Clinical Application of

Pharmacogenomic

Testing in Opioid Use

Disorder Management Earl Ettienne, LPD, MBA, RPh

Director of Graduate Programs and Industry Partnerships

Assistant Professor, Department of Clinical and

Administrative Sciences

Howard University College of Pharmacy

Adaku Ofoegbu, PharmD 2nd year PhD Student, Department of Clinical and Administrative Sciences

Howard University College of Pharmacy

1

Disclosure Statement Drs. Ettienne and Ofoegbu have no actual or

potential conflict of interest in relation to this

presentation

2

Planning Committee, Disclosures

AAAP aims to provide educational information that is balanced, independent, objective and free of bias

and based on evidence. In order to resolve any identified Conflicts of Interest, disclosure information from

all planners, faculty and anyone in the position to control content is provided during the planning process

to ensure resolution of any identified conflicts. This disclosure information is listed below:

The following developers and planning committee members have reported that they have no

commercial relationships relevant to the content of this webinar to disclose: AAAP CME/CPD

Committee Members Dean Krahn, MD, Kevin Sevarino, MD, PhD, Tim Fong, MD, Tom Kosten, MD, Joji

Suzuki, MD; and AAAP Staff Kathryn Cates-Wessel, Miriam Giles, and Justina Pereira.

All faculty have been advised that any recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care

of patients. All scientific research referred to, reported, or used in the presentation must conform to the generally accepted standards of experimental design, data collection, and analysis. The content of this CME activity has been reviewed and the committee determined the presentation is balanced, independent, and free of any commercial bias. Speakers must inform the learners if their presentation will include discussion of unlabeled/investigational use of commercial products.

3

Target Audience

The overarching goal of PCSS-O is to offer

evidence-based trainings on the safe and

effective prescribing of opioid medications in

the treatment of pain and/or opioid addiction.

Our focus is to reach providers and/or

providers-in-training from diverse healthcare

professions including physicians, nurses,

dentists, physician assistants, pharmacists,

and program administrators.

4

Presentation Objectives

Review a basic history of the science behind

pharmacogenomics

Define pharmacogenomics and lay the foundation for its use in

the clinical setting

Discuss clinical applications for pharmacogenomics as it

pertains to opioid use disorder (OUD) management

Review a real-world example of clinical pharmacogenomics

implementation for OUD management

Consider the implications of clinical pharmacogenomics

testing on policy and regulatory affairs

5

Abbreviations Used in This Presentation

ASAM = American Society of Addiction

Medicine

ASIPP = American Society Of Interventional

Pain Physicians

CYP = cytochrome P450

DSM-V = Diagnostic and Statistical Manual of

Mental Disorders, 5th edition

EDDP = 2-ethylidene-1,5-dimethyl-3,3-

diphenylpyrrolidene

EM = extensive metabolizer (phenotype)

EMR = electronic medical record

HCP = health care provider

IM = intermediate metabolizer (phenotype)

MAT = medication-assisted treatment

NMDA = N-methyl-D-aspartate

OUD = opioid use disorder

PD = pharmacodynamics

PGx = pharmacogenomics

PK = pharmacokinetics

PM = poor metabolizer (phenotype)

SAMHSA = Substance Abuse and Mental Health

Services Administration

SNP = single nucleotide polymorphism

UGT = Uridine 5'-diphospho-

glucuronosyltransferase

UM = ultrarapid metabolizer (phenotype)

6

History of

Pharmacogenomics

7

Genomics History and the

Human Genome Project

8

https://unlockinglifescode.org/timeline

The Central Dogma of Molecular

Biology and Omics

DNA

• Genomics

mRNA

• Transcriptomics

Proteins (enzymes, receptors,

transporters, etc.)

• Proteomics

Metabolites

• Metabolomics

9

Transcription

Translation

Metabolism

The study of the structure, function, and

expression of all the genes in an organism

The study of the mRNA

within a cell or organism

The large-scale study of proteins,

including their structure and

function, within a cell/system,

organism

The study of global

metabolite profiles in a

system under a given set of

conditions

Types of Mutations

10

Source of Images:

National Library of

Medicine

Types of Mutations 11

Source of Images:

National Library of

Medicine

Pharmacogenomics

and its Clinical

Foundation

12

What is pharmacogenomics?

Pharmacology Genomics

the widespread

study of genes and

their functions

the science of

drug kinetics and

dynamics of

response

Clinical Pharmacogenomics Testing brings

the science of pharmacogenomics from the

bench to the bedside

13

Pharmacogenomics, Pharmacogenetics, Personalized Medicine, And Precision Medicine

Precision Medicine

Pharmacogenetics

Personalized medicine

Pharmacogenomics Improve

treatment

outcomes

14

Pharmacogenomics:

Targets of Interest

Pharmacodynamics

What the drug does to the body

• Drug receptors

• Drug transporters

• Enzymes

Pharmacokinetics

What the body does to the drug

• Proteins impacting drug absorption,

distribution, metabolism, or excretion, such

as the cytochrome P450 (CYP450) enzymes

15

Comparison of

Guideline-based vs.

