Paris, FRANCE, Wednesday 05 October, Pharmacy Out of Cycle Meeting

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1 Joint with IHE Pharmacy Paris, FRANCE, Wednesday 05 October, 2011 Pharmacy Out of Cycle Meeting Attendees: John Hatem Oracle USA Hugh Glover Blue Wave UK Tom de Jong Nova Pro Netherlands Simon Letellier EAHP France Julie James Blue Wave UK Gert Koelewijn Nictiz Netherlands Melva Peters (scribe) Gordon Point Informatics CA Jean Duteau Gordon Point Informatics CA Charles Rica ASIP Santé France Ana Estelrich Phast France Nicola Canu Phast France Marco Demarmels Lake Griffin, LLC Switzerland Thierry Geraud Care Fusion France Agenda Topics - Agenda Supporting Documents None Minutes/Conclusions Reached 1. Introductions 2. Overview of IHE Pharmacy IHE Pharmacy co-chair provided an overview of the focus and activities of their group. First profiles developed last year Some issues during connect-a-thon 6 companies testing the profiles - very little time to do development (about 4 months) Wants to attract more input from US (and Canada) 3. HL7 Pharmacy Tom provided an overview of HL7 and HL7 Pharmacy 4. Medication Document NICTIZ AORTA Will use HL7 v3 Will not create repository of data a registry will contain a reference to source data Participants will determine how they store data - can be CDA, but doesn't have to be Guideline for Medication Transfer Every care provider has to do whatever it takes to make information relevant to medication safety available to others, further down the chain Every care provider has to do whatever it takes to get information.

2 Will contain: Prescribed medication Dispensed medication Administered medication - typically hospitals Actual medication usage - as captured by drs or patients Use of alcohol and recreational drugs Reason for stopping or changing medication Julie's Thesis - Medication Profile Julie provided an overview of her thesis on medication profiles 5. Discussion of profile requirements One way of exchanging the medication profile is through a query/response mechanism. This coincides with what used to be called the Generic Patient-Related Pharmacy Query in the HL7 Pharmacy materials. This could be merged together. in IHE world - actors - may be a prescription actor that is different than a dispenser actor Action Item: HL7 Pharmacy WG to create a project scope statement to work on the payload design IHE to create use cases and actors and will provide to HL7 Pharmacy WG 6. Supply Chain IHE Pharmacy has developed a white paper - looking at concepts that need to be considered Action Item: HL7 Pharmacy will review the use cases from IHE Pharmacy Supply chain requirements are primarily related to V2 message structures 7. Perfusion Administrations Discussion of requirements for perfusion administrations. 8. Expression of Substitution IHE Pharmacy provided an overview of their representation of substitution HL7 Pharmacy expressed concerns about the representation Action Item: Jean to send note to Jurgen with concerns [done] Action Item: HL7 Pharmacy will re-work our representation of substitution 9. Workflow management XDS discussion the user of XDW is now optional within the community profile. Some questions concerning XDW were discussed not directly relevant to HL7 Pharmacy 10. Roadmap planning HL7 - IHE This was a very productive day that was long over due Both groups are willing to have joint meetings in the future should do this periodically - annually or perhaps somewhat more frequently try to synchronize once or twice per year HL7 Pharmacy was encouraged to sign up for IHE Pharmacy list serve and vice versa Would allow for a wider set of authors for use cases 11. Next steps for continued collaboration IHE Pharmacy will send a draft of their schedule - perhaps we could try to "tweak" in order to meet together Action Item: HL7 Pharmacy will send HL7 WGM meeting schedule to Jurgen Both groups have committed to meet F2F in one year time if we have not met before then

3 Action item: Review Mission and Charter to determine if we need to update to include the association with IHE Pharmacy Both groups need to jointly review any material to be distributed to a broader audience before it is sent out Action Item: Pharmacy co-chairs to craft wording for IHE Pharmacy Tom is preparing an article for an upcoming HL7 Newsletter Action Item: Tom to forward information on IHE Pharmacy mailing list Access to IHE documents and white papers typically posted to mailing list IHE Pharmacy - Google Group

