1. Jürgen Brandstätter, MSc Co-chair Pharmacy Planning committee Co-chair Global Deployment Coordination Committee (GDC) IHE International Board CodeWerk Software GmbH, Austria IHE Pharmacy Domain Update Webinar

2. Learning objectives Understand PHARM vision, mission and strategic goals Understand PHARM domain's liaison and collaboration with HL7 and ISO Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan Overview of other PHARM domain activities, including Supply Chain, FHIR Understand how PHARM work benefits the pharmacists How to get involved in PHARM committee work

3. Learning objectives Understand PHARM vision, mission and strategic goals Understand PHARM domain's liaison and collaboration with HL7 and ISO Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan Overview of other PHARM domain activities, including Supply Chain, FHIR Understand how PHARM work benefits the pharmacists How to get involved in PHARM committee work

4. What is IHE? eHealth Projects IHTSDO IETF Standards Use cases typically require „combinations“ of standards - but how to compose?

5. What is IHE? eHealth Projects IHTSDO IETF StandardsProfiling and Testing

6. Products Projects IHE methodology Use Case Identify available standards Products declare IHE Easy to integrate products RFPs with IHE reqs

7. IHE: Difference to classic SDO Classic Standards Developing Organization Develops „future“ standards in certain areas IHE Uses „existing“ standards to profile Interoperability use-cases IHE is a non-profit association dedicated to interoperability in health information technology. IHE: A forum for agreeing on how to implement standards and processes for making it happen

8. Pharmacy within IHE landscape Pathology since 2006 Radiation Oncology since 2004 Radiology since 1998 Cardiology since 2003 Patient Care Devices since 2005 Patient Care Coordination since 2005 Eye Care since 2006 Quality Research & Public Health since 2007 Laboratory since 2003 (Healthcare) IT Infrastructure since 2003 since 2008 Pharmacy since 2008 IHE Dental IHE Endoscopy

9. Our needs in hospital Cover the overall medication workflow from prescription via validation and dispense to the administration to the patient

10. Our needs in community Cover the overall process from planning medication and prescription at the GP via dispense at the Pharmacy to ambulant administration

11. IHE Pharmacy overview Vision: “Pharmacy processes runs seamless in the community and hospital domain as well as cross-domain.” Mission: “IHE Pharmacy produces profiles and guidance that addresses information sharing, workflow and patient care in both community and hospital domain.” Most actively involved … Many European countries USA/Canada Australia 1 whitepaper, 6 profiles, Whitepaper work on certain (rather complex) topics Sponsors & Supporters EAHP, NICTIZ, Réseau Phast

12. Strategic goals Promote widespread adoption and implementation of IHE Pharmacy developed profiles by... Marketing and promoting the profiles globally Reaching out for national/regional e-Prescription programs in order to (1) learn requirements and demands which lead to developments within IHE Pharmacy and (2) stimulate leveraging of IHE Pharmacy profiles as basis for their national specifications Improve information exchange between healthcare providers and organizations that depend on Pharmacy related workflows and processes Develop ways to automate collaborative workflow between physicians and pharmacists in both community and hospital pharmacy environment Establishing and maintaining collaboration to... other IHE domains HL7 Pharmacy ISO TC215 WG6 Pharmacy NCPDP Big success: European Commission recognizes 27 IHE profiles that “should be referenced in public procurement documents” 1) -> 2 Pharmacy profiles included (PRE, DIS)! Big success: European Commission recognizes 27 IHE profiles that “should be referenced in public procurement documents” 1) -> 2 Pharmacy profiles included (PRE, DIS)! 1) http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_199_R_0011 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_199_R_0011

13. Learning objectives Understand PHARM vision, mission and strategic goals Understand PHARM domain's liaison and collaboration with HL7 and ISO Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan Overview of other PHARM domain activities, including Supply Chain, FHIR Understand how PHARM work benefits the pharmacists How to get involved in PHARM committee work

14. Liaisons ISO TC 215 WG6 „Pharmacy“ / CEN TC 251 Global recognition ISO TC 215 WG6 „Pharmacy“ / CEN TC 251 Global recognition HL7 Pharmacy Base Standards HL7 Pharmacy Base Standards IHE Pharmacy Profiling Layer Friendly collaboration

15. Liaisons ISO TC 215 WG6 / CEN Global recognition ISO TC 215 WG6 / CEN Global recognition HL7 Pharmacy Base Standards HL7 Pharmacy Base Standards IHE Pharmacy Profiling Layer Contributions User/Vendor Input ISO Standards Base and legal binding standards

