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tags: USCDI v4
title: Medications
cat: hard
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## :new: Medications Data Elements
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
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Draft


Final

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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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