Transcript No Slide Title

Perspectives and achievements with Rational
Pharmacotherapy
Meeting under Danish EU presidency
Implementation of Rational Pharmacotherapy
Copenhagen , November 6, 2002
WHO/EURO
Kees de Joncheere, Regional Adviser Pharmaceuticals
Overview of the presentation
•
•
•
•
Pharmaceutical policies in Europe
Rational use of medicines
Comparing European countries
Improving the prescribing and use of
medicines
• Concluding remarks
Challenges for pharmaceutical
policies in Europe
• Equitable access for patients to effective, safe and good
quality medicines
• Enhancing appropriate use of medicines for better health
outcomes
• Ensuring value for money
• Balance with industrial policy objectives
Values underpinning health systems : equity, quality,
solidarity, participation and accountability
Pharmaceutical policies and the EU
• EU regulatory framework and legislation
• National responsibilities on pricing and reimbursement
(“subsidiarity”)
• Transparency directive
• Industrial policy communication 1995
• Single market communication 1998
• Public health communication 2000
• Portugal 2000, EU MINE , DG5/health High Level
committee, G 10 , …
• Review 2000-1
Medicines and Public health in EU
• Future of the European system for evaluations and
supervision of medicinal products
• Relevance of the added therapeutic value of medicinal
products ( registration criteria ? Placebo or comparator?)
• Aspects determining innovation and research
• Rational use of medicinal products
• Importance and evolution trends for the information
systems
• Increasing use of generic medicines
• Adoption of EU public health action plan, 2002
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ec a n
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H ga
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G ary
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e
T u ce
rk
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Total expenditure on pharmaceutical goods as
a percentage of total expenditure on health
(OECD 2000)
45
40
35
30
0
1970
1980
1990
1996
25
20
15
10
5
a
Ire rk
la
N nd
Lu or
xe wa
y
Sw mbo
it ur
N zerl g
et an
he d
r
A land
us s
t ra
A lia
us
tr
N Fin ia
e w la
Ze nd
a
Sw land
ed
ni T en
t e ur
d ke
Ki y
ng
d
U Ca om
ni na
te da
d
S
Ge tate
rm s
a
Ic ny
el
Be and
lg
iu
m
Ita
l
Ja y
pa
Sp n
Cz F ain
ec ra
h nc
Re e
p
H ubl
un ic
ga
G ry
re
Po ece
rtu
ga
l
m
D
en
2.5
Total expenditure on pharmaceutical goods
as a share of GDP (OECD 2000)
2
1970
1980
1990
1996
1.5
1
0.5
0
Link between total expenditure on pharmaceutical goods per
capita and GDP per capita at purchasing power parities
Total expenditure on pharmaceutical goods, $/capita PPP
(OECD 2000)
400
350
JPN
FRA
ISL
BEL
ITA DEU
300
PRT
GRC
250
CZE
USA
CAN
AUT
ESP
200
HUN
GBR SWE
FIN
AUS
NZL
NLD
150
LUX
CHE
NOR
DNK
IRL
100
50
5000
10000
15000
20000
GDP per capita $ ppp
25000
30000
35000
d
St
Ca ates
na
da
Ita
Be ly
lg
i
Fi um
n
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us
t
D rali
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us
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G ria
Sw re
itz e c e
er
la
Fr nd
an
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t e rt u
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et do
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el
an
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Ge gar
rm y
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a
Ire in
la
N nd
Lu or
xe wa
m y
b
Cz T our
ec ur g
h ke
Re y
pu
bl
ic
U
ni
te
Public pharmaceutical expenditure within total
pharmaceutical expenditure (OECD 2000)
100%
90%
80%
1970
1980
1990
1996
70%
60%
50%
40%
30%
20%
10%
0%
Rational use of medicines
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•
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Right patient with right indication
Right medicine
Right dose/administration
Right information
Right moment to stop or change
Inappropriate use leads to
• Adverse effects
• Sub-optimal outcomes
• Waste of resources ( money, health
professionals and patients time)
Why are drugs not used
rationally ?
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Lack of training and knowledge
Marketing practices
Financial incentives for irrational use
Availability problems
Patient expectations
Prescribing as a means to finish the consultation
Health systems and services effects
…
Main discrepancies in the EU pharma
markets
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Number of licensed medicines
Reimbursement classes
Legal categories
Price differentials
Licensed indications and dosages
Utilisation
Medicines withdrawn from a country still
used in others
15 different systems for 15 Member States
An overview of the European differences
C01EB15 - Trimetazidine
Trade
Names
Presentations
Average
Reimbursement
Expenditure
by health
systems (€)
Rank by
cost
UK
-
DNK
+
1
1
34%
103,382
FRA
+
16
31 78%
85,371,000
ITA
+
1
1
0%
0
PLN
+
1
2
0%
0 46
Source: EURO-Medicines database
(EURO)
withdrawn from the market
4
An overview of the European differences
Approved Indications of Trimetazidine oral forms (tablets and solution)
FRA ITA IRL DNK
Angina pectoris
Ischemic eye diseases
Ischemic ear diseases
(symptomatic treatment)
Meniere’s disease (DK only)
Source: EURO-Medicines database
+
+
+
+
-
+
+
+
+
prescriptions
PPI Prescribing - Diagnosis at first prescription
3500
GI Misc.
