Pharmacovigilance & Managed Care Pharmacy. Issues for Medication Safety in Korea

Transcription

1 Pharmacovigilance and Managed Care Pharmacy Issues for Medication Safety in Korea Hyun Taek Shin, Pharm.D. Professor, College of Pharmacy Sookmyung University & President, Korean Academy of Managed Care Pharmacy -1 -

2 Fatal ADR Cases and Risks 2 Pharmacovigilance & Managed Care 2

3 Fatal ADR cases USA (population : ~300 million) JAMA, 1998:279: ) >100,000 cases/year in hospitals Japan (population : ~130 million) Governmental report(2003) 1,239 cases (2001) UK (population : ~61 million) BMJ, 2004:329:15-19 > 10,000 cases/year in hospitals Korea (population : ~49 million) Research report filed in congress (2006.9) > 17,000 cases/year 3

4 Strategic Perspectives Pharmacovigilance Act on drug products not on patients Add warning labels Withdraw from market Changes the product name and features Managed Care Pharmacy Act on medication uses by patients Prevent potential ADR risks by DUR programs Promote cost-effective uses of drugs by various programs 4

5 Presentation - I Pharamavovigilance Issues for Medication Safety 5

6 Pharmacovigilance Issues Definition and Goal Definition : the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drugrelated problems Goal : to improve medication safety Issue in Korea Under-reporting of ADRs Inefficient ADR monitoring and reporting system Relatively fewer domestic new drugs Weak motivation for finding new ADRs Mainly PMS for most imported drugs 6

7 Recent Improvement Increasing ADR reports to KFDA 6 Regional Pharmacovigilance Centers 7

8 Current Projects Regional pharmacovigilance centers 15 centers in hospitals supported by KFDA Networking with pharmacies and clinics New KFDA project (2009.7~2011.6) Pharmacovigilance research network project 4 subprojects for improving detection, assessment, understanding and prevention of ADRs 12,761 cases during ~ Mandated ADR monitoring system in hospitals Hospital accreditation program from

9 Future Works Improving voluntary reports Healthcare professionals Still fewer reports than from drug companies Consumers Few reports Electronic reporting of ADRs Need web-based reporting system at KFDA Ex) FDA s MedWatch or MHRA s YellowCard Harmonized with international standards ISO standards for electronic reporting of ADR 9

10 Issues and Questions Voluntary reports from healthcare professionals will increase after termination of research funding for pharmacovigilance research network? May decrease? What will be the driving forces for ADR reporting? Easy and convenient reporting pathway for all Electronic ADR reporting system Mandated ADR monitoring requirement for hospitals and manufacturers 10

11 To make it easy to report ADR cases Electronic ADR reporting system 11

12 ISO Publication 12

13 Experts List Task Group Leader Hyun Taek-Shin, Korea Experts Garry Cruickshank, Canada Alessandra Pastorino, Italy Oyoo Otieno, Kenya David Cousins, UK Shaun Fiddes, UK Ian Shepherd, UK Luann Whittenburg, USA Randy Levin, USA 13

14 ICH Framework for e-reporting 14

15 ISO Framework for e-reporting <Other country> Product Manufacturer Regulatory Body <Country of Event 1> WHO Product Manufacturer Regulatory Body Interim Reporter Provider Consumer 15

16 ISO s New Standards Basic format Modified E2B format (ICH) ISO standard ADR terminology WHO-ART vs MedDRA SNOMED Reporting pathway Reporter Interim reporter (Regional Pharmacovigilance Center) National Pharmacovigilance Center WHO UMC (Uppsala Monitoring Centre) 16

17 Ongoing Works New ISO standards for ADR reporting Health informatics Pharmacovigilance Individual Case Safety Report Joint project with CEN and HL7 Recent drafts Part 1 : The framework for adverse event reporting Part 2 : Human pharmaceutical reporting requirements for ICSR May include the products used for medicinal purposes (medicinal products, medical devices, biological products, dietary supplements etc) 17

