The Federal Interagency Steering Committee for Adverse Drug Events approved six measures to assess progress on the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). The ADE Action Plan focuses on reducing the incidence of adverse drug events that are common, clinically significant, and measurable using existing surveillance systems — adverse events from anticoagulants, diabetes agents, and opioid analgesics. The measures are intended to be a means of broad, national-level tracking of population-based ADE harm as the Action Plan is being implemented, with ambitious but achievable targets set as goals for reduction. Tracking the progress of ADE prevention at the regional, local, and facility levels and for specific patient populations within federal health systems — such as the Indian Health Service, Department of Defense, and Veterans Health Administration — and non-federal health systems will continue to be critical in helping advance the goals of the ADE Action Plan.
The ADE reduction measures were chosen on the basis of the following considerations:
- They address ADEs in both inpatient and outpatient settings
- They are outcomes-based rather than process-based
- They are derived from surveillance systems that (a) are nationally-representative, (b) can provide baseline estimates from which to measure progress on prevention, and (c) use consistent and stable ADE measurement methodology for the foreseeable future
- They align ADE measurement with other departmental medication safety measures and goals (e.g., Partnership for Patients, Healthy People 2020)
The six measures use data from the Agency for Healthcare Quality and Research (AHRQ), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA).
Inpatient Settings
The ADE Action Plan 2020 targets for inpatient settings address the following measures from the ADE Action Plan:
- Reduce adverse drug events (unintended measurable harm or injury) from anticoagulants among U.S. inpatient stays
- Reduce adverse drug events (unintended measurable harm or injury) from diabetes agents among U.S. inpatient stays
- Reduce adverse drug events (unintended measurable harm or injury) from opioid analgesics among U.S. inpatient stays
The inpatient measures include baseline rates using data from 2014 and 2016 and establish targets to be achieved by 2020.
| Measure1 | Numerator | Denominator | Baseline Year | Target Reduction | Departmental Measure Alignment2 |
|---|---|---|---|---|---|
|
Rates of adverse events from anticoagulants among U.S. inpatient stays |
Number of U.S. hospital discharges with adverse events from 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 hypoglycemic 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 opioid analgesics among U.S. inpatient stays |
Number of U.S. hospital discharges with adverse events from opioid analgesics |
Number of U.S. hospital discharges in which opioid analgesics were administered |
2016 |
10% |
Not currently aligned |
1 Measures may be added or refined for adverse events from anticoagulants, diabetes agents, and opioid analgesics, and for additional medication classes in the future.
2 The hospital-acquired condition rate is currently calculated using all U.S. hospital discharges as a denominator. This measure would use U.S. hospital discharges with anticoagulant and diabetes agent exposure as the denominator for each respective measure.
Data Source(s)
Medicare Patient Safety Monitoring System (MPSMS) and Quality and Safety Review System (QSRS), ARHQ. Data from MPSMS and QSRS are based on a review of a random sample of approximately 20,000 to 30,000 medical records in patients hospitalized in the U.S. each year, using a structured protocol and software tool. Currently, the sample consists of all U.S. patients hospitalized (all-payor) with principal diagnosis of acute myocardial infarction or pneumonia, or who receive major surgery. In 2017, an expansion of the QSRS sample to all adult inpatients is planned, as is discontinuation of the MPSMS measures. For more information, please refer to: http://www.ahrq.gov/professionals/quality-patient-safety/pfp/index.html
Related Citation(s)
- Wang Y, et al. National trends in patient safety for four common conditions, 2005-2011. N Engl J Med 2014;370(4):341–351.
- Classen DC, et al. Adverse drug events among hospitalized Medicare patients: epidemiology and national estimates from a new approach to surveillance. Jt Comm J Qual Patient Saf 2010;36(1):12–21.
Outpatient Settings
The ADE Action Plan 2020 targets for outpatient settings address the following measures from the ADE Action Plan:
- Reduce U.S. emergency department visits for adverse drug events (unintended measurable harm or injury) from anticoagulants
- Reduce U.S. emergency department visits for adverse drug events (unintended measurable harm or injury) from diabetes agents
- Reduce U.S. emergency department visits for adverse drug events (unintended measurable harm or injury associated with therapeutic use) from opioid analgesics
The outpatient measures include baseline rates using data from 2014 and establish targets to be achieved by 2020.
| Measure1 | 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 settings |
10% |
HHS Healthy People 2020 Medical Product Safety Objective 5.12 |
|
Rate of visits to U.S. hospital EDs for injury from insulin |
Number of visits to U.S. hospital EDs for injury from insulin |
Number of patients receiving dispensed insulin in U.S. retail outpatient settings |
10% |
HHS Healthy People 2020 Medical Product Safety Objective 5.23 |
|
Rate of visits to U.S. hospital EDs for injury associated with therapeutic use of opioid analgesics |
Number of visits to U.S. hospital EDs for injury associated with therapeutic use of opioid analgesics |
Number of patients receiving dispensed opioid analgesics in U.S. retail outpatient settings |
10% |
HHS Healthy People 2020 Medical Product Safety Objective 2.34 |
1 Measures may be added or refined for adverse events from anticoagulants, diabetes agents, and opioid analgesics, and for additional medication classes in the future.
2 The HP2020 measure utilizes the number of U.S. outpatient department visits at which an oral anticoagulant was prescribed or continued as a denominator.
3 The HP2020 measure utilizes the number of U.S. outpatient department visits at which insulin was prescribed or continued as a denominator.
4 The HP2020 measure is currently archived.
Data Source(s)
Numerator: NEISS-CADES, CDC. Data from NEISS-CADES are based on a review of medical records from a nationally representative, stratified probability sample of U.S. hospitals (excluding psychiatric and penal institutions) that have a minimum of 6 beds and a 24-hour ED, using a structured medical record abstraction tool. For more information, please refer to: Jhung MA, et al. Evaluation and overview of the national electronic injury surveillance system-cooperative adverse drug event surveillance project (NEISS-CADES) [PDF - 427 KB]. Medical Care 2007;45 (10 Suppl 2):S96–S102.
Denominator: Total Patient Tracker®, IMS Health™ (secured through FDA). Total Patient Tracker (TPT) is a national-level projected audit designed to estimate the total number of unique patients across all drugs and therapeutic classes in the retail outpatient setting over time. TPT derives its data from the Vector One® database, which integrates prescription activity from a sample received from payers, switches, and other software systems that may arbitrage prescriptions at various points in the sales cycle. Vector One® receives over 2.1 billion prescription claims per year.
Related Citation(s)
- Budnitz DS, et al. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006;296(15):1858–1866.
- Shehab N, et al. National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin. Arch Int Med 2010;170(21):1926–1933.
- Geller AI, et al. National estimates of insulin-related hypoglycemia and errors leading to emergency department visits and hospitalizations. JAMA Intern Med 2014;174(5):678–686.
