Regulatory Focus™ > News Articles > HHS Looks at New Ways to Track Adverse Events Linked to Anticoagulants, Diabetes Drugs and Opioids

HHS Looks at New Ways to Track Adverse Events Linked to Anticoagulants, Diabetes Drugs and Opioids

Posted 19 October 2016 | By Zachary Brennan 

HHS Looks at New Ways to Track Adverse Events Linked to Anticoagulants, Diabetes Drugs and Opioids

The US Department of Health and Human Services (HHS) on Wednesday proposed six new inpatient and outpatient measures to track as part of efforts to reduce adverse drug events (ADEs) from anticoagulants, diabetes agents and opioid analgesics.

Based on input from the Federal Interagency Workgroups for Adverse Drug Events, the six national measures and targets for the reduction of ADEs are being proposed in line with the ADE Action Plan from 2014. The primary ADE concerns include:

  • Bleeding for anticoagulants 
  • Hypoglycemia for diabetes agents
  • Accidental overdoses, oversedation and respiratory depression for opioids 

Descriptions of the surveillance systems, measures and targets can be found here: https://health.gov/hcq/ade-measures.asp (Editor’s note: the link did not work as of the morning of 10/19/2016 but an HHS employee involved with the site told Focus it will go live later today or on Thursday).

Inpatient Settings

The measures will set baseline rates using data from 2014 and 2016 and establish targets to be achieved by 2020. 

Measure

Numerator

Denominator

Baseline Year

Target Reduction

Departmental Measure Alignment*

Rates of adverse events  from oral or parenteral anticoagulants among U.S. inpatient stays

Number of U.S. hospital discharges with adverse events from oral or parenteral anticoagulants

Number of U.S. hospital discharges in which anticoagulants were administered

2014

10%

Aligned with the current measure used to calculate the national hospital-acquired condition rate for anticoagulant adverse events in the Partnership for Patients initiative

Rates of adverse events from hypoglycemic agents among U.S. inpatient stays

Number of U.S. hospital discharges with adverse events from hypoglycemic  agents

Number of U.S. hospital discharges in which diabetes agents were administered

2014

10%

Aligned with the current measure used to calculate the national hospital-acquired condition rate for diabetes agent adverse events in the Partnership for Patients initiative

Rates of adverse events from any opioid analgesics among U.S. inpatient stays

Number of U.S. hospital discharges with adverse events from any opioid analgesics

Number of U.S. hospital discharges in which opioid analgesics were administered

2016

10%

 Not currently

*The hospital-acquired condition rate is currently calculated using all U.S. hospital discharges as a denominator. This proposed measure would use U.S. hospital discharges with anticoagulant and diabetes agents exposure as the denominator for each respective measure.

Outpatient Settings

The outpatient will set baseline rates using data from 2014 and establish targets to be achieved by 2020.


Metric

Numerator

Denominator

Target Reduction

Departmental Measure Alignment

Rate of visits to U.S. hospital EDs for injury from oral anticoagulants

Number of visits to U.S. hospital EDs for injury from oral anticoagulants

Number of patients receiving dispensed oral anticoagulants in U.S. retail outpatient setting

10%

HHS Healthy People 2020 Medical Product Safety Objective 5.1*

Rate of visits to U.S. hospital EDs for injury from insulin

Number of visits to U.S. hospital EDs for injury from injectable insulin

Number of patients receiving dispensed diabetes agents in U.S. retail outpatient settings

10%

HHS Healthy People 2020 Medical Product Safety Objective 5.2**

Rate of visits to U.S. hospital EDs for injury associated with therapeutic use from opioid analgesics

Number of visits to U.S. hospital EDs for injury associated with therapeutic use from opioid analgesics

Number of patients receiving dispensed opioid analgesics in U.S. retail outpatient settings

10%

HHS Healthy People 2020 Medical Product Safety Objective 2.3***

*The HP2020 measure utilizes the number of U.S. outpatient department visits at which an oral anticoagulant was prescribed or continued as a denominator.
**The HP2020 measure utilizes the number of U.S. outpatient department visits at which insulin was prescribed or continued as a denominator.
***The HP2020 measure is currently archived.
NEISS-CADES = National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project.

Data

The six proposed measures will use data from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention and the US Food and Drug Administration.

The inpatient and outpatient measures for anticoagulants and diabetes agents and the outpatient measure for opioids will set baseline rates using data from 2014 and establish targets for 2020. The inpatient opioids measure will have a 2016 baseline and a 2020 target year.

The inpatient opioids measure will use data from AHRQ’s Quality Safety Review System (QSRS), which will begin collecting data in 2016, while the inpatient measures for anticoagulants and diabetes agents will use AHRQ’s Medicare Patient Monitoring System (MPSMS) for 2015 and QSRS for 2016- 2020 and data will be adjusted accordingly. MPSMS did not include an opioid-specific measure but QSRS now allows AHRQ to now track inpatient opioids adverse drug events.

Background

In September 2012, in response to heightened awareness of the contribution of ADEs to the burden of health care-related harm and costs, the Office of the Assistant Secretary for Health (OASH) created an interagency partnership, known as the Federal Interagency Steering Committee and Workgroups for Adverse Drug Events, which went on to develop the ADE Action Plan and identify these measures to track national progress in reducing ADEs and targets to meet based on those measures.

Implementation of these strategies is intended to result in safer and higher quality health care services, reduced health costs, informed and engaged consumers and, ultimately, improved health outcomes. The reduction of ADEs will be tracked by the proposed measures and will aim to meet the targeted reduction rate by 2020.

Interested persons or organizations are invited to submit written comments in response to the proposed measures and targets and should not exceed more than two pages per ADE measure.

Federal Register


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