Calcium and 880IU Vitamin D3
is considered adequate supplementation
Dosage instruction: Please refer to API below
Actonel® 5mg or Actonel® Once a Week 35mg or Actonel® Combi (risedronate sodium 35mg Once a Week / calcium carbonate 1250mg) film-coated tablets or
Actonel® Plus Ca & D (risedronate sodium 35mg Once a Week film-coated tablets + 1000mg /880 IU effervescent granules)
ABBREVIATED PRESCRIBING INFORMATION: PRESENTATION: film-coated tablets contain the
equivalent of: Actonel 35 mg (light-orange tablet): 32.5mg risedronic acid, Actonel 5 mg (yellow
tablet): 4.64mg risedronic acid; Calcium Carbonate 1250mg (blue tablet in Actonel Combi): 500mg
elemental calcium. Effervescent Granules (in Actonel Plus Ca + D): Each sachet contains:
2500mg calcium carbonate equivalent to 1000mg calcium and 22 micrograms (880 IU)
colecalciferol (vitamin D3) INDICATIONS: 5mg, 35mg, Combi and Actonel Plus Ca & D: Treatment
of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of
established postmenopausal osteoporosis, to reduce the risk of hip fractures. 5mg only:
Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis. To
maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3
months), systemic corticosteroid treatment at doses ≥7.5mg/day prednisone or equivalent. 35mg
only (not Actonel Combi or Actonel Plus Ca &D): Treatment of osteoporosis in men at high risk
of fractures. Actonel Plus Ca & D is only intended for use in assessed patients for whom the
amount of calcium and vitamin D3 included is considered to provide adequate supplementation.
DOSAGE AND ADMINISTRATION: Actonel 5mg: once a day orally. Actonel 35mg: once a week
orally. Combi: Take one Actonel 35mg tablet on the first day followed on the next day by one
calcium 500mg tablet daily for 6 days. The 7 day sequence is then repeated each week. Actonel
Plus Ca & D: Take one Actonel 35mg tablet on the first day followed on the next day by one
sachet of effervescent granules daily for 6 days. The 7 day sequence is then repeated each
week. Actonel 5mg or 35mg: Take Actonel at least 30 minutes before the first food, other
medicinal product or drink (other than water) of the day. Do not suck or chew the tablets. Actonel
is to be taken while in an upright position with a glass of plain water (≥120 ml). Do not lie down
for 30 minutes after taking Actonel. Calcium 500mg (in Actonel Combi): take with food and
swallow whole. Effervescent granules (in Actonel Plus Ca & D): the contents of the sachet
should be poured into a glass of plain water, stirred and drunk immediately once the fizzing has
subsided. Children: Safety and efficacy has not been established in children and adolescents.
CONTRAINDICATIONS: Actonel 5mg and 35mg: Known hypersensitivity to risedronate sodium,
or any of the excipients, hypocalcaemia, pregnancy and lactation, severe renal impairment
(creatinine clearance <30ml/min). Actonel Combi (in addition to those for Actonel):
Hypersensitivity to calcium carbonate or any excipients, hypercalcaemia, hypercalciuria,
nephrolithiasis. Actonel Plus Ca & D (in addition to those for Actonel and Actonel Combi):
hypersensitivity to colecalciferol or any excipients (in particular soya-bean oil), diseases
associated with hypercalcaemia and/or hypercalciuria, Hypervitaminosis D. PRECAUTIONS:
Actonel 5mg and 35mg: Caution should be used in patients who have a history of oesophageal
disorders which delay oesophageal transit or emptying (e.g. stricture or achalasia) or who are
unable to stay in the upright position for at least 30 minutes after taking the Actonel tablet.
Hypocalcaemia should be treated before starting therapy. Other disturbances of bone and
mineral metabolism should be treated at the start of therapy. This medicine contains lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine. Foods, drinks (other than plain
water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron
and aluminium) may interfere with the absorption of Actonel. Strict adherence to dosing
recommendations is necessary. Osteonecrosis of the jaw has also been reported in patients
with osteoporosis receiving oral bisphosphonates. A dental examination with appropriate
preventive dentistry should be considered prior to treatment with bisphosphonates in patients
with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor
oral hygiene). While on treatment, these patients should avoid invasive dental procedures if
possible. Limited evidence to support the efficacy of Actonel in very elderly women (>80 years)
Actonel Combi (in addition to those for Actonel): In patients with mild to moderate renal
impairment or history of absorptive or renal hypercalciuria, nephrolithiasis, kidney stone
formation or hypophosphataemia, renal function, serum and urinary calcium and phosphate
should be monitored regularly. Actonel Plus Ca & D (in addition to those for Actonel and Actonel
Combi): Vitamin D3 should be used with caution in patients with impairment of renal function and
the effect on calcium and phosphate levels should be monitored. In patients with severe renal
insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and another
form of vitamin D should be used. During long-term treatment, serum and urinary calcium levels
should be followed and renal function should be monitored through measurement of serum
creatinine. In case of hypercalcaemia or signs of impaired renal function, treatment with
calcium/vitamin D3 sachets should be discontinued. The dose of vitamin D3 in the sachets should
be considered when prescribing other drugs containing vitamin D. Calcium/vitamin D3 sachets
should be used with caution in patients suffering from sarcoidosis because of the risk of
increased metabolism of vitamin D to its active metabolite. Calcium/ vitamin D3 sachets should
be used with caution in immobilised patients with osteoporosis due to the increased risk of
hypercalcaemia. This medicinal product contains sorbitol and sucrose. Patients with rare
hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicinal product. INTERACTIONS: Actonel 5mg
and 35mg: No formal interaction studies have been performed, however no clinically relevant
interactions with other medicinal products were found during clinical trials. Risedronate sodium
is not systemically metabolised. Actonel Combi (in addition to those for Actonel): Thiazide
diuretics can increase risk of hypercalcaemia and if used concomitantly serum calcium should
be monitored. Systemic corticosteroids reduce calcium absorption. Calcium carbonate may
interfere with absorption of tetracycline preparations. These should be taken at least 2 hours
before or 4 to 6 hours after oral calcium intake. Hypercalcaemia may increase toxicity of cardiac
glycosides and such patients should be monitored by ECG and serum calcium levels. If sodium
fluoride is used concomitantly, this preparation should be administered at least 3 hours before
the intake of calcium carbonate. Oxalic acid and phytic acid (found in some foods) may inhibit
calcium absorption. Actonel Plus Ca & D (in addition to those for Actonel and Actonel Combi):
Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as
paraffin oil may reduce the gastrointestinal absorption of vitamin D. USE IN PREGNANCY AND
LACTATION: Actonel 5mg, 35mg, Combi and Plus Ca & D must not be used during pregnancy or
by breast-feeding women. SIDE EFFECTS: Actonel 5mg and 35mg: The majority of undesirable
effects observed in clinical trials were mild to moderate in severity. The following common
adverse reactions were reported by the investigators as possibly or probably related to the
medicinal product in ≥1%, <10% of patients and at an incidence greater than placebo in placebo
controlled trials of Actonel 5mg, or in ≥1%, <10% of patients in trials of 35mg vs 5mg: constipation,
dyspepsia, nausea, gastrointestinal disorder, abdominal pain, diarrhoea, musculoskeletal pain
and headache. The following uncommon adverse reactions associated with bisphosphonates
were reported by the investigators as possibly or probably medicinal product related in ≥0.1%,
<1% of patients: iritis, gastritis, oesophagitis, dysphagia, duodenitis, oesophageal ulcer. Rare
(≥0.01%,<0.1%): abnormal liver function tests, oesophageal stricture, glossitis. Early, transient,
asymptomatic and mild decreases in serum calcium and phosphate levels have been observed
in some patients. Reported during post-marketing use (frequency unknown): osteonecrosis of the
jaw, iritis, uveitis, hypersensitivity and skin reactions, including angioedema, generalised rash,
and bullous skin reactions, some severe. Actonel Combi (in addition to the above for Actonel):
The following additional adverse events have been described; Uncommon: hypercalcaemia and
hypercalciuria. Rare: flatulence. Actonel Plus Ca & D (in addition to those for Actonel and
Actonel Combi): following additional adverse events have been described; Rare: pruritus, rash
and urticaria. PACK QUANTITY: Actonel 5mg: 28 tablets, 35mg: 4 tablets, Combi: four blisters
each with one Actonel 35mg tablet and 6 calcium carbonate tablets. Actonel Plus Ca & D: 4
Actonel Once a week tablets and 24 effervescent granules sachets. MARKETING
AUTHORISATION NUMBERS: 5mg: PA170/20/1, 35mg: PA170/20/3, Actonel Combi: PA170/21/1,
Actonel Plus Ca & D: PA170/22/1. LEGAL CATEGORY: POM MARKETING AUTHORISATION
HOLDER: Procter & Gamble Pharmaceuticals UK Limited, Rusham Park, Whitehall Lane, Egham,
Surrey, TW20 9NW, UK. In Ireland for further information, please contact: [email protected]. Refer to Summary of Product Characteristics before prescribing which can be
found on IPHA @ http://www.medicines.ie/. Information about adverse event reporting can be
found at www.imb.ie. Date of preparation Nov 2007. ACT-3653/ IE-RIS- 07.11.18
Reference:
1. Fardellone, Osteoporosis Int 2007; 18(Suppl 1): P365-366.
*Therapeutic equivalence has been shown between 35mg and 5mg in terms of BMD.
Date of document preparation: January 2008. ACT3799F/IE.RIS.07.11.08/55937.02
In Ireland for further information, please contact:
[email protected]. Refer to Summary
of Product Characteristics before prescribing
which can be found on IPHA @ www.medicines.ie.
Information about adverse event reporting
can be found at www.imb.ie
news
news
IPOS take HSE to court for
breach of contract
The Independent Pharmacy
Ownership Scheme (IPOS) have
announced that they are to take
individual legal actions against the
HSE in relation to its proposal to
unilaterally reduce the reimbursable
price of medicines payable to retail
pharmacists by more than eight per
cent.
The 150 IPOS members believe
that the HSE’s attempt to reduce the
reimbursable price is in breach of their
individual contracts with the HSE,
which provide for the current level of
payments.
IPOS has strongly criticised the
HSE’s proposals as putting at risk the
future of community pharmacy in
Ireland as it will significantly decrease
pharmacies’ profits and turnover. A
recent audit of the sector conducted
on behalf of IPOS found that the HSE’s
proposals – including the introduction
of a flat rate dispensing fee of €5 per
item – will reduce the profits of the
average community pharmacy by 75
per cent.
“It is clear that this short-sighted
decision by the HSE has the potential
to decimate community pharmacy in
Ireland. Such a massive reduction in
profits is not sustainable. This will lead
to job losses and pharmacy closures,
particularly in rural communities and
high GMS areas, which will damage
patient care,” said Tom Howard,
Network Director of IPOS.
“Community pharmacy is one of
the few areas of the health sector that
works. It plays a critical role nationally
and locally by not only dispensing
medicines and delivering the GMS
scheme, but also providing healthcare
advice and reducing the need for
patients to attend A&E. This planned
action by the HSE puts short-term
gain ahead of the immediate and
long-term benefits of excellent patient
care,” added Howard.
IPOS has called on the HSE to
honour its contracts with individual
pharmacists and for the Minister for
Health, Mary Harney, to intervene with
the HSE in order to protect the future
of community pharmacy.
“The contract that our members
have with the HSE is clear and given
the belligerent attitude of the HSE,
who have consistently refused to
engage with pharmacists on this
matter, they have no choice but to
instigate legal action to force the HSE
to honour its contracts,” said Howard.
MSc graduate in Pharmaceutical Medicine
conferred in Trinity
Ms Caitriona Scott was conferred by Trinity College
Dublin with the MSc in pharmaceutical medicine
in February. This course is one of two part-time
courses in pharmaceutical medicine. Begun in 2004
by the Centre for Advanced Clinical Therapeutics,
St James’s Hospital in association with Trinity
College Dublin, these are the first such courses to be
established in this specialty in Ireland.
Dr MaryJo MacAvin Course
Ms Scott who works in Medical Information in
Co-ordinator, Ms Caitriona Scott
MSc Graduate in Pharmaceutical
Wyeth (Irel) said: “This course explained about
Medicine , Dr Mary Teeling (Course
medicines from all perspectives and the role of
Director) at the conferring.
the various stakeholders, including regulators,
healthcare professionals, the pharmaceutical
industry and patients in the regulation of medicines.
and pharmaceutical industry. The MSc course is open
It has been of great benefit to me in dealing with medical
to physicians and health science graduates, while the
information queries”.
Postgraduate Diploma is open to physicians only.
The courses cover topics such as drug development and
licensing, clinical research, pharmaco-economics and drug
More information on these courses is available from
safety and are designed to enable healthcare professionals
the Centre for Advanced Clinical Therapeutics, St James’s
extend their professional role within the healthcare system
Hospital (Tel: 01 4103671/[email protected]).
Test your kidneys!
World Kidney Day will take place on Thursday, 13th
March, 2008. It’s focus is to raise awareness about the
importance of early detection of kidney disease in slowing
its progression as well as to highlight the increasing global
pandemic of kidney disease.
The Irish Kidney Association together with the Irish
Nephrology Society are undertaking a ‘Know Your Kidney’
campaign to inform the general public about the incidence
of kidney disease and encourage them to have a simple
blood test taken to determine how well their kidneys are
working. Visit website www.worldkidneyday.org
Launching Organ Donor Awareness Week 2008 at the
Mansion House, Dublin on Tuesday, 25th March, will be
Minister for Health Promotion and Food Safety, Pat the
Cope Gallagher. The annual Organ Donor Awareness
Week campaign will take place from Saturday, 29th
March until Saturday, 5th April. This campaign aims to
10
highlight to the general public the ongoing need for organ
donation for people awaiting life saving organ transplants
including heart, lung, liver, kidney and pancreas. It is also
a fundraising exercise for the Irish Kidney Association
(IKA) and IKA volunteers will be out on the streets and in
shopping centres throughout the country selling ‘forget me
not flower’ emblems (the symbol of transplantation), flower
pins and donor card keyrings.
The campaign is organised by the Irish Kidney
Association, the organisation charged with promotion and
distribution of the organ donor card in Ireland.
For the second year in a row, TV and radio personality,
Ryan Tubridy, will endorse the campaign and will feature in
radio advertising and on posters which will be distributed to
pharmacies, GP surgeries and medical centres and around
the country. The campaign will also include TV advertising
and will be backed up by a public relations campaign.
news in brief - UK
Nurses – ‘grubby, drunken
and promiscuous’
Lord Mancroft a Tory peer called
British nurses “grubby, drunken
and promiscuous” during a debate
in the House of Lords on 29th
February. In the debate he claimed
it was a miracle that he was still
alive after his stay in filthy wards at
teh Royal United Hospital in Bath.
He also claimed that the nurses
chatted to one another about their
sex lives and alcohol intake in front
of patients, some of whom they
regarded simply as “a nuisance”.
The Royal College of Nursing said
Lord Mancroft’s comments were
“grossly unfair on nurses across the
UK” and were a “sexist insult about
the behaviour of British women”.
Lord Mancroft, is a member of
Pratt’s Club in St James’s, London.
Costs awarded against
Society in FTP case
The Royal Pharmaceutical Society
Costs had costs, estimated at
£20,000, awarded against them
recently following unsuccessful
disciplinary proceedings against
two pharmacists.
The RPS had brought a case
against two brothers who jointly
owned a community pharmacy
with their third brother. The RPS
alleged the two brothers were
guilty of misconduct because the
third brother incorrectly endorsed
a number of NHS prescriptions.
The two brothers were not
involved in the running of the
pharmacy.
Pharmacists reject child
protection registration
Pharmacy organisations in
the UK say that pharmacists
and pharmacy staff should be
excluded from legislation which
requires individuals working with
children and vulnerable adults
to register with the Independent
Safeguarding Authority (ISA).
They argue that pharmacists and
registered pharmacy technicians
are already regulated by the
Royal Pharmaceutical Society and
registration with the ISA would
lead to unnecessary duplication of
information and effort.
As well as criticising potential
duplication, the response also
points to the lack of consistency
in requirements across the UK. It
suggests that working under two
different schemes could lead to
different levels of protection being
provided to the public.
pharmexx Ireland has arrived…
Laurence Carroll, Pharmacy Business Manager, Ascent Healthcare;
Steve Thomas, Sector Manager, Boehringer Ingelheim, Consumer
Healthcare; Neil Lawrence, Divisional Director, Boehringer
Ingelheim, Consumer Healthcare
Steve White, Director, pharmexx UK; Nigel Mansford, Managing
Director, pharmexx UK
Steve White, Director, pharmexx UK; Aisling Dillon, Sales and
Marketing Manager, pharmexx Ireland; Nigel Mansford, Managing
Director, pharmexx UK; Jo Shields, Project Support Manager,
pharmexx Ireland
Steve Thomas and Aisling Dillon
Colm Moran and Jo Shields
Aisling Dillon, Sales and Marketing Manager, pharmexx Ireland; Jo
Shields, Project Support Manager, pharmexx Ireland
Europe’s Leading Contract Sales & Marketing Organisation
Launched in January 2008 Pharmexx Ireland
provides high quality contract sales and
marketing services supporting prescription,
OTC and general healthcare brands.
Pharmexx provides a total portfolio of
services to both large and small customers
ranging from starting a completely new
company for a client to providing bespoke
solutions for large established pharmaceutical
companies.
Pharmexx has over 300 clients worldwide,
100 of whom are transnational, including 21 of
the top 25 top pharma groups. Over 6,000 sales
staff successfully market innovative products in
55 global markets.
Pharmexx is the largest Contract Sales
Organisation (CSO) in Europe and has won
awards as one of Europe’s fastest growing
companies. In 2006 Pharmexx achieved the
status of No.1 CSO.
Pharmexx has the capability to draw upon
an international total service offering or to
activate local expertise as required, backed by
a strong management team with considerable
industry experience .
Pharmexx Ireland is based in Pharmapark,
Chapelizod, Dublin. ‘Ascent Healthcare’ is the
first pharmacy salesforce, now detailing and
selling the Boehringer Ingelheim Consumer
Healthcare Portfolio
Trevor Lysaght (Munster) - 086 0456 817
Laurence O’Carroll (Leinster) - 086 0456816
Colm Moran (Connacht) - 086 0470989
Alternatively for more information on our
services, please contact our office:
Sales and Marketing Manager – Aisling Dillon
– [email protected]
Project Support Manager – Jo Shields
– [email protected]
Telephone: 01 – 630 5260 and
Fax: 01 – 623 2414
Email: [email protected]
news
news
UniPhar plc to make two acquisitions in Britain
UniPhar plc announced on 28th
February that it is to acquire
Forth Medical and NorthStar
Orthopaedics in Newbury, England
for an undisclosed sum.
