federal interagency workgroups for adverse drug events
DESCRIPTION
Federal Interagency Workgroups for Adverse Drug Events. Federal Interagency Workgroups for Adverse Drug Events: A Path Toward a National Action Plan for Prevention. Presentation to the ONC Health IT Policy Committee Quality Measures Workgroup Monday, June 3 rd , 2013. - PowerPoint PPT PresentationTRANSCRIPT
Federal Interagency Workgroups for Adverse Drug Events
Presentation to the ONC Health IT Policy Committee Quality Measures WorkgroupMonday, June 3rd, 2013
U.S. Dept of Health & Human Services (HHS) http://www.hhs.gov/ Office of the Assistant Secretary for Health http://www.hhs.gov/ash/Office of Disease Prevention and Health Promotion http://odphp.osophs.dhhs.gov/
Federal Interagency Workgroups for Adverse Drug Events: A Path Toward a National Action Plan for Prevention
Participating Federal Partners Office of the Assistant Secretary for Health
Administration on AgingAgency for Healthcare Research and
QualityAssistant Secretary for Planning and
EvaluationBureau of Prisons
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid ServicesDepartment of Defense
Food and Drug AdministrationHealth Resources and Services
AdministrationIndian Health Service
National Institutes of HealthOffice of Disease Prevention and Health
PromotionOffice of the National Coordinator for
Health ITVeterans Health Administration
Participating Federal Partners
A D E s – O p p o rtu n ity fo r Imp a c t
ADEs – Opportunity for Impact
Yael Harris, PhD, MHAOffice of Disease Prevention and Health Promotion
ADEs
Harms to patients that occur during medical care
Patient safety and public health challenge owing to associated morbidity, costs, and preventability
Largely unaddressed in coordinated, aligned, and targeted fashion across federal agencies
Adverse Drug Events (ADEs)
ADEsADEs – Opportunity for Impact
INSIDEthe
hospital
Most common causes of inpatient complications prolong length-of-stay and increase costs
−Affect ~1.9 million hospital stays annually
−Add 1.7 to 4.6 hospital days
−Cost $4.2 billion USD annually
Classen DC et al. Health Aff (Millwood) 2011;30:581–9.Agency for Healthcare Research and Quality, Rockville, MD, 2011 April. HCUP Statistical Brief #109.Classen DC et al. JAMA 997;277:301–6. Bates DW et al. JAMA 1997;277:307–11.
~63% of ADEs:1. Excessive bleeding
(anticoagulants)2. Delirium or change in
mental status (opioids, benzodiazepines)
3. Hypoglycemic event (insulin, oral hypoglycemics)
~50% of ADEs judged to be preventable
ADEs as Causes of Inpatient Complications
HHS Office of Inspector General (OIG). Washington, D.C., 2010 November. Report No.: OEI-06-09-00090.
ADEs as Causes of Outpatient Complications
ADEs responsible for ~100,000 emergent hospitalizations in older Americans, annually
− ~ Two-thirds resulting from just four medication classes (anticoagulants, insulin, oral hypoglycemics, antiplatelets)
− ~ Two-thirds resulting from unintentional overdoses (or supratherapeutic effects)Budnitz DS et al. N Engl J Med 2011;365:2002–12.
ADEs as Causes of Outpatient Complications
ADEs as Result of Care Transitions
ADEs as Result of Care Transitions
FromINSIDE
toOUTSIDE
the hospital
Most common causes of post-discharge complications
−Comprise ~two-thirds of post-discharge complications*
−Comprise ~one-half of preventable post-discharge complications
Forster AJ et al. Ann Intern Med 2003;138:161–7.*Within 3 weeks of hospital discharge.
ADEs
Important contributors to outpatient complications
ADEs – Opportunity for Impact
OUTSIDEthe
hospitalHospital
Admissions
EmergencyDept Visits
Physician Office Visits
~1 million
~125,000
~ 3.5 million
Bourgeois FT et al. Pharmacoepidemiol Drug Saf 2010;19:901–10.CDC, unpublished data. Update to Budnitz DS et al. JAMA 2006;296:1858–66.