16. Liaisons ISO TC215 WG6 / CEN Global recognition ISO TC215 WG6 / CEN Global recognition HL7 Pharmacy Base Standards HL7 Pharmacy Base Standards IHE Pharmacy Profiling Layer Projects High-level Technical Profiles (Use Cases) HL7 Standards ISO Standards

17. Learning objectives Understand PHARM vision, mission and strategic goals Understand PHARM domain's liaison and collaboration with HL7 and ISO Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan Overview of other PHARM domain activities, including Supply Chain, FHIR Understand how PHARM work benefits the pharmacists How to get involved in PHARM committee work

18. Our approach Create and maintain a common data model A common approach for Community and Hospital Pharmacy environment Profile existing standards Hospital pharmacy: HL7v2.x standard (Message-based) Community pharmacy: HL7v3 CDA standard (Document-based) Technical Framework describes the details of each Integration Profile Use-case Actors, Transactions Connectathons to validate implementations of the IHE Pharmacy Integration Profiles First tested at European CAT in Pisa/Italy, April 2011

19. What has been done? 7 profiles for … … Hospital Pharmacy HMW Hospital Medication Workflow … Community Pharmacy CMPD Community Medication Prescription and Dispense PRE Content Profile: Medication Prescription PADV Content Profile: Pharmaceutical Advice DIS Content Profile: Medication Dispense PMLContent Profile: Pharmacy Medication List MTPContent Profile: Medication Treatment Plan 1) 1) Currently in publishing process

20. The White Paper… IHE White Paper  Foundation of all current profiles Final version  Released in early 2010 78 pages  Community Pharmacy use cases  Hospital Pharmacy use cases  Harmonization of actors definitions Current version: ftp://ftp.ihe.net/Pharmacy/White%20Paper/IHE_Eur_Pharmacy_White_Paper_Final_Text_1.3.3.pdf

21. IHE Pharmacy – Key process Validation of the prescription (ICA check, etc.) Validation of the prescription (ICA check, etc.)

22. Hospital Pharmacy profile Workflow and Content Hospital Medication Workflow (HMW) – Basic use case: Hospital physician prescribes in a ward Hospital pharmacist reviews orders Pharmacy technician dispenses Nurse administers drugs to the patient – Systems it would impact: Prescription placer modules Pharmacy (Validation, encoding…) software Medication dispensing systems Medication administration informer modules – Based on HL7 v2.5/v2.6: Message based to fit into hospital environment

23. HMW Interoperability Model

24. Medication Dispenser (supply and distribution are covered, but not profiled yet)

25. Community Pharmacy profiles Workflow Community Medication Prescription and Dispense (CMPD) Technical Integration, Actors, Transactions, based on IHE ITI XDS Content (based on HL7v3 CDA extended with HL7 Medication CMETs) Prescription (PRE) In sync with upcoming ISO DTS 17523 “Requirements for electronic prescriptions” and ePrescription guideline of the EU / eHGI Dispense (DIS) In sync with upcoming ISO DTS 19293 “Requirements for the record of Dispense Medicinal Products”

26. Community Pharmacy profiles Content (based on HL7v3 CDA extended with HL7 Medication CMETs) Pharmaceutical Advice (PADV) Used for … –Validating a prescription »e.g., Medication Interaction Checking Issue Management –Managing of prescriptions and dispenses (Change, Cancel, …) »Always related to PRE, DIS or MTP Pharmacy Medication List (PML) Information on prescribed and dispensed medication to a patient Contains Prescription-, Dispense-, Pharmaceutical Advice Items „On-demand“ document Medication Treatment Plan (MTP) Information on planned medication to a patient Contains Medication Treatment Plan Items (alike PRE items) Prescriptions and Dispenses may be referencing MTP

27. CMPD actor diagram

28. Create Prescriptions/Dispenses Create Prescription Create Dispense

29. Create Prescriptions/Dispenses Create Prescription Create Dispense Medication Interaction Checking

30. Manage Prescriptions/Dispenses Manage Prescriptions/Dispensations

31. Manage Prescriptions/Dispenses Manage Prescriptions/Dispensations Medication Interaction Checking

32. Query/Retrieve Medication Documents

33. The way of a prescription PRE Physician prescribes a prescription with 5 prescription items PI 1 PI 2 PI 3 PI 4 PI 5

34. PADV The way of a prescription PRE Physician changes PI 1 PI 1 PI 2 PI 3 PI 4 PI 5 PADV 1 PADV PADV 3 Physician cancels PI 3