Forth Medical specialises in the
sales, marketing and distribution
of implants and devices used in ENT
surgery, neurosurgery and spinal
surgery throughout Ireland and
Britain. NorthStar Orthopaedics
specialises in the marketing
and distribution of orthopaedic
implants and ancillaries throughout
Ireland and Britain. The businesses
employ 40 people between them.
Making the announcement, Jim
Canavan, CEO, UniPhar plc said:
“These investments are a great fit
for UniPhar, in terms of the core
competences in sales, marketing
and distribution of medical and
surgical devices, and also the
ethos of customer relationships,
which is the cornerstone on which
these businesses have been built.
We look forward to investing in
these successful businesses and
delivering future growth to their
principals and to the shareholders
of UniPhar plc.”
George Strang, Managing
Director, Forth Medical and
NorthStar Orthopaedics, said:
“This is a very exciting time in the
evolution of the Forth Medical and
NorthStar Orthopaedics businesses.
We look forward to working
with UniPhar plc in developing
and growing our customer
relationships, driving growth in the
businesses and further developing
our footprint in Britain and Ireland.”
UniPhar plc, headquartered in
Dublin, was formed in 1994 and is
owned by Community Pharmacists.
Its core competencies are in the
fields of distribution, marketing,
sales and market-driven value
added initiatives.
The company consists of eight
divisions, operating within the
healthcare and health related
sectors, and the products and
services are designed to promote
the ‘wellness’ concept for people,
animals and the environment.
Group turnover has grown to
over €705 million and the company
employs in excess of 700 people.
news in brief – Us
US scientist clones
himself
US scientist Samuel Wood, a
researcher in La Jolla, California,
has created a cloned embryo
from his own skin cells. Wood
used cells taken from his own skin
and injected them into donated
eggs that had been treated
to remove their own genetic
material. The eggs developed
into very early stage embryos that
were genetically identical to the
scientist’s own DNA. This research
would indicate that it will soon
be possible to create supplies of
embryonic stem cells genetically
matched to patients, which could
be used to regenerate diseased or
damaged tissues without the risk
of immune rejection.
Sunshine protects against
cancer
A recent study carried out at the
Brookhaven National Laboratory
in the US suggests that the health
benefits of vitamin D, could justify
a modest increase in the amount
of time we spend in the sun.
The study showed that people
with higher levels of vitamin
D were more likely to survive
cancers of the colon, breast and
lung. Increased sun exposure
may lead to improved cancer
prognosis and, possibly, give
more positive than adverse health
effects according to the studythe
researchers. There is growing
evidence that people in Ireland
and the UK not getting enough
vitamin D. Experts recommend 5
to 25 mgs of the vitamin a day.
12
See the Difference
fibre can make in supporting your
nutritionally compromised patients
Fortisip Multi Fibre’s unique MF6TM blend of
fibres is clinically proven to reduce laxative use,
relieve constipation, reduce the incidence of
diarrhoea and improve gut transit for patients
requiring nutritional support.1-4
Recommend Fortisip Multi Fibre and
see the difference for yourself.
For advice, samples or more information, call
Freephone 1800 923 404.
Nutricia Clinical, Block 1, Deansgrange Business Park, Deansgrange, Co. Dublin. | Tel: +353 1 289 0283 | Fax: +353 1 289 0255 | Email: [email protected]
References: 1. Vandewoude MFJ et al. Age and Ageing 2005; 34: 120–4. 2. Trier E et al. J Pediatr Gastroenterol Nutr 1999; 28(5): 595–6. 3. Silk DB et al. Clin Nutr 2001; 20(1): 49–58.
4. Elia M et al. Alimentary Pharmacology & Therapeutics. 2008; 27:120-145.
ALCHEMY FEB AD_FEB 08:Layout 1
14/02/2008
12:15
Page 1
‘‘your formula to sourcing exempt medicinal products and manufactured specials”
We
■ are a one-stop service for exempt sourced medicinal products1
■ supply manufactured specials/extemporaneous products within 24-48hrs
■ have experienced support staff to manage the intricacies associated with handling exempt sourced
medicinal products in an ethical and professional manner from the initial request, through to the supply
of the medicine
■ source, import and supply irregular and once off products
■ no extra delivery charges using customers current delivery arrangements
■ provide a first class cold chain service
If you are a hospital or community pharmacist, doctor, dentist or a veterinarian and you have a product
enquiry or order, contact your local CMR telesales office or the Alchemy specialist team and we will then
source, price and oversee the delivery of your order making sure you get what you need quickly and costeffectively. Working with Alchemy and CMR provides you with instant access to a multitude of international
possibilities to fulfil your exempt sourced medicinal products requests.
CMR & Alchemy operates in line with Irish Medicines Board (IMB) guidelines.
1
S.I. No. 538 of 2007: MEDICINAL PRODUCTS (CONTROL OF WHOLESALE DISTRIBUTION) REGULATIONS 2007, (SEC 2 (17)).
Contact Details
Dublin
Sligo
Cork
Nóilín O'Hora
(Dip Pharm Tech)
Specialist Product Manager
Alchemy
email: [email protected]
Cahill May Roberts
Cahill May Roberts
Cahill May Roberts
Tel: + 353 1 630 5155
Fax: + 353 1 626 8164
Tel: +353 71 9161801
Fax: +353 71 9161977
Tel:+353 21 4965588
Fax: +353 21 4965669
the law
Contract Law –
co r m ac o’n ei l l
general principles
The implications of contract law are inescapable for anyone who runs a business.
C
ontract law surrounds us all day every day and we generally
go about our business without paying any attention to
the fact that most of our transactions are governed by it.
A restaurateur selling a meal, a publican selling a pint of
beer and a pharmacist selling both prescription and non
prescription medicines are all involved in transactions with
contractual implications.
When a pharmacist or a business enters into a contract it confers rights
and responsibilities on all of the parties who have agreed to be bound by
the contract.
Perhaps the reason why so many pharmacists go about their business
entering into countless number of contracts without ever paying much
attention to contract law is because the vast majority of contracts are
performed without much trouble. It is only when things go very wrong
that a pharmacist will have to focus their attention on contract law.
If businesspeople and pharmacists were more familiar with the basic
provisions of contract law it would give them increased confidence when
negotiating contracts, particularly the larger ones where they are more
exposed to business and economic risks. Also if businesspeople are aware
of contract law it may help them avoid conflict in the future and thus
reduce significantly the number of cases ending up in the courts.
An Agreement – not necessArily A contrAct
It is important to understand that a contract is simply an agreement
that legally binds the parties who have entered into it. The concept
of agreement is the cornerstone upon which the contract rests. An
agreement is reached after one party makes an offer to another and the
other accepts the offer. Once this happens it is said that an agreement has be
reached.
However there is much more involved in a contract than an agreement. Many
agreements are entered into by people every day where it is understood that
neither party intends the agreement to have legal consequences. An example
perhaps would be where one friend agrees to have another friend come to
spend the night at their home with their family. Contract law principles do not
“
A person must be able to show that
there was consideration present before
he can sue for breach of contract.
normally follow this type of agreement.
VerbAl Agreements
The majority of contracts are known as simple contracts. They may be oral,
written or inferred from conduct. It is often thought by people that oral
contracts are worthless, this assumption is false. Oral contract is recognised by
the law. Oral contracts have the obvious difficulty of proof of existence but this
does not make such a contract invalid.
Witness
Contracts in writing may have their own difficulties associated with them. There
are certain contracts required by law to be in writing, such as hire purchase
agreements and contracts for the sale of land. Contracts of this nature, not
witnessed in writing, are likely to face enormous difficulty with enforceability
and are indeed invalid if not in writing. Pharmacists buying or selling premises
will need to have all agreements in writing to be enforceable.
legAlly binding
After reaching an agreement the parties have concluded the first step in the
process of forming a contract. The second step for both parties is to intend the
agreement to be legally binding. The test which the court uses in assessing
whether the necessary intention existed is to simply analyse the words used in
the negotiations, the circumstances surrounding the negotiations and also to
analyse the conduct of the parties and ask would a reasonable man come to the
conclusion that the parties intended the agreement to have legal consequences.
When analysing contracts for this purpose the courts draw a distinction
between agreements of a commercial or business nature and those of a social or
domestic nature. The presumption is that with commercial type agreements the
parties do intend to be legally bound. However, if the necessary evidence can be
produced in court this presumption can be rebutted.
Conversely, where an agreement is of a social nature, the presumption exists
that the agreement is not intended to have legal consequences. The courts
may however allow admissible and relevant evidence to be submitted which
shows that an agreement reached in a social setting was intended to have legal
consequences. Therefore agreements reached in a domestic setting can have
legal consequences in contract law.
‘considerAtion’ defined
Once it is shown that an agreement was reached and the parties intended
the agreement to have legal consequence, it must be demonstrated that
consideration was present. The term consideration in contract law means that
some advantage must have been promised by each party to the other party to
the agreement. A person must be able to show that there was consideration
present before he can sue for breach of contract. It can be difficult to identify
15
the law
the consideration present in many contracts and it
can be a difficult legal principle to understand. So
perhaps an example would help to demonstrate.
If a pharmacy or supermarket agrees to provide
groceries to a client or customer for the sum of €100,
it means that each party to the agreement has made
a promise to the other. The shop has promised the
groceries and the customer has promised €100.
This is the consideration. A number of rules have
been developed by the courts over the centuries
regarding the essential element of consideration.
1. The consideration must be sufficient in law but
need not be commercially adequate. This means
it must exist but the courts will not investigate
whether it was a good and fair deal for each party.
2. The consideration must have been supplied by
the plaintiff. If the consideration was provided by
someone else this will frustrate the claim.
3. The consideration must not be vague, illegal or
impossible to perform.
4. The consideration must not be in the past, it must
not have been provided before the agreement
was reached.
TerminaTion of conTracT
Once a contract has been entered into there are a
number of ways by which it will come to an end.
The contract will be regarded as being discharged
when all of the obligations of the parties have been
performed. The most common way by which a
contract reaches its conclusion is by performance. A
contract is said to have been performed when the
parties to the contract have fulfilled exactly all of
their respective promises to one another.
‘SubSTanTial performance’
In the past the courts required that everything was
to be done exactly as promised for the contract
to be deemed to have been performed. This was
known as specific performance. This rule was
considered to be rather harsh and lead to some
very harsh decisions. Over time a new doctrine
emerged known as substantial performance. This
requires that if the majority of the work has been
done the majority of the price should be paid. Our
judiciary now has judicial discretion in this matter
and applies the rule which best fits the facts of a
particular case. Their objective is to see that justice
is done and judicial discretion in this matter allows
judges to avoid harsh decisions as much as is
practically possible.
Contracts are entered into by way of agreement
and so they can only be exited by agreement. If
both parties agree that the contract has come to
an end the courts will uphold such decisions and
agreements reached by the parties to a contract.
The parties can also agree to form a new contract. If
they vary the terms of the original contract, and as
long as consideration (discussed above) is present, a
new contract comes into being.
conTracT ‘fruSTraTed’
If something happens which makes it impossible for
the parties to perform their tasks and duties under
the contract, the law will allow the contract to come
to an end. This is referred to as the contract being
frustrated. If a shop was destroyed by fire and all of
the stock was unavailable for sale then through no
fault of their own there is nothing that the retailer
can do to perform the contract. This is an example
of a situation where the law is likely to recognise the
contract as being frustrated. Any monies paid over
(e.g. a deposit to a supplier) should be returned.
However the law will allow for a deduction for
any expenses incurred prior to the contract being
frustrated.
breach of conTracT
Contracts are said to have been breached if one
party indicates that he is unwilling to perform his
promise. The innocent party may sue for damages
immediately in such a situation or may wait to see
if the wrongdoer performs his duties.
A breach of contract may also occur if one party
indicates that he is unable or unwilling to perform
his duties by the agreed time. This too gives a
right to the innocent party to sue for damages
immediately. It is very important that the innocent
party treats as a breach only that which involves a
fundamental term of the contract. If a minor term
is breached this will not give rise to a cause of
action for breach of contract.
damageS
The innocent party may sue the wrongdoer
for breach of contract and seek to recover
damages for actual loss suffered. Damages are
an amount of money awarded to the innocent
party as compensation. Damages attempt to
place the innocent party as much as possible
into the position they would have been in had
the contract been performed. The Statute of
Limitations 1957 sets down specific time limits
within which an injured party must commence
their action. In general an action in contract must
commence within six years. It is important to seek
professional advice regarding limitations because
some causes of action are now statute barred
after one year. IP
COrmAC O’NeILL is a barrister practising on
the Dublin and South Western circuits. He is
also a Chartered management Accountant with
considerable experience in industry and banking.
In addition Cormac lectures on Business and Law
in the Institute of Technology in Tralee and can be
contacted on 087 657 1124.
16
Issue 3 Vol 9 march 2008
Europe’s Leading Contract Sales
& Marketing Organisation
Q&A
ró n A n Q u i r k e
Rónan Quirke is the immediate past
President of the Pharmaceutical
Society and is a council member of
the PSI. He operates a community
pharmacy in Clonmel. He works in the
Sports Department of Tipp FM Radio
and presents a sports magazine show
every Monday night.
What other career might you have chosen?
I have done a bit of sports journalism and really enjoy it. It is hard to make a
living from it though.
What figure in Irish life (living or dead) do you admire and why?
I admire the late Dr Noel Browne. When he left the Department of Health,
real and tangible improvements to the nation’s health had occurred. How
many Ministers for Health before or since can claim that?
What is the one thing you would suggest to improve the Irish health
service?
Acute beds must mean beds for the acutely ill. That means
improving step down facilities, long term care and rehabilitation
units. It also requires 7-day consultant cover, appropriate
discharge planning and improvements in the primary and
secondary care interface. Actually that’s not one thing is it?
noted for its humour.
Who or what is the greatest love of your life?
Tara, Munster rugby and Tipperary hurling. The order is subject to change
periodically.
How do you relax?
Really good red wine. Works every time.
Favourite TV/Radio programme?
Father Ted. Morning Ireland and Off the Ball.
Favourite composer/entertainer/rock group?
The Rolling Stones and The Stone Roses
Favourite film and book?
It’s a Wonderful Life and Stand up and Fight; How Munster Beat the All-Blacks. I
would like to have this book on the Leinster school curriculum.
What is your motto?
Keep going.
How would you like to be remembered?
Like everyone would; as one of the good guys.
IP
What is your earliest memory?
Running through a plate glass window aged 2. There wasn’t
a mark on me but the window, and my mother’s nerves, were
shattered.
What is your greatest fear?
Plate glass windows
When and where were you happiest?
Killarney, September 2002. Long story! Brendan Hayes was on
the piano but it was a great night despite that.
What would your super power be?
The ultimate power of persuasion. It’s all about taking hearts and
minds with you.
What is the worst job you’ve done?
I worked as a barman in England on New Year’s Eve 1992. It was
carnage.
What is your best trait?
My perseverance.
What is your most unappealing habit?
My German ancestry means I have to be either early or on time
for everything. That seems to irritate people.
What trait do you most dislike in others?
Arrogance.
Do you use alternative medicine? What kind?
I don’t use alternative medicines as such. I eat a lot of garlic in the
hope that it may be doing me some good.
Cat or dog?
If I had time, I would love to have a dog. I regard cats as the
spawn of Satan.
What keeps you awake at night?
I’m still sleep deprived after the last two years with the PSI.
Nothing keeps me awake anymore.
Who or what makes you laugh?
My three friends, Owen, Ed and Kevin are the funniest guys I
know. Unbelievably they are all pharmacists, not a profession
17
the coalface
THANK YOU,
PROFESSOR DUM DUM
dav i d j o r da n
If only the HSE had negotiated with the IPU they
wouldn’t now be facing the prospect of negotiating with
1500 recently politicised pharmacists.
T
o start off, I would like to give thanks where thanks are due.
Pharmacists by our nature tend to be professionally isolated.
Standing, physically present in our dispensaries up to 60 hours
per week, we get little enough chance to meet with our fellow
pharmacists. Now however thanks to Prof Dum Dum and his cohorts
I have been meeting with my fellow pharmacists on a weekly basis. I
have got to know many more of my peers than I would have if I had
I been left to my own devices. I find this to be empowering and for that I
thank you Professor. This experience has also re-politicised me and for this
my long suffering wife and family do not thank you!
The HSE is essentially saying ‘trust us, we will give you a fair fee’. They will
set the prices and decide how much you are to be paid regardless of how
much you have to pay your wholesaler for an item or how much it costs to
operate your pharmacy. If you don’t like it then tough, we can just terminate
your contact at three months notice. I was detailing all this to a friend who
had just returned to Ireland after a prolonged period in Africa. His reaction
was, “that’s exactly what Mugabe is doing in Zimbabwe”.
It’s ironic that the head of the HSE, appointed by those crusaders for the
free market – the PDs, is trying to set up a command economy – we set the
price, we tell you what you can do. The last time that was tried was back in
the days of the old Soviet bloc. It didn’t work then and it won’t work now.
Profit motive
Being in business I have no problem with the notion that a business should
make a profit. I take an income from the profits and pay my taxes. My taxes
fund the government and they provide for the nation.
If my patients don’t like the service that I provide then they can choose to
take their prescriptions and custom elsewhere. As my patients can choose
their pharmacy, I can choose my suppliers. We sit down, discuss terms,
“
Nothing is this article should be
used to imply that Professor Brendan
Drumm of the HSE is in fact a
communist.
agree a price. Over the years I have built up relationships with my suppliers
and patients. If something needs to change we discuss it and come to an
agreement. This is called the free market. The HSE doesn’t seem to think
that this works.
Communist laCkeys
As I ponder the HSE’s way of doing business and dealing with pharmacists it
occurs to me that Prof Drumm might be a closet communist. As with the old
communist states only trade unions that toe the state line are tolerated. Not
much hope for the IPU there.
I can see how the HSE might have a difficulty conducting 1500 sets of
negotiations with pharmacy owners. Let’s not forget the smoke and mirrors
argument about the Competition Act. Wouldn’t it be so much easier if
18
there was just one body that they could discuss these things with? No wait,
surprise, surprise, such a body exists. Can you guess who they are? Even
SWMBO, Mary Harney, has done her bit by announcing that there is to be
an independent body which will set remuneration rates for healthcare
professionals. Suddenly the Competition Act mirror is broken.
But still the HSE rush ahead with their new interim contract. They are
obviously trying to pre-empt the independent commission. One wonders
what they have to fear from an independent commission. Maybe, heaven
forbid, it might be truly independent. Maybe it might be unwilling to
rubber stamp whatever the HSE wants. Might there be a few flaws in HSE’s
arguments? Have they not got enough confidence in themselves. Or maybe
it might just say something they don’t want to hear. For they already have
previous form when an expert body produces a report that is paid for by the
HSE. It told them something that they didn’t want to hear. The HSE tried to
bury the Indecon Report when it said that there should be no pre-emptive
changes and that there should be consultation with all parties.