Annually
FIW for ADEs
Federal Interagency Workgroups (FIW) for
ADEsYael Harris, PhD, MHA
Office of Disease Prevention and Health Promotion
The Charge
Initiate discussions that identify coordinated approaches to ADEs
Surveillance and measurement Evidence based prevention Incentives and Oversight Research Needs
Focus on drug classes associated with ~two-thirds of ADEs
Incorporate approaches into National Action Plan for ADE Prevention
The Charge
Organization
Workgroup 1ANTICOAGULANTS
Evidence-Based
Prevention Tools
Surveillance
Incentives & Oversight
Research (Unanswered Questions)
Workgroup 2DIABETES AGENTS
Evidence-Based
Prevention Tools
Surveillance
Incentives & Oversight
Research (Unanswered Questions)
Workgroup 3OPIOIDS
Evidence-Based
Prevention Tools
Surveillance
Incentives & Oversight
Research (Unanswered Questions)
Federal Interagency Steering Committee for Adverse Drug Events
Health IT
Health IT
Health IT
Health IT
Health IT
Health IT
Health IT
Health IT
Health IT
Health IT
Health IT
Health IT
Organization
Stage 2 MU
MU Meaningful UseVTE Venous thromboembolism
Core Measures
Use computerized provider order entry (CPOE) for medication orders (EP Core 1)
Medication reconciliation (EP Core 14)Clinical Quality Measures
Use of high-risk medications in the elderly
Documentation of current medications in the medical record
Warfarin Time in Therapeutic Range (TTR)
VTE patients receiving unfractionated heparin with dosages/platelet count monitoring by protocol (or nomogram)
VTE patients receiving warfarin discharge instructions
Currently, very few MU requirements targeted at ADEs
Office of the National Coordinator (ONC)Electronic Health Record (EHR)
Meaningful Use (MU) Stage 3 Requirements
FIW Recommendations for Incorporation of Adverse Drug Event Considerations into
EHR MU Stage 3 RequirementsCapture Key Data Elements within EHRRetool Stage 2 Quality Measures to Detect/Prevent ADEsInclude New ADE-related Quality MeasuresUtilize CDS for ADE Detection or Prevention
FIW for ADEs – Anticoagulants
FIW for ADEs – Anticoagulants
Nadine Shehab, PharmD, MPHCenters for Disease Control and Prevention
Anticoagulation Safety EHR Recommendations:
Eligible Providers
Patient Lists • Patient lists stratified by INR testing interval (30 days, 60 days, 90 days, 90+)
Quality Measure Concepts
• Percent of patients on anticoagulants with INR test 7 -14 days following out-of-range INR
Clinical Decision Support (CDS)
• If no INR test in past 30 days, recommend evaluation for INR re-testing• Notification when individual on warfarin prescribed new anti-infective medication
Patient List
Name of List Last INR test
Population Patients age >18 years
Medication Chronic warfarin therapy (> 180 days)
Laboratory Test Results
Has not received an INR test within past:• 30 days• 60 days• 90 days• >90 days
Justification: Allows providers to re-evaluate need for follow-up INR test based on individual patient’s needs (e.g., concomitant medications, co-morbidities, dose, diet)
List of patients on warfarin stratified by time since last INR test
Anticoagulation Safety Current National Measures
NQF-endorsed measures:– NQF 0555: Lack of monthly INR monitoring– NQF 0556: INR test 3-7 days after new anti-
infective medication
2012 ACCP (Chest) Guidelines:– For patients taking VKA therapy with
consistently stable INRs…[recommend] INR testing frequency of up to 12 weeks
– For patients taking VKAs…avoid concomitant treatment with…certain antibiotics
National Quality Forum. NQF Endorsed Patient Safety Measures. Available at: www.qualityforum.org/topics/overview_of_safety_measures.aspx. Holbrook A et al. Chest 2012;141:e152S-e84S.
Measure Percent of patients on anticoagulants with INR test 7 to 14 days following out-of-range INR
NumeratorAll patients who had an INR test 7 to 14 days after presenting with a single out-of-range INR below or above therapeutic during the measurement period
Denominator
Number of patients, aged 18+, with nonvalvular atrial fibrillation, on chronic warfarin therapy for at least 180 days before the start
and during the measurement period, with previously stable therapeutic INRs,
presenting with a single out-of-range INR below or above therapeutic during the measurement period
Holbrook A et al. Chest 2012;141:e152S-e84S.Rose AJ et al. Circ Cardiovasc Qual Outcomes 2011;4:276-82.Schulman S et al. Thromb Res 2010;125:393-7.
