issue 2 volume 11 FEBRUARY • 2009
www.greencrosspublishing.ie
The independent monthly for Irish Pharmacists
NEWS
•Pharmacists provide c460
million in services free of
charge to Exchequer
•Five fold increase in State’s
drug bill to c1.74 billion
•New pharmacy course
in Coleraine to link with
pharmacists in Republic
EU LAW MAY RESTRICT
OWNERSHIP OF PHARMACIES
TO PHARMCISTS
Gary Finnegan
EPHARMACY : IRELAND’S FIRST
HEALTH INFORMATION BILL June Shannon
Q AND A
Prof Marek Radomski
Interview
CLINICL REVIEW
Managing the symptoms of
cold and flu
18/09/2008
MAKING A DIFFERENCE
Buttercup 24.5cm x 8.5cm Ad
David Jordan
03:16 pm
Caught in the middle – pharmacy and
the Irish healthcare system
Dr Martin Henman TCD
Page 1
° All Purpose and All Natural Cough, Cold and Sore Throat Remedy
° Suitable for Adults and Children over 2 years of age
° Buttercup Original Syrup does not cause drowsiness
° TV, Radio and Press Campaign throughout the cough and cold season
Just one bottle of Buttercup for any type of cough
Further information available on request.
Chefaro Ireland Limited, Famham Drive, Finglas, Dublin 11, Ireland.
Tel: 01 879 0647 Email: [email protected]
Introducing
New JANUMET
for powerful glucose reductions
®
For patients not at goal
on metformin alone
In clinical studies of patients with type 2 diabetes,
Powerful and sustained HbA1c reductions over 1 year1,2
Weight loss and less hypoglycemia vs an SU* + metformin
(with sitagliptin 100 mg + metformin)3
Janumet 50mg/850mg and Janumet 50mg/1000mg film-coated tablets (50 mg of sitagliptin as phosphate monohydrate and 850
mg or 1000mg of metformin hydrochloride).
ABRIDGED PRODUCT INFORMATION
Refer to Summary of Product Characteristics before prescribing.
PRESENTATION Janumet 50mg/850mg film-coated tablets: Capsule-shaped, pink film-coated tablet with “515” debossed on one
side containing 50 mg of sitagliptin as phosphate monohydrate and 850 mg of metformin hydrochloride. Janumet 50mg/1000mg
film-coated tablets: Capsule-shaped, red film-coated tablet with “577” debossed on one side containing 50 mg of sitagliptin as
phosphate monohydrate and 1000 mg of metformin hydrochloride. USES For patients with type 2 diabetes mellitus: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Janumet is also
indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. DOSAGE AND ADMINISTRATION The dose
of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient’s current regimen, effectiveness,
and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin. For patients not adequately
controlled on metformin alone, the usual starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg
total daily dose) plus the dose of metformin already being taken. For patients switching from co-administration of sitagliptin and
metformin, Janumet should be initiated at the dose of sitagliptin and metformin already being taken. For patients inadequately
controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea, the dose of Janumet
should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already
being taken. When Janumet is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to
reduce the risk of hypoglycaemia. All patients should continue their diet with an adequate distribution of carbohydrate intake
during the day. Overweight patients should continue their energy-restricted diet. Janumet should be given twice daily with meals
to reduce the gastrointestinal undesirable effects associated with metformin. Use in renal insufficiency: Janumet should not be
used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/min). Use in hepatic insufficiency: Janumet should not be used in patients with hepatic impairment. Use in elderly: Janumet should be used with caution as age increases.
Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis. Limited safety data on
sitagliptin is available in patients > 75 years of age and care should be exercised. Use in children: Not recommended for use in
children below 18 years of age. CONTRAINDICATIONS • hypersensitivity to the active substances or to any of the excipients • diabetic ketoacidosis, diabetic pre-coma • moderate and severe renal impairment (creatinine clearance < 60 ml/min) • acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents • acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure recent
myocardial infarction, shock • hepatic impairment • acute alcohol intoxication, alcoholism • lactation. PRECAUTIONS Janumet
should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis. Lactic acidosis:
It is a very rare serious metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis
in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis
can and should be reduced by also assessing other associated risk factors. If metabolic acidosis is suspected, treatment with the
medicinal product should be discontinued and the patient hospitalised immediately. Renal function: As metformin-related lactic
acidosis increases with the degree of impairment of renal function, serum creatinine concentrations should be determined at least
once a year in patients with normal renal function and at least two to four times a year in patients with serum creatinine levels at
or above the upper limit of normal and in elderly patients. Decreased renal function in elderly patients is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating
antihypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID). Hypoglycaemia: Patients receiving Janumet in combination with a sulphonylurea may be at risk for hypoglycaemia. Therefore, a reduction in
the dose of the sulphonylurea may be necessary. The use of Janumet in combination with insulin has not been adequately studied.
Hypersensitivity reactions: Postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have
been reported. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports
occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue Janumet, assess for other potential causes
of the event, and institute alternative treatment for diabetes. Surgery: As Janumet contains metformin hydrochloride, the treatment
should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia. Janumet should not usually
be resumed earlier than 48 hours afterwards and only after renal function has been re-evaluated and found to be normal. Administration of iodinated contrast agent: The intravascular administration of iodinated contrast agents in radiological studies can lead
to renal failure which has been associated with lactic acidosis in patients receiving metformin. Therefore, Janumet should be
discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been
re-evaluated and found to be normal. Change in clinical status of patients with previously controlled type 2 diabetes: A patient with
type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague
and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. Evaluation should include
serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels. If acidosis of
either form occurs, Janumet must be stopped immediately and other appropriate corrective measures initiated. Drug interactions:
Co-administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter
the pharmacokinetics of either sitagliptin or metformin in patients with type 2 diabetes. There is increased risk of lactic acidosis in
acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active
substance of Janumet. Consumption of alcohol and medicinal products containing alcohol should be avoided. Cationic agents that
are eliminated by renal tubular secretion (e.g., cimetidine) may interact with metformin by competing for common renal tubular
transport systems. Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and
changes in diabetic treatment should be considered when cationic agents that are eliminated by renal tubular secretion are coadministered. The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis. Therefore, Janumet should be discontinued prior to, or at the time of
the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal.
Combination requiring precautions for use: Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics
have intrinsic hyperglycaemic activity. The patient should be informed and more frequent blood glucose monitoring performed,
especially at the beginning of treatment with such medicinal products. If necessary, the dose of the anti-hyperglycaemic medicinal
product should be adjusted during therapy with the other medicinal product and on its discontinuation. ACE-inhibitors may decrease the blood glucose levels. If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during
therapy with the other medicinal product and on its discontinuation. Effects of other medicinal products on sitagliptin: Clinical data
described below suggest that the risk for clinically meaningful interactions following co-administration of other medicinal products
is low. Cyclosporine: A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the
pharmacokinetics of sitagliptin. Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of
cyclosporine increased the AUC and Cmax of sitagliptin by approximately 29 % and 68 %, respectively. These changes in sitagliptin
(sitagliptin/metformin)
Changing the course to glucose control.
pharmacokinetics were not considered to be clinically meaningful. The renal clearance of sitagliptin was not meaningfully altered.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors. In vitro studies indicated that the
primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8. In patients with
normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin. Metabolism may
play a more significant role in the elimination of sitagliptin in the setting of severe renal insufficiency or ESRD. For this reason, it is
possible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the phamacokinetics
of sitagliptin in patients with severe renal insufficiency or ESRD. The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study. In vitro transport studies showed that sitagliptin is a substrate for p glycoprotein
and OAT3. OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful
interactions is considered to be low. Concomitant administration of OAT3 inhibitors has not been evaluated in vivo. Effects of sitagliptin on other medicinal products: In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes. In clinical
studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or
oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8,
CYP2C9, and organic cationic transporter (OCT). Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild
inhibitor of p-glycoprotein in vivo. Digoxin: Sitagliptin had a small effect on plasma digoxin concentrations. Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma Cmax on average by 18 %. No dose adjustment of digoxin is recommended. However, patients at risk of
digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly. Use in pregnancy and
lactation: Janumet should not be used during pregnancy or breast-feeding. Effects on ability to drive and use machines: No studies
on the effects on the ability to drive and use machines have been performed. However, when driving or operating machines, it
should be taken into account that dizziness and somnolence have been reported. Patients should be alerted to the risk of hypoglycaemia when Janumet is used in combination with other sulfonylurea agents. SIDE EFFECTS There have been no therapeutic
clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin
has been demonstrated. Sitagliptin and Metformin Adverse reactions considered as drug related reported in excess (> 0.2 % and
difference > 1 patient) of placebo and in patients receiving sitagliptin in combination with metformin in double-blind studies are
listed below. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
(≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Sitagliptin with Metformin In a placebo-controlled 24-week study of sitagliptin 100 mg
once daily added to ongoing metformin, the incidence of adverse reactions considered as drug-related in patients treated with
sitagliptin added to ongoing metformin compared to treatment with placebo added to ongoing metformin was 9.3 % and 10.1 %,
respectively. Investigations Uncommon: blood glucose decreased. Nervous system disorders Uncommon: somnolence. Gastrointestinal disorders Common: nausea Uncommon: upper abdominal pain, diarrhoea. In a 1-year study of sitagliptin 100 mg once daily
added to ongoing metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin
added to ongoing metformin compared to sulphonylurea added to ongoing metformin was 14.5 % and 30.3 %, respectively. In
pooled studies of up to 1 year in duration comparing sitagliptin added to ongoing metformin to a sulphonylurea agent added to
ongoing metformin, adverse reactions considered as drug-related reported in patients treated with sitagliptin 100 mg occurring in
excess (> 0.2 % and difference > 1 patient) of that in patients receiving the sulphonylurea agent are as follows: Metabolism and
nutrition disorders Uncommon: anorexia. Investigations Uncommon: weight decreased. Sitagliptin with Metformin and a Sulphonlylurea In this 24-week placebo-controlled study of sitagliptin 100 mg once daily added to ongoing combination treatment with
glimepiride and metformin, the overall incidence of adverse reactions considered as drug-related in patients treated with the addition of sitagliptin to the ongoing treatment with glimepiride and metformin was 18.1 % compared to treatment with the addition of
placebo to the ongoing treatment with glimepiride and metformin which was 7.1 %. Gastrointestinal disorders Common: constipation. Metabolism and nutrition disorders Very common: hypoglycaemia In a 24-week study of initial combination therapy with
sitagliptin and metformin administered twice daily (sitagliptin/metformin 50 mg/500 mg or 50 mg/1,000 mg), the overall incidence of
adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to
patients treated with placebo was 14.0 % and 9.7 %, respectively. The overall incidence of adverse reactions considered as drugrelated in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0 % each) and
greater than sitagliptin alone (6.7 %), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions. Additional information on the individual active substances of the fixed dose combination. Sitagliptin In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2 % and difference > 1 patient) of that in patients
receiving placebo are headache, hypoglycaemia, constipation, and dizziness. In addition to the drug related adverse reactions
described above, adverse events (reported regardless of causal relationship to medicinal product) occurring in at least 5 % and
more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis. Additional adverse events that occurred more frequently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an
incidence of > 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity. Across
clinical studies, a small increase in white blood cell (WBC) count was observed due to an increase in neutrophils. This observation
was seen in most but not all studies. This change in laboratory parameters is not considered to be clinically relevant. No clinically
meaningful changes in vital signs or in ECG (including in QTc interval) were observed with sitagliptin treatment. Post-marketing
data Sitagliptin During post-marketing experience of Janumet or sitagliptin, one of the active substances of Janumet, the following
additional adverse reactions have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome. Metformin. Nervous system disorders
Common: metallic taste. Gastrointestinal disorders Very common: gastrointestinal symptoms. Skin and subcutaneous disorders
Very rare: urticaria, erythema, pruritis. Metabolism and nutrition disorders Very rare: lactic acidosis, vitamin B12 deficiency. Hepatobiliary disorders Very rare: liver function disorders, hepatitis. PACKAGE QUANTITIES Janumet 50mg/850mg and 50mg/1000mg
film-coated tablets, 56 tablets POM Date of preparation: July 2008 Marketing Authorisation numbers: Janumet 50mg/850mg filmcoated tablets, EU/1/08/455/003. Janumet 50mg/1000mg film-coated tablets, EU/1/08/455/010. Marketing Authorisation Holder:
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK © Merck Sharp & Dohme Limited 2008. All
rights reserved. References: 1. Data on file, MSD. 2. Goldstein BJ, Feinglos MN, Lunceford JK, et al; for the Sitagliptin 036 Study
Group. Effect of initial combination with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients
with type 2 diabetes. Diabetes Care. 2007;30:1979–1987. 3. Nauck MA, Meininger G, Sheng D, et al; for the Sitagliptin Study Group
024. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with
type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes
Metab. 07;9:194–205. * SU = sulfonylurea; specifically glipizide. Additional prescribing information available on request or from
www.medicines.ie
Merck Sharp & Dohme Ireland (Human Health) Ltd.
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
09-09-JMT-2008-IRL-2072-J
3-D Control: comprehensive mechanism of action
targets 3 key defects of type 2 diabetes1
New
The independent monthly for Irish Pharmacists
contents
editorial
issue 2 volume 11 • FEBRUary 2009
4-16News
18-19
Interview
Dr Martin Henman, School of Pharmacy, TCD
20Evolution in action
Terry Maguire
22
Making a difference
David Jordan
24-25 Our people
Julian Judge
26
Bonus Schemes
Cormac O’Neill
28The glass is half full
Iain Cahill
29
Q and A
Professor Marek Radomski
31
e-pharmacy
The Holy Grail of Irish health
June Shannon
32
Clinical Review
Managing the symptoms of cold and flu
Dawn O’Shea
Community pharmacy’s extraordinary
contribution to the Irish health service
The recent Review of Community Pharmacy in
Ireland 2007, by PriceWaterhouseCoopers which
estimates that pharmacists provide a mindblowing €460 million in services for free to the
Exchequer is hugely welcome.
Finally the contribution made by community
pharmacy to the Irish health service has been
quantified and communicated in the one language
currently on everyone’s lips – cold, hard figures.
The facts and figures contained in the IPUcommissioned report speak for themselves.
There was an estimated 96 million visits to
pharmacy outlets in Ireland in 2007, this equates to
23 visits per person. In 2007, pharmacists dispensed
more than 60 million medicines under the public
drug schemes, which accounted for approximately
88 per cent of all demand. They also advised the
public a massive 15 million times on minor medical
ailments. Non-remunerated pharmacy services,
including minor ailment advice, removed an
estimated 3.9 million visits to GPs and more than
500,000 A&E attendances.
The fees and mark-ups earned by pharmacy
outlets from public schemes accounted for just
3 per cent of total HSE spend in 2007. More than
€400 million in tax was generated by community
pharmacy in 2007.
The IPU is to be congratulated for commissioning
this report, which should be read by everybody
involved in the Irish health service.
NEW!
36-38 Product News
38
Crossword
40
Outside Edge
Karmic retribution and me
Fintan Moore
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Editor: June Shannon
Design: Barbara Vasic
SUB-EDITOR: Tim Ilsley
Publisher: Graham Cooke
Publisher: Maura Henderson
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Coughlan, David Jordan, Julian
Judge, Fintan Moore, Cormac
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* 2 x 200mg tablets, 3 x daily. When wrap worn for 8 hours.
Also available:
news
news
Pharmacists provide €460 million
in services for free to Exchequer
A massive €460 million in services are
provided by pharmacists which are
not remunerated by the Exchequer
according to a new report.
These findings formed part of an
independent review of community
pharmacy services undertaken by
PricewaterhouseCoopers on behalf of
the IPU.
The report, which covered the
period January to December 2007,
revealed that the estimated value
of pharmacy services not directly
remunerated by the Exchequer is
approximately €460 million. It also
found that the average person visited
a pharmacy 23 times a year.
The report looked at pharmacy
services, the number and location of
pharmacies and specifics in relation
to ownership structure, turnover,
overhead costs, profit margins and
an analysis of medicine demand and
expenditure on pharmacy services.
It found that the average net profit
margin of a community pharmacy is
6 per cent. This figure includes profits
from non-medicine retail activities,
such as the sale of cosmetics.
The report was presented at a
special seminar on ‘Pharmacy and
Health Economics’, organised by the
Irish Pharmacy Union (IPU), late last
month. Delegates also heard that
the advice and services provided by
pharmacists to patients across the
country saved an estimated 3.9 million
patient visits to GPs and more than
500,000 A&E attendances.
Speaking at the seminar, IPU
President, Ms Liz Hoctor, said: “For
the past 18 months, pharmacists
have being battling with the HSE to
protect services for our patients and
try and maintain a viable profession.
This report supports our argument
that pharmacists are in the frontline
of delivering primary healthcare and
the importance of the job performed
by pharmacists. Not alone do we have
the confidence of patients who visit
us in huge numbers every day but we
are saving the Exchequer millions of
euro in avoiding unnecessary GP and
A&E visits. We welcome the report’s
findings which dispels many of the
misleading characterisations of our
profession, especially in relation to
profit margins.”
A number of expert speakers
addressed the seminar. These were:
Mr John Crawford, Healthcare
Solutions Manager, IBM Business;
Mr Dennis Helling, Executive
Director, Pharmacy Operations and
Therapeutics, Kaiser Permanente,
Colorado; Ms Rachel Morgan, Director,
Pricewaterhouse Coopers, who spoke
on ‘The Economics of Community
Pharmacy in Ireland’; and Dr Martin
Henman, School of Pharmacy, TCD,
who addressed the seminar on ‘The
Future Development of the Role of the
Pharmacist’.
In looking at the future of
community pharmacy, Dr
Henman identified three areas for
development: prescription medicines
use and disease management, the use
of non-prescription medicines and
public health awareness campaigns.
“There are choices to be made by
the custodians of the Health Service
and everyone should play their part,”
he said.
(See pages 18 and 19 for a full interview
with Dr Martin Henman.)
IPHA calls for some prescription-only
medicines to be available OTC
The Irish Pharmaceutical Healthcare
Association (IPHA) has called for the
introduction of an appropriate and
effective system of self-medication for
minor ailments, which would involve
making a number of prescription-only
medications available to patients over
the counter.
In its submission to the Joint
Oireachtas Committee on Health’s
Report on Primary Medical Care in
the Community, the IPHA stated that
the “benefits of self-medication have
not been fully realised in Ireland.
Pharmacists have a critical role to play
in ensuring that such benefits are
secured”.
“Pharmacists are trained to recognise
the symptoms of minor ailments and
know which ones can be managed by
self-medication and which ones should
be referred to the family doctor. In fact,
the range of medicines suitable for
switching to non-prescription status
is significant due to the availability
of pharmacists who can apply their
professional expertise in a gatekeeper
way,” the submission continued.
According to the submission:
“Effective and appropriate self-
medication through the use of
non-prescription medicines can help
patients feel better sooner. It can also
help generate savings, which can be
put to better use elsewhere in the
healthcare system.”
The IPHA also outlined a number
of medicines which, following the
introduction of a partnership model
between regulators, pharmacists,
doctors and patient groups in the
UK are now available OTC there, yet
remain prescription-only in Ireland.
These include the emergency
contraceptive pill, levonorgestrel,
hyoscine transdermal patches for
the prevention of travel sickness,
chloramphenicol 0.5 per cent eye
drops and 1 per cent eye ointment
for the treatment of acute bacterial
conjunctivitis and simvastatin 10mg
to reduce the risk of a first major
coronary event in people likely to be
at moderate risk of coronary heart
disease.
“Through a similar partnership in
Ireland, medicines such as these could
be made available to Irish consumers
with health, social and economic
benefits for all,” the submission stated.
State’s drug bill increases five-fold since 1997 to €1.74 billion
Ireland’s expenditure on medicines
has increased five-fold in the past
decade and the spending on medicines
under the Community Drugs Schemes
reached a massive €1.74 billion in 2007
according to a new report.