4 Paris, FRANCE, Thursday 06 October, 2011 Attendees: John Hatem Oracle USA Hugh Glover (chair) Blue Wave UK Tom de Jong Nictiz Netherlands Simon Letellier EAHP France Julie James Blue Wave UK Gert Koelewijn Nictiz Netherlands Melva Peters Gordon Point Informatics CA Jean Duteau Gordon Point Informatics CA Charles Rica ASIP Santé France Ana Estelrich (scribe) Phast France Nicola Canu Phast France Marco Demarmels Lake Griffin, LLC Switzerland Thierry Geraud Care Fusion France Agenda Topics Additional topics: Vocabulary Infusion Project Scope Statement Generic Patient-Related Pharmacy Query Clinical Statement Project Common Product Model Harmonization Topics Supporting Documents IHE Pharmacy profiles Minutes/Conclusions Reached 1. Institutional cases One of the major purposes of this OOC meeting is to look at four major areas in HL7 Pharmacy and see how they apply to the institutional area. The topics identified were: Ordering Dispensing Supply Pharmaceutical Advice as defined in IHE (suggested by Tom) The group unanimously agreed to split the group in two to look at the order and the dispense. The institutional administration has deemed to be covered well enough in the Medication Statement and Administration Topic. Each group will: Determine what needs to be changed in the current material in order to address the institutional process? Use existing v2 implementation and the existing IHE Pharmacy HMW profile. 2. Vocabulary throughout the material published It was noted that we need to ensure that the proper vocabulary is in place, and that it fits properly with the intended use. Marco will be the go-between to IHE Pharmacy when it comes to common terminology as he is doing the glossary in the IHE Whitepaper.

5 3. Infusion We will be working on the processes of infusion. It was suggested that this be a separate topic to be added to the discussion on October 7 th, HL7 V3 Std: Pharmacy, Release 1: Generic Patient-Related Pharmacy Query Project Melva has been in touch with Dave Hamill about the Generic Patient-Related Pharmacy Query Project (aka Patient Medication Profile) Dave is requesting target dates for this work item Based on the discussion on Day 1, it is possible that this work may become an active project sooner than expected. Action Item: Melva will provide a response to Dave for now target start date of April 1, 2012 and a target end date of March 30, Clinical Statement Project John is doing a comparison between the Pharmacy DMIM with the Clinical Statement model covering pharmacy medications, supply, and administration This should be a separate project Action Item: Melva will work with John and co-chairs to create a project scope statement. Action Item: John s findings will be brought forward for review at an upcoming teleconference 6. Common Product Model harmonization items This will be discussed as a separate topic on Oct 7 th 7. Work Session Institutional Use Cases The IHE HMW profile was reviewed and the following actors were identified: Prescription Placer Pharmaceutical Adviser The Medication Dispenser The Medication Administrator Informer Other considerations: Formulary - is normally implicit, perhaps it can be considered as a real actor. Formulary is the reference that brings all the proprietary of a medication that can be prescribed to a patient. It can also be a subset of a database that has complete information. Pharmaceutical Adviser It needs a cross-referencing of the generic and brand names Typically used by pharmacists along with their own knowledge to accept information provided or to ignore the information provided. Formulary is part of this advice Is the Pharmaceutical Adviser always the response to an order or not? In France yes, but not all the time, for example while on rounds the physician asks the pharmacist and gets advice. This is important in terms of the workflow The pharmacist is consulted by phone or by the attending doctor in the hallway. In UK you would initiate an order. Pharmaceutical advice is always triggered by an order but the pharmacist always advises and provides independent feedback EHR Repository What constitutes the authorizing part of the system that allows an order to come into existence? The order exists, it is sent to the hub, then the hub may refuse it.

