Australian Medicines Terminology and the

Pharmaceutical Benefits Scheme

a case study

Introduction

• 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 community1st 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.

• [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of Health and Ageing (unpublished).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 on-

line

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:– 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

Participant(Person with authorised

access to PharmCIS)

WorkspaceTask

SubmissionCalendarMessagesMeetingSearch

Data extract(DIST XML)

Document

Agenda Paper

CorrespondenceApplicant Response

Sub-Committee AdviceMinutes

PartyPerson role

Committee memberAuthorised representative

Marketing managerManaging Director

Evaluation team member

Organisation roleApplicant

Responsible PersonEvaluator

Address Contact details

Submission

Requested listing

ProductMedicinal ProductTrade

Product

Clinical UseMain

indicationComparator

Classification

TGA Registratio

n

Evaluation

Committee

PBAC

PBPA DUSC

ESC Members

Wednesday, June 25, 2008

Page 1

PharmCIS

Meeting

ParticipantsDate

Venue

PharmCIS - things to be managed

PBS Schedule

PBS Schedule

ATC

Medicinal ProductAmoxycilin

AMT Example

Medicinal Product Unit of UseAmoxycilin

250 mgcapsule

Medicinal Product Pack

Amoxycilin250 mg

capsule, 20

Trade ProductAmoxil

Trade ProductUnit of Use

Amoxil250 mgcapsule

Trade Product PackAmoxil250 mg

capsule,20

Containered TPPAmoxil250 mg

capsule,20Blister pack

GTIN

GTIN

GTIN

PBS

Is A (attribute)

Is A (attribute)

Is A (attribute)

Is A (attribute)

Is A (attribute)

Has MPUU

Is A (attribute)

Has TPUU

Is A (attribute)

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.

Pharmaceutical Benefit

Drug

Medicinal Product

Pharmaceutical item

Medicinal Product PackManner of Administration

Brand

Trade Product Pack (Trade Product Pack name)

Prescribing rulePBS number Max Quantity

Number of repeatsDPMQ

RestrictionAuthority method

PBS

AMT

PBS and AMT alignment

Pharmaceutical Benefit

Drug

Medicinal Product

Medicinal Product PackManner of Administration

Brand

Trade Product Pack (Trade Product Pack name)

Prescribing rulePBS number Max Quantity

Number of repeatsDPMQ

RestrictionAuthority method

PBS

AMT

Medicinal Product Unit of Use

Proposed alignment and impact

• 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 AMTLegislation (NHA) Business Term AMT/PBS

Drug (active ingredient) Drug (active ingredient) Medicinal Product (MP)

Form - ‘strength, type of unit, size of unit or otherwise’

Dosage form and strengthMedicinal 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#

Potential PBS web site TPP view

New#

ACIHEXAL 200 mg tablet: uncoated, 25 tablets

ACYCLO-V 200 mg tablet: film-coated, 25 tablets

LOVIR 200 mg tablet: uncoated, 25 tablets

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

• 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

• 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

• New Brand• Adding new TPPs to existing MPP and selecting the prescribing rule

• New Listing • 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• 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

• www.nehta.gov.au

• AMT release notes

• AMT data

• AMT UML class diagram

• AMT editorial rules

• AMT viewer (Windows and Mac)

• email: terminologies@nehta.gov.au

Useful web sites

• www.pbs.gov.au

• www.health.gov.au

• www.nehta.gov.au