federal interagency workgroups for adverse drug events

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resentation to the ONC Health IT Policy Committee Quality Measures Workgroup Monday, June 3 rd , 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

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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 Presentation

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Page 1: Federal Interagency Workgroups for Adverse Drug Events

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

Page 2: Federal Interagency Workgroups for Adverse Drug Events

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

Page 3: Federal Interagency Workgroups for Adverse Drug Events

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

Page 4: Federal Interagency Workgroups for Adverse Drug Events

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)

Page 5: Federal Interagency Workgroups for Adverse Drug Events

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.

Page 6: Federal Interagency Workgroups for Adverse Drug Events

~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.

Page 7: Federal Interagency Workgroups for Adverse Drug Events

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

Page 8: Federal Interagency Workgroups for Adverse Drug Events

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.

Page 9: Federal Interagency Workgroups for Adverse Drug Events

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

Page 10: Federal Interagency Workgroups for Adverse Drug Events

FIW for ADEs

Federal Interagency Workgroups (FIW) for

ADEsYael Harris, PhD, MHA

Office of Disease Prevention and Health Promotion

Page 11: Federal Interagency Workgroups for Adverse Drug Events

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

Page 12: Federal Interagency Workgroups for Adverse Drug Events

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

Page 13: Federal Interagency Workgroups for Adverse Drug Events

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

Page 14: Federal Interagency Workgroups for Adverse Drug Events

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

Page 15: Federal Interagency Workgroups for Adverse Drug Events

FIW for ADEs – Anticoagulants

FIW for ADEs – Anticoagulants

Nadine Shehab, PharmD, MPHCenters for Disease Control and Prevention

Page 16: Federal Interagency Workgroups for Adverse Drug Events

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

Page 17: Federal Interagency Workgroups for Adverse Drug Events

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

Page 18: Federal Interagency Workgroups for Adverse Drug Events

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.

Page 19: Federal Interagency Workgroups for Adverse Drug Events

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

Page 20: Federal Interagency Workgroups for Adverse Drug Events

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

Page 21: Federal Interagency Workgroups for Adverse Drug Events

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

Page 22: Federal Interagency Workgroups for Adverse Drug Events

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

Page 23: Federal Interagency Workgroups for Adverse Drug Events

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

Page 24: Federal Interagency Workgroups for Adverse Drug Events

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

Page 25: Federal Interagency Workgroups for Adverse Drug Events

Example Inpatient Anticoagulant Flowsheet

Page 26: Federal Interagency Workgroups for Adverse Drug Events

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

Page 27: Federal Interagency Workgroups for Adverse Drug Events

Q & A

Page 28: Federal Interagency Workgroups for Adverse Drug Events

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

Page 29: Federal Interagency Workgroups for Adverse Drug Events

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

Page 30: Federal Interagency Workgroups for Adverse Drug Events

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

Page 31: Federal Interagency Workgroups for Adverse Drug Events

Examples as used by VA

Page 32: Federal Interagency Workgroups for Adverse Drug Events

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

Page 33: Federal Interagency Workgroups for Adverse Drug Events

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

Page 34: Federal Interagency Workgroups for Adverse Drug Events

Proposed CDS Display

Proposed CDS Display

Page 35: Federal Interagency Workgroups for Adverse Drug Events

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

Page 36: Federal Interagency Workgroups for Adverse Drug Events

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

Page 37: Federal Interagency Workgroups for Adverse Drug Events

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.

Page 38: Federal Interagency Workgroups for Adverse Drug Events

Proposed CDS Display

Proposed CDS Display

Page 39: Federal Interagency Workgroups for Adverse Drug Events

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

Page 40: Federal Interagency Workgroups for Adverse Drug Events

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

Page 41: Federal Interagency Workgroups for Adverse Drug Events

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

Page 42: Federal Interagency Workgroups for Adverse Drug Events

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)

Page 43: Federal Interagency Workgroups for Adverse Drug Events

Proposed Data Display

Proposed Data Display

Page 44: Federal Interagency Workgroups for Adverse Drug Events

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

Page 45: Federal Interagency Workgroups for Adverse Drug Events

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

Page 46: Federal Interagency Workgroups for Adverse Drug Events

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

Page 47: Federal Interagency Workgroups for Adverse Drug Events

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

Page 48: Federal Interagency Workgroups for Adverse Drug Events

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

Page 49: Federal Interagency Workgroups for Adverse Drug Events

Proposed CDS Display

Proposed CDS Display

Page 50: Federal Interagency Workgroups for Adverse Drug Events

Q & A

Page 51: Federal Interagency Workgroups for Adverse Drug Events

FIW for ADEs - OpioidsFIW for ADEs – Opioids

Deborah Perfetto, PharmDAgency for Healthcare Research and Quality

Robert Kerns, PhDDepartment of Veterans Affairs

Page 52: Federal Interagency Workgroups for Adverse Drug Events

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

Page 53: Federal Interagency Workgroups for Adverse Drug Events

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

Page 54: Federal Interagency Workgroups for Adverse Drug Events

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

Page 55: Federal Interagency Workgroups for Adverse Drug Events

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

Page 56: Federal Interagency Workgroups for Adverse Drug Events

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

Page 57: Federal Interagency Workgroups for Adverse Drug Events

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.

Page 58: Federal Interagency Workgroups for Adverse Drug Events

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

Page 59: Federal Interagency Workgroups for Adverse Drug Events

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

Page 60: Federal Interagency Workgroups for Adverse Drug Events

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

Page 61: Federal Interagency Workgroups for Adverse Drug Events

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

Page 62: Federal Interagency Workgroups for Adverse Drug Events

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

Page 63: Federal Interagency Workgroups for Adverse Drug Events

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

Page 64: Federal Interagency Workgroups for Adverse Drug Events

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

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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

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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

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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

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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

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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

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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

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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

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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

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Opioid Medications

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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

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Q & A

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Key ConsiderationsKey Considerations

Yael Harris, PhD, MHAOffice of Disease Prevention and Health Promotion

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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)

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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

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Q & A

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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