588105
research-article2015
AJMXXX10.1177/1062860615588105American Journal of Medical QualityBaehr et al
Article
Adverse Drug Event Prevention: 2014 Action Plan Conference
American Journal of Medical Quality 1–10 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1062860615588105 ajmq.sagepub.com
Aaron R. Ducoffe, MD1, Avi Baehr, BA1,2*, Juliet C. Peña, MD, MPH1*, Briana B. Rider, PharmD1*, Sandra Yang, MPH1*, and Dale J. Hu, MD, MPH1
Abstract Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use. Keywords adverse drug events, anticoagulants, opioids, diabetes agents, quality Adverse drug events (ADEs) are among the largest contributors to health care–related harms and are a significant cause of morbidity and mortality for both outpatients and inpatients within the United States. An ADE is defined by the Institute of Medicine as “an injury resulting from medical intervention related to a drug,”1 and these events include but are not limited to medication errors, adverse drug reactions, allergic reactions, and overdoses. In outpatient settings, national surveillance data indicate that ADEs account for more than 3.5 million physician office visits2 and an estimated 1 million emergency department (ED) visits each year.3 In inpatient settings, ADEs account for an estimated one third of all hospital adverse events4 and affect nearly 2 million hospitalizations annually.5 Given the large and ever-increasing magnitude of medication exposure in the US population, ADEs represent a major patient safety and public health challenge. To reduce the patient harms from ADEs, the Office of Disease Prevention and Health Promotion (ODPHP), in conjunction with the Federal Interagency Steering Committee and Workgroups for ADEs, developed the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). The ADE Action Plan seeks to identify, coordinate, and communicate opportunities and gaps within public and private sectors in order to promote safe use of prescription medications and high-quality patient care.
The Steering Committee identified 3 drug classes as being associated with common, clinically significant, preventable, and measurable ADEs: anticoagulants, diabetes agents, and opioids. These 3 drug classes, all of which require careful monitoring, were implicated in one third of ADEs in a national inpatient sample of Medicare beneficiaries.4 To address each of the unique challenges that these medication classes present, the Steering Committee established 3 Federal Interagency Workgroups with representation from across federal agencies working in conjunction with subject matter experts. The workgroups focused on each of these drug classes and agreed to target their efforts to address 4 critical areas: surveillance, evidence-based prevention, incentives and oversights, and additional research needs. These 3 drug classes and 4 areas of focus helped define the framework of the ADE Action Plan. 1
US Department of Health and Human Services, Office of Disease Prevention and Health Promotion, Rockville, MD 2 Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA * All of these authors contributed equally to the manuscript’s production. Corresponding Author: Dale J. Hu, MD, MPH, Division of Health Care Quality, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Email: [email protected]
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
2
American Journal of Medical Quality
On October 30, 2014, ODPHP, on behalf of the Office of the Assistant Secretary for Health and the Department of Health and Human Services, held the ADE Prevention: 2014 Action Plan Conference in Washington, DC. This conference provided an opportunity for more than 200 inperson and webcast participants to (1) coordinate and collaborate in the initiative to reduce preventable ADEs and (2) discuss potential measures to track national progress in ADE prevention as highlighted in the ADE Action Plan.3 The conference drew participants from the private and public sectors and included academicians, health policy leaders, clinicians, and pharmacists. The ongoing momentum of ADE prevention, however, will require continued engagement and collaboration within and beyond the clinical quality improvement community.
Opening Remarks and Conference Agenda Don Wright, MD, MPH (Deputy Assistant Secretary for Health and Director of ODPHP); Wanda Jones, DrPH (Principal Deputy Assistant Secretary for Health); and Dale Hu, MD, MPH (Acting Director, Division of Health Care Quality, ODPHP; Captain [CAPT], US Public Health Service) welcomed conference participants and gave an overview of the ADE Action Plan. Morning plenary sessions provided an overview of the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of 3 drug classes. Afternoon breakout sessions allowed for facilitated dialogue among conference participants in order to discuss measures for tracking national progress in ADE prevention and to identify opportunities to ensure safe and high-quality care for patients who are prescribed the high-priority medications outlined in the ADE Action Plan.
