De l`efficacité pharmacologique à l`efficience thérapeutique…

Transcription

CUSO / 3ème Cycle, Section des sciences pharmaceutiques / Efficience des médicaments
3ème cycle en sciences pharmaceutiques
8 septembre 2008
“L’efficience des thérapies: un défi commun pour l’ambulatoire et l’hôpital”
De l’efficacité pharmacologique à
l’efficience thérapeutique…
Prof Olivier Bugnon, Anne Niquille
Unité de Pharmacie Communautaire, Section des sciences pharmaceutiques,
Université de Genève et Université de Lausanne
Pharmacie de la PMU, Lausanne
The actual contradiction of
present health care systems :
The present health care system is
neither safe, effective nor efficient…
To resolve this contradiction Æ
different practice of health care,
new roles for the patients, physicians, other health
professionals and for health services
[1] Preparing a health care workforce for the 21st century – The challenge of chronic conditions. WHO (2005).
[2] Crossing the Quality Chasm: a new health system for the 21st century. Institute of medicine (March 2001).
Prof O. Bugnon, A. Niquille / Unité de Pharmacie communautaire / Pharmacie de la PMU / 2008
Page 1
Efficacy is the extent to which an intervention
does more good than harm when delivered
under optimal conditions
Efficacy versus Effectiveness
Epidemiology Æ cardiovascular mortality risk
increases as blood pressure rises
Measurements taken in individuals aged 40-69 years, beginning with a blood pressure of 115/75 mmHg
1) Lewington S et al. Lancet 2002; 360 : 1903-13
2) Chobanlan AV et al. JAMA 2003; 289 : 2560-72
Page 2
losartan
atenolol
Losartan Intervention For Endpoint
Reduction in Hypertension Study
LIFE Study Overview
Double-blind, randomized trial to compare the effects of losartan and
atenolol on cardiovascular morbidity and mortality in high-risk
patients with hypertension and left ventricular hypertrophy (LVH)
Population
• 9,193 patients (55 to 80 years old) from 945 sites in 7 countries
– previously treated or untreated essential hypertension (systolic
BP 160–200 mmHg or diastolic BP 95–115 mmHg)
– ECG LVH
• 1,195 patients (13%) had diabetes at baseline
Dahlof B, et al. Lancet. 2002;359:995-1003.
www.hypertensiononline.org
Page 3
LIFE Study
Baseline Characteristics* (1)
Losartan group Atenolol group
n=4,605
(n=4,588)
Age (yrs)
66.9
66.9
Female (%)
54
54
BMI (kg/m2)
28
28
174.3/97.9
174.5/97.7
Blood pressure (mmHg)
Heart rate (bpm)
73.9
73.7
2834.4
2824.1
Sokolow-Lyon (mm)
30
30.1
Framingham risk score (%)
22
22
Smokers (%)
16
17
Cornell product (mm x msec)
*P=NS for all comparisons
Reprinted with permission from Elsevier Science.
LIFE Study Blood Pressure
and Heart Rate Results
Losartan
Atenolol
(n=4,605) (n=4,588)
SBP last visit (mmHg)
Change in SBP*
DBP last visit (mmHg)
Change in DBP
MAP last visit (mmHg)
144.1
145.4
-30.2
-29.1
81.3
80.9
-16.6
-16.8
102.2
102.4
BP <140/<90 (%)
48
45
SBP <140 mmHg (%)
49
46
DBP < 90 mmHg (%)
87
89
Change in HR (bpm)†
-1.8
-7.7
*P=0.017
†P<0.0001
Page 4
How is the blood pressure (BP) control of
hypertensive patients in routine care ?
Controlled blood pressure was defined as < 140/90 mmHg and expressed as a % of all hypertensives
1)
2)
3)
4)
Primatesta P et al. Hypertension 2001; 38:827-32
Chobanian AV et al. JAMA 2003; 289: 2560-72
Wolf-Maier K et al. Hypertension 2004; 43:10-7
Ong KL et al. Hypertension 2007; 49: 69-75
Page 5
Efficacy versus Effectiveness
Effectiveness trials test whether interventions are
effective under “real-world” conditions of
routine care or in “natural” settings
Efficacy-effectiveness gap in clinical research
Efficacy studies
Effectiveness in routine
- Patients highly selected, who
are likely to cooperate
- Strict settings and prescribing
protocols
- Patients heterogeneity
- Strict medical follow-up Æ short
drop-out rate
- Usual follow-up or not Æ high
drop-out rate
- No health problems other than
the condition being investigated
- Multiple illness and existing non
adherence
- Short-term follow-up
- Long-term follow-up
- Standard = randomised, doubleblind, placebo-controlled trial
- Individualised treatment,
therapeutic relationship
- Contextual and human factors (e.g.
prescribing practices, staff training)
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1. How can the pharmacists improve the
effectiveness of …
- drugs used by patients ?
ECH Outcomes
DRUGS Efficacy-effectiveness gap
EFFICACY
PRACTICE gap
DRP gap
ADHERENCE gap
EFFECTIVENESS
Drug development
Pre- marketing
phase
Post- marketing
phase
Page 7
Patient-related barriers to effective drug treatment
•
Limited access to health care
•
•
e.g. health insurance, drugs, health care providers
Increased susceptibility
•
e.g. severe chronic illness, advanced age, polymorbidity, pediatry,
pregnancy, addiction, kidney or hepatic failure, mood distress
•
Drug related problems (DRP)
•
Factors of non adherence to therapy :
•
•
•
Cognitive, psychological and emotional factors (e.g. knowledge,
motivation, believes and confidence in treatment/ care providers, selfefficacy, aims in life, routine and strategies, regular life style)
Social, economic and health-care system factors (e.g. cultural barriers,
no social support, conflict with social life, disruptive circumstances of life)
Disease and treatment-related factors (e.g. complex regimen, side
effects, poor quality of execution, med taste or size, bad previous
experiences with drug, poor QoL under treatment)
Health care providers-related barriers to effective
drug treatment
•
Unfamiliarities or disagreement with the EBM therapy guidelines
•
Lack of scientific evidences for specific groups of patients (i.e.
geriatrics, pediatrics, women)
•
Overestimation of patient adherence
•
Lack of communication skills
•
Lack of confidence between patients and providers
•
Therapeutic or follow-up inertia
•
Lack of time at office/pharmacy visits
•
Lack of skills and incentives for collaborative care (i.e. physicianspharmacists)
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2. How can we improve the effectiveness of …
ECH Outcomes
PHARMACEUTICAL SERVICES
efficacy-effectiveness gap
EFFICACY
POLICY gap
EDUCATION gap
IMPLEMENTATION
STRATEGY gap
EFFECTIVENESS
Pharmaceutical services development
Concept and dissemination
Implementation
(research in pharmacy practice)
Page 9
Efficacy of an adherence intervention programme for
hypertensive patients conducted by community
pharmacists in an university medical outpatient clinic

