Medications

CMS-CCSQ/CDC Joint USCDIv4 Priority - Medication Administration

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.  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.

CDC's Consolidated Comment for USCDI v4

• CDC-CMS Joint Priority Data Element

CMS and CDC urge adding more specificity to the USCDI Medications Data Class as interoperability of medication information and management of medications is critical to patient care and coordination between providers, as well as quality and public health enterprises. We continue to support the concept of a USCDI Task Force to appropriately specify and advance this important data class. Specifically on medication administration, the completion of an administration is important clinical information to ensure appropriate clinical care and is used in quality measurement and across public health reporting systems, including vital records, electronic case reporting (e.g., routine HIV and LTBI/TB surveillance), and the antibiotic use and resistance (AUR) module of CDC's National Healthcare Safety Network. The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and administered/prescribed to the patient. And this lack of differentiation presents significant challenges to joint agency enterprises such as patient safety surveillance and quality measurement in inpatient settings. For example, measurements for hypoglycemia (an important quality measure) rely on patients having received a certain medication -- not solely having the medication ordered. Orders are insufficient for this purpose because orders may be PRN or range orders and therefore not reflect what the patient received.

Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. Medication details 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. Specifically, this medication data element is necessary for understanding adverse drug events, opioid use and misuse, and medication access

 CDC and CMS urge adding more specificity to the USCDI Medications Data Class as interoperability of medication information and management of medications is critical to patient care and coordination between providers, as well as related quality and public health enterprises—we continue to support the concept of a USCDI Task Force to appropriately specify and advance this important data class. 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. Specifically, these medication data elements are necessary for understanding adverse drug events, opioid use and misuse, and medication access.  The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and administered/dispensed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. These detailed medication data were also previously identified as a joint CMS-CDC priority area as they are used extensively in quality measurement and public health—for example, to monitor and respond to antibiotic prescribing patterns that facilitate the emergence of drug-resistant pathogens, but also exposes patients to needless risk for adverse effects. They are also and are routinely exchanged when prior authorization is required

• Additional use cases: 

1. Patient safety quality measurement and public health surveillance via NHSN
2. AUR surveillance via NHSN

• Comments from NACCHO: NACCHO is looking for more information on completion of medication status and types of order in various scenarios such as when a patient is not in care. It is necessary to be accurately differentiated for quality clinical care. While, it has added benefits to the public health, there is a necessity of more clarity on this data element
• Comments from CSTE: CSTE agrees with CDC's recommendation for this data element.

Please include Medication Administration in USCDI v4

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/regulatory sphere, one of which I make below.  But I wanted to emphasize these elements are not niche needs for a few research requirements.  These 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 4.

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 leathal, misjudgments on patient medication usage.

An FDA/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.

CMS-CCSQ/CDC Joint USCDIv4 Priority - Medication Administration

CMS urges adding more specificity to the USCDI Medications Data Class as interoperability of medication information and management of medications is critical to patient care and coordination between providers, as well as related quality and public health enterprises—we continue to support the concept of a USCDI Task Force to appropriately specify and advance this important data class. 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. Specifically, these medication data elements are necessary for understanding adverse drug events, opioid use and misuse, and medication access.

The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and actually administered/dispensed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. These detailed medication data were also previously identified as a joint CMS-CDC priority area as they are used extensively in quality measurement and public health —for example, to monitor and respond to antibiotic prescribing patterns that facilitate the emergence of drug-resistant pathogens, but also exposes patients to needless risk for adverse effects. They are also routinely exchanged when prior authorization is required.

Maturity: These elements are classified as Level 2 by ONC and continues to have strong standardization and be in wide use.

• Current standards:
  • In FHIR US Core, there is a distinction between "Medication" and "Medication Request”; base FHIR and FHIR Quality Improvement (QI) Core IG includes "Medication Administration" and “Medication Request” profiles.
  • Within Medication Request, the ‘category’ is used to define discharge medications.
• Current uses, exchange, and use cases: Medication data are routinely captured in electronic health record (EHR) systems used by hospitals, providers, and other healthcare stakeholders, including pharmacies, and are routinely exchanged across providers and payers. Medication data are used extensively in CMS quality measurement and public health for surveilling national trends. Additionally, when prior authorization is necessary for a medication, details related to the medication (e.g., why the medication is given, the quantity needed) are exchanged to support the approval process. As noted in the ISWG recommendations report for USCDI v3, many medication data elements are already required for Health Information Technology (IT) Certification via other standards (National Council for Prescription Drug Programs [NCPDP] SCRIPT, Consolidated Clinical Document Architecture [C-CDA]) and are therefore already routinely exchanged, posing little additional burden by adding them to the USCDI.

CDC's comment on behalf of CSTE for USCDI v4

CSTE agrees with CDC. Medication data is critical for exchange with public health and is included in eCR standards. It is especially important for STI programs, HIV and TB surveillance as well as for public health response and surveillance for antimicrobial resistant pathogen infections. 

