Medications

ANI's comment on USCDI draft v7: Medications

ANI strongly supports the addition of Route of Administration and Medication Dispense Quantity to the Medications data class, and regards both as essential elements of comprehensive, safe medication documentation. Nurses, as the primary administrators of medications in virtually all inpatient and many ambulatory settings, are responsible for verifying and documenting the correct route for every administration, and the absence of this element in prior USCDI versions represented a meaningful gap in interoperable medication data. Together, these elements advance the completeness and clinical utility of interoperable medication records and reduce risk at care transitions where incomplete medication data is a leading contributor to preventable adverse drug events. ANI further advocates for implementation guidance that addresses nursing-specific medication administration record (MAR) documentation nuances, including PRN administration, dose modifications, and route changes, to ensure these elements are implemented in ways that reflect actual nursing workflow.

Address complexity of the medication lifecycle

The lifecycle of ordering, dispensing and administering medications is complex and not easily conveyed in a single data class. Expansion of the existing Medication data class into distinct data classes for orders, dispense and administrations would make it more clear as to the expectations around sharing data on each of these different types of activities.

CDC's comment for support of the Medication Class

Use Cases to support advancement of Medication Data Elements: The misuse of opioids and antibiotics poses significant public health challenges in the United States. Opioid overdoses have risen sharply, particularly among adolescents and young adults following dental procedures, while antibiotic resistance results in millions of infections and thousands of deaths annually. Understanding prescribing habits and addressing overprescription in both areas are critical for improving patient safety and health outcomes.

While some elements are already included, the following data elements did not have the supporting use cases listed. The element names and links are provided for your review:

• Medication Administered Performer
  https://www.healthit.gov/isp/taxonomy/term/2761/level-0
• Medication Administered Reason Reference
  https://www.healthit.gov/isp/taxonomy/term/1571/level-0
• Medication Administration Dose Units
  https://www.healthit.gov/isp/taxonomy/term/1566/level-0
• Medication Prescribed Code
  https://www.healthit.gov/isp/taxonomy/term/1506/level-0
• Medication Prescribed Dose
  https://www.healthit.gov/isp/taxonomy/term/1511/level-0

Difficulties with the Medications requirement reflected in specs

On behalf of the Department of Veterans Affairs

We on the HL7 C-CDA-to-FHIR mapping project observe difficulties with the Medications requirement reflected in specifications.

USCDI specifies "medications" at both the element and class levels as "Pharmacologic agent used in the diagnosis, cure, mitigation, treatment, or prevention of disease."

This seems like a valid definition at the element level, but the class should represent an association between one of these pharmacologic agents and a specific patient. The inclusion of dose and instruction imply that this is the intended definition.

a. Change the name of the class to reflect its difference from the element (e.g.,"Patient Medication"). It should include known patient medications that are active or recently discontinued or expired, whether ordered by the responding system or not, and whether there is an actual record of administration or not.

b. Ensure that the requirement is stated clearly enough to resolve existing difficulties in specifications. Currently, CDA semantics distinguish between intended and actual administrations but leave ongoing orders unaddressed. FHIR semantics suggest a distinction between requests and statements that is supplanted in US Core.

CDC comment on MedicationAdministration Resource

MedicationAdministration Resource

• MedicationAdministration describes the event of a patient consuming or otherwise being administered a medication. This may be as simple as swallowing a tablet or it may be a long running infusion. Related resources tie this event to the authorizing prescription, and the specific encounter between patient and health care practitioner as defined here in Section 11.2 of HL7 FHIR Release 4: https://hl7.org/fhir/R4/medicationadministration.html. 
• Examples can be found here: https://hl7.org/fhir/R4/medicationadministration-examples.html.  
• Usage notes: The scope of this resource covers the recording of medications and vaccine administrations that are oral, injected, intra-venous within care settings.  This includes self-administered medications. This concept is distinct from medication orders, dispensations, and procedures and, to the best of our knowledge and experience with real-world FHIR data, this concept is not currently represented by any other FHIR resource or data element. For additional details, please see Section 11.2.1 of HL7 FHIR Release 4: https://hl7.org/fhir/R4/medicationadministration.html. 
• Applicable standard: FHIR v4.0.1 https://hl7.org/fhir/R4/index.html  

Narrative or Evidence for inclusion in USCDI v6

In a prior ONC evaluation, MedicationAdministration was evaluated as “applying to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements”. Additionally, MedicationAdministration was deemed as a specialized use or subset of an existing USCDI v4 data element Performance Time in the Procedures data class of USCDI v4.  

