Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Data Element

Information from the submission form

Date Medication Administered
Description
A specific date/time or interval of time during which the administration took place (or did not take place, when the 'notGiven' attribute is true).

Comment

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. 
  • However, I want 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 lethal, 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.

CDC's comment on behalf of CSTE for USCDI v4

CSTE Comment:
  • 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's Consolidated Comment for USCDI v4

CDC strongly supports inclusion of this element in the USCDI v4. Also, please add the following use case: Birth reporting use case: Healthcare facilities are required to report to state vital records offices if antibiotics were administered under two circumstances: 1) for the mom during labor and delivery and 2) for the newborn for suspected neonatal sepsis.  At the point of clinical care these elements identify suspected neonatal sepsis of the newborn and if the mother received antibiotics during labor.  These medications must be properly identify, and if they were administered in order to complete facility worksheets and birth certification.  It is required to report the administration of these medications to the State VROs electronic birth registration systems (EBRS), and to the National Vital Statistics System (NVSS).  This medical information is collected within the Facility Worksheet for the Live Birth Certificate (cdc.gov), and reported within the US Standard Certificate of Live Birth for national level reporting.  At the population level the state VROs and the NVSS provide aggregate data on births and risk factors that may impact the mother or newborn during labor and delivery and throughout life. 

CDC's Consolidated Comment

  • Collected as part of antiretroviral history for routine HIV surveillance.
  • 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/
  • Important for National Healthcare Safety Network (NHSN) measures, including hypoglycemia and Clostridioides difficile (C Diff).
  • Additional Technical Specifications: HL7 FHIR Health Care Surveys Content Implementation Guide (http://hl7.org/fhir/us/health-care-surveys-reporting/2022Jan/); HL7 FHIR Central Cancer Registry Reporting Content Implementation Guide (http://hl7.org/fhir/us/central-cancer-registry-reporting/2022Jan/).
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.

Unified Comment from CDC

  • Additional Use Case: Information about medications prescribed, administered, and reasons for prescribing are collected as part of CDC's routine nationally notifiable condition surveillance for HIV, tuberculosis and sexually transmitted diseases. This information is collected to understand trends in treatment initiation and completion (as applicable), and as part of a health department's case management work.  
  • Additional Use Case: This data item is currently standardized and used by central cancer registries in all states. Data received through data exchange from medical facilities (e.g., laboratories, hospitals, physician EHRs, etc.) to central cancer registries for CDC and NCI’s national cancer surveillance systems, as required by law.   
  • Number of stakeholders who capture, access, use or exchange this data element: All US States and DC are funded through CDC’s Division of HIV Prevention, Division of TB Elimination and Division of STD Prevention flagship Notice of Funding Actions to perform surveillance activities, including collection of these data for surveillance purposes.  
  • Healthcare Aims: Improving patient experience of care, Improving health of populations, Reducing cost of care, Improving provider experience of care  
  • Use of data element: Extensively used in production environments  
  • This element is used by CMS Quality Reporting and is marked Required or Must Support in the FHIR QI Core IG  
  • CSTE supports inclusion of this measure into USCDI v3: Helpful for PH to know if treatment was administered or prescribed to indicate a need to contact patient and connect with other wraparound services/linkage to care (e.g., STIs, Hepatitis C/B)

data medication administered

The CDC Division for Heart Disease and Stroke Prevention and the Million Hearts® 2022 Hearts national initiative (co-led by and the Centers for Medicare & Medicaid Services) uses this data as it is available for monitoring and evaluation to prevent 1 million heart attacks and strokes in 5 years. Furthermore, the CDC plans to leverage this data further in the future for surveillance and epidemiology studies if advanced through policy and available from EHRs. The Multi-state EHR-based Network for Disease Surveillance (MENDS) pilot will use electronic health record (EHR) data collected in clinical settings leading to a real-time, chronic disease surveillance model to plan and evaluate short-term outcomes of policies and program interventions.

USCDI_Version_2_Draft_Template for Comments_DHDSP_MENDS_04.15.2021_7.docx

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