Transcript Australian Medicines Terminology and the Pharmaceutical

Australian Medicines Terminology
and the Pharmaceutical Benefits
Scheme
a case study
Introduction
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Background
The Australian Medicines Terminology
The Pharmaceutical Benefits Scheme
Integration vs adoption
Issues and benefits
Australian Medicines
Terminology
• Development of a common terminology for medicines
last 10 years
• Initially managed by Standards Australia, Department of
Health and HL7 Australia
• completed by NEHTA
• a system of naming and identification of all registered
and listed medicines by TGA
• for use in prescribing, dispensing applications for ehealth
in hospitals and community
1st release in December 2007
• Updated monthly
• Available www.nehta.gov.au
AMT as SNOMED CT
• Designed to be an extension of SNOMED CT
• Delivered in SNOMED CT format
• Concepts, Relationships and Descriptions
• The AMT has need used the structures of
SNOMED and added additional concepts
and relationships eg has MPP, has
ingredient, has multi-component indicator
Pharmaceutical Benefits
Scheme
• The Pharmaceutical Benefits Scheme[1] (PBS)
subsidises around 72% of prescriptions dispensed in
Australia. The Australian Government subsidises about
85% of the $6.4 billion spent on the PBS. The PBS
comprises 844 medicines[2] available in approximately
2067forms and marketed as over 3603 trade products.
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[1] A brief guide to the Pharmaceutical Benefits Scheme, Commonwealth of Australia 2007
[2] PBS Schedule entity counts July 2008, Pharmaceutical Benefits Division, Australian Government Department
of Health and Ageing (unpublished).
New medicines on the PBS
• All new medicines are assessed for clinical
benefit and cost-effectiveness compared with
other treatments or products for the same
condition
• Pharmaceutical Benefits Advisory Committee
may reject or make recommendations about a
medicine’s use and conditions
• Pharmaceutical Benefits Pricing Authority
considers the pricing
Modernising the PBS
• The Department of Health and Ageing has
undertaken an series of reforms to
– Modernise the business and IT systems
– Monthly publishing of the PBS Schedule online
Reference: Working Together to improve the Pharmaceutical Benefits Scheme
Review of Post PBAC Processes Report Commonwealth of Australia 2004
PharmBiz
• A project to undertake the modernisation
and procure new information management
systems
• Monthly publishing system (Dec 2006)
• PharmCIS to support the business
processes of the PBAC and PBPA and
PBS data
PharmCIS
• A comprehensive information management
system designed to support the business
process and data requirements for managing the
PBS.
• PharmCIS will enable the introduction of:
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streamlined business processes
more timely listing of products on the PBS
greater transparency in decision making
adoption of Australian Medicines Terminology into the
PBS
PharmCIS functions
• Workflow – embodies a business process, manages
what is done and when
• Tasks engine – the tasks in a workflow to be
completed by users; manages task assignment,
delegation and completion.
• Templates – creation of templates, style sheets for
documents, agenda, minutes
• Email – addressing, creation and sending
• Access control – manage user access to entities,
system processes, documents, system functions
PharmCIS - things to be managed
PharmCIS
Wednesday, June 25, 2008
Submission
Party
Product
Medicinal
Product
Trade
Product
Clinical Use
Main
indication
Comparator
Evaluation
Requested
listing
Classificatio
n
TGA
Registratio
n
ESC
PBPA
DUSC
Participant
(Person with authorised
access to PharmCIS)
Organisation role
Applicant
Responsible Person
Evaluator
Contact details
Address
Document
Committee
PBAC
Person role
Committee member
Authorised representative
Marketing manager
Managing Director
Evaluation team member
Members
Agenda
Paper
Correspondence
Applicant Response
Sub-Committee Advice
Minutes
Workspace
Task
Submission
Calendar
Messages
Meeting
Search
Meeting
Date
Venue
Participants
Data extract
(DIST XML)
Page 1
PBS Schedule
PBS Schedule
AMT Example
Medicinal Product
Trade Product
Amoxycilin
Amoxil
Is A (attribute)
Is A (attribute)
Medicinal Product
Unit of Use
ATC
Is A
(attribute)
Amoxycilin
250 mg
capsule
Trade Product
Unit of Use
Is A
(attribute)
Has MPUU
Is A
(attribute)
GTIN
Has TPUU
Medicinal Product
Pack
Amoxycilin
250 mg
capsule, 20
Amoxil
250 mg
capsule
Trade Product Pack
Is A
(attribute)
Amoxil
250 mg
capsule,20
Is A (attribute)
Containered TPP
Amoxil
250 mg
capsule,20
Blister pack
PBS
GTIN
GTIN
AMT
• Fully Specified name
• Preferred Term
• Synonym
• Sprycel (dasatinib (as
monohydrate) 50 mg)
tablet: film-coated, 60
tablets, blister pack
(containered trade
product pack
• Sprycel 50 mg tablet:
film-coated, 60 tablets,
blister pack
• Sprycel 20 mg
Potential benefits of introducing
AMT
• Broader health sector and the eHealth
agenda – the national medicines
terminology when adopted by the PBS will
support interoperability (functional and
semantic) of medicines data between
prescribers, pharmacies and other health
care providers and enable linkage to the
supply chain.