It may be some consolation to Joe Higgins on losing his Dáil seat that
there is an old style communist running the HSE.
“When consultants mock and pharmacists jeer
He’ll keep the red flag flying here.”
Nothing is this article should be used to imply that Professor Brendan
Drumm of the HSE is in fact a communist. I merely sought to compare the
actions of the HSE to those of the totalitarian regimes of Honecker and
Ceaucescu. However, like a clumsy cowboy the HSE has shot it self in the
foot. And here’s how.
the life of Brendan
If they had negotiated a new pharmacy contract with the IPU, chances
are that most pharmacists would have accepted whatever the HSE and
the IPU agreed. There might have been a bit of grumbling but by and
large it would have gone through. But by forcing us to go to law to get
the current contract paid, they have made us all aware of the terms of our
current contract. In Monthy Python’s Life of Brian the mob chants, “We are
all individuals, we are all different”. So now when the independent body
comes up with an economic fee, 1500 pharmacists will sit down and do their
figures. They will all have to decide which deal is better for their pharmacy.
The High Court has already decided that the HSE cannot unilaterally
change the terms of our contract. So if the HSE want me to accept a new
contract, then I will have to look and see what’s in it for me. While I support
most of what the IPU does on my behalf, and have appointed them as my
representatives in my dealings with the HSE, at the end of the day I will
decide if Jordan’s Pharmacy Ltd is going to accept any new deal. And 1500
other pharmacists will have to make a similar decision.
After watching the HSE’s performance in front of the Oireachtas
committee last week I have one comment and one question. Who let them
out with a gun and live ammunition – get the first aid box ready for their
next performance. IP
David Jordan has worked in community pharmacy since 1979, qualifying
as a pharmacist in 1983. He was chairperson of the Community Employee
Committee of the IPU from 1990 to 1998 and Treasurer from 1994 to 1996. His
main stress relief is riding his motorbike with his friends from Irishbikerforum.
com.
Your energy and immune systems are at its lowest…
metatone will help you fight and restore from winter ailments!!
metatone tonic original flavour provides an essential Vitamin and Mineral complex in
a liquid formula, giving a gentle boost during and after illness and when you are feeling
tired and run down.
■
metatone tonic is suitable for Adults and Children over 6 years of age.
■
RRP: €7.49.
Further information available on request.
Chefaro Ireland Limited, Farnham Drive, Finglas, Dublin 11, Ireland.
Tel: 01 879 0600
E-mail: [email protected]
SHORT STORY
An Inspector Calls
‘H
e’s gettin’ into me! Oh God.
He’s getting’ into me’. She just
wouldn’t stop screaming.
Jack stared. Everything looked
perfect to him except to her it
clearly wasn’t. She was panicking
now and beginning to hyperventilate. ‘He’s
getting’ into me. He’s getting into me’
Who was he? Where was he and how in the
name of God was he getting in?
His unfinished pizza was still in its box beside
her. In the context it didn’t look right. He closed
the lid over. It was the only thing to do that
made sense.
Jack’s world had crossed some strange
boundary and was now in the surreal.
Three of them had burst in moments earlier.
Jack heard the slam. They had been held up
recently but this was different. Teenage girls
really could scream when they wanted to. One
had her top open. The second held a bra. He
saw that it was red.
At first he just stopped until he realised that she
was going to take her clothes off right there.
Money, Crab and an elderly couple all froze.
Something actually was going to happen here
and fast.
He motioned to her to go inside quickly. Always
contain a problem. Some people call it taking
charge. Whatever was going to happen next, it
was not happening on the shop floor.
He followed her into the office. She was now
topless.
‘Look!! Oh please he’s getting’ in. He’s
getting’ in.’
‘Calm Down. It’s alright. Everything’s going to
be okay.’
Always reassure. You may not know what’s
wrong or even have the faintest idea but it
sounds good and it gives you time to think.
Always buy yourself time.
But exactly what was wrong here? She held one
up and really screamed ‘He’s getting’ in oh
please.’
Jack still saw nothing wrong but now her
panic was affecting him. Think Jack think, just
what can be going on here. She grabbed his
shoulder. ‘Oh please Help...Look...Ah he’s
getting’ in Look’
He looked and looked again. Everything was
still fine. Just exactly what did she want him
to do? Hold it, feel it, weigh it, put it in his
pocket, dispense it? And above all who was he?
Jack was scared to ask in case he was missing
something of the extremely obvious.
‘Look what’s wrong?’
20
‘Oh he’s gettin’ in!
It was then the reality of the situation or rather
the lack of it hit Jack.
He’d had a phone call from another that
morning.
‘They had just been inspected and to watch
out. She could still be in the area’.
He had spent the rest of the day housekeeping
in case she called.
What if she called now?
Maybe this was some sort of ethical test. Maybe
this was a set up by The Inspector of The
Pharmaceutical Society of Ireland. Perhaps this
was the Inspector herself.
Get backup in here now and fast.
‘Are you all right Jack’ said Crab.
Her and Money were in the office. What did she
think?
‘Money, get one of her friends in here now.’
Money came back. She had chosen the friend
with the bra. That might come in useful. She
could be clever that way. On the other hand
Jack could never figure out Crab. She found it
difficult to change from one thought process to
another. Once she was on one track everything
was ok but…………
He had just sent her on a veterinary course and
was impressed at what she had picked up. Last
week she had dealt with a farmer and a difficult
query regarding fleas. Then the phone rang. A
guy asked her ‘What should he do with Crabs’
she said ‘As far as I know you just drop them in
boiling water’.
‘It’s just there. Look’ said her friend and
pointed. He followed her finger and there just
in the centre and underneath was a tiny circle
with two black sticks.
J U L I A N J U D G E, M PS I
‘We thought maybe you could pull it out. You
know, a tweezers. That’s why we came’.
Jack tried to think. Maybe they could pull him
out? A tweezers perhaps? It sounded good but
this wasn’t quite the same as digging into his
knee as a teenager. It might work but if it went
wrong…?
Suddenly Crab handed him a tweezers. She
and Money held it and looked at Jack, eyes
raised. They held it up and steady. The tweezers
approached. Be careful Jack. Don’t go for this.
The friend was right. This tick did not want
to come out. In fact at the first brush of the
tweezers it took off like Atlantis.
She had been right all along. He was ‘getting
into her’ and she could feel it. At this stage so
could Jack. She screamed from some primal
source and tried to grab it with her fingers. It
was too small.
Enough. Ring Doctor Wesley. He was closest
and had given Jack a direct line last week. This
was the first time he had used it. ‘Right send
her up.’
Money took her in her car.
He opened his pizza box lid. The whole episode
had only taken about two minutes, so it was
still warm. Jack tried but he wasn’t that hungry
anymore.
Then later a phone call.
‘Well Jack it was a little tick. It took a while but
we got it out. Stubborn little….’
‘Thanks Doctor’
‘No problem. I’ve dressed it and told her to
come back in a few days. She’ll be fine’
‘Thanks Doctor’
‘Oh Jack’
‘Yes doctor’
It was really shiny and its two back legs were
scrambling. It could have been a dog digging
for a bone except that it wasn’t. Jack knew that
on the inside there were more legs and a big
pair of sharp front claws burrowing their way in.
‘One more thing’
A Tick. Well thank God for that. For a while, Jack
thought something was really wrong.
Julian Judge qualified as a pharmacist
in 1990. He was recently accepted for
a Masters in Creative Writing at the
Department of English, UCD.
Money reassured her. Jack reassured himself.
Relief was a great thing. What to do now? They
looked. Jack had had a few himself and used
to squeeze them out. He knew they were quite
obstinate and that it took an effort.
‘Have you tried squeezing it?’ Money asked.
‘We did but then he started wrigglin’ and goin’
in further’ said the friend.
‘Yes doctor’
‘How many legs do those things have?’
This is the first of a series of short stories
which Julian has written exclusively for Irish
Pharmacist. These stories are based on his
experience as a pharmacist but they are fictional
and any similarities they might have to any
persons living or dead is entirely co-incidental.
The stories are based on a notional pharmacy in
the East of the country.
FIRST NEW CLASS in Hypertension
for over 10 years
A Breakthrough in Hypertension:
The 1st
D IRECT
R ENIN
INHIBITOR
NEW
RASILEZ ABBREVIATED PRESCRIBING INFORMATION
Please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Rasilez film-coated tablets containing 150mg and 300mg of aliskiren. Indications: Treatment of essential hypertension. Dosage: 150mg to 300mg once daily with a light meal, alone or in combination with
other anti-hypertensive agents. No adjustment of initial dose require in elderly (>65 years), renal and liver impairment. Not recommended < 18 years of age. Contraindications: ◆ Hypersensitivity to the active substance or excipients. ◆ Pregnancy. Warnings/Precautions: ◆ Increased risk of
DRI power that lasts.
hyperkalaemia in patients receiving other RAS agents, and/or those with reduced kidney function and/or diabetes mellitus ◆ Caution in patients with heart failure ◆ Close medical supervision in patients with marked volume- and/or salt-depletion due to risk of hypotension ◆ Caution in patients with severe
renal dysfunction, renal artery stenosis, a history of dialysis, nephrotic syndrome, or renovascular hypertension ◆ Not recommended during pregnancy or when planning to become pregnant, to be discontinued if pregnancy occurs. ◆ Not recommended in breastfeeding women. ◆ In event of severe and
persistent diarrhoea, Rasilez should be stopped. Interactions: ◆ Monitoring when used concomitantly with furosemide ◆ Interaction with ketoconazole ◆ Concomitant treatment with drugs that may increase serum potassium levels ◆ Possible interaction with digoxin, irbesartan, St. John’s wort, and
rifampicin ◆ Meals with high fat content substantially reduce absorption. Adverse Reactions: ◆ Common: diarrhoea ◆ Uncommon: Rash ◆ Rare: Angioedema ◆ Laboratory values: decrease in haemoglobin and haematocrit, increase in serum potassium. Please refer to SmPC for a full list of adverse
events. ◆ Legal Category: POM ◆ Pack Sizes: 14 and 28 film-coated tablets ◆ Marketing Authorisation Holder: Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom. ◆ Marketing Authorisation Numbers: EU/1/07/405/2-3, 12-13
◆ Full prescribing information is available on request from Novartis Ireland Ltd, Beech Hill Office Campus, Clonskeagh, Dublin 4. Tel: 01 2601255 ◆ Date of Revision of Text: August 22 2007 ◆ Date of Preparation: February 2008 ◆ NO1207619
interview
Honoured
by her peers
Head of the School of Pharmacy at UCC and recipient
of two awards at last year’s Pharmacy Awards, including
that of Pharmacist of the Year, Professor Caitriona
O’Driscoll discusses her work with Irish Pharmacist.
i n t erv i e w by j ay cu rt i s
s pec i a l co r r es p o n d en t
P
rofessor Caitriona O’Driscoll was honoured with no less than two awards
at the recent Irish Pharmacy Awards, one of which was the ultimate
accolade – Pharmacist of the Year. She is also the driving force behind
the establishment of the first School of Pharmacy outside Dublin.
Cork born Professor O’Driscoll spent most of her adult life in Dublin
where she studied pharmacy at UCD. After graduating in 1976 she
followed the transfer of pharmacy from UCD to Trinity College Dublin
(TCD) where she did a PhD.
Like most Cork people however, the homing gene proved very strong and
following a successful career as a Senior Lecturer in Pharmaceutics at TCD – coupled
with a 12 month sabbatical in the School of Pharmacy in Kansas in the US, where
she worked on targeted drug delivery systems – Caitriona returned to Cork in 2003
to take up the position of Professor of Pharmaceutics and Head of the School of
Pharmacy in UCC.
first stuDents
Professor O’Driscoll had just five short months between her home-coming in June
to welcoming the first class of pharmacy students in October 2003. That same year
UCC received accreditation from the Pharmaceutical Society of Ireland (PSI) for its
four-year degree programme. Just 18 months later following a period in temporary
accommodation, Cork University constructed a brand new building for its fledgling
school.
22
The Cavanagh Pharmacy Building is
named in honour of Dr Tom and Mrs
Marie Cavanagh. Dr Cavanagh, a UCC
commerce graduate, is Vice-Chairman
of the university’s Governing Body and a
director of the Cork University Foundation.
Located in the main UCC campus Professor
O’Driscoll described it as “a terrific state-ofthe art building” with sophisticated teaching
facilities and high-spec laboratories for the
School’s 55 undergraduate, and increasing
number of post graduate, students.
Built at a cost of €22.3m, The Cavanagh
Pharmacy Building comprises 5,600
sq metres of teaching and research
laboratories, lecture theatres, seminar rooms
and support space. It is home to both the
undergraduate and postgraduate facilities
of UCC’s School of Pharmacy, as well as
the university’s Analytical and Biological
Chemistry Research Facility (ABCRF). It
also houses a dedicated industry suite to
facilitate collaboration between UCC and
the pharmaceutical industry.
Commenting on the challenges associated
with establishing the first School of
Pharmacy outside the Capital, Professor O’
Driscoll gave huge credit to the support she
received from the Cork College.
“UCC were very supportive. They had
been planning to establish pharmacy here
in the University for several years. When I
arrived that was one of the things I noticed,
people were very enthusiastic for the new
course. The university was very supportive
…we got this terrific building within a
very short period of time and they were
very supportive in hiring staff…other disciplines are
very keen to teach on the course and to help us, so
everybody was very supportive.”
Competition not ConfliCt
The established School of Pharmacy at TCD and the
relative new comer to pharmacy the Royal College
of Surgeons in Ireland (RCSI) which set up its School
in 2002, were also very welcoming of the new UCC
degree.
“I came from an established school,” Professor
O’Driscoll said with a smile.
“Everybody now knows and appreciates that
competition is healthy and there really isn’t any conflict
between us at all. In fact we just recently got together
to collaborate on a Science Foundation Ireland (SFI)
research cluster. There is a lot of interaction going
on between the schools, it is all very positive. I also
think it will be very good in the future, we will have
an opportunity to share research and do more
collaborative work.”
Drug Delivery researCh
In fact the UCC School of Pharmacy is already engaging
in a highly successful collaborative research project.
Together with the Conway Institute, UCD and the
Schools of Pharmacy in TCD and the RCSI, UCC forms
part of the Irish Drug Delivery Network (IDDN) which
recently secured a massive €5.2 million Strategic
Research Cluster from SFI.
The grant is one of the largest ever given to a drug
delivery consortium in the EU. Engaged in genuine
translational science, the IDDN will make oral and
inhaled formulations of biotech molecules that
normally require injection. The molecules will be
protected from break-down by capping with novel
shielding polymers formulated as particles.
The Industry partners are Genzyme Ireland, Sigmoid
INTERVIEW
Biotechnologies and Warwick Effect Polymers.
“
I was very
honoured to
win the award.
It is a great
thing to be
picked out by
your fellow
pharmacists for
an award like
this.
Manpower shortage
According to Professor O’Driscoll, the UCC School of
Pharmacy was established to fulfil a manpower shortage
in the profession, which had been identified in Ireland.
While she believed that the shortage still existed, the Cork
Professor told Irish Pharmacist that it would take some
time before the full impact of the extra graduates from the
new schools in UCC and the RCSI would be seen.
“It’s very difficult to be exact about the manpower
situation into the future because it is hard to quantify the
degree of freedom of movement into Ireland from other
European countries for example. If our economy isn’t as
good in the future as it has been in the recent past, that
might change. So there are a whole lot of other unknowns
that can influence the manpower situation,” Professor
O’Driscoll explained.
Pharmacists are entitled under European Union (EU) free
movement Directives to register in Ireland if they hold a
qualification from an EU or European Economic Area (EEA)
member state and are nationals of a member state of the
EU or EEA.
Despite increasing numbers of pharmacists coming
to work in Ireland and the relatively recent arrival of two
new pharmacy schools, Professor O’Driscoll said that a
manpower shortage still existed particularly in community
and hospital pharmacy.
“At present over 80 per cent of graduates from all the schools
probably go into community pharmacy. There are also huge
opportunities for graduates in the pharmaceutical industry
and they are growing all the time because the pharmaceutical
industry has a very significant presence in the country,” she
said.
However Professor O’Driscoll added that the attraction
of a generous salary in community pharmacy coupled with
the demand for retail pharmacists has meant that Irish
graduates have not fully exploited the opportunities in the
industrial sector.
A 2005 report in the Sunday Business Post stated that
a newly qualified pharmacist could expect a starting
package of €50,000 a year, with that salary scale escalating
quickly to approximately €70,000 within seven or eight
years.
points prohibitive
However, it must also be stated that the Leaving Certificate
points required to study pharmacy are among the highest
– 550 to 560 – and the course is demanding.
Commenting on this Professor O’Driscoll said she
would like to see pharmacy more accessible to those who
may not achieve such high points, similar to the reforms
currently underway in undergraduate medicine.
“I would like to see it more accessible but we also
have to be conscious that we don’t want to have too
many pharmacists in the country which could result in
unemployment, if you have too many graduates. So there
is a balance there. Again I think it’s too early to see the
effects of the new schools. In a few years time when we
have been producing these extra numbers of graduates
for a continuous number of years, then that may affect the
points.”
hospital pharMacy
In relation to hospital pharmacy the UCC Professor said
that a lot of graduates were interested in working in the
area as “the career prospects and nature of the work has
become very exciting.”
However, she said that unfortunately current budgetary
constraints that are affecting all other healthcare
professionals mean that the number of jobs available in
hospital pharmacy is limited.
Coupled with community, hospital and industrial
pharmacy Professor O’Driscoll added that the versatility
of a pharmacy degree means that a number of alternative
and varied career paths are open to graduates including
research, science journalism and regulatory affairs.
“From that point of view it is a very good degree
because it opens up a lot of choices for graduates.”
Doubly honoureD
On the same night she was named Pharmacist of the Year,
Professor O’Driscoll was also presented with the Award for
Professional Excellence at the 2007 Pharmacist Awards.
Her excellence is evident not only in her commitment
to education but also through her extensive work in
pharmaceutical research.
A career in academia has allowed the Professor of
Pharmaceutics to combine her two loves of teaching
and research. Now that she has successfully established
the new School, she intends to turn her attention to
research.
“Now that we have our new building and our courses up
and running, we are turning our attention to developing
research within the school. That will be our main driver for
the coming years, to develop and extend our research and
to interact more with the clinical profession and industry,”
she stated.
Professor O Driscoll’s own area of expertise is drug
delivery with a particular interest in drug delivery
following oral administration.
“What we are really interested in, are drugs, for
example, like peptide and protein drugs, a classic
example would be insulin, and trying to work on
non-injectable forms. The oral route of administration
from a patient’s point of view is the most acceptable;
their compliance would go up and it is generally a safe
route.