89 patients (62% men; median
age 53; median BMI: 30 kg/m2;
70% Caucasian)

Most of them were taking 3
concomitant anti-HTA drugs

Median follow-up with the
electronic pill boxes MEMS: 224
days (quartiles: 126-500)
Figueiredo H. et al. Poster presented in the FIP Congress 2005
Efficacy of an adherence intervention programme for
hypertensive patients
in primary care physicians-pharmacists quality circles

Cluster 12-month randomised
controlled study

34 patients in usual care group
versus 34 patients in intervention
group

Follow-up by electronic pill
boxes MEMS and adherence
interventions by community
pharmacists
Santschi V. et al. European Journal of Internal Medicine (2008)
Page 10
Effectiveness of an adherence intervention
programme for non-adherence risk cardiovascular
patients in Swiss community pharmacies ??????

A national implementation programme monitored by an university study
Remunerated service
Existing education and coaching programme
Inclusion of patients by the pharmacists and medical follow-up by GPs
Æ need for communication skills and networking
AFTER 10 MONTHS…
25 participating pharmacies (of 600 !)
only 8 participating physicians and 4 patients included !!!
Added value of community pharmacists ?????????????
Marquis J et al. Study in progress
Pharmacy practice research and development
-related factors
Factors for optimizing
the effectiveness
of pharmaceutical services
Professional policy and routine practice
-related factors
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Pharmacy practice research and development -related factors
Practical
significance in
terms of public
health and/or
professional
values/skills
Clear definition
of the
intervention
High quality
EFFICACY and
EFFECTIVENESS
studies
Generalizability
of efficacy
studies findings
the effectiveness
-
- Efficacy Æ RC Trials
- Clear causal inferences of the
intervention
- Precision of outcomes measurement
- Effectiveness Æ long term observational
studies; qualitative studies
Morbidity / mortality
Patient safety
QoL
Cost-effectiveness
Standards of practice
- Readily availability of
manuals, guidelines,
training and technical
support
Harmonious implementation
process and research in
concordance with the mission and
the vision of the host environment
- Change management
- Analysis of barriers and facilitators
- Coaching
- Business model
- Education programm
- Follow-up and monitoring
- Representative sample
of the specified realworld target population
- Long-term effects
- Replication of outcomes
- Readily usable representative
datasets
- Acceptance, compliance,
adherence and involvement of
target audience and
subgroups of interest in the
service Æ high integrity and
level of implementation
delivery of the service
the effectiveness
Good
relationship
between the
practice
environment and
the research
team
Dissemination,
implementation and
monitoring strategy
High level of
exposure to the
intervention
Professional policy and routine practice -related factors
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Efficacy
Effectiveness
Efficiency
Return on investment
( rendement) as :
- Prevention of morbidity /
mortality
- Cost-effectiveness
- Improved QoL
- Improved patient safety
Closing the efficacy-effectiveness gap
Take home Messages
•
To improve the quality of pharmacy practice research
• Both internal validity (efficacy) and external validity (effectiveness)
are critical elements of evaluating interventions Æ improve the
transfer from efficacy studies to effectiveness research
• Build a closer relationship between research teams and pharmacists
• Educate pharmacists for practice research
•
To guarantee the effectiveness of pharmaceutical care services
• give priority for services with practical significance in terms of public
health and professional values / skills
• determine a precise strategy for dissemination, implementation and
monitoring of the service, based on efficacy-effectiveness outcomes
research
• develop a better networking of pharmacists with physicians
• develop better communication skills to include patients
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