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RATIONAL DRUG USE. IRRATIONAL DRUG USE. . REGULATORY AGENCIES. PHYSICIANS. INDUSTRY. PHARMACYST. PATIENTS. RATIONAL DRUG USE. Right indicationRight drugRight route, dosage, durationRight patientRight patient informationRigtht evaluationRight price. 7R.
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1. Rational Drug Use & Pharmacoeconomy F. Cankat Tulunay
Dept. Opf Clinical Pharmacology, Medical School of Ankara University, Ankara, TURKEY
4. RATIONAL DRUG USE Right indication
Right drug
Right route, dosage, duration
Right patient
Right patient information
Rigtht evaluation
Right price Emphasize that this is medical model.Emphasize that this is medical model.
5. Irrational Drug Use = Pathological prescription Drug use unproper indication
Wrong drug in specific disease
Use of drugs without evidence for some indications
Emniyeti bilinmeden ilaç kullanmak
Etkisi ve emniyeti bilinen ilaçlari kullanmamak
Ilaçlari yanlis dozda, sürede ve yoldan kullanmak
Yeni çikan ilaçlari hemen kullanmak
Pahali ilaç iyi ilaçtir’a inanmak Request an example of each practice from participants.Request an example of each practice from participants.
6. Factors affecting irrational drug use Emphasize interrelationship of factors and that problems rarely have single cause.Emphasize interrelationship of factors and that problems rarely have single cause.
7. Outcomes of irrational drug use
11. PARANTERAL MELOXICAM Only reimbursable in Turkey
Treatment of OA symptoms?
It is not analgesic!
Original (Mobic) does not have paranteral form!
Mobic®, Mobec®, Mobicox®, Movalis®, Movatec® (meloxicam) is a non-steroidal anti-inflammatory drug indicated fo:
Symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease)
Symptomatic treatment of rheumatoid arthritis
Symptomatic treatment of ankylosing spondylitis
12. Dr. Frank DEGNERMedical Department, Boehringer Ingelheim, Germany, COX concept: MELISSA and SELECT report, 1998 15 mg Meloxicam highly significantly differnt than 7.5 mg.
15 mg Meloksikam is equipotent with 20 mg Piroksicam.
17. PROPER TREATMENT
Right knowledge
Right drug
Right dosage
Right duration
Right quality
Right price
19. HEALTH ECONOMICS Applying economic principles and theories to health and to the health care sector
21. PHARMACOECONOMICS An application of the tools of microeconomics to the ongoing evaluation of the impact of new and emerging technologies in health care systems from perspectives of (i) manufacturer, (ii) reimburser and (iii) prescriber
22. PHARMACOECONOMICS Pharmacoeconomics is the scientific discipline that asseses the overall value of pharmaceutical health care products, services, and programs.
Of necessity, it addresses the clinical, economic, and humanistic aspects of health care interventions in the prevention, diagnosis, treatment and management of disease.
It provides information critical to the optimal allocation of health care resources.
23. PHARMACOECONOMY The description and analysis of the cost of drug therapy to healthcare systems and society
Pharmacoeconomic research identifies, measures, and compares the cost and consequences of pharmaceutical products and services
Pharmacoeconomic analysis employs tools for examining the impact of alternative drug therapies and other medical interventions
25. pharmacoeconomy 1. COST-MINIMIZATION (MALIYET AZALTICI)
2. COST-BENEFIT (MALIYET-FAYDA)
3. COST-EFFECTIVENESS (MALIYET-ETKENLIK)
4. COST-UTILITY (MALIYET-KULLANIM)
26. COST “COST” IS NOT “PRICE”.
Cost refers to the sacrifice of alternative benefits made when given a resource is used for any purpose.
Cost in health economics refers to the resources consumed during the provision of health care.
27. TYPES OF COST DIRECT COST
Refers to those resources whose consumption is wholly attributable to use of the health care intervention in question. It includes resources such as physical goods, labor, and time.
