it in pharmacy

IT IN PHARMACY

Semmelweis Medical University, BudapestFaculty of Medicine, Health Informatics Institute

1

Gergely ZAJZON Dr. Med.

INTRODUCING HUNGARY...

Situated in the heart of Europe Member of the EU since 2004 Population: ~ 10.000.000 Area: 93.000 km2

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...FROM PHARMACEUTICAL PROSPECTIVE

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OGYI (NCA)OGYI (NCA)

OEP (Insurer)OEP (Insurer)

PatientPatient

WholesalerWholesaler

PharmacyPharmacyPrescribing Prescribing

DoctorDoctor

Health IT SystemHealth IT System Administrators/ Developers Administrators/ Developers

Ministry of HealthMinistry of Health

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

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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 also5

PHARMACIES PharmacyPharmacy

Private providers At least one of the owners has to be

a 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

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

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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

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PHARMACEUTICAL IT SYSTEMS

Around 10-12 different system Some providers

Novodata Quadrobyte HC-Pointer LX-Line …

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OGYI (NCA)OGYI (NCA)

OEP (Insurer)OEP (Insurer)

PharmacyPharmacy

Prescribing Prescribing DoctorDoctor

Health IT SystemHealth IT System Administrators/ Administrators/

DevelopersDevelopers

Ministry of HealthMinistry of Health

PuPHAPuPHA

CertifiedCertified

Prescribing Prescribing

SoftwareSoftware

PharmacyPharmacy

SoftwareSoftware

PUPHA

PuPublic PHAPHArma 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

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ROLE OF ÁTFO IN UNIFORM COMMUNICATION OF THE HEALTH SECTOR

PUPHAPUPHA

Prescription tool

OWL

Public MP finder

DOPA

OSAP-1913Wholesaler reporting

PUPHAUser

InterfaceSEJK

Pharmacy softwares

BÉVER

OEP DWH

MIHA

PUPHA – PUBLICATION PROTOCOL

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10. 15. 20.5.

OGYI gives information on all products having MA

Closing OWL – end of monthly price bid

Publishing PUPHA for controll before finalizing

Publishing the final version of PUPHA

1.

PUPHA published in the previus month goes alive

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 specialization14

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 15

OVERVIEW OF THE HUNGARIAN HEALTH PROVISION SYSTEM – A ‘CLASSIC’ SINGLE-INSURER MODEL

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OEP

NHIF*Municipality-run providers

State-run providers

Financing and reimbursement

Local municipalities

Health care service providers

Tax Bureau

Central Budget

Ministry of Health

Private investors

Monetary services (e.g. sick pay, financial aid)

Regulatory bodies, payers and other

governmental stakeholders

‘Co-payment’

Payers of social security tax = patients* NHIF – National Health Insurance Fund

Private providers

Services in kindSocial security tax

HOW DO WE PURCHASE A ‘NO-FRILLS’ OVER-THE-COUNTER PAINKILLER?

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Pharmacy

Wholesaler

MAH (manufacturer,

importer)Medicinal product

Ex factory price – rebates

Medicinal product

Wholesaler price – rebates

Medicinal product

Retail price – rebates

Patients

NO REGULATORY PRICE CONTROL

HOW IS REIMBURSEMENT PROVIDED?

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• 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

Source: Kutzin 2001.

HEALTH INSURANCE

SYSTEMS

PHARMACEUTICAL REIMBURSEMENT IS ONLY ONE COMPONENT OF HEALTH INSURANCE SYSTEMS

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Other services (ambulance,

home aids etc.)

