Medications

CSTE Comment - v6

CSTE supports inclusion of this data element in USCDI V6. Please see previously submitted CSTE comments for additional recommendations.

This must be included in USCDI

• This MUST finally be included in USCDI.  Multiple agencies have made a STRONG case for this. Continued lack of inclusion in USCDI is difficult to comprehend as at is a basic healthcare component used widely around the globe.  Additionally, relegation all the way to Level 0 contradicts all fact:
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• Not represented by a terminology standard or SDO-balloted technical specification or implementation guide:  FALSE: Represented by many FHIR IG's including Vulcan RWD IG (https://build.fhir.org/ig/HL7/vulcan-rwd/) , AU Base Medication Administration - AU Base Implementation Guide v4.2.2-ci-build (fhir.org), Home - Epic on FHIR, etc)
• In the Vulcan RWD IG, the IG does not ask for very much, but it does expect Administered Medication to be standardized in HL7 FHIR.  The minimum the RWD IG requires is 
• ... status        code    in-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
  ... medication[x]    CodeableConcept, Reference(Medication)    What was administered
  ... subject    S    1..1        Who received medication
  ... effective[x]    dateTime, Period    Start and end time of administration
• Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
• Data element is electronically exchanged in limited environments, such as connectathons or pilots: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
• Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.

• Level 2 at minimum is more accurate, and it used to be in Level 2.  And it really should be part of USCDI
• Represented by a terminology standard or SDO-balloted technical specification or implementation guide.
• Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
• Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
• Use cases apply to most care settings or specialties.

CSTE Comment - v5

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. CSTE also strongly agrees that the ability to exchange data on prescribing of opioid medications in particular is of great importance to public health programs which aim to reduce opioid overdoses and deaths.

CDC's Comment for draft USCDI v5

CDC-CMS Joint Priority Data Element. 

See letter here (submitted on 1/29/2024): https://www.healthit.gov/isa/sites/isa/files/2024-02/FINAL_CDC%20and%20CMS-CCSQ%20Joint%20USCDI%20v5%20submission%20letter_012924.pdf 

CDC and CMS-CCSQ Joint Support for Date Medication Administered

Thank you for opportunity to comment on this data element. The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) emphasize the importance of patient safety being reflected in the USCDI standards. As an integral aspect of patient safety, medication management is critical to patient care and coordination between providers, and related quality and public health enterprises. Medication administration, specifically, is a critical concept for CMS and CDC programs that support quality improvement and public health surveillance. We continue to emphasize the need for greater specificity in the USCDI Medications data class. The medications data class in USCDI is currently inadequate to support patient safety, quality improvement, or public health. The medication data elements do not differentiate among medications that are active, ordered, and 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 and promote patient safety. CMS and CDC strongly recommend the Date Medication Administered (Level 0) in the Medications data class be added to USCDI.