Quality Measure Concept
Justification: Anticoagulation control, as measured by Time in Therapeutic Range (TTR), is improved by prompt, repeat testing after out-of-range INR values
Clinical Decision Support # 1
Rule Title No INR in Past 30 Days
Population On chronic warfarin therapy (> 180 days)Triggering Condition > 30 days since last INR testDetails for Triggering Previous INR tests
Clinical reminder to assess need for INR test Indications:
―Patients currently on warfarin therapyAND
― > 30 days since last INR test
Displayed message
Patient has not received INR test within the past 30 days. Assess patient need for INR re-testing (e.g., in presence of recent change in concomitant medications, co-morbidities, dose, or diet). Longer testing frequencies can be considered for patients with consistently stable INRs (e.g., at least 3 months of consistent results with no need to adjust warfarin dosing).
Data elements from previous 3 to 6 months should be automatically displayed for the provider (e.g., as in the table above).
Indicate the following actions were taken:
Patient re-evaluated for timing of INR re-test
Schedule INR re-test for: Insert MM/DD/YY here
Other (please describe): _____________________
INR Result Date (MM/DD/YY)Date Date Date Date
INR goalINRTotal weekly dose
Proposed CDS Display
Rule Title New Interacting Anti-Infective Medication
Population Patients on chronic warfarin therapy (>180 days)
Triggering Condition Newly initiated treatment with anti-infective medication
Details for Triggering Newly started interacting anti-infective medication
Notification when patient on warfarin prescribed new interacting anti-infective medication
Indications:―Patients currently on warfarin therapy
AND―Initiated treatment with new anti-infective medication
Clinical Decision Support # 2
Displayed message
Patient is currently receiving warfarin therapy and has started a course of an interacting anti-infective medication. Longer testing frequencies can be considered for patients with consistently stable INRs (e.g., at least 3 months of consistent results with no need to adjust warfarin dosing).
Data elements should be displayed for provider (e.g., as in tables above)
Select action(s) to take (may select more than one option):
Instruct patient to hold warfarin dose: Indicate patient instructions here.
Change anti-infective medication to: Indicate alternative anti-infective agent here
Notify anticoagulant provider.
Schedule INR re-test for: Insert MM/DD/YY here
Anti-infective medicationDate of anti-infective treatment initiationDuration of anti-infective treatment courseLast INR resultDate of last INR result
Proposed CDS Display
EHR Functionality/ Usability
Electronic anticoagulation management flowsheet • Lab results (e.g., INR, PTT, anti-factor Xa,
Hgb, Hct, SCr) linked to• Pharmacy data (agents, doses)
Key elements: - linked lab-pharmacy data in single view- real-time
Justification: complexity, acuity of hospitalized patients require informed, individualized decision-making by providers on rapidly-changing clinical and laboratory parameters
Anticoagulation Safety EHR Recommendations:
Eligible Hospitals
Example Inpatient Anticoagulant Flowsheet
EHR Requirements: Current Gaps in Anticoagulation
Safety Newer oral anticoagulants (e.g.,
dabigatran, rivaroxaban)− Dosing, adherence, and transition
from warfarin
Parenterally-administered anticoagulants (esp. hospital uses)− Pertinent laboratory monitoring
parameters
Outcomes-based metrics− Bleeding events
Transitions of care-related metrics− Communication and hand-off
Evolving and early science
Lack of consensus, uniformity across sites
Limitations in diagnostic coding
Complex process metric
Q & A
FIW for ADEs – Diabetes Agents
FIW for ADEs – Diabetes Agents
Leonard Pogach, MD, MBA, FACPDepartment of Veterans Affairs
Cindy Brach, MPPAgency for Healthcare Research and Quality
Mary Andrawis, PharmD, MPHCenters for Medicare and Medicaid Services
Diabetes AgentsEHR Recommendations:
Eligible Providers
Patient Lists • Stratify patients by specific lab values and certain risk factors
Clinical Decision Support (CDS)
• Addressing potential risk for hypoglycemia• Shared Decision Making• Action Plan for prevention of hypoglycemia
Data Elements • Record co-morbid conditions
Quality Measure Concepts • Overtreatment measure
Data Elements & Patient ListsExisting Data Elements New Data Elements to CaptureCognitive impairment / dementia Prior hypoglycemic reactionsAdvanced microvascular diabetes complicationsLimited life expectancyCurrent substance useRecent discharge from inpatient setting
Generate lists of diabetic patients with A1c level and key risk factorsFor all patients with diabetes, patient panels should be generated with the following information