Patients could also self administer, so there are huge
advantages to oral administration. But there are also some
drugs that can’t – because of their chemical nature – be
given by the oral route unless they are protected in some
way. So that is what we are trying to achieve, protecting
those drugs and making sure that they can overcome
barriers in the gut and can be absorbed and travel to the
disease site to treat only the cells that are diseased and
avoid the healthy cells.”
The Professor of Pharmaceutics explained that drugs
can be protected in various ways including the use of
excipients and the addition of a targeting ligend for
particular cell types.
biotechnology
According to Professor O’Driscoll, novel drug delivery
is “a very exciting area to work in” and she believes that
we will see a number of very exciting developments in
the area over the coming years particularly in the area of
pharmaceutical biotechnology.
“We also have a project ongoing here where we are
looking at gene delivery. Who knows, in 10 or 20 years you
might be able to go into the pharmacy and buy a gene
delivery product. I think there are great opportunities
for us now. It’s exciting. The research is great, I get great
satisfaction from it and it complements the teaching as
well.”
Coupled with research in the area of pharmaceutics
Professor O’Driscoll said there were a number of other
research projects currently underway in the UCC School
including pharmaceutical and medicinal chemistry,
neuropharmacology, vaccine design and delivery and
clinical pharmacy.
In conclusion, Professor O’Driscoll expressed her delight
at being named the 2007 Pharmacist of the Year. For the
soft spoken pharmacist the recognition of her colleagues
and peers was particularly special.
“I was very honoured to win the award. It is a great thing
to be picked out by your fellow pharmacists for an award
like this. I was absolutely thrilled and very honoured. To
be picked out by your fellow professionals is a very special
thing.” IP
23
finance
‘Short Term
Economic Outlook’ –
Does it really matter?
I
“
Pau l a . Ov ery
In market
conditions
such as
today, you
will see the
professional
investors
purchasing
from the nonprofessionals
as those nonprofessionals
let media
hype scare
them out of
the market.
f you have been reading the newspapers, listening to
radio or watching TV recently, you could be forgiven
for believing that we are in economic meltdown. Doom
and gloom prevails as interest rates remain “high”, the
“Sub Prime” problem remains “unsolved” and the world’s
stock markets are “bearish”. Corrective action taken by
some state institutions (the FED in the US for example) is
described as “panicked” and the old stalwart of “cash is King”
has been resurrected.
Time To buy?
All of these ‘issues’ are short-term and thus the question must
be asked, in our client’s attempts to create sustainable ‘financial
freedom’ over the long term, whether these short-term issues
really matter? Sustainable financial freedom is built over the
long-term (a recent internal survey suggests that, on average,
our clients achieve their objective over an average of 11 years)
and these short-term problems, in our view, represent much
more of an opportunity than a threat. Today, you can buy
certain blue chip shares, for example, at a far lesser price than
just six months ago. The same is true of certain properties,
both here in Ireland and overseas, and these lower prices must
represent an excellent buying opportunity, as long as one
believes that the markets will recover.
Let’s look at a mathematical example on an investment
property, using the example of a property being purchased
today with 75% finance at an interest rate of 5%. If you pay
€300,000 today for this property, which I will assume grows in
value by 5% per annum over the next 15 years (i.e. sale price of
€624,000) and on which you receive an average annual rent of
€10,000, the Internal Rate of Return (IRR) on your investment
will be:
14.57% p.a.
Note: The IRR is based on the net, after all taxes, out of
pocket expense to the investor over the 15 year term
Now suppose, instead of buying today you wait for 6 months
and purchase the same property for €270,000 (10% drop in
price) and all other assumptions remain the same, what will be
the IRR after 15 years?
14.84% p.a.
Note: The IRR is based on the net, after all taxes, out of
pocket expense to the investor over the 15 year term
The six month delay, which in our example assumes you get
the timing perfectly correct (i.e. you buy exactly at the bottom
of the market), delivers an additional IRR of just 0.27% per
annum. And here is the point I want to make; while short-term
market fluctuations can be painful (as we watch our hard won
assets decrease in value), and are made all the more painful
by media reports, in the longer-term they make very little
difference. Economic markets move in cycles, sometimes
the cycle is in a downward phase, more often than not the
movement is upwards. As long as you believe this is NOT
the end of the world as we know it, recent market problems
present more opportunities than problems.
24
‘Time’ is everyThing
Not even the professionals can accurately call the bottom of
a market and so for you to do so is most unlikely. However,
we do not believe, where true financial freedom is your
objective, that “TIMING is everything”, because in the race to
accumulate sustainable wealth, TIME is the most important
thing! “Timing is everything” is the battle cry of the product
sellers because, quite frankly, they want you to BUY NOW. You
have already seen in the example above that waiting for the
property market to drop another 10%, makes a tiny difference
over TIME. Indeed, in the market conditions that prevail today,
the ordinary (lay) investor is often paralysed by financial fear
as they consume more and more doom and gloom media
reports. Such paralysis typically lasts far longer than the
downward phase of the market, which means that these (lay)
investors only re-invest when much of the losses have been
regained (i.e. their financial fear being allayed by many more
positive financial stories) and thus miss the opportunities that a
recovery offers.
WhaT are The professionals doing?
So, in closing, our message to those clients who are making
investments in an attempt to create sustainable financial
freedom; is to ignore much of the negative market hype and
to look for the substantial opportunities that such market
conditions present.
Remember, in any financial transaction there are two
opposing opinions present. For example, if you own bank
shares and decide to sell them due to recent losses, it has to
be true that the buyer of those shares holds the opposite view
to you. In market conditions such as today, you will see the
professional investors purchasing from the non-professionals
as those non-professionals let media hype scare them out
of the market. For our clients, our suggestion is to mirror the
actions of the professionals, rather than the actions of those
who let financial fear and panic dictate their actions.
Over the coming weeks and months we in Financial
Engineering (FE) will be putting together a number of
investments to take advantage of the opportunities presented
by recent market conditions. As usual, they will be relatively
long-term (3-5 years +) and will be structured in a manner
to offer our clients the very best potential possible in as low
a risk environment as we can negotiate. We look forward to
discussing them with you as they come to market. IP
Paul A Overy QFA, FLIA, is the co-founder of Financial Engineering
Network Ltd, www.fen.ie
Financial Engineering is regulated by the Financial Regulator.
Paul is the author of the best selling book, The Tricks of the Rich
Tel: 01 614 8000
FE will be holding a seminar in Days Hotel, Castlebar, Co Mayo
at 6:15pm on 11th March
Please contact Marie Fitzpatrick if you would like further
information Tel: 01 614 8070 Email: [email protected]
view from above
Getting a
grip
The role of the
pharmacist in prevention
is being taken seriously
by our near neighbours.
I
f I were to appear before the Statutory Committee and
the case against me stated that I left the pharmacy during
business hours and that I went to a public house where
alcohol was being consumed and that there I asked men
to feel their testicles then I should not be surprised if the
Chairman of the committee instructed that my name be
removed from the register. Most practising pharmacists would
agree; such behaviour could only bring the profession into
disrepute. Yet, at least one pharmacist from Northern Ireland did this
very thing, and did it on more than one occasion, and rather than a
trip to the Committee, he got paid by the Building the Community
Pharmacy Partnership (BCPP) for his efforts.
HealtH streams
In the UK public health is at last becoming prominent within primary
and secondary care. This means we are wakening up to the fact that
the health services have to date consisted of primary care treating
sick people and secondary care treating even sicker people. Sir
Donald Acheson, Chief Medical Officer in 1997, gave us the “stream”
metaphor for ill health suggesting that health services were very
good at saving people “down-stream” after they had fallen in but
not good at stopping them getting to this point. Prevention is better
than cure and less expensive so why do we not offer more effective
preventive services, Acheson asked.
“
The Building the Community
Pharmacy Partnership is without
doubt the most innovative
pharmacy-based public health
initiative in the UK.
Primary care services are difficult to re-engineer towards
prevention activities and away from treatment and cure. What
determines an individual’s health and the health of communities is
complex and deficiencies often exist because of social inequalities.
Prime Minister Gordon Brown, attempting to gain some selfrespect recently committed England to a Public Health initiative
that amounts to screening and action based on results. This comes
from the work of Derek Wanless who considered how the UK Health
Service might pay for itself twenty years from now. Wanless, in
support of Achenson 10 years earlier, asked for more “up-streaming”
of health services, interventions that might stop people getting ill
in the first place but Mr Brown’s approach is not near far enough
“up-stream” since it does not engage with people early enough. The
pharmacy-based model, the BCPP, is.
t er ry m ag u i r e
PHarmacy initiative
The Building the Community Pharmacy Partnership (BCPP) is
without doubt the most innovative pharmacy-based public
health initiative in the UK. It is by far the best example of how
community pharmacy can plug into public health and begin to
make a difference. The BCPP has come a long way since it was first
conceived by DHSSPS. The key was finding the funding; this came
through Executive Funds made available by the first Executive.
Flexibility in programme design and delivery and a partnership
approach define the scheme’s success.
The community if falling over itself to partner with a local
pharmacy in securing funds. In December I was asked to become
involved in three separate projects; work with street-drinking young
men, medicines management for the housebound and obesity.
The BCPP projects are at the heart of communities supporting
individuals make healthy choices. I suppose the challenge now for
BCPP is how to mainstream the BCPP projects.
Fat is a Falls road issue
Some years back I had a successful BPCC project addressing obesity
in the local community. We partnered with the Falls Women’s
Association as tough and proud a bunch as you’ll meet. They did not
allow us to use the words “fat” or “obese” in any publicity material
and who was I to disagree but it proved difficult. We innovatively
came up with the Healthy Weight Challenge and enrolled 33 women
with whom we worked for a year each had a body mass index of
35 or greater. This group became known affectionately as Terry’s
Tubbies. Simply we set them targets, advised on food and exercise
and followed them up every two weeks. Eleven lost 1-5 lbs, 10 lost 510 lbs and 12 dropped out and went back to Kentucky Fried Chicken.
Back then, I found it difficult to continue with the work. I now can
get continuation funding but I wonder how we might develop an
evidence-base for specific successful initiatives. This would allow
other pharmacies to adopt the service model defined by a national
standard specification. It seems an unusual role for a pharmacist
who should be dispensing prescriptions but if, as a profession, we
really are committed to improvements in public health we will need
to engage with people where they are and therefore it might make
sense for pharmacists to, on occasion, leave the pharmacy and go
to where people are. This might include showing men how to check
themselves for testicular cancer and other things that will kill them if
they don’t adopt healthier lifestyles. IP
Terry Maguire BSc, PhD, FCPP, FPSNI, MRPharmS (Hon Member) FPSI.
Dr Maguire owns and managers two pharmacies in Belfast, Northern
Ireland. He is an honorary senior lecturer at the School of Pharmacy,
the Queen’s University of Belfast. His research interests include the
contribution of community pharmacy to improving public health.
25
AROMASIN®
Switch to Aromasin
for improved survival1
ENHANCING LIFE’S EXPECTATIONS
*17% reduction in risk of death versus continuing on tamoxifen. P=0.05 (1)
1. Coombes RC et al. Survival and safety of exemestane versus tamoxifen after 2–3 years’ tamoxifen
treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007; 369:559–70.
2. Goldhirsch A et al. Meeting highlights: International Expert Consensus on the Primary Therapy of Early
Breast Cancer 2005. Ann. Oncol 2005; 16: 1569-83.
3. Winer EP et al. ASCO technology assessment 2004. J Clin Oncol 2005; 23(3): 619-29.
AROMASIN® Prescribing Information. Presentation: Coated tablet. Each tablet contains 25mg exemestane.
Uses: Adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant
tamoxifen therapy and until completion of 5 years of combined sequential adjuvant hormonal therapy or tumour relapse. Treatment of advanced breast
cancer in postmenopausal women, whose disease has progressed following an anti-oestrogen therapy. Efficacy has not been established in patients with
oestrogen receptor negative status. Dosage and administration: One 25mg tablet to be taken once a day preferably after a meal. Contra-indications:
Known hypersensitivity to the active substance or any of its excipients, pre-menopausal women and pregnant or lactating women. Warnings: Should
not be administered to women with premenopausal endocrine status or patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency and should be used with caution in patients with hepatic or renal impairment. Tablets contain methylp-hydroxybenzoate which may cause allergic reactions (possibly delayed). Bone mineral density and risk of fracture should be assessed at the start of
treatment. Treatment for osteoporosis should be initiated as appropriate and patients should be carefully monitored. Interactions: In vitro evidence
showed that the drug is metabolised through CYP450 3A4 and aldoketoreductases. Co-administration of drugs and herbal preparations known to induce
CYP 3A4 may reduce the efficacy of Aromasin. Use cautiously with drugs metabolised by CYP 3A4 that have a narrow therapeutic window. Should not
be co-administered with oestrogen containing medicines. Side Effects: Adverse events were usually mild to moderate. The withdrawal rate due to
adverse events in clinical trials was 7.4% in patients with early breast cancer and 2.8% in patients with advanced breast cancer. Very common (>10%)
were: insomnia, headache, hot flushes, nausea, increased sweating, joint and musculoskeletal pain, fatigue. Common (>1%, ≤10%) were: anorexia,
depression, dizziness, carpal tunnel syndrome, abdominal pain, vomiting, constipation, dyspepsia, diarrhoea, rash, alopecia, osteoporosis, fracture,
pain, peripheral oedema. Uncommon (>0.1%, ≤1%) were: somnolence, asthenia. Thrombocytopenia and leucopenia have been rarely reported. An
occasional decrease in lymphocytes has been observed, particularly in patients with pre-existing lymphopenia. Elevation of liver function test parameters
including enzymes, bilirubin and alkaline phosphatase have been observed. Gastric ulcer was observed at a higher frequency in patients who received
concomitant treatment with non-steroidal anti-inflammatory agents. Storage: 3 year shelf life. No special precautions for storage. Package Quantities:
30 tablets in blister strips. Marketing Authorisation Number: PA 936/35/1. Marketing Authorisation Holder: Pharmacia Ireland Limited, 9 Riverwalk,
National Digital Park, Citywest Business Campus, Dublin 24. Further information is available on request from: Medical Information at Pfizer Limited,
Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Tel: +44 (0) 1304 616161
Date of Preparation: September 2007
hospital pharmacy
Breast cancer:
AN OVERVIEW
In this article Sandra Melville and Lucy Heycock outline
the pathology of breast cancer and the role pharmacists
can play in prevention and patient support
sa n d r a m elv i l l e, lu c y h e yco c k
B
reast cancer affects almost 42,000 people in
the UK each year and there are 12,700 deaths
from the disease annually — it is the most
common cause of death in women between
the ages of 35 and 55 years. One in nine
women in the UK will develop breast cancer
and although the incidence is increasing,
recent advances in prevention and screening
together with new treatments have resulted
in improved survival rates.1,2
Breast cancer also occurs in men,
accounting for 1 per cent of cases in the UK.
However, this article only applies to breast
cancer in women.
Pharmacists, particularly in the community,
are ideally placed not only to give lifestyle
advice about risk reduction, but also to act as
a valuable resource for patients experiencing
side effects during treatment.
Structure of the breaSt
The mature female breast is composed of fat,
connective tissue and glandular tissue, and
can be divided into lobes. On average, there
are 15–20 lobes in each breast and, within
these, many smaller lobules, which ultimately
end in dozens of tiny milk-producing bulbs.
A network of ducts, leading to the nipple
link these lobes and lobules. The areola
around the nipple has large glands around it
which produce fluid to lubricate the nipple.
Connective tissue, known as stroma, supports
these structures and fat fills the spaces
around the lobules and ducts.
There are no muscles in the breast, but
muscles lie under each breast and cover the
ribs. The breast is responsive to a complex
interplay of hormones (mainly oestrogen,
progesterone and prolactin) that cause the
tissue to develop, enlarge and produce milk.
It also contains a network of lymph vessels
which connect to lymph nodes, located
mainly in the armpits, near the chest wall and
over the collarbone and neck region.
riSk factorS
Breast cancer is an extremely complex
disease. There are many types with differing
histological, biological and immunological
Table 1. Risk facToRs foR
developing bReasT canceR
• Age Incidence increases from 1 in 900 in those
under 30 years old to 1 in 10 in those over 85
years.
• Oestrogen therapy Oral contraceptives slightly
increase the risk of breast cancer. Hormone
replacement therapy increases the risk of
breast cancer and decreases sensitivity of
mammography.3
• Obesity Women who are obese, particularly
post menopause, are at increased risk. Adipose
tissue is the main body source of oestrogen after
menopause.
• Menstrual and pregnancy history Early menarche,
late menopause, fewer pregnancies and shorter
duration of breastfeeding are all associated with
increased risk.
• Race Variations are seen with age and race. In
women under 40 years old, Caucasian women are
more likely than Black or Asian women to develop
breast cancer, while in women over 40 years,
Black women are at increased risk compared with
Caucasian or Asian women. Asian women of all
ages are at a decreased risk.
• Family history A small proportion of breast
cancers have a strong genetic link. Carrying the
BRCA1 or BRCA2 gene mutation leads to a 50-80
per cent chance of developing breast cancer.
• Height at age 14 Women who were taller than
165cm at the age of 14 years are at increased risk
and those under 150cm at the age of 14 years
are at decreased risk. (Women in between these
heights are at average risk.)
• Birth weight Women who weighed over 4.43kg at
birth are at increased risk and those weighing less
than 3.18kg are at decreased risk.
• Socio-economic status There is a positive
correlation between risk and socioeconomic
status — those of higher status are at greater risk.
• Geographical location Women in urban areas are
at higher risk than those in rural areas.
characteristics. Many women
mistakenly believe that most breast
cancers are hereditary but, in fact, only
five per cent of breast cancers have a
genetic link. Generally, the greatest
risk factor for developing breast
cancer is age, with 80 per cent of cases
occurring in women over the age of 50
years. Incidence in women under 30
years of age is rare.
Table 1 describes risk factors for
developing breast cancer but it should
be noted that these are relative risks
and having one or more of these does
not mean that a patient will develop
the disease.
oeStrogen in breaSt
cancer
Levels of oestrogen vary during a
woman’s lifetime and will influence
her breast cancer risk. Oestrogen
stimulates the growth and division of
breast tissue cells and it is believed that
the greater the growth rate, the greater
the risk of cancerous mutations.
Oestrogen levels change dramatically
during puberty, pregnancy and
the menopause, and are affected
by hormone replacement therapy
(HRT) and the oral contraceptive pill.
Elevated oestrogen levels are linked
to an increased risk of breast cancer,
and is relevant in two-thirds of breast
cancers.
These are termed ‘oestrogen
receptor positive’ (or ‘oestrogen
responsive’). The million women study3
confirmed that both current or recent
use of HRT can increase the risk of
developing breast cancer.
the Study alSo found that:
• Users of HRT are at a 22 per cent
relative increased risk of death from
breast cancer compared with women
who have never used HRT.