Morning Plenary Session 1: Preventing Anticoagulant ADEs and Monitoring Progress Nadine Shehab, PharmD, MPH (Senior Service Fellow, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention) Dr Shehab provided an overview of the tremendous national burden of anticoagulant-related ADEs and presented strategies for population-based prevention of these events. She outlined the capabilities and challenges of existing anticoagulant-related ADE surveillance systems. For example, at the national level, administrative claims data can be useful for capturing bleeding events, but the accuracy of diagnostic coding (International Classification of Diseases, Ninth Revision [ICD-9]) for identifying these
events is not well-established. The impact of the transition to ICD-10 is unknown. Current systems developed for the monitoring and prevention of health care–associated infections, such as the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network, might serve as a good example for benchmarking progress and gaps in ADE prevention efforts. In addition to highlighting the need for improved surveillance systems, Dr Shehab outlined health policy strategies that might be effective in preventing anticoagulant-related ADEs. She recommended that 2 key areas be addressed: minimizing payment or coverage barriers to delivering evidence-based anticoagulant management and expanding nationally recognized health care quality measures to address safe use of anticoagulants. Dr Shehab noted that current nationally recognized health care quality measures generally focus on whether anticoagulants are being used, but do not include adequate metrics for whether anticoagulants are used safely. For example, the National Quality Forum (NQF) has endorsed a number of measures related to venous thromboembolism prophylaxis but far fewer that relate to bleeding risk mitigation. Dr Shehab concluded by summarizing that the surveillance of anticoagulant-related ADEs is currently conducted through a variety of national and local data sources (Table 1). For example, the Medicare Patient Safety Monitoring System (MPSMS) collects national data on inpatient bleeding events within selected patient populations via retrospective chart review, and a number of local process metrics support appropriate monitoring of patients on warfarin. Moving forward, the ADE Action Plan suggests that existing quality measures should be expanded to address (1) safe use of anticoagulants, (2) use of new oral anticoagulants, (3) high-risk populations and settings (eg, long-term care), and (4) clinical outcomes versus surrogate indicators. Anita Thomas, PharmD (Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services [CMS]) Dr Thomas provided additional background on strategies for the prevention of anticoagulant-related ADEs. The ADE Action Plan highlights improved communication, patient engagement, and care coordination as a key strategy for anticoagulant-related ADE prevention. Medication reconciliation and appropriate simplification of medication regimens are also areas for improvement. She further emphasized that although evidence-based practices are optimal, it is also critical to engage communities to identify local best practices. Dr Thomas then highlighted the role of the CMS Quality Improvement Organization (QIO) in decreasing ADEs. The QIO is an integral part of national quality
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
3
Baehr et al Table 1. Inventory of Potential Measures for Identifying Anticoagulant ADEs. Anticoagulant Outcome and Process Measures Scope Inpatient
Measure/Data Elements National
Agency
1. Incidence of bleeding events and coagulation abnormalities
AHRQ
2. Incidence of bleeding events and coagulation abnormalities in Federal Health System Populations
a. IHS
Local/facilitylevel
b. VA
3. Quality improvement process measures
Inpatient/ outpatient
4. Rates of clinician-diagnosed or patient-reported ADEs
5. Proposed Meaningful Use Measures (Stage 3)
a. DOD b. FDA c. VA ONC
Outpatient
National
6. Incidence of bleeding events and coagulation abnormalities
a. FDA b. CDC
c. AHRQ 7. Incidence of bleeding events and coagulation abnormalities in Federal Health System Populations
a. DOD b. VA c. IHS
Data System/Brief Description a. H CUP—Inpatient stays with ICD-9 codes and E-codes from administrative claims and/or EHR data b. MPSMS—Inpatient stays with coagulation laboratory abnormalities from medical record review a. Resource and Patient Management System (RPMS) EHR—Adverse Reaction Tracking (ART) System b. Integrated Databases—ADE identification by ICD-9 codes, primary hospitalizations, ED or clinic visits, and laboratory values Individual Facility Reports: a. TJC 2014 National Patient Safety Goal 03.05.01 element: Evaluate anticoagulation safety practices, take action to improve practices, and measure the effectiveness of those actions in a time frame determined by the organization b. N umber of VTE patients receiving unfractionated heparin with platelet count monitoring by nomogram or protocol (former NQF 0374) c. N umber of VTE patients discharged to home, home health, home hospice with written discharge instructions (former NQF 0375) Spontaneous Reports: a. Patient Safety Reporting System b. FAERS c. VA-ADERS a. Inpatient Electronic Anticoagulation Management Flowsheet b. C linical notification of INR testing with interacting anti-infective medication c. INR test performed 7 to 14 days following out-ofrange INR d. INR retesting evaluation (>30 days since last INR test) e. Last INR test (patients’ lists stratified by 30-day intervals) a. S entinel, Mini-Sentinel—ED visits, hospitalizations for ADEs from administrative claims/EHR b. NEISS-CADES—ED visits, emergent hospitalizations, diagnosed anticoagulant-related bleeding or coagulation abnormality from medical record review c. NEDS—ED visits, emergent hospitalizations, diagnosed anticoagulant-related bleeding or coagulation abnormality from administrative claims a. Pharmacovigilance Defense Application System— Outpatient clinic visits, ED visits, ICD-9/CPT codes b. Integrated Databases—ADE identification by ICD-9 codes, primary hospitalizations, ED or clinic visits, and laboratory values c. RPMS EHR (continued)
