10/21/19 1 Disclosure There are no relevant financial relationships with ACCME- defined commercial interests for anyone who was in control of the content of the activity. 2 1
10/21/19 Implementing Pharmacogenomics in Your Business NCPA Annual Convention 2019 Amina Abubakar, PharmD, AAHIVP CEO of Rx Clinic Pharmacy and President of the Avant Institute 3 Pharmacist & Pharmacy Technician Learning Objectives 1. List strategies for marketing to and building relationships with other health care professionals who could provide enhanced patient care with pharmacogenomic information. 2. Describe different ways of implementing pharmacogenomic services that benefit your patients and business. 3. Identify opportunities to determine which patients may be eligible to receive pharmacogenomic services. 4 2
10/21/19 Please go to MEET.PS/PGX to answer poll questions! 5 6 3
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10/21/19 12 Precision Medicine The Future of Individualized Medicine 14 5
10/21/19 ALF Value- Specialists: based Care Cardiac and Providers Pain Business Opportunities Concierge Wellness Mental and Behavioral Health 15 PRECISION MEDICINE INITIATIVE National Institutes of Health (NIH) ● http://www.nih.gov/precisionmedicine/ Mission Statement ● To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized treatments 1 6 16 6
10/21/19 Over 250+ FDA Approved Drugs with PGx Information on Drug Labeling Clopidogrel PPIs • • Warfarin Tamoxifen • • Opioids Anti-cancer • • agents Infectious Disease • Celecoxib Carbamazepine • • Clozapine Carvedilol • • Diazepam • http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm 17 PHARMACOGENETICS & THE FDA CURRENT STATE OF AFFAIRS 18 7
10/21/19 19 DEFINITION OF PHARMACOGENOMICS Study of how genes affect a person’s medication response which combines pharmacology & genomics 20 8
10/21/19 PHARMACOGENOMICS VS. PHARMACOGENETICS Pharmacogenomics ● broader based term ● encompasses all genes in the genome that may determine drug response Pharmacogenetics ● more narrow term ● generally used in relation to genes determining drug metabolism Can and are used interchangeably 2 Genetics Home Reference Website. Accessed at http://ghr.nlm.nih.gov/handbook/genomicresearch/pharmacogenomics, November 13, 2014. Br J Clin Pharmacol. 2001 Oct; 52(4): 345–347. 1 21 SOURCES OF VARIATION IN DRUG METABOLISM Pharmacogenetics Age, Gender Disease States (liver, Drug-Drug kidney or gut Interactions function) Environmental Factors (smoking, alcohol, diet, lifestyle) Ma Q, Lu AYH. Pharmacogenetics, Pharmacogenomics, and Individualized Medicine. Pharmacological Reviews. 2011. 63(2):437-459. 22 9
10/21/19 PHENOCONVERSION • Phenoconversion is a phenomenon that converts the genotype of an individual into a different phenotype, thereby modifying their clinical response to that of genotype • Drugs and other disease states can contribute to this phenomenon 23 PHARMACOGENOMICS (PGX) • Drugs currently are available and prescribed in a “one size fits all” fashion • ADR related hospitalizations and doctor’s visits average $136 billion annually • 2.2 million serious ADRs • 100,000+ death ADRs are the 4 th leading causes of hospitalization and death in the US 24 http://dukepersonalizedmedicine.org/pharmacogenomics 24 10
10/21/19 BENEFITS TO PATIENTS Eliminates trial and error prescribing, ● resulting in cost and health benefits Potentially decreasing ADRs and side- ● effect profiles Confidence and peace of mind for the ● patient in their regimen 25 BENEFITS TO MEDICAL PROVIDERS AND PHARMACISTS Provides baseline or guidance for drug initiation based on ● genetic implications Strengthens Relationship ● Saves physician time ● Eliminates trial and error prescribing and dispensing ● Promotes patient adherence ● Provides an additional innovative service for the medical ● clinic for precision medicine 26 11
10/21/19 EXTENSIVE, BROAD SPECTRUM PANEL 27 PGX PANEL CAN BE USED TO BETTER PRESCRIBE FOR A WIDE RANGE OF HEALTH CONDITIONS ● ADHD ● Epilepsy ● Asthma ● Heart Disease ● Cancer ● HIV/AIDS ● Cholesterol ● Pain ● Depression ● Ulcers/Acid Reflux ● Psychosis ● Dementia Question: if a single swab can provide genetic information on all of these conditions at once, is it better to run a single panel or broad panel? 2 8 28 12
