Eric Haas
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    --- tags: USCDI v4 title: Medications cat: hard --- <style>.markdown-body { max-width: 1500px; }</style> ## :new: Medications Data Elements Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease. <!-- quote --> Draft ![](https://hackmd.io/_uploads/HJ_LPop7n.png) ![](https://hackmd.io/_uploads/Skjvviamh.png) Final ![](https://hackmd.io/_uploads/r1hWQJAc2.png) <!-- table --> DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)|US Core V6 Proposal ---|---|--- **Medication Instructions**<br/>Directions for administering or taking a medication.<br/><br/>Examples include but are not limited to prescription directions for taking a medication, and package instructions for over-the-counter medications.<br/><br/>Usage notes: May include route, quantity, timing/frequency, and special instructions(PRN, sliding scale, taper).||**No Change**: US Core`MedicationRequest.dosageInstruction` is a Must Support element **Medication Adherence**<br/>Statement of whether a medication has been consumed according to instructions.<br/><br/>Examples include but are not limited to taking as directed, taking not as directed, and not taking.| Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, March 2023 Release|<!--**Option 1** :new: "SHOULD Support" US Core MedicationStatement Profile with [R5 Adherence Element Extension](http://hl7.org/fhir/R5/medicationstatement-definitions.html#MedicationStatement.adherence)<br />**Option 2** :new:"SHOULD Support" MedicationAdherance Observation<br />**Option 3** -->:new: 0..* *Additional USCDI Requirement* MedicationAdherance extension on MedicationRequest ### :thinking_face: Key question: * **Should a single Medication Adherance field inspire a new resource?** See [below](#Background) for detailed background on using MedicationStatement and MedicationRequest in US Core ### Detailed Options #### Option 1: MedicationStatement with R5 element adherance extension #### :arrow_right: [MedicationStatement Profile and Examples](/XP18l_WNQI6JwebrORJACQ) - MedicationStatement in R4 was removed from US Core because it failed to adequately address self prescribes and medication adherance. These issue are still extant. - Does adding a Medication Adherance extension Solve the issue with MedicationStatement in R4? :thinking_face: |No.|Issue with MedStatement|Solved with Med Adherance Extension| |---|---|---| |1|We can’t use MedicationStatement when status = not-taken)|Maybe - would need to exclude "not taken" as a status| |2|MedicationStatement can't convey status of what was ordered|No| |3|Systems often don’t differentiate between reported MedicationRequests vs MedicationStatements|No| - Need for R5 extension to meet Data Element is problematic for documentation and publishing - Adding MedicationStatement in R4 complicates the Medication List, because now can use both (with a precedent to use MedicationRequest for self-prescribed meds)often duplicating the information. #### Option 2: Medication Adherance Observation #### :arrow_right: [Medication Adherence Observation Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#medication) - Using an Observation with value bound to [R5 MedicationStatement Adherence Codes](http://hl7.org/fhir/R5/valueset-medication-statement-adherence.html) and a component.code = medication - Does adding a Medication Adherance Observation Solve the issues with MedicationStatement and MeidicationRequest in R4? :thinking_face: |No.|Issue with MedStatement|Solved with Med Adherance Extension| |---|---|---| |1|We can’t use MedicationStatement when status = not-taken)|Yes - MedStatement not used| |2|MedicationStatement can't convey status of what was ordered|Yes - MedStatement not used| |3|Systems often don’t differentiate between reported MedicationRequests vs MedicationStatements|Yes - MedStatement not used| - Temporary with switch to MedicationStatement when US Core moves to R5 - Institutional inertia means may never switch in IRL - Opposition from HL7 community members - Clear transformation to C-CDA #### Option 3: MedicationRequest with Medication Adherance Extension #### :arrow_right: [MedicationRequest with Adherance Extension Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#medication) Yes - MedStatement not used| - Does adding a Medication Adherance Observation Solve the issues with MedicationStatement and MeidicationRequest in R4? :thinking_face: |No.