Pharmaceutical reimbursement

Outpatient care

Acute hospital

careChronic hospital

care

Primary care (GP’s, dental care, home care)

Health insurance

PROVISION OF HOSPITAL DRUGS WITHIN A CLASSIC SINGLE-INSURER MODEL – THE EXAMPLE OF HUNGARY

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Service provider (hospital)

Wholesaler

MAH (manufacturer,

importer)Medicinal product

Ex factory price – rebates

Medicinal product

Wholesaler price – rebates

Medicinal product

Co-payment (only in specific cases)

Patients / taxpayers

National Health Insurance Fund

(OEP)DRG payments

Central budget

Social security tax

Deficit subsidies

!NO PHARMACY AND PRESCRIPTION FOR HOSPITAL DRUGS

PHARMACEUTICAL REIMBURSEMENT WITHIN A CLASSIC SINGLE-INSURER MODEL – THE EXAMPLE OF HUNGARY

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Pharmacy(retailer)

Wholesaler

MAH (manufacturer,

importer)

100%-X

%

Medicinal product

Ex factory price – rebates

Medicinal product

Wholesaler price – rebates

Medicinal product

PrescriptionCo-payment

Patients / taxpayers

X%National Health Insurance Fund

(OEP)Reimbursement

Central budget

Physician

Prescription Social security tax

Deficit subsidies

REIMBURSEMENT RATES USED IN HUNGARY

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Unconditional reimbursement (general prescription right for all

physicians in all indications listed in the marketing authorisation)

• Unconditional 25%• Unconditional 55%• Unconditional 80%

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%)

REASONS FOR REFERENCE PRICING

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In any reimbursement system, it is possible that…

…the prices of two biologically equivalent drugs are different.

…the prices for two drus, which are used in the same therapeutic area with similar therapeutic effect, are different.

…the price of the same drug differs in different countries.

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.

Payers can cancel the reimbursement of a product (de-listing).

Payers can set the reimbursement value according to the lower price level of other substitutable products.

THE BASIC MODEL FOR GENERIC REFERENCING

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Ref

eren

ce p

rodu

ct:

%-b

ased

rei

mbu

rsem

ent

DC

T o

f the

pro

duct

is lo

wer

th

an r

efer

ence

DC

T

%-b

ased

rei

mbu

rsem

ent

Reimbursement amount of reference product

DC

T o

f te

prod

uct i

s m

ax. 1

0% h

ighe

r th

an r

efer

ence

DC

T:

set

reim

burs

emen

t am

ount

The

pro

duct

wil

l be

de-l

iste

d if

its

dail

y co

st o

f the

rapy

(D

CT

) is

mor

e th

an 3

0% h

ighe

r th

an th

e re

fere

nce

DC

T

DC

T o

f te

prod

uct i

s m

ore

than

10%

hi

gher

than

ref

eren

ce D

CT

: s

et r

eim

burs

emen

t am

ount

Savings for the patient

Co-payment

Co-payment

Reimbursement amount of a

below-reference product

∆>

30%

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

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

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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

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GUIDED PRESCRIPTION PRACTICE

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Information for doctors

Price monitoring: Information of the cheapest available bioequivalaent

product – with colour coding

Software Certified Prescribing Software mandatory for all doctors

Incentive systemPenalizing the doctors not prescribing

cost-effectively

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Doctor Id.

Patient Id.Birth Date

ICD Code

Doctors seal and signature

Patient’s

Health ins. ID.

Date of prescripttion

Extra barcode

Unique Prescription ID

Can not be substitued

Legal base for reimbursement

Registry number in doctor’ diary

Information on specialist in case of conditional reimbursement

Patient signature

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

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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!

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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?

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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?33

19%

22%

10%18%

20%

11%oncology

cardiology

immun/autoi.

psychiatry/neurology

other

pediatrics

Conditional reimbursent rules in different areas of healthcare

BARCODE – HALF WAY: FROM PAPER TO ELECTRONIC

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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

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

identificationDisadvantage: different printing qualities,

barcode reader quality36

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

prescription37

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

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PRICE OF A MEDICINAL PRODUCT