• The relative risk of breast cancer
varies significantly among the different
27
hospital pharmacy
HRT types and is substantially greater in users of oestrogenprogestogen combinations than in users of other preparations.
The use of HRT has to be balanced with the benefits of
treatment (e.g. relief of hot flushes and night sweats, prevention of
osteoporosis etc) and women should be encouraged to discuss the
pros and cons fully with their GP before making a decision.
Use of the combined oral contraceptive (COC) pill slightly
increases the risk of developing breast cancer. The risk is highest
for women who started using these pills as teenagers. However, 10
or more years after stopping COCs, the risk of developing breast
cancer returns to the same level as women who have never taken
them. In addition, the Committee on Safety of Medicines advises
that a possible small increase in the risk of developing breast
cancer should be weighed against the benefits and evidence of a
protective effect against cancers of the ovary and endometrium.
Prevention
Obesity is one of the few modifiable risk factors for breast cancer.
Recent evidence suggests that physical activity has a preventive
effect on breast cancer although it is not clear if this is caused by
exercise having a direct effect on hormonal and growth factor
levels or simply as a result of it lowering body mass index.
There is a significant association between alcohol intake and
breast cancer. There is some evidence to suggest that animal
fat intake may cause a small increased risk in breast cancer, but
this is not thought to play as large a role as previously thought.
Breastfeeding has an association with a reduction in risk, which is
another reason for promoting it to young mothers who may seek
advice.
SignS and SymPtomS
Early breast cancer can present with any of the following:
• Breast or chest pain.
• Palpable lump in breast or armpit.
• Nipple inversion or discharge.
• Puckering or dimpling of skin (‘peau d’orange’).
• Change in size or shape of breast.
Metastatic disease can present with bony
pain or pathological fracture, breathlessness
due to pleural effusion or jaundice.
In addition to providing lifestyle advice,
pharmacists are ideally placed to promote
the importance of breast awareness. Recent
research carried out by Breakthrough
Breast Cancer found that 80 per cent of
women had not checked their breasts in the
previous month and the study highlighted
that the main reason was that they simply
did not know how.
In fact, there is no special routine for
breast examination. What is important
is that a woman looks at and feels her
breasts so that any changes are noticed.
A check can be done in any way that feels
comfortable, for example in the bath or
shower or when dressing or lying down.
Women should be encouraged to become
familiar with their breasts, how they
usually look and feel, and what is normal
at different times of the menstrual cycle.
If a woman notices anything unusual
she should report it to her GP. It is worth
stressing to women that 9 out of 10 lumps
are not cancerous but it is vital that any
breast changes are reported to their GP
because early detection improves survival.
The prompt detection of breast cancer
offers the best chances of survival
and pharmacists can help women by
encouraging those between the ages of 50
and 70 years to participate in [Breast Check
screening] so that a mammography can be
performed. Mammographies can detect
cancerous lesions before they are large
enough to become palpable.
diagnoSiS
Mammography and ultrasound (performed
after a mammograph if necessary) can help
to detect a lesion or to confirm a lesion
as suspicious. Diagnosis of the disease is
by biopsy and pathological assessment
to confirm type (e.g, adenocarcinoma,
medullary, inflammatory, mucinous,
Paget’s), hormone receptor status and
HER2 status. For example, tests on a sample
of breast cancer cells can show if they
‘respond’ to oestrogen.
Breast cancers can be divided into two
types: oestrogen responsive (ER+) and nonoestrogen responsive (ER–). Establishing
this status is important because it
determines whether or not hormone
28
hospital pharmacy
therapy is appropriate. Whether or not a breast cancer is
progesterone receptor positive also affects how a woman will
respond to hormone therapy, although to a lesser extent than
being ER+.
HER2 is a protein found on the surface of some cancer
cells. It is made by a specific gene called the HER2/neu gene.
HER2 is a receptor for a particular growth factor called human
epidermal growth factor, which occurs naturally in the body.
When human epidermal growth factor attaches itself to HER2
receptors on breast cancer cells, it can stimulate the cells to
divide and grow. Some breast cancers have many more HER2
receptors than others. In this case, the tumour is described
as being ‘HER2 positive’. It is thought that about one in five
women with breast cancer will have HER2-positive tumours.
These tumours have a worse prognosis than HER2-negative
tumours and are more likely to respond to trastuzumab. If
metastatic disease is suspected, computed tomography scans
and bone scans are required.
table 2. staging of breast cancer
UICC staging
TNM staging
Tumour, nodes, metastases
Stage 1
T1 N0 M0
Tumour <2cm, Node negative
Stage 2
A T1/2 N0/1 M0
Tumour 2–5cm, or < 2cm with 1–3 nodes
Stage 2B
T2/3 N0/1 M0
Tumour 2–5cm with1–3 nodes or >5cm
with no nodes
Stage 3A
up to T3 N1/2 M0
Tumour >5cm but free from chest wall
4–10 nodes
Stage 3B
T4 and N
Tumour >5cm and fixed to chest wall,
any node state
Stage 4
M1
Distant metastases
Staging and grading
The stage of a cancer describes its size and
whether it has spread beyond its original
site. The grade gives an idea of how quickly
the cancer could develop. (see Table 2).
Grading is determined by the appearance
of the cancer cells under the microscope.
There are three grades: grade 1 (low grade),
grade 2 (moderate or intermediate) and
grade 3 (high). The higher the grade, the
more abnormal the appearance of the cells
and the more aggressive the cancer.
Many women will know their grade
of breast cancer and appreciate the
significance of this, so an understanding
of this terminology can provide a useful
background for healthcare professionals
involved in their care.
typeS of breaSt cancer
A breast cancer can be described as either
in situ or invasive. In situ means there are
cancerous changes in the cells but these
are still limited to the lining of the glands
or ducts, and have not begun to invade the
surrounding tissue. Invasive implies that
cancerous cells have broken through the
lining layer and begun to penetrate the
surrounding tissue from where they can
gain access to the lymphatics and blood
vessels for further dissemination.
Most breast cancers are
adenocarcinomas, originating in the
epithelia of the ducts and lobes. About 80
per cent of breast cancers are invasive at
presentation. Invasive ductal carcinomas
account for around 90 per cent of these.
These generally present with poorly
defined hard lumps, peau d’orange or
nipple inversion or both.
Invasive lobar carcinomas account for the
other 10 per cent of invasive breast cancers
and these tend to be harder to detect
without a mammography because they
are relatively diffuse tumours. Pre-invasive
carcinomas account for the remaining cases
of breast cancer, and are known as ductal or
lobular carcinomas in situ (DCIS or LCIS).
The important considerations are:
• Size of tumour.
• Grade.
• Margin of clearance (distance of tumour
from edge of the healthy tissue that can
be surgically removed — the more tissue
that can be removed, the better).
• Number of nodes involved.
Issue 2 Vol 10 February 2008
29
hospital pharmacy
• Oestrogen or progesterone receptor
positivity.
• HER2 status.
“
how the positive and empathic approach
of healthcare professionals can make a real
difference.
Studies show that patients often feel they
Stage at diagnosis Survival (per cent)
Prognosis
are imposing on their doctor’s time if they
1
85
Outcome primarily depends on the intrinsic
ask questions during appointments yet do
2
55
growth rate of the tumour (which can
not seem to have the same reservations in
3
40
vary dramatically), the age at diagnosis
the pharmacy. Pharmacists can encourage
4
<5
and numerous biological parameters (e.g.
women to talk about their treatment and
histology, grade, hormone receptor levels,
side effects.
proliferation rate and presence of tumour
Just having someone listen can be
suppressor gene p53) that ultimately define
therapeutic in itself and also provides an
the natural history of the disease. Simplistically, survival at 15 years
opportunity for information to be gathered, which can be
after diagnosis is linked to staging at diagnosis, as illustrated in
used to direct patients to the most appropriate sources of
Table 3.
support. In addition, a review of patients’ medications in the
light of their diagnosis can sometimes highlight valuable
Successful treatment of early stage disease can still result
anomalies, such as inappropriate continuation of oral
in relapse, even as long as 30 years later. It is interesting that,
contraceptives or HRT slipping through the net on repeat
irrespective of the length of disease-free interval, the behaviour of
prescriptions.
tumours at relapse are similar and predictable. The average survival
An understanding of current issues related to breast cancer
at this point is around three years (but can vary from a few months
in order to address fears fuelled by media scares (e.g. stories
to five years). Women who are younger than 34 years at diagnosis
linking antibiotic or antiperspirant use to breast cancer risk)
generally have a worse prognosis, with less than half surviving at
will also be useful, as will steering people away from less
five years and most relapsing within three years.
trusted sources of information, such as unreliable websites,
Predicting prognosis can be aided by using the Nottingham
and enabling them to make more objective choices.
prognostic index (NPI). This is a formula that uses the size, stage and
Signposting local sources of help can include support
grade of a tumour to calculate a prognostic score:
groups, breast care nurse specialists, hairdressers and wig
suppliers and complementary health centres.
NPI = (tumour size x 0.2) + grade + node status.
National organisations include charities such as the Irish
For example, for a 5cm, grade 3 tumour with two nodes, the NPI is
Cancer Society provide written information, telephone
(5 x 0.2) + 3 + 2 = 6.
support and websites.
Patients often need an extra bit of encouragement to take
the step to access a support group or telephone a helpline and
it is worth spending a little time encouraging them to do this.
table 3: survival 15 years
post diagnosis
Just having someone listen can
be therapeutic in itself and also
provides an opportunity for
information to be gathered, which
can be used to direct patients to the
most appropriate sources of support.
The NPI can be used to advise patients of their chances of a cure
and to help select appropriate pharmacological treatment options.
For example, no chemotherapy is needed if NPI is less than 3.4.
Those with a score between 3.5 and 5.4 will derive the maximum
benefit from chemotherapy and for those with a score of more than
5.4, chemotherapy is essential. The lower the score, the better the
prognosis.
TreaTmenT oPTions
Treatment of breast cancer depends on various factors, such as
stage of disease, age, menopausal status, size and grade of the
tumour and hormonal status.
Pharmacy suPPorT
As one of the most accessible members of the healthcare team,
the pharmacist is ideally placed to provide cancer patients with the
information and support they need to get through what can be one
of the most difficult times of their lives. Testimonies of women who
have undergone treatment for breast cancer tell us time and again
30
summary
Being diagnosed with breast cancer can be bewildering and
frightening. Women can experience a range of emotions
including fear, anger and anxiety. They have to deal with a
vast array of different health professionals and negotiate a
confusing maze of healthcare systems. During treatment,
people can often be exhausted, nauseated and unwell. They
may also be trying to come to terms with the loss of a breast.
Then they often lose their hair during treatment, at a time
when they are already feeling at a low point. The amount of
distress that this can cause to women at a time in their lives
when they are vulnerable should not be underestimated.
Being aware of these issues will be invaluable when
someone with breast cancer comes to the pharmacy. There is
a vast amount of help and advice that pharmacists can offer to
provide significant psychological support as well as improved
pharmaceutical care. IP
references
1. The Institute of Cancer Research. Chemotherapy clinical
trials. Available at www.icr.ac.uk (accessed on 2 July 2007).
2. NHS Cancer Screening Programmes. Screening for breast
cancer in England: past and future. Available at www.
cancerscreening.nhs.uk (accessed 2 July 2007).
3. The million women study. Available at www.icnet.uk
(accessed 28 September 2007).
Sandra Melville, BSc, MRPharmS, is clinical pharmacist at Lorn &
Islands District General Hospital, Oban, Argyll, and Lucy Heycock,
MSc (cancer nursing), who is a Macmillan nurse specialist.
This article first appeared in Hospital Pharmacy
First-line treatment of metastatic breast cancer (mBC)
Why anti-angiogenesis is so important...
Life Itself.
Vessels diminished.Survival extended.1,2
Doubles median progression-free survival (PFS)
in first-line metastatic breast cancer2
References: 1. Hurwitz H et al. N Engl J Med. 2004;350:2335-2342. 2.Miller KD, et al. N Engl J Med. 2007:357; 2666-2676.
ABRIDGED PRESCRIBING INFORMATION
(For full prescribing information refer to the Summary of Product Characteristics [SmPC])
AVASTIN® (bevacizumab) 25mg/ml concentrate for solution for infusion
Indications: In combination with fluoropyrimidine-based chemotherapy for treatment of patients with metastatic carcinoma of the
colon or rectum (mCRC). In combination with paclitaxel for first-line treatment of patients with metastatic breast cancer (mBC).Avastin
in addition to platinum based chemotherapy is indicated for first line treatment of patients with unresectable advanced, metastatic or
recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology. In combination with interferon alfa2a for first line treatment of patients with advanced and/or metastatic renal cell cancer (mRCC). Dosage and Administration:
Physicians experienced in antineoplastic medicines should supervise administration of Avastin. Initial dose: 90 minute IV infusion;
second dose: 60 minute IV infusion, if initial dose well tolerated; subsequent doses: 30 minute IV infusion, if second dose well tolerated.
Do not administer as an IV push or bolus. Do not administer or mix with glucose solutions. Administer until disease progression. Not
recommended in children or adolescents. No dose adjustment is required in elderly. No data in renal or hepatic impairment. mCRC:
Recommended dose: 5mg/kg or 10mg/kg body weight given once every two weeks or 7.5mg/kg or 15mg/kg of body weight given
once every three weeks. Dose reduction due to side effects not recommended. If indicated, therapy should either be permanently
discontinued or temporarily suspended. mBC: 10mg/kg body weight once every two weeks or 15mg/kg body weight once every three
weeks. NSCLC: Administer in addition to platinum based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single
agent until disease progression. Recommended dose: 7.5mg/kg or 15 mg/kg body weight once every three weeks. mRCC:
Recommended dose: 10mg/kg body weight once every 2 weeks. Contraindications: Hypersensitivity to bevacizumab, Chinese
Hamster Ovary cell products, recombinant human or humanised antibodies or any excipients. Pregnancy. Untreated CNS metastases.
Warnings and Precautions: Increased risk of gastrointestinal (GI) perforation when taking Avastin. Intra-abdominal inflammatory
process may be a risk factor for GI perforations in patients with mCRC - permanently discontinue in patients developing GI perforation.
Increased risk of developing fistulae when treated with Avastin. Permanently discontinue Avastin in patients with TE
(tracheoesophageal) fistula or any grade 4 fistula. Consider discontinuing Avastin in cases of internal fistula not arising in the GI tract.
May affect wound healing; do not initiate for at least 28 days following major surgery or until surgical wound has healed. Withhold
therapy for elective surgery and in patients experiencing wound healing complications during therapy until wound fully healed. Dosedependent hypertension observed. Preexisting hypertension should be adequately controlled before starting Avastin treatment.The use
of diuretics to manage hypertension is not advised in patients who receive a cisplatin-based chemotherapy regimen. Permanently
discontinue treatment in patients with medically significant hypertension that cannot be adequately controlled or in patients who
develop hypertensive crisis or hypertensive encephalopathy. Monitor blood pressure during therapy. Risk of proteinuria, especially in
patients with history of hypertension, may be dose-dependent; monitor patient before and during treatment; Permanently discontinue
if Grade 4 proteinuria (nephrotic syndrome) occurs. Risk of arterial thromboembolic events including cerebrovascular accidents,
transient ischaemic attacks and myocardial infarctions (especially if prior history of arterial thromboembolic events or age over 65 years
– exercise caution with these patients). Permanently discontinue in patients developing arterial thromboembolic events. Increased risk
of tumour associated haemorrhage; discontinue permanently if Grade 3/4 bleeding. Caution in patients with congenital bleeding
diathesis, acquired coagulopathy or those taking full dose anticoagulants for thromboembolism prior to starting Avastin therapy. Risk
of CNS haemorrhage in patients with CNS metastases not evaluated – do not use Avastin in these patients. Risk of congestive heart
failure (CHF) in particular in patients with metastatic breast cancer who had prior anthracycline therapy, prior radiotherapy to the left
chest wall or other risk factors for CHF, such as pre-existing coronary heart disease or concomitant cardiotoxic therapy. Symptoms range
from asymptomatic declines in left ventricular ejection fraction to symptomatic CHF. Exercise caution when treating patients with
clinically significant cardiovascular disease or pre-existing CHF. In combination with some myelotoxic chemotherapy regimens,
increased rates of severe neutropenia, febrile neutropenia or infection with severe neutropenia (including some fatalities). Risk of
serious and in some cases fatal pulmonary haemorrhage/haemoptysis in NSCLC patients. Patients with recent pulmonary
haemorrhage/haemoptysis (>2.5mL of red blood) should not be treated. Rare reports of Avastin treated patients developing signs and
symptoms of Reversible Posterior Leukoencephalopathy Syndrome (RPLS), confirm by brain imaging, treat symptoms and discontinue
Avastin. The safety of re-initiating Avastin in patients previously experiencing RPLS is unknown. Risk of developing venous
thromboembolic events, including pulmonary embolism. Discontinue in patients with life-threatening (Grade 4) pulmonary embolism,
patients with <Grade 3 need to be closely monitored. Drug Interactions: No clinically relevant pharmacokinetic interaction of coadministered chemotherapy on Avastin disposition has been observed. No difference in clearance of Avastin in patients treated with
single agent Avastin compared to patients receiving Avastin in combination with the bolus-IFL regimen. The effect of other coadministered chemotherapies on Avastin clearance is considered not clinically significant. No significant effects of bevacizumab on
pharmacokinetics of irinotecan and its active metabolite SN38, capecitabine and its metabolites, oxaliplatin, interferon alfa-2a and
cisplatin. The impact of bevacizumab on gemcitabine pharmacokinetics is unknown. The safety and efficacy of concomitant
administration of radiotherapy and Avastin has not been established. Pregnancy and Lactation: Contraindicated during pregnancy.
No data on use in pregnant women. Animal studies have shown reproductive toxicity including malformations. May inhibit foetal
angiogenesis and is suspected to cause serious birth defects if administered during pregnancy. Women of childbearing potential must
use effective contraception during treatment and for six months after last dose. Discontinue breast-feeding during treatment and for
at least six months after last dose as Avastin may harm infant growth and development. Side Effects and Adverse Reactions: Most
serious adverse drug reactions (ADRs): GI perforations, haemorrhage including pulmonary haemorrhage/haemoptysis which is more
common in NSCLC patients and arterial thromboembolism. Most frequently observed ADRs: Hypertension, fatigue or asthenia,
diarrhoea and abdominal pain. The occurrence of hypertension and proteinuria with Avastin is likely to be dose dependent. NCI-CTC
grade 3-5 reactions with >2% difference between the Avastin group compared to control group; Very Common (>10%): leucopenia,
thrombocytopenia, neutropenia, peripheral sensory neuropathy, hypertension, diarrhoea, nausea, vomiting, fatigue and asthenia.
