Transcript Problems associated with the implementation of the Rational Use of

Rianto Setiabudy
Dept. of Pharmacology FKUI
The Launching of IONI
Jakarta, 26 October 2009
Background
 Irrational use of medicines is a global
problem
 The examples of this problem:
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Polypharmacy
The use of medicines that are not related to the
diagnosis
Unnecessary use of expensive medicines
Inappropriate use of antibiotics
The purpose of this discussion is to recognize
factors which may hamper the implementation
of RUM and to set up strategy to apply it
Outlines
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Factors influencing the use of medicine
How to critically appraise new drugs?
Steps toward the rational
pharmacotherapy
Factors influencing the use of
medicine (1)
 Intrinsic factors:
 Do we provide adequate training for the medical
students in the Rational Use of Medicine (RUM)?
 Drug information:
 The main source of drug information for the practicing
doctors
 What do we need? Drug information which is
objective, informative, systematic, and
comprehensible (preferably not in local language)
Factors influencing the use of
medicine (2)
 The working group:
 Cooperation with industry → “local policy”
 Conflict of interests
 The working environment:
 The “negative and positive goalkeeper”
 Overburdened health workers: information for
patients?
 Poorly maintained equipments
Factors influencing the use of
medicine (3)
 The demand of patients:
 Request for injection
 Reject generic drugs
 Request for “patent” or expensive drugs
 Refill of prescription
 Request for antibiotics, vitamins, “brain energizers”
 The attractiveness of new drugs
Why are doctors inclined to prescribe new
drugs?
 Introduction of new features
 The launching of new drugs large
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scientific events
Image as up-to-date doctors
The presence of cases who failed to
respond to the existing treatments
Rewards
Curiosity
The selling points of new drugs
 Better efficacy
 Better tolerability
 More simple dosing regimen
 Shorter treatment period
 Others:
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Less complications
Less likely occurrence of resistance
Better QOL
Better laboratory results
How to critically appraise claim of new drugs?
1. The availability of clinical data:
 Sample size is adequate?
 Derived from peer-reviewed journals?
 Is data from meta-analysis available?
 Position is clear ? (As adjuvant? For
new cases? Mono therapy? For
complicated cases?)
How to critically appraise new drugs?
2. Serious side effects
 The rarely occurring SAEs are usually not
detectable in the pre-marketing clinical
trials
 They are usually detected in the postmarketing surveillance
Anasarca and new oral antidiabetic
How to critically appraise new drugs?
3. New drugs appear to have less side
effects:
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This may not be true simply because the
drug is still new
In contrast, old drugs with a long list of
side effects may not be necessarily
dangerous in reality
E.g.: aspirin, paracetamol, amoxicillin
How to critically appraise new drugs?
4. Long-term side effects are still
unknown:
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The safety and efficacy data of new
drugs are derived from the relatively
short clinical trials
Drugs for long-term use require special
precaution, e.g. anti-glaucoma,
antihypertensive agents, anti arrhytmics,
oral hypoglycemic agents, NSAIDS, etc.
QT interval prolongation
How to critically appraise new drugs?
6. Understanding the dramatic reduction of
complications associated with a new drug:
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A new drug is often claimed capable of a
dramatically reduce the complication as
compared to that of the conventional treatment.
This should be critically assessed.
For example: A study shows that using the
conventional drug, the incidence of stroke is 2%
per year.
Using the new drug, the incidence of stroke is
only 1% per year.
This a 50% reduction (looks very impressive!)
How to critically appraise new drugs?
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The Relative Risk Reduction (RRR)= 50%
But:
The Absolute Risk Reduction (ARR) is 1% (!)
More interestingly:
NNT = 1 : ARR = 1 : 1% = 100 means that we
have to treat 99 patients to protect only 1
patient from being hit by stroke. The 99 patients
take the drug for nothing.
How to critically appraise new drugs?
