Reduced Risk & Improved Efficacy through Integrated Pharmacogenetics



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August 13, 2014 Reduced Risk & Improved Efficacy through Integrated Pharmacogenetics Allscripts Client Experience 2014 1

Reduced Risk & Improved Efficacy through Integrated Pharmacogenetic Analysis Stone Run Family Medicine: Joseph Weidner, Jr. MD, FAAFP Genelex Corp: Kristine Ashcraft, COO 2

Agenda Adverse Drug Event Risk Stone Run Family Medicine - Present Integration and Workflow Case Presentation of Usefulness of Improved Efficacy Future Integration Plans 3

Learning Objectives: Identify patients at highest risk for drug to gene interactions. Incorporate genetic testing and analysis into the clinical decision making process and workflow of Allscripts ProEHR. Capture pharmacogenetic analysis & lab results as structured data to reduce the risk from drug to gene interactions. 4

Reduced Risk & Improved Efficacy through Integrated Pharmacogenetic Analysis Adverse Drug Event Risk & YouScript Kristine Ashcraft, COO, Genelex Copyright 2013 Allscripts Healthcare Solutions, Inc. 5

Prescribing in the United States 3.7 billion drug prescriptions written in 2011 48% of the population on at least one prescription medication in 2008 All medication use carries risks of unforeseen consequences 6

Heart Disease Cancer Stroke Car Crashes Adverse Drug Events: Avoidable medical problem 700,000 600,000 2.2 MILLION severe adverse drug events per year 500,000 400,000 300,000 FOURTH leading cause of death in the U.S. 200,000 100,000 0 Rx Drugs and Genes play a significant role in causing ADEs Sources: U.S. Center for Disease Control and Prevention and Journal of the American Medical Association (JAMA) 7

Drug Interactions and Patient Genetics Pharmacogenetics (PGx) is the understanding of how genetic variability changes drug response Cytochromes (CYPs) are the metabolic factories in the liver and intestine Genes, OTCs, herbals and other drugs change CYP levels 75% of patients have variations in at least one CYP and do not metabolize medications normally Medication management can help avoid these interactions 8

Personalized Prescribing BLOCKBUSTER One size fits all approach to drug development and prescribing PERSONALIZED PRESCRIBING Enables selection of the right drug and dose 9

YouScript Personalized Prescribing Software Sophisticated CDS tool Can be used with or without Genetic information for Medication Management Population Risk Analysis Ranked Alternate Selector Incorporates herbals, over-the-counter and recreational drugs Genotype-based drug and dosage recommendations Only solution to factor multi-drug and cumulative effects Evidence-based, thousands of links to clinical literature 10

Bringing Real-Time Analytics to Prescribing 11

Personalized Prescribing Meets the Triple Aim Roughly half of all prescribers are using software applications which allow for clinical decision support (CDS) tools, a meaningful use requirement. Utilizing pharmacogenetics and advanced medication management tools strongly align with the Institute for Healthcare Improvement s Triple Aim: 12

Predict Risks Alerts help caregivers avoid potential Adverse Drug Events and treatment failures by: Devoting extra vigilance to side effects Changing the medication s dose Choosing a new therapeutic route Analyzing entire population also helps reveal wider trends Highlights high-risk patients Predict who may have significant unknown risks 13

Frequency of Drug and Gene Interactions DGIs and DDGIs accounted for 33.9% of major or significant interactions Increase of 51.3% when compared to DDIs alone May represent a large portion of interactions that go undetected E.g. clopidogrel (Plavix )and CYP2C19 Major or Significant Interaction Predicted DDI, 66.10% DGI, 14.70% DDGI, 19.20% 2014 Genelex 14

Clinical Study Preliminary Data Study background: 2 arms dividing a 700,000 patient, ~ 2000 physician plan, 1000 patient genetic testing subarm Patients stratified into Warned or Unwarned Physician response to warnings was voluntary Patients 65+ on 5+ meds compared in 2 arms to assess healthcare resource utilization * 1 st 6 months vs. Control Arm Hospitalizations -2.9% Total number of drugs used* -2.0% Imaging Procedures (MRI, CT, U/S, X-ray) -3.0% MDs changed prescribing habits in 40% of accessed warnings $530 USD per patient savings seen although only 15% of MDs accessed warnings In high healthcare resource consuming patients, savings was $2400 USD 15

Reduced Risk & Improved Efficacy through Integrated Pharmacogenetic Analysis Reducing Risk at Stone Run Family Medicine (Present Integration) Copyright 2013 Allscripts Healthcare Solutions, Inc. 16

About Stone Run Family Medicine Family medicine practice located in Rising Sun, MD 2MD/1.5 PA-C; 9 FTE staff; NCQA Level 3 4500 active patients (past two years) 14000 office encounters/year Visits:13.7% Medical Assistance; 22% Medicare; 5% Self Pay Patients: 18% >age 65; 14% <age 18 17

Allscripts Professional Environment Hosted at Union Hospital of Cecil County Since 2007 53 providers (46% of outpatient providers in catchment area of 120,000) Community: 56% of primary care and 38% of specialists use Allscripts Professional EHR Professional EHR Clinical Module Version 13.0 Service Pack 2 Hot Fix 1 Build 13.2.0.98 Allscripts PM 10.5.3.17 18