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
4
American Journal of Medical Quality
Table 1. (continued) Anticoagulant Outcome and Process Measures Scope
Measure/Data Elements Local/facilitylevel
8. Quality Improvement Process Measures
Agency CMS
Data System/Brief Description a. Average percentage of monthly intervals in which INR test not received (NQF 0555) b. Percentage of episodes of patient receiving concomitant antibiotic therapy with INR test performed (NQF 0556) c. A verage percentage of time patients have INR test results within therapeutic range (ie, TTR) (CMS EHR Incentive Program)
Abbreviations: ADE, adverse drug event; AHRQ, Agency for Healthcare Research and Quality; CDC, Centers for Disease Control and Prevention; CMS, Centers for Medicare & Medicaid Services; CPT, Current Procedural Terminology; DOD, US Department of Defense; E-codes, External Cause-of-Injury Codes; ED, emergency department; EHR, electronic health record; FAERS, FDA Adverse Event Reporting System; FDA, US Food and Drug Administration; HCUP, Healthcare Cost and Utilization Project; IHS, Indian Health Service; ICD, International Classification of Diseases; INR, international normalized ratio; MPSMS, Medicare Patient Safety Monitoring System; NEDS, National Electronic Disease Surveillance; NEISS-CADES, National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project; NQF, National Quality Forum; ONC, Office of the National Coordinator for Health Information Technology; TJC, The Joint Commission; TTR, time in therapeutic range; VA, US Department of Veterans Affairs; VA-ADERS, VA Adverse Drug Event Reporting System; VTE, venous thromboembolism.
strategies to improve care for individuals, improve health for populations, and reduce health care costs. Within the QIO, the Quality Innovation Network champions locallevel, results-oriented change while facilitating learning and action networks as well as providing technical assistance for ADE prevention. Scott Kaatz, DO, MSc, FACP (Chief Quality Officer, Hurly Medical Center, Michigan State University, College of Human Medicine) Dr Kaatz provided a clinical perspective on opportunities for improvement in anticoagulation use. He recognized that fiscal constraints can limit the ability of health care systems to implement inpatient anticoagulation services, and that the lack of reimbursement for outpatient anticoagulation clinics limits their widespread utilization. Dr Kaatz emphasized, however, that large integrated health care systems can successfully implement systems-based strategies to manage anticoagulation, as exemplified by the US Department of Veterans Affairs (VA). Resources for a systems-based approach to improving anticoagulation safety are readily available through the Anticoagulation Forum’s Anticoagulation Centers of Excellence, the National Certification Board for Anticoagulation Providers, and the Indian Health Service’s 3-day training program, among other training programs. Dr Kaatz concluded the anticoagulation session with an emphasis on the proposed incentives and oversight opportunities for preventing anticoagulant-related ADEs across health care settings. Within the inpatient environment, quality incentives robust enough to effect
change are needed. Moving forward, the outpatient side will require modifications in the reimbursement structure for anticoagulation clinic care. Furthermore, there must be a mechanism for anticoagulation clinics to manage extended care.
Afternoon Breakout Session Summary: Preventing Anticoagulant ADEs and Monitoring Progress Dan Budnitz, MD, MPH (Director, Medication Safety Program, Division of Healthcare Quality Promotion, CDC; Captain [CAPT], US Public Health Service) provided an overview of the key themes emerging in the anticoagulant-related ADE prevention breakout session where the potential measures for tracking national progress (Table 1) were discussed among conference participants. CAPT Budnitz noted that collecting information about ADEs through national measures is important to generate action on a national level, but comprehensive information on patient populations across health care settings probably cannot be based on a single system. Using administrative claims codes to measure anticoagulantrelated ADEs can be problematic and may require additional examination and validation. Similarly, facility measures useful for local quality improvement may require modifications in order to scale to the national level. CAPT Budnitz emphasized that in considering ways to improve anticoagulation management and reduce these ADEs, the benefits of well-managed anticoagulation should not be overlooked.