The study, Drug Expenditure in
Ireland 1997-2207, by Dr Michael Barry
and staff from the National Centre
for Pharmacoeconomics, St James’s
Hospital in Dublin, revealed that
community prescribing now accounts
for 85 per cent of Ireland’s total drug
expenditure. It also found that the yearon-year increase in spending is one of
the highest in Europe with medicines
now accounting for approximately 13.5
per cent of total healthcare spending.
According to the study, a total of
44.3 million prescription items were
issued under the GMS scheme in 2007
4
Issue 2 Vol 11 February 2009
and expenditure under this scheme
exceeded €1 billion. Aspirin was the
most frequently prescribed medication
with atorvastatin (Lipitor) being the
number one selling drug. Expenditure
under the Drugs Payment Scheme
(DPS) and Long-Term Illness (LTI)
Scheme in 2007 was €2.34 million and
€125.8 million, respectively.
In 2007, payments to wholesalers
under the High Tech Drugs (HTD)
Scheme was €238.5 million and
payment to pharmacies to cover
dispensing fees was €11.4 million.
This total expenditure of €249.9
million under the HTD Scheme in 2007
represents a massive nine-fold increase
since 1997, the report also revealed.
Dr Barry’s report, which was
published in a recent issue of the
Irish Medical Journal, also examines a
number of proposals to reduce Ireland’s
spiralling drugs bill, such as generic
prescribing and the introduction
of a flat fee structure for pharmacy
payment.
According to the report:
“Although it is widely accepted that
generic prescribing enhances costeffectiveness, the generic prescribing
rate in Ireland is low as compared with
other EU member states.”
It further revealed that, over the
past decade, generic prescribing rates
have fallen “significantly”. In 2007,
just over 19 per cent of prescription
items were dispensed generically with
branded generics accounting for 16.5
per cent and non-branded generics
2.6 per cent. In expenditure terms,
generic prescribing accounted for just
over 8.2 per cent in 2007 compared to
1997 when the percentage of items
prescribed generically exceeded 22
per cent by volume and 12 per cent by
expenditure.
Dr Michael Barry
Think calories. Think Calogen.
Calogen provides more energy
than any other supplement.
Research indicates that
Calogen increases
energy intake by 31%,
with no change in appetite
and no adverse effects.1
Recommend Calogen
3 x 30ml per day
for your patients.
Reference: 1. Faxén-Irving G, Cederholm T. Energy rich formula distribution at medication rounds to elderly
geriatric patients – feasability and potential effects on energy intake. Clin Nutr Suppl 2007; 2: 33–34.
For samples or further information,
call Nutricia on Freephone 1800 923 404
Nutricia, Block 1 Deansgrange Business Park, Deansgrange, Co. Dublin.
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ON-Sept08-03
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news
news
IPU to address Joint Oireachtas
Committee on Health on Primary Care
in the Community
The Irish Pharmacy Union (IPU)
was due to come before the Joint
Oireachtas Committee on Health
on Thursday, 29 January to present
its submission on the Committee’s
report on ‘Primary Medical Care in the
Community,’ Irish Pharmacist reports.
In its submission, the IPU has called
for the introduction of a number of
new services, such as vaccination and
warfarin clinics, needle exchange
programmes and communitybased palliative care services into
community pharmacies in an effort to
extend the role of the pharmacist in
the community.
According to the IPU, an estimated
636,000 people visit the 1,540
community pharmacies in Ireland
each week. “Currently, pharmacists
play a vital role in healthcare delivery
but are still one of the most underutilised resources in the health
service.”
The submission states that, in
the context of better outcomes for
patients’ and government’s need for
better value for money, the IPU has
been advocating the introduction of
a number of cost-saving initiatives.
These include the roll out of
Medicines Use Reviews, Minor
Ailments Schemes, Structured Health
Promotion Services, Health Screening
Services and Generic Substitution
throughout community pharmacy in
Ireland.
In relation to generic substitution,
the IPU argued that, similar to their
colleagues in countries such as
Denmark, Germany and France,
pharmacists should be enabled to
“dispense an alternative medicine,
where it is safe to do so. In this way,
the pharmacist would be able to offer
less expensive generic alternatives.”
Generic substitution, the Union
stated, has the potential to save in
excess of €12.7 million on the Medical
Card Scheme and €9.1 million on the
Drugs Payment Scheme for the top 30
drugs by expenditure.
Putting neuropathic pain in the frame
– sufferers called to tell their stories
Irish film director, Jim Sheridan, at the launch of Reeling in the Pain
Critically-acclaimed Irish film
director, Jim Sheridan, is backing
an initiative calling on Irish people
living with neuropathic pain to tell
their story so others don’t suffer
in silence. Reeling in the Pain is a
national competition being run by
the Irish Chronic Pain Association
(ICPA) in conjunction with Pfizer
Healthcare Ireland which hopes to
raise awareness of neuropathic pain
through film.
People with neuropathic pain are
6
Issue 2 Vol 11 February 2009
invited to submit a short written
explanation of their experiences of
living with this condition and the
daily challenges they face. Three
stories will be selected to help with
the production of a collection of
short films on neuropathic pain, a
condition that affects an estimated
120,000 people in Ireland.
Treasurer of the ICPA, Gina
Plunkett, is a sufferer of
neuropathic pain. She explained
that, as pain cannot be seen, the
“The Union has made a number
of submissions calling for generic
substitution but the Department of
Health and Children and the HSE have
not, as yet, taken up this proposal,”
the IPU stated.
In conclusion, the IPU’s submission
to the Joint Oireachtas Committee
stated that community pharmacists,
“as the experts in medicines and as
independent health professionals,
are recognised as a valuable resource
capable of delivering more on
Government healthcare priorities in
a timely and cost-effective manner
which would provide true value for
money.
“With the shortage of funding
for the HSE in the current economic
climate, it makes sense to look for
new ways to deliver healthcare
services to patients. The forthcoming
merger of PCCC [Primary, Community
and Continuing Care Services] and
the National Hospitals Office in
September 2009 provides an ideal
Liz Hoctor, IPU President
opportunity for the HSE to move
a significant number of healthcare
services out of secondary care
and into primary care. Community
pharmacies provide the perfect
location for some of these new
primary care services to be delivered
to patients.”
More female than male
smokers want to quit
More than half or 68 per cent of Irish
women who smoke would like to quit
the habit compared to 58 per cent
of Irish male smokers, according to a
recent survey.
The survey, carried out by
Nicorette, found that, of the women
who would like to quit the habit,
more than a half would “seriously
consider” using a nicotine patch to
help them with this. Health concerns
and saving money were the two top
reasons cited by all respondents for
giving up cigarettes.
According to pharmacist, Mr Owen
Daly: “My advice is that it is really
important to plan your first few days
and think about how you will deal
with the challenges that quitting
will bring. There is no doubt that
it is a difficult habit to break. The
Nicorette research revealed that 82
per cent of smokers would consider
quitting with an aid, such as nicotine
replacement therapy or NRT.
“Clinical trials have shown that a
smoker who uses an NRT is twice as
likely to succeed in quitting than a
smoker who uses willpower alone.
Look for advice from your pharmacist
and get the support you need from
friends and family.”
One-third (34 per cent) of
respondents said that willpower was
their main quit method, despite the
fact that NRT doubles a smoker’s
chances of quitting than willpower
alone.
most common challenge for people
with the condition is to explain
their pain to others.
“Many patients who are
diagnosed often feel their own
family don’t understand the
extent of their suffering, leading
to feelings of isolation and
helplessness. The films will not
only enable others to visualise and
comprehend a painful condition
but also provide a cathartic
medium for both audience and
sufferer.”
Winners will receive a digital
camcorder and their stories will be
produced by award-winning Irish
film production company, Antidote.
Entry forms are available from
local GP surgeries and pain clinics
or can be downloaded from: www.
chronicpainireland.com
Entries must be received by
5.00pm on Friday, 6 March 2009
and sent to: Reeling in the Pain, 7
Lower Fitzwilliam Street, Dublin 2.
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news
news
Over 200 pharmacists sign
up to ‘DUMP’ campaign
Pharmacies throughout Cork and Kerry have
signed up to a new campaign, which facilitates
the safe disposal of unused or out of date
prescription and OTC medicines.
Organised by the Health Service Executive
(HSE) South with the community pharmacists
and supported by Cork City Council, Cork County
Council and Kerry County Council, the ‘Dispose
of Unused Medicines Properly’ (DUMP) campaign
will run from January 26 to March 08 2009.
Medicines can accumulate in the home for
a variety of reasons e.g. unfinished courses of
antibiotics, condition/illness no longer a problem
and remainder of medication not required etc.
Older people can often have large amounts
of medicine at home. Whatever the reason,
the HSE would urge householders to take this
opportunity to dispose of prescription or over
the counter medicines safely.
Over 200 pharmacies have signed up to the
scheme, which will ensure that all medicines
returned will be disposed of safely.
In 2007 the National Poisons Information
Centre received in excess of 11.000 inquiries, the
vast majority of the 11,000 inquiries received by
the National Poisons Information Centre in 2007
related to pharmaceutical overdoses over half of
which regarded accidents involving children.
The HSE has advised people to take certain
steps to ensure that medication in their homes
is safely secured these include: asking their
pharmacist to put medicines into a childresistant container; keeping all medicines, even
seemingly harmless medicines well out of reach
and sight of children on a high shelf or in a
locked press; always keeping medicines in their
original pack or bottle and not to take the label
off.
Maintain a
healthy life...
Students get a taste for
pharmacy at RCSI Open Day
Pictured at RCSI Open Day is Sarah Shannon from
Tression School, Donnybrook, Dublin.
Hundreds of students from second-level schools around
the country got a flavour for life as a pharmacy, medical and
physiotherapy student at the Royal College of Surgeons in
Ireland (RCSI)’s annual Open Day last month.
During the day-long event, Leaving Certificate and A
Level students got the chance to chat to staff, graduates
and students so they could get an idea of what it is like to
study pharmacy, medicine and physiotherapy. A series of
informative talks were held on the range of courses available
at RSCI and how to apply to RCSI through the CAO system
and the new Health Professional Admissions Test (HPAT) that
is being introduced as part of the selection process for EU
student applying for medicine in 2009. An exhibition was
hosted by various faculties and staff, who were on hand to
answer any questions.
Philip Curtis, Head of Admissions at RCSI said “The annual
open day is probably the best opportunity to get a sense of
life at RCSI and the academic programmes it has to offer. The
day comprises informative talks by our staff, students and
graduates, who are there to facilitate those students who have
an interest in pursuing careers in the healthcare area.”
First approved weight loss
product to be available OTC
...with
The only Effervescent drink with
the power of 20 sun ripened oranges
and Glucose in every tablet
Talk to your local Pharmacist today and ask
how RUBEX can help to defend your immune
system from colds and flu
8
Issue 2 Vol 11 February 2009
Rubex is used for the prophylaxis and
treatment of ascorbic acid deficiency.
GlaxoSmithKline (GSK) has received a non-prescription licence
for alli (orlistat 60mg); the first time the European Commission
has approved a non-prescription product for weight loss. The
centrally approved marketing authorisation means GSK can
now introduce alli for adults with a BMI of 28 kg/m2 or more,
in Ireland and all 27 EU member countries. Plans are underway
to launch alli in the coming months here.
Ms Elizabeth Reynolds, General Manager, GSK Consumer
Healthcare Ireland said: “alli, in the US, has successfully helped
millions of users lose weight gradually and steadily, and adopt
a healthy lifestyle. We are very excited about the opportunity
to create similar success in Ireland and we will be launching alli
in pharmacies throughout Ireland soon.”
According to GSK Clinical trials show that alli, when used in
conjunction with a reduced calorie, lower-fat diet, can help
people lose 50 per cent more weight than by dieting alone.
This 50 per cent represents the average additional weight loss
achieved with alli and results may vary. For every two pounds
lost by dieting alone, alli could help users lose one more. It
works by stopping some of the fat you eat being absorbed
into the body and turning into extra pounds.
Leading medicines expert, Dr. Martin Henman, Senior
Pharmacology Lecturer, Trinity College Dublin added:
“Research has shown that consumers are spending their
money on products that often have no evidence to back them
up, such as fad diets, fat burners and weight loss supplements.
By making a licensed non-prescription product available,
Irish consumers will have the option of a proven therapy,
used in conjunction with a balanced, low fat diet, which can
support them with their struggle to achieve sustained weight
loss. For many, losing weight can become the catalyst to
improvements in their overall health and self-esteem.”
For further information please contact: Bayer Consumer Care, The Atrium, Blackthorn Road, Sandyford Industrial Estate, Dublin 18. Telephone: 00 353 (0)1 2999313.
news
news
Pharmaceutical
Society of
Ireland and Irish
Medicines Board
sign agreement
The Pharmaceutical Society of
Ireland (PSI) and the Irish Medicines
Board (IMB) signed a memorandum
of understanding last month
which according to the bodies:
“will increase mutual cooperation
between the two regulators.”
The memorandum is intended to
provide a framework to assist the
joint working of the two statutory
regulators to ensure maximum
effectiveness and efficiency for
public safety when carrying out
their functions.
Areas in which the two bodies
intend to collaborate more closely
include the sharing of information
and the discharge of their
respective regulatory functions,
particularly with regards to the sale
and supply of medicinal products
and medical devices.
The memorandum sets out
the principles underlying this
collaboration and provides
guidance on the exchange of
information between the two
bodies.
Welcoming the agreement, Dr
Ambrose McLoughlin, Registrar
and Chief Executive of the PSI,
said: “The Pharmaceutical Society
of Ireland is pleased to formalise
our already close co-operation
with the IMB, thus ensuring
more effective regulation. This
memorandum of understanding
is designed to ensure that the
relationship is effective and
meets each organisation’s aims
and objectives, particularly when
there are overlapping interests
and responsibilities. It is vital for
patients and public safety than
there is no disconnect between
our two statutory agencies and
enhanced co-operation will help to
ensure that.”
Mr Pat O’Mahony, Chief
Executive of the IMB, said that the
new agreement would further
strengthen the already good
working relationship between
the IMB and the PSI. “This new
memorandum formalises the
existing relationship between our
organisations. Patient safety is
at the core of the IMB’s work and
this new agreement will allow for
greater collaboration on important
issues pertaining to the sale
and supply of human medicines
and medical devices which will
ultimately benefit public and
patient safety.”
10
Issue 2 Vol 11 February 2009
Cork Pharmacist awarded
ABLE Business Excellence
Award
At the recent launch of the ABLE Business Excellence Awards, Paul O’Keefe of
Walsh’s Pharmacy, Dillon’s Cross, Cork City, receives a certificate of recognition
from Billy Kelleher, Minister of State at the Dept of Enterprise, Trade and
Employment, in recognition of providing work experience and employment
opportunities to learners from National Learning Network training courses.
Also in picture is Mr Tom O’Connor, Employer Based Training Coordinator
at National Learning Network, Hollyhill and Mr Joe Gantly, President of Cork
Chamber of Commerce.
Pharmaceutical industry reduces
price of nearly 700 medicines IPHA
Last month saw the continued
implementation of the 2006
agreement between the Irish
Pharmaceutical Healthcare
Association (IPHA) and the HSE,
which has resulted in the price of
many leading medicines being
reduced by 35 per cent over the past
22 months, according to the IPHA.
On 1 March 2007, patients saw a
reduction of up to 20 per cent in the
price of nearly 600 different packs of
medicines on the Irish market. The
second phase of price reductions,
which was implemented on 1
January 2009, resulted in the price of
these medicines falling by a further
15 per cent.
The price of a further 45 medicines
will also be reduced by 20 per cent
and will be reduced again by a
further 15 per cent on 1 November
2010.
It has been estimated that savings
of the order of €300 million across
the GMS and community drugs
schemes, and in the cost of drugs to
hospitals will be achieved over the
four years of the agreement to 2010.
According to the President of
the IPHA, Dr Gerald Farrell: “The
pharmaceutical industry is built
on a foundation of innovation.
We can only source the large
sums needed to invest in research
and development if we can be
reasonably certain that, where we
achieve success, we will ultimately
be rewarded for our endeavours.
Notwithstanding, the industry
recognises that new therapies
put pressure on State budgets,
particularly in these strained
financial times and understands
the need for optimum efficiency
and cost-effectiveness in the State’s
expenditure on medicines.
“These latest price reductions
demonstrate the pharmaceutical
industry’s commitment to Irish
patients. We continue to hope that
the substantial savings achieved
through our action will allow for
greater investment by the HSE into
the most advanced, innovative,
cost-effective medicines, ultimately
helping Irish people live longer,
healthier, more active lives.”
in brief
Business relationships between
pharmacists and GPs come under
the microcsope
Certain economic and business
relationships between pharmacists
and GPs will be prohibited when the
Minister for Health commences the
remaining sections of the Pharmacy
Act in the first half of this year.
According to the PSI the remaining
sections of the Act to be introduced
are Sections 63 and 64, which
include the introduction of a fitness
to practise regime for pharmacists
and a fitness to operate regime for
retail pharmacy businesses. It will
also prohibit certain economic and
business relationships between
pharmacies and doctors.
Meanwhile the online public
register of Retail Pharmacy
Businesses is due to be published
shortly on the PSI website. This will
allow patients, members of the
public, healthcare professionals and
agencies to check the registration
status of a pharmacy.
Details on the new register
will include information on retail
pharmacy businesses, pharmacists
and pharmaceutical assistants.
HSE urges people in high-risk
groups to get flu vaccine
The HSE has urged everyone in
high-risk categories to get vaccinated
against influenza because of the high
rate of flu experienced across the
country last month. In January, the
Executive experienced an increase
in admissions of older people to
hospitals presenting with respiratory
conditions.
The HSE also advised that people
should look after older persons at
this time, checking on relatives and
neighbours, ensuring that they are
adequately heating their houses and
staying inside during any cold snaps.
High-risk groups for influenza are
people who are aged 65 years and
over, adults and children with chronic
illness that requires regular medical
follow-up, e.g. chronic lung disease,
chronic heart disease and diabetes,
those with lower immunity due to
disease or treatment, including those
who have had their spleens removed,
children or teenagers on long-term
aspirin therapy, residents of nursing
homes, old people’s homes and other
long-stay facilities, and healthcare
workers and carers of those in risk
groups.
Flu vaccination is available from
GPs. Both the vaccine and the
consultation are free for people in the
high-risk groups who have a Medical
Card or a GP Visit Card. Those who do
not have a Medical Card or GP Visit
Card may have to pay a consultation
fee.
Don’t let pain
STOP you.
7.5 mg & 15 mg Tablets
Prescribing Information for Mobicam 7.5 mg & 15 mg Tablets.
Qualitative and Quantitative Composition: Each tablet contains meloxicam 7.5 mg or 15 mg. Pharmaceutical Form: Pale yellow coloured round tablet with a score line on one side. Therapeutic Indications: Short-term symptomatic
treatment of exacerbations of osteoarthrosis. Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis. Posology and Method of Administration: Oral use. Exacerbations of osteoarthritis: 7.5mg / day up
to a maximum of 15mg/day. Rheumatoid arthritis and ankylosing spondylitis: 15mg /day, which may be reduced to 7.5mg/day according to therapeutic response. Max. dosage: 15mg/day. Take as a single dose with water during a
meal. Undesirable effects may be reduced by taking the lowest effective dose for the shortest time necessary. Elderly: For the treatment of rheumatoid arthritis and ankylosing spondylitis: 7.5mg/day. Renal and hepatic impairment:
refer to the SPC. Contraindications: Hypersensitivity to meloxicam, to one of the excipients or to substances with a similar action e.g. NSAID’s, aspirin. This medicine should not be given to patients who have developed signs
of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of acetylsalicylic acid or other NSAID’s. Third trimester of pregnancy and during lactation. Active or history of recurrent gastrointestinal
(GI) ulcer. Severely impaired liver function. Non-dialysed severe renal failure. GI bleeding, cerebrovascular bleeding or other bleeding disorders. Severe heart failure. Severe congestive heart failure (chf). Special Warnings
and Precautions for Use: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Appropriate monitoring and advice are required for patients with a
history of hypertension and/or mild to moderate chf as fluid retention and oedema have been reported in association with NSAID therapy. Patients with cardiovascular and/or cerebrovascular disease should only be treated with
meloxicam after careful consideration. Similarly before initiating longer-term treatments of patients with risk factors for cardiovascular disease. Any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to
ensure their total cure before starting treatment with meloxicam. Attention should routinely be paid to the possible onset of a recurrence in patients. Patients with or with a history of GI symptoms / disease (i.e. ulcerative colitis,
Crohn’s disease) should be monitored for digestive disturbances, especially for GI bleeding. As with other NSAID’s, GI bleeding or ulceration/perforation, in rare cases fatal, have been reported at any time during treatment, with
or without warnings symptoms or a previous history of serious GI events. Particular caution is required if treating the elderly. If GI bleeding or ulceration occurs in patients during treatment, the drug should be withdrawn. The
possible occurrence of severe skin reactions and serious life threatening hypersensitivity reactions (i.e. anaphylactic reaction) is known to occur with NSAIDs including oxicams. Meloxicam should be withdrawn immediately and
careful observation is necessary. Should any abnormality be present following laboratory analysis of serum or liver function tests, the administration of meloxicam should be stopped and appropriate investigations undertaken.
Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics and consequently possible exacerbations of the condition of patients with cardiac failure or hypertension may occur
with NSAID’s. NSAIDs, by inhibiting the vasodilating effect of renal prostaglandins, may induce a functional renal failure by reduction of glomerular filtration. This adverse event is dose-dependant. For further information refer to
the SPC. Sodium and water retention with possibility of oedema, hypertension or hypertension aggravation, cardiac failure aggravation. Hyperkalaemia can be favoured by diabetes or concomitant treatment known to increase
kalaemia. Regular monitoring of potassium values should be performed. Adverse reactions are often less well tolerated in elderly, fragile or weakened individuals, who therefore require careful monitoring. As with other NSAIDs,
particular caution is required in the elderly, in whom renal, hepatic and cardiac functions are frequently impaired. The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect nor
should an additional NSAID be added to the therapy because this may increase the toxicity while therapeutic advantage has not been proven. In the absence of improvement after several days, the clinical benefit of the treatment
should be reassessed. Meloxicam, as any other NSAID, may mask symptoms of an underlying infectious disease. This medicine, like those of it’s class may impair fertility and is not recommended in women attempting to conceive.
In women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of meloxicam should be considered. Caution is required if meloxicam is administered to patients suffering from, or with a
previous history of bronchial asthma. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Full information regarding
special warnings and precautions is available in the SPC. Interaction with Other Medicinal Products and Other Forms of Interaction: Other NSAID’s, including acetylsalicylic acid, oral anticoagulants, thrombolytics and anti
platelet drugs, diuretics, ACE inhibitors and angiotensin-II antagonists, other antihypertensice drugs (e.g. Beta-blockers), cyclosporins, glucocorticoids, intrauterine devices, lithium, methotrexate, cholestyramine. Please refer to
the SPC for further information. Undesirable effects: Common: anaemia, light-headedness, headache, gastrointestinal disorders, pruritus, rash, oedema including oedema of the lower limbs. For further information, please refer
to the SPC. Shelf Life: 3 years. Marketing Authorisation Holder: Ranbaxy Ireland Ltd, Cashel, Co. Tipperary. Marketing Authorisation Number: PA 408/62/1-2. Distributed by: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel,
Co. Tipperary. This medicine is a prescription only medicine. Further prescribing information is available on request. Date of Revision of Text: October 2008.
Ireland’s No.1 Generic Healthcare Specialists
www.pinewood.ie
P I N E W O O D
HEALTHCARE
A Better choice for your patients’ health
news
news
New pharmacy course in Coleraine to link with
pharmacists in Republic
Northern Ireland’s newest Pharmacy Department in the
University of Ulster (UU) Coleraine is seeking to establish
links with pharmacists in the North East who may be
interested in assisting in the development of its new
Master of Pharmacy course.
Speaking to Irish Pharmacist, Professor Paul
McCarron, Head of the Department of Pharmacy and
Pharmaceutical Sciences at UU, said he would be keen to
hear from pharmacists in Donegal, Sligo and Monaghan
who may be interested in teaching students or taking
them on as part-time assistants in their pharmacies.
“Our plans are to embrace the Irish profession,” Prof
McCarron said.
The new Master of Pharmacy (MPharm) programme
at Coleraine, which aims to have its first intake of 35
students in September, is designed to provide an
academically challenging and vocationally relevant
Professor Paul McCarron, Head of
pharmacy education that will lead to registration as a
the Department of Pharmacy and
pharmacist in Northern Ireland.
Pharmaceutical
Sciences
at
University
However, Prof. McCarron said that the course was also
Exputex 145x210 16/10/2008 10:51 Page 1
of Ulster, Coleraine.
geared towards students from the Republic in that it will
Good News
for chesty coughs
Exputex
™
Carbocisteine mucolytic syrup
COMPLETE WITH
CHILD RESISTANT
TAMPER EVIDENT
CAP
SUGAR FREE
✓ Non drowsy
✓ Mentholated
✓ 300ml - the lowest cost
sugar free carbocisteine
mucolytic syrup (on a ml
per ml basis 250mg/5ml)1
Prescribing Information
(Please refer to full Summary of Product Characteristics [SmPC])
Exputex 250mg/5ml Oral Solution
Presentation: Carbocisteine provided as 250mg/5ml oral solution. Uses: As
a mucolytic adjunct for respiratory tract disorders characterised by excessive
or viscous mucous. Dosage and administration: Oral. Adults/Elderly:
Three 5ml spoonfuls three times daily initially. Reduce to two 5ml spoonfuls
three times daily when a satisfactory response has been obtained. Children:
6-12 years: 5ml spoonful (250mg) two to three times daily. 2-5 years: Half a
5ml spoonful (125mg) two to three times daily. Under 2 years: Not recommended. Contraindications: Hypersensitivity, patients with known active
peptic ulceration. Special Warnings and Precautions: Patients with a history of peptic ulceration, avoid in patients with active ulceration, patients on a
controlled sodium diet. Contains parahydroxybenzoates (E215, E217 and
E219), sunset yellow FCF (E110) and ethanol. Interactions: None listed.
Pregnancy and Lactation: Not recommended. Undesirable Effects:
Nausea, headache, gastrointestinal upset and skin rash. Overdose: No
experience.12
SeriousIssue
effects 2
not
expected.
Legal category:
Vol
11 February
2009 S1B(E) Product
Authorisation number: PA 488/14/1. Product Authorisation holder:
Monmouth Pharmaceuticals Limited, Hampshire International Business Park,
Chineham, Basingstoke, Hampshire, RG24 8EP, UK. Distributed by: Cahill
May Roberts, Pharmapark, Chapelizod, Dublin 20. Further information is
available from: Shire Pharmaceuticals Limited, Hampshire International
Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, UK. Tel: +44
1256 894000. Date of revision: June 2008. Exputex is a registered trademark of Shire US Inc. in Ireland.
Adverse events should be reported to the Pharmacovigilance Unit
at the Irish Medicines Board (IMB) ([email protected]).
Information about adverse event reporting can be found on the IMB
website (www.imb.ie). Adverse events may also be reported to
Shire Pharmaceuticals Ltd on +44 1256 894000.
MONMOUTH
P H A R M A C E U T I C A L S
1 MIMS May 2008
Monmouth Pharmaceuticals Ltd,
Hampshire International Business
Park, Chineham, Basingstoke, Hants
RG24 8EP
Date of preparation: October 2008 IRE/EXP/08/0001
accept the Irish Leaving Certificate and a final year elective
will focus on the Irish pharmacy system. He added, however,
that prospective students must be made aware that they will
be responsible for transferring their registration to enable
them to practice in the Republic. This can be done through
the Pharmaceutical Society of Ireland. In an effort to further
broaden accessibility to the new course, applications from
pharmacy assistants will be facilitated and encouraged.
The University is currently working towards accreditation
of the MPharm by the Royal Pharmaceutical Society of Great
Britain and the Pharmaceutical Society of Northern Ireland.
The course will be run by Prof. McCarron, a pharmacist who
worked for seven years as a pharmacy lecturer at Queen’s
University Belfast, together with hospital pharmacist, Dr
Kathy Burnett, Course Director and their team. A further three
new members of staff were appointed last month.
“We welcome students from the South and would like
to form links with practitioners up around Donegal, Sligo
and Monaghan … We would like to invite people in to give
lectures, help us design the course and get as much input as
possible from practitioners. We are doing that at the moment
with practising pharmacists from the Derry and Portrush
areas,” Prof. McCarron explained.
Pharmacists in the North East who are interested in getting
involved with the new MPharm course in Coleraine can
contact Prof. McCarron on email: [email protected]
More details are available at: www.ulster.ac.uk
Ireland’s outpatient antibiotic
use in danger of growing to
among highest in Europe
The consistently increasing trend in outpatient antibiotic
usage may lead to Ireland having among the highest rates
of usage in Europe according to the latest data from the
Health Protection Surveillance Centre (HPSC).
The Centre’s annual report for 2007 revealed that
outpatient antibiotic consumption has been increasing at
3 per cent per year since 2000. In 2007, the overall rate was
22.5 DID, an increase from the 2006 rate of 22.5.
In 2007, outpatient consumption of penicillins accounted
for the largest class used (50 per cent of total at 11.3 DID),
followed by macrolides (18 per cent, 4.0 DID), tetracyclines
(14 per cent, 3.3 DID), cephalosporins (9 per cent, 1.9 DID),
quinolones (5 per cent, 1.0 DID) and sulphonamides (4 per
cent, 0.9 DID). Other antibiotic classes accounted for about
1 per cent of total use.
The HPSC report also found that an analysis of Primary
Care Reimbursement data showed that patients entitled
to reimbursement are prescribed about 55 per cent of the
antibiotics in terms of cost.
According to the report in an analysis of recent Irish
data: “The consistently increasing trend in outpatient
antibiotic usage may lead to Ireland having among the
highest rates of usage in Europe. Furthermore, strong
seasonal fluctuations, over-reliance on broad-spectrum
antibiotics and high-density usage in some regions are
factors that may work together to increase the pressure for
selection of resistant variants of bacterial pathogens.”
In relation to hospital antibiotic consumption, the HPSC
report, which analysed information from 35 public acute
hospitals, found that the median usage rate was 80.6 DBD.
“This was a rise from the previous year’s rate of 78.7 DBD.
These levels are again mid-to-high in Europe.”
According to the report, there was an increase
in the consumption of some “high risk” antibiotics
(fluoroquinolones and penicillins such as co-amoxiclav)
and reserved antibiotics (vancomycin and teicoplanin)
in 2007. “This is one area where antibiotic stewardship
programmes would help to limit the spread and
development of drug-resistant organisms that can cause
healthcare-associated infections,” the report stated.
For every
cigarette, there’s
a nicorette
®
PA Holder: McNeil Healthcare (Ireland) Ltd., Airton Rd, Tallaght, Dublin 24. PA: 823/49/2,9,10,13.
Contains Nicotine. Product not subject to a medical prescription. Full prescribing information available on request.
NIK/019/00
Ask your Pharmacist first
•Paracetamol,theactiveingredientinPanadol,hasthefewestcontra-indications
ofanypainmedicine.1
•ParacetamolisrecommendedbytheUSNationalKidneyFoundationforepisodic
useinthosewithrenalproblems.2,3(Patientswithrenalproblemswhoneed
touseparacetamolonaregularbasisshouldbesupervisedbytheirdoctors.)
•It'salsothefirst-choiceanalgesicforpatientswithgastrointestinal4,5
andcardiovascularproblems.6,7
•Whenusedatrecommendeddoses,theoccurrenceofsideeffects
withparacetamolhasbeenillustratedtobelow.8,9
References 1. Prescott LF. 2000. Therapeutic misadventure with paracetamol: fact or fiction? American Journal of Therapeutics. 7 (2),pp 99-114. 2. US National Kidney Foundation. A-Z Health Guide:
analgesics. [online]. [Accessed 10th Nov 2006]. Available from the World Wide Web. http://www.kidney.org/atoz/atozItem.cfm?id=23 3. Henrich WL, Agodoa LE, Barrett B, et al.1996. Analgesics and the
kidney: summary and recommendations to the Scientific Advisory Board of the National Kidney Foundation from an Ad Hoc Committee of the National Kidney Foundation. American Journal of Kidney
Diseases. 27(1), pp.162-5. 4. Singh G.2000. Gastrointestinal complications of prescription and over-the-counter non-steroidal anti-inflammatory drugs: a view from the ARAMIS database. American
Journal of Therapeutics. 7 (2), pp.115-121. 5. Lewis SC et al. 2002. Dose-response relationships between individual non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and serious upper
gastrointestinal bleeding: a meta-analysis based on individual patient data. British Journal of Clinical Pharmacology. 54(3), pp 320-326. 6. Hillis WS. 2000. Areas of emerging interest in analgesia:
cardiovascular complications. American Journal of Therapeutics. 9(3), pp 259-269. 7. Whelton A. 2000. Renal and related cardiovascular effects of conventional and COX-2 specific NSAIDs and non-NSAID
analgesics. American Journal of Therapeutics. 2000, 7(2), pp 63-84. 8. British National Formulary. Edition 52, September 2006. Chapter 4: Central nervous system: non-opioid analgesics. 9. Panadol Tablets
500mg. SPC.
Panadol Tablets Product Information. For further information please see Summary of Product Characteristics. Presentation: Each tablet contains paracetamol 500 mg. Indications: used
as a mild analgesic and antipyretic for the short-term management of headaches, musculoskeletal disorders, menstrual pains, toothache and for symptoms of common colds and ‘flu. Panadol may also be
used in the symptomatic relief of mild to moderate pain associated with osteoarthritis, as diagnosed by a doctor. Dosage and administration: Adults (including the elderly): 2 tablets, repeated if necessary,
up to 3-4 times daily. Not more than 8 tablets in 24 hours. Children 6-12 years: Half to one tablet, repeated if necessary, up to 3-4 times daily to a maximum of 4 tablets in 24 hours.Children under 6 years:
Not suitable. Do not exceed the stated dose. Contraindications: Hypersensitivity to paracetamol or any of the other constituents. Use in children under 6 years of age. Precautions: Use with caution in
patients with severe renal or severe hepatic impairment, moderate or severe liver disease. Caution required in patients taking warfarin and other coumarins, domperidone, metoclopramide, cholestyramine.
Not to be taken concurrently with other paracetamol-containing products. Pregnancy and lactation: Paracetamol is the mild analgesic of choice during pregnancy. However caution should be exercised
in it’s use during the first trimester. Paracetamol is excreted in breast milk, however the level present is not considered to be harmful. If symptoms persist, a doctor should be consulted. Prolonged use
except under medical supervision may be harmful. This product should only be used when clearly necessary. Side effects: rare, but hypersensitivity, including skin rash, may occur. Overdose: Immediate
medical advice should be sought in the event of overdosage, even if the patient feels well, because of the risk of irreversible liver damage. For further information please see Summary of Product
Characteristics. Legal Classification: as an item for General Sale (12’s), Pharmacy Only (24’s), Prescription Only (96’s, 100’s). Product Authorisation number: PA 678/39/5 Product Authorisation
holder: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16. Package quantity: 12’s, 24’s, 96’s, 100’s. Panadol is a registered trademark. Further information is
available upon request. Date of last revision: January 2009.
news
UK/WORLD news
Number of cancer drugs
set to double
The number of drugs available for
the treatment of cancer in Europe
has increased substantially over the
last 10-15 years; however, European
cancer patients still face unequal
access to treatment depending on
where they live, according to a new
report.
The Comparator Report on Patient
Access to Cancer Drugs in Europe
by researchers from Stockholm
found that approximately 25 cancer
drugs were approved in the 10 years
between 1995 and 2005 and it is
expected that double that amount
will be approved during the period
2007-2012.
The report also found that there are
large variations between countries
in terms of the level of uptake of new
drugs and that European patients
still face unequal access to cancer
treatment, depending on where they
live. With inequalities and gaps in
survival of cancer patients particularly
noticeable when comparing Eastern
Europe with Northern and Western
Europe.
The report further revealed
that, while cancer incidence is
increasing, cancer mortality is
decreasing, indicating the positive
impact of screening programmes
and improvements in treatments. It
found that, in 2006, over 2.4 million
new cases of cancer were diagnosed
in Europe about 10 per cent more
than 2002; however, mortality only
increased by 0.4 per cent in the same
period.
“New treatments have made it
possible to target diseases more
effectively. For cancer patients, these
newer therapies mean an improved
quality of life, with less time spent in
hospital and the chance to return to
their day-to-day activities earlier”, said
Dr Nils Wilking, Clinical Oncologist at
the Karolinska Institutet, Stockholm,
and one of the main authors of the
report.
However, the report also
highlighted wide gaps in Europe in
relative survival rates. For example, in
Sweden 60.3 per cent of men and 61.7
per cent of women diagnosed with
cancer survive, compared to only 37.7
per cent of men and 49.3 per cent of
women in the Czech Republic.
Patients in Austria, France and
Switzerland have the broadest access
to newer cancer treatments while
Poland, the Czech Republic and the
UK continue to lag behind.
The report’s authors urged
policy-makers to take action - 1.2
million deaths were caused by
cancer in Europe in 2006 - and
proposed new policies to improve
treatment access for patients in
Europe. These included: to adapt
healthcare budgets generally and
hospital budgets specifically to
incorporate the introduction of
new cancer therapies; to introduce
separate funding for cancer therapies,
with or without requirements of
an additional gathering of data; to
expedite (regulatory and economic)
review times for innovative cancer
therapies; and to promote a European
collaborative approach to collecting
available scientific information for
Health Technology Assessment (HTA).
The report, based on findings from
the 27 EU Member States (excluding
Cyprus and Malta), Iceland, Norway
and Switzerland, was supported by
an unrestricted grant from the EFPIA,
the Federation of the research-based
pharmaceutical industry in Europe,
of which the Irish Pharmaceutical
Healthcare Association (IPHA) is a
member.
Analyses were conducted by i3
Innovus, a company specialising in
health economics and outcomes
research. “Appropriate access to new
treatments is vital, and examining
variations in patient access between
countries is a positive way to stimulate
discussions on the optimal use of new
technologies and treatment,” said Mr
Brian Ager, Director General of EFPIA.
Pharmaceutical industry donates
$9.2 billion to improve health in
low- and middle-income countries
Since 2000, the pharmaceutical
industry has donated a massive $9.2
(€7) billion worth of medicines,
vaccines, diagnostics, equipment and
other materials and labour to lowerand middle-income countries, of
which $2.4 (€1.8) billion was donated
in 2007 alone.
According to the results of the
latest International Federation of
Pharmaceutical Manufacturers
and Associations’ (IFPMA) Health
Partnerships Survey, IFPMA
members – which include the
Irish Pharmaceutical Healthcare
Association (IPHA) — have assisted
a massive 1.37 billion people in
developing countries through the
donation of medicines and other
health interventions.
The survey, which measures the
research-based pharmaceutical
industry’s contribution to attaining
the health-related United Nations’
Millennium Development Goals
(MDGs), also values the total health
assistance provided by the industry to
the developing world in 2005 at more
than $1.5 (€1.1) billion. At the end
of 2006, the total number of health
interventions stood at 1.37 billion.
Mr Fred Hassan, President of
the IFPMA, Chairman and CEO
of Schering-Plough, said: “This is
the third such IFPMA survey, and
it confirms that our industry’s
contribution to improving the health
of people in developing countries is
substantial and sustained. It reflects
not only product contributions but
also education and other actions for
the long term. And it does not even
include our industry’s investment in
R&D for developing world diseases.”
The health interventions made
available by the industry include
products donated, healthcare
interventions, education for patients
and people at risk, and training for
healthcare workers.
“The latest survey reveals what
may be a certain stabilisation in
the number of interventions made
available by our industry each year,
whereas the period 2000-2005 was
characterised by rapid growth.
One noticeable shift that has been
picked up in the new survey is that
the volume of donated products
actually decreased in 2007, while that
of products sold at cost continued to
increase.
“The industry continues to play
a significant role in strengthening
healthcare systems in developing
countries, providing training for more
than 50,000 developing country
health workers each year,” Mr Hassan
added.