CDC's Consolidated Comment for USCDI v5

****PROPOSING ADDING THE FOLLOWING USE CASES TO THE ELEMENT

1. NHSN’s antibiotic usage and resistance surveillance will require the date and time of medication administration in order to accurately calculate total number of days of therapy of each antibiotic that have been administered for a given encounter. Although medication request timestamps are currently readily available, NHSN believes that this data element does not accurately reflex whether a medication was truly administered. For example, if a physician orders vancomycin every 12 hours and the patient requires a procedure the time of an administration, the patient could miss the scheduled administration and NHSN would not be able to detect the missed administration if relying on medication request. As such, NHSN needs the ability to differentiate medications that are administered vs ordered using standardized structured data formats.
2. NHSN's hypoglycemia event monitoring. NHSN looks to monitor inpatient hypoglycemic events, and these events likely have a time association with an antidiabetic medication administered during a patient encounter. Commonly, inpatient encounters have standing medication orders for insulin, these orders generally do not provide a scheduled frequency of administration and are typically listed as “PRN AS NEEDED”. As such, NHSN cannot infer if a hypoglycemic event may have been tied to the medication administration, as NHSN can only access the medication request data. A patient could have received administration 4 times in a day or 0 times, but it cannot be inferred from the medication request.
3. "Medication Opioids": Unintentional injuries are the leading cause of death for Americans aged 1–44 years. The leading cause of death for unintentional injury is poisoning, specifically drug overdose. Overdose deaths continue to climb each year and accelerated during the COVID-19 pandemic. The majority of national overdose deaths involve opioids. Many patients receive their first exposure to opioids following surgery, and dentists are the leading prescriber of opioids among adolescents aged 10-19 and second-leading prescriber among young adults aged 20–29. In 2004, an estimated 3.5 million patients had wisdom teeth extracted. Filled opioid prescriptions after wisdom tooth extraction is associated with higher odds of persistent opioid use among opioid-naïve patients. Better understanding prescribing habits can help identify risk factors and particularly vulnerable populations.
4. "Medications Antibiotics": More than 2.8 million antimicrobial-resistant infections occur in the United States each year, and more than 35,000 people die as a result. When Clostridioides difficile is added to these, the US toll exceeds 3 million infections and 48,000 deaths. The threat of antibiotic resistance undermines progress in health care, food production, and life expectancy. Addressing this threat requires preventing infections in the first place, slowing the development of resistance through better antibiotic use, and stopping the spread of resistance when it develops. Research shows that dentists overuse antibiotics, particularly for patients who are underinsured. Dentists prescribe 10% of all outpatient antibiotics, although there is significant geographical variability. Better understanding prescribing practices, knowledge, and beliefs can aid in the development of meaningful antimicrobial stewardship efforts addressing case selection and areas of practice.

• NACCHO supports CDC's comment.

Additional comment from CDC for USCDI v4

• Additional Use Cases from Department of Oral Health

1. Medication - Opioid Overdose: Unintentional injuries are the leading cause of death for Americans aged 1–44 years. The leading cause of death for unintentional injury is poisoning, specifically drug overdose. Overdose deaths continue to climb each year and accelerated during the COVID-19 pandemic. The majority of national overdose deaths involve opioids. Many patients receive their first exposure to opioids following surgery, and dentists are the leading prescriber of opioids among adolescents aged 10­­–19 and second-leading prescriber among young adults aged 20–29. In 2004, an estimated 3.5 million patients had wisdom teeth extracted. Filled opioid prescriptions after wisdom tooth extraction is associated with higher odds of persistent opioid use among opioid-naïve patients. Better understanding prescribing habits can help identify risk factors and particularly vulnerable populations.
2. Medication - Antibiotic Overuse: More than 2.8 million antimicrobial-resistant infections occur in the United States each year, and more than 35,000 people die as a result. When Clostridioides difficile is added to these, the US toll exceeds 3 million infections and 48,000 deaths. The threat of antibiotic resistance undermines progress in health care, food production, and life expectancy. Addressing this threat requires preventing infections in the first place, slowing the development of resistance through better antibiotic use, and stopping the spread of resistance when it develops.

   Research shows that dentists overuse antibiotics, particularly for patients who are underinsured. Dentists prescribe 10% of all outpatient antibiotics, although there is significant geographical variability. Better understanding prescribing practices, knowledge, and beliefs can aid in the development of meaningful antimicrobial stewardship efforts addressing case selection and areas of practice.

CDC's Consolidated Comment for USCDI v4

• This data element is CDC-CMS joint priority for V4.

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. re. They are also and are routinely exchanged when prior authorization is required.

• Additional comment from CDC & DHQP Use Case: Surveillance for inpatient safety and quality is dependent on having medication administration present in the data. There are many quality measures coming under surveillance for inpatients that cannot be calculated without data elements for medications that have been administered. 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.
• Request to update the record with following information: Additional use cases: Patient safety quality measurement and public health surveillance via NHSN & AUR surveillance via NHSN

1. Comments from NACCHO: NACCHO supports including the data element date medication administered. However, more discussion is required on how this is tracked for patients that are not in-patient.
2. Comment from CSTE: 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.
    

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.