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
5
Baehr et al
Morning Plenary Session 2: Preventing Diabetes Agents ADEs and Monitoring Progress Leonard Pogach, MD, MPH, FACP (National Director of Medicine, Office of Specialty Care/Office of Patient Care Services, VA) Dr Pogach provided an overview of serious hypoglycemic events in outpatient settings and highlighted the contribution of hypoglycemia to the burden of ADEs. Insulin is the most common drug implicated in ADErelated ED visits,6 and insulin and oral diabetes agents are implicated in 25% of emergent hospitalizations for ADEs in older adults.7 Opportunities for advancing the prevention of hypoglycemia include safer care, patient and family engagement, effective communication and coordination of care, and science-driven prevention and treatment. Dr Pogach described the VA’s leadership role in preventing hypoglycemia and emphasized strategies such as individualized glycemic targets and shared decision making, as well as universal health literacy and health numeracy. Dr Pogach concluded his portion of the presentation with a discussion of health information technology including recommendations for more robust electronic health records (EHRs) that link pharmacy and laboratory data, include data elements that record comorbid conditions, and are able to create patient lists stratified by specific lab values and certain risk factors. Mary Andrawis, PharmD, MPH (Senior Advisor, Innovation Center, CMS) Dr Andrawis gave an overview of the impact of diabetes agents–related ADEs and then focused on the prevention of serious hypoglycemic events in inpatient settings. She noted that challenges to inpatient glycemic control include the lack of a standard definition for serious, severe, or clinically significant hypoglycemia; conflicting evidence regarding ideal glycemic targets; a lack of systematic identification of patients at risk for hypoglycemia; and barriers to multidisciplinary coordination. Dr Andrawis discussed 2 significant challenges that underscore the need to systematically identify inpatients at risk for hypoglycemia: (1) failure to adjust insulin/diabetes regimens in response to decreases in oral intake such as an unexpected interruption of tube feedings or other sources of nutrition and (2) failure to respond appropriately to an initial hypoglycemic event. To address these challenges and help prevent hypoglycemia in the inpatient setting, Dr Andrawis recommended adopting basal/bolus insulin protocols instead of sliding-scale insulin, instituting a nurse-driven protocol for hypoglycemia management, and coordinating
blood glucose administration.
testing
with
meals
and
insulin
Andrew I. Geller, MD (Medical Officer, Division of Healthcare Quality Promotion, CDC; Lieutenant Commander (LCDR), US Public Health Service) LCDR Geller highlighted key considerations in surveillance, such as selecting data sources and metrics for monitoring ADEs, and the relative importance of quantifying known ADEs rather than signal detection of rare or unrecognized ADEs. Accurate quantification requires active surveillance as opposed to relying on passive or voluntary reporting systems, and when possible, actual patient harms should be measured rather than surrogate markers. LCDR Geller focused on data sources that can be leveraged to monitor diabetes agents–related ADEs in both the inpatient and ambulatory settings. The discussion included an overview of sources such as the Agency for Healthcare Research and Quality’s MPSMS, which has been used to measure the percentage of patients administered hypoglycemic agents with an episode of hypoglycemia requiring intervention in the inpatient setting. For ambulatory patients, the National Health Interview Survey, a household survey that quantifies the number of Americans self-reporting a diabetes diagnosis and treatment with insulin or oral diabetes agents, can be leveraged to derive denominator data. LCDR Geller then reviewed several of the existing measure concepts for hypoglycemia (Table 2). For ambulatory patients, Healthy People 2020’s Medical Product Safety (MPS) topic area currently has an objective (MPS5.2) to reduce ED visits for overdoses from injectable antidiabetic agents. For hospitalized patients, NQF Endocrine Measure 2363 looks at the rate of severe hypoglycemic events following the administration of an antidiabetic agent. LCDR Geller’s discussion of data sources and metrics laid the groundwork for the afternoon breakout sessions.
Afternoon Breakout Session Summary: Preventing Diabetes Agents ADEs and Monitoring Progress Dr Pogach summarized key themes discussed in the diabetes agents–related ADE measures breakout session where the potential measures for tracking national progress in diabetes agents ADE prevention were discussed (Table 2). First, the breakout participants agreed that it was important to meet meaningful use criteria in order to improve and monitor patient care; however, it is essential to carefully consider unintended consequences of these
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
6
American Journal of Medical Quality
Table 2. Inventory of Potential Measures for Identifying Diabetes Agents ADEs. Diabetes Agents Outcome and Process Measures Scope Inpatient
National
Measure/Data Elements
Agency
Data System/Brief Description
1. Incidence of hypoglycemic events
AHRQ
2. Incidence of hypoglycemic events in Federal Health System Populations
a. IHS
a. HCUP—Inpatient stays with ICD-9 codes and E-codes from administrative claims and/ or EHR data b. MPSMS—Inpatient stays with combination of laboratory triggers and clinical triggers from medical record review a. Resource and Patient Management System (RPMS-EHR)—EHR entry in the Problem List of “hypoglycemia” b. Integrated Databases—ADE identification by ICD-9 codes, primary hospitalizations, ED or clinic visits, and laboratory values a. P roposed Meaningful Use Measure Concept Severe hypoglycemia (9% a. DOD