UK Government
plans to
make certain
prescription-only
drugs available
OTC given thumbs
down
UK Government plans to make
certain prescription-only drugs for
common problems available over
the counter have overwhelmingly
been given the thumbs down by
healthcare professionals, according
to a survey of readers of the
influential Drug and Therapeutics
Bulletin (DTB) in the UK.
The prevailing view among
readers, many of whom are
healthcare professionals working
in primary care, was that drug
companies, rather than patients,
have most to gain from proposed
switches to OTC availability.
DTB readers were asked about
plans being considered by the
drugs regulator, the Medicines and
Healthcare products Regulatory
Agency (MHRA), to make
trimethoprim and tamsulosin
(Flomax) available over the counter.
Trimethoprim is an antibiotic,
commonly used to treat
women with symptoms of the
urinary infection, cystitis, while
tamsulosin is prescribed for urinary
symptoms related to an enlarged
prostate gland (benign prostatic
hyperplasia).
Most of the 251 survey
respondents disagreed with the
plans.
Almost two-thirds (64.5 per cent)
felt the move to make trimethoprim
available in pharmacies without
prescription was a bad idea. And
over half (58.2 per cent) cited a
consequent increase in antibiotic
resistance as their main concern.
Just over half (52.2 per cent) felt
that patients might misdiagnose
their symptoms, while a similar
proportion thought that OTC
availability might encourage
patients to overuse or misuse the
drug.
The proposal to make tamsulosin
available without prescription was
rejected by even more respondents
- four out of five (79.7 per cent) with most (just under 73 per cent)
citing the risk of misdiagnosis by
patients as their main concern.
Seven in 10 respondents said that
OTC availability could delay patients
from seeking help for more serious
underlying disease.
Overall, most respondents felt
that the needs and wishes of the
public and the NHS should be the
key driver for a switch to OTC status.
Issue 2 Vol 11 February 2009
15
news
eu
news
Gary Finnegan
Ownership of pharmacies may
be limited to pharmacists
Controversial laws passed by several
EU member states which restrict
the ownership of pharmacies may
be given the green light, it has
emerged.
Attempts by Germany and Italy to
insist that all pharmacies be owned
and operated by pharmacists have
been challenged on the basis that
they might run counter to Europe’s
free market policies.
However, an influential judge at
the European Court of Justice (ECJ)
has published an opinion stating
that European countries are entitled
to place limits on how pharmacies
are run if such measures are in the
interest of public health.
In a legal opinion published
through the ECJ Advocate General,
Mr Yves Bot, said EU member states
can enforce restrictive laws in the
health sector which might otherwise
be considered anti-competitive.
He was commenting on a case
taken by German pharmacist, Ms
Helga Neumann-Seiwert, who
sought to block a Dutch-owned
DocMorris from operating a
pharmacy chain in Saarbrucken.
The case turned the spotlight on
Germany’s controversial national
law limiting ownership of retail
outlets which sell medicines.
The European Commission has
itself sought to challenge member
states, including Austria, Bulgaria,
France, Germany, Italy, Portugal and
Spain, for perceived over-regulation
of their pharmacy sectors.
The Commission believes that
reserving ownership of pharmacy
retailers exclusively for qualified
pharmacists is in breach of ‘freedom
of establishment’ clauses enshrined
in European treaties. The principle of
freedom of establishment is central
to Europe’s internal market and
means every European person and
company can operate anywhere in
the EU.
However, Mr Bot said that
preventing non-pharmacists from
entering the market is justified in
this instance because it guarantees
the quality and variety of medicinal
products to the public.
He said an individual owning a
pharmacy, who is both proprietor
and employer, inevitably has an
influence on the policy followed
by that pharmacy in relation to the
dispensing of medicinal products.
“Therefore, the choice made by the
ECJ Advocate General, Yves Bot
Italian and German legislatures to
link the professional qualification
and the economic ownership of
the pharmacy is justified under
the objective of protecting public
health.”
Mr Bot emphasised the
importance of ensuring that
medicinal advice is “competent and
objective”, adding the quality of
the service of dispensing medicinal
products is closely linked to the
independence of professional
pharmacists. He said laws
restricting ownership of pharmacies
introduced in Italy and Germany
were aimed at preserving this
independence.
“Consequently, the Advocate
General considers that the
requirement that the person
who has economic control over
the pharmacy and, on that basis,
determines its commercial policy, be
a pharmacist is consistent with the
Treaty provisions on the freedom
of establishment,” the ECJ said in a
statement.
Mr Bot’s comments are not
binding on the ECJ which is to rule
on the issue later this year, but his
opinion is seen as highly significant
in this landmark case.
Ms Helga Neumann-Seiwert
welcomed Mr Bot’s opinion, saying:
“I appreciate that the Advocate
General has confirmed the limits of
deregulation and considered the
ban on outside ownership legally
compliant with Common Law.
He confirmed that it was right to
defend ourselves against the illegal
conferral of a pharmacy operation
license to an anonymous capital
corporation.”
The Pharmaceutical Group of the
European Union, which represents
community pharmacists, noted
the judge had highlighted the role
of individual EU member states in
determining their own healthcare
policies.
“Crucially from the point of
view of the whole pharmacy
sector in Europe, Mr Bot stresses
that subsidiarity in healthcare
is a meaningful principle – the
internal market cannot be ignored,
but member states have a wide
discretion in choosing the standards
and regulatory tools to be applied,
even if these are more restrictive
than in other states.”
Rare diseases targeted with funds
Patients with rare diseases are set
to benefit under new proposals
from the European Commission
which would see pooling of
resources and investment in
research on rare diseases.
Approximately 36 million
Europeans suffer from a rare
disease, defined as an illnesses that
affects fewer than five in every
10,000 people. The Commission is
16
Issue 2 Vol 11 February 2009
calling for an EU-wide strategy to
improve diagnosis and treatment
of such diseases, and wants
member states to set out national
plans to address the problem.
Greater co-operation between
EU centres of excellence on
rare types of cancer, autoimmune diseases and congenital
malformations is suggested,
and greater funding for research
and drug development for rare
conditions will also form part of
the plan.
Currently, some 45 therapies
exist for rare diseases, but the
Commission estimates that
around 5,000 to 8,000 conditions
have been identified, with new
forms discovered every day. Such
therapies can also cost up to
€7,000 per patient per day.
Concern over
shortage of radiopharmaceuticals
in EU
The European Commission has
expressed concern over the
shortage of radiopharmaceuticals
across Europe. The Commission
has called for a report to assess the
severity of the problem with a view
to finding alternative sources of
products used in the diagnosis and
treatment of a range of diseases.
The shortage was brought into
focus late last year due to the
closure of several nuclear reactors
across Europe that produce
radiopharmaceuticals.
The temporary shutdown of a
reactor in Petten, the Netherlands,
triggered major concern last year as
the site has been a key production
site for Europe’s radionuclides. The
Committee for Medicinal Products
for Human Use said alternative
treatments or diagnostic procedures
are available where supply of
radiolabelled products has been
disrupted.
European
Medicines Agency
promises greater
transparency
The pan-European body charged
with evaluating new medicines has
pledged to improve public access
to drug information as part of its
efforts to improve transparency.
The European Medicines Agency
(EMEA) is also promising to give
patients a greater say in whether
a drug is granted marketing
authorisation. Mr Noel Wathion,
Head of Post-authorisation
Evaluation of Medicines for Human
Use at the Agency, said safety could
be improved through increased
transparency.
Mr Wathion said it was time to
“re-open the debate on company
confidentiality and see what is the
best balance” between protecting
companies’ commercial interests
and addressing safety concerns.
The EMEA is now beginning a
consultation process on changing
its policy with regard to allowing
access to its documentation.
LEAD THE WAY IN
BP CONTROL
Direct
✓ 1st
Renin
Inhibitor
and
✓ Powerful
sustained
efficacy
1,2
new
✓ For
patients and
as add-on
NOT ACTUAL PATIENTS
1,2
ALREADY PRESCRIBED TO
OVER 300,000
PATIENTS WORLDWIDE †
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 (as hemifumarate). Indications: Treatment of essential hypertension. Dosage: 150mg to 300mg once daily with a light meal (do not take with grapefruit juice),
alone or in combination with other anti-hypertensive agents. No adjustment of initial dose required in elderly (>65 years), renal and liver impairment. Not recommended < 18 years of age. Contraindications: ◆ Hypersensitivity to the active substance or excipients. ◆ Second and third trimesters of pregnancy ◆ Concomitant
use with ciclosporin and other potent P-gp inhibitors (quinidine, verapamil). Warnings/Precautions: ◆ Increased risk of hyperkalaemia in patients receiving other RAS agents, and/or those with reduced kidney function and/or diabetes mellitus ◆ Caution in patients using moderate
P-gp inhibitors concomitantly ◆ Caution in patients with severe heart failure (NYHA class III/IV) ◆ 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, other moderate P-gp inhibitors and potent P-gp inhibitors ◆ Concomitant treatment with drugs that may increase serum potassium levels ◆ Possible interaction with digoxin, irbesartan, St. John’s wort, rifampicin, other
P-gp inducers and grapefruit juice ◆ 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 API Text: September 9th 2008 ◆ Date of Preparation: to be completed by marketing ◆ NO1008569
1. Üresin Y
. J Ren An Ald system 2007,8(4),190-198 2. Oh B-H
. JACC 2007;49 : 1157-63 † IMS Disease Analyzer - Verispan 2008
INTERVIEW
Caught in the middle
– pharmacy and the
Irish healthcare system
I n t erv i e w D r M a rt i n H en m a n TCD
Dr Martin Henman, Head of the Practice of Pharmacy at the School of
Pharmacy at TCD, addressed the 6th annual IPU Seminar recently on the future
development of the role of the pharmacist. Here he speaks to Irish Pharmacist
on the challenges facing the practice of pharmacy in Ireland today. By June
Shannon
Dr Martin Henman believes that the problems faced by pharmacy in Ireland
are not simply the price of medicines or the need to expand the role of
pharmacists; instead they lie in the fundamental difficulties of delivering a
service within our overly complex two-tier primary care sector.
According to Dr Henman the changes which have come about in
community pharmacy over the past 20 years, which have seen it develop
from a practice of simply purchasing and supplying medicines to one which
has an increasing clinical component, has come from a number of drivers,
not least of which was from patients themselves.
Dr Henman said that these developments have come about not just as a
result of campaigning by the profession for an expanded role, and “almost
certainly” not because of things that have been done by the State. (With the
exception of the 1996 Pharmacy Contract and the 1978 document on the role
of the Hospital Pharmacist).
“Other than those two interventions, really the State didn’t do that much,”
he said.
Patient driven
“If anything it has come primarily because of a drive from patients wanting
more information, seeing that other people can get it in other countries.
It has also come from the media looking at that, pursuing it and actually
promoting it or promoting people’s awareness of it. The other way has been
the law because the law essentially said that the staff of the pharmacy have a
duty of care [towards their patients].”
The TCD pharmacist said that the vast majority of people outside
pharmacy did not quite understand the duty of care that the law places on
the pharmacist.
This duty of care extends to whatever the pharmacist believes is necessary
to execute their professional judgement, Dr Henman explained.
Therefore a number of the services currently being discussed as ways
18
Issue 2 Vol 11 February 2009
which community pharmacists can expand their service such as patient
counselling, medication review, cost effectiveness, and minimisation of
wastage are all in fact already contained in the 1996 Pharmacy Contract.
However, he said that to date pharmacy had not being supported in carrying
out these services.
“Almost everything which keeps on turning up, which bright sparks say
is important…in actual fact, that 1996 contract said pharmacists could help
with… and it was sitting there waiting for people to say now, how are we
going to help them do it?’
“So my question to most of the health service and to some extent to the
pharmacy organisations is — is it not time that we said this is how you can
help us to do this?”
Despite the fact that under the 1996 contract pharmacists are permitted
to carry out extended services such as medication reviews and patient
counselling it is not, according to Dr Henman simply a matter of expecting
“
….as a pharmacist, I am not sure
that I am prepared to accept that
someone is going to define…what it
is that I do. They should accept that I
am an expert around medicines and I
am therefore involved in patient care
around medicines,”
INTERVIEW
pharmacy to provide it. The reason why pharmacy has to date been
relatively slow to provide these services is he believes, a result of the
fundamental problem posed by the delivery of primary care in this
country, through two different strands of public and private care.
“
GMS
“There are two sets of incentives, determinants of professionals and
patient behaviour involved with those scenarios. GMS patients have no
reason not to visit their doctor and no reason not to seek a prescription.
The doctors who care for them have a great deal of demand placed upon
them. They would like to see a system for managing the relatively minor
symptoms and conditions that they [GMS patients] bring to them so they
can spend more of their time on the complex parts of their cases. They also
have a lot of discussion about how much they spend when they prescribe
for them. So when pharmacists try to get involved in that people say ‘well
the pharmacist is getting all these prescriptions so that should satisfy the
pharmacists’…in a sense it functions like the NHS in England,” Dr Henman
explained.
Pharmacist versus GP
“UTV runs adverts ‘Consult your pharmacist’, we never had that here because
the other group of patients pay to see the doctor, this is private medicine.
The introduction of the DPS scheme ensured that the prescribers had
no concern whatsoever about the cost of the medicines they prescribed,
because beyond a standard fee the State was going to pick up the rest. The
prescriber therefore has an interest in looking after the patient. They don’t
have an interest in doing it necessarily in a cost effective manner. If the
pharmacist is going to intervene in this it might change the frequency with
which that patient visits that doctor or it could even mean that patient feels
they should go to another doctor, so that sets up a conflict between the
pharmacist and the GP.”
On the converse Dr Henman asked why should pharmacists change
the habit of a lifetime? Why should they move from their pigeonhole of
purchasing and supplying, a place in which they have been restrained by
legislation, to one, which may bring them into conflict with prescribers? Why
should they provide additional services without being supported by the HSE
or indeed without even being paid for them?
Dr Henman believes that this stalemate persists as a result of the HSE and
the Department of Health’s approach to pharmacy.
“At the moment the approach of the Department and the HSE is more or
less to say ‘tell us what services you would like to provide, make a business
case for those services — if we like it, we will buy it. If we don’t, we won’t.
There are two things wrong with that from my point of view. The first is that
it implies that neither the Department nor the HSE knows what they want
pharmacists to do. And if they don’t know what they want pharmacists to do
then what are they doing running the health service?”
“The second thing is that if pharmacists engage with it, and I have a
concern that the 2020 document in a sense does almost that, it is a little bit
like going to the pick ‘n’ mix section of the supermarket, setting out a set of
services, costing them and the HSE and Department of Health come along
and pick the ones they want.
Well as a pharmacist, I am not sure that I am prepared to accept that
someone is going to define in that way what it is that I do. They should
accept that I am an expert around medicines and I am therefore involved in
patient care around medicines,” he stated.
It is this notion of the importance of patient care and the need for health
authorities to take a more holistic approach to pharmacy that Dr Henman
believes is crucial for the future development of the service.
Patient care
He also believes that one crucial component of the role of the pharmacist has
not been addressed to date. This is the need to view the patient, his or her
symptoms and the medicines prescribed or taken to treat the symptoms as
one whole concept.
“It is not possible to separate the medicine from the condition or the
symptom. You do not take a medicine in isolation from a symptom or a
condition...you take it because you have a symptom or condition and you
take it in a particular way because you think that it relates to how it works to
treat your condition. So if we are going to have a conversation we can’t have
a discussion about the medicine without talking about the condition.”
This is why Dr Henman said, all the Schools of Pharmacy have
systematically called for students to be taught more about medical
conditions and the link between how best drugs are used to treat them.
He also pointed out that evidence has concluded that the more a patient
understands this link the more compliant they tend to be in taking their
medication.
A further challenge facing the delivery of pharmacy services is the lack of
The Department nor the HSE knows
what they want pharmacists to do.
And if they don’t know what they want
pharmacists to do then what are they
doing running the health service?”
interaction between prescribers and pharmacists which Dr Henman believes
could be overcome by the creation of a ‘team’ made up of the prescriber, the
pharmacist and the patient.
However, he acknowledges that this would call for increased resources
in ICT infrastructure including the creation of a Unique Patient Identifier.
This he felt might be a while off, particularly given the current economic
environment. However, he felt it was important that the level of interaction
between prescribers and pharmacists was increased for the overall benefit of
patient care.
Universal healthcare system
Another way, which Dr Henman suggested could increase interaction
between healthcare providers, was the introduction of a universal healthcare
system. Coupled with the obvious equitable benefits of guaranteed access
to the health service for all based on clinical need, as opposed to our current
system, which is based largely on an ability to pay, the introduction of a
universal health system would also streamline the cumbersome methods of
payments currently in use for individual contractors such as GPs, pharmacists
and dentists.
“Given the fact that we now probably don’t have the money to pay for the
health service as it stands …we have to look at it again and say how best can
we provide healthcare within a reasonable budget?” he said.
Dr Henman also believes that having one central health system would
enable a more seamless delivery of care between and within primary care
and between primary and secondary care. This would replace the two
different health systems, (three if you count the hospital sector) we have
today, which he said are complicated by two different ways of pricing, two
different sets of incentives, two different sets of patient and practitioner
behaviour and two sets of sanctions.
“If you create a single system with certain add-ons, you can then create,
at least for the general level of healthcare, a more even system on which to
build a collaborative care model,” he explained
“Medicines are the most common used tool in all areas of the health
system. You can’t simply sit back and say we are going to let it run in bits,
which is what we are saying at the moment. Fundamentally, we have to look
at it and say; this is not necessarily about the role of individual practitioners,
it is about the care of patients. If it is about the care of patients, it is in our
interests to foster collaborative team based care. If that is the case we
therefore need a common system for remunerating and providing that care
— it is never going to be perfect and it never going to be exactly the same,
however, it would at least give us a fighting chance of getting it done.”
Issue 2 Vol 11 February 2009
19
view from above
Evolution in action
t er ry m ag u i r e
T
Irish Pharmacist’s Terry Maguire enjoyed a rare free
afternoon in London recently at the Natural History
Museum’s Charles Darwin exhibition
he vagaries of cheap air travel and the capriciousness
of meeting schedules recently conspired to place me in
central London with a few hours to spare. So I took this rare
opportunity to visit the Gothic cathedral that is the Natural
History Museum (NHM) and, in particular, to see the Charles
Darwin exhibition. In my youth, pathetically in the eyes of
my peers, Darwin was my hero; his simple but powerful idea
excited me sufficiently to make studying science a joy rather than a chore.
Recently, I have been drawn back to my childhood hero. This time in much
greater depth, given our vastly improved knowledge of his dangerous idea
that has appeared over the past 40 years. I have had excellent guides in the
likes of Richard Dawkins, Daniel Dennett and Steve Jones.
This year Darwin’s big idea is 150 years old and the more we test his
theory of natural selection as the engine for evolution of the species, the
more we are compelled to accept that, we humans, like the other animals
and the plants, have evolved and, more importantly, are still evolving.
Need for proof
His great-great granddaughter, the poet, Ruth Padel, expresses her
disappointment that too many people today choose not to believe in
evolution. Although not a scientist, she rightly feels that scientists, and I
include pharmacists in this privileged group, should do more to promote
and support scientific understanding.
Scientists use empirical observation to produce theories that are then
tested in the field and, if the theories don’t hold up, they are discarded. The
slate falling off the roof is proof of Newton’s Theory of Gravity, opening the
doors of a Boeing 747 at 37,000 feet while travelling at 620 miles per hour
over the ground would be an impressive, yet fatal, proof of Einstein’s Theory
of Relativity.
Why Darwin’s theory elicits such popular resistance, in spite of our
inability to disprove it, is not down simply to religious belief, rather it seems
people just don’t like the idea that they evolved from apes. Such vanity
could only be human.
Of microbes and men
There is much to stimulate at the NHM Darwin Exhibition. In essence,
evolution is about variation, inheritance, selection by the environment and,
of course, time. Generally the process needs plenty of time. For a species
that lives a number of years (never mind the three-score and ten normally
attained by humans), time is the reason we fail to see evolution in action. Yet
this is not so for microbes.