• Most recent A1c value• Age• Cognitive impairment• Advanced microvascular diabetes complications
• Cardiovascular complications • Limited life expectancy• Alcohol or substance abuse• Recent discharge• Prior hypoglycemic reactions
Examples as used by VA
MeasurePercent of patients on sulfonylurea / insulin therapy with out-of-range A1c (overtreatment measure)
Numerator
# of patients with A1c:• <6• <6.5• <7 (primary outcome)
Denominator
Patients on sulfonylurea or insulin therapy with chronic co-morbid conditions and / or age >65 years
Exclusions Younger (<65 years old) patients not on hypoglycemic agents without specified co-morbid conditions
Quality Measure Concept
Clinical Decision Support # 1
Rule Title Identification of patients at risk for hypoglycemia
Objective Identify patients at high risk for hypoglycemia and outline recommended action steps
Risk Group Persons with diabetesTriggering Condition
Risk factors that place a person with diabetes at risk for hypoglycemic events
Proposed CDS Display
Proposed CDS Display
Clinical Decision Support # 2
Rule TitleShared Decision Making between physician and patient on target A1c values
ObjectiveUse CDS to improve performance in persons with diabetes (a high-priority health condition)
Risk Group Persons with diabetes
Triggering Condition
When A1c value is reported to the physician’s office
Proposed CDS Display
VISN 12 ExperienceDepartment of Veterans Affair
Shared-Decision Making and Hypoglycemia Risk Reduction in Type 2 Diabetes
Proposed CDS Display: Example used by VA
Clinical Decision Support # 3Rule Title Action Plan for prevention of
hypoglycemia
Recommendations on EHR Functionality/ Usability
Appropriate steps should be taken after physician alerted to patient risk factors for hypoglycemia
Objective Use CDS to improve performance in persons with diabetes (a high-priority health condition)
Risk Group Persons with diabetes
Triggering Condition
When physician is notified that that there is a potential for risk factor that places the patient at risk for hypoglycemia.
Proposed CDS Display
Proposed CDS Display
Objective Select patient education materials on high risk medications that follow health literacy principles and meet language needs and confirm understanding
Recommendations on EHR Functionality/ Usability
Provides pre-determined order set of patient education material(s) that follows health literacy principles (e.g., does not use jargon or vague terms, breaks down action steps into manageable explicit steps) according to patient’s preferred language.
Diabetes Agents Patient EngagementEP: Recommendation 1
Diabetes Agents Patient Engagement EP: Recommendation # 2
Objective
Present structured, trended lab results with links to interpretive information displayed on the same screen.
Add structured, trended lab values and graphics to discharge information.
6 months 12 months
18 months
24 months
6.4
6.8
7.2
7.6
8
SmithGoalNational Mean
Example: Mr. Smith’s A1c Levels
NOTE: Individualized goal decided on by both provider and patient
Diabetes AgentsEHR Recommendations:
Eligible Hospitals
Quality Measure Concepts
• Hypoglycemia, severe• Hyperglycemia• Hypoglycemia, Mild• Recurrent Hypoglycemia
Clinical Decision Support (CDS)
• Notification of occurrence of repeated hypoglycemia
Data Display • Display of pertinent information for prevention of hypoglycemia
Data DisplayData DisplayRule Title Data display for prevention of hypoglycemiaRecommendations on EHR Functionality/ Usability
Flowsheet with certain elements should be presented on a single page to the physician
ObjectiveUse CDS to improve performance in patients with hyperglycemia / diabetes (a high-priority health condition)
Risk Group Persons with ongoing POC glucose testing
Triggering Condition
When physician is alerted that the patient is on an hypoglycemic agent (Unfortunately, some are not on hypoglycemic agents in spite of uncontrolled hyperglycemia, so flowsheets are available in all with regular monitoring)
Proposed Data Display
Proposed Data Display
Focus
Hypoglycemia, Severe*The rate of hypoglycemic events during exposure to anti-diabetic agent(Better quality = lower score)
Numerator
Total number of hypoglycemic events (<40 mg/dl) that were:
• not followed by another glucose test with result >80 mg/dL within 5 minutes• preceded by administration of regular insulin within 12 hours OR preceded by an anti-diabetic agent (other than insulin) within 24 hours• at least 20 hours apart from the previous hypoglycemic event
Denominator
Total number of hospital days with at least one anti-diabetic agent administered
Target population: inpatient admissions during the measurement period for patients who are at least 18 years of age at admission