Common (>1-<10%): sepsis, abscess, infection, febrile neutropenia, anaemia, dehydration, cerebrovascular accident, syncope,
somnolence, headache, cardiac failure congestive, supraventricular tachycardia, thromboembolism (arterial), deep vein thrombosis,
haemorrhage, pulmonary embolism, dyspnoea, hypoxia, epistaxis, intestinal perforation, ileus, intestinal obstruction, abdominal pain,
gastrointestinal disorder, palmar-plantar erythrodysaesthesia syndrome, muscular weakness, proteinuria, urinary tract infection,
lethargy and pain. All grade reactions with >10% difference between the Avastin group compared to control group. Very Common
(>10%): anorexia, dysgeusia, headache, eye disorder, hypertension, dyspnoea, epistaxis, rhinitis, constipation, stomatitis, rectal
haemorrhage, exfoliative dermatitis, dry skin, skin discolouration, proteinuria, asthenia, pain and pyrexia. For a full listing of adverse
reactions, please refer to the SmPC. Legal Category: Limited to sale and supply on prescription only. Presentations and Marketing
Authorisation Numbers: EU/1/04/300/001 for 100mg/4ml (Pack size of one); EU/1/04/300/002 for 400mg/16ml (Pack size of
one). Marketing Authorisation Holder: Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden
City, AL7 1TW, United Kingdom. Avastin is a registered trade mark. Further information is available from Roche
Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700.
Fax: (01) 4690791. Date of Preparation: February 2008.
P04/02/08.
meetting report
The manufacture and use
of biopharmaceuticals
s t eph en m e y l er
The EMEA’s new guidance on biosimilar medicines attempts to deal with the issues
that arise from the complexities of the manufacture, clinical use and regulation of
biopharmaceuticals and biosimilars.
S
ince Genentech launched
recombinant human insulin in 1982,
the footprint of biopharmaceuticals
in medicine has become ever larger.
Biopharmaceuticals in use today
include blood factors (Factor VIII
and Factor IX), hormones (growth
hormone, gonadotrophins, as well as
insulin), erythropoiesis stimulating
agents (ESAs like EPO), interferons and
monoclonal antibodies.
The global biopharmaceutical
industry was estimated to be
worth approximately $37 billion in
2006, with the ten largest biotech
companies accounting for 85% of this
figure. Biologics now play a crucial
part in the treatment of people with
previously intractable diseases such as
chronic kidney disease. For example,
of the 325,000 people on regular
dialysis in the EU, 95% are treated with
ESAs, typically with three injections a
week for five to 10 years.
These agents have characteristics in
common that differentiate them from
‘traditional’ chemical drugs; these
characteristics create challenges to
manufacturers in terms of similarity,
efficacy, safety and quality, both from
batch to batch within one company
and for companies attempting to
produce post-patent follow-on drugs,
or biosimilars, of innovator drugs.
These challenges are reflected in
regulation of biopharmaceuticals
and biosimilars. The very name
‘biosimilar’ was coined and is officially
recognised in EMEA literature
because ‘biogeneric’ does not
accurately describe the impracticality
of making exact copy follow-on
biopharmaceuticals.
The gulf beTween aspirin
and epO
Biopharmaceuticals have particular
characteristics that set them apart
from purely chemical entities. The
most basic difference is one of size.
Most biopharmaceuticals are large
proteins with a basic composition
of several hundred amino acid
residues; each one of these amino
acids is comparable in size to a single
molecule of aspirin. For example,
EPO is approximately 30 kiloDaltons
(kD), while aspirin is 0.2kD. This large
size has implications at all stages
of production as well as in clinical
practice.
The tertiary and quaternary
structure of proteins is affected
by conditions during inoculum
development, fermentation,
harvesting and separation. Physical
factors such as temperature, pH,
oxygen and CO2 concentration can
affect a protein’s physicochemical
structure; at an individual amino acid
level and the degree of modification
by glycosylation, sulphur bridging,
33
meeting report
methylation, etc, as well as at a larger
scale in the way the molecule folds.
Production must also take account of
enzyme activity both during and after
fermentation; the release of proteases
and other enzymes from damaged,
dying and dead cells can alter the
biopharmaceutical’s structure.
The end result of each cycle of
fermentation will be a population of
proteins with a range of activity, half
life, stability and immunogenicity
that must be within defined
parameters to meet EMEA standards.
Ensuring that this is the case is one
of the most challenging aspects of
biopharmaceutical production and
one that necessitates a different
system of pharmacovigilance than
the traditional one used for quality
assurance in chemical drugs.
EPO is regarded as a ‘typical’
biopharmaceutical. It was approved as
recombinant human EPO (rhuEPO) in
1991 for the treatment of anaemia in
patients with chronic kidney disease
“
inadequate patient education about
home injection for some products, or
as a result of breaks in the cold storage
chain in the re-importation trade that
exists between the US and Canada.
ImmunogenIcIty
At the fermentation and purification
stage, undesirable immunogenicity
can be introduced if folding of the
tertiary structure of the EPO protein
occurs in the ‘wrong’ way. This may
result from variations in a large
number of factors as previously
mentioned, such as pH, temperature
and nutrient concentrations; as well as
variations in the ‘natural’ population
of slightly different proteins that are
the result of each fermentation cycle.
Although the ideal aim of each cycle is
to reproduce an identical population
of proteins, it is impossible to avoid
single atom substitutions in such
complex molecules; such changes
may or may not affect the product’s
characteristics. Beyond the translation
Biopharmaceuticals have
particular characteristics
that set them apart from
purely chemical entities.
with or without dialysis. Unlike some
other hormones such as insulin,
it was never available from a host
source, but has entered clinical use
only as a recombinant molecule. It is
a glycoprotein, requiring extensive
glycosylation during production of
a useful form. For this reason, EPO is
produced in a Chinese Hamster Ovary
(CHO) vector that has been modified
with human DNA coding for EPO, in
a very tightly controlled large scale
eukaryotic cell fermentation. The CHO
cell line is used because it is a highly
characterised one, particularly for the
glycosylation steps necessary for the
production of relatively stable, active
and safe EPO.
Another factor that differentiates
biopharmaceuticals like EPO from
chemical drugs is immunogenicity.
This is a critical issue for
biotechnologically derived medicines.
The risk of immune responses to
recombinant proteins was made clear
by approximately 200 cases of pure
red cell aplasia (PRCA) in patients
receiving Eprex, an EPO approved
in Europe, in the years following
1998. These cases were traced to
a small change in the formulation
of the product – the removal of
human serum albumin (HSA) – that
eluded the rigorous controls in
place at the time. The undesirable
immune response occurred in
patients who had EPO administered
subcutaneously. However, the FDA in
the US has also suggested that PRCA
may be induced by incorrect storage
of EPO products as a consequence of
34
of DNA and RNA to protein sequences,
glycosylation, essential to activity, also
produces a population of isoforms,
with marked differences in stability,
half-life and bioactivity. Effective
production of biopharmaceuticals
aims to create with each cycle the
same mix of variants with the same
‘mean’ activity.
BIosImIlars not the same
This leads to another challenge in
the manufacture of biologics. Unlike
chemical drugs, biopharmaceuticals
and biosimilars, because of the
complexity of the fermentation,
purification and formulation
processes, may differ slightly between
batches of the ‘same’ product as well
as between the innovator reference
biologic and a follow-on biosimilar.
For biosimilars, EU regulations require
defined studies to show that the
biosimilar medicine is similar and as
safe and effective as the biological
reference medicine. According to
the EMEA, “These studies involve a
step-by-step process starting with
a comparison of the quality and
the consistency of the medicinal
product and of the manufacturing
process. Studies are also conducted
to compare the safety and efficacy
of the medicines. These studies
should demonstrate that there are
no meaningful differences between
the biosimilar and the biological
reference medicines in terms of safety
or efficacy. When the biological
reference medicine is used to treat
different diseases, the efficacy and
safety of the biosimilar medicine may
also have to be assessed using specific
tests or studies for each disease.”
However, a problem, particularly
for biosimilar manufacturers who do
not have access to the innovators’
databases and the history of
incremental change they record, is
just what particular analyses to apply
to prove that their product is similar
enough to be licensed. The advanced
analysis methods currently available
quite often reveal ever more physicochemical differences between batches
as well as different companies’
products, and deciding which
differences are relevant is challenging.
Complete characterisation of complex
molecules like EPO is impossible,
so the historical data available to
innovators becomes crucial when
investigating biosimilarity.
treatIng cKD
The advent of biologics has allowed
the development of highly targeted
therapies to alter processes
that lead to disease – cancer,
rheumatoid arthritis, lupus and
other auto-immune diseases. A
number of conditions result in
chronic kidney disease (CKD),
notably diabetes, hypertension
and glomerulonephritis. CKD
is a growing problem in an
ageing population; in some
European countries the number of
people requiring renal replacement
therapy to support impaired kidney
function as a result of CKD has almost
doubled and one estimate is that over
two million people will require dialysis
worldwide by 2010.
In the US, diabetes and
hypertension account for 43% and
27% of all new late-stage kidney
disease cases, respectively. The result
of these disease processes is damage
to nephrons and a subsequent decline
in the glomerular filtration rate (GFR),
the rate at which creatinine is cleared
from the blood by kidneys. As kidney
function declines, CKD’s role as a
‘disease multiplier’ kicks in, increasing
the patient’s risk of hospitalisation,
cardiovascular disease and overall
mortality.
Renal anaemia results as CKD
progressively damages the
ability of specialised kidney cells
to produce erythropoietin. In
normal kidney function, these cells
detect relative oxygenation in red
blood cells (RBCs) and produce
erythropoietin in response to a
decline in oxygenation. The hormone
stimulates differentiation of RBCs
(erythropoiesis) from unspecialised
cells in the bone marrow. In CKD the
loss of erythropoietin-producing cells
results in anaemia as RBC production
drops off in the bone marrow. The
most significant cause of death in CKD
is cardiovascular disease, the result
of the extra burden to the heart of
pumping sufficient oxygenated blood
to the brain, liver and other organs.
Globally, there are approximately one
million deaths annually from endstage renal disease.
Before the introduction of EPO,
CKD-induced anaemia was treated
with blood transfusions, with the
risk of iron overload and bloodborne
infections. When EPO came into
clinical practice in the early 1990s,
straightforward and effective anaemia
management became possible for the
first time. The first EPO product was
Epogen/Eprex, introduced in 1989.
A primary goal in the subsequent
development of ESAs has been to
overcome the problem of the rapid
drop-off in erythropoietin levels
after administration of the previous
generations of ESAs. This results
from the relatively high affinity of
ESAs to cells in the bone marrow
involved in RBC production, which
can produce a pattern of spikes and
troughs in haemoglobin levels that
make it difficult to maintain clinical
haemoglobin targets.
Mircera, the first approved of a
new generation of agents that act as
continuous erythropoietin receptor
activators have a reduced affinity
for the receptors involved in RBC
production. It binds to them less
tightly and is absorbed more slowly.
As a result, there is a more sustained
stimulation of RBC production that
closely imitates the natural control of
the process. Mircera’s longer half-life
(approximately 180 hours, three to five
times that of other ESAs) means that
it could maintain stable haemoglobin
levels in patients with once-monthly
or fortnightly administration.
regulatory uncertaInty
A problem for clinical ESA use
remains regulatory uncertainty.
As the early generations of ESAs
and other biologics reach the end
of their patents, the questions
about pharmacovigilance of
biosimilars is great. Will biosimilar
manufacturers be allowed access to
originator companies’ data for new
indications?
Biosimilar manufacturers would
argue that this would allow them
to more likely achieve the same
standards of quality demanded of
the innovators. However, aside from
the economic implications to future
biopharmaceutical development
that such access would have, the
innovators argue that even with the
advantage of original data, each
manufacturing location will continue
to produce significantly ‘different’
products in terms of activity, stability
and immunogenicity.
Biosimilars will only ever be ‘similar’,
never ‘generic’ or identical and the
challenge for regulators, clinicians
and manufacturers is to ensure that
pharmacovigilance structures are
up to the job of monitoring them,
during development, manufacturing
and for the entire life of the
biopharmaceutical.
Your recommended daily allowance
needn’t always be a mouthful
With its unique formulation, Rubex Essentials guarantees you the
recommended daily allowance of the “Essential” vitamins, minerals and the
amino acid lutein in a pleasant, easy to take form. Just pop one in a glass of
water and ease your way into a busy day.
For more information contact your pharmacy.
e-pharmacy
Health in
your hand
From medical compliance to pro-active health promotion, Short Message
Service (SMS) is being used as an effective tool to create a more competitive
and satisfactory patient experience.
SMS text messaging allows you to
communicate cheaply, effectively
and quickly with patients.
I
Sponsored by Helix Health
n the 1990s, mobile phones were seen by many as an
optional extra. Today, mobile phone technology is a
key part of our society with more mobile phones in
Ireland than there are people. According to the latest
figures from the Commission for Communications
Regulation, mobile phone penetration in Ireland
now stands at 114 per cent of the population. It is no
surprise then that the mobile market is becoming
hugely popular as a means of communicating with
customers. This same logic is now being applied in the
healthcare sector where mobile phone technology
is changing the way healthcare professionals deliver
services and communicate with patients.
Vital signs
With the growing computing capability of mobile
phones, the potential benefits of this new and
evolving technology are enormous. Currently, the US
and Britain are leading the way in developments with
this technology, where mobile phones are beginning
to be used in a variety of ways throughout the
healthcare sector.
A unique system has already been developed which
uses a mobile phone to transmit a person’s vital signs,
including complex ECG, heart signal, blood pressure
and oxygen to hospitals and clinics. Mobile phones
that are now being developed can monitor your pulse
and even double as glucose meters to monitor blood
sugar levels in diabetics.
Monitoring treatMent
Another area benefiting from this technology is
chemotherapy-associated side effects management.
In October 2007, a feasibility study was undertaken
in Oxford, which examined home monitoring of
patients’ symptoms via a mobile phone. Cancer
patients receiving chemotherapy entered symptom
data onto screens on a mobile phone twice daily. This
real time assessment of symptoms was then sent via a
secured connection to a remote computer where the
symptoms were then analysed. The study showed that
the technology worked very well (Weaver et al 2007).
Healthcare system providers are increasingly
looking for developments in mobile phone
communication technology; to help improve the
services they provide to healthcare professionals
and enhance patient care. One application within
mobile phone technology, which is currently
demanding attention in Ireland, is the use of SMS text
messaging to patients. This application offers further
opportunities to deploy the benefits of mobile phone
technology and to improve access to healthcare and
health information. According to UK based analysts
(Wireless Healthcare) this mobile phone application
is said to be an early indication of the move towards
automated communication between the health
provider and the patient.
Confidentiality
Short Messaging Service (SMS) or text messaging
is a mobile phone technology that enables people
to send and receive messages to mobile phones
or computers. Such SMS technology allows for a
previously unattainable level of communication with
the patient and supports the fundamental tenets
for the transfer of health information through the
privacy, confidentiality and direct communication that
it affords. Because we carry our phones with us at all
times, text messages are a non-intrusive and personal
37
e-pharmacy
convenience of patients and consumers. For
example, St Luke’s Hospital uses SMS (texting)
to remind patients about doctor/consultant
appointments. The Blood Transfusion Board also
uses SMS to text specific donors when there is a
shortage of certain blood types.”
An example
of the SMS
functionality in
Helix Health’s
QicScript
Professional.
way of communicating with patients. As well as being
more efficient and cheaper than paper correspondence,
SMS texting is also an instant way of getting information
directly to the receiver. Current research shows that they
are an especially successful means of communicating
with people between the ages of 16 and 40, but the use
of SMS is certainly not restricted to this target range.
In a report by iReach, commissioned by O2 in 2007,
Ireland ranked seventh out of the EU 15 in its use of
online and mobile communications across the public
sector. However, it found that Ireland was below average
in the health category even though it was above average
in all other areas. The potential benefits of SMS texting
“
Pharmacists can also use SMS
to let patients know when their
prescription is ready for collection
thereby reducing waiting times
and enhancing the overall patient
journey and pharmacy experience.
applications will not be fully recognised until there is
greater adoption of this mobile communication within
the Irish healthcare sector.
On-line medical advice
Oisin Byrne of iReach states, “In order for the Irish
healthcare system to become best in class and match
leading countries such as Sweden, Denmark and
Finland there needs to be a greater drive towards online
electronic communications and integration between
stakeholders such as patients, doctors, consultants and
nurses, and public bodies. For example in Scandinavian
countries integrated health IT systems allow booking of
hospital beds and online medical advice.”
Billy D’Arcy of O2 adds, “Some Irish health
organisations are starting to exploit the immediacy and
pervasiveness of mobile technology for the benefit and
38
cOmpliance
In healthcare, SMS has the potential to increase
medication compliance, decrease the number
of missed appointments and improve treatment
outcomes. By using a patient management
software system that has SMS technology built
in, the healthcare professional, with the consent
of the patient, can send individual reminders and
batch information messages quickly and easily,
directly from the software package using the
patient details and mobile numbers they have
already recorded.
In situations where patients need to return
for 6 monthly or yearly visits such as to their GP,
specialist consultant or pharmacist, a reminder
can be sent without the usual administrative
work for the provider or an onus on the patient to
remember distant appointments.
Throughout primary care messages can be
sent to inform patients when their lab results
arrive to the surgery, when they are due a smear,
a return visit, a medical assessment, a visit for a
repeat prescription or even just to inform a large
number of patients of a change to opening times in the
practice.
In pharmacy, SMS can be used to significantly increase
medication compliance. It is estimated that as many as
50% of patients do not adhere fully with their medication,
and therefore, do not get the full benefit of their
medication therapies. A text message reminder service
will prompt the patient to take their medication at the
right time, limiting the potential for medication errors to
occur. Pharmacists can also use SMS to let patients know
when their prescription is ready for collection thereby
reducing waiting times and enhancing the overall
patient journey and pharmacy experience. Patients can
be reminded not only when a new prescription is due
but can also receive a text when their old prescription is
running out, thereby significantly reducing the chance of
a time lapse between repeat prescriptions.
invitatiOn tO yOur custOmers
An SMS text messaging service can also be used
effectively to improve health promotion. Patients can
be invited to special pharmacy themed days based on
their medical conditions e.g. asthma clinics or diabetes
days. Specific health campaigns can be greatly enhanced
through the use of SMS. For example, during a quit
smoking campaign individual patients that are signed up
can be sent regular messages telling them the benefits of
quitting smoking and suggestions on how to deal with
withdrawal symptoms and cravings.
While it is clear that SMS can be used effectively to
benefit the patient it can also create cost savings and
increase revenue for many healthcare providers. SMS
texting can be of particular benefit to community
pharmacies offering new pharmacy services such as
immunisations and screening services.
New developments and improvements are constantly
evolving within the healthcare technology industry and
the SMS text messaging application is just one of theses
emerging technologies that can be used as an effective
tool to create a more competitive and satisfactory
customer experience. Its simplicity, ease of use and low
cost, make SMS mobile technology an ideal application
for any computerised pharmacist or healthcare
professional. IP
e-pharmacy
The Weird and
Wonderful World
Irish Pharmacist reviews
some of the better health
related websites.