3000
Non specific
Abdominal Pain
Non Ulcer
Dyspepsia
2500
2000
1500
1000
Hiatus
Henia/Reflux
Unlicensed Indications
Oesophagitis
Ulcer
unspecified
Indication licensed
since 1991
Gastric
500
Duodenal
0
1991
1995
Source of Data : General Practice Research Database (GPRD)
DEPARTMENT OF MEDICINES MANAGEMENT
Tel: 01782 583444 Fax: 01782 713 586 E-mail: [email protected]
Measuring and monitoring the
use of medicines
• Describe and compare existing situations
and patterns
• Identify differences and potential problems
• Monitor results of interventions
• Lessons drawn from other countries`
experiences
From drug utilisation to costeffective intervention (1)
• Drug utilisation studies
tend to be descriptive, aggregated data : WHAT?
• Indicator studies
more focused on rational drug use:
WHAT?  HOW MUCH?
• Qualitative studies
WHY?
From drug utilisation to costeffective intervention (2)
• Intervention studies
HOW MUCH? WHY? (intervention) HOW MUCH NOW?
Conclusion  DOES IT WORK? IS THE
INTERVENTION EFFECTIVE?
• Management studies
IS THE INTERVENTION REPRODUCABLE?
IS IT COST-EFFECTIVE?
Examples of indicators (WHO/INRUD)
Prescribing indicators
• Average number of drugs per encounter (<2)
• Percentage of drugs prescribed by generic name
(close to 100%)
• Percentage of encounters with an antibiotic
prescribed (<30%)
• Percentage of encounters with an injection
prescribed (<10%)
• Percentage of drugs prescribed from EDL or
formulary (close to 100%)
Examples of indicators
(EU countries )
• Rate indicators
–
–
–
–
–
NSAIDs
antibiotics
benzodiazepines
anti-ulcer drugs
inhaled corticosteroids
• Choice indicators
–
–
–
–
–
inhaled corticosteroids/beta agonists
quinolones/total antibiotics
short/long acting NSAIDs
PPI/total anti-ulcer
trimethoprim/cotrimoxazole
Examples of indicators
• Appropriateness
– drugs of limited value
– agreement with clinical practice guidelines
• ASA after AMI
• ACE-s in CHF
• Statins in secondary prevention
• Economic
– choice of branded/generic agents
– cheaper drug classes
– compliance with budgets
• Errors
– drug-drug interactions
– duplication (drug or class)
– dosage
(con`t)
Challenges on monitoring drug use
• Pharmaco-epidemiology is often concerned with
links between exposure and outcomes (usually
adverse)
• Drug prescribing data-sets have other uses
– Budget tracking and forecasting
– Examining trends in drug use
– Assessing appropriateness of drug selection and
accuracy and safety of prescribing
• Clear need for going beyond basic statistics and
for developing better analytical methods and
benchmarking tools
Challenges for monitoring drug use
• Intercountry variability as ‘learning device’
• Improving networking of researchers and
policy makers
• Gap between sales/aggregated consumption
data and individual patient data (privacy!)
Financial measures on improving
prescribing and containing costs
 Fixed and indicative budgets for prescribers
 Budgeting for regions, PHC groups with pay-back
mechanisms
 Price regulations and reference prices
 Patient co-payment
 Financial incentives to pharmacies for better
dispensing
 Differential reimbursement rates
 Promote generics
Managerial measures on improving
prescribing and containing costs
 Positive and negative lists
 Disease management
 Restrict distribution and prescription
 Prescribing support systems
 Regulate marketing, approved indications and
commercial information
 Practice guidelines
Improving prescribing and containing costs :
educational and informational measures
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
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


Formularies
University training and continuing information
EBM - evidence based practice guidelines
Pharmaceutical care
Prescriber information
Drug committees in hospitals and primary care,
coordinated approach
 Feedback and discussion of drug use data
 Behavioural approaches
 Patient information
Promoting rational prescribing
Effective interventions
• Combination of strategies
• Participation and ownership by health
professionals
• Follow-up to avoid relapse
• Feedback and active discussion
• Best practices
Promoting rational prescribing
proven effective interventions
• Standard treatment guidelines, when evidencebased, developed with end-users, with active
dissemination and follow-up
• Essential Medicines lists,
• Hospital Drugs and Therapeutic Committees
• Undergraduate training
• Discussion groups with feedback of prescribing
data
• “Academic detailing”
• Comprehensive approach, with all components
Promoting rational prescribing
interventions that need more testing
Mixed results, probably effective:
• Pharmacists interventions
• Public education
• Financial incentives and reimbursement measures
Mixed results, probably ineffective:
• Drug information bulletins and other printed
materials used in isolation
• Arbitrary prescription limitations
• Traditional stand-up lecturing
Promoting rational use : involving
patients and sharing experience
Patient
• experience of illness
• social circumstances
• attitude to risk
• values
• preferences
Picker Institute
Health professional
• diagnosis
• disease aetiology
• prognosis
• treatment options
• outcome probabilities
Conclusions
• Room for improving drug use, e.g
minimising risk and improving outcomes
• Important role for health professionals ,
patients and coordinated team approach
• Need for better evidence and information on
interventions that work