IT in Pharmacy

1. Gergely ZAJZON Dr. Med. IT inPharmacy Semmelweis Medical University, Budapest Faculty of Medicine, Health Informatics Institute

2. Introducing Hungary... • Situated in the heart of Europe • Member of the EU since 2004 • Population: ~ 10.000.000 • Area: 93.000 km2

3. ...fromPharmaceuticalProspective Ministry of Health Prescribing Doctor Pharmacy Wholesaler OEP (Insurer) Patient OGYI (NCA) Health IT System Administrators/ Developers

4. National Institue of Pharmacy • OGYI (NIP) National Competent Authority for: • Clinical Trial Authorization • Marketing Authorization of Medicinal Product • Summary of product characteristics • Indications ( Off-Label) • Substituition / Bioequilaency • GLP /GCP/GMP/GDP inspections • Pharmacovigilance

5. National Health Insurance Fund Administration • NHFIA (OEP) • Single Insurer • Operated by the State • Special role in the pharmaceutical market: • As single actor, OEP is able to controll the way of all reimbursed medicines • All insured patients registerred in one database • Plays active role in defining the methods of prescription • OEP Prescription is used for not reimbursed products also

6. Pharmacies Pharmacy • Private providers • At least one of the owners has to bea pharmacist • Number of pharmacies: around 2500 • Low risk OTC (without prescription) medicines can be sold outside pharmacies also (from 2006) • Every Pharmacy: • uses Pharmaceutical IT system • has internet connection

7. Pharmaceutical IT systems • Why are they needed? • Around 5000 different medicine, more then 12000 different package on the market • Monthly changing prices • Quarter/half yearly changing reimbursement • Online connection with wholesalers • Ordering medicines • Transporting medicines 1-2 times a day! • Online Reporting to Health Insurance • Use of barcode • ? E-Prescription

8. Pharmaceutical IT systems • Functions • Price Information System • Drug Information System • Drug Interaction, incompatibilities • Checking products with same or similar active ingredient • List of interchangable (bioequivalent) products • Cash System • Different payment methods: Bank card reader • Inventory (Stock) Management System • Online ordering of medicines • Online controll system (checking insurance status) • Book-keeping, Financial functions

9. Pharmaceutical IT systems • Around 10-12 different system • Some providers • Novodata • Quadrobyte • HC-Pointer • LX-Line • …

10. PuPHA Prescribing Doctor Certified Prescribing Software Ministry of Health Health IT System Administrators/ Developers OEP (Insurer) Pharmacy Pharmacy Software OGYI (NCA)

11. PuPHA Public PHArma Database • Official, authentic, public product information • A service operated by OEP (NHIFA) • Available formats: dbf, mdb • Source of information for different applications in the health sector • The new valid version is automatically downloadable from 1st of every month

12. Role of ÁTFO in uniform communication of the health sector PUPHAUser Interface Public MP finder SEJK BÉVER Pharmacy softwares DOPA PUPHA OWL OEP DWH MIHA Prescription tool OSAP-1913Wholesaler reporting 12

13. PUPHA – Publication protocol PUPHA published in the previus month goes alive Publishing the final version of PUPHA Closing OWL – end of monthly price bid 5. 10. 15. 1. 20. OGYI gives information on all products having MA Publishing PUPHA for controll before finalizing

14. PuPHA Why is it official and authentic? • Data structure is defined in a legislation • Regular publication • All informations stored in the database are coming from their original source: • OGYI - Basic product information based on MA • OEP - Price and reimbursement data • EÜM (Ministry of Health) – reimbursement condition list • EEKH (Office of Health Authorisation and Administrative Procedures) – list of specialization

15. Informations in PuPHA All medicinal product with a Marketing Authorization! • Basic product information • ATC, DDD, DOT, DCT of the product • Prices and reimbursement information • Reimbursement conditions • Bioequivalency and substitution possiblities • ICD and specialization list for controlling the presciption of drugs with conditional reimbursement

16. Overview of the Hungarian health provision system – a ‘classic’ single-insurer model Central Budget Ministry of Health Tax Bureau Local municipalities Private investors Regulatory bodies, payers and other governmental stakeholders OEP NHIF* Financing and reimbursement Municipality-run providers Private providers Services in kind State-run providers Social security tax Monetary services (e.g. sick pay, financial aid) Health care service providers ‘Co-payment’ Payers of social security tax = patients * NHIF – National Health Insurance Fund

17. How do we purchase a ‘no-frills’ over-the-counter painkiller? MAH (manufacturer, importer) Medicinal product Ex factory price – rebates Wholesaler Medicinal product NO REGULATORY PRICE CONTROL Wholesaler price – rebates Pharmacy Medicinal product Retail price – rebates Patients

18. How is reimbursementprovided? • Sourcing is predominantly provided by employers and employees • The mechanism can either be individual savings or society-level redistribution (through taxation or insurance contributions) • The level of organization may be national, regional or local HEALTH INSURANCE SYSTEMS Source: Kutzin 2001.

