it in pharmacy
DESCRIPTION
Gergely ZAJZON Dr. Med. IT in Pharmacy. Semmelweis Medical University, Budapest Faculty of Medicine, Health Informatics Institute. Introducing Hungary. Situated in the heart of Europe Member of the EU since 2004 Population: ~ 10.000.000 Area: 93.000 km 2. - PowerPoint PPT PresentationTRANSCRIPT
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
2
...FROM PHARMACEUTICAL PROSPECTIVE
3
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
4
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
7
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
8
PHARMACEUTICAL IT SYSTEMS
Around 10-12 different system Some providers
Novodata Quadrobyte HC-Pointer LX-Line …
9
10
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
11
12
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
13
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
16
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?
17
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?
18
• 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
19
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
20
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
21
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
22
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
24
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
25
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
26
GUIDED PRESCRIPTION PRACTICE
27
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
28
29
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
30
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!
31
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?
32
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
35
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
39
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
41
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.
42
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
44
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