6 This is more common in the community pharmacy but a similar system cannot be found in the hospital. What we find in the hospital are the Medication Statements. The actions that take place in the hospital do not get sent to the DIS. Misc Use Cases to consider Patients own meds There are examples in the UK where a patient may be admitted to hospital with his own medication taken over by the staff and administered to him while an inpatient Holland if a patient is admitted with medication that has been prescribed outside the institution, either the patient is administering them, or the medication is taken away by the physician and administered to the patient (This can be done either as a way to save money for the patient, for safety reasons, or just as a local policy). This is also done for the PRN medication (take as needed). RQO Medication Order is to use a medication. It is a true substance administration. Will there be an order for all medication used in a hospital setting? We believe so Protocols pre-established set of rules of the treatment for a specific condition For example, Broken leg and the protocol indicate that you can give codeine, but there is no order because there is part of the protocol (but this will eventually become an order). The nurse will take a box from a shelf and will write the patients name on it the doctor did not prescribe it but participated in creation of the protocol. This will generate a record that will be captured. Relationship of order to dispense Patient registered, diagnosis, order the order sometimes does not trigger a dispense, but the dispense triggers the order, and the workflow is different. ICU/ER don t wait for an order. Often done after the treatment. Therapy plans and orders Within the hospital there is pharmacist and a pharmacy technician and the global view follows all the patient treatment according to the unit of care, hospitalization, and it could be part of software (Simon) IHE workflow diagram - review 8. Use cases storyboards. A comparison is made between the HL7 and the IHE Community. It was noted that our storyboards are at the Domain level rather than the topic level Action Item: Update this topic with storyboards from IHE Pharmacy use cases Action Item: Look at moving the storyboards to the topic level. Documenting use cases that we need to cover off: Discussion of the hl7v2 messages in HMW. What is a dispense? There may be differences depending on the workflow especially where robotics may be involved. Likely at the point when a substance is physically attached to a patient maybe when it is loaded into the robot or when the nurse requests the meds for a patient from the machine. We must have a definition that is independent of logistics. 9. Work Session Notes Institutional Medication Order

7 This is not currently covering the use cases (Story Board). The use case the prescription is to lower the dosage (this is considered like an order to change the order to lower dosage, to suspend, to cancel). What is the difference between a prescription and an order. The word prescription is just one example of order. It was agreed that prescription was the more common term. Action Item: Include changes identified by Order group in ballot material We have the issues of logistics versus instructions. Order does not imply a certain type of dispense. The logistical part is secondary to the clinical part. The clinical decision is the essence. This is the clinical decision of the medication. Does the medication order mean the same thing? This is used in HL7 terms. There has been a history between orders and observation. You never stop to make a decision to make a lab analysis. If you were to take this as a model, can you still do the same? If we are in a clinical decision mood, would it be the same? This is not so much an order for someone to use a medication but it is a decision (putting into a decision plan). The prescription must exist so that the medicine can be administered. The dispense is secondary. Debate on how to translate the prescription and what prescription means. Is prescription the right word to be used in an institutional setting? Institutional prescription Tom is working on it. Virtual model of medication in UK. Scan by barcode and populate your inventory and this will give you what it is. The terminology does a lot of work for UK. The terminology resource will interact. This interactions happen in all places. The terminology resource has to be shared and it will not really be inside the prescription placer every system uses it it is a given you don t have to go outside to get it. We are moving towards some architecture when a new medication is on a market the central repository will be populated via linking to this database. This is similar to a national formulary which is linked to local formulary. For the medication there are are not so many updates (but for medical supplies you have a lot, for example up to 500 a week). Discussion concerning application roles HL7 IHE Application Role = Actor Interaction = Transaction Just because an Actor is defined does not mean that it has to be implemented in all cases where the profile is deployed. PCC has developed some profiles where a specific actor is helpful for some cases, but not entirely necessary to the basic profile capabilities. What gets implemented by a user is not a question that IHE needs to address; rather it is a question that implementers and users need to address. They get to decide what parts of an IHE profile are important to them. Looked at story board, completed, moved onto HMW to compare with v3, made suggestion. Review the HMW and see what improvement can be brought in terms of IHE format and also in terms of the granularity of the data elements (what is necessary, what is not, what needs more granularity). This is a project to address within IHE with Tom. 10. Work Session Notes Institutional Medication Dispense Review of Medication Dispense model the following changes were identified: Look at implementation guidance on population of author/performer/etc fields substanceadministrationrequest vs supplyevent - not sure why supplyevent is optional Change to correct patient model if available - see to do notes on model Review and update definitions