19. Pharmaceutical reimbursement is only one component of health insurance systems Primary care (GP’s, dental care, home care) Other services (ambulance, home aids etc.) Outpatient care Health insurance Acute hospital care Pharmaceutical reimbursement Chronic hospital care

20. Provision of hospital drugs within a classic single-insurer model – the example of Hungary MAH (manufacturer, importer) Medicinal product Ex factory price – rebates Wholesaler Central budget Wholesaler price – rebates Deficit subsidies Medicinal product Service provider (hospital) National Health Insurance Fund (OEP) DRG payments Medicinal product Co-payment (only in specific cases) NO PHARMACY AND PRESCRIPTION FOR HOSPITAL DRUGS Social security tax Patients / taxpayers

21. Pharmaceutical reimbursement within a classic single-insurer model – the example of Hungary MAH (manufacturer, importer) Medicinal product Ex factory price – rebates Wholesaler Central budget Wholesaler price – rebates Deficit subsidies Medicinal product X% Pharmacy (retailer) National Health Insurance Fund (OEP) Reimbursement 100%-X% Prescription Co-payment Medicinal product Prescription Social security tax Physician Patients / taxpayers

22. Reimbursement rates used in Hungary Unconditional reimbursement (general prescription right for all physicians in all indications listed in the marketing authorisation) Conditional reimbursement (prescription rights restricted to certain medical professions and / or reimbursement is granted only in a subset of authorised indications) • Conditional 50% (Eü. 50%) • Conditional 70% (Eü. 70%) • Conditional 90% (Eü. 90%) • Conditional 100% (Eü. 100%) • Unconditional 25% • Unconditional 55% • Unconditional 80%

23. Payers cannot be expected to accept such price differences. Thus, they set reimbusement amounts in a way to motivate the manufacturer to reduce or fully eliminate price differences. In any reimbursement system, it is possible that… …the prices for two drus, which are used in the same therapeutic area with similar therapeutic effect, are different. Payers can set the reimbursement value according to the lower price level of other substitutable products. …the prices of two biologically equivalent drugs are different. Payers can cancel the reimbursement of a product (de-listing). …the price of the same drug differs in different countries. Reasons for reference pricing

24. The basic model for generic referencing • Co-payment • reduces unnecessary drug consumption and the risks of polipragmasy • enhances health and cost consciousness of patients • shifts part of the risk onto patients ∆>30% Co-payment Savings for the patient Co-payment The product will be de-listed if its daily cost of therapy (DCT) is more than 30% higher than the reference DCT Reimbursement amount of reference product DCT of te product is max. 10% higher than reference DCT: set reimbursement amount Reference product: %-based reimbursement DCT of te product is more than 10% higher than reference DCT: set reimbursement amount DCT of the product is lower than reference DCT %-based reimbursement Reimbursement amount of a below-reference product

25. Prescription tools All prescription tools • have to be certified by Health Insurance Supervisory Authority • have to use the official data from PuPHA • have to be able to handle special prescription rules defined by OEP (NHIFA) • have to be able to print extra barcode

26. Use of prescription tools in mandatory from 2008 • Except: urgent cases and outside office cases • OEP (NHIFA) provides free prescription tool for doctors • Doctors can also use other certified products: • Actually ~50 on the market

27. Guided prescription practice Certified Prescribing Software mandatory for all doctors Software Price monitoring: Information of the cheapest available bioequivalaent product – with colour coding Information for doctors Penalizing the doctors not prescribing cost-effectively Incentive system

29. Unique Prescription ID Patient’s Health ins. ID. Doctor Id. ICD Code Patient Id.Birth Date Date of prescripttion Legal base for reimbursement Can not be substitued Registry number in doctor’ diary Information on specialist in case of conditional reimbursement Doctors seal and signature Extra barcode Patient signature

30. Informations on the Prescription • Prescription identification – unique barcode identifier • Information on doctor & praxis • Doctor identification • Name /Praxis ID • Seal Nr. / Seal • Signature • Patient identification • Name, Address, Birth Date • Health Insurance ID Nr. (TAJ) • Signature

31. Informations on the Prescription • Pharmaceutical information • Trade name • Strength • Dosage form • Quantity, Dosage • In Hungary currently only one medicine can be prescripted on one form!

32. Informations on the Prescription • Legal base for reimbursement • Normative reimbursement • Higher reimbursement for special indication • Working accident • Soldier • Substitution: can it be changed for a bioequivalent, generic drug?

33. Informations on the Prescription For conditional reimbursement purposes: • ICD Code • Identification on the specialist: • Some medicines can be prescripted by specialists or after the recommendation (proposal) of a specialist – in case of conditional reimbursement Conditions: • Indication (coded with ICD) • Specialization - who can prescribe • How long can it be prescribed in primary care?