A
the Web
lbert Einstein, Sir Isaac Newton, Sir Winston Churchill, Charles
Darwin, Renoir and Pablo Picasso were all premature babies. Every
year in Ireland, an estimated 2,000 babies are born prematurely
and until now, there has been a dearth of specific information
on caring for these tiny new borns. A new Irish Web site, www.
prematurebaby.ie gives advice, information and tips for parents
following the very early arrival of their new baby.
A premature baby is one who has been born less than 37 weeks
into a pregnancy. While many of the factors that cause babies to
be born prematurely are still unknown the website lists some of
the known risks which include: pre-eclampsia, abnormal placenta,
anaemia, malnutrition and premature rupture of the membranes.
According to the site the risk of giving birth prematurely is higher
in women under 17 and over 35, those carrying twins or other
multiples and women who have already had a premature baby.
Divided into five main sections: General Information; While
Your Baby is in the Hospital; Going Home; Keeping a Record; and
For More Information – the web site gives advice on topics such as
what to expect at a special care baby unit and the importance of
touch in the development of a premature baby.
The Web site also provides parents with a glossary of medical
terms, along with practical advice, such as choosing an infant
j ay cu rt i s, i t co r r es p o n d en t
car seat and a shopping list of items they may require for their baby’s
arrival.
“Approximately five per cent of all deliveries in Ireland occur less
than 37 weeks”, said Dr Eugene Dempsey, consultant neonatologist,
at Cork University Maternity Hospital (CUMH). “It is hoped that this
web site will provide parents of premature babies and their families
with additional information to help them come to terms with having
their baby in the intensive care unit, often for weeks or even months in
some cases. This is a useful source of information to prepare them for
the transition home and the immediate post discharge period.”
Sponsored by Abbott, the website also provides a comprehensive
account of the health risks to premature babies, along with a list of
symptoms to look out for, and an overview of the treatment any such
conditions require.
New website for irelaNd’s 470,000 asthma
sufferers
The Asthma Society of Ireland has re-launched its website www.
ashtmasociety.ie, providing vital information for Ireland’s 470,000
asthma sufferers. The updated site has new features including a
39
e-pharmacy
“
section for parents with children
suffering from asthma and for
teachers who may have students
with asthma, all presented in a
colourful and easy-to-use format.
www.ashtmasociety.ie offers
users a wide range of information
on asthma, including advice on how
to develop good school asthma
management guidelines and how
best to manage asthma during exam
times.
Further information on asthma
triggers, advice on medicines and
treatment and best practice management in the event of an asthma
attack is also available.
The website further boasts a section, entitled ‘Airplay’, dedicated
to educating children with asthma in a fun, child friendly manner.
Airplay provides children with advice on managing and treating
asthma and includes tips on exercise techniques that benefit asthma
symptoms.
The site also features a ‘Latest News’ section which contains all
current and breaking news on asthma related stories. This section
includes a direct feed
from www.irishhealth.com
which filters all asthma
related breaking news
stories to the website.
The publications section
of the site provides
a library of material
available to read online,
download or order.
Literature includes an
‘Asthma and Allergic
Rhinitis’ booklet, ‘Top
Tips on Exercising with
Asthma’ and ‘Take Control
of Your Asthma’, which
provides a range of information for asthma sufferers.
Sword swallowers “run a
higher risk of injury when
they are distracted…
but injured performers
have a better prognosis
than patients who suffer
iatrogenic perforation.”
Find out what goes on ‘inside Your gut’
In January the Minister for Enterprise, Trade and Employment, Mr
Michéal Martin launched a new interactive science website for
primary school students and teachers http://microbemagic.ucc.ie
Commenting on the new site, Minister Martin, said “Websites such
as Microbe Magic are important tools in encouraging students to
consider careers in science and engineering. By using resources like
this we hope to have a positive impact on the next generation of
scientists and engineers. Young people use computers for learning
and entertainment and this website provides a tool to deliver both
of these objectives.”
Intuitively entitled Microbe Magic the new website will be a
major information resource for students on body and health issues
that will provide access to research undertaken by the Alimentary
40
Pharmabiotic Centre (APC), the Science Foundation Ireland (SFI)
funded research centre at UCC, in collaboration with Teagasc,
Moorepark which conducts cutting-edge research at the interface
between food and medicine.
The site has informative links that explore ‘Your microbes’ and
what goes on ‘Inside your gut’. The website also allows students to
‘Explore your body’ and provides information on ‘Healthy living’.
There are a number of educational games to play online or students
can download the computer game Gut Reaction, in which players
travel through the intestines and have to harness the energy from
probiotic (or good) bacteria in the gut in order to kill the bad
bacteria, viruses and cancers before they kill the human host.
‘Ask a Scientist’ allows students to interact with scientists. With
regular news and competitions and over 500 pages of scientific
information, there is always something to
interest students, teachers and everyone
else who is curious about what goes on in
our bodies.
Professor Fergus Shanahan,
Director APC, said: “Microbe Magic
will provide a wonderful learning
experience and resource for students
and teachers to explore cutting edge
research undertaken at the Alimentary
Pharmabiotic Centre (APC) in UCC. It is a
major information resource on biological
science and supports the APC mission – to
link Irish science with industry and society
through excellence in research, education
and outreach in gastrointestinal health”.
ig noble Prize
For a little light relief visit www.ignoble.
com to check out the very weird and wonderful world of scientific
research. The website features a list of Ig Nobel Prize winners from
1991 to the present day.
Awards are based on silliness more than anything else, Ig Nobel
Prizes honour achievements in scientific research that first make
people laugh, and then make them think. The prizes are intended
to celebrate the unusual, honour the imaginative and spur people’s
interest in science, medicine, and technology. Commenting on
the 2006 awards, Marc Abrahams, editor of Annals of Improbable
Research, co-sponsor of the awards, said: “The prizes are intended
to celebrate the unusual, honour the imaginative - and spur people’s
interest in science, medicine and technology.”
The 2007 Ig Nobel Prizes were awarded in October last year and
you can watch archived video of the ceremony on the website.
The 2007 Ig Nobel prize for Medicine was awarded to Brian
Witcombe of Gloucester, and Dan Meyer of Antioch, Tennessee,
for their penetrating medical report “Sword Swallowing and Its
Side Effects” which was published in the BMJ in December 2006.
(Reference: “Sword Swallowing and Its Side Effects,” Brian Witcombe
and Dan Meyer, British Medical Journal, December 23, 2006, vol. 333,
pp. 1285-7).
The objective of the research was to evaluate information on
the practice and associated ill effects of sword swallowing and
the researchers wrote to 110 sword swallowers from 16 countries
requesting information on technique and complications.
Perhaps not surprisingly the research concluded that sword
swallowers “run a higher risk of injury when they are distracted
or adding embellishments to their performance, but injured
performers have a better prognosis than patients who suffer
iatrogenic perforation.”
The study also revealed that perforations mainly involved the
oesophagus and usually had a good prognosis. “Sore throats
are common, particularly while the skill is being learnt or when
performances are too frequent. Major gastrointestinal bleeding
sometimes occurs, and occasional chest pains tend to be treated
without medical advice. Sword swallowers without healthcare
coverage expose themselves to financial as well as physical risk.”
The 2008 Ig Nobel ceremony will take place on 02 October so
there is still time to nominate someone you know or submit your
weird and wonderful research projects for an illustrious Ig Nobel
award. IP
product news
Gardasil demonstrates
high efficacy against
precancerous cervical
lesions in longest
follow-up of large phase
III clinical studies
A combined analysis of four phase II/III studies which
enrolled more than 20,000 women confirmed that
the quadrivalent (6,11,16,18) cervical cancer vaccine
Gardasil has sustained 98% to 100% efficacy in the
prevention of vaccine virus type-related precancerous
cervical lesions in young women. These new data
were recently at the 19th International Congress on
Anti-Cancer Treatment (ICACT) in Paris, France.
In light of the high and sustained efficacy of
Gardasil, the independent Data and Safety Monitoring
Board (DSMB) of the large phase III studies (FUTURE
I & II) recommended last year that these studies be
terminated as soon as feasible. Thus, the studies were
ended after four years and the women in the placebo
group have now been offered Gardasil, to give them
the opportunity to benefit from vaccination.
In the primary study population of young women
(16-26 years), Gardasil prevented 98% of HPV 16/18related precancerous cervical lesions (CIN2/3 or AIS),
according to the combined analysis.
Supplementary analyses in a sub-population of
young women (16-26 years) revealed 100% efficacy
against HPV 16/18-related CIN2/3 or AIS. This subpopulation was chosen to approximate a population
before sexual debut. Government funded HPV
vaccination programmes have generally targeted
young girls because it is thought that the maximum
benefit and protection from HPV vaccination could be
achieved from vaccination prior to the onset of sexual
activity.
The new results are consistent with previous results
from the five years follow-up of the pivotal phase
II study in a smaller population. “This extends the
robustness of the data from a few hundreds to many
thousand women,” adds Patrick Poirot, vice president
for Medical and Scientific Affairs at Sanofi Pasteur
MSD. “Phase III results are of greatest importance for
regulatory and health authorities when they evaluate
a vaccine”.
In addition, the follow-up of the pivotal phase
II study has ended after five years. The women
in the placebo group have also been offered the
opportunity to be protected with Gardasil.
In addition to the robust follow-ups in phase II and
III studies, Gardasil®has been demonstrated to induce
immune memory. Demonstrating immune memory
means demonstrating that the immune system
has memorised the vaccine virus types and can be
expected to provide protection when exposed again
to these types, potentially even years later. Experts
consider the demonstration of immune memory a
hallmark of long-term protection.
“With five years of follow up in phase II studies
followed by the demonstration of immune memory
plus the longest ethically acceptable follow up in our
large phase III studies we have provided the three key
elements to make mothers, young women, physicians
and health authorities confident about long-term
protection with Gardasil”, concludes Patrick Poirot.
Perrans say Pants to Cellulite!
There are over 1.3 million women in Ireland
that suffer with Cellulite – Perrans has the
answer! Clinically proven to reduce the
appearance of cellulite and reduce inches, Lipo
Contour is the only underwear garment that
gives a constant micro massage! Developed
by Professor Marco Gasparotti, from more than
20 years clinical practice and experience in the
field of liposuction and liposculpture.
Initially used as an elastic and compressive
sheath in 4000 clinical cases, proving that
the properties of the Lipo Contour sheath go
beyond the mere effects of compression and
support.
What makes Lipo Contour different from all
other compression garments is its patented
fabric, giving a constant micro massage on
those problem areas (hips, thighs, buttocks and
stomach). Increasing circulation, that in turn
helps break down cellulite. Resulting in firmer
smoother skin, a reduction in the appearance
of cellulite, and more importantly, inch loss. For
clinical data information visit www.lipocontour.
co.uk
Lipo Contour available in two designs: Short
RRP 75.99 (Trade 41.87) Euros, Body RRP 89.99
(Trade 49.58) Euros, 5 sizes, 10, 12, 14, 16 & 18.
This exciting new product will be supported
by a comprehensive PR and Advertising
Campaign with an investment of over 100,000
euros. For further details contact Perrans
Distributors on: 01 806 8666
Intrinsa patch significantly
improves sexual desire in women
The first licensed treatment for women
concerned by low sexual desire following
surgically-induced menopause is now available
in Ireland. The female testosterone patch,
called Intrinsa, is indicated for the treatment
of low sexual desire associated with distress
in women who have experienced an early
menopause following hysterectomy involving
a bilateral oophorectomy and are receiving
concomitant oestrogen therapy.
According to results from the Women’s
International Study of Health and Sexuality
(WISHeS) trial, approximately 40% of surgically
menopausal women suffer from low sexual
desire. Further results showed that 14% of
these surgically menopausal women were
classified as having low sexual desire with
associated distress, also known medically as
hypoactive sexual desire disorder (HSDD)
Surgery to remove the ovaries during
hysterectomy leads to a 50% decrease in
testosterone, a naturally occurring hormone in
women, that may be a key mediator of sexual
desire.
“It is very rarely mentioned that in young
women testosterone levels are actually
higher than oestrogen. Many of my surgicallymenopausal patients tell me they feel sexually
numb and are really concerned about their
relationships”, comments Dr Shirley McQuade,
Medical Director, Well Woman Centre, Dublin.
“Intrinsa offers real medical hope to these
women as studies showed that the patch
increases sexual desire and satisfying sexual
activity, while reducing associated distress.”
Clinical trials (INTIMATE SM1 and INTIMATE
SM2) involving over 1,000 surgicallymenopausal women with low sexual desire and
associated distress on concomitant oestrogen
therapy, demonstrated significantly increased
sexual desire (p=0.0006 and p<0.001) and
satisfying sexual activity from baseline at six
months with Intrinsa compared with placebo,
as well as significantly decreased personal
concern due to low sexual desire. In studies
SM1 and SM2, Intrinsa increased sexual desire
by 56% and 49% from baseline, increased
satisfying sexual activity by 74% and 51% from
baseline and reduced distress by 65% and 68%
from baseline. In six-month studies, Intrinsa
is generally well tolerated, with the most
common side effects being considered mild
and reversible. Few participants discontinued
treatment because of side effects. Of the 79%
of patients who completed the studies, 96%
elected to continue in a six-month open label
study. Further long-term safety studies are
ongoing.
Intrinsa is a thin, clear patch worn on the
abdomen, applied twice a week, which
delivers a low dose of testosterone (300
micrograms/24 hours) and achieves serum
testosterone concentrations compatible with
premenopausal levels. The testosterone used in
the patch is identical to testosterone produced
naturally in all women.
Further information for healthcare
professionals can be found at www.intrinsa.
co.uk
For further information please contact: Jane
Quigley, Procter & Gamble Pharmaceuticals.
Tel: +44 (0) 1784 474 436
41
product news
Quit smoking challenge
With the increased availability of
information through online, print
and radio sources, consumers
today cannot but be aware of
the health risks associated with
smoking. However, you may be
surprised to learn that over 350,000
of current smokers do not want to
quit with fifty one percent of current
smokers enjoying almost every
cigarette they smoke.
This Lent, Nicorette asked smokers
to take the ‘Lent Quit Smoking
Challenge’ and see how much
healthier they would feel giving up.
With an average smoker smoking 17
cigarettes per day, he/she could have
782 fewer cigarettes smoked over the
46 days of Lent.
New Irish research, carried out in
November 2007, revealed that forty
seven per cent of current smokers
said the main reason they would
give up smoking was to improve
their health. The benefits of giving
up smoking can be seen in just
20 minutes with blood pressure
returning to normal. After 48 hours,
nicotine is no longer detectable in
the body, after 72 hours breathing
becomes easier and energy levels
increase.
“Sometimes people forget how
quickly the benefits of not smoking
can be seen. This is a great incentive
for people to try and quit. Make sure
you get some help. You are more
likely to succeed using a nicotine
replacement therapy (NRT) over
willpower alone so visit your local
pharmacist who can give you advice
on quitting”, commented pharmacist
Owen Daly.
Other key reasons current smokers
gave for giving up smoking include:
quitting to save money (40 percent)
and feeling unhealthy (35 percent).
Thirty two percent of parents said
they would give up smoking as it is
unhealthy for their children.
Nicorette offers psychological and
lifestyle advice through the Nicorette
‘Start Afresh’ programme, designed
to support quitters throughout the
quitting process. To order a free
Nicorette ‘Start Afresh’ pack, log on
to www.nicorette.ie or callsave 1850
430 530.
Anti-inflammatory warning
According to an NHS review (Cardiovascular and gastrointestinal
safety of NSAIDs) into the safety profile of anti-inflammatory
treatments in the UK, GPs should review the use of the most widely
prescribed NSAID (diclofenac) and switch to ibuprofen or naproxen.
The National Prescribing Centre’s review of cardiovascular
risks associated with traditional NSAIDs and cox-2 inhibitors
suggests that the high level of diclofenac prescribing should
be ‘reconsidered’. According to the report, all patients taking
diclofenac should be reviewed and switched to low-dose ibuprofen
or naproxen if possible, to reduce their cardiovascular thrombotic
risk.
Dr Neil Maskrey, director of evidence-based therapeutics at the
National Prescribing Centre, said reviewing NSAID use should be
a priority for GPs. He said many patients could be shifted to other
analgesics, or moved to an NSAID with a better safety profile. “It
has taken a while to become clear – but we do know that ibuprofen
1,200mg a day or naproxen 1,000mg a day don’t carry the increased
cardiovascular risk, so they would be the first and second choice
NSAIDs, weighing up gastrointestinal and cardiovascular safety,”
he said.
42
Astellas receives positive opinion
Mycamine(R) for the treatment of
serious fungal infections
Astellas Pharma Europe Ltd
announced recenly that the
Committee for Medicinal
Products for Human Use (CHMP)
of the European Medicines
Agency (EMEA) issued a
positive opinion by consensus,
recommending a marketing
authorisation for Mycamine(R),
a treatment for systemic
fungal infections, which are
very serious, life-threatening
conditions.
The CHMP’s positive
recommendation is a critical step
in the approval
process, and Astellas expects to
obtain the European Commission
decision in March.
Mycamine(R) is a novel
treatment for a serious fungal
infection known as invasive
candidiasis, and its efficacy and
safety have been demonstrated
in an extensive and robust
clinical development programme
including more than 3,500
patients in 16 clinical trials.
These trials not only cover large
Mycamine(R) patient numbers
but a broad range of patients
including nearly 300 children.
Mycamine(R) is the market
leader in Japan where it was
launched in 2002 (Brand Name
in Japan: Funguard(R)), and in
the US, where Mycamine(R) was
launched in 2005, the product
has already achieved a 20%
market share. In these two major
markets more than 350,000
patients have been treated with
the product.
Contacts for enquiry or
additional information: Astellas
Pharma Europe
Jeannine Nolan Communications
consultant
Mobile: +44(0)7785508478
Email: jeannine.nolan@
eu.astellas.com
Dry Mouth – awareness is key!
Dry Mouth (Xerostomia)
caused by a decrease in saliva
production is a common
complaint affecting over 10% of
the population. The prevalence
rises as the number of prescribed
medications taken increases
and with the number of medical
conditions present. Indeed,
as many as 25% of people
over 65 suffer from dry mouth
rising to almost 50% among
institutionalised elders.
While the aetiology of dry
mouth maybe multi-factorial
many dry mouth cases are drug
related with over 400 commonly
prescribed medications know
to be xerogenic. Among the
most commonly implicated
are tricyclic antidepressants,
antipsychotics, atropines,
antihistamines, beta blockers,
bronchodilators and diuretics.
