Medications

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 Medication Admin. Dose

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 Medication Administration Dose (Level 0) in the Medications data class be added to USCDI.

CDC's comment on behalf of CSTE for USCDI v5

CSTE agrees with CDC's recommendation for this data element.  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 Consolidated Comment for USCDI v5

• 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 actually received.
• ** ADD THIS USE CASE TO SUBMISSION **

1. "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.
2. "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.
3. NHSN hypoglycemia event monitoring: NHSN plans to monitor the hypoglycemic events associated with an anti-diabetic medication administered. Currently inpatients have standing orders for insulin sliding scales that have range doses i.e., 0 - 10 units and NHSN cannot infer if an administration had actually occurred if the lower dose limit contains 0. We would need the actual dose administered to confirm if an administration had occurred.

NACCHO supports CDC's recommendation.

CMS-CCSQ/CDC Joint USCDIv4 Priority Medication Admin. Dose

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.

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

• 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 actually received.
• Comments from NACCHO: NACCHO supports inclusion of this data element. However, NACCHO recommends to add additional data elements that indicate the type administration dose.
• Comments from CSTE: CSTE agrees with CDC's recommendation for this data element.

Please include Medication Administration elements 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 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.