Current medication and procedure concepts in USCDI are incomplete representations of medication administration. Alternate FHIR medication data elements do not capture: 

• Whether the patient actually received the medication. This is fundamentally different than “ordered” medication in MedicationRequest resource, https://hl7.org/fhir/r4/medicationrequest-definitions.html#MedicationRequest. 
• The final dose of the administered medication. This is fundamentally different than the “amount” of the medication in the Medication resource, https://hl7.org/fhir/r4/medication-definitions.html. 
• The route of administration of the medication. This is fundamentally different than “dose form” of the medication in the Medication resource, https://hl7.org/fhir/r4/medication-definitions.html#Medication.form. 

“Procedure” resource, https://hl7.org/fhir/r4/procedure.html, cannot be relied upon as a representation of medication administration as this does not reflect the reality of the EHR clinical workflow in U.S. hospitals—i.e., “medication” instances are not intended to be captured under “procedure” concepts. In CDC/NHSN’s current use of real-world FHIR data, we have not yet found any evidence that medication administration instances can be reliably identified based on Performance Time in the Procedures data. 

“Medication” resource, https://hl7.org/fhir/r4/medication.html, specifies the actual medication, but it does not differentiate between medication requests (i.e., orders), medication administrations, and medication dispense activities, and it does not provide information about when the medication was ordered, dispensed, or administered to the patient.   

“MedicationRequest” resource, https://hl7.org/fhir/R4/medicationrequest.html, represents medication orders/prescriptions. Published evidence demonstrates that orders/prescriptions are not accurate or sufficient representations of the medication ultimately received by the patient.1 A medication request represents a clinician’s order or a prescription. It is distinctly separate from administration activities, as the medication administered can have differences from the order. This occurs because medication orders can be changed, cancelled, or never administered, thus orders do not reflect actual medication exposure. 

MedicationAdministration is a required resource for reporting of FHIR digital quality measures (dQMs) to CDC/NHSN. The CDC/NHSN dQMs that require MedicationAdministration will adhere to the reporting framework requirements in the balloted HL7 NHSN dQM Reporting Implementation guide (IG), https://hl7.org/fhir/us/nhsn-dqm/2024SEP/index.html. CDC’s National Healthcare Safety Network has balloted an HL7 that defines the framework for reporting FHIR dQMs. The CDC/NHSN dQM Content IG that will follow this IG points to specific use cases where MedicationAdministration is a required resource to support national public health surveillance and patient safety efforts. This HL7 NHSN dQM Reporting IG was tested during the May 24, 2024, HL7 FHIR Connectathon and Working Group Meeting: https://confluence.hl7.org/display/FHIR/2024+-+05+NHSN+dQM+Reporting. Selected data elements within the MedicationAdministration resource will be “required” or “must support” as part of requirements to report digital quality measures to CDC/NHSN: https://www.cdc.gov/nhsn/fhirportal/about.html.   