Dry mouth can also be brought
on by cancer treatments (radio
and chemotherapy) as well as
conditions like diabetes, renal
failure, cystic fibrosis, Sjogren’s
syndrome etc. Other common
causes include mouth breathing,
stress, tobacco and alcohol.
There is a lack of awareness of
dry mouth both among sufferers
and health professionals.
Despite the number of sufferers
and its adverse effects on their
quality of life it is often not
talked about or explained. If not
recognised and treated it can
cause difficulty when speaking/
swallowing and can lead to gum
disease, bad breadth and tooth
caries.
Biotene is the original and
world leader in bio-enzymatic
oral care technology for dry
mouth, providing both relief and
protection. All Biotene products
are sodium laurly sulphate and
alcohol free. Biotene uses the
same natural bio-active enzyme
systems as healthy saliva that
restore and boost saliva’s
natural antibacterial defences to
maintain a healthy mouth.
Biotene is made in Ireland and
is available through United Drug
and Uniphar. The range includes:
Toothpastes (original, gel &
sensitive), Mouthwash, Oral
Balance Gel, Chewing Gum and
Oral Balance Moisturising Liquid
(*new).
For further information
and free samples contact
Europharma Concepts Ltd. Clara,
Co. Offaly. Tel. 057 9364950,
Email [email protected] or Website
www.epc.ie (click on Products).
Target your customers with the
*
No.1 selling over the counter brand
For 25 years Nurofen - the brand which introduced Ibuprofen
- has been recognized and trusted by pharmacists and customers alike.
With a presence in all three analgesic categories, Adult, Paediatric and Cold & Flu, Nurofen's
range of targeted pain relievers continues to achieve double digit growth within pharmacy.
More innovation, more of your needs met, more pain relieved. That’s our ongoing target!
Full prescribing information available on request from Reckitt Benckiser Ireland Ltd., 7 Riverwalk,
Citywest Business Campus, Dublin 24. Nurofen products are available through pharmacies only.
*IMS OTC IRL Quarterly Jan 08
product news
Perrans takes over Nourkrin, Europe’s
leading ‘hair recovery natural
supplement’
Perrans Distributors Ltd,
leaders in the natural
healthcare market in Ireland,
has taken over sales, marketing
and distribution for Nourkrin,
Europe’s leading ‘hair recovery
natural food supplement’.
“First introduced 12 years
ago, the Nourkrin natural food
supplement range reduces
hair loss by nourishing thinning
hair and promoting existing
growth”, explains Peter Noone,
general manager, Perrans
Distributors Ltd. “It is now
Europe’s leading hair recovery
natural supplement.
“With an estimated one in
three women suffering hair loss
at some stage in their lives and
given the growing interest and
demand for evidence-based
‘natural and safe treatments’,
it is no surprise that the
market for Nourkrin has grown
dramatically. Sales in Ireland and the UK have grown from just 1,500 units a
month in 2003 to 42,000 units per month last year – a €55 million retail market.
“With an estimated 50 per cent of men suffering hair loss before the age of
50 and 70 per cent of men over 50 also suffering hair loss, there is already a
significant market for Nourkrin Man.”
The two key products in the Nourkrin treatment programme range
are Nourkrin Extra Strength for women and Nourkrin Man. There is also a
maintenance product (Nourkrin Maintain), shampoo, conditioner, scalp lotion
and scalp sun block. In a recent independent study conducted on Nourkrin,
published in ‘The Journal of International Medical Research 2006’, participants
showed an increase in hair growth of 35.7 per cent after a six month treatment
programme.
The key ingredient in Nourkrin is a marine protein extract which is blended
with an organic, soluble silica and vitamin C. Nourkrin is approved by the Irish
Medicines Board (IMB) and MHRA (UK).
Dr David H. Kingsley, an internationally renowned trichologist and author of
“The Hair-Loss Cure: A Self-Help Guide” said, “Hair loss is a devastating problem
to have - especially for women. I see so many people whose self-esteem is rock
bottom because of problems with losing their hair. What I like about Nourkrin is
that all the ingredients are naturally based giving people an alternative that will
have no side effects”
Nourkrin will be running a significant media campaign in 2008 featuring
movie legend Britt Ekland.
Nourkrin Extra Strength and Nourkrin Man retail for €69.95 for a one month
supply (60 tablets).
For more information about The Nourkrin Natural Hair Recovery Programme
Range please contact Perrans Orders at 01.806.86.66 or at perransorders@
tpwhelehan.ie or contact your local Perrans representative. Also see www.
perrans.ie
Torisel now available
Wyeth Pharmaceuticals Limited have announced you that TORISEL
(Temsirolimus) 25 mg/ml concentrate and diluent for solution
for infusion is now available. TORISEL is the first mTOR inhibitor
indicated for the treatment of advanced renal cell carcinoma (RCC).
For further information on TORISEL please refer to the Summary
of Product Characteristics available at www.medicines.ie or
contact Wyeth Pharmaceuticals Medical Information Department
on 01 4493524.
44
Teva Pharmaceuticals Ireland
announce launch of Rispeva Filmcoated Tablets, a newly available
risperidone branded generic
Rispeva, a selective monoaminergic antagonist is now available to prescribers.
Rispeva Film-coated Tablets are presented in ‘patient friendly’ packaging to aid
compliance and offer a variety of presentations.
Prices per pack size, together with colour description, are as follows:
Rispeva 1mg 20 pack, white tablet
€13.48
Rispeva 1mg 60 pack, white tablet
€40.40
Rispeva 2mg 60 pack, pale brown tablet
€79.73
Rispeva 3mg 60 pack, yellow tablet
€117.24
Rispeva 4mg 60 pack, pale green
€154.74
Rispeva Film-coated Tablets are round, bevelled and biconvex in shape.
Teva’s excellence in quality standards is assured. For more information call the
Teva Customer Service FREEPHONE 1800 201 700
Trial shows positive outcome
of lacosamide in patients with
diabetic neuropathic pain
UCB Pharma recently announced positive results from a Phase III trial
evaluating lacosamide (400 mg per day) in the treatment of diabetic
neuropathic pain. With a standard titration regimen, the trial met its
primary objective with sustained and statistically significant reduction in
average daily pain scores.
The randomised, double-blind, placebo controlled trial in 551 patients
with diabetic neuropathic pain was designed to evaluate the efficacy and
safety of lacosamide (400mg per day) in two different titration schemes: a
standard titration regimen in which patients reached their target dose at
day 22, and a fast titration scheme in which the target dose was reached at
day 8.
The primary efficacy results showed that the change in the average
daily pain score as measured from baseline to the last four weeks of the
12-week maintenance period, was significantly greater with lacosamide
400mg per day given in standard titration than placebo (p=0.0410).
The change in pain score with the lacosamide fast titration regimen was
numerically better than placebo but did not reach statistical significance
(p=0.2902). The median time to achieve sustainable pain relief was 10
and 11 days for the lacosamide standard and fast titration regimens,
respectively compared with 31 days for the placebo group. Lacosamide
was generally well tolerated. The incidences of adverse events were higher
in the lacosamide fast titration group than in the standard titration group.
The most common adverse events in this trial were dizziness, nausea,
headache, nasopharyngitis and vertigo.
The results from this trial will support the dossiers filed for lacosamide
in diabetic neuropathic pain which were submitted to the European and
U.S. regulatory authorities in 2007. Data from this trial will be submitted for
presentation at upcoming international scientific meetings.
About Diabetic Neuropathic Pain: Diabetic Neuropathic Pain is a
painful and potentially debilitating condition, resulting from damage
or dysfunction to the peripheral nervous system as a result of diabetes
or impaired glucose tolerance. The condition is often characterized by a
stabbing or burning sensation in the legs, feet, and/or hands. With the
overall prevalence of diabetes in the U.S. estimated at 20.8 million people,
it is thought that as many as 7.7 million have some degree of diabetic
neuropathic pain.
About lacosamide: lacosamide has a novel and dual mode of action. It
selectively enhances slow inactivation of sodium channels and interacts
with the neuroplasticity-relevant target - collapsin-response mediator
protein-2 (CRMP-2).
For further information contact Fergal Egan on 01 4637395 or e mail
[email protected]
Small Group Authentic Adventures
Irish Pharmacist is proud to introduce our readers to one of the most dynamic new travel companies
operating out of Ireland – Zara’s Planet Ltd is a 100% Irish owned, fully bonded and licensed travel
company (No:0643) offering small group adventure and cultural trips with monthly departures
throughout the year. Zara’s Planet provides discerning clients with a deeper local insight into the place
they visit. We bring you to places slightly off the beaten track but without sacrificing comfort or style.
A long weekend in South
West France
for Wine Lovers and Foodies
Price: €545 (includes all taxes) per person based on
double/twin share.
Single supplement: €150
Travel Dates: 19 - 22 April 2008
South Africa –
Safari Adventure
Price: €1,699 (includes all taxes) per person based on
double/twin share
Single supplement: €150
Dates: 13 June - 22 June or 30 June – 9 July 2008
Summary of Trip
Our hideaway is in the stunning malaria-free Waterburg region north of
Johannesburg. You will be staying on an estate in a beautiful, authentic,
thatched African cottage full of antiques. You will be looked after from the
moment you arrive in Johannesburg
where your group will be met and
transferred to your cottages which are
set in a stunning rose garden. Relax
in the heated pool which is gated for
safety.
We have put together an itinerary
which includes game drives with the
best guides in the area, bush walks,
GPS game tracking, astronomy/star
gazing nights, and water volleyball
for the active as well a host of other
options.
Let yourself be immersed in true
South African hospitality and be awe
inspired by the wild zebras, giraffes,
elephants and rhinos at some of the
best game parks normally only reserved for guests staying at 5* lodges
Ask us about a Cape Town, Mozambique or Victoria Falls add on…
Included: Flights to Johannesburg, all transfers, game drives and trips as
per itinerary, 3 self catering cottage accommodation (some share but private
bathrooms), full time guides and hosts.
Excluded: Meals, tips
**Full board option available with delicious home style cooking (organic
beef, chicken, salads, BBQ, pototatoes etc) for €199 per person.
Summary of Trip
On the French side of the stunning
Pyrenees mountains lies the highly
coveted appellation of Irouléguy,
This little know treasure sits in the
heart of the Basque country and is a
must for any wine lover. Come on the
trip and find out more about these
magnificent wines and their history
while taking our vineyard tour. You
will be staying in the picturesque
seaside town of Capbreton. Staying
at the 3 star Hotel L’Oceane chosen
for its comfort and great location
– you will be able to step out to the
beach every morning.
The marina is wonderful to
explore and the huge variety of cafes
and restaurants won’t leave you
wanting. Your Irish host speaks both
languages and will happily introduce you to the local community and
give you advice on the best entertainment. He will also be on hand
to make bookings and act as a concierge for the trip. Your host will
accompany you on all transfers and pre-organised excursions. The
highlight of the trip will
be a wonderful guided
tour of Le Cave Irouléguy
deep in the Pyrenees
which is home to some
of the most exciting
wines to be found in
France.
Included: Flights with
Ryanair to Biarritz, all
transfers and trips in
minibus, 3 nights bed
and breakfast in Hotel
L’Oceane, excursion to La
Cave Irouleguy vineyard
and St. Etienne De
Baigorry for lunch, full
time guide and host.
Excluded: Other meals,
tips
For more information on these exclusive trips, please call: (01) 440 7477 to book or log on to www.zarasplanet.ie
45
ip crossword no. 3a
3
4
6
5
7
Across
6. New hernial gizmo for treating asthma? (7)
7. Cabs involved in tax issue! (5)
9. Jumper on dog can be irritating! (4)
10. A musical US state? (8)
11. It is bound to keep a bone in place! (6)
13. The agony of French bread! (4)
15. A rash place for a bee to live? (4)
16. One gets foot-sore in this bally place in Kerry (6)
18. A word of 26 letters (8)
21. A bit of leg, we hear, in Kildare (4)
22. South American range (5)
23. Colourful fabric for Rev. Ian (7)
8
9
10
11
13
12
14
15
16
17
18
19
22
20
22
21
Down
1. An elk, surprisingly, just over one foot (5)
2. A rotten papal bed could spoil the whole barrel! (3,5)
3. Animal doctor gets nought for prohibition (4)
3. Swear it’s a hot mixture! (4)
5. Par Avion letters (7)
8. Let gun off, aggravating ceoliac disease (6)
12. Drink mixed mebbii! (6)
13 Slap rope around to show downward displacement of organ (8)
14. Aer Lingus or trachea, perhaps (7)
17 It always comes between two and four! (5)
19. Despicable person under 1 Down? (4)
20. A sucker, but that’s an udder matter (4)
Name:
Across 1. Biceps 4. Ague 8. Who 9. Tallyho 10. Cell 11. Ovary 14. Dwarf 16. Edit
18. Relapse 20. IRA 21. Drew 22. Larynx
Down 1. Bawl 2. Cholera 3. Petal 5. Guy 6. Eponym 7. Alto 12. Acidity 13. Adored
15. Fops 16. Enema 17. Manx 19. Lee
2
LAST MONTh’S CROSSWORD ANSWERS
1
Congratulations to the winner of last month’s crossword,
Nora McGrath, The Square, Cappawhite, Co Tipperary.
For a chance to win e70, please send completed entries
to: The Editor, Irish Pharmacist, Unit 4, St Kieran’s
Enterprise Centre, Sandyford Industrial Estate, Dublin 18.
Closing date: 24th March.
Address:
e-mail:
We are currently recruiting
supervising Pharmacists
for positions with Excellent
Retail Pharmacies throughout
Ireland for immediate start.
Candidates must have 3 years
post qualification experience
preferably in the
Irish market.
To place your recruitment
For more details or to apply
please forward
CVs to [email protected] or
call Ann-Marie
on 01 4188117.
46
advert here contact graham@
greencrosspublishing.ie
Helix Health - helping to manage
your Pharmacy Dispensing
QicScript Professional is a
progressive Windows-based
system that will help you
to run your dispensary
more efficiently and free
up time to spend with
your patients.
By switching to QicScript Professional
you can benefit from ...
GMS Claims 2
Integrated Monitored Dosage Support
Fast simple dispensing with editable prescriptions and
Drug Usage Review
Full integration with Tosho, Willach Consis and ARX Robotics
Advanced Stock Control and ordering to reduce overstocking
and eliminate stock outs
Cheap, quick and effective communication with Patients through SMS
and email
“Business Intelligence” - Full reporting functionality available online
and much more...
Consider Qicscript now and get 10% off with free data migration
QicScript professional is pharmacy software built for the future
QicScript p
professional
Helix Health Limited, 52 Broomhill Road, Tallaght. Dublin 24
T: 01 4633 000 F: 01 4633 011 E: [email protected] W: www.helixhealth.com
GOLD CERTIFIED
Partner
outside edge
Clash of cultures
“Yes, as through this life I’ve wandered,
I’ve seen lots of funny men,
Some will rob you with a six-gun,
And some with a fountain pen.”
Woody Guthrie
At the time of writing I have just seen news of Mary
Harney’s announcement regarding the setting
up of an independent body to review fees in the
pharmacy sector. She’s presenting it as the light
at the end of the tunnel but I think it may just be
another train. Time will tell.
What I do know is that from the outset of this
dispute there seems to have been a failure at a
high level of management in both the HSE and the
Department of Health to understand the mindset
of pharmacists. They seem unable to appreciate
the depth of the fury they have unleashed, or that
the reasons for this fury go way beyond the threat
of financial loss. I will try to explain my reason,
which I think echoes the sentiments of many other
pharmacists. Let me start by telling a story.
Pickaxe vs hammer
About two years ago, a drug addict came into my
shop with a scarf over his face, carrying a hammer.
He came behind the counter to the girl at the till
and told her to open it. I was in the dispensary and
had seen him come in. I have always kept a pickaxe
handle in the dispensary for such an occasion, but
this was my first time to need it. When I bought it
nearly a decade ago I choose the biggest one in
the hardware shop – it weighs probably close on
ten pounds. I took it in my hands, lifted it above
my shoulder and stepped around the corner of
fi n ta n m o o r e
the dispensary to within range of the raider. He
tensed and made a shape with the hammer, and I
did likewise with the pickaxe handle. The standoff
ended in seconds because he had the sense to
see he was outgunned and left my shop. If he had
pushed events the other way and attacked me I
would have splintered his skull without a second’s
hesitation.
My reason for going to the edge had nothing
to do with him wanting my property – I am not
particularly materialistic. Nor is it the fact that I
was being threatened with violence – that threat
merely determined my choice of response. My
reason was quite simple; my shop is my turf and I
don’t take crap from people on my turf.
If you talk to pharmacists, or many other small
business owners, they will usually cite their reason
for ‘going out on their own’ as being a desire to
make their own decisions about their working
life. Given the extra hours involved and all the
extra hassle, a lot of proprietor pharmacists would
actually earn more money if they put in the same
effort working for somebody else. But most
will say that they simply prefer to be their own
boss. As a friend of mine put it ‘It’s my ship and I
decide what way it runs.’ And it’s not about taking
a power trip and giving orders to people – it’s
about not having to take orders from anybody
above them.
De haut en bas
Hence the anger among pharmacists at being
dictated to by the HSE and the Department of
Health. A bunch of suits with calculators are
attempting to set financial constraints that will
determine whether or not your pharmacy will
survive, what staff levels you can budget for, what
hours you can afford to open, whether you can
afford the security guard you need to keep your
methadone patients, if you can pay the wages of
the employee pharmacist who runs your diabetes
clinic...the list goes on. All these decisions
regarding your working environment had been
made by you based on the contract you have, but
you will have to re-evaluate all of them.
civil servant vs entrePreneur
Maybe the apparent inability of HSE management
to understand pharmacists is down to a cultural
divide between a civil service mentality and
an entrepreneurial one. I have never worked in
the civil service so I’m just guessing here, but I
suppose the hierarchical structure accustoms
people to taking orders from above and relaying
them below. Pharmacists on the other hand have
complete responsibility for their piece of turf and
the buck starts and stops with them. The obvious
example of where this culture clash had very
negative consequences was when pharmacists
withdrew from the methadone protocol. This
was a drastic measure driven by desperation
and anger, but up to the eleventh hour the HSE
seemed to believe that pharmacists would stop at
the brink. As a result the HSE’s contingency plans
were woefully inadequate. If there was a proper
understanding of our state of mind then a better
alternative service could have been provided.
To paraphrase Mario Puzo’s famous line in the
Godfather
‘It’s not just the business – it’s personal.’ IP

assistant - GreenCross Publishing

Transcription

Similar documents

RXportfolios “Welcome Package” content

RxInsider Ad - Mobile MedSoft

Harding Students Lobbied for Arkansas Therapeutic Substitution Law

www.lillypulitzer.com

It`s Digest Time Again

Arjun Rampal Poster - Ogaan Cancer Foundation

PDF - First Nations Health Authority

FMP Direct Service

New cancer drug inquiry