Literature-based Pharmacogenomics

Information

Guideline-based

Literature-based

More challenging to interpret findings

Broader information on potentially

clinically-actionable variants

Allows HCP to use clinical judgment

Not all possible variants included

Provides evidence-based clinical

decision support

Lists clinically-actionable variants

(gene-drug)

• Clinical Pharmacogenetics

Implementation Consortium (CPIC)

Guidelines

(https://cpicpgx.org/genes-drugs/)

• Dutch Pharmacogenetics Working

Group (DPWG) Guidelines

• Canadian Pharmacogenomics

Network for Drug Safety (CPNDS)

• Pharmacogenomics Knowledge

Base (PharmGKB)

Sources of Information on

Clinical Pharmacogenomics

16

Cytochrome P450 Enzymes Commonly

Associated With Drug Metabolism

CYP1A2 CYP2B6 CYP2C8

CYP2C9* CYP2C19* CYP2D6*

CYP3A4 CYP3A5* CYP4F2*

17

*CYP enzymes that are included in the CPIC guidelines

CYP450 Enzyme Nomenclature:

Haplotype

CYP 3 A 4 * 1B Family Sub

Family Variant Allele Super

Family

18

CYP450 Enzyme Nomenclature:

Genotype

19

CYP3A4*1

Mother

CYP3A4*1B

Father CYP3A4*1/*1B

You

♀ ♂

What is the physical presentation

(phenotype) of this genotype?

Cytochrome P450 Metabolizer

Phenotypes

MIN MAX

EM IM

PM UM

MIN MAX

EM IM

PM UM

MIN MAX

EM IM

PM UM

MIN MAX

EM IM

PM UM

Extensive

Metabolizer (EM) Ultrarapid

Metabolizer (UM)

Intermediate

Metabolizer (IM)

Poor Metabolizer (PM)

20

Normal

Rate

of

Metabolism

Pharmacogenetic Testing Process 21

A genetic sample is

collected either via buccal

swab or a blood sample

The clinician sends the sample

to a reference laboratory that

will sequence the DNA and

characterize the genetic

variations of the patient

The reference laboratory

sends a comprehensive

pharmacogenetic testing

report to the clinician for

the patient

Example of Pharmacogenetic

Testing Results

22

Genetic Test Genotype Phenotype Result Interpretation

CYP2C9 *1/*1 Extensive

metabolizer

Normal dosing anticipated; follow standard dosing

practices for CYP2C9 substrates

CYP2C19 *1/*9 Intermediate

metabolizer

Reduced metabolism of CYP2C19 substrates.

Decreased sensitivity to Plavix and other prodrugs

CYP2D6 *2B/*41 Intermediate

metabolizer

Higher serum concentrations of CYP2D6 substrate

medications expected at any treatment dose

CYP3A4 *1B/*1B Ultrarapid

metabolizer

Lower serum concentrations of CYP3A4 substrate

medications, including buprenorphine

CYP3A5 *1A/*6 Intermediate

metabolizer

Consider dose adjustments for CYP3A5 substrate

medications

Clinical Application of

Pharmacogenomic

Testing in Opioid Use

Disorder Management

23

Opioid Use Disorder (OUD)

According to the DSM-V, opioid

use disorder (OUD) is defined as

“a problematic pattern of

opioid use leading to clinically-

significant impairment or

distress” characterized by the

presence of at least two of the

following criteria over a 12-

month period.

24

Severe

(6 or more symptoms)

Moderate

(4 – 5 symptoms)

Mild

(2 – 3 symptoms)

OUD Diagnostic Criteria

1. Using larger amounts of opioids or over a longer period than was intended

2. Persistent desire to cut down or unsuccessful efforts to control use

3. Great deal of time spent obtaining, using, or recovering from use

4. Craving, or a strong desire or urge to use substance

5. Failure to fulfill major role obligations at work, school, or home due to recurrent opioid use

6. Continued use despite recurrent or persistent social or interpersonal problems caused or

exacerbated by opioid use

7. Giving up or reducing social, occupational, or recreational activities due to opioid use

8. Recurrent opioid use in physically hazardous situations

9. Continued opioid use despite physical or psychological problems caused or exacerbated

by its use

10. Tolerance (marked increase in amount; marked decrease in effect)

11. Withdrawal syndrome as manifested by cessation of opioids or use of opioids (or a closely

related substance) to relieve or avoid withdrawal symptoms.