For me, there was a special resonance in a small section of the exhibition
on drug-resistant microbes and viral mutation. Our current problems with
MRSA and Clostridium diff. and our worries about pandemic and avian flu
are problems pharmacists know all too well yet these are really problems
of evolution in action, a proof of the great man’s big idea, and an angle on
these clinical challenges I had not before appreciated.
As a species, humans have been successful through use of their intellect in
fighting infection in practical ways but, in general, these living agents prove
more tenacious than we would like. Life is hard to kill and this is the secret of
evolution.
Pharmacologically speaking
Another linked aspect of the exhibition I found fascinating was co-evolution.
Too often we are fooled into thinking that two species were made for each
other when, in fact, and over geological time, this perfect fit has just come
about by means of a wasteful process. The honey bee that perfectly fits the
flower, the bat with the ten inch tongue that neatly reaches the bottom of
the ant hill.
The most poisonous salamander in the world, an animal the size of a frog,
has enough toxin to kill 100 people and it has evolved this level of toxin in
an attempt to avoid being eaten by its main predator, the snake. The snake
in turn has evolved a resistance to the toxin so that it can gobble down the
salamanders with impunity; such poisons are the basis of pharmacology.
20
Issue 2 Vol 11 February 2009
Intriguing history of HIV
For humans there are many such examples of co-evolution. Sickle cell
anaemia and thalassaemias are diseases that are the result of genetic
attempts to out-wit malarial infection and Tay-Sachs disease, a similar
process in surviving TB infection.
The proposition put forward by Steve Jones in his book The Language of
the Genes that HIV had existed for many years in the human population in
East Africa I found particularly intriguing. The population in this corner of
Africa was generally monogamous and the virus needed to keep a host alive
long enough until he or she had a second sexual contact. Only with sexual
excess came the opportunity to infect multiple partners over a shorter
period of time and this seems to have been the spur for the virus to evolve
into a more virulent and deadly form.
Disgraceful attack
It is often said that nothing in biology makes any sense other than in the
context of evolution. The more we look, the more we find that Darwin was
right. Yet an increasing number of educated people, particularly in the US,
are unwilling to accept the science and, for me, this is hugely disappointing.
The distain and contempt with which science is treated exists among
pharmacists as exemplified by those who attacked Professor Edvard Ernst,
Professor of Complementary Medicines in the UK’s Pharmaceutical Journal in
July 2008 when he was attacked for saying pharmacists were unprofessional
for selling homeopathic remedies. Pharmacists are scientists and we have
a public responsibility to respect scientific discipline and improve its public
understanding.
Final irony
I was glad I had to rise at 5.00am to catch the flight that got me to London
too early and sorry the afternoon meeting wasn’t cancelled so I could
remain among my childhood hero’s specimens and personal belongings. As
I left the NHM, I thought of the irony of housing Darwin’s things in a building
that looks like a religious institution.
Terry Maguire owns two pharmacies in Belfast. 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.
the coalface
Making a difference
dav i d j o r da n
T
While pharmacists may not change the world, they can make
a real difference in the lives of their patients and, for Irish
Pharmacist’s David Jordan, this realisation has made all the
difference.
here are times when most of us sit down and ask: “What’s
the point of all this?” or “How did I end up here?” or “What
difference is my being a pharmacist making to the world?”
It seems that not so long ago, we were sitting down to
fill out our CAO forms, with or without help from family or
school. What made us put ‘pharmacy’ as choice number
one? And it nearly always was the number one choice.
Those who got the points for pharmacy usually end up
getting their number one choice.
Upstairs downstairs
Well for me the choice was a simple but a misguided reason: money! A
pharmacy that I passed on my way to school every day always had a shining
new Mercedes parked outside. The callous 16 year old inside me thought:
yes, I’ll have one of those. This sadly was misguided as the Mercedes
belonged to the doctor who had a surgery over the pharmacy and not to
the pharmacist! He drove a more mundane family saloon, which he parked
around the back. But when I sat my Leaving Cert in 1978, these thoughts
were far from my mind.
Even as I waited for my Leaving results, I wasn’t too bothered. Like many
potential pharmacists, I had a choice of alternative careers. I had already
been offered a post with the then Department of Posts and Telegraphs and
with one of the banks. To this day, I still can’t see myself as a civil servant
(working for the HSE perhaps) or a banker. So for better or worse, I ended
up as a pharmacist and I set out to make my mark on the world.
25 years later
So now, 25 years later, I sit down with my metaphorical pipe and slippers
and ask what difference to the world have I made? And to be brutally frank,
not a lot. But then on thinking about it further I realised that the differences
I’ve made have been on a person-to-person level rather than on a world
scale. As a pharmacist, I endeavour to give everyone who comes into my
pharmacy the best possible service. A lot of the time all you get is a polite
thank you and no indication of any difference that you have made to that
person. But every now and again there comes along someone like Mary.
“
So now, 25 years later, I sit down
with my metaphorical pipe and
slippers and ask what difference
to the world have I made?
There’s something about Mary
Needless to say Mary is not her real name. She is a resident in a nursing
home. She has been and is still suffering from severe chronic back and
bone-related pain. Some time back, she returned to hospital for an
outpatient appointment. She was prescribed a new pain-killing patch.
When she returned, the nursing home contacted me and asked me to
send up some of the patches. A quick check revealed that they were an
unlicensed medicine, not readily available and not covered by the medical
card.
I telephoned the home to inform them of this and told them I would see
if I could get them. No big deal, I’ve sorted out ULMs many times. We all
know the drill. Ring the wholesalers to find out about availability and price,
fax and then post the details to the Health Board looking for an order form.
When that is forthcoming, fill out the paperwork for the wholesaler and sit
back and wait. So I did all this and everybody came up trumps.
By the following afternoon I had the patches. I delivered them to the
nursing home that evening on my way home making sure that they were all
acquainted with the directions for their usage. I didn’t think much more of it
until the month end when I processed the paper work in order to get paid.
22
Issue 2 Vol 11 February 2009
Thank you letter
Then it arrived. A typed thank you letter and a handwritten thank you card
from Mary. Two sentences from the letter summed it all up. “I slept all night
with the patch . . . Jordan’s Pharmacy will not close down as long as I’m
alive.” Now I’m a bit of a hard chaw but even I was touched by this.
A few weeks later, I was in the nursing home sorting out a few bits and
pieces. I called over to talk to Mary and again she was full of thanks. I tried
explaining that it was all just part of the job for me but she was having
none of this. I made the difference as she now gets a night’s sleep. I was
a bit embarrassed as there was no mention of the doctor who diagnosed
and prescribed the appropriate treatment or the nurses who apply it every
night. To me it was just doing my job but to Mary it was the difference
between a restful night and a sleepless one.
Help is at hand
I don’t think that this is an unusual case. We, as pharmacists, all do things
like this every day. Everything we do for our clients is done with the goal of
making their lives better. It doesn’t matter if it is making them feel better
physically or mentally or just making their lives easier by taking some of
the hassle out of it. Much of the time we may never see or hear from the
client again and often we will follow the client through their illness to
recovery. It’s hard to know exactly how much difference we as pharmacists
are responsible for with each individual but, be rest assured, we do make a
difference.
Mary’s case was slightly exceptional as she put her gratitude into
concrete form. And, in that way, she made a difference to me. Her thank
you card made me feel good inside. As I put away my metaphorical pipe
and slippers for another day, I can say to myself “Yes I did make a positive
difference for at least one person.”
Battle roar
I keep it pinned up over my desk. So now when I get days when the HSE
takes another swipe at pharmacy and does its best to close us down, I take
a look at Mary’s letter and card. I flex my shoulders and stiffen my chest and
let roar “Come on Professor Dum Dum, give it your best shot!”
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 www.
irishbikerforum.com
A body
of evidence
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Enriched with added free arginine, it stimulates tissue repair
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Prescribe Cubitan and see the evidence yourself.
1
Soriano et al. The effectiveness of nutritional supplementation in the healing of pressure ulcers. Journal of Wound Care. 2004 Vol 13(8)pp.319-23
2
Benati et al. Impact on pressure ulcer healing of an arginine enriched nutritional solution in patients with severe cognitive improvement. Acch. Gerontol Geriatr. Suppl 7 2001; 43-47
Block 1 Deansgrange Business Park,
Deangrange, Co Dublin
Tel: 01 2890283
Email: [email protected]
SHORT STORY
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“
Unfortunately our people are living longer.”
Mary Hanafin, a Minister of State, said that on 15
October 2008 on RTE. This column is supposed to
be creative, perhaps light hearted, but something
is rotten in this State and I feel that I have to say it.
I am going to focus on Hanafin’s use of the words
“our people”. Mary, I know your use of words was
unfortunate and that you didn’t mean it literally,
but your little Freudian slip cuts to the heart of
what’s rotten. At least Antoinette was honest with “Let
them eat cake.” It’s 200 years later but the attitude is still the
same.
Here’s a story for you Mary. It’s not creative. It’s true and
it’s about one of our people who, unfortunately you have
to deal. Just as unfortunately you have to deal with the fact
that our people are growing older.
A story for Mary
A man called Christopher (not his real name) is currently
in Mountjoy for drug dealing. In 1992, Christy was a boy
of about six with a father who didn’t exist and a drunken
mother who did. Christy would wander our shopping
centre car park. The cobble lock was broken outside the
pharmacy and Christy spent his time playing with the
bricks. I’d arrive to open up and there he’d be, as cold as his
future.
For a week during the winter of 1992, we adopted Christy.
Probably out of guilt but we did. He loved ‘facing off’
shelves; everything just had to be so straight. Lisa bought
one of those jotters with the red and blue lines and tried
to teach him to write his name. A few days later, the social
services took Christy over. Despite their efforts, he ended
up in Mountjoy. What chance did he ever have?
Second adoption
Ten years later, we had a second Christy. He was about 60
years old and drove the local school bus. It was one of those
bus runs that wandered through the hills and dropped you
right to your door. He’d had the job for years. The route
was franchised out and Christy was let go. He couldn’t get
further employment. His only training was to be helpful. He
descended into a spiral of depression and, dull with drugs,
he’d wander the same car park like his juvenile namesake
had done 10 years earlier. The local bakery gave him free
lunch and we let him sit in the pharmacy drinking tea. He’d
sit there for ages.
One thing though, he always gave that seat up for a
pregnant woman or elderly patient. Christy was well
brought up. I guess you could say we adopted him.
Orphans are good for an establishment. They remind the
hardy of their frailty but, above all, they awaken a social
conscience.
SHORT STORY
Who are our people?
They come into our pharmacies every day. They are our
elderly, our parents, mothers and fathers who will pay for
new
nap
py r
ash
20g t
rave
avail l pack
able
ts
rea
Sacred cows
Thirdly we (that’s our people) have just paid eight billion to
bail out a system of financial Fairy Liquid. I have a question
for Mr Sean Fitzpatrick of Anglo Irish Bank - what did you
mean when you said: “It’s time to tackle the sacred cow of
child benefit, state pensions and medical cards for the over
seventies?”
Believe me our people’s bailout of your financial Fairy
Liquid has ‘tackled’ your sacred cows. Point is they were
your sacred cows, but it’s our money. Do you understand
that, Sean?
Our people have paid through the nose for planning
tribunals to be told what we already knew. Just say to our
people: ‘We wanted to make money. We had the position
of power and basically if a developer wanted to build
something, well anything really, he just bribed us with
cash and we fixed it. As regards our people, well we didn’t
care. Schools, hospitals, whatever; they didn’t come into it.
Basically we got bribed per house. The more houses, the
more cash for us. We just didn’t care.’
That’s another waste of our people’s taxes; no schools,
welfare, medical care, social services, roads, hospitals. For
our young and our old Christies.
Julian Judge qualified as a pharmacist in 1990. He has recently completed a Masters
in
Creative Writing
at the Department
EnglishPage
at UCD.
Caldesene
A5IP 1/'09
19/1/09 of
14:34
1 Contact Julian at email:
[email protected]
&t
Credibility deficit
Archbishop Diarmuid Martin, who has inherited an
unenviable position none of which is his doing, spoke
recently of the “credibility deficit” and how being a bishop
these days can be “very frustrating”. And I quote: “As we
have seen in these days, we have to face scandals, or better
said we have to face the scandal of the suffering of our
people whose trust in the Church was abused and then not
recognised.”
He equates this to a credibility deficit. Exactly what is a
credibility deficit? Look at the basic reality of what is not
said.
This is what Diarmuid Martin’s statement equates to in
my opinion: as an institution (whose special position was
recognised in your constitution until 1973) we aided your
devotion. You trusted us, gave us money every week, gave
us your children for education. In fact, you did anything we
asked you to. Some of us abused your children. Each and
every other member of our institution knew absolutely
nothing about this. When forced to, we had to be dragged
to give any sense of basic acknowledgement. Money has
had to be paid in compensation to those whom we abused.
We are grateful that you, our people, have bailed us out in
this regard with your taxes.’
That’s what a credibility deficit means. Anything else is
divine Dettol.
The point here is that our people paid for this; over a
billion euro and still counting. That’s a billion euro of
less education for our people (the young Christies) or less
medical care for our people who unfortunately are living
longer.
this with their health. They are our children, our hope, our future who will not have what our
parents’ generation worked for. They are our teachers who will have less to work with, back to
prefabs, fill out a requisition form to get the roof repaired.
Our nurses with less to care with, watching the elderly waiting on trolleys beside closed
wards full of empty beds. Our workers, be they private or public, legal or illegal (yes I did say
that). Our people are all around us.
Our people, Mary, who are growing older, built this country. From our hospice nurses to
our baby infant teachers, our mothers who stayed at home or who went to work, fishermen,
farmers, guards, our armed forces, the list is endless.
Watch our people come into your pharmacy and see them separate the euro from the fifty
cent and believe me they will. Their fingers won’t be greasy. You’ll see their broken dreams in
the dirt of their bitten fingernails.
As I said Mary, I know you did not mean it literally, but here’s the monkey, or the rat: you
didn’t say ‘Fortunately our people are living longer and therefore …‘
nts
Anarchy in Ireland
The people, our people of this country have been raped of
their basic humanity by the status quo of the Establishment.
It’s been boiling and this sore is about to burst. A piece of
me hopes it does.
The politically correct cliché has entered our lives. It
presents itself as some sort of divine Dettol or financial Fairy
Liquid which cleans and respects our basic intelligence
in the same way as you wipe a toilet after use. Instead of
considering what the status quo says (or apologises later for
how they might have been misinterpreted) consider what it
doesn’t say.
e
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2008/ADV/Cal/025
the law
Bonus Schemes –
Co r m ac O’N ei l l
a rewarding experience
for everyone
Cormac O’Neill on why staff incentives and bonus schemes are a good idea
and should not be culled, even in these difficult times
S
ometime ago I attended a meeting of the directors of a pharmacy
chain called together to identify options for saving money. The
business had grown very successfully over the past eight years,
however the onset of the global economic turmoil had presented it
with an unexpected challenge of getting to grips with its cashflow
fast.
“
Bonus cuts or job losses?
The business had availed of overdraft facilities, which it feared were no
longer as reliable as before. I was attending in my capacity as an external
adviser as I am a chartered accountant and a barrister with many years’
experience of this particular industry. As the meeting progressed, it became
apparent that staff costs were an area that could be tackled to provide
a benefit to the company. It was the feeling of those present that cash
could be saved in this area without hurting the company’s viability in the
future. The executives discussed not paying bonuses or other incentives
in preference to identifying jobs which could be made redundant as
redundancies were considered to be the only other option available.
On the face of it, this made sense. After all, it is reasonable to assume
that individual employees would rather lose this year’s bonus than face
redundancy. As the meeting progressed, the idea quickly ran into difficulty.
One of the managers said she had used the bonus scheme to great effect
since her promotion to senior management and she was very reluctant to
have it taken away.
If people feel that they are being
managed and listened to fairly, they are
much more likely to accept bad news
and constructive feedback.
She explained that she saw her role as a manager encompassing three
main responsibilities: planning the work of the shop, controlling its
operation and quality and recording forecasts and actual results. As the
discussion progressed, comments were made about how effective the
scheme had been at encouraging the pharmacists and other staff to adapt
their work on how to suit the organisation’s needs. The pharmacists are all
highly accomplished, well educated and responsible with their own views
on research, budget management and how and when to communicate with
colleagues and managers. The bonus scheme had been used to increase the
accuracy of information recorded, self-initiative, teamwork and the focus on
customer care and quality control.
Important incentives
The manager went on to explain that the bonus scheme, along with other
incentives offered by the company, were much more than salary which
could be cut back in difficult times. She added that such reward schemes
were important to the proper functioning of a chain of pharmacies, which
employs staff without a primary degree in business management or
executive responsibility for business and strategic matters.
Many of the incentives offered by organisations to manage staff
performance are not cash based. Rather they may include share awards,
deferred bonuses for up to five years, stock options, gifts and holidays. These
incentives do not cost the company very much and therefore doing away
with them will not save the amount management might think possible.
On analysis of the envisaged saving, it is discovered that the overall reward
would not be worth the drawbacks of cutting the bonus and incentive
scheme.
26
Issue 2 Vol 11 February 2009
In fact, the bonus system had been so successful that there was a
suspicion that it could have, in fact, generated more cash for the company
than it had cost. The reason for this was because one of the targets asked of
employees was to identify cost avoidance measures. Many of the salaried
pharmacists and administrative staff really bought into this idea. They had
been very inventive and proactive in challenging expenditure and had often
found new ways of performing routine tasks, which cut down on incurring
costs.
Rip-off Ireland?
It was very interesting for me to hear that some staff considered Ireland to
be a “rip-off economy”. Many saw paying for overpriced supplies as simply
the wrong thing to do, leading them to challenge everything from the cost
the company was paying for their coffee to almost re-engineering the way
the shop dispensed medicines.
The bonus system rewarded them for this behaviour and they achieved
status for getting good results. Successful staff ideas for cost control were
announced publicly and praise was given by managers, directors and
colleagues.
Slowly those attending the meeting started to realise that, instead of
doing away with incentive schemes to save money, they should, in fact,
consider extending them to improve staff participation in the management
of a very difficult period ahead.
Setting up a bonus scheme
Successful bonus schemes are always led from the top and are therefore
championed by the managing director. The benefits to the organisation
are clearly understood by the board of directors, pharmacists, managers
and staff. A formal incentive scheme must be controlled by a properly
established committee, which can assess each employee’s contribution.
It is also imperative that the scheme and its objectives are fully
communicated to every employee before, during and after each period of
assessment. Every effort should be made to ensure that bias on the part of
the people assessing performance is fully eliminated. One way of limiting
bias is to have a number of people make the assessment together. If people
feel that they are being managed and listened to fairly, they are much more
likely to accept bad news and constructive feedback.
Target time
When employees are set targets, which both they and the organisation
value, the likelihood is that the outcome will be successful which will serve
to motivate staff to achieve set targets. If, however, the employee perceives
that the target is unrealistically ambitious, they are likely to become
demotivated.
A bonus system should encourage all staff to become more involved with
the business and apply their knowledge, education, skills and know-how to
the problems the company may be facing.
People have been described as the lifeblood of a company because
they have the ability to keep the organisation alive and healthy. Any
organisation’s staff is possibly its greatest resource and every effort must be
made to harness this resource for the collective good. Bonus and incentive
schemes have the potential to facilitate the management process necessary
in these difficult economic times and at all other times too. Any proposals to
cut back on bonus schemes are likely to be counterproductive.
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.
Ireland’s No.1
prescribed anti-depressant.
1
Active response for
effective treatment
2,3
of depression.
• Major Depressive Episodes • Generalised Anxiety Disorder • Social Anxiety Disorder • Panic Disorder • Obsessive Compulsive Disorder 4
Abbreviated Prescribing Information: Please refer to the Summary of Product Characteristics before
prescribing. Presentation: Lexapro™ tablets 5 mg, 10 mg, 15 mg and 20 mg containing escitalopram
as the oxalate. Indications: Treatment of major depressive episodes. Panic disorder with or without
agoraphobia. Social Anxiety Disorder. Generalised Anxiety Disorder. Obsessive Compulsive Disorder.