8 How do we identify a device - choice box on 'RECEIVER' - make it more generic switch consumable and product CMETs - to CPM walk through needed comments on product vs consumable need to be improved add sequence number - "in fulfillmentof" change cardinality of SupplyEvent Add time of creation to "performer" Review of Office Supply Model the following changes were identified: receiver - needs to be a choice box - person or device change to CPM CMETs when the supply request is developed - that model will replace "infulfillmentof" Add time of creation to "performer" walk through will need to be clear about institutional vs community Trigger Event authorization of a prescription (aka pharmaceutical advice) Application Roles medication dispenser system, Record fulfiller, record tracker Dispensing System Record Tracker RMIM PORX_RM UV Trigger Event request supply this is net new Interactions (new) Application Roles medication stock ordering system and medication sock fulfilling system RMIM new Storyboard new

9 Trigger Event abort office supply (net new)

10 Paris, FRANCE, Friday 07 October 2011 Attendees John Hatem Oracle USA Hugh Glover (chair) Blue Wave UK Tom de Jong Nictiz Netherlands Julie James Blue Wave UK Melva Peters Gordon Point Informatics CA Jean Duteau Gordon Point Informatics CA Charles Rica ASIP Santé France Ana Estelrich (scribe) Phast France Nicola Canu Phast France Thierry Geraud Care Fusion France Agenda Topics Supporting Documents Minutes/Conclusions Reached 1. Review of work sessions from each group The proposal is to merge the results from the two groups in the out of cycle meeting together and ballot just one time. There are three main topics: order dispense administration 2. Summary of the order group Work done on the institutional cases will probably bring some changes to the administration as well We need to make material more consistent Use a common storyboard? Application Roles We need to re-define application roles Can we have domain application roles and can they be used from topic to topic, or will this be too much administrative work? Reviewed the document updated by Tom yesterday the dispense group decided to stick to the same pattern that was based on the medication statement. The order group has decided to make changes to the application roles. If application roles are changed in one instance it should be harmonized. Can the same application role be used for the community pharmacy and institutional pharmacy? The answer seems to be yes. When the question is asked about should the same query be used, the answer is perhaps not. Action Item: Hugh, Tom and Melva to review the application roles across our material. Prescription vs Order The order group Order discussed the use of a word "prescription" should that be changed to indicate "order" since in an institutional setting the word "medication order" is used. A change was made from "prescribing system" to "prescription placer".

11 An addition to the glossary is needed. Review of content Look at the v2 specifications and integration profiles and make sure that all that this present in the v2 is reflected in v3. Some gaps were identified in the IHE HMW profile. Tom reviewed list present in the IHE profile identifying the data elements in the data model. No gaps in V3 identified Do we have separate RMIMS for institution and community? Our model has all the looseness that can capture both. Most hospital prescribing is done at a very virtual level with no product in mind. For example, Amoxicillin 500mg is to be given orally every 3 hrs, but the prescriber does not care how it is given. Any combination is ok. The model supports that now, and the supply request part is completely optional. It was determined that a universal model with optional elements would be usable for both settings. Debate about the schema and the discharge medication versus the inpatient order. Will you be authorizing supply or just protocol? This is an issue too complex to detail for implementers. Tom suggests that this is the difference between IHE and HL7. In the RMIM there is the medication order and the group would need to come up with an institutional model. It is estimated that at least 80% of the institutional model is already present in the medication order. The group should be adding to the implementation guide some institutional cases. Action Item: Determine what goes into next ballot Action Item: Consider encoded orders 3. Report from the dispense group: There is no storyboard look at the IHE content. Trying to analyze the IHE use cases on which the order group did and did some analysis. Hugh suggested modifying the dispense in order to adapt to the order group. A question arose whether or not to have the medical context to do this. The Second story boards look at the application roles. Is the medication dispense event tracker the medication dispenser. New Application Roles were created see diagrams attached to notes. One role that was added was the one of the robot dispenser. The association is made between the medication and the patient. This definition is consistent with IHE: the medication is bound to a particular patient. No major changes are needed. Changes: Dispense Header Look at a substitution administration request and a supply request. The dispense request associated with the supply is changed from 1 to 0 indicating an event occurring for a prescription that is not yet in the system so that it can be filled. 0..* supplyevent. Can be multiple payloads. Is this a push or a query? Get about 100 messages at once. Discussion about the dispense header not exactly being structurally representative since it had been a cut and paste form the order. The application roles present in the dispensation are also not fully agreed upon. The v2 approach is used in the hospital. The most used message is the RDE message discussion on how does the encoded order fit with the pharmaceutical advice. Is the pharmaceutical advice used just hospitals or not?