PBS and AMT alignment
PBS
Drug
AMT
Medicinal Product
Pharmaceutical Benefit
Pharmaceutical item
Medicinal Product Pack
Manner of Administration
Brand
Trade Product Pack
(Trade Product Pack name)
Prescribing rule
PBS number
Max Quantity
Number of repeats
DPMQ
Restriction
Authority method
PBS
AMT
Drug
Medicinal Product
Pharmaceutical Benefit
Medicinal Product
Unit of Use
Medicinal Product Pack
Manner of Administration
Brand
Trade Product Pack
(Trade Product Pack name)
Prescribing rule
PBS number
Max Quantity
Number of repeats
DPMQ
Restriction
Authority method
Proposed alignment and impact
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How the PBS concepts align with the AMT
PBS Drug equates with Medicinal Product
Form (NHA) does not equal an AMT concept
Dosage form and strength equates to 2 AMT
concepts.
• Align with one consistent expression AMT MPP
PBS Legislation to AMT
Legislation (NHA)
Drug (active ingredient)
Form - ‘strength, type of
unit, size of unit or
otherwise’
Business Term
AMT/PBS
Drug (active ingredient)
Medicinal Product (MP)
Dosage form and strength
Medicinal Product Pack Unit of
Use (MPUU) - used as a grouping
concept only for browsing Schedule
Other
Dosage form, strength and pack
size
Medicinal Product Pack (MPP)
Manner of Administration
(MOA)
Manner of Administration
Manner of Administration
Bioequivalence/ Biosimilarity
As defined by TGA or PEB
As defined by TGA or PEB
Brand (Name)
Brand name/product
Trade Product Pack (TPP / TPP
Brand Name synonym
Pharmaceutical Benefit
Drug, Form, MOA, Brand, Max
quantity, Repeats, Restriction, Price
MP, MPP, MOA, TPP, Max
quantity, Repeats, Restriction,
Price
Pharmaceutical Item
Drug, Form, MOA
Not explicitly defined in
PharmCIS but implicitly modeled
as:
MP, MPP or MPUU, MOA
PBS Item
PBS Number, Drug, Form, MOA,
Restriction, Brand(s)
PBS Number, MP, MPP, MOA,
Restriction, Brand(s)
Potential business impact benefits
• Powerful data search and retrieval using AMT
concepts and relationships
• Able to support queries from the abstract and trade
view points
• Able to associate/group products at pack or unit of
use levels
• Supports all aspects of the business ie policy
development, submission evaluation and pricing
Potential impact
• A small number prescribing rules (PBS items) that
comprise 2 or more packs. For example the prescribing
rule 9108J Doxycycline 100 mg tablet includes both:
• Doxycycline (GenRx) 100 mg tablet: uncoated, 21 tablets
• Doxycycline (ChemMart) 100 mg tablet: uncoated, 7 tablets
• This proposal would make the 2 pack sizes explicit and
include the 21 tablet pack in a separate prescribing rule.
MPP and Max Quantity
• Maximum Quantity is currently defined as a multiple of the
form description.
• Define Max Quantity in 2 ways as a multiple of the unit of
use and of the number of trade product packs to be
supplied.
• Necessary to preserve claims processing system at
Medicare Australia as application cannot manage fractions
or amounts less than one.
MPP and Max Quantity cont
• Proposed data elements:
• Max quantity (unit of use) The maximum units of use to be
supplied for a given PBS Prescription. This concept does not
apply to multi-component trade products packs.
• Max quantity (number of packs) The maximum number of trade
product packs to be supplied for a given PBS prescription
• Unit of use not given for multi-components, pack not
broken and certain containered products
• New prescribing rules needed to avoid confusion in the
transition period
PBS web site view - Current
Potential PBS web site MPP/Brand
view
New
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Potential PBS web site TPP view
ACIHEXAL 200 mg tablet:
uncoated, 25 tablets
ACYCLO-V 200 mg tablet:
film-coated, 25 tablets
LOVIR 200 mg tablet:
uncoated, 25 tablets
New
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ACICLOVIR (GenRx) 200 mg tablet, 50
ZOVIRAX 200 mg tablet:
dispersible, 25 tablets
Potential PBS web site MPP view
Impact – business processes and work
practice translation
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Clarify the concepts expressed in the rules. Understanding the trigger
events and managing the flow-on effects is facilitated by the relationships
between the concepts in AMT eg
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New Brand
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Adding new TPPs to existing MPP and selecting the prescribing rule
New Listing
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Formulary moves for all TPPs of an MP
Statutory Price Reduction - all TPPs of an MPP with same MOA
Price Disclosure - all TPPs of an MPP with same MOA
Adding an MP, MPP and TPPs and creating the prescribing rules
Agreeing the pricing of a TPPs and deriving prices for the prescribing rules
De-listing
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De-list an Medicinal Product. All related MPPs, TPPS and prescribing rules
will automatically be identified
Impact – beyond the Department
• Minimise impact on receiving systems and PBS
data users.
• Predicting a change in the reading of the data
file to select the correct maximum quantity
definition
• Needs further consultation
NEHTA
• NEHTA are committed to maintaining AMT with
updates from TGA
• AMT releases each month with TGA and PBS
product updates - October release will include all
PBS and RPBS medicines, foods and devices
• AMT releases more frequent if necessary to
support prescribing in hospitals and community
Next Steps
• Continue consultation with PBS and
stakeholders
• Continue collaboration with NEHTA
• Contribute to refinement and development
of AMT and editorial rules
• Continue to learn about SNOMED CT
(AMT) and system integration
AMT resources
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www.nehta.gov.au
AMT release notes
AMT data
AMT UML class diagram
AMT editorial rules
AMT viewer (Windows and Mac)
email: [email protected]
Useful web sites
• www.pbs.gov.au
• www.health.gov.au
• www.nehta.gov.au