7. The new drug still works in cases which
already failed to respond to other agents:
 If this occurs, it does not necessarily
mean that this new drug is more effective
than the conventional agents because the
contrary is also true.
 Example: antihypertensive agents
How to critically appraise new drugs? (2)
8. Real clinical benefit felt by the patient:
 claims of superiority of new drugs should
be sensible by the patient, e.g. reduction
of case fatality rate, sequelae, length of
hospitalization, risk of amputation,
walking distance, etc.
 Improvement of various markers is only
clinically meaningful if they correlate well
with the clinical improvement , e.g.
HbA1c, LDL cholesterol, sputum
conversion, etc.
How to consistently maintain RUM with regards
to the introduction of new drugs? (1)
1. Do not prescribe a drug because of it is
new, but because of it is safe, effective,
suitable, and affordable
2. Appraise critically the claim of efficacy and
safety of new drugs
3. Use EBM as the foundation to prescribe
new drugs
4. Assess whether the price of a new drug is
worth its superiority
How to consistently maintain RUM with regards
to the introduction of new drugs? (1)
5. Find out whether the new drug is a “me-
too drug”
6. In general, it is usually wise to wait for a
while before one start prescribing new
drugs
7. In contrast: do not hesitate to abandon
poor old drugs, when the better new ones
are available
Steps towards the rational
pharmacotherapy (1)
 The PROSPECT approach
 Problem identification
 Objective of treatment
 Suitable choice of treatment
 Prescribing of the drug(s)
 Education and information
 Check, termination or modification of
treatment
Steps towards the rational
pharmacotherapy (2)
 Problem identification:
 One problem may be caused by different etiologies which
require different approaches. E.g., cough could be due to:
o Excessive smoking
o Chronic obstructive pulmonary disease (COPD)
o Asthma
o Heart failure
o Tuberculosis
o Captopril
o Malignancies, etc.
Steps towards the rational
pharmacotherapy (3)
 Patient’s problems are not only confined to
complaints due to disease. It may also be related
to the need of prophylaxis, sickness certificate, refill
of prescription, side effect, etc.
 Failure to correctly identify the patient’s problem
and establish the diagnosis may lead to irrational
use of drugs
Steps towards the rational
pharmacotherapy (4)
 Objective(s) of treatment:
 Different problem leads to different objectives/
approach. E.g.:
o Excessive smoking → stop the habit
o Chronic obstructive pulmonary disease (COPD) →
oxygen, ipratropiumbromide
o Asthma → bronchodilator, steroid
o Heart failure → diuretics, captopril, spironolactone
o Tuberculosis → antituberculosis agents
Steps towards the rational
pharmacotherapy (5)
 Suitable choice of drug treatment for individual
patients:
4 factors to be considered (de Vries et al, 1994):
1. Efficacy
2. Safety
3. Suitability
4. Cost
 This should be applied at the stage when doctor
want to determine the group of drug and the
specific drug in the group
Steps towards the rational
pharmacotherapy (6)
Question: a 32-yr old woman is suffering from typhoid
fever. She is not hospitalized and being on her 16th
week of pregnancy. What is the most appropriate antityphoid drug for her?
DRUG
chloramphenicol
thiamphenicol
amoxicillin
ciprofloxacin
ceftriaxone
EFFICACY SAFETY SUITABILITY
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COST
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Steps towards the rational
pharmacotherapy (7)
 Education and information
Education and information for the patient is of
paramount important to maintain patient
compliance
 Check, termination or modification of treatment
 Drug treatment cannot be left open ended
 The doctor needs to evaluate the outcome of the
treatment, monitor it, modify or terminate it in due
time
Conclusions
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The rational use of medicine is influenced by
many factors
The objective, informative, systematic, and
comprehensible drug information is important
to support the rational use of medicine
The over-enthusiasm to use new drugs may
also contribute to the irrational use of
medicine
The PROSPECT approach could become a
practical way to implement the rational use of
medicine
Thank You