MedicationAdministration is in now required as part of real-world implementation use cases across U.S. hospitals and being requested for national public health surveillance use cases from different EHR vendors (e.g., Epic, Oracle/Cerner, Altera, Meditech).  NHSN and U.S. hospitals are currently undertaking Production (real-world) implementations of FHIR digital quality measures for which this Resource is required to calculate patient safety metrics, including healthcare-associated infections and adverse drug events, and to support pandemic preparedness as described here: https://www.cdc.gov/nhsn/nhsncolab/index.html: https://academic.oup.com/jamia/advance-article/doi/10.1093/jamia/ocae064/7639052.  While we know of one EHR vendor voluntarily supporting exposing the MedicationAdministration resource and able to successfully exchange these data with NHSN, other vendors do not. This creates a disparity among U.S. hospitals in data reporting and does not allow for accurate national enumeration and benchmarking of patient safety events. The MedicationAdministration resource is required for data exchange for numerous use cases across Department of Health Human Services agencies, including CDC, CMS, and FDA: 

 https://hl7.org/fhir/us/nhsn-dqm/2024SEP/index.html. 

 https://build.fhir.org/ig/HL7/fhir-icsr-ae-reporting/branches/main/index.html  

 CDC requires MedicationAdministration data as part of reporting FHIR digital quality measures (dQMs) to CDC/NHSN. NHSN FHIR dQMs currently utilize the US Core 3.1.1 standard, which, along with all current US Core versions, does not include MedicationAdministration. In addition to US Core, NHSN dQMs leverage the MedicationAdministration profile requirements defined in HL7 quality measure standards, including Da Vinci DEQM 3.1.0: https://hl7.org/fhir/us/davinci-deqm/STU3.1/ and QI Core 4.1.1:  https://hl7.org/fhir/us/qicore/STU4.1.1/ to evaluate data.

Medication exposure happens across the full spectrum of U.S. healthcare—ambulatory care, acute care, long-term care, surgical care, and numerous other healthcare settings. The importance of enumerating medication exposure across outpatient and inpatient settings was well-highlighted during the 2020 COVID-19 pandemic, during which challenges emerged in reporting of COVID-19 medication data to state and federal public health agencies limited our understanding and mitigation of the pandemic. Additionally, the lack of medication administration data presents a substantial challenge to CDC and jurisdictions in responding to healthcare-related outbreaks, where improper use of medications is often implicated in multi-state outbreaks.

CMS-CCSQ Support for Medication data elements for USCDI v6

Data Elements: Medication Administered Code, Medication Administration Dose, and Medication Administered Reason Reference (Level 0)

1. Recommendation: Advance the Medication Administered Code, Medication Administration Dose, and Medication Administered Reason Reference data elements to Level 2 and add to Final USCDI v6.
2. Rationale: CMS requests the inclusion of the Medication Administered Code, Medication Administration Dose, and Medication Administered Reason Reference data elements in USCDI v6 to fill critical gaps in patient safety and care quality. These data elements are important for medication reconciliation and continuity of care especially during transitions of care between acute and post-acute settings. They are also supported by RxNorm. Medication administration continues to remain a key priority for CMS and CDC programs as its essential for quality improvement and public health surveillance.

Medication Administration FHIR Resource and US Core

CDISC supports the use of the MedicationAdministration Resource as part of US Core IG Medication Profile.  

We recommend the ONC and USCDI promote the use of FHIR MedicationAdministration Resource elements to support the HL7 US Core to use case. This will aid in the full picture of the medication perspective. The current US Core has Medication, MedicationDispense,and MedicationRequest. Currently, the US Core which is informed by USCDI does not include the MedicationAdministration Resource.

This will help researchers understand all aspects of the medication: the request (order), the dispense (pharmacy filling), the statement (patient/participant stating meds taken) and finally, the most important in healthcare - the medication administration (the health providers giving the drugs to the patients).

The record of medication administration is a central healthcare use case. It represents the record where a healthcare provider has administered the drug. This data not only helps with clinical research but will provide insight into drugs ordered (MedicationRequest), drugs dispensed (MedicationDispense) by having the ability to see in the hospital/healthcare setting which drugs were actually administered against those ordered and provided which makes a difference in the analysis of how sick a patient is. For example, the Levophed was ordered and given is very different than the Levophed was on standby for hypotension.  Consider as well, the use of MedicationStatement which means the patient said they were taking these medications. This likely is the most accurate reflection of what the person is actually taking. This can be validated against the MedicationRequest and MedicationDispense which provides insight on if indeed the person is taking the medications and if they are taking them as often as prescribed.

