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Problems in the implementation of Rational Use of Medicine

Problems in the implementation of Rational Use of Medicine. 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: Polypharmacy

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Problems in the implementation of Rational Use of Medicine

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  1. Problems in the implementation of Rational Use of Medicine Rianto Setiabudy Dept. of Pharmacology FKUI The Launching of IONI Jakarta, 26 October 2009

  2. 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

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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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?)

  10. 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

  11. Anasarca and new oral antidiabetic

  12. 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

  13. 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.

  14. QT interval prolongation

  15. 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!)

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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

  21. 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

  22. 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.

  23. 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

  24. 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

  25. Steps towards the rational pharmacotherapy (5) • Suitable choice of drug treatment for individual patients: 4 factors to be considered (de Vrieset 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

  26. 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?

  27. 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

  28. 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

  29. Thank You

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