ExclusionsDenominator: Exclude admissions with length of stay > 120 days
Stratification for risk adjustment is under consideration
Quality Measure Concept #1
Focus
Hyperglycemia*Average percentage of hyperglycemic hospital days for individuals with a diagnosis of diabetes mellitus, anti-diabetic drugs (except metformin) administered, or at least one elevated glucose level during the hospital stay(Better quality = lower score)
Numerator
Sum of the percentage of hospital days in hyperglycemia (>200 mg/dL) for all admissions in the denominatorHyperglycemic days are defined as:• two or more elevated blood glucose levels (>200 mg/dL) that are at least 6 hours apart OR• one elevated blood glucose level if only one value was available that day OR• no glucose level if not preceded by 2 normoglycemic days
Denominator
Total number of admissions with:• diagnosis of diabetes mellitus OR• at least one administration of insulin or any oral anti-diabetic medication except metformin OR• at least one elevated blood glucose value (>200 mg/dL) at any time during the entire hospital stay
Exclusions
Denominator: Exclude admissions with• diagnosis of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS)• length of stay greater than 120 days• no hospital days included in the analysis
Stratified by care units (acute vs. surgical), and patient type (medical vs. surgical).Other stratification for risk adjustment is under consideration
Quality Measure Concept #2
Focus Hypoglycemia, Mild
Numerator Monitored days in which any hypoglycemic event (<70 mg/dL) reported
Denominator
Hospital days monitored with POC glucose testing (no need to have both POC and serum events) in which at least one hypoglycemia inducing agent is administered.
Quality Measure Concept #3
Focus Recurrent Hypoglycemia
NumeratorPatients suffering at least one recurrent hypoglycemic event on a subsequent hospital day during the same hospital stay.
Denominator All patients identified in suggested measure #1 that suffers an index hypoglycemic (< 70 mg/dL) event.
Quality Measure Concept #4
Clinical Decision Support
Rule TitleNotification and documentation of occurrence of repeated hypoglycemia (more than 2 readings) glucose values of < 70 mg/dl
Recommendations on EHR Functionality/ Usability
When there is patient who has experienced repeated (more than 2 readings) blood glucose value of < 70 mg/dl, the provider should be alerted that there is a potential for risk and take action OR state the reason why there was no action taken.
Objective Use CDS to improve performance in diabetic patients (a high-priority health condition)
Triggering Condition
Risk factors that places a patient at risk for hypoglycemic events. • Experiencing prior hypoglycemic event
Proposed CDS Display
Proposed CDS Display
Q & A
FIW for ADEs - OpioidsFIW for ADEs – Opioids
Deborah Perfetto, PharmDAgency for Healthcare Research and Quality
Robert Kerns, PhDDepartment of Veterans Affairs
Opioid EHR Recommendations:Eligible Providers
Clinical Decision Support (CDS)
Rules • Clinical decision support to support Quality Measure Concepts
Quality Measure Concepts
• High Daily Dose• Co-Prescribing CNS Depressants• Use of Toxicology Screening• Use of PDMPs• Written Care Plan Agreement• Mental Health Screening • Propensity to Prescribe
PDMPs Prescription Drug Monitoring Programs
Data Elements • New opioid safety related data elements to capture
Guideline Based Risk FactorsOutpatient Risk Factors for Opioid Overdose
Risk Factor Description Guidelines
High Opioid Daily Dose APS/AAPM and Canadian Guidelines recommend increased monitoring and reassessment for doses >200 mg morphine equivalent doses (MED) per day, AMDG recommends consulting for doses >120mg MED per day
APS/AAPM, AMDG, Canadian
Co-Prescribing of CNS depressants (especially benzodiazepines)
Concomitant use of CNS depressants with opioids, especially benzodiazepines, is consistently shown to increase risk of opioid overdose. All guidelines recommend against co-prescribing and recommend caution if co-prescribing is necessary
APS/AAPM , VA/DOD, AMDG, Utah, ASIPP, Canadian
Significant/Untreated Mental Health Disorder
Significant or untreated mental health disorders are shown to increase overdose risk. All guidelines recommend mental health screening prior to starting opioid therapy
APS/AAPM , VA/DOD, AMDG, Utah, ASIPP, Canadian
Active/History of Substance Abuse
Substance abuse is risk factor for opioid overdose. All guidelines recommend risk assessment for active substance abuse and assessing family history for substance abuse
APS/AAPM , VA/DOD, AMDG, Utah, ASIPP, Canadian
Multiple Prescribers Receiving opioids from multiple prescribers correlates with an increased risk for opioid overdose.