Dosage: Treating depression: Adults: Usual dosage is 10 mg once daily. The dose may be increased
to a maximum of 20 mg/day. Panic Disorder with or without agoraphobia: An initial dose of 5 mg
is recommended for the first week before increasing the dose to 10 mg/day. The dose may be further
increased, up to a maximum of 20 mg/day. Social Anxiety Disorder: Usual dosage is 10 mg once daily.
The dose may subsequently be decreased to 5 mg or increased to a maximum of 20 mg/day.
Generalised Anxiety Disorder: Initial dosage is 10 mg once daily. The dose may subsequently be
increased to a maximum of 20 mg/day. Obsessive Compulsive Disorder: Initial dosage is 10 mg
once daily. The dose may be increased to a maximum of 20 mg daily. Elderly (>65 yrs): Initial
treatment with half the usually recommended dose and a lower maximum dose should be considered.
The efficacy of Lexapro in social anxiety disorder has not been studied in elderly patients. Children
and adolescents (<18 years): Not recommended. Reduced hepatic/renal function: In
mild/moderately impaired hepatic function an initial dose of 5 mg/day for the first two weeks of
treatment is recommended, the dose may be increased to 10 mg/day. Caution and careful dose
titration advised in patients with severely reduced hepatic function. Dosage adjustment is not
necessary in patients with mild or moderate renal impairment. Caution is advised in patients with
severely reduced renal function (CLcr<30 ml/min). Contraindications: Hypersensitivity to
escitalopram or to any of the excipients. Concomitant treatment with a nonselective, irreversible
monoamine oxidase inhibitor (MAOI). Concomitant treatment with a reversible MAO-A inhibitor e.g.
moclobemide or reversible non-selective MAO-inhibitors e.g. linezolid. Lexapro may be started 14 days
after discontinuing treatment with an irreversible MAOI. At least 7 days should elapse after
discontinuing Lexapro treatment, before starting a non-selective irreversible MAOI. Pregnancy and
Lactation: Lexapro should not be used during pregnancy unless clearly necessary. Neonates should be
observed if maternal use of Lexapro continues into the later stages of pregnancy, particularly the third
trimester. Abrupt discontinuation should be avoided during pregnancy. Refer to the full prescribing
information for a list of serotonergic or discontinuation symptoms, which may occur in the neonate
after maternal SSRI/SNRI use in later stages of pregnancy. Breast-feeding is not recommended during
treatment. Precautions: Patients should be cautioned about the risk to their ability to drive a car and
operate machinery. No pharmacokinetic or pharmacodynamic interactions are expected with
concomitant alcohol intake, however the combination is not advised. Combination with serotonergic
compounds is not recommended. Insulin and/or oral hypoglycaemic dosage may need to be readjusted
in diabetics. Hyponatraemia has been observed rarely with SSRI use, caution required in patients at risk
of hyponatraemia. Caution is advised with coadministration of ECT and in patients with a history of
mania/hypomania. Caution advised with concomitant use of oral anticoagulants, products affecting
platelet function and in patients with known bleeding tendencies. Avoid in patients with unstable
epilepsy and monitor patients with controlled epilepsy. Stop treatment immediately if patient
develops serotonin syndrome. Use at a low starting dose for panic disorders. Avoid abrupt
discontinuation. Gradual discontinuation by dose tapering is advised.As with all SSRIs it is advisable to
closely monitor patients for suicide and self-harm risk in the first few weeks of treatment and until
significant remission occurs. Caution is advised in patients with coronary heart disease. The use of
SSRIs/SNRIs has been associated with the development of akathisia, increasing the dose in these
patients may be detrimental. Drug Interactions: MAO inhibitors (see Contraindications/ Precautions),
advise caution in use with irreversible selective MAO-B inhibitors (selegiline). Caution in use with
lithium, tryptophan, serotonergic medicinal products or with products capable of lowering the seizure
threshold. Avoid concomitant use with St. John’s Wort. In known poor metabolisers, with respect to
CYP2C19, an initial 5 mg/day dose should be used, which can be increased to 10 mg after assessment.
Caution is advised with co-administration of drugs metabolised by enzymes CYP2C19 and CYP2D6.
Co-administration with CYP2C19 inhibitors, and general enzyme inhibitors e.g. cimetidine may require
reduction of the Lexapro dose. Caution recommended with concomitant use of products metabolised
by CYP2D6 with a narrow therapeutic index and those metabolised by CYP2C19. Adverse Events:
Adverse reactions are most frequent during the first or second week of treatment and usually decrease
in intensity and frequency with continued treatment. Very Common (≥1/10) & common (≥1/100 to
<1/10) adverse drug reactions are listed below. Frequencies are not placebo-corrected. Very
Common: Nausea; Common: Decreased & increased appetite, anxiety, restlessness, abnormal dreams,
libido decreased, female anorgasmia, insomnia, somnolence, dizziness, paraesthesia, tremor, sinusitis,
yawning, diarrhoea, constipation, vomiting, dry mouth, sweating increased, arthralgia, myalgia,
ejaculation disorder, impotence, fatigue, pyrexia, weight increased. Overdosage: Clinical data on
escitalopram overdose is limited and many cases involve concomitant overdoses with other drugs.
Doses between 400-800 mg of Lexapro alone have been taken without any severe symptoms.
Symptoms seen in reported overdose of Lexapro mainly relate to the central nervous system, the
gastrointestinal system, the cardiovascular system and electrolyte/fluid balance conditions. There is no
specific antidote. Treatment is symptomatic and supportive with monitoring of cardiac and vital signs.
Gastric lavage and the use of activated charcoal should be considered. Legal Category: POM. Product
Licence holder: H. Lundbeck A/S, Ottiliavej 9, DK-2500, Copenhagen – Valby, Denmark. PA Numbers:
5 mg PA805/2/1; 10 mg PA805/2/2; 15 mg PA805/2/3; 20 mg PA805/2/4. Further information is
available upon request from Lundbeck (Ireland) Ltd., 7 Riverwalk, Citywest Business Campus, Citywest,
Dublin 24.‘Lexapro’ is a trademark ™ 2002 Lundbeck Ltd. Date of preparation: May 2008. References:
1. Combined IMS Hospital and IRLP Data (Unit Sales) YTD March 2008 2. Gorman J, et al. CNS
Spectrums 2002; 7 (Suppl 1): 40-44 22. 3. Wade A, et al. (2006), Curr Med Res Opinion; 22(11)21012110. 4. Lexapro (Escitalopram) Summary of Product Characteristics.
LX3/5/08
finance
The glass is half full
Iain Cahill
In a refreshing bout of optimism, Irish Pharmacist’s financial expert, Iain Cahill,
reminds us that more millionaires were created during the Depression in the
1930s in America than at any other time in US history.
B
y now, we are all well settled into 2009 as a business
year and are reflecting on our New Year’s resolutions
and progress (or not) to date. If you would kindly
indulge me, I would like to take the opportunity to
share some of the thoughts that are evolving at present
within both our own business and those of our clients.
You may see some similarities as to how you are
approaching your own business and family financial
planning in light of the evolving marketplace.
Within our core financial planning both for
ourselves and some of our clients, the key trends and
conversations are broadly focusing on three themes.
Tax management
The government has clearly indicated that, as long as the current economic
climate prevails, we are all in for a sustained period of increasing taxation,
regardless of how we earn our money. Already in the 2008 budget, most of
which has been brought in at this stage, we have seen:
•
An increase in the VAT rate from 21 to 21.5 per cent.
•
An increase in deposit interest rate tax (DIRT) from 20 to 23 per cent.
•
Capital gains tax (CGT) raised from 20 to 22 per cent.
An income tax levy of 1 per cent imposed on incomes greater than
€17,542 (the average industrial wage); which increases by 1 per cent where
household income is greater than €100,000.
While there have been other changes, the above not only gives you a
flavour of what has happened but, more importantly, helps you recognise
that virtually everyone is affected by these changes. Those of you who
have read previous articles of mine in Irish Pharmacist are familiar with my
thoughts regarding the current system, which actively encourages all of us
not to plan our taxation but simply to accept the reality of paying a tax bill.
However, now more than ever, the need for active tax planning will be
much more important. Far too often I come across occasions where planning
first and executing a financial decision second would have yielded a much
better result for a client. Do not let that be you in 2009. While I do not share
the over-pessimism that exists right now, money will be harder to earn this
year and will need to be better minded than ever before.
Risk management
When people consider risk management, for most of them it refers to
investment-oriented thinking. While this will always be valid, some of the
investment outcomes I am seeing for people suggest that the concept of risk
has not been fully explored. What do I mean by this? Firstly, let us consider
the traditional thinking about risk protection:
•
•
•
All long-term debt should adequately be insured.
All income should be protected.
Any gap in the difference between the value of your assets and your
desired lifestyle income needs to be insured to protect your family.
Many of you may already be doing this. But what about some of the
areas that are not truly discussed or may not be properly understood? For
example:
•
•
•
•
28
Ensuring that the business can continue in the event of death or
accident;
Planning for the succession of the business;
Using the economic climate to create estate planning opportunities
and reduce long-term taxation issues; or
Ensuring that the proper legal structures exist to protect you and your
family in the future.
Issue 2 Vol 11 February 2009
By now we have all heard of winners and losers from the change in the
economy, but how many of the losers could have been helped through
proper risk management? The road to financial freedom is both rewarding
and challenging, but it doesn’t make sense to put roadblocks in the way by
increasing the risks associated with the journey.
Cash flow management
There is no doubt that when you look at the implications of both increased
taxation and the need for greater risk protection, all this has a bearing
on how to manage cash flow for both your business and your family’s
requirements. In early 2009, you should look to focus on maintaining or
growing your income with less financial cost than you currently have. Not an
easy trick I hear you cry (or words to that effect)!
Agreed, but this is where I have been putting my thoughts for the last
couple of months as I look to personally achieve two financial objectives
– firstly to take advantage of the current opportunity with regards to
reducing interest rates and, secondly, to take advantage of the investment
opportunities that will present themselves in 2009. Baron Rothschild is famed
for saying that the time to buy is when there is blood on the streets. While we
are not back at the stage of the French Revolution, it is worth remembering
that more millionaires were created during the Depression in the 1930s in
America than at any at any other time in US history.
Overcoming relentless pessimism
Over the coming months, I aim to flesh out each of these themes in greater
detail to give you ideas about how you can make changes within your
own financial planning. While there is no substitute for actually seeking
and receiving advice from specialists, at least you will have the basis for a
conversation about how to act in the current climate rather than react to the
relentless pessimism that is being portrayed right now.
Good luck on your continued journey to your family’s financial freedom.
Financial Engineering is regulated by the Financial Regulator.
Iain Cahill ACCA MBA QFA, Director, Financial Engineering, 32 Upper
Fitzwillam Street, Dublin 2. Tel. +353 1 614 8000; direct fax +353 1 614 8080;
email: [email protected]; web: www.fen.ie
Europe’s Leading Contract Sales
& Marketing Organisation
Q&A
Pro fes s o r M a r ek R a d o m s k i
Professor Marek Radomski is the Head of the School
of Pharmacy and Pharmaceutical Sciences and
Professor of Pharmacology at Trinity College Dublin
(TCD).
Originally from Poland, he studied medicine
at the Jagiellonian University in Krakow where
he also successfully completed a PhD in
pharmacology. Prof. Radomski has worked in
Canada and the US where he held the positions
of Professor, Department of Pharmacology, and
Adjunct Professor, Department of Obstetrics
and Gynaecology at the University of Alberta,
Edmonton. In the US he was Professor, Department
of Integrative Biology and Pharmacology, and
Director of the Vascular Biology Section, Institute
of Molecular Medicine for the Prevention of Human
Disorders at the University of Texas, Houston.
A multi award-winning researcher and scientist,
Prof. Radomski is also widely published and his
research interests include: nanopharmacology,
nanotoxicology nanoparticles, platelets,
inflammation and cancer.
Q. What other career might you have chosen?
A. Journalism.
Q. Which figures in Irish life (living or dead) do you admire and
why?
A. President Mary McAleese: a compelling example of an academic
who became a great statesperson. I admire her for her unassuming
yet influential way of office.
Q. What is the one thing you would suggest to improve the Irish
health service?
A. Unfortunately, there is no single magic bullet to improve the Irish
or any other national health service. A universal, free-of-charge
health service is the best that we have invented to date, but it is very
costly and requires constant investment and support. In pharmacy,
it would be worth considering prescribing rights for pharmacists in
Ireland.
Q. What is your earliest memory?
A. Standing in front of four doors in our new house and asking:
where is my mummy?
Q. What is your greatest fear?
A. That the funding for higher education and research in Ireland will
be cut even more this year.
Q. When and where were you happiest?
A. This Christmas playing peek-a-boo in Toronto with our 18 monthold granddaughter, Bella.
Q. What would your superpower be?
A. Super flying ability to get me and my wife once a week to Toronto.
Q. What is the worst job you have ever done?
A. I guess I have been lucky so far, and have no complaints.
Q. What is your best trait?
A. I like people around me.
Q. What is your most unappealing habit?
A. Ask people around me . . .
Q. What trait do you most dislike in others?
A. Lack of reliability and punctuality.
Q. Do you use alternative medicines? What kind?
A. No I do not. I am an old-style pharmacologist.
Q. Cat or dog?
A. I like both.
Q. What keeps you awake at night?
A. Unsolved work or home problems.
Q. Who or what makes you laugh?
A. Our granddaughter any time of day or night, sharing laughs with
other people.
Q. Who or what is the greatest love of your life?
A. Always my wife, but now she and Bella.
Q. How do you relax?
A. Good books, a glass of Rioja (especially when shared with friends),
walks by the sea and watching Spanish football team, La Liga.
Q. What word or phrase do you overuse?
A. Crucial.
Q. Favourite TV/radio programme?
A. BBC World Service and Sky Sport for coverage of Spanish soccer.
Q. Favourite film and book?
A. Milos Forman’s movies, such as Amadeus and One Flew Over the
Cuckoo’s Nest. Isaac Asimov’s science fiction books, such as I, Robot.
Q. What is your motto?
A. Nulla dies sine linea (no day without a line).
Q. How would you like to be remembered?
A. As I am.
Issue 2 Vol 11 February 2009
29
First Irish online reference site devoted to promoting self care
www.yourmedicines.ie
New site lists all leading Irish non-prescription medicines
Site also contains information about illnesses and the proper use
of OTC medicines available for their treatment.
Edited by Dr Martin Henman, the new site not only acts as
a reference guide for pharmacists and other healthcare
professionals, it also aims to encourage the public in the correct
approach to self-medication.
www.yourmedicines.ie will be supported by an online
advertising campaign along with promotion in mainstream media.
e-pharmacy
Holy Grail of Irish health
june shannon
The introduction of Ireland’s first ever Health Information Bill will be a further step
towards the holy grail of an Electronic Health Record System. June Shannon reports.
“
It is essential that the pharmacist
has access to the patient’s full
medicinal therapy history, including
prescription and non-prescription
therapies in order that they can
counsel patients appropriately on
the use of their medicines.” The
Pharmaceutical Society of Ireland,
in its submission to the Health
Information Bill.
The Department of Health, in cooperation with the HSE and the Health
Services National Partnership Forum,
held a major consultation exercise on
the proposed Health Information Bill
last month. This involved workshops
with approximately 100 members
of the public drawn from diverse
backgrounds, ages and interests.
According to the HSE, it is intended
that the new Bill will deal with “the
collection, use, sharing, storage
and disclosure of personal health
information as well as the rights of
individuals in relation to their health
information”.
The main purposes of the Bill will be:
to provide clear legal rules to enable
information - in whatever form; to be
used to enhance medical care and
patient safety throughout the health
system; to strengthen patient rights
in relation to their information; to
facilitate the greater use of information
technologies for better delivery of
patient services; and to underpin an
effective information governance
structure for the health system in
general.
Secure footing
In June 2008, the Department
advertised for submissions on the Bill
and received over 60 from a wide range
of bodies including hospitals, research
and teaching institutions, health
professional and consumer bodies and
government agencies. One of these
was the Pharmaceutical Society of
Ireland (PSI).
The Department of Health has
published a synopsis of the submissions
it received on its website and according
to the document “there was a very
positive welcome for the proposed
Health Information Bill. It was seen as
timely and necessary: for placing the
processing of health information on a
secure footing, and for bringing muchneeded clarity and consistency into
the legal framework within which this
processing occurs.”
Security measures
There was widespread support among
the submissions for the underlying
principles and objectives of the
legislation, especially the proposals to
(a) introduce a Unique Health Identifier,
(b) support the establishment of
population registers, (c) clarify the
diverse legal and ethical rules on using
and disclosing information and (d)
define “personal health information”.
According to the synopsis document,
while the general view was that the
Bill would impact positively on the
health of the whole population, it was
considered important that patient
information collected should not be
used or disclosed in manner that would
facilitate discrimination – intentionally
or unintentionally — against any group.
Not surprisingly “security, a changed
cultural attitude in organisations
towards safeguarding patient
information and genuine accountability
and punishment for breaches of rules
emerged as the biggest issues in the
submission process”. Therefore the
submissions expressed “strong support
for upholding principles of privacy,
confidentiality and data protection
in relation to the information to be
maintained about patients”.
Protecting privacy
In its submission, the Irish Patients
Association stated that “personal
healthcare information is probably the
most sensitive form of information that
most patients want to keep private”
and asserted that “confidentiality
is important to establishing the
relationship between a healthcare
professional and patient because
it facilitates a patient disclosing a
suspected illness or condition”.
It called for legislation to “regulate
access to and use of personal
healthcare information for purposes
other than the treatment of the patient
while, at the same time, protecting the
privacy of patients”.
The synopsis document also found
that there was also general agreement
that the Bill should apply to all agencies
and persons holding personal health
information, irrespective of their legal
form or whether operating in the
private, public or voluntary sectors and
a related call that all of them should be
required to put in place an accessible,
available and comprehensive
information usage and confidentiality
policy.
Defining healthcare
A recurring theme was that the Bill
should ensure that information follows
the service user along their health
service pathway. This means that all
agencies involved in providing health
services should be covered by and
benefit from the provisions of the Bill.
The value of an appropriate
definition of “personal health
information” was widely recognised.
However, formulating a suitable one
was seen as “challenging”.
It was also generally agreed that
the new legislation should clearly
define what is meant by a ‘healthcare
professional’ and specify the range
of healthcare roles covered by it. The
general view of the submissions was
that the establishment of protocols
and standards for managing access to
patient health information by the vast
array of healthcare professionals and
health providers was essential in this
legislation.
Unique Health Identifier
It was also felt from the views
submitted that a major aim of the Bill
should be to reduce the requirements
on individuals to provide the same
information in relation to their
condition on more than one occasion
during different stages of receiving
healthcare.
Therefore the introduction of a
Unique Health Identifier (UHI) for
patients was seen as essential if current
and future developments in health
information are to be used for the
purposes of safeguarding patient
safety and promoting continuing
improvements in the effectiveness
of health services generally. Similarly,
there was agreement that all health
professionals should have a unique
number, which is registered for all
patient contacts.
According to the synopsis
of submissions received by the
Department of Health, everyone
agreed on one thing “that to the
greatest extent possible, any UHI
that might be introduced should be
assigned at birth”.
Similarly, there was widespread
agreement among respondents
that such an identifier can enhance
individual patient care by enabling
access to patient information from
multiple locations, and so ensure
continuity of care. Submissions also
agreed that a UHI was an “essential prerequisite to harnessing the full potential
of health research for improved
patient care and developing a National
Electronic Health Records system”.
EU compatibility
In relation to the introduction of such a
system, the Pharmaceutical Society of
Ireland (PSI) stated it would welcome
“the use of an Electronic Health Record
System incorporating medication
records”.
The PSI also pointed out that, in the
context of the proposed EU Directive
on the application of patients’ rights in
cross-border healthcare, it is necessary
to examine what other member
states use, as in the future there may
be a need for a shared system across
Member States and, in any event, that
patient mobility creates the imperative
for patient records systems in different
EU countries to be compatible.
The PSI also stated that an integral
part of the role of the pharmacist is
in the provision of information and
counselling to patients regarding
their medicinal therapy. The Society,
therefore, felt “it is essential that the
pharmacist has access to the patient’s
full medicinal therapy history, including
prescription and non-prescription
therapies in order that they can counsel
patients appropriately on the use of
their medicines”.