25

Opioid Use Disorder (OUD)

Management

Several organizations involved in

OUD treatment recommend a

combination of pharmacological

measures, such as medication-

assisted treatment (MAT), and

psychosocial approaches, such

as recovery support groups, to

reduce both illicit opioid use and

harm related to opioid use while

improving quality of life

26

MAT options for OUD management

Buprenorphine/naloxone

Methadone

Injectable Naltrexone

Methadone Buprenorphine/

Naloxone

Naltrexone Naloxone

Standard

Dosing for

OUD

management

/Overdose

80-120 mg/day

PO; Start: 20-30

mg PO x1, then

5-10 mg q2-4h

prn

START: 2-8 mg SL

qd x1 day, then 8-

16 mg qd x1-2

days; 4 mg/1 mg-

24 mg/6 mg

buccally/SL qd

Start: 25 mg PO x1,

repeat in 1h if no

withdrawal; Alt:

100 mg PO qod,

150 mg PO q3

days

0.4-2 mg

SC/IM/IV q2-

3min prn; Alt:

0.005 mg/kg IV

x1, then 0.0025-

0.16 mg/kg/h IV

Pharmacokinetics

Metabolism CYP3A4,

CYP2B6,

CYP2C19,

CYP2C9,

CYP2D6

CYP3A4, UGT1A1,

UGT1A3, UGT2B7

Glucuronidation Glucuronidation

Metabolite(s) EDDP (inactive) Norbuprenorphine

(active)

6-β-naltrexol

(major) and others

Naloxone-3-

glucuronide

Pharmacodynamics

Mechanism of

Action

Full mu-opioid

agonist

NMDA receptor

antagonist

Partial mu-opioid

agonist

Kappa-opioid

receptor

antagonist

Full opioid

antagonist

Full opioid

antagonist

27

Buprenorphine Metabolism

28 Methadone Metabolism

Effect of CYP450 Metabolizer Phenotypes

on Drug Levels: An Example

MIN MAX

EM IM

PM UM

MIN MAX

EM IM

PM UM

Extensive

Metabolizer (EM)

Phenotype

Ultrarapid

Metabolizer (UM)

Phenotype

Beginning of Dosing

Interval

29

Effect of CYP450 Metabolizer Phenotypes

on Drug Levels: An Example

MIN MAX

EM IM

PM UM

MIN MAX

EM IM

PM UM

Extensive

Metabolizer (EM)

Phenotype

Ultrarapid

Metabolizer (UM)

Phenotype

End of Dosing Interval

30

Opioid Analgesics and Their Metabolism

Opioid Analgesic Metabolism

Codeine CYP2D6

Morphine Glucuronidation

Hydrocodone CYP2B6, CYP2C19, CYP2D6, CYP3A4 (primary)

Hydromorphone UGT1A3, UGT2B7

Oxycodone CYP2D6, CYP3A4 (primary)

Oxymorphone Glucuronidation

Methadone CYP3A4, CYP2B6, CYP2C19, CYP2C9 (minor), CYP2D6 (minor)

Tramadol CYP2B6, CYP2D6, CYP3A4

Fentanyl CYP3A4

Buprenorphine CYP3A4, UGT1A1, UGT1A3, UGT2B7

Meperidine CYP2B6 (primary), CYP2C19, CYP3A4

Nalbuphine Unknown

Pentazocine Unknown

Tapentadol UGT substrate; CYP2C9, CYP2C19, CYP2D6

31

Opioids with FDA-Approved Labeling

Describing Abuse-Deterrent Properties

Brand Name Generic

Oxycontin® Oxycodone (extended release)

Targiniq ER® Naloxone/oxycodone (discontinued)

Embeda® Morphine (extended release)

Hysingla ER® Hydrocodone (extended release)

Morphabond ER® Morphine (extended release)

Xtampza ER® Oxycodone (extended release)

Troxyca® Naltrexone/oxycodone (extended release)

Arymo® Morphine (extended release)

Vantrela® Hydrocodone (extended release)

Roxybond® Oxycodone

32

A Real-World Example

of Clinical

Pharmacogenomics

Implementation

33

A Case Report of Clinical Pharmacogenetic

Testing in a Patient with OUD

Patient is an African-American male over the age of 50 and is

receiving buprenorphine as MAT for OUD management from a clinic

in the Washington DC/Maryland/Virginia area

Married, employed, stable home, history of Hepatitis C viral (HCV)

infection, HIV-negative

He consented to clinical pharmacogenetic testing within the regular

course of treatment

He received pharmacogenetic test results, which were used in the

clinical decision-making process

He is a Medicaid recipient

Between December 2015 and June 2016, the insurance company

mandated a maximum buprenorphine dose restriction to 24 mg/day

34

Patient 2D6 3A4 3A5 Ending Dose

(mg/day)