(continued)
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
7
Baehr et al Table 2. (continued) Diabetes Agents Outcome and Process Measures Scope
Measure/Data Elements
13. Rates of patients with HbA1c control
14. aPercentage of patients ≥65 years with diabetes, out-ofrange HbA1c, and chronic comorbidities
Agency
Data System/Brief Description
NCQA
a. HEDIS—Data from HMOs and PPOs. Control defined as HbA1c
research-article2015
AJMXXX10.1177/1062860615588105American Journal of Medical QualityBaehr et al
Article
Adverse Drug Event Prevention: 2014 Action Plan Conference
American Journal of Medical Quality 1–10 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1062860615588105 ajmq.sagepub.com
Aaron R. Ducoffe, MD1, Avi Baehr, BA1,2*, Juliet C. Peña, MD, MPH1*, Briana B. Rider, PharmD1*, Sandra Yang, MPH1*, and Dale J. Hu, MD, MPH1
Abstract Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use. Keywords adverse drug events, anticoagulants, opioids, diabetes agents, quality Adverse drug events (ADEs) are among the largest contributors to health care–related harms and are a significant cause of morbidity and mortality for both outpatients and inpatients within the United States. An ADE is defined by the Institute of Medicine as “an injury resulting from medical intervention related to a drug,”1 and these events include but are not limited to medication errors, adverse drug reactions, allergic reactions, and overdoses. In outpatient settings, national surveillance data indicate that ADEs account for more than 3.5 million physician office visits2 and an estimated 1 million emergency department (ED) visits each year.3 In inpatient settings, ADEs account for an estimated one third of all hospital adverse events4 and affect nearly 2 million hospitalizations annually.5 Given the large and ever-increasing magnitude of medication exposure in the US population, ADEs represent a major patient safety and public health challenge. To reduce the patient harms from ADEs, the Office of Disease Prevention and Health Promotion (ODPHP), in conjunction with the Federal Interagency Steering Committee and Workgroups for ADEs, developed the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). The ADE Action Plan seeks to identify, coordinate, and communicate opportunities and gaps within public and private sectors in order to promote safe use of prescription medications and high-quality patient care.
The Steering Committee identified 3 drug classes as being associated with common, clinically significant, preventable, and measurable ADEs: anticoagulants, diabetes agents, and opioids. These 3 drug classes, all of which require careful monitoring, were implicated in one third of ADEs in a national inpatient sample of Medicare beneficiaries.4 To address each of the unique challenges that these medication classes present, the Steering Committee established 3 Federal Interagency Workgroups with representation from across federal agencies working in conjunction with subject matter experts. The workgroups focused on each of these drug classes and agreed to target their efforts to address 4 critical areas: surveillance, evidence-based prevention, incentives and oversights, and additional research needs. These 3 drug classes and 4 areas of focus helped define the framework of the ADE Action Plan. 1
US Department of Health and Human Services, Office of Disease Prevention and Health Promotion, Rockville, MD 2 Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA * All of these authors contributed equally to the manuscript’s production. Corresponding Author: Dale J. Hu, MD, MPH, Division of Health Care Quality, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Email: [email protected]
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
2
American Journal of Medical Quality
On October 30, 2014, ODPHP, on behalf of the Office of the Assistant Secretary for Health and the Department of Health and Human Services, held the ADE Prevention: 2014 Action Plan Conference in Washington, DC. This conference provided an opportunity for more than 200 inperson and webcast participants to (1) coordinate and collaborate in the initiative to reduce preventable ADEs and (2) discuss potential measures to track national progress in ADE prevention as highlighted in the ADE Action Plan.3 The conference drew participants from the private and public sectors and included academicians, health policy leaders, clinicians, and pharmacists. The ongoing momentum of ADE prevention, however, will require continued engagement and collaboration within and beyond the clinical quality improvement community.
Opening Remarks and Conference Agenda Don Wright, MD, MPH (Deputy Assistant Secretary for Health and Director of ODPHP); Wanda Jones, DrPH (Principal Deputy Assistant Secretary for Health); and Dale Hu, MD, MPH (Acting Director, Division of Health Care Quality, ODPHP; Captain [CAPT], US Public Health Service) welcomed conference participants and gave an overview of the ADE Action Plan. Morning plenary sessions provided an overview of the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of 3 drug classes. Afternoon breakout sessions allowed for facilitated dialogue among conference participants in order to discuss measures for tracking national progress in ADE prevention and to identify opportunities to ensure safe and high-quality care for patients who are prescribed the high-priority medications outlined in the ADE Action Plan.