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MAH / Manufacturer

Wholesaler

Pharmacy

Patient

Producers Price

Wholesaler Price

Consumer Price

Refunding

+ Wholesaler price spread

+ Retail price spread

- Reimbursment • Insurer

PRICE OF A MEDICINAL PRODUCT

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MAH / Manufacturer

Wholesaler

Pharmacy

Patient

Producers price

Wholesaler price

Refunding

• Insurer

Reimbursement

PRICE OF A MEDICINAL PRODUCT

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MAH / Manufacturer

Wholesaler

Pharmacy

Patient

Producers price

Wholesaler price (max. 30 days)

Co-Payment• Insur

er

ReimbursemReimbursementent

SETTLEMENT SYSTEMSETTLEMENT SYSTEM

• Settlement frequency: 1, 2, or 4 times per month

(5 days after settlement)

BÉVER - NHIFA SETTLEMENT SYSTEMWhat has to be reported?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 pharmaciesIn case of any mistakes correction can be sent to the

system.

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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

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BÉVER - NHIFA SETTLEMENT SYSTEM

Much more than a 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

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PUPHA

BÉVERc

PRESCRIPTION TOOL

PHARMACY SOFTWAREOEP (Insurer)OEP (Insurer)

PharmacyPharmacy

Prescribing Prescribing DoctorDoctor

MIHA

Paper with barcode

INTERNATIONAL PRESCRIPTIONS

DR. ZAJZON GERGELY

Betegbiztosító ill. Költségviselő

Biztosított neve Születési időTérítés köteles

Nem térítés köteles

Egyéb

Baleset

Éjszakai pótlék nélkül

Munkahelyi baleset

Munkahelyi balesetnél kitöltendő

Baleset napja

Baleseti üzem vagy munkaadó száma

Orvos aláírása

Gyógyszertárba való leadás dátuma

Szerződéses orvos bélyegzőjeÜzem DátumOrvos

száma

Biztosító-száma

Biztosított-száma

Állapot

Bundesversorgungsgesetz

SegédeszközOltóanyag

Gyógyszertár száma

Segédeszköz/gyógyszer száma

DE

DR

. ZA

JZO

N G

ER

GE

LY

US1. Beteg azonosítása

(név, kora, címe)2. Kiállítás dátuma3. A gyógyszer neve4. A gyógyszer dózisa5. Adagolás6. Beviteli mód7. Milyen gyakran kell

beszedni és milyen módon pl.

naponta8. Az egyszeri kiadható

dózis pl. 1 doboz, egy havi adag9. Újbóli kiadások száma10. DEA szám11. Orvos aláírása

DR

. ZA

JZO

N G

ER

GE

LY

Beteg adatai: neve, címeBeteg kora

Születési dátumNap/hónap/év

Gyógyszerre vonatkozó adatok

Kiállítás dátuma

Kezelési napok száma

Orvos aláírása

Orvos adatai:Hatóság, orvos neve,

pecsét száma,címeUK

DR

. ZA

JZO

N G

ER

GE

LY

AUS

Orvos adatai:neve, címe,

telefonszáma

Beteg „medicare” száma

Beteg adatai:neve, címe

Orvos aláírásaKiállítás dátuma

Gyógyszer formája, adagja, erőssége

Ismétlődés száma

Ha az orvos nem akar generikus változatotPBS

RPBS:Repatriation

PharmaceuticalBenefits Scheme

DR. ZAJZON GERGELY

2D BARCOCE

UK – Wales

DR. ZAJZON GERGELY

E-PRESCRIPTION

DR. ZAJZON GERGELY

E-PRESCRIPTION IN THE EU

Nationally available

& operational

Regionally available

& operational

Not available

EU memberstate(not participating)

Non EU country

>25%

<25%

>25%

<25%

Europe, 2008.

DR. ZAJZON GERGELY

75 % or more

50% -74 %

26% - 49%

1 % - 25%

0% / < 1%

August 2000 100 000 e-prescriptions

January 20092,3 Mil. e-prescriptions

Of all new prescriptions that were dispensed at the local pharmacies

3 % 76 %

SWEDEN

THANK YOU!

Gergely Zajzon Dr. Med.E-mail: zajzon.gergely@zazacom.hu

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