|Issue with MedStatement|Solved with Med Adherance Extension| |---|---|---| |1|We can’t use MedicationStatement when status = not-taken)|Yes - MedStatement not used| |2|MedicationStatement can't convey status of what was ordered|Yes - MedRequest can convey the status| |3|Systems often don’t differentiate between reported MedicationRequests vs MedicationStatements|Yes - MedStatement not used - Is MedRquest appropriate spot to communicate adherance? - Is it more client friendly - What about for measuring compliance? - If our intent is to add MedStatement is R5 is this a bad precedent? ### Issue: Using SNOMED CT vs [MedicationStatement Adherence Codes](http://hl7.org/fhir/valueset-medication-statement-adherence.html) - SNOMED CT Contains 50% of MedicationStatement Adherence Codes from 3 different heirarchies. It also contains many more granular concepts. - MedicationStatement Adherence Codes are not well differentiated. For example, what is the difference between "The medication is not being taken." and "The medication is stopped not as directed." ##### Draft Mapping MedicationStatement Adherence Codes and SNOMED CT |code|display|definition|SNOMED CT|preferred term| |---|---|---|---|---| |taking| Taking|The medication is being taken.|1156699004|Complies with drug therapy (finding) |taking-as-directed| Taking As Directed|The medication is being taken as directed.|1156699004|Complies with drug therapy (finding) |taking-not-as-directed| Taking Not As Directed|The medication is not being taken as directed.|275928001|Non-compliance of drug therapy (finding) |taking-not-as-directed| Taking Not As Directed|The medication is not being taken as directed.|275928001|Drugs - partial non-compliance (finding) |taking-not-as-directed| Taking Not As Directed|The medication is not being taken as directed.|457831000124109|Medication therapy compliance variable (finding) |not-taking| Not Taking|The medication is not being taken.|275927006|Drugs - total non-compliance (finding) |on-hold| On Hold|The medication is on hold.|- |- |on-hold-as-directed| On Hold As Directed|The medication is on hold as directed.|- |- |on-hold-not-as-directed| On Hold Not As Directed|The medication is on hold not as directed.|- |- |stopped| Stopped|The medication is stopped.|- |- |stopped-as-directed| Stopped As Directed|The medication is stopped as directed.|- |- |stopped-not-as-directed| Stopped Not As Directed|The medication is stopped not as directed.|- |- |unknown| Unknown|Whether the medication is being taken or not is not currently known.|26166500*|Unknown (Qualifier) * Note: No more specific unknown code vs FHIR DAR code??? Update Med Adherence Codes (SNOMED CT) |Code (SCT ID)|Preferred Term|Available Acceptable Term (Synonym)|Available Acceptable Term (Synonym)| ---|---|---|---| 1156699004|Complies with drug therapy (finding)| Adheres to drug therapy|Adheres to medication regime| 702565001|Non-compliance of drug therapy (finding)| Drug therapy non adherence|Medication therapy non-adherence| 275928001|Drugs - partial non-compliance (finding)||| 275927006|Drugs - total non-compliance (finding)||| 457831000124109|Medication therapy compliance variable (finding) | Medication therapy compliance variable| Medication adherence variable| 26166500*|Unknown (Qualifier) \* Note: No more specific unknown code vs FHIR DAR code??? ### Decisions Based on Straw Poll on August 16th Call - :tada: Option 3 (MedicationRequest with an Adherence Extension) :tada: (See table) - Use SNOMED CT vs MedicationStatement Adherence Codes Extensible (see table) #### :arrow_right: [MedicationRequest with Adherance Extension Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#medication) ### Next Steps :thinking_face: Discussed adding ballot comment on design decision. (or will be like putting a :dart: on our back) Present Decision and Rationale to HL7 Pharmacy, Patient Care, QI-Core/CQI ### Background #### Submission > These foundational FHIR resources are part of a suite of resources and should all be under USCDI Medication as they are needed for eCare Plans, including but not limited to the Pharmacist eCare Plan. [Pharmacist eCare Plan](https://www.ecareplaninitiative.com/) :Question: Uses CarePlan to communicate "identification of the patient's adherence to the medication regimen and adherence barriers". >... The FHIR version of the pharmacist care plan is based on the C-CDA on FHIR standard, so the document is profiled as a Composition resource.... From [FHIR **R5**](https://www.hl7.org/fhir/medications-module.html): >At transitions of care, it is