34. Conditional reimbursent rules in different areas of healthcare

35. Barcode – Half way: from paper to electronic • With barcode reader you can: • identify informations, which are allready stored in a database • decrease manual data input • Bar codes used in the Pharmacy • Barcodes can identify: • Products (EAN Code) • Prescription form identifier: • Containing information on the Doctor & Praxis • Extra barcode

36. Extra barcode ‘Semi e-Prescription solution’ • All information of the prescription is coded into this barcode • Transfer from doctors prescribing system to the system of the pharmacy on paper! Advantage: • Quicker data input in pharmacy • Improving patient safety by easier identification Disadvantage: different printing qualities, barcode reader quality

37. Content of the extra barcode 43 digit • Unique Patient ID • Unique Product ID • Unique ID of Prescption Tool • Prescribed Quantity • Substitution • Date of prescription • Legal base of reimbursement • ICD code • Conditional reimbursement:Specialist ID, date of recommendation • Validity date of PuPha used for prescription

38. e-Prescription • Project started in 2009 sponsored by EU Structure Funds for electronic Patient ID Card • E-Prescription is part of this package • ? 2012 • Double identification system: • Patient ID card • Doctor & Pharmacy ID (Health Professional ID) • Parallel identification will be needed for transfers

39. Price of a medicinal product • + Wholesaler price spread • + Retail price spread • - Reimbursment • MAH / Manufacturer • Wholesaler • Pharmacy • Patient Producers Price Wholesaler Price Consumer Price Refunding • Insurer

40. Price of a medicinal product • MAH / Manufacturer • Wholesaler • Pharmacy • Patient • Producers price • Wholesaler price • Refunding Reimbursement • Insurer

41. Price of a medicinal product • MAH / Manufacturer • Wholesaler • Pharmacy • Patient • Producers price • Wholesaler price (max. 30 days) • Co-Payment Reimbursement (5 days after settlement) • Insurer SETTLEMENT SYSTEM • Settlement frequency: 1, 2, or 4 times per month

42. BÉVER - NHIFA Settlement System What has to be reported? • Pharmacy identifier • Prescription identifier • All Informations from Extra Barcode (see there) • In case of substitution: identifer of the given product Report has a predefined format. The report format is created by the different softwares used by the pharmacies In case of any mistakes correction can be sent to the system.

43. BÉVER - NHIFA Settlement System 2010: • Mandatory e-Reporting of Pharmacy settlement • Online reporting tool of OEP (NHIFA) was introduced in 2008 • Around 20 users testing in the live system in 2009 • Mandatory weekly settlement frequency

44. BÉVER - NHIFA Settlement System Much more than a settlement system... Advantage of the Single Insurer... • Controll posssiblity of all reimbursed drugs • Source online incentive tool for doctors • Health Care Statistics Prescribing Doctor MIHA PRESCRIPTION TOOL PUPHA Paper with barcode BÉVERc OEP (Insurer) PHARMACY SOFTWARE Pharmacy

45. International Prescriptions

46. DE Gyógyszertár száma Bundesversorgungsgesetz Segédeszköz Oltóanyag Betegbiztosító ill. Költségviselő Térítés köteles Biztosított neve Születési idő Nem térítés köteles Biztosító-száma Biztosított-száma Éjszakai pótlék nélkül Állapot Egyéb Segédeszköz/gyógyszer száma Baleset Munkahelyi baleset DR. ZAJZON GERGELY Üzem Orvos száma Dátum Szerződéses orvos bélyegzője Gyógyszertárba való leadás dátuma Munkahelyi balesetnél kitöltendő Orvos aláírása Baleset napja Baleseti üzem vagy munkaadó száma

47. 1. Beteg azonosítása (név, kora, címe) 2. Kiállítás dátuma 3. A gyógyszer neve 4. A gyógyszer dózisa 5. Adagolás 6. Beviteli mód 7. Milyen gyakran kell beszedni és milyen módon pl. naponta 8. Az egyszeri kiadható dózis pl. 1 doboz, egy havi adag 9. Újbóli kiadások száma 10. DEA szám 11. Orvos aláírása US DR. ZAJZON GERGELY

48. Beteg adatai: neve, címe Beteg kora Születési dátum Nap/hónap/év Kezelési napok száma Gyógyszerre vonatkozó adatok DR. ZAJZON GERGELY Kiállítás dátuma Orvos aláírása Orvos adatai: Hatóság, orvos neve,pecsét száma,címe UK

49. Orvos adatai:neve, címe,telefonszáma Beteg „medicare” száma Beteg adatai:neve, címe Ha az orvos nem akar generikus változatot PBS RPBS: RepatriationPharmaceuticalBenefits Scheme Gyógyszer formája, adagja, erőssége DR. ZAJZON GERGELY Ismétlődés száma Orvos aláírása Kiállítás dátuma AUS

50. 2D BARCOCE UK – Wales DR. ZAJZON GERGELY