Medicines Management Programme
Regional Prescribers’ Forum
Cork University Maternity Hospital
November 7th 2013
Dr Helen Flint
National Lead Medicines Management
Office of the Nursing & Midwifery Services Director
Clinical Strategy and Programmes Directorate
Health Services Executive, Dublin, Ireland
“The prescribing of medicines is the
commonest healthcare intervention in
developed countries”
National Medicines Information Centre, 2004
Approximately 10,000 medicinal products authorised for use in
Ireland
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this includes products authorised nationally and through EU
assessment procedures, with no national licenses issued for some of
the latter, which is how the IMB count
the figures relate to product authourisations (licenses), rather than to
substances, so includes a significant number of generics as well as
‘product families’, i.e. different strengths and formulations of the same
brand/substance etc., as each is the subject of an individual
authorisation (license)
includes parallel product authourisations (PPAs), where licenses are
granted for products which are already the subject of an authorisation,
but there is parallel importation of version for sale, usually because of
price
Number of prescriptions?
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No published Irish studies relating to the number of prescriptions
written here on a daily basis
Difficult to capture that information as details of purely private
prescriptions (i.e. where the patient does not make a claim under the
DPS) would be recorded only on individual GP records
Annual report from the PCRS details the number of prescription items
that pharmacists were reimbursed for on the GMS, DPS and LTI
scheme
This could be used as a guide to the number of prescriptions written
under these community schemes
How many prescriptions?
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United Kingdom every day
 2 million written by General Practitioners
 0.5 million in hospitals
 927 million items dispensed overall
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One Irish hospital (600 beds)
 4-18 drugs per patient (mean= 14)
 8400 drugs administered daily
Polypharmacy
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Common in Ireland
One-in-five people <50 years take five or more medicines
One-in-two people <75 years take five or more medicines
(Dublin TILDA, 2011)
Patients taking two medicines have a 13% risk of adverse drugdrug interactions (an avoidable cause of adverse drug reactions)
Four medicines = 38% risk
Seven or more = 82% risk
Associated with increased risk of adverse drug reactions
Prescribing cascade
Falls
Non-compliance
“The annual cost to the State of supplying
medicines exceeds €2.24 billion – a greater than sixfold increase has occurred over a decade. This level
of growth in expenditure is unsustainable”
Tilson and Barry, 2010
Where does taxpayer invest?
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Lipid modifying agents - €160M
Acid Related Disorders - €127M
Renin-Angiotensin system - €75m
Drugs for Obstructive Airways Disease - €110M
Clinical Nutritional Products - €52M
Psycholeptics and Psychoanaleptics - €149M
The above groups accounted for 36% (23m) of all prescriptions and
53% of all drug costs under the GMS / DPS / LTI schemes in 2008
Pharmacoeconomic Evaluation in Ireland
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The National Centre for Pharmacoeconomics (NCPE) in Ireland
evaluates cost-effectiveness of new medicines prior to
reimbursement and conducts pharmacoeconomic (P/E)
evaluations to inform public policy (e.g. infant pneumococcal
vaccination) and prescribing in primary care (e.g. statins for
primary and secondary prevention of coronary heart disease)
Pharmacoeconomics
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Pharmacoeconomics refers to the scientific discipline that
compares the value of one pharmaceutical drug or drug therapy
to another
Sub-discipline of health economics
A pharmacoeconomic study evaluates the cost (expressed in
monetary terms) and effects (expressed in terms of monetary
value, efficacy or enhanced quality of life) of a pharmaceutical
product
Pharmacoeconomic assessment of all new
medicines
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National Centre for Pharmacoeconomics/HSE consider the
cost–effectiveness of all new medicines following receipt of an
application for reimbursement
In practice, all medicines are subjected to a preliminary rapid
review (2–4 weeks)
review of the number of eligible patients in the population
the rate of uptake and whether the technology replaces or is added to
current practice
the potential budget impact of the new technology
the price compared with the appropriate comparators
clinical effectiveness, as well as cost–effectiveness data from other
jurisdictions (if available)
Products are then either recommended for reimbursement or
referred for a formal pharmacoeconomic assessment
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The average time from the issue of the product licence to
reimbursement was 7 months (average duration of the P/E
process was 2.7 months)
Of interest, the review noted that the NCPE recommendations
concurred with those of the UK evaluation agencies (the