Morning Plenary Session 1: Preventing Anticoagulant ADEs and Monitoring Progress Nadine Shehab, PharmD, MPH (Senior Service Fellow, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention) Dr Shehab provided an overview of the tremendous national burden of anticoagulant-related ADEs and presented strategies for population-based prevention of these events. She outlined the capabilities and challenges of existing anticoagulant-related ADE surveillance systems. For example, at the national level, administrative claims data can be useful for capturing bleeding events, but the accuracy of diagnostic coding (International Classification of Diseases, Ninth Revision [ICD-9]) for identifying these
events is not well-established. The impact of the transition to ICD-10 is unknown. Current systems developed for the monitoring and prevention of health care–associated infections, such as the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network, might serve as a good example for benchmarking progress and gaps in ADE prevention efforts. In addition to highlighting the need for improved surveillance systems, Dr Shehab outlined health policy strategies that might be effective in preventing anticoagulant-related ADEs. She recommended that 2 key areas be addressed: minimizing payment or coverage barriers to delivering evidence-based anticoagulant management and expanding nationally recognized health care quality measures to address safe use of anticoagulants. Dr Shehab noted that current nationally recognized health care quality measures generally focus on whether anticoagulants are being used, but do not include adequate metrics for whether anticoagulants are used safely. For example, the National Quality Forum (NQF) has endorsed a number of measures related to venous thromboembolism prophylaxis but far fewer that relate to bleeding risk mitigation. Dr Shehab concluded by summarizing that the surveillance of anticoagulant-related ADEs is currently conducted through a variety of national and local data sources (Table 1). For example, the Medicare Patient Safety Monitoring System (MPSMS) collects national data on inpatient bleeding events within selected patient populations via retrospective chart review, and a number of local process metrics support appropriate monitoring of patients on warfarin. Moving forward, the ADE Action Plan suggests that existing quality measures should be expanded to address (1) safe use of anticoagulants, (2) use of new oral anticoagulants, (3) high-risk populations and settings (eg, long-term care), and (4) clinical outcomes versus surrogate indicators. Anita Thomas, PharmD (Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services [CMS]) Dr Thomas provided additional background on strategies for the prevention of anticoagulant-related ADEs. The ADE Action Plan highlights improved communication, patient engagement, and care coordination as a key strategy for anticoagulant-related ADE prevention. Medication reconciliation and appropriate simplification of medication regimens are also areas for improvement. She further emphasized that although evidence-based practices are optimal, it is also critical to engage communities to identify local best practices. Dr Thomas then highlighted the role of the CMS Quality Improvement Organization (QIO) in decreasing ADEs. The QIO is an integral part of national quality
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
3
Baehr et al Table 1. Inventory of Potential Measures for Identifying Anticoagulant ADEs. Anticoagulant Outcome and Process Measures Scope Inpatient
Measure/Data Elements National
Agency
1. Incidence of bleeding events and coagulation abnormalities
AHRQ
2. Incidence of bleeding events and coagulation abnormalities in Federal Health System Populations
a. IHS
Local/facilitylevel
b. VA
3. Quality improvement process measures
Inpatient/ outpatient
4. Rates of clinician-diagnosed or patient-reported ADEs
5. Proposed Meaningful Use Measures (Stage 3)
a. DOD b. FDA c. VA ONC
Outpatient
National
6. Incidence of bleeding events and coagulation abnormalities
a. FDA b. CDC
c. AHRQ 7. Incidence of bleeding events and coagulation abnormalities in Federal Health System Populations
a. DOD b. VA c. IHS
Data System/Brief Description a. H CUP—Inpatient stays with ICD-9 codes and E-codes from administrative claims and/or EHR data b. MPSMS—Inpatient stays with coagulation laboratory abnormalities from medical record review a. Resource and Patient Management System (RPMS) EHR—Adverse Reaction Tracking (ART) System b. Integrated Databases—ADE identification by ICD-9 codes, primary hospitalizations, ED or clinic visits, and laboratory values Individual Facility Reports: a. TJC 2014 National Patient Safety Goal 03.05.01 element: Evaluate anticoagulation safety practices, take action to improve practices, and measure the effectiveness of those actions in a time frame determined by the organization b. N umber of VTE patients receiving unfractionated heparin with platelet count monitoring by nomogram or protocol (former NQF 0374) c. N umber of VTE patients discharged to home, home health, home hospice with written discharge instructions (former NQF 0375) Spontaneous Reports: a. Patient Safety Reporting System b. FAERS c. VA-ADERS a. Inpatient Electronic Anticoagulation Management Flowsheet b. C linical notification of INR testing with interacting anti-infective medication c. INR test performed 7 to 14 days following out-ofrange INR d. INR retesting evaluation (>30 days since last INR test) e. Last INR test (patients’ lists stratified by 30-day intervals) a. S entinel, Mini-Sentinel—ED visits, hospitalizations for ADEs from administrative claims/EHR b. NEISS-CADES—ED visits, emergent hospitalizations, diagnosed anticoagulant-related bleeding or coagulation abnormality from medical record review c. NEDS—ED visits, emergent hospitalizations, diagnosed anticoagulant-related bleeding or coagulation abnormality from administrative claims a. Pharmacovigilance Defense Application System— Outpatient clinic visits, ED visits, ICD-9/CPT codes b. Integrated Databases—ADE identification by ICD-9 codes, primary hospitalizations, ED or clinic visits, and laboratory values c. RPMS EHR (continued)