10/21/19 DIFFERENT APPROACHES • Pre-emptive • Patient DNA tested for a broad panel of markers early on before medications are needed • Cost Savings in doing test as a batch • Avoid major delay when a need arises • Semi Pre-emptive • Selecting high “at-risk” patient population • Reactive • Initiating testing when a patient has an indication to receiving medication that have genetic implications • When a patient has failed therapy or multiple therapies 29 Workflow • Trigger • Verification of prescription • Medications with implications • Patient complaint • Discontinuation of medication • Patient education • Provider order • Appointment-based model • Close loop with provider 30 13
10/21/19 Learning Activity Discussion: What would semi pre- emptive testing look like in a pharmacy? 31 DRUG METABOLIZER STATUS TYPES Poor Metabolizers (PM) Two non-functional alleles ● Little to no enzyme activity ● Intermediate Metabolizers (IM) One non-functional allele and one normally functioning allele ● Decreased enzyme activity ● Extensive (Normal) Metabolizers (EM) 2 normally functioning alleles ● Normal enzyme activity ● Ultra-rapid Metabolizers (UM) One or more alleles ● Increased enzyme activity compared to extensive metabolizers ● 3 https://cpmc.coriell.org/Sections/Medical/DrugsAndGenes_mp.aspx?PgId=216 2 32 14
10/21/19 PRODRUG vs. ACTIVE DRUG Prodrug Active Drug MUST BE activated by metabolism to have its No metabolism needed to have its intended effect intended effect Metabolism of an active drug renders it inactive Example: codeine is activated by CYP2D6 ● Example: omeprazole ● metabolism in the liver into morphine (active form) Poor Metabolizer Poor Metabolizer ● Good efficacy ● Poor Efficacy ● Accumulation may produce adverse effect ● Possible accumulation of prodrug form ● Lower dose may be necessary Rapid Metabolizer Rapid Metabolizer ● Good Efficacy ● Poor efficacy ● Rapid effect ● Higher dose or slow release formulation may be necessary Morris-Rosendahl DJ. The future of genetic testing for drug response. Dialogues Clin Neurosci. Mar 2004; 6(1): 27-37. 33 EXAMPLES OF PRO- AND ACTIVE DRUGS IN A PGX TEST 34 15
10/21/19 TRANSPORTER FUNCTIONALITY • Transporter proteins • Moves substances such as drugs across biological membranes • Example: Increased transporter function • Medications are absorbed into target tissue more efficiently • Removed from target tissue more efficiently 3 5 35 RESOURCES FOR CLINICAL GUIDANCE 36 16
10/21/19 CLINICAL PHARMACOGENETICS IMPLEMENTATION CONSORTIUM (CPIC) • Available at cpicpgx.org • Considered to be the “Gold Standard” evidence-based clinical guidelines • Designed to understand HOW genetic test results should be used to optimize drug therapy • Standardized formats • Evidence Levels: strong, moderate, optional 37 PHARMGKB • Available at www.pharmgkb.org • CPIC guidelines are posted on PharmGKB and CPIC website • Online database encompasses clinical information for PGx • Dosing guidelines • Drug labels • Clinical annotations • Actionable gene-drug associations • Genotype-phenotype relationships 38 17
10/21/19 PHARMACY ROLE IN INTEGRATING PHARMACOGENETICS WITH MTM 39 MEDICAL PROVIDER RELATIONSHIP • Replacing vs. Collaborating • Coordinating care with all medical providers • Trusting the information • Weighing the risk vs. benefits by using genetically-based dosing • Evidence based guidelines • CPIC, PRO, DPWG • Time constraints • Free the provider for activities more worth their time • Practicing at the top of their license • Technology challenge & solutions • Prior Authorization for third party billing • Avoid Direct-to-consumer 40 18
10/21/19 PERFORMING THE PERSONALIZED MTM 41 PERFORMING THE TEST 42 19
10/21/19 PERFORMING A PHARMACOGENETIC REVIEW • Majority of tests use some type of “stop light” categorization • Avoid misconceptions – patients may apply their own interpretation • “Stop Light” reporting is not as straightforward as it seems • Cannot base precision medication selection and dosing on this means alone 43 IMPORTANT CLINICAL EXAMPLES FOR PGX APPLICATION 44 20
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