35. PADV The way of a prescription PRE PI 1 PI 2 PI 3 PI 4 PI 5 PADV 1 Pharmacist dispenses all PIs DIS DIS 1 DIS DIS 2 DIS DIS 4 DIS DIS 5

36. PADV The way of a prescription PRE PI 1 PI 2 PI 3 PI 4 PI 5 PADV 1 Physician changes dosage of DIS 2 and instructs the patient to stop intake of DIS 5 DIS DIS 1 DIS DIS 2 DIS DIS 4 DIS DIS 5 PADV PADV 2 PADV PADV 5

37. Planning / Actual PREDIS PADV Change Plan Actual Action Physician starts medication treatment Physician changes dosage Patient runs out of medication s Physician changes dosage again Logical flowLeads to PREDIS MTP PADV Change Reference to MTPReference to PREReference to DIS Time …

38. Becoming real – in epSOS European Patient Smart Open Services Goals (relevant for IHE Pharmacy) Cross-border prescription and dispense Demonstrated in pilot use Covered use-cases Prescription query (cross-border) Dispense create (cross-border) Community Pharmacy profiles used Content: PRE, DIS Synced 1)Concept derived from epSOS 2)Worked in sync with epSOS 3)Further elaborated in IHE

39. Becoming real – in Austria Austrian e-Medication project Goal of the project Increasing patient safety by providing a “Medication List” of a patient for physicians and pharmacists to support prescribing and medication interaction checking Nation-wide rollout (8 mio people): All physicians and pharmacists will be connected Rollout and startup on volunteer basis 2016, mandatory use for physicians and pharmacies starting 2017 To achieve the goal … … prescriptions and dispenses have to be captured electronically to act as data-source for the medication list (e-prescription/dispense system) does not replace paper prescription yet (just for capturing data)! Covered use-cases Prescription create / query / cancel / change Dispense create / query / stop intake / change dosage (including OTC) Query Medication List Community Pharmacy profiles used Workflow: CMPD Content: PRE, DIS, PADV, PML Embedded into national Health Record infrastructure (ELGA) based on IHE XDS

40. Becoming real – in Saudi Arabia Saudi e-Health Exchange project Goals of “Medication track” Introducing e-Prescription/Dispense (replacing paper) Providing a “Medication List” of a patient for physicians and pharmacists including hospital medications (out of discharge summary) Provide a central service for “Medication Interaction Checking” Specification phase now completed Covered use-cases Prescription create / query / cancel / change / suspend Dispense create / query / stop intake / change dosage / suspend (including OTC) Query Medication List Central Medication Interaction Checking and Issue Management Community Pharmacy profiles used Workflow: CMPD Content: PRE, DIS, PADV, PML Embedded into Saudi e-Health Exchange infrastructure (SeHE) based on IHE XDS

41. Becoming real – in Switzerland Swiss e-Medication project Goal of the project (Geneva driven) Increasing patient safety by sharing the “Medication Treatment Plan” of a patient between all stakeholders (hospitals, private physicians, pharmacists, home care, …) Defining a national profile for sharing patient’s medication related information in relation with the forthcoming federal law on the electronic patient record (2017) Cantonal roll-out – hospital, physicians, pharmacists and home care will be connected to the shared treatment plan module of the regional Health Information Exchange Rollout and startup first quarter 2016 on a voluntary basis To achieve the goal … Implementation of IHE content profiles based communication in the regional HIE Implementation of the management of the CDAs as an OpenSource project (eHealth-Connector) in order to ease the integration by third party vendors Wide concertation will all stakeholders in the country in order to promote the national exchange format Covered use-cases Query Medication List and Medication list update Prescription create / query / cancel / change Dispense create / query / stop intake / change dosage (including OTC) Add comments to plan / prescription / dispense (home care ) Community Pharmacy profiles used Content: MTP, PRE, DIS, PADV, PML

42. Learning objectives Understand PHARM vision, mission and strategic goals Understand PHARM domain's liaison and collaboration with HL7 and ISO Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan Overview of other PHARM domain activities, including Supply Chain, FHIR Understand how PHARM work benefits the pharmacists How to get involved in PHARM committee work

43. Other Pharmacy activities IHE started by covering the clinical part of the medication circuit: From prescription to administration Based on the de facto standards: CDA and HL7 v2. This clinical part must be interoperable with other parts: The distribution / supply of medication across and inside institutions The management of medications Other processes using medication (radiology, surgery)

44. Supply of Products for Healthcare A cross-domain and cross-standard guidance on how to exchange information for the supply of products: Order from suppliers, delivery inside an institution, automated dispensing, traceability, barcode-enabled tracking and stock management Whitepaper being developed, work on profiles starting as well GS1 and HL7 are the enabling standards