INDIRECT COST
Is used differently in different disciplines; however in pharmacoeconomics and outcomes research, it generellay refers to lost productivity (paid or unpaid) resulting from morbidity or mortality.
INTANGIBLE COST
Refers to the pain and suffering imposed by disease and its treatment and are typically more difficult perspectives.
28. SUBTERMS RELATED TO COSTS IN HEALTH ECONOMICS Acquisiton cost
Allowable cost
Ancillary cost
Averted cost
Incremental cost
Intangible cost
Out-of-pocket cost
29. Which drugs should be included on the hospital formulary?
What is the best drug for a pharmaceutical industry to develope?
What is the best drug for a particular patient?
Which drug delivery system is the best for a hospital?
Which drug should be included social security formulary?
What is the cost per quality of life extended by this drug?
Will patient QoL be improved by a particular drug-therapy desicion?
What is the patient outcome of various treatment modalities?
30. Formulary decision making has been described as involving assessments of clinical effectiveness, safety, cost of treatment, cost-effectiveness, and quality of life.
Formulary management is one of the major strategies employed in hospital settings to manage the quality and costs of pharmaceuticals
The use of a formulary can ensure quality and control costs if its use is based on appropriate clinical and pharmacoeconomic considerations.
31. Barriers to Using Pharmacoeconomic Information The Role of Pharmacoeconomic Information From the Pharmaceutical Industry PerspectiveE P. Armstrong, et al., PharmD Drug Benefit Trends 13:39-45, 2001.
37. Pharmaceutical Reimbursement Policies in European Countries (C. Huttin, “Comparative Prices and Reimbursement Systems for Regulating Pharmaceutical Expenditures in the European Community, “Report to the)
38. All European countries have a common health policy objective
39. EQUITY Justice according to natural law or right
Something that is equitable
Everybody must benefit from system
40. Transparency Directive (89/105/EEC) Does not alter the rights of goverment to manage pricing and reimbursement of pharmaceuticals, but stipule that:
The system must not discriminate against imports
Desicion should be based on objective criteria
Pricing and reimbursement desicion should be taken with specified time limits
A reason must be given for any refusal of a price or price increase
A right of appeal is provided in cases of national dispute
41. Implementation of EU Directive 89/105/EEC on Transparency Includes New legal background
Defining the principles of desicion making (evidence based medicine, equity, publicity, transparency, cost-effectiveness, budget constraints)
Setting up the formal procedure
Establishment of an transparency agency for pharmacoeconomy and/or reimbursement
44. WHAT DO WE NEED! A system without corruption
To prevent waste / wastefulness
To be rational
To realize that we all are sailing the same boat
To trust each other
Harmonization on all subjects (patient handout forms, education, etc.)
45. WHAT DO WE NEED! Pharmacoeconomic analysis of a treatment
Not to have reimburse “drug is not a drug”
Appropriate pricing according to the purchasing power
Medications to be available to everyone
Standardized diagnosis-treatment guidelines
Standardized education at all universities
Clinical, pharmacological and epidemiological research
Independent "Govermental Drug Institution”
46. Current Decision Making Process There is only one institution responsible for the national level in Turkey. This is the Turkish Social Security Agency.
The decision is given in two steps:
The first step evaluation is based on technical assessment. It may be called as mini HTA. Thereafter the appraisal is given by an upper commission, which is more a political decision.
These process is currently only for pharmaceuticals. The medical devices are evaluated by another department in the SSA. However the process is not defined well and probably very soon the process for medical devices will be changed to the same with pharmaceuticals.
The commission collects and declares their decision 4 times a year. There are some exemptions for some special diseases and drugs.
47. Current Decision Making Process The members of the technical commission are:
Turkish Social Security Agency (SSA)
Ministry of Health
Ministry of Finance
pharmaceutical company associations
Academics
The members of upper commission are from
Turkish Social Security Agency
Ministry of Health
Ministry of Finance