APS/AAPM , VA/DOD, AMDG, Utah, ASIPP, Canadian
Data Elements
Existing Data Elements New Data Elements to CaptureMedication List – discontinued medications with reasons
Morphine Equivalent Dose (MED)
Toxicology Screening Results Record if patient is on long-term opioid therapy
Mental Health Screening Document:• Date and results of most recent review of PDMP data• Written opioid treatment plan, with treatment goals• Primary opioid prescriber• Opioid risk assessment
History of drug abuseFamily history of drug abuse
PDMPs Prescription Drug Monitoring Programs
Denominator
Number of patients on long-term opioid therapy (patients with active opioid prescriptions for greater than 90 days)
Exclusions Patients on palliative or end of life care
Quality Measure Concepts
Measure Numerator Rationale
1 # of patients on high daily dose
(>200mg MED per day)
Guidelines recommend increased monitoring / reassessment at 200 mg
morphine equivalents/day
MED Morphine Equivalent Dose
Clinical Decision Support # 1
Rule Title Caution when prescribing more than 200 mg MED per day
Population Patients on long-term opioid therapy
Triggering Condition
> 200 mg MED per day in long-term opioid user that is not in palliative or end of life care
Alert for prescriber that flags doses > 200 mg MED per day Indications:
―Patients on long-term opioid therapyAND
―Daily opioid dose > 200 mg MED per day
MED Morphine Equivalent Dose
Denominator
Number of patients on long-term opioid therapy (patients with active opioid prescriptions for greater than 90 days)
Exclusions Patients on palliative or end of life care
Quality Measure Concepts
Measure Numerator Rationale
1 #of patients on high daily dose (> 200 mg MED per day)
Guidelines recommend increased monitoring / reassessment at 200 mg morphine equivalents/day
2 # of patients co-prescribed CNS depressants
Co-prescribing of opioids with CNS depressants, especially benzodiazepines, is
associated with opioid overdose deaths.
Clinical Decision Support # 2
Rule Title Caution when co-prescribing opioids and CNS depressants
Population Patients on long-term opioid therapy
Triggering Condition
Patients that have an active prescription for opioids and a CNS depressant
Alert for prescriber that flags when patients are prescribed opioids when they have an active prescription for a CNS depressant or vice versa
Indications:―Patients on long-term opioid therapy
AND―Co-prescribed opioid and CNS depressant
Denominator
Number of patients on long-term opioid therapy (patients with active opioid prescriptions for greater than 90 days)
Exclusions Patients on palliative or end of life care
Quality Measure Concepts
Measure Numerator Rationale
1 #of patients on high daily dose (>200mg MED per day)
Guidelines recommend increased monitoring, reassessment at 200 mg morphine equivalents/day
2 # of patients co-prescribed CNS depressants
Co-prescribing of opioids with CNS depressants, especially benzodiazepines, is associated with
opioid overdose deaths. 3 # of patients with toxicology
screeningGuidelines recommend toxicology screen
prior to initiating opioids
Clinical Decision Support # 3
Rule Title Toxicology screen out of date
Population Patients on long-term opioid therapy
Triggering Condition
Patients that do not have a toxicology screen on record or it has been >1 year since the last screen
Alert to obtain toxicology screening when there is no toxicology screen on record
Indications:―Patients on long-term opioid therapy
AND―No toxicology screen on record or >1 year since last
toxicology screen
Denominator
Number of patients on long-term opioid therapy (patients with active opioid prescriptions for greater than 90 days)
Exclusions Patients on palliative or end of life care
Measure Numerator Rationale
1 #of patients on high daily dose (>200mg MED per day)
Guidelines recommend increased monitoring, reassessment at 200 mg morphine equivalents/day
2 # of patients co-prescribed CNS depressants
Co-prescribing of opioids with CNS depressants, especially benzodiazepines, is associated with
opioid overdose deaths. 3 # of patients with toxicology
screeningGuidelines recommend toxicology screening prior
to initiating opioids
4 # of patients checked in PDMPs
Guidelines recommend monitoring PDMPs when available
PDMPs Prescription Drug Monitoring Programs
Quality Measure Concepts
Clinical Decision Support # 4a
Rule Title PDMP Data Out of Date
Population Patients on long-term opioid therapy
Triggering Condition
Patients that do not have PDMP data on record or it has been >1 year since the last time PDMP was checked
Alert to check relevant PDMP when PDMP data is missing or out of date
Indications:―Patients on long-term opioid therapy
AND―No PDMP data on record or >1 year since last time
PDMP was checked
PDMPs Prescription Drug Monitoring Programs