The PSI further proposed that the Bill
should “facilitate and support the early
introduction of [European-wide] Smart
Cards to our health system subject to
high level security being applied”.
Further information
More information is available on the
Department of Health’s website.
Issue 2 Vol 11 February 2009
31
clinical review
Managing
the symptoms of
cold and flu
daw n o’s h e a
T
he cold and flu season is most definitely upon us. A steady line
of runny noses and sore throats can be found in every pharmacy
and GP waiting room around the country. It is estimated that
the average adult suffers between two and five colds each
winter season. For young children, the figures rise to between
four and eight.1 The most recent statistics from the HSE’s Health
Protection Surveillance Centre suggest an increase in flu-like
illnesses this winter compared with the previous season. During week 2 of
2009, the GP consultation rate for flu-like illness rose to 120.5 per 100,000
population from a rate of 100.2 per 100,000 in week 1.2 The rates for weeks 1
and 2 of 2008 were 52.4 and 46.0.3,4
Ireland has long been criticised for the inappropriate use of antibiotics
to treat colds and flu. This criticism, combined with concerted educational
campaigns aimed at healthcare professionals and the public, have increased
awareness of the importance of treating these conditions properly. As a
result, more and more patients are heading to the local pharmacy for advice
and assistance on managing cold and flu symptoms.
Cold, influenza or pneumonia?
With any patient who presents with flu-like symptoms, the pharmacist’s first
responsibility is to determine if symptoms are due to the common cold or a
more serious condition.
The common cold is a viral infection. No bacterial pathogens are implicated
and, as a result, treatment with antibiotics is futile. Rhinoviruses are the most
common cause but other viruses can also be implicated. Transmission usually
results from touching a contaminated object and then touching the eyes,
nose or oral tissues.5
In contrast, influenza disease (‘the flu’) is caused only by Haemophilus
influenza viruses – H. influenza A, B or C. Transmission is primarily through
inhalation of infected droplets when an infected individual sneezes or
coughs.5
Pneumonia can be caused by bacteria, viruses, fungi and other organisms
as well as non-infective agents such as chemicals and foreign bodies. It is
unusual for healthy individuals to contract pneumonia. Pneumonia is most
often an opportunistic condition, occurring in individuals with weakened
immune systems, e.g. the elderly, very young, immunosuppressed, smokers
etc.5
While a cold or flu is generally self-limiting and only requires symptomatic
relief, pneumonia should be treated by a doctor.
The three conditions can generally be distinguished by the symptoms but,
in the event of uncertainty or where conflicting symptoms are present, the
patient should be referred to a GP.
The symptoms of the common cold depend on its viral cause but certain
generalisations can be made. Symptoms usually begin in the throat but
this usually resolves within a few days.5 This is often the point where nasal
“
Ireland has long been criticised for
the inappropriate use of antibiotics to
treat colds and flu.
32
Issue 2 Vol 11 February 2009
symptoms become more obvious, with congestion and discharge.5 A
cough tends to appear as these nasal symptoms resolve. The cough can be
productive (chesty) initially, gradually becoming dry and non-productive
(dry cough).5 Other symptoms may also be present including fever, sneezing,
headache, aches and pains, and watery eyes.5
In contrast to a cold, the onset of flu is much more abrupt and symptoms
are more severe. Early flu symptoms are similar to those of the common
cold – sore throat, nasal discharge etc. Headache and fever are more
common in flu, with temperatures sometimes exceeding 41˚C.5 The flu is
also associated with flushing, reddened eyes and warm skin but perhaps the
most distinguishing difference between the common cold and the flu is the
degree of malaise seen with the latter. The flu causes severe aches and pains,
generally in the muscles, joints and peri-ophthalmic region.5 The flu can be
severe and can cause serious illness and even death. Persons at risk should be
advised on vaccination.
Pneumonia can mimic the cold or flu but generally it presents as laboured
breathing with the individual complaining of shortness of breath and
rapid breathing. Bacterial pneumonia can be accompanied by chills, fever,
sweating, chest pain and a productive cough with yellow-green mucus.5
Viral pneumonia can cause muscle pain, fatigue, fever, headache and a nonproductive cough.5 Pneumonia can cause death and, where suspected, the
patient should be advised to seek urgent medical care.
Prevention
As with all conditions, prevention is better than cure. Vaccinations are
available against the influenza viruses, Streptococcus pneumoniae – a
common cause of pneumonia.
The flu vaccine is recommended annually for people 65 years of age
and older, healthcare workers and care-givers, residents of long-stay care
facilities and younger people with chronic diseases such as diabetes, chronic
respiratory, lung or kidney conditions and those with a suppressed immune
system.6
In recent years, Strep. pneumoniae has become resistant to many
antibiotics making treatment much more difficult. Consequently, prevention
is more important than ever.7 Pneumococcal vaccination is recommended
for all persons aged 65 years and over, and for younger people with one or
more of the following conditions:
·
·
·
·
·
·
Diabetes mellitus.
Chronic heart, respiratory or liver disease.
Chronic renal disease or nephritic syndrome.
Sickle cell disease.
Immunodeficiency.
Non-functioning or absent spleen.
Smoking damages the ciliated cells which line the respiratory tract and play
a crucial role in protecting the lungs. As a result, smokers are more likely to
suffer respiratory tract infections. Smokers should be advised of this risk and
should be given advice and assistance to quit smoking at every opportunity.
Vapourisers and humidifiers can be helpful as they augment the effect of the
ciliated cells by liquefying the mucus.
USE THE POWER TO
help your patients quit
1-4
Quitting smoking is an uphill struggle,5-7 but
choosing CHAMPIX can make all the difference
for your patients.
CHAMPIX offers:
reduced craving and withdrawal symptoms1-3
significantly greater quit success vs. NRT
patch, bupropion or placebo at 12 weeks4, 8
over 8.9 million patients’ experience worldwide9
A 12 week CHAMPIX course, together with
your support and advice, can help your patients
overcome their smoking addiction.1-4
CONQUERING SMOKING ADDICTION
PRESCRIBING INFORMATION CHAMPIX
Please refer to the SmPC before prescribing Champix 0.5 mg and 1 mg. Presentation: White,
capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on
the other side and light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on
one side and “CHX 1.0” on the other side. Indications: Champix is indicated for smoking
cessation in adults. Dosage: The recommended dose is 1 mg varenicline twice daily following
a 1-week titration as follows: Days 1-3: 0.5 mg once daily, Days 4-7: 0.5 mg twice daily and
Day 8 – End of treatment: 1 mg twice daily. The patient should set a date to stop smoking.
Dosing should start 1-2 weeks before this date. Patients who cannot tolerate adverse effects
may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Patients should
be treated with Champix for 12 weeks. For patients who have successfully stopped smoking
at the end of 12 weeks, an additional course of 12 weeks treatment at 1 mg twice daily
may be considered. Following the end of treatment, dose tapering may be considered in
patients with a high risk of relapse. Patients with renal insufficiency; Mild to moderate renal
impairment: No dosage adjustment is necessary. Patients with moderate renal impairment
who experience intolerable adverse events: Dosing may be reduced to 1 mg once daily. Severe
renal impairment: 1 mg once daily is recommended. Dosing should begin at 0.5 mg once daily
for the first 3 days then increased to 1 mg once daily. Patients with end stage renal disease:
Treatment is not recommended. Patients with hepatic impairment and elderly patients:; No
dosage adjustment is necessary. Paediatric patients; Not recommended in patients below
the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of
the excipients. Warnings and precautions: Effect of smoking cessation; Stopping smoking
may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which
dosage adjustment may be necessary (examples include theophylline, warfarin and insulin).
Depression, suicidal ideation and behaviour and suicide attempts have been reported in
patients attempting to quit smoking with Champix in the post-marketing experience.
Date of preparation: December 2008 ©Pfizer 2008
Not all patients had stopped smoking at the time of onset of symptoms and not all patients
had known pre-existing psychiatric illness. Champix should be discontinued immediately
if agitation, depressed mood or changes in behaviour that are of concern for the doctor,
the patient, family or caregivers are observed, or if the patient develops suicidal ideation or
suicidal behaviour. Depressed mood, rarely including suicidal ideation and suicide attempt,
may be a symptom of nicotine withdrawal. In addition, smoking cessation, with or without
pharmacotherapy, has been associated with the exacerbation of underlying psychiatric illness
(e.g. depression). The safety and efficacy of Champix in patients with serious psychiatric
illness has not been established. There is no clinical experience with Champix in patients
with epilepsy. At the end of treatment, discontinuation of Champix was associated with an
increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients,
therefore dose tapering may be considered. Pregnancy and lactation: Champix should not be
used during pregnancy. It is unknown whether varenicline is excreted in human breast milk.
Champix should only be prescribed to breast feeding mothers when the benefit outweighs
the risk. Driving and operating machinery: Champix may have minor or moderate influence
on the ability to drive and use machines. Champix may cause dizziness and somnolence
and therefore may influence the ability to drive and use machines. Side-Effects: Adverse
reactions during clinical trials were usually mild to moderate. Most commonly reported side
effects were abnormal dreams, insomnia, headache and nausea. Commonly reported sideeffects were increased appetite, somnolence, dizziness, dysgeusia, vomiting, constipation,
diarrhoea, abdominal distension, stomach discomfort, dyspepsia, flatulence, dry mouth and
fatigue. See SmPC for less commonly reported side effects. Overdose: Standard supportive
measures to be adopted as required. Varenicline has been shown to be dialyzed in patients
with end stage renal disease, however, there is no experience in dialysis following overdose.
Legal category: POM.
Package quantity:
Pack of 25 11 x 0.5 mg and 14 x 1mg tablets Card (EU/1/06/360/003)
Pack of 28 1mg tablets Card (EU/1/06/360/004)
Pack of 56 0.5 mg tablets HDPE Bottle (EU/1/06/360/001)
Pack of 56 1mg tablets Card (EU/1/06/360/005)
Pack of 53 11 x 0.5 mg and 42 x 1mg tablets Card (EU/1/06/360/012)
Not all pack sizes may be marketed / marketed at launch
Marketing Authorisation Holder: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United
Kingdom. Further information on request: Pfizer Healthcare Ireland, Pfizer Building 9,
Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Last revised: 08/2008,
Ref: CI5_0.
References: 1. Coe JW et al. Varenicline: An α4β2 nicotinic receptor partial agonist for
smoking cessation. J Med Chem 2005; 48:3474-3477. 2. Jorenby DE et al. Efficacy
of varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or
sustained-release bupropion for smoking cessation. A randomized controlled trial. JAMA
2006; 296:56-63. 3. Gonzales D et al. Varenicline, an α4β2 nicotinic acetylcholine receptor
partial agonist, vs sustained-release bupropion and placebo for smoking cessation. A
randomized controlled trial. JAMA 2006; 296:47-55. 4. Nides M et al. Varenicline versus
bupropion SR or placebo for smoking cessation: a pooled analysis. Am J Health Behav
2008; 32:664-675. 5. Jarvis MJ. Why people smoke. BMJ 2004; 328:277-279. 6. West
R, Shiffman S, Fast Facts. Smoking cessation. Indispensable guides to clinical practice.
2004, Oxford: Health Press. 7. Dani JA, Harris RA. Nicotine addiction and comorbidity with
alcohol abuse and mental illness. Nature Neuroscience 2005; 8:1465-1470. 8. Aubin
H-J et al. Varenicline versus transdermal nicotine patch for smoking cessation: Results
from a randomised, open-label trial. Thorax 2008; 63:717-724. 9. IMS Midas data:
July 2006-June 2008.
CHA/2008/041
clinical review
Advice on transmission pathways and tips on avoiding infection can be useful and
frequent hand-washing should be encouraged, especially during peak cold and flu
seasons.
Treating symptoms
Although the common cold and flu are usually self-limiting conditions, symptoms can
be distressing and debilitating. Fortunately, a range of over-the-counter medications is
available to mitigate the impact of cold and flu symptoms.
Nasal and sinus symptoms are most often treated with sympathomimetic agents which
act by direct or indirect stimulation of the alpha- and beta-adrenergic receptors, resulting
in the contraction of swollen nasal and sinus blood vessels, leading to a reduction in
congestion and discharge. Local and systemic agents are available.
Pain and fever can be controlled with simple analgesics such as paracetamol, aspirin
and ibuprofen. Because of the inflammatory nature of rhinovirus and the generalised
muscle and joint pain seen with flu, ibuprofen may be the most appropriate choice for
pain relief.8
Where a sore throat is present, a specific analgesic which acts locally in the oral cavity
and throat can be used. Such products are available in the form or sprays and lozenges.
Cough is often a bothersome symptom of the common cold and flu. A productive
cough is an important part of the body’s natural defence mechanism, helping to prevent
pathogens from lodging in the lungs. An expectorant-containing cough preparation can
assist in keeping the cough productive. A dry cough suggests that there are no secretions
in the lung and, therefore, no risk of pneumonia. In these situations, an antitussive can be
used to alleviate the cough.
As many of the symptoms of cold and flu occur simultaneously, combination products
are often the most effective and least expensive way of managing the spectrum
of symptoms. Over-the-counter products are available which combine analgesics,
decongestants, antitussives and expectorants in various combinations. Combination
products should be targeted at the symptoms of the individual patient. Where several
combination products are required, it is important to check interactions.
Difflam is a locally acting
analgesic and anti – inflammatory
Difflam relieves painful
inflammatory conditions of the
mouth and throat
Difflam is effective for relief of
sore throats, mouth ulcers and is
used following oral surgery
Further information is available on request from Meda Pharma,
Office 10, Dunboyne Business Park, Dunboyne, Co Meath
Tel: 01 802 6624 Fax: 01 802 6629
Email: [email protected]
www.meda.ie
34
Issue 2 Vol 11 February 2009
Dietary supplements
A variety of herbal and dietary products have been used over the years to treat colds and
flu. Eucalyptus oil is often used as an expectorant and echinacea is considered a ‘natural
antibiotic’ which can stimulate the immune system response to cold and flu infections.1
It has been suggested that, when absorbed through the throat or nasal tissues, zinc can
decrease viral replication and adherence to the respiratory epithelium.1 However, there
is a lack of strong clinical evidence to support the use of zinc in the management of cold
and flu symptoms.1
The debate surrounding the use of vitamin C to prevent and treat colds has raged on
for more than three decades. In 1970, the acclaimed US scientist, Linus Pauling, published
‘Vitamin C and the Common Cold’ to mixed reviews. While the publication was met with
scepticism in certain quarters, it did spur interest in the use of high-dose vitamin C. Some
studies have since shown that megadoses of vitamin C can shorten the duration and
severity of respiratory infections but the issue still remains controversial.1
The recommended daily intake of vitamin C for an adult is currently 75mg. Studies
looking at the use of high-dose vitamin C to prevent and treat colds have used doses up
to 2g per day.
Conclusion
With the increasing emergence of antimicrobial resistant organisms, the importance of
treating viral conditions appropriately has become a major issue in Ireland and globally.
Campaigns targeting healthcare professionals and the general public have stressed
that the common cold and flu are viral infections and, as such, antibiotics are ineffective
in managing the condition and its symptoms. Consequently, more and more people
are making their way to the local pharmacist for advice and assistance on managing
symptoms. It is more important than ever that the pharmacist is able to properly advise
these patients.
The first step must be to determine whether the individual is suffering from the
common cold or flu, or whether a more serious, possibly non-viral infection is present.
Where the latter is suspected, the patient should be referred to their GP for investigation.
If the patient is suffering from a cold or the flu, the pharmacist can provide valuable
assistance to alleviate the distress caused by symptoms. A variety of single-agent
and combination therapies are available to treat sore throat, cough, fever, pain and
congestion. It is important to suggest a product or products which best target the
individual’s symptoms. The pharmacist should advise the patient on possible interactions
between cold and flu products, and with any medications the patient may be receiving
for other conditions.
For at risk individuals, a recommendation on flu vaccination should be offered. Basic
advice on transmission routes and preventative measures can also have an impact during
the winter months.
There is still much controversy surrounding the use of herbal remedies and dietary
supplementation in the prevention and treatment of colds and the flu. What is obvious
is that many people will try anything to relieve the distress and disability which can
accompany a common cold and the flu. Consequently, it is worth being informed about
the use of these agents and their side effects, contraindications and interactions.
References on request
product news
YAZ — new everyday oral
contraceptive pill
New product protects children from
colds and flu
Bayer Schering Pharma’s new low-dose oral contraceptive YAZ has been
approved and is now available in Ireland. YAZ is the first oral contraceptive
on the Irish market containing the unique progestin drospirenone combined
with a low dose of ethinyl estradiol in a new dosing regimen of 24 days of
active hormone tablets and four days of placebo.
YAZ is an innovative 24+4 dosing regimen that provides women with three
additional days of antimineralcorticoid and antiandrogenic activity. This
extended delivery system also results in a reduction of hormonal fluctuations
which often occur with conventional 21+7 OCs. Clinical studies demonstrate
that a shortened hormone free interval of 3-4 days provides many benefits
and reduces the frequency of side effects that commonly occur with
traditional 21+7 regimens. YAZ effectively improves the emotional and
physical symptoms associated with the menstrual cycle (headaches, breast
tenderness, bloating) and improves skin condition.
Welcoming the launch of YAZ, Dr Tina Peers, Specialist in Contraception
and Reproductive Healthcare said, “Ongoing research and development in
the area of women’s health is resulting in the introduction of innovative and
unique products like YAZ. A first in class, YAZ’s unique 24+4 dosing system
will be particularly important for women who typically experience hormone
fluctuations and withdrawal symptoms more commonly seen with the
conventional 21+7 OC. This new dosing regimen provides three additional
days of antimineralcorticoid and antiandrogenic activity which is shown
to improve the emotional and physical symptoms associated with the
menstrual cycle and also moderate acne. I think YAZ will be a very attractive
option for Irish women.”
YAZ is a safe and well tolerated oral contraceptive offering women
excellent cycle control comparable to other low dose combined OCs.
YAZ, with its 24-day regimen and the mode of action of its progestin
drospirenone, offers more benefits to women which have resulted in high
levels of patient satisfaction.
Dr Mary Short, Specialist in Women’s Health, Dublin stated, “Research has
shown that one in five young women forget to take their pill at least twice
a month. With over 220,000 unplanned pregnancies worldwide everyday,
the importance of
taking the pill at the
right time must not be
understated. The new
everyday regime may
help in this regard as
there is no break from
the pill: you take one
everyday. With the
pills that are currently
available, women
often forget to restart
their pill at the correct
time after the 7day
break.”
Hypomer, a new, family-friendly seawater nasal spray, is a simple low-tech
way to wash out viruses, bacteria, and all other foreign bodies which land
inside the nose and sinus passages and contribute to colds, nasal congestion,
sinus infections, and other respiratory ills.
With its high mineral and trace marine content, and a unique infant safety
nozzle, Hypomer is a natural daily nasal cleanser, which can be used by all
people of all ages, from baby right through to adult.
Dr Turlough Bolger, Consultant in Paediatrics, Mount Carmel Hospital,
believes nasal sprays such as Hypomer can help lighten this load. “In my
experience this is very beneficial in clearing the nasal passages of dried
mucus which is common at this time of year. It can lead to improved feeding,
as infants are able to breathe easily and results in less respiratory distress. It
also has the added effect of removing the need for unnecessary medication
and trips to your GP.”
An added stress is the
disruption to work. Mums and
dads are forced to take leave
from the office to look after
their sick children, and the
fact that most young children
catch 8-10 colds on average
before they have even turned
two years old, doesn’t help1.
Determined to conquer
the snuffly noses of her
three children, Dublin Mum
Thomasena O’Nuallain talked
about her experiences with
Hypomer. “As a part-time
lecturer, I find my hectic
schedule far too demanding
to take extra time off work
when my children are sick.
All three of my children get
chronic colds at this time of
year, and when my third child
came along, I decided the least I could do was to find a solution to ease the
family’s discomfort from constant colds.
