1. Australian Medicines Terminology and the Pharmaceutical Benefits Scheme a case study

2. Introduction Background The Australian Medicines Terminology The Pharmaceutical Benefits Scheme Integration vs adoption Issues and benefits

3. 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 1 st release in December 2007 Updated monthly Available www.nehta.gov.au

4. 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

5. 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][2] [1] A brief guide to the Pharmaceutical Benefits Scheme, Commonwealth of Australia 2007[1] [2] PBS Schedule entity counts July 2008, Pharmaceutical Benefits Division, Australian Government Department of Health and Ageing (unpublished).[2]

6. 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

7. 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

8. 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

9. 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

10. 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

11. PharmCIS - things to be managed

12. PBS Schedule

14. ATC Medicinal Product Amoxycilin AMT Example Medicinal Product Unit of Use Amoxycilin 250 mg capsule Medicinal Product Pack Amoxycilin 250 mg capsule, 20 Trade Product Amoxil Trade Product Unit of Use Amoxil 250 mg capsule Trade Product Pack Amoxil 250 mg capsule,20 Containered TPP Amoxil 250 mg capsule,20 Blister pack 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)

15. 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

16. 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.

17. Pharmaceutical Benefit Drug Medicinal Product 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 PBS and AMT alignment

18. Pharmaceutical Benefit Drug Medicinal Product 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 Medicinal Product Unit of Use

19. 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

20. PBS Legislation to AMT Legislation (NHA)Business TermAMT/PBS Drug (active ingredient) Medicinal Product (MP) Form - ‘strength, type of unit, size of unit or otherwise’ 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 Bioequivalence/ BiosimilarityAs defined by TGA or PEB Brand (Name)Brand name/productTrade Product Pack (TPP / TPP Brand Name synonym Pharmaceutical BenefitDrug, Form, MOA, Brand, Max quantity, Repeats, Restriction, Price MP, MPP, MOA, TPP, Max quantity, Repeats, Restriction, Price Pharmaceutical ItemDrug, Form, MOANot explicitly defined in PharmCIS but implicitly modeled as: MP, MPP or MPUU, MOA PBS ItemPBS Number, Drug, Form, MOA, Restriction, Brand(s) PBS Number, MP, MPP, MOA, Restriction, Brand(s)

21. 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

22. 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.

23. 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.

24. 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

25. PBS web site view - Current

26. Potential PBS web site MPP/Brand view New #

27. 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

28. Potential PBS web site MPP view

29. 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

30. 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

31. 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

32. 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

33. 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

34. Useful web sites www.pbs.gov.au www.health.gov.au www.nehta.gov.au