Problems in the implementation of Rational Use of Medicine

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Problems in the implementation of Rational Use
of Medicine

• Rianto Setiabudy
• Dept. of Pharmacology FKUI
• The Launching of IONI
• Jakarta, 26 October 2009

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Background

• Irrational use of medicines is a global problem
• The examples of this problem
• 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

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Outlines

• Factors influencing the use of medicine
• How to critically appraise new drugs?
• Steps toward the rational pharmacotherapy

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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)

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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

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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

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Why are doctors inclined to prescribe new drugs?

• Introduction of new features
• The launching of new drugs?? large scientific
  events
• Image as up-to-date doctors
• The presence of cases who failed to respond to
  the existing treatments
• Rewards
• Curiosity

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The selling points of new drugs

• Better efficacy
• Better tolerability
• More simple dosing regimen
• Shorter treatment period
• Others
• Less complications
• Less likely occurrence of resistance
• Better QOL
• Better laboratory results

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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?)

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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 post-marketing
  surveillance

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Anasarca and new oral antidiabetic
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How to critically appraise new drugs?

• 3. New drugs appear to have less side effects
• 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

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How to critically appraise new drugs?

• 4. Long-term side effects are still unknown
• 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.

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How to critically appraise new drugs?

• 5. Data on drug interaction is still scanty
• In pre-marketing trials, study on drug
  interaction is still limited.
• Example
• Prolongation of QT interval of a new drug may
  not be clinically significant in the
  pre-marketing studies. In the real clinical
  setting the outcome may be pronounced because of
  polypharmacy practice.

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QT interval prolongation
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How to critically appraise new drugs?

• 6. Understanding the dramatic reduction of
  complications associated with a new drug
• 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!)

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How to critically appraise new drugs?

• 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.

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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

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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.

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How to consistently maintain RUM with regards
to the introduction of new drugs? (1)

• Do not prescribe a drug because of it is new,
  but because of it is safe, effective, suitable,
  and affordable
• Appraise critically the claim of efficacy and
  safety of new drugs
• Use EBM as the foundation to prescribe new drugs
• Assess whether the price of a new drug is worth
  its superiority

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How to consistently maintain RUM with regards
to the introduction of new drugs? (1)

• Find out whether the new drug is a me-too
  drug
• In general, it is usually wise to wait for a
  while before one start prescribing new drugs
• In contrast do not hesitate to abandon poor old
  drugs, when the better new ones are available

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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

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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
• Excessive smoking
• Chronic obstructive pulmonary disease (COPD)
• Asthma
• Heart failure
• Tuberculosis
• Captopril
• Malignancies, etc.

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Steps towards the rational pharmacotherapy (3)

• Patients 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 patients
  problem and establish the diagnosis may lead to
  irrational use of drugs

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Steps towards the rational pharmacotherapy (4)

• Objective(s) of treatment
• Different problem leads to different objectives/
  approach. E.g.
• Excessive smoking ? stop the habit
• Chronic obstructive pulmonary disease (COPD) ?
  oxygen, ipratropiumbromide
• Asthma ? bronchodilator, steroid
• Heart failure ? diuretics, captopril,
  spironolactone
• Tuberculosis ? antituberculosis agents

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Steps towards the rational pharmacotherapy (5)

• Suitable choice of drug treatment for individual
  patients
• 4 factors to be considered (de Vries et al,
  1994)
• Efficacy
• Safety
• Suitability
• Cost
• This should be applied at the stage when doctor
  want to determine the group of drug and the
  specific drug in the group

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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 anti-typhoid drug for her?
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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

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Conclusions

• 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

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Thank You