*5/*17

Intermediate

*1/*1B

Ultrarapid

*3A/*7

Poor 32 mg

35

Challenges with Undertreated

Patients with Opioid Use Disorder

Withdrawal symptoms

Criminal activity

Risk of exposure to HIV and Hepatitis C

Risk of death

Productivity

Overall health and wellbeing

36

OUD Management as

a Bio-Psycho-Social

Approach

37

Social

Biomedical Psychological

Policy and Regulatory Implications of

Clinical Pharmacogenomics Testing in Opioid Use Disorder Management

38

Key Stakeholder

Perspectives on

Policy-Relevant

Concerns

Surrounding

Pharmacogenomics Ettienne/Ofoegbu

39

Barriers to Implementation of

Clinical Pharmacogenomics Testing

HCP knowledge of

PGx

Dissemination of PGx test

results

Housing of PGx data (MD vs.

PharmD)

Clinical decision support

Integration of PGx data into

the EMR

Cost-effectiveness

of testing

Payor reimbursement

Preemptive v. reactive testing

Diversity of PGx testing algorithm

40

DNA

Sequencing

Costs (2001-

2015)

41

Pre-emptive vs. Reactive Clinical

Pharmacogenomics Testing

Have PGx test results readily

available

Bulk testing may reduce costs

Only order PGx testing for genes of

interest

More costly upfront

May order more than what is needed

Lag time due to lab analysis may delay availability of test

results

Pre-emptive Reactive

Pros:

Cons:

42

Implementation of

Clinical

Pharmacogenomics

Testing in the

Accountable Care

Organization

Accountable Care

Organization

Patient Centered

Medical Home

Patients Health Care

Providers (HCPs)

Physicians (order PGx test)

Pharmacists (interpret/house

results)

Other HCPs (nurses, etc.)

HCPs work collaboratively to

implement clinical

pharmacogenomics testing

43

FDA Response to Opioid Epidemic 44

FDA Opioid Action Plan

Expand use of advisory committees

Develop warnings and safety information for immediate-release (IR) opioid labeling

Strengthen postmarket requirements

Update Risk Evaluation and Mitigation Strategy (REMS) Program

Expand access to abuse-deterrent formulations (ADFs) to discourage abuse

Support better treatment

Reassess the risk-benefit approval framework for opioid use

Source: https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm484714.htm

45

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48

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https://ghr.nlm.nih.gov/primer/mutationsanddisorders/possiblemutations

3. Illustration: National Library of Medicine (US). Genetics Home Reference [Internet]. Bethesda (MD): The Library; 2017

Sep 26. [Illustration] Insertion; [cited 2017 Sep 26]; [about 1 screen]. Available from: https://ghr.nlm.nih.gov/primer/mutationsanddisorders/possiblemutations

4. Illustration: National Library of Medicine (US). Genetics Home Reference [Internet]. Bethesda (MD): The Library; 2017

Sep 26. [Illustration] Deletion; [cited 2017 Sep 26]; [about 1 screen]. Available from:

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Sep 26. [Illustration] Frameshift mutation; [cited 2017 Sep 26]; [about 1 screen]. Available from:

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Sep 26. [Illustration] Repeat expansion; [cited 2017 Sep 26]; [about 1 screen]. Available from:

https://ghr.nlm.nih.gov/primer/mutationsanddisorders/possiblemutations

49

PCSS-O Colleague Support Program

and PCSS Discussion Forum • PCSS-O Colleague Support Program is designed to offer general information to health professionals

seeking guidance in their clinical practice in prescribing opioid medications.

• PCSS-O Mentors comprise a national network of trained providers with expertise in addiction

medicine/psychiatry and pain management.

• Our mentoring approach allows every mentor/mentee relationship to be unique and catered to

the specific needs of both parties.

• The mentoring program is available at no cost to providers.

• PCSS Discussion Forum: A resource that provides an “Expert of the Month” who will answer questions about educational content that has been presented through PCSS projects. To join, register here:

http://pcss.invisionzone.com/register

For more information on requesting or becoming a mentor visit:

www.pcss-o.org/colleague-support

50

PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership

with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American

Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of

Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American

Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA),

American Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and Southeast Consortium for Substance Abuse Training (SECSAT).

For more information visit: www.pcss-o.org

For questions email: pcss-o@aaap.org

Twitter: @PCSSProjects

Funding for this initiative was made possible (in part) by grant no. 5H79TI025595-03 from SAMHSA. The views expressed in written conference materials or publications and by

speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices,

or organizations imply endorsement by the U.S. Government.

51

Questions?

52