18 Presentation - II Managed Care Pharmacy Issues for Medication Safety 18

19 We are already living in the era of managed care pharmacy. Managed care is not new. It has been around since the early 1900s when 2 physicians were contracted to provide medical care for a fixed fee per employee. - in the report of T/F on managed care pharmacy (AJPE, 1998) 19

20 Current Managed Care in Korea Monopolized by governmental agencies Single payer for Medicaid program (tax based) and national health insurance program (premium based) Fixed fee-for-service payment for medical services Reimbursement for formulary drugs with no margin in retail sites Fixed copayment by patients (30%) Formulary management National formulary (closed type) Single formulary for all National P&T committee with limited functions After use reimbursement system based on EDI claims 20

21 Reimbursement for pharmacy service Community pharmacy No margin permitted Only dispensing fee for making money Competition for getting more prescriptions Hospital pharmacy No margin permitted Only dispensing fee lower than for community pharmacy Other pharmacy services (clinical, professional) Mostly not reimbursed 21

22 Health Cost Trend Benefit Year Total Healthcare 205, , , , , ,366 Pharmacy Benefit 55,830 63,535 72,288 84,040 95,126 95,610 Occupancy of Pharmacy Benefit 27.19% 28.42% 29.15% 29.43% 29.49% 29.41% Cost trend of Pharmacy Benefit % +13.8% +16.3% +13.2% +7.6% 22

23 Ongoing National Policy on Pharmacy Benefit Strong cost control over drug price and possibly dispensing fee 23

24 Issues and Challenges How to develop pharmacy benefit management for pharmaceutical care? Sound national formulary management Prospective DUR program Generic substitution, step-therapy etc How to implement GPP (Good Pharmacy Practice) standards? KGPP was proposed by KPhA in 2005 How to develop the practice training sites for pharmacy students? Community pharmacies, hospitals, pharmaceutical companies and managed care pharmacy institution 24

25 Current Pharmacy Benefit Management in Korea May position pharmacy profession and all healthcare industries at risk

26 Lessons learning from US PBMs About 50 PBMs Serve for >95% population, >70% prescription drug Main functions 1. Formulary management Closed or Open formulary Pharmacy & Therapeutic Committee 2. Prior authorization formulary exception process 3. Drug Utilization Review program Prospective DUR program Refusal of drug dispensing if inappropriate Retrospective DUR program Annual reporting to health plans 4. Disease management program 5. Mail order pharmacy service 6. Others (generic substitution, rebate arrangement etc) 26

27 Pharmacy Claims Processing (Real-time, Online Prospective DUR) Outsourcing with guides/regulations Health Plans PBMs Claim processing with c-dur Claim Adjudication Hospital/Clinic MDs Benefit Arrangement Community Pharmacy POS DUR instore DUR Visit Rx drugs Rx Patient 27

28 Current DUR Network (Korea) Outsourcing with guides/regulations Health Plans HIRA Rx Adjudication Rx processing with c-dur Hospital/Clinic MDs Benefit Arrangement Community Pharmacy POS DUR Visit Rx drugs Rx Patient 28

29 DUR alerts (US PBM) General patient safety alerts Drug allergy Severe drug interactions Drug interactions Therapy duplication Drug Gender Drug disease Potential Drug Name Confusion Excessive daily dosing Cyclic Max Dose Ineffective dosing Under Use (Check Compliance) Refill Too Soon Maximum Daily Quantity Minimum Daily Quantity Pediatric patient safety alerts Drug age Excessive daily dosing Women patient safety alerts Drug pregnancy Senior patient safety alerts Drug age Excessive daily dosing Drug interactions Drug disease 29

30 Current DUR alerts (Korea) DUR criteria ( current) Contraindicated drug interactions Age-contraindications Drug-pregnancy DUR criteria ( ~) Add therapeutic duplication May add more criteria Issues The program can be matured to effective system? Who will take the initiatives for DUR? Pharmacists, physicians and administrators? 30

31 Formulary Issues Formulary type? Strictly closed formulary without PA May block benefit to non-formulary drugs May harm consumer s rights to access valuable drugs Formulary decision? Heavily depends on cost-effectiveness data Drug pricing? Government driven downward pricing control with various new tools and systems Many ongoing issues exist. 31