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
4
American Journal of Medical Quality
Table 1. (continued) Anticoagulant Outcome and Process Measures Scope
Measure/Data Elements Local/facilitylevel
8. Quality Improvement Process Measures
Agency CMS
Data System/Brief Description a. Average percentage of monthly intervals in which INR test not received (NQF 0555) b. Percentage of episodes of patient receiving concomitant antibiotic therapy with INR test performed (NQF 0556) c. A verage percentage of time patients have INR test results within therapeutic range (ie, TTR) (CMS EHR Incentive Program)
Abbreviations: ADE, adverse drug event; AHRQ, Agency for Healthcare Research and Quality; CDC, Centers for Disease Control and Prevention; CMS, Centers for Medicare & Medicaid Services; CPT, Current Procedural Terminology; DOD, US Department of Defense; E-codes, External Cause-of-Injury Codes; ED, emergency department; EHR, electronic health record; FAERS, FDA Adverse Event Reporting System; FDA, US Food and Drug Administration; HCUP, Healthcare Cost and Utilization Project; IHS, Indian Health Service; ICD, International Classification of Diseases; INR, international normalized ratio; MPSMS, Medicare Patient Safety Monitoring System; NEDS, National Electronic Disease Surveillance; NEISS-CADES, National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project; NQF, National Quality Forum; ONC, Office of the National Coordinator for Health Information Technology; TJC, The Joint Commission; TTR, time in therapeutic range; VA, US Department of Veterans Affairs; VA-ADERS, VA Adverse Drug Event Reporting System; VTE, venous thromboembolism.
strategies to improve care for individuals, improve health for populations, and reduce health care costs. Within the QIO, the Quality Innovation Network champions locallevel, results-oriented change while facilitating learning and action networks as well as providing technical assistance for ADE prevention. Scott Kaatz, DO, MSc, FACP (Chief Quality Officer, Hurly Medical Center, Michigan State University, College of Human Medicine) Dr Kaatz provided a clinical perspective on opportunities for improvement in anticoagulation use. He recognized that fiscal constraints can limit the ability of health care systems to implement inpatient anticoagulation services, and that the lack of reimbursement for outpatient anticoagulation clinics limits their widespread utilization. Dr Kaatz emphasized, however, that large integrated health care systems can successfully implement systems-based strategies to manage anticoagulation, as exemplified by the US Department of Veterans Affairs (VA). Resources for a systems-based approach to improving anticoagulation safety are readily available through the Anticoagulation Forum’s Anticoagulation Centers of Excellence, the National Certification Board for Anticoagulation Providers, and the Indian Health Service’s 3-day training program, among other training programs. Dr Kaatz concluded the anticoagulation session with an emphasis on the proposed incentives and oversight opportunities for preventing anticoagulant-related ADEs across health care settings. Within the inpatient environment, quality incentives robust enough to effect
change are needed. Moving forward, the outpatient side will require modifications in the reimbursement structure for anticoagulation clinic care. Furthermore, there must be a mechanism for anticoagulation clinics to manage extended care.
Afternoon Breakout Session Summary: Preventing Anticoagulant ADEs and Monitoring Progress Dan Budnitz, MD, MPH (Director, Medication Safety Program, Division of Healthcare Quality Promotion, CDC; Captain [CAPT], US Public Health Service) provided an overview of the key themes emerging in the anticoagulant-related ADE prevention breakout session where the potential measures for tracking national progress (Table 1) were discussed among conference participants. CAPT Budnitz noted that collecting information about ADEs through national measures is important to generate action on a national level, but comprehensive information on patient populations across health care settings probably cannot be based on a single system. Using administrative claims codes to measure anticoagulantrelated ADEs can be problematic and may require additional examination and validation. Similarly, facility measures useful for local quality improvement may require modifications in order to scale to the national level. CAPT Budnitz emphasized that in considering ways to improve anticoagulation management and reduce these ADEs, the benefits of well-managed anticoagulation should not be overlooked.