Clinical Decision Support # 4b
Rule Title Multiple Opioid Prescribers
Population Patients on long-term opioid therapy
Triggering Condition Multiple opioid prescribers identified in PDMP data
Alert when multiple prescribers are identified in PDMP Indications:
―Patients on long-term opioid therapyAND
―Multiple opioid prescribers in PDMP data
PDMPs Prescription Drug Monitoring Programs
Quality Measure Concepts
Denominator
Number of patients on long-term opioid therapy (patients with active opioid prescriptions for greater than 90 days)
Exclusions Patients on palliative or end of life care
Measure Numerator Rationale
1 #of patients on high daily dose (>200mg MED per day)
Guidelines recommend increased monitoring, reassessment at 200 mg morphine equivalents/day
2 # of patients co-prescribed CNS depressants
Co-prescribing of opioids with CNS depressants, especially benzodiazepines, is associated with
opioid overdose deaths. 3 # of patients with toxicology
screeningGuidelines recommend toxicology screening prior
to initiating opioids
4 # of patients checked in PDMPs Guidelines recommend monitoring PDMPs when available
5 # of patients that have evidence of Written Care Management Agreement
Guidelines recommend using opioid care management plans that identifies the goals
of therapy and the expectations for the patient
Quality Measure Concepts
Clinical Decision Support # 5
Rule Title Need Written Opioid Agreement
Population Patients on long-term opioid therapy
Triggering Condition Multiple opioid prescribers identified in PDMP data
Alert when no evidence of written opioid care management agreement
Indications:―Patients on long-term opioid therapy
AND―No evidence of written opioid care management
agreement
Denominator
Number of patients on long-term opioid therapy (patients with active opioid prescriptions for greater than 90 days)
Exclusions Patients on palliative or end of life care
Measure Numerator Rationale
1 #of patients on high daily dose (>200mg MED per day)
Guidelines recommend increased monitoring, reassessment at 200 mg morphine equivalents/day
2 # of patients co-prescribed CNS depressants
Co-prescribing of opioids with CNS depressants, especially benzodiazepines, is associated with
opioid overdose deaths. 3 # of patients with toxicology
screeningGuidelines recommend toxicology screen prior to
initiating opioids
4 # of patients checked in PDMPs Guidelines recommend monitoring PDMPs when available
5 # of patients that have evidence of Written Care Management
Agreement
Guidelines recommend using opioid care management plans that identifies the goals of therapy and the expectations for the patient
6 # of patients that have evidence of mental health
screening
Guidelines recommend assessment for mental health disorders prior to initiating
opioids
Quality Measure Concepts
Clinical Decision Support # 6
Rule Title Need Mental Health Assessment
Population Patients on long-term opioid therapy
Triggering Condition Multiple opioid prescribers identified in PDMP data
Alert when no evidence of mental health assessment Indications:
―Patients on long-term opioid therapyAND
―No evidence of mental health assessment
PDMPs Prescription Drug Monitoring Programs
Opioid EHR Recommendations:Eligible Hospitals
Clinical Decision Support (CDS)
Rules
• Caution when prescribing more than 60 mg MED in opioid naïve patient• Inappropriate opioid dose titration
Quality Measure Concepts
PDMPs Prescription Drug Monitoring Programs
Data Elements • New opioid safety related data elements to capture• Percent of patients receiving patient controlled analgesia (PCA) who receive appropriate monitoring• Percent of opioid naïve patients started on high-dose opioids in the inpatient setting
Existing Data Elements
New Data Elements to Capture
Sedation Score Morphine Equivalent Dose (MED)
Pulse Oximetry Record if patient is opioid naïve
Respiratory Rate
Data Elements
Measure Percent of patients receiving patient controlled analgesia (PCA) who receive appropriate monitoring
Numerator
Hospitalizations during which the maximum time interval between documentation of each of the following parameters does not exceed 2.5 hours, during the 24 hours after the first initiation of IV PCA opioid administration, excluding any interval during which the PCA is not available to the patient:
1. Respiratory rate 2. Sedation score 3. Pulse oximetry
Denominator
All patients who receive an intravenous opioid via patient controlled analgesia in a hospital setting for more than 2.5 continuous hours
Exclusions Patients on palliative or end of life care
RationaleImproved inpatient monitoring for respiratory depression is a widely accepted best practice. Some studies suggest that up to half of PCA-related adverse events could be prevented through appropriate monitoring.