best practice to perform a medication reconciliation process in order to determine the status of: >- existing medication prescription orders >- orders from other providers that the patient is aware of, but that their primary care provider or other clinical staff might not be aware of >- reported over the counter medications the patient is taking >- medication history – this may include herbals, illegal drugs, supplements, etc. >- **adherence to taking/not-taking drugs is a separate process; this information may be useful when creating a Medication Reconciliation list. This process documents whether the patient is taking or not taking a medication or whether a patient is taking or not taking a medication as prescribed** From USCDI Comments: > Medication adherence is now a metric for Primary Care Providers (PCPs). PCPs are measured by the Centers for Medicaid and Medicare Services (CMS, which affects value-based metric scores through accountable care organizations (ACOs). #### US Core and MedicationStatement: - [Argonaut Data Query DSTU2](https://www.fhir.org/guides/argonaut/r2/index.html) through [US Core up to ver 2.0.0](http://hl7.org/fhir/us/core/STU2/index.html) (based on FHIR R3) used MedicationStatement and MedicationRequest: "Both the Medicationstatement and MedicationStatement resources can be used to record a patient’s medication" - [US Meds Implementation Guide]() (Release 1.2.0 based on FHIR R3): provides guidance to use MedicationStatement exclusively to represent "all medications and all active medications for a patient:" - in [US Core ver 3.1.1]() (based on FHIR R4) MedicationStatement was removed and Medication List guidance provided using *only* MedicationRequest. This has continued through all the subsequest versions of US Core. >- US Core - uses MedicationRequest.intent=plan[for self-prescribed] and MedicationRequest.intent = order [for practitioner prescribed]... still won't be able to say "aren't taken" Cerner - looking for compliance attributes on MedUsage for future will look for guidance with intents and status ##### The problem with MedicationStatement in FHIR R4: From [Sydney 2020 WGM Pharmacy WorkGroup Minutes](https://confluence.hl7.org/display/PHAR/Patient+Medication+List+Guidance ) >The Problem > >Using MedicationStatement exclusively in R4 doesn’t work since we lost the ability to use MedicationStatement.status to convey whether a not-taken medication is active or not. Some not-taken medications are associated with active orders/prescriptions while other not-taken statements are associated with old orders/prescriptions that have since been completed or stopped. >Furthermore, the boundaries between MedicationStatement and a reported MedicationRequest present a challenge for systems that don’t make that fine distinction. For example, the following use cases are often handled in the same way: > >* Patient conveys to provider A that another provider B prescribed a given medication (this is debatable whether it is a MedicationStatement or a recorded MedicationRequest) > >* Patient conveys they took an OTC medication (this is a MedicationStatement – since the patient isn’t requesting a new prescription) > >* The system programmatically learns of an existing medication and makes a non-authoritative copy (this is a recorded MedicationRequest) > >Most systems CAN differentiate between: > >* What the patient said about their medication usage (taken vs not taken) > >* Whether the provider wants to keep the recorded MedicationRequest or MedicationStatement on the active medication list > >In summary, we have a bit of a catch 22 where: > >* We can’t use MedicationStatement exclusively (when status = not-taken), nor can we use MedicationStatement to convey status of what was ordered (when usage differs from what was ordered). > >* We can’t use MedicationRequest exclusively (when scope excludes patient statements about OTC medications) [we address patient-prescribed medicaion in US Core guidance at this WGM - see this [Jira](https://jira.hl7.org/browse/FHIR-25035)] > >* Systems often don’t differentiate between reported MedicationRequests vs MedicationStatements, so the boundaries are challenging to honor.[:raised_hand: is this true?] ### IG Updates - [x] USCDI Mapping Table - [ ] Update US Core Profile - [x] :thinking_face: US Core Profile/Extensions - [X] :thinking_face: Implementation Specific Guidance - [X] New Example(s) - [ ] Update Example(s) ---

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