32 Government Pricing Issue Anti-competitive pricing (AMCP position statement 2000) Government mandated drug prices would result in significant cost increases for all. Government imposed anti-competitive pricing may jeopardize the research and development of new drug products could result in increased utilization of more costly and risky therapies such as surgery and hospitalizations Government mandated pharmaceutical prices will not guarantee long-term savings to the consumer Government price controls would ultimately increase the number of uninsured and decrease quality of care Current Korea s pricing Government driven downward pricing control Outcome? Possible solution Need more insights with managed care concepts 32

33 Future PBM Model in Korea Plan Sponsor(MOHWF) Call Center PBM with Sound Formulary Management & Concurrent DUR Outsourcing reporting Health Plan(NHIC) HIRA Real-time Adjudication Pharmacy (RPh) Prospective DUR Hospital/Clinics (MD) visit Rx Rx Drug Patients 33

34 How about medication safety for hospitalized patient? May need fast conversion to DRG system from fee-for-service reimbursement & the strengthened hospital accreditation standards for medication safety 34

35 IOM s Recommendations for Mediation Safety in Hospitals (2001) No. Strategies Systems/Tools 1 Adopt a system-oriented approach to ADEs(anticipate, uncover, analyze, action) ADR reporting system 2 Implement standard process for medication doses, dose timing & dose scales 3 Standardize prescription writing and prescribing rules 4 Limit the numbers of types of equipment used to deliver medications 5 Implement physician order entry CPOE system 6 Use pharmaceutical software Medication Use Evaluation system 7 Implement unit dosing system of drug distribution Unit Dose System 8 Centralize pharmacy supply of high-risk drugs 9 Have special protocols for high-risk drugs 10 Do not store concentrated solutions high-risk drugs on patient units 11 Ensure availability of pharmaceutical decision support Clinical Decision Support System 12 Include a pharmacist during rounds of patient care units Clinical Pharmacists 13 Make relevant patient information available at point-of-care Electronic Medical Record 14 Improve patient knowledge about their treatment Medication Teaching 35

36 Current Issues Clinical pharmacy services in hospitals can be expanded and also reimbursed by national insurance body? No, may be due to the shortage of clinical pharmacists and financial limitation of healthcare money Who is caring for medication safety in hospitals? Consumer group? Insurance bodies? Medical profession? Pharmacy profession? 36

37 Aging Population Cost containment on pharmacy benefit will be the continued major issue for all countries Limited Financing for Pharmacy Benefit Increasing Demand for Pharmaceuticals 37

38 Key Words Correct use of 1 dollar prescription drug can save many (6 in US) dollars healthcare cost. Efforts Maximizing the Value of Pharmaceuticals (Managed Care Pharmacy Researches and Applications) True Value of Pharmaceuticals 38

39 New positioning of pharmacy True Value of Pharmaceuticals Managed Care Pharmacy Hospitals Pharmaceutical Care Good Pharmacy Practice Pharmacies Clinical Pharmacy Medicinal Products Industrial Pharmacy 39

40 Hopeful Challenges Educational renovation to educate clinical pharmacists 6 year curriculum from 2011 with 15 new added colleges Educational goal : to educate pharmacists for GPP Increased public concern on medication safety is major driving force for new roles of pharmacists National program for DUR to be expanded Cost-effective uses of medications will be final answer for upcoming financial crisis Managed care pharmacy can answer to the questions related to pharmacy benefit design for all Koreans 40

41 KAMCP Foundation ( ) 41

42 KAMCP Activities Education Support managed care pharmacy curriculum in new 6 year curriculum Twice monthly academic seminars Formulary forum and Seminar on contemporary issues Publish textbook Korean version Managed Care Pharmacy Practice, Robert Navarro (to be published on Nov. 2010) Research Publish official journals (KJMCP) Fund academic researches National initiatives on pharmacy benefit designs & policies Open symposia (spring & fall) International collaborations Academy of Managed Care Pharmacy 42

43 Closing Remarks Can we think about proliferative clinical pharmacy practice without managed care pharmacy umbrella in the future? 43