Quality Measure Concept #1
Quality Measures Concept #2
Measure Percent of opioid naïve patients started on high-dose opioids in the inpatient setting
NumeratorNumber of patients started on inpatient opioid therapy with no active opioid prescription within the past 90 days that are started on > 60 mg morphine equivalent dose (MED)
Denominator
Number of patients started on inpatient opioid therapy with no active opioid prescription within the past 90 days
ExclusionsComfort measure only orderAllow natural death order
Rationale
Prescribing errors are a significant problem that can lead to opioid overdose in the inpatient setting, especially in high potency formulations. This measure will help to get more information around inappropriate inpatient prescribing.
Quality Measure Concept #2
Clinical Decision Support # 1
Rule Title Caution when prescribing more than 60 mg MED in opioid naïve patient
Population Patients started on inpatient opioid therapy with no active opioid prescription within the past 90 days
Triggering Condition >60 mg MED for opioid naïve patient
Alert for prescriber that flags doses >60 mg MED in opioid naïve patient
Indications:―Patients started on inpatient opioid therapy with no
active opioid prescription within the past 90 daysAND
―Started on opioid dose >60 mg MED
MED Morphine Equivalent Dose
Opioid Medications
Clinical Decision Support # 2
Rule Title Inappropriate opioid dose titration
Population Patients on inpatient opioid therapy
Triggering Condition Increase in opioid dose of >50% at one time
Alert for prescriber that flags if there is inappropriate titration
Indications:―Patients on inpatient opioid therapy
AND―Increase dose of opioid by >50% at one time
Q & A
Key ConsiderationsKey Considerations
Yael Harris, PhD, MHAOffice of Disease Prevention and Health Promotion
Information Relevant to Next Steps
CQMs: NQF Call for Measures for Medications in 2014 Low cost, 2-3 months for eSpecification of retooled measures
CDS− Proposal already developed by Osheroff & Maynard to use
CDS4MU worksheet to develop CDS related to ADEs.
Patient Lists Some providers have already programmed patient panels to
address patients at high risk for ADEs (e.g. diabetics at risk for hypoglycemia)
Clinical Decision Support / Quality Improvement
Configuration TemplatePerformance Target:Current Performance on Target:
Decision Support
Opportunity
Care Activities
Specific Tasks Setting
Current CDS Interventions Implementation
Considerations
Proposed Enhancements (locally or
by EHR vendor)
Who (people), What (information), Where
(channels), How (formats), When (workflow)
Patient-specific ActivitiesNot hospitalization-relatedBefore hospitalizationEmergency DepartmentDuring hospitalization*After hospitalizationPopulation-oriented ActivitiesOutside Patient-specific Encounters
* i.e., History / Assessment, Documentation, Care Planning / Shared Decisions, Orders / Prescriptions, Therapy Execution (dispensing, administration), Results / Monitoring / New Events, Discharge / Transfer / Referrals
Source: TMIT Consulting, LLC
Q & A
Thank you
Presentation to the ONC Health IT Policy Committee Quality Measures WorkgroupMonday, June 3rd, 2013
U.S. Dept of Health & Human Services (HHS) http://www.hhs.gov/ Office of the Assistant Secretary for Health http://www.hhs.gov/ash/Office of Disease Prevention and Health Promotion http://odphp.osophs.dhhs.gov/
Federal Interagency Workgroups for Adverse Drug Events: A Path Toward a National Action Plan for Prevention
Thank You