The key aspect of capturing med records distinctly include collecting all core bits of information regarding the records of medications and their administration should be a part of the US Core. 

In the current US Core FHIR build, R6.
MedicationAdministration is Maturity Level 2; MedicationDispense is Maturity Level 2; MedicationRequest is Maturity Level 4; MedicationStatement is Maturity Level 4; Medication is Maturity Level 4

The Medication Administration resource is used in the following IGs:

• HL7 Vulcan Retrieval of Real World Data for Clinical Research
• HL7 FHIR to CDISC Joint Mapping Implementation Guide
• CDISC side - FHIR to CDISC Joint Mapping Implementation Guide (published simultaneously in a joint effort to bridge clinical research across the two communities, healthcare and research)

This fulfills the following criteria for promotion:

• Criterion #1 - Maturity - Current standards: Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
• Criterion #2 - Maturity - Current Use: Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
• Criterion #3 - Maturity - Current Exchange: Level 1 - Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
• Criterion #4 - Use Case(s) - Breadth of Applicability - Level 1 - Use cases apply to several care settings or specialties.
   
• Further rationale:

•    The record of an actual administration of a medication to a patient is one of the most central healthcare use cases.  Currently a suite of Medication administration-related concepts are in the Level 2 section of USCDI.   All of these are central healthcare components so the longer the data for these concepts remain wildly unstandardized in US EHRs, the longer there will be no realistic expectation of interoperability. There are many strong justifications for need of standardized structured data of this concept the clinical research: 
•    These elements are not niche needs for a few research requirements.  They are the center of patient-provider data exchange and the continued lack of standardized representation of these concepts should be the single driving reason for their inclusion in USCDI version 5.
•    Healthcare use case: The lack of any standardized representation of administration of medications inherently prevents interoperability of this information and restricts critical sharing of this information across health systems (such us in those qHINs participating in TEFCA).  Lack of easy sharing of administered drugs can result in serious, sometimes lethal, misjudgments on patient medication usage.
•    A Clinical research context: Retrospective analyses of healthcare data are becoming a more common tool in clinical research for safety or efficacy for new indications of existing medications. In such analyses there may be one or more “exposure” drugs (ie, the drug of interest) and one or many “concomitant” medications. Researchers (and regulatory reviewers) will need to know enough information of the status of a drug administration where applicable. This information will supply critical differential information with which a researcher or regulatory reviewer can assess the relative probability of the listed drug record actually resulting in consumption by the patient. They can then determine the utility of the information in the context of the specific research and evidence generation needs of any given clinical study.

Medications Data Class - L2 Data Elements as of 9.20.2023

• Emory Healthcare (EHC) submits its support for the inclusion of all Data Elements currently listed as Level 2 under the Medications data class in draft USCDI v5.
• EHC submits its particular interest in the inclusion of Date Medication Prescribed and Date Medication Administered in Draft USCDI v5. EHC providers and quality officers use the time from prescription to delivery as a factor that can be reviewed to support responsive patient care. Longer periods of time can be indicators of more systemic problems – from workflow to SDOH-related patient experiences. If a framework for collecting these data elements were consistently available across the healthcare ecosystem, EHC and others would be better able to identify opportunities to improve care quality, provide patient support and/or implement new best practices, especially if available in concert with Negation Rationale and statuses. The applicable Fast Health Care Interoperability Resources (FHIR®) data type referenced in the data element submission supports a level of specificity, referencing both date and time, that would assist with care quality improvement activities.
• However, EHC encourages ONC to evaluate the benefit of having data elements that support the distinction of medication administration (i.e., given in an inpatient setting) and dispensation (i.e., given in an outpatient setting). Emory Healthcare offers for consideration “Date Medication Administered” and “Date Medication Dispensed,” which would mirror the Date Medication Administered Level 2 data element, but support a better understanding of the care context.

Comment

Recommend adding Medication Start Date and Medication End Date as data elements. This will ensure patient safety during medication administration and support the future of FHIR resources.