12 In UK there is not a pharmaceutical advice. KP commented that work had to be done with the physicians in the use of the RDE message. France this is captured in the patient chart. Action Item: We need the equivalent of the RDE message to be present in the message but it should not be enforced. Use cases should be used to talk about this. 4. Encoded Medication Order RMIM. The mood is promise (due to the header). This must be changed because the header has been changed (see later). We have a substance administration which is now a promise. This is a request sent by the pharmacy for a review and not a promise. This is a promise only on the supply side. How can a pharmacy system promise a substance administration? It is not a request, nor an event but an intent and /or proposal. Workflow: Prescriber requests and the pharmacy responds with the intent (encoded order). The pharmacy does not have the physical ability to administer but it promises at the supply level. Pharmaceutical Adviser Reviews the order and makes changes as allowed by the business rules. Two different business processes here rolled into one. The realization happens in the Pharmacy or the realization can happen in the ward. The actualization (realization) can happen in two places there are two distinct business processes. Where is this represented in the model? Do you split out the pharmaceutical adviser into 2 roles and two RDE messages? What does this means in term of artifacts? We have a set of interactions that does not require a new model We have the promise mood and here I am making it real (like the existing model - this is the promise to supply and it is part of the order topic. Medication order topic will contain the Pharmaceutical Adviser. Pharmaceutical Advice does not imply a promise to dispense (an order and no payload). The Pharmaceutical Adviser indicates what the administering unit or the nurse should do based on the prescription. How does the Pharmaceutical Advice deal with the automatic substitution vs the Conditional Substitution (France) substitution is allowed automatically if the product is not available etc/ vs the substitution is allowed only in certain conditions and the prescriber must validate. Encoded order 2 cases normal case Pharmacist does not need to request RDE v2 this is not the same because it is not a request to the prescriber. The pharmaceutical advice is not an RDE because it indicates his intention. Thierry explains the role of RDE In the HMW this is not the validation. It is actualization. The changes will be done from within the IHE Pharmacy. This is a clinical decision process - this is achieved only when the pharmacist says ok. Put this into order section. You got a transition from a transition deciding what to do with it and splitting into two different topics.

13 Discussion on the topic they want to become part of IHE and make comments and change the profile HMW. Discussion on the content with the web services. In some case where interacting with it we should allow for that possibility. Ballot or not ballot? Do the institutional use cases and then have a release 2. Are we going to clean up the DMIM Pharmacy as part of this? 5. Planning Re-ballot IDMP Republish topics from previous ballot Re-ballot Medication Knowledge Base Query and Medication Statement and Administration Prepare material for Medication Order Release 2 and Medication Supply Event Release 2 in time for San Antonio WGM and ballot for May Medication Statement It was reviewed in Exeter OOC meeting Review of use cases has anything changed as a result the last 2 days? Review of institutional IV cases PCA may not be supported Action Item: Ana to provide PCA use-case to give to John for review 7. SVN Overview Jean gave an overview of the reorganization of SVN for HL7 Pharmacy material 8. Update on Application Roles based on review Need to define application role naming convention - look at PUBDB to see if the naming conventions fall out Action item: Hugh to try to come up with naming conventions. Try to find naming conventions in HL7 material

14 9. CPM Harmonization Proposals Julie reviewed the harmonization proposals.

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