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
5
Baehr et al
Morning Plenary Session 2: Preventing Diabetes Agents ADEs and Monitoring Progress Leonard Pogach, MD, MPH, FACP (National Director of Medicine, Office of Specialty Care/Office of Patient Care Services, VA) Dr Pogach provided an overview of serious hypoglycemic events in outpatient settings and highlighted the contribution of hypoglycemia to the burden of ADEs. Insulin is the most common drug implicated in ADErelated ED visits,6 and insulin and oral diabetes agents are implicated in 25% of emergent hospitalizations for ADEs in older adults.7 Opportunities for advancing the prevention of hypoglycemia include safer care, patient and family engagement, effective communication and coordination of care, and science-driven prevention and treatment. Dr Pogach described the VA’s leadership role in preventing hypoglycemia and emphasized strategies such as individualized glycemic targets and shared decision making, as well as universal health literacy and health numeracy. Dr Pogach concluded his portion of the presentation with a discussion of health information technology including recommendations for more robust electronic health records (EHRs) that link pharmacy and laboratory data, include data elements that record comorbid conditions, and are able to create patient lists stratified by specific lab values and certain risk factors. Mary Andrawis, PharmD, MPH (Senior Advisor, Innovation Center, CMS) Dr Andrawis gave an overview of the impact of diabetes agents–related ADEs and then focused on the prevention of serious hypoglycemic events in inpatient settings. She noted that challenges to inpatient glycemic control include the lack of a standard definition for serious, severe, or clinically significant hypoglycemia; conflicting evidence regarding ideal glycemic targets; a lack of systematic identification of patients at risk for hypoglycemia; and barriers to multidisciplinary coordination. Dr Andrawis discussed 2 significant challenges that underscore the need to systematically identify inpatients at risk for hypoglycemia: (1) failure to adjust insulin/diabetes regimens in response to decreases in oral intake such as an unexpected interruption of tube feedings or other sources of nutrition and (2) failure to respond appropriately to an initial hypoglycemic event. To address these challenges and help prevent hypoglycemia in the inpatient setting, Dr Andrawis recommended adopting basal/bolus insulin protocols instead of sliding-scale insulin, instituting a nurse-driven protocol for hypoglycemia management, and coordinating
blood glucose administration.
testing
with
meals
and
insulin
Andrew I. Geller, MD (Medical Officer, Division of Healthcare Quality Promotion, CDC; Lieutenant Commander (LCDR), US Public Health Service) LCDR Geller highlighted key considerations in surveillance, such as selecting data sources and metrics for monitoring ADEs, and the relative importance of quantifying known ADEs rather than signal detection of rare or unrecognized ADEs. Accurate quantification requires active surveillance as opposed to relying on passive or voluntary reporting systems, and when possible, actual patient harms should be measured rather than surrogate markers. LCDR Geller focused on data sources that can be leveraged to monitor diabetes agents–related ADEs in both the inpatient and ambulatory settings. The discussion included an overview of sources such as the Agency for Healthcare Research and Quality’s MPSMS, which has been used to measure the percentage of patients administered hypoglycemic agents with an episode of hypoglycemia requiring intervention in the inpatient setting. For ambulatory patients, the National Health Interview Survey, a household survey that quantifies the number of Americans self-reporting a diabetes diagnosis and treatment with insulin or oral diabetes agents, can be leveraged to derive denominator data. LCDR Geller then reviewed several of the existing measure concepts for hypoglycemia (Table 2). For ambulatory patients, Healthy People 2020’s Medical Product Safety (MPS) topic area currently has an objective (MPS5.2) to reduce ED visits for overdoses from injectable antidiabetic agents. For hospitalized patients, NQF Endocrine Measure 2363 looks at the rate of severe hypoglycemic events following the administration of an antidiabetic agent. LCDR Geller’s discussion of data sources and metrics laid the groundwork for the afternoon breakout sessions.
Afternoon Breakout Session Summary: Preventing Diabetes Agents ADEs and Monitoring Progress Dr Pogach summarized key themes discussed in the diabetes agents–related ADE measures breakout session where the potential measures for tracking national progress in diabetes agents ADE prevention were discussed (Table 2). First, the breakout participants agreed that it was important to meet meaningful use criteria in order to improve and monitor patient care; however, it is essential to carefully consider unintended consequences of these
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
6
American Journal of Medical Quality
Table 2. Inventory of Potential Measures for Identifying Diabetes Agents ADEs. Diabetes Agents Outcome and Process Measures Scope Inpatient
National
Measure/Data Elements
Agency
Data System/Brief Description
1. Incidence of hypoglycemic events
AHRQ
2. Incidence of hypoglycemic events in Federal Health System Populations
a. IHS
a. HCUP—Inpatient stays with ICD-9 codes and E-codes from administrative claims and/ or EHR data b. MPSMS—Inpatient stays with combination of laboratory triggers and clinical triggers from medical record review a. Resource and Patient Management System (RPMS-EHR)—EHR entry in the Problem List of “hypoglycemia” b. Integrated Databases—ADE identification by ICD-9 codes, primary hospitalizations, ED or clinic visits, and laboratory values a. P roposed Meaningful Use Measure Concept Severe hypoglycemia (9% a. DOD
(continued)
Downloaded from ajm.sagepub.com at University of Manitoba Libraries on June 12, 2015
7
Baehr et al Table 2. (continued) Diabetes Agents Outcome and Process Measures Scope
Measure/Data Elements
13. Rates of patients with HbA1c control
14. aPercentage of patients ≥65 years with diabetes, out-ofrange HbA1c, and chronic comorbidities
Agency
Data System/Brief Description
NCQA
a. HEDIS—Data from HMOs and PPOs. Control defined as HbA1c