Objectives Identify if integrating pharmacogenetic analysis provides better patient outcomes & reduced adverse drug events Reduce time required to incorporate pharmacogenetic analysis in patient care Improved workflow determining pharmacogenetic analysis at the point of care Determine if proactive identification of high-risk patients improves patient care 19

Testing & Review Workflow Overview Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 20

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On 21

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 22

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 23

Active Medication Sync Active or Current Medications in patient EHR charts sync to YouScript in realtime. Professional EHR Image Allscripts Healthcare, LLC. 24

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 25

Daily Testing Recommendations Each night YouScript looks at scheduled patient appointments for the next day, and indicates high-risk patients with an appointment who would benefit from genetic testing by sending a message to a staff person. Professional EHR Image Allscripts Healthcare, LLC. 26

Office Protocol / Workflow YouScript testing entered into comments section of patient schedule of Allscripts Practice Management 27

Office Protocol / Workflow YouScript testing entered into comments section of patient schedule of Allscripts Professional EHR 28

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 29

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 30

Custom Lab Order Template Patient Consent Form for patient to sign YouScript patient and insurance billing policies (give to patient) Lab requisition form Active medications Allergies Problem list and other past medical history Professional EHR Image Allscripts Healthcare, LLC. 31

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 32

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 33

Provider Results Messaging Professional EHR Image Allscripts Healthcare, LLC. John Doe John Doe Jane Plain Walter Melon Billy Rubin Ray Dium Gene U Lux 34

Provider Results Messaging Professional EHR Image Allscripts Healthcare, LLC. 35

Provider Results Messaging Open Encounters 36

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 37

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 38

Lab Report Document - Patient Chart Attachments 39

Lab Report Document sent to Patient Chart 40

Lab Report Document sent to Patient Chart Lab reports with medication analysis send to the patient chart after genetic testing and pharmacist recommendations are complete. Professional EHR Image Allscripts Healthcare, LLC. 41

Lab Report Document sent to Patient Chart 42

Lab Report Document sent to Patient Chart 43

Stone Run's Top 20 Drugs Impacted by Genes 44

Stone Run Prescribing Suggestion Actions 547 Count of Prescribing Suggestions Nov 16, 2013 - Aug 1, 2014 38% 18% 44% 45

Stone Run Prescribing Suggestion Actions 239 Drug-Gene / Drug-Drug-Gene Prescribing Suggestions Nov 16, 2013 - Aug 1, 2014 46

Stone Run Prescribing Suggestion Actions Major or Significant Interaction Predicted Major or Significant Interaction at Stone Run Family Medicine DGI, 15% DGI, 24% DDI, 66% DDGI, 19% DDI, 53% DDGI, 22% 47

NOT 48

NOT 49

Case Presentation - Utilization in the workflow of the office 75 year old white female Hypertension, Asthma, CHF, Hypothyroidism, GERD 50

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 51

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 52

Genetic Problem List Entry A problem list entry is made for each tested patient, listing their genetic results, which are constant for the rest of their life. These diagnosis codes are searchable in the EHR reporting module and an associated encounter is created. Professional EHR Image Allscripts Healthcare, LLC. 53

Genetic Problem List Entry 54

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 55

Integration Features Used Active Medication Sync Daily Testing Recommendations for Scheduled Appointments Custom Lab Order Template Provider Results Messaging Lab Report Document sent to Patient Chart Genetic Problem List Entry YouScript Single-Sign-On Testing & Review Workflow Comprehensive identification of high risk patients through the Allscripts Professional EHR Reporting Module Patient schedule notations within Allscripts Practice Management Clinical & nonclinical staff collaboration for patient notification of testing Customized requisition form/consent form printed out Chart attachment & provider notifications of YouScript pharmacogenetic analysis Provider review of pharmacogenetic analysis & medication changes 56

YouScript Single Sign-On 57

YouScript Single Sign-On 58

YouScript Single Sign-On 59

Outcomes Reduced time to determine drug to gene interactions, compared with previous available tools. Improved identification of high risk patients who would benefit from pharmacogenetic screening. Streamlined office processes to apply pharmacogenetic testing and analysis. Optimizing prescription writing decision making process utilizing drug to gene interaction analytics. 60

Lessons Learned Using pharmacogenetic to deliver individualized care creates a shift in how we think about adverse drug events. Side effects previously ignored because they are expected now become solvable problems. Updated current Medication and Problem Lists are important in order to generate the best pharmacogenetic analysis, and determine best who to test. Improve workflow during the testing process. Identify how to capture the most appropriate testing. Retrospective vs Time of Prescribing Decision Making. Corroboration with other specialists pitfalls and mental gymnastics More pointed Drug/Drug/Gene interaction checker than present Drug/Drug Interaction Checker 61

Reduced Risk & Improved Efficacy through Integrated Pharmacogenetic Analysis Future Integration Plans Copyright 2013 Allscripts Healthcare Solutions, Inc. 62

Next Steps Weekly reports of highest risk recommendations Have other providers at Stone Run Family Medicine utilize YouScript Recruit other practitioners from local Allscripts user network to integrate Truly reduce Adverse Drug events and deaths in this group Realize savings in reduced health care expenditures Ideal scenario: Helix or other alert beside meds at time of prescribing 63

Next Steps 64

Next Steps The good green double helix 65

Reduced Risk & Improved Efficacy through Integrated Pharmacogenetic Analysis Questions Copyright 2013 Allscripts Healthcare Solutions, Inc. 66