National Institute for Health & Clinical Excellence, the Scottish
Medicines Consortium and the All Wales Medicines Strategy
Group), with the exception of two anti-cancer agents sunitinib
and lapatinib, which were reimbursed in Ireland
The NCPE publishes all of its pharmacoeconomic evaluations
on its website: check out www.ncpe.ie]
PCRS Annual Report 2011
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1,768,344 people held Medical Cards
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18,737,510 General Medical Services prescriptions were dispensed
(57,986,608 GMS items)
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3,269,901 Drug Payment Scheme prescriptions reimbursed
(10,105,249 DPS items)
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€1.8bn of the €2.5bn paid out by PCRS was on pharmaceutical
services
Disinvestment: new drugs for old
“…the funding of new, expensive medicines
relies increasingly on releasing funds by displacing other
treatments”
Hughes and Ferner, 2010
Generic prescribing
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A generic medicine contains the same qualitative and
quantitative composition of active substances as the proprietary
version of that drug
Reduces the potential for confusion and error
Cost-effective and safe for the patient
Exceptions: modified-release preparations/ some combination
products/drugs with a narrow therapeutic index
“Bio-similar medicines” similar to reference product: additional
studies on case-by-case basis
indicator of good prescribing practice
Generic Usage in Primary Care
Ireland 2008:
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11% - 18% of prescription items dispensed generically
England 2008:
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83% of prescription items prescribed generically
Canada 2009:
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56% – 61% of all prescriptions were generic
Objective:
 Introduces a system of generic substitution and reference pricing
Benefits:
 Enhance price competition
 Increase usage of generics (~18% in Ireland)
 Improve value for money
 Ensure continued access to innovative medicines
 Consistent with best international practice (patient safety and commercial
arrangements)
International Perspective:
 24 of 27 EU Member States have generic substitution
/ reference pricing
 83% rate of generic prescribing in UK
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Roles under the legislation
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Department of Health (DoH):
- Preparation of legislation
- Policy decisions
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Health Service Executive (HSE):
- Reimbursement and pricing of medicines
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Irish Medicines Board (IMB):
- List of Interchangeable Medicines on IMB website
Health (Pricing and Supply of Medical Goods) Bill 2012
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Reference pricing involves the setting of a common
reimbursement price, or reference price, for a group of
interchangeable medicines
Eligible patients will not face any additional costs for products
priced at or below the reference price
If a patient would like to receive a particular brand that costs
more than the reference price then the patient will have to pay
the additional cost of that product
In cases where substitution is prohibited for clinical reasons,
patients will not face any additional costs if the prescribed
product costs more than the reference price
Health (Pricing and Supply of Medical Goods) Bill 2012
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The Bill provides for the introduction of a system of generic substitution
and reference pricing
Currently, when a specific brand of medicine is prescribed for a patient,
a pharmacist can only supply that particular brand, even when less
expensive generic versions of the same medicine are available
The Bill permits pharmacists to substitute medicines which have been
designated as interchangeable by the Irish Medicines Board
A generic medicine is a medicine that is similar to an original, brand
named medicine. It has the same active substances as the original
medicine and is made to the same standard to make sure it is safe and
effective
A generic medicine must meet exactly the same standards of quality
and safety and have the same effect as the original medicine
Substitution will only be allowed where it is safe to do so
Role of IMB
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Establish, consult, publish and maintain a List of
Interchangeable Medicines on IMB website
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Medicines on the List may be substituted for each other in order
to enable savings to be made for patients or the HSE, or both,
where lower priced medicines are supplied
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Criteria for interchangeability
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INCLUDED:
Same qualitative and quantitative composition
Same pharmaceutical form
Same route of administration
EXCLUDED
Differences in bioavailability whih may lead to
clinically significant differences in efficacy
Device with significantly different instructions for use
e.g. inhalers
Biological medicines cannot be safely substituted