“From my personal experience and from trying many nasal sprays, I have
found Hypomer effectively cleanses and relieves the nasal passages of my
whole family.”
Children spend enough time learning all their daily healthy habits and
mountain of life skills: feeding themselves, brushing their teeth, and washing
their hands, for starters. Few can be messier than blowing their noses and
the frustration of congestion can in fact inhibit them from learning as fast
as they should — which is why Hypomer can help make home life easier for
families in the winter months.
Hypomer is now available in pharmacies nationwide in a 100ml bottle
for RSP €9.95 and is a better value alternative compared to other similar
products on the market.
For Further information on YAZ, please contact Lucy McGillion on 01 2999313
New data show MabThera enables leukaemia patients to live longer
Significant new data from two pivotal phase III studies, presented at the 50th
Annual Meeting of the American Society of Hematology (ASH) in San Francisco
in December 2008, show that patients with chronic lymphocytic leukaemia
(CLL) treated with MabThera (rituximab) in combination with chemotherapy
live considerably longer without their disease progressing, compared to
patients treated with chemotherapy alone. The results could pave the way to a
new approach to treating this incurable form of adult leukaemia.
The key results of the two studies are:
• Previously untreated patients: The CLL-8 study showed that at two years,
more than three quarters (76.6 per cent) of patients on MabThera plus
chemotherapy lived without their disease progressing compared to 63.3 per
cent of those treated with chemotherapy alone.
• Relapsed/refractory patients: The REACH study demonstrated that
with MabThera, patients who had relapsed lived an average 10 months
longer without their disease progressing compared to those receiving
chemotherapy alone (30.6 months vs 20.6 months).
Commenting on the new data, Professor Michael O’Dwyer, Consultant
Haematologist, University College Hospital Galway, said, “The new data
36
Issue 2 Vol 11 February 2009
demonstrate the encouraging benefits that MabThera can provide to
improving outcomes in patients with CLL. It is a significant development for a
disease which claims on average 170 Irish lives annually.”
Professor Michael Hallek, University Hospital Cologne, Germany, who led the
German CLL Study Group (GCLLSG) in conducting the CLL-8 trial said, “With
new therapies emerging, the management of CLL is set to change markedly,
with physicians having more options and greater treatment expectations
for their patients. These data, which come from the largest randomised
clinical trials ever reported, suggest that MabThera used in combination with
chemotherapy has the potential to become the new standard of care for CLL
patients.”
CLL is the most common type of leukaemia in adults, accounting for
approximately 25-30 per cent of all forms of leukaemia. Incidence of CLL in
Western countries is around 3 per 100,000, and is twice as common in men
compared to women. It mainly affects the elderly with 95 per cent of patients
diagnosed after the age of 55. While CLL is generally considered a disease that
is slow to progress, a significant proportion of patients have rapidly progressing
forms of the disease.
product news
VIMPATe— new epilepsy treatment for
partial-onset seizures
UCB (Pharma) Ireland have announced that the European Commission (EC)
has approved VIMPAT (lacosamide) as adjunctive therapy in the treatment of
partial-onset seizures with or without secondary generalisation in patients
with epilepsy aged 16 years and older and it is now available for prescription
in Ireland. VIMPAT is the first new antiepileptic drug (AED) for partial-onset
seizures in three years and offers a new treatment option for European
patients living with uncontrolled partial-onset epilepsy.
Professor Elinor Ben-Menachem, Clinical Trial Investigator, Department
of Clinical Neuroscience, Goteborg University, Sweden said, “VIMPAT offers
new hope for improved seizure control in adult patients with partial onset
seizures. The novel mode of action of VIMPAT makes it different from all
other antiepileptic drugs currently available. VIMPAT should be considered a
valuable treatment option for adult patients with partial-onset seizures who
need additional seizure control.”
A novel mode of
action
Preclinical studies
indicate that
VIMPAT has a novel
mode of action.
While the precise
mechanism by which
VIMPAT exerts its
antiepileptic effect in
humans remains to
be fully elucidated,
in preclinical studies VIMPAT has been shown to modulate sodium channel
activity differently compared with other sodium channel blocking AEDs.
Improved seizure control when added to a wide range of antiepileptic
drugs
In clinical trials VIMPAT improved seizure control when added to a wide
range of first and second generation antiepileptic drugs. Pooled analysis
shows that treatment with VIMPAT200 mg/day and 400 mg/day reduced
seizures by half in 34% and 40% of patients with partial-onset seizures,
respectively, compared with 23% in the placebo group. VIMPAT was
generally well tolerated with the most common adverse events (≥10% and
greater than placebo) reported in these trials including dizziness, headache,
nausea and diplopia.
Multiple formulations for ease of use
VIMPAT has been approved as oral tablet (50mg, 100mg, 150mg, 200mg),
oral syrup (15mg/ml) and solution for infusion (10mg/ml), to allow for
additional dosage formulation options. VIMPAT solution for infusion is an
alternative for patients when oral administration is temporarily not feasible.
For more information please contact Ms Gillian Bermingham, Product
Manager Vimpat ([email protected]) or Emma
Lynch, onMedical Scientific Advisor ([email protected]) 01
4637395.
Joint Aid – helping aid joint mobility
Joint Aid is now being marketed and
distributed by Clonmedica — the OTC
division of Clonmel Healthcare Ltd.
Joint Aid contains high potency
glucosamine sulfate 750 mg and
chondroitin sulfate 400 mg. Joint Aid
also contains vitamin C 100 mg and
manganese sulfate 10 mg. Vitamin
C and manganese help increase
the absorption of glucosamine and
chondroitin and have themselves a
beneficial effect on joint function.
Joint Aid will be supported with a
promotional campaign throughout
2009 and an attractive bonus deal is available through the Clonmedica
representatives.
NeoMercazole 20mg tablets x 100 —
new EAN barcode from 1st February
2009.
Amdipharm wish to announce that from the 1st February 2009 all packs of
NeoMercazole 20mg tablets (PA1142/2/2/.) distributed by Irish Wholesalers
will carry a new EAN barcode. This action has been taken to avoid any
confusion between the Irish NeoMercazole 20mg tablet pack and a UK
licenced pack of Detrunorm 15mg tablets, as both packs currently have the
identical EAN bar codes.
A Caution in Use Notification letter should continue to be issued with every
pack of Detrunorm 15mg tablets sent to retail chemists.
Product Name: NeoMercazole 20mg Tablets
Pack Size 100 tablets
MA holder Amdipharm
New bar code 5060064171783
Vichy launch new Dercos Technique
Derma-Hair care range
Vichy laboratories have launched a pioneering new derma-hair care range
dedicated to the treatment of common hair and scalp conditions and is
available in pharmacies nationwide from January 2009. Dercos Technique is
7 products individually formulated by Vichy to combat various hair problems
- target the appearance of dandruff in dry or oily hair, a nourishing cream
shampoo and conditioner for dry/damaged/brittle hair, a shampoo for
sensitive scalp conditions and an oil control solution.
New Vichy Dercos Technique Derma-Hair Care Range:
Anti-Dandruff Treatment
• Dercos Technique Anti-Dandruff Regulating Treatment Shampoo for
normal to oily hair 200ml €11.50
• Dercos Technique Anti-Dandruff Regulating Treatment Shampoo for dry
hair 200ml €11.50
Sensitive Scalp
• Dercos Technique Frequent Use Dermo-Soothing Shampoo for normal to
oily hair 200ml €10.50
• Dercos Technique Frequent Use Dermo-Soothing Shampoo for normal to
dry hair 200ml €10.50
Dry/Damaged/Brittle hair
• Dercos Technique Nourishing Reparative Cream Shampoo 200ml €10.50
• Dercos Technique Nourishing Reparative Conditioner 150ml €10.50
Oily scalp and hair
Dercos Technique Sebum Correcting Shampoo 200ml €10.50
Dercos Technique is already a leading brand in European pharmacies
thanks to its combination of active ingredients with pleasurable formulas
and visible results. With over 30 years commitment to advanced hair care
research, Vichy understand that there are many diverse influences for each
hair and scalp condition, which vary according to the individual and in
order for the products to work most effectively, they need to be designed
specifically for the physiology of the scalp and hair roots.
For further press information and products please contact:
Breena Cooper, Market Match, Tel: 01 639 14 60 Email: breena@marketmatch.
ie
Issue 2 Vol 11 February 2009
37
product news
Betnovate-N Cream 30g — discontinued
Mirap Orodispersible launched
GlaxoSmithKline wishes to announce that Betnovate-N (Betamethasone
Valerate 0.1% w/w. Neomycin Sulphate 0.5% w/w, Cream 30g) will be
discontinued on 27th February 2009. This does not affect other products
in the Betnovate range. Alternative products are licensed in Ireland for the
treatment of corticosteroid sensitive dermatoses complicated by infections
due to micro-organisms sensitive to the anti-infectives.
Please call 01-4955000 for further information if required.
GlaxoSmithKline apologises for any inconvenience caused.
Rowex Ltd have announced the launch of Mirap Orodispersible Tablets
15mg, 30mg and 45mg (Mirtazapine).
Circadin
Lundbeck Ireland Ltd. is delighted to announce the introduction of
CIRCADIN, Ireland’s first and only melatonin agent licenced for primary
insomnia, to the Irish market on 1st February 2009. Circadin is indicated
as monotherapy for the short – term treatment of primary insomnia
characterised by poor quality of sleep in patients who are aged 55 or over.
Circadin is not reimbursed – the cost to patient is approximately €24.00
For further
information contact:
Lundbeck Ireland Ltd.,
7 Riverwalk, Citywest
Business Park,
Citywest, Dublin 24.
Tel: 01 - 4689800
Mirap Orodispersible 15mg, 30mg and 45mg are indicated for major
depressive episodes.
Mirap (Mirtazapine) pricing details are as follows:
Mirap 15mg Orodispersible Tablets - €13.64
Mirap 30mg Orodispersible Tablets - €27.24
Mirap 45mg Orodispersible Tablets - €40.86
This presentation is fully reimbursable under the GMS.
The brand leader is 25per cent more expensive than MIRAP Orodispersible
Tablets 15mg, 30mg and 45mg.
For further information contact Rowex Ltd, Bantry, Co. Cork. Freephone 1800
304 400, email [email protected]
ip Crossword No.161
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38 Issue 2 Vol 11 February 2009
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Down
1. Complain about an M.O.? (4)
2. The funny bone? (7)
3. She is good for a spell! (5)
5. T.V. doctor with questionable name? (3)
6. Anaesthetist, perhaps, who reads the meter! (6)
7. Small measurement for small island! (4)
12. Crooked mob gear lends to suspension of commerce (7)
13. Seizures of MS pass, srangely enough (6)
15. New mode for vaulted roof (4)
16. Box for Judy’s husband? (5)
17. Tangled bale is competent (4)
19. Climber seen in privy (3)
oedema 13. tug-of-war 14. stretch 17. astir 19. king 20. acne
12
otic 16. dosage 18. leukemia 21. fast 22. scene 23. antacid
11
Down: 1. melon 2. ascorbic 3. idle 4. neat 5. almoner 8. fungus 12.
10
Hairstyle of American Indian (6)
Drink with tipsy wigs perhaps (4)
Supply weapons - for a memeber? (3)
10 X Don = sinews! (7)
Part of the foot, sometimes fallen (4)
Laughing scavenger (5)
Bewildered dopes assumed an affected attitude (5)
Bars licensed premises? (4)
British doctor, murderer and sailor perhaps (7)
Spare bone? (3)
Pig-pen, we hear, is an eyesore! (4)
Pick or chews, we hear (choose)
Across: 6. seaside 7. heals 9. toto 10. eruption 11. oblong 13. tees 15.
1. 4. 8. 9. 10. 11. 14. 16. 18. 20.
21. 22. 9
LAST MONTH’S CROSSWORD ANSWERS
Across
8
Congratulations to the winner of last month’s crossword,
Clodagh Putt, 31 Rathfarnham Rd, Terenure, Dublin 6W. For
a chance to win €70, please send completed entries to: the
Editor, Irish Pharmacist, GreenCross Publishing, Lr Ground
Floor, 5 Harrington Street, Dublin 8 or fax to (01) 478 9764 by 27
February 2009.
PatientPak the new personal anti-superbug kit
* Helps protect against superbugs, viruses and bacteria *
The Allphar Sales Team is pleased to inform you of their newly amended product portfolio for 2009. Allphar Services is one of Irelands leading pharmaceutical agent
and distributor partnering some of the worlds leading companies. The very exciting news is that Allphar have now added PatientPak Personal Anti-Superbug Kit to their
product listing and our pharmacy business managers will be happy to detail PatientPak and all of our other product ranges to you.
An innovative new kit, PatientPak, has been launched in response to consumer demand for personal antimicrobial products that are effective in combating superbugs
associated with hospital infections. Consumers can use PatientPak to help protect them when they visit hospital as it is proven to kill superbugs, viruses and bacteria
including MRSA, and is effective within 10 seconds. As PatientPak is proven to kill a wide spectrum of viruses and bacteria including Avian Flu (H5N1), Norovirus, Listeria,
Campylobacter, Salmonella and E Coli, it will also be purchased by consumers for use in the home or on their travels.
PatientPak comprises essential items for patient safety and comfort, the core of which are highly effective low alcohol wipes and sprays that contain a unique patented
formula developed by doctors. The formula - extensively used by top hospitals is now available to the consumer for the first time – uniquely kills bugs in six different ways
which stops harmful bacteria building up resistance to the active ingredients. The kit includes antimicrobial sanitising wipes, face and body wipes, a hand sanitising spray
and a hair and body wash. There’s also soap in a dish plus a nailbrush, essential in the battle against C difficile. Other essential items include lip balm, a toothbrush with a
protective cover and toothpaste.
The ‘pak’ is designed to help combat the transfer of superbugs between the hospital and the home, so includes a range of essential items, for easy disposal at the end
of the hospital stay. comprehensive and informative leaflet educates the consumer about how to improve personal protection against superbugs and there is also a
polite notice that patients can place next to their bed reminding carers and visitors to make sure they have clean hands. Technically PatientPak includes both biocidal and
cosmetics products and being the first product of its kind, is expected to forge a new sector. Its ideal position in store is adjacent to wipes, health and beauty, first aid kits
and amongst travel products
The PatientPak kit contains
1. Antimicrobial Sanitising Wipes – contains the patented antimicrobial formula
proven to kill MRSA and other superbugs. For use on any surface, particularly
those that are most likely to harbour germs.
2. Antimicrobial Hand Sanitising Spray – Easy to apply and allows regular
disinfection of hands. Only 5% alcohol content – helps ensure that hands
don’t dry or become sore after multiple use.
3. Antimicrobial Fabric Spray – This new product has been developed to kill
germs that can survive on fabric.
4. Antimicrobial hair and body wash – Kills superbugs whilst being kind and
gentle to the hair and skin.
5. Face and Body Wipes – designed to be gentle on the skin, leaving the patient
clean and fresh. The formula contains a softener to protect skin during longterm use.
6. Soap, Dish and Nail brush as clean hands are vital to prevent the spread of
germs. These items help remove spores such as C. difficile and other harmful
microbes.
7. Toothpaste and Toothbrush with protective cover for everyday good dental
hygiene. The disposable brush ensures that microbes are not carried between
hospital and home.
8. Lip Balm - to help prevent lips becoming dry or sore, this often happens in
sterile hospital environments and when people are ill.
9. Pen as germs can spread quickly from a shared pen. Disposable to prevent
transfer of germs between hospital and home.
10. Hygienic Wash Bag – convenient and waterproof container.
11. Bag to hygienically enclose kit and products for disposal on leaving hospital.
12. A comprehensive educational leaflet explaining how to use the products,
communicating the need for good hygiene practices, plus a polite notice.
For further information please visit www.patientpak.com or contact your Allphar rep:
Mr Brian Woods Dublin, Carlow, Kilkenny, Kildare, Laois, Offaly, Wicklow & Wexford. 087-236 2850
Mr Paul Hayes Cork, Clare, Kerry, Limerick, Tipperary & Waterford. 087-854 8073
Mr Dermot Mc Mahon Cavan, Donegal, Galway, Louth, Leitrim, Longford, Mayo, Meath, Westmeath,
Monaghan, Roscommon & Sligo. 087-4142174
Mr Michael Griffin, Allphar Sales Manager (087-2563567) or Ms Laura Jacob, Sales & Marketing
Executive (01-4041605)
outside edge
Karmic retribution and me
fi n ta n m o o re
This month, our hero writes on Boots and walking into a particularly cringe-worthy
situation
Boots Special Offer
One of the shortest-lived special offer
campaigns ever run by Boots occurred in the
early days of January 2009. In case you blinked
and missed it, Boots had advertised that they
were not going to increase the Drug Payment
Scheme threshold from €90 up to €100 as
announced in the budget. The powers that be
in Boots, being the considerate and consumerfriendly people that they are, were going to
absorb the loss of the tenner, so the patient
would benefit without the HSE losing out.
Shucks – how do these sweethearts ever turn a
profit when they just go so soft on customers.
The problem with the plan was, of course,
that it was in breach of their contract with the
HSE. In any event, Boots pulled the plug on the
campaign almost as soon as it started, so they
were afraid of something. What is it about this
cruel world that sees a company living in fear of
getting punished just for being nice?
There are a couple of positive messages
in this story. The obvious one is that even a
behemoth like Boots was unable to breach their
contract and get away with it. This should serve
as a warning to Tesco as they plan the details of
their probable entry into the pharmacy market.
The idea of discounting prescription prices
would be right up their street, or more accurately,
given their level of morality, I should say right down
their alley. The less obvious positive is that Boots were
only going to run the tenner-off discount for three
months, not indefinitely. The fact that even a large
and profitable organisation like Boots was unwilling or
unable to absorb the hit indefinitely should indicate
to the HSE that there is a limit to what pharmacists can
afford to negotiate away.
Guilty pleasures
Speaking of people being nice, I walked myself into a
situation a few weeks ago where somebody was really
nice to me, but I felt about an inch tall as a result. It all
started on a busy Friday when a very nice patient of
ours came in to the pharmacy and asked me to order in
her tablets, saying that she would collect them the next
day. I assured her that I would have her prescription
ready, bade her farewell, then immediately got
distracted and so it completely slipped my tiny mind to
order the tablets.
Roll on the Saturday, and not once did I think of the
lady until she called in to pick up the prescription. I
immediately slipped into my default mode for dealing
with these situations and told a little grey lie, namely
that I ‘had ordered the tablets but my usual wholesaler
didn’t have them in stock, and my other wholesaler
won’t be delivering until Monday’. She was very
understanding, but unfortunately also very out of
tablets. I told her to wait a minute and started ringing
my neighbouring pharmacies. I got lucky on the first
call – they had plenty in stock, and I was welcome
to what I needed. I asked my patient to call back in a
while, and that I would have the tablets for her.
One of my staff drove over and got the tablets. My
patient called back as arranged, ever so grateful for all
the bother that I had gone to, as I played it down as just
being part of what we do for everyone, and it was no
bother at all really. Then she presented us with a jar of
sweets as a thank you for looking after her so well. Did
I say I felt an inch tall? I’ll need to go metric on this one
– try a millimetre. If karmic retribution is a reality, then I
should choke on one of the sweets sometime soon.
Funny science
One of my Christmas pressies was a DVD of one of
the funniest men around, stand-up comedian, Dara O
Briain. He has a science degree and a cutting wit, and
he combines the two to very good effect when he
slates the bullshit pseudo-scientific alternative therapy
field. He is particularly scathing, and rightly so, about
homeopathy, i.e. the sale of water dressed as medicine.
He does acknowledge that it is free from side effects,
apart, of course, from the fact that “you could drown”.
He asks the very relevant question as to why it is that
only in the field of medicine do completely unfounded
theories get taken seriously. As he points out, NASA
engineers don’t have to go on chatshows and debate
scientific facts with people who believe that the sky
is a carpet and that the stars are just velcroed on. As
O Briain himself says: “Science doesn’t have all the
answers, but that doesn’t mean you can just fill in the
gaps with whatever you’re having yourself.”
The DVD is called ‘Dara O Briain Talks Funny’. Go and
buy it. If you don’t laugh, I’ll give you the money back
myself.