Rational Drug Use Pharmacoeconomy

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