CDC-CMS Joint Priority Data Element for USCDI v4

CDC continues to recommend inclusion of this high priority data element in USCDI v4.  This element is also shared high priority item for CMS/CDC as outlined in our joint letter

CDC-CMS Shared Priority

This data element is CDC-CMS shared priority to be included in USCDI v3

CDC's Consolidated Comment

• NCPDP SCRIPT Standard v2017071 for electronic ePrescribing was mandated effective September 1, 2021 for providers who electronically prescribe.  This standard now requires software to support for tracking the dispensing and administering of medications.  https://surescripts.com/GetSCRIPT
• Collected for Tuberculosis (TB) and Latent Tuberculosis Infection (LTBI) Surveillance and are included in the TB and LTBI Message Mapping Guides (MMG).  https://ndc.services.cdc.gov/mmgpage/tuberculosis-and-latent-tb-infection-message-mapping-guide/

CSTE Comment:

• Medication data is critical for exchange with public health and is included in eCR standards. It is especially important for STI programs, HIV and TB surveillance as well as for public health response and surveillance for antimicrobial resistant pathogen infections.

FDA Support for ONDEC Medication Administration Submission

This comment is intended to document FDA’s support for the addition of the Medication Administration data class to USCDI. Improving the interoperability of this data class and its underlying elements (i.e., FHIR MedicationAdministration elements medication, status, statusReason, category, subject, occuranceDateTime, occurrenceReason, performer, note, dosage) are critical to numerous use cases related to almost every purpose of use (i.e., operations, payment/financial, research, patient data access, public health, and treatment). Of particular importance to FDA’s mission are public health-related use cases such as enabling safety and effectiveness surveillance using real world data. While MedicationRequest data are valuable for some FDA regulated drugs and products, many are administered in the inpatient setting and are therefore not captured by that resource, or if they are captured, there is uncertainty on the status of administration. Inclusion in USCDI will enable higher levels of capture of these exposures for potential adverse event cases– both as a drug/product of interest or  as a concomitant medication. These data are already extensively captured within electronic medical records and exchanged via different paradigms (e.g. HL7 V2, CDA).

For these reasons, we recommend promotion of MedicationAdministration-related elements from USCDI Level 2 to Version 3. 

Support for Medication Administration (& related data elements)

Medication data are integral to informing the quality, safety, and costs of U.S. healthcare, supporting federal, state, and local public health, and guiding clinical decision-making in patient care. Across a wide range of healthcare settings, including, acute care, long-term care, and post-acute care, medication administration—as captured by electronic medication administration (eMAR) records—is considered the gold standard for accurately measuring medication exposure, including identifying the exact medications patients have received, in what formulations, doses, and for what length of time. Published data indicate that alternative data sources for medication exposure, such as pharmacy “order” (or billing) data and medication “lists” do not always reflect the medications actually received by patients. Pharmacy order/billing data are discordant with medication administration data due to variability in when billing events occur relative to actual medication administration (1,2). For example, billing can occur upon order entry or upon dispensing, neither of which reflects actual medication administration to the patient. Medication “lists”, such as those generated during medication reconciliation are based on processes that are highly variable across U.S hospitals with regard to their accuracy and comprehensiveness (3). Medication lists can also have a high level of discordance with actual administration of medications (4,5). It is crucial that medication administration be added as a requirement of US Core standards to improve the accuracy of FHIR Resources in HL7. The case for this has never been clearer as during the COVID-19 pandemic, where identification of the medications that acutely ill hospitalized patients with COVID-19 had received was integral to understanding clinical management of this new public health threat and directing public health resources, including scarce medications.

There is a wide range of medication workflows in patient care, such as Medication Request, Medication Dispense, Medication Administration, and Medication Knowledge. These data elements represent distinct patient care events related to ordering, dispensing, administering, and recording of medications. Reliance on Medication Request alone provides an inaccurate picture of the wide spectrum of medication workflows in the healthcare system. The continued reliance on the Medication Request as the only USCDI medication data element is a severe limitation in achieving accurate representation of medication exposure in U.S. healthcare data. It is essential that the full range of medication events be specified in USCDI and available to support public health, regulatory, research, and pandemic response.

There is a “Medication” data element that specifies the actual medication and that it should be represented with RxNorm, 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.

A medication request represents a clinician’s order or a prescription. It is distinctly separate from administration and dispensation activities, as the medication actually administered or dispensed may have differences from the order. The US Core specification currently has a US Core MedicationRequest profile, but the request concept should be clearly called out in USCDI, which should also firmly declare that medication requests are for orders/prescriptions and are not sufficient to represent administration or dispense activities.

1. Courter JD, Parker SK, Thurm C, Kronman MP, Weissman SJ, Shah SS, Hersh AL, Brogan TV, Patel SJ, Smith MJ, Lee BR, Newland JG, Gerber JS. Accuracy of administrative data for antimicrobial administration in hospitalized children. J Pediatric Infect Dis Soc 2018;7(3):261-63.  
2. Schwartz DN, Evans RS, Camins BC, Khan YN, Lloyd JF, Shehab N, Stevenson K. Deriving measures of intensive care unit antimicrobial use from computerized pharmacy data: methods, validation, and overcoming barriers. Infect Control Hosp Epidemiol 2011;32(5):472-80.   
3. Pevnick JM, Shane R, Schnipper JL. The problem with medication reconciliation.  BMJ Qual Saf 2016; 25(9):726-30.
4. Rose AJ, Fisher SH, Passche-Orlow MK. Beyond medication reconciliation. The correct medication list. JAMA 2017;317(20):2057-8. 
5. Gupta A, Yek C, Hendler RS. Phenytoin toxicity. JAMA 2017;317(23):2445-6. 
6. HL7 FHIR Release 4. Medications Module Available at: https://www.hl7.org/fhir/medications-module.html.