Medications

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.

CMS/CDC v4 Priority: Medication Admin. Route and Date and Time

Management of medications is critical to patient care and coordination between providers, as well as related quality and public health enterprises. The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and actually administered/prescribed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care.

• We recommend the following elements be added regarding medications:
  • Medications Prescribed
  • Medications Administration/Medication Administered Code
  • Discharge Medications
  • Medication Administration Route
  • Medication Administration Dose
  • Medication Administration Date and Time

We continue to urge adding more specificity to the USCDI Medications Data Class. These medication data elements are necessary for understanding adverse drug events, opioid use and misuse, and medication access.

The highlighted additional data elements serve the ONC USCDI v4 stated priorities related to mitigating health inequities and disparities, addressing needs of underserved populations, and addressing public health reporting needs.

NCPDP Comment

For all of data elements under Medication data class in Level 2, NCPDP recommends a review and restructure because it currently creates confusion and potential duplication.

Medication Administration Date/Time and Route

Consider adding data elements for:

• Date/Time of Medication Administration
• Route of Medication Administration

This comment is submitted on behalf of the National Emergency Medical Services Information System (NEMSIS) Technical Assistance Center.

Level 2 data element to USCDI v3

Vizient recommends adding the below Level 2 data elements to USCDI v3 to the Medications class. In support of these additions, use cases are also provided for consideration:

o Medication Administration: This allows for further insight and analyses of which medications were administered within visits.
o Negation Rationale: This will allow for analyses as to what medication orders are being placed and then subsequently cancelled on a regular basis in addition to why they are being cancelled.
o Dosage: This information allows for sharing of detailed dose information to patients and other parties rather than simple medication name which can lead to additional insights on dosing patterns.
o Discharge Medications: This distinguishes which medications were prescribed for a patient to start/continue from the point of discharge and minimize confusion with medications prescribed as an inpatient.
o Medications Dispensed: The allows for differentiation of which ordered medications were actually dispensed (e.g., generic). This may be different from what was ordered or administered as it is the result of a pharmacy system responding to a medication order.

Lantana Consulting Group Comment

The details of prescribing, dispensing, and administering medications are essential to patient care, care coordination, and quality measurement. Adverse drug events and opioid use/misuse is difficult to properly evaluate without the specifics of when a medication was administered or prescribed.  

Relying on Medication Request as the only USCDI medication data element limits the representation of medication exposure in healthcare data in the U.S and provides a distorted and inaccurate picture of the medication workflows in the healthcare system. A medication request is the clinician’s prescription but is a separate event from dispensing and administering the medication. A different medication may be dispensed or administered. 

We support data elements for full range of medication events to support public health, regulatory, research, and pandemic response. Lantana recommends the following elements for inclusion in USCDI V3:

• Medication Administration

• Code
• Performer
• Reason Reference
• Date/DateTime

• Medication Prescribed
  • Code
  • Date
  • Reason Reference

• Medication Dispensed
• Discharge Medications (Medication Request)
• Dosage
• Dosage/Route
  • Administered Dose
  • Administered Dose Units
  • Prescribed Dose
  • Prescribed Dose Units
  • Negation Rationale

The current Medication data elements specify the actual medication but does not differentiate medication order, medication administrations, and medication dispensing activities. It also does not provide information about when the medication was ordered, dispensed, and administered to the patient.

The current MedicationRequest profile should emphasize that it represents requests or orders. The MedicationAdministration profile which would represent medications received at the hospital remains at USCDI Level 2 which impedes accurate medication data collection.

Data Class: Medications

IMO would like to note while many the proposed Level 2 data elements for the Medication data class are collected and exchanged by ONC certified HIT, not all the proposed Level 2 data elements meet ONC criteria for inclusion in USCDI V3.  We have categorized our review of the proposed data elements by these criteria.

Data Elements for Medications: Meet Level 2 Critiera

These data elements are incorporated in eCQMs reported in CMS quality programs, represented in implemented terminology specifications, and incorporated in requirements for ONC Certified HIT.

• Level 2 Data Element: Medication Administration
• Level 2 Data Element: Negation Rationale
• Level 2 Data Element: Dosage
• Level 2 Data Element: Discharge medications
• Level 2 Data Element: Date Medication Prescribed
• Level 2 Data Element: Medication Prescribed Code
• Level 2 Data Element: Medication Prescribed Dose
• Level 2 Data Element: Medication Prescribed Dose Units
• Level 2 Data Element: Date Medication Administered
• Level 2 Data Element: Medications Dispensed
• Level 2 Data Element: Medication Request
• Level 2 Data Element: Medication Statement

Data Elements for Medications: Do Not Meet Level 2 Critiera

The following technical specifications are cited in support of proposed Level 2 data elements. These technical specifications vary in maturity and do not yet have widespread implementation in ONC Certified Health IT.  Specifications include:

• FHIR US Core MedicationRequest Profile - FHIR v4.0.1
• FHIR US Core MedicationStatement Profile - FHIR v4.0.1
• HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) Release 1, STU Release 3.0
• Making EHR Data More Available for Research and Public Health (MedMorph) Reference Architecture

As the technical specifications that include these proposed data elements mature and are implemented in production environments these data elements could be reconsidered in future versions of USCDI.

• Level 2 Data Element: Therapeutic Medication Response
• Level 2 Data Element: Medication Prescription Do-Not-Perform
• Level 2 Data Element: Medication Prescription Status
• Level 2 Data Element: Medication Prescription Patient
• Level 2 Data Element: Medication Knowledge
• Level 2 Data Element: Medication Administration Status
• Level 2 Data Element: Medication Administered Performer
• Level 2 Data Element: Medication Prescribed Reason Reference
• Level 2 Data Element: Reported Medication (unique)

Prime Therapeutics Comments on USCDI V3

Prime Therapeutics LLC (Prime) helps people get the medicine they need to feel better and live well. Prime provides total drug management solutions for health plans, employers, and government programs including Medicare and Medicaid. We serve nearly 33 million people and are collectively owned by 19 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans. 

Prime Therapeutics requests ONC add National Drug Code (NDC) as an identifier for medications all.  RXNORM codes do not contain the specificity to identify specific drug manufacturer, all the active and inactive ingredients, etc.