45. Supply – areas covered Catalog maintenance Orders and returns Inventory management Usage report & tracking Billing Selection of vendors | Pricing & Contracts | Update product data Internal data (Clinical data, internal prices, usage rules, usage instructions) Availability and recall Permissions, availability, recall Stock orders and bulk orders Consignment items Point of care ordering & order processing Consult product data Consignment items Patient charges / intra-hospital charges Hospital billing Manufacturer Distributor Hospital Dispensing Systems Point of care Patient usage Stock status, consumption

46. Common Pharmacy Profile Health IT is moving to support innovation, distributed applications, mobile computing, web-enabled solutions,... This requires faster-to-adopt, faster-working interoperability. HL7 FHIR is a draft standard that enables it. A new set of profiles is being created to advise implementers how to prepare for the new standard: “The Common Pharmacy Profile” Includes aspects like workflow management, constraints and recommendations to support from traditional systems to mobile applications We do this by using the best of our existing profiles, our experience and preparing a common profile, ready for the future challenges

47. “Common” Panorama Dispensing Administration Supply Medication Lists ADE reporting Planning Medication Statements Medication Catalog Prescribing Review / Advice For Communities For Hospitals FHIR-based (common) ADE = Adverse Drug Event

48. Other activities Medication Catalog / Formulary How do we identify medication across different systems? Are names sufficient? Are codes necessary? How do we distribute the medication attributes across several systems? Medication Data capture / Medication Documentation How to retrieve data from prescriptions, dispenses, etc. In order to create a “medication list” Medication Administration (in Community domain) More and more eligible to document electronically also in Community domain Ambulant Chemotherapy, Controlled drug-substitution,...

49. Learning objectives Understand PHARM vision, mission and strategic goals Understand PHARM domain's liaison and collaboration with HL7 and ISO Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan Overview of other PHARM domain activities, including Supply Chain, FHIR Understand how PHARM work benefits the pharmacists How to get involved in PHARM committee work

50. So, do we need to change our habits?  eHealth is going to play a very important role in our real life in Hospital and Community Pharmacies  Emergence of patient-enabling solutions  Increased trend to automate distribution of medications  Traceability becomes important – for clinical reasons, as well as prevention of falsification We (pharmacists) have to focus on the:  Clinical Pharmacy  Use of medication across settings and domains  Oncology Pharmacy  Social Pharmacy  Pharmacy Informatics  … Patients must be our main concern!

51. For Pharmacists, IHE Pharmacy, means:  Improved Hospital Pharmacy information through integrated access to medication information  Reduced physicians and nurses callbacks to pharmacists due to lack of medication information  Eliminating pharmacist call backs to physicians and nurses to resolve medications issues  Reduced pharmacists time to process special authority requests and logistics IHE Pharmacy is the key to help us find solutions! is the key to help us find solutions!

52. Learning objectives Understand PHARM vision, mission and strategic goals Understand PHARM domain's liaison and collaboration with HL7 and ISO Overview of existing PHARM profiles and Community and Hospital Pharmacy, including Community Medication Prescription and Dispense, Hospital Medication Workflow, Medication Treatment Plan Overview of other PHARM domain activities, including Supply Chain, FHIR Understand how PHARM work benefits the pharmacists How to get involved in PHARM committee work

53. How to participate in IHE Pharmacy Committee work follows the IHE Profile Cycle Annual cycle Sep – Dec: Call for proposals Dec – Jun: Working on work-items Jun – Jul: Public comment Jul – Aug: Ballot & Release Opportunities for IHE members (and non-members) to participate in cycle Register at http://groups.google.com/group/ihe-pharmacyhttp://groups.google.com/group/ihe-pharmacy Meetings are F2F and TCons Just join in! Participate IHE’s Profile Cycle

54. Links White Paper ftp://ftp.ihe.net/Pharmacy/White%20Paper/ Technical Frameworks http://www.ihe.net/Technical_Framework/index.cfm#pharmacy Pharmacy Wiki http://wiki.ihe.net/index.php?title=Pharmacy Strategic planning page http://wiki.ihe.net/index.php?title=PHARM_Strategic_Planning Roadmap http://wiki.ihe.net/index.php?title=PHARM_Roadmap Committees http://wiki.ihe.net/index.php?title=Pharmacy_Planning_Committee http://wiki.ihe.net/index.php?title=Pharmacy_Technical_Committee Google group http://groups.google.com/group/ihe-pharmacy

55. Changing the Way Healthcare CONNECTS http://www.ihe.net Our new mortar is digital