gender differences and substance abuse: eliminate

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#Rx Summit www.NationalRxDrugAbuseSummit.org

Gender Differences and Substance Abuse: Eliminate Discrimination,

Improve Treatment and Save LivesAndrea Barthwell, MD, DFASAM, Founder and Director

Two Dreams Treatment CentersShruti Kulkarni, JD, Policy Director,

Center for Lawful Access and Abuse DeterrenceBehshad Sheldon, Chair, Board of Directors,

Female Opioid-Addiction Research and Clinical Experts

Advocacy Track

Moderator: Michael Barnes, JD, Chairman, Center for Lawful Access and Abuse Deterrence, and Member, National Rx

Drug Abuse & Heroin Summit Advisory Board

#Rx Summit www.NationalRxDrugAbuseSummit.org

Disclosures

Shruti Kulkarni, JD, and Michael Barnes, JD, have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

Andrea Barthwell, MD, DFASAM – Consulting fees: Braeburn Pharmaceuticals, Appletree Partners, Ideal Option, Treatment Management Company, LLC; Ownership Interests: Encounter Medical Group, Treatment Partners, EMG Global

Behshad Sheldon – Salary and Ownership Interest: Braeburn Pharmaceuticals

#Rx Summit www.NationalRxDrugAbuseSummit.org

Disclosures

All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

The following planners/managers have the following to disclose:- Kelly J. Clark, MD, MBA, FASAM, DFAPA –

Consulting fees: Braeburn, Indivior

#Rx Summit www.NationalRxDrugAbuseSummit.org

Learning Objectives

Describe how gender differences play an important role in addiction and other disease progression, effects of medications, and barriers to treatment.

Identify laws and other institutionalized sanctions that are levied against people with SUDs —especially against women with addiction.

Recommend practical solutions that can help improve treatment and reduce discrimination and societal costs.

#Rx Summit www.NationalRxDrugAbuseSummit.org

Gender Differences and Substance Abuse: Eliminate Discrimination,

Improve Treatment and Save LivesAndrea Barthwell, M.D., D.F.A.S.M.

Behshad SheldonShruti Kulkarni, J.D.

#Rx Summit www.NationalRxDrugAbuseSummit.org

https://www.vogue.com/article/opioid-crisis-womens-health-heroine-oscar-nominated-documentary-

addiction-recovery

It’s Time to Talk About the Opioid Crisis as a Women’s Health IssueMARCH 6, 2018 4:38 PMBY IVANA RIHTER

#Rx Summit www.NationalRxDrugAbuseSummit.org

Disclosures: Dr. Andrea Barthwell

Apple Tree Partners (Consultant) Braeburn Pharmaceuticals (Consultant) Encounter Medical Group, P.C. (Partner) Ideal Options (Consultant) Treatment Management Company LLC

(Consultant) Treatment Partners LLC (Owner) Two Dreams (Founder) U.S. DOJ (Consultant)

#Rx Summit www.NationalRxDrugAbuseSummit.org

Disclosures: Behshad Sheldon

Epiodyne (consultant) R-pharm-US (consultant) Camurus (consultant)

#Rx Summit www.NationalRxDrugAbuseSummit.org

Disclosures: Shruti Kulkarni

Shruti Kulkarni has no relevant, real or apparent, personal or professional, financial conflicts to disclose. CLAAD’s funders include members of the

pharmaceutical, addiction treatment, and laboratory industries, and are disclosed on its website, www.claad.org.

#Rx Summit www.NationalRxDrugAbuseSummit.org

Topics

Women’s Health Considerations Substances and Consequences Screening Tools Treatment Needs Regulatory, Legislative, and Policy

Considerations Call to Action

#Rx Summit www.NationalRxDrugAbuseSummit.org

Fundamental Beliefs

Drug use is a preventable behavior Addiction is a

treatable disease of the brain Recovery is possible

#Rx Summit www.NationalRxDrugAbuseSummit.org

#Rx Summit www.NationalRxDrugAbuseSummit.org

#Rx Summit www.NationalRxDrugAbuseSummit.org

To link to this article: http://dx.doi.org/10.1080/10550881003684640

#Rx Summit www.NationalRxDrugAbuseSummit.org

Women’s Health

572,000 admission to SA Tx vs. 182,000 diagnoses of breast CA (2006) $182 billion per year Historical perspective

- Social exclusions- 1973 Our Bodies, Our Selves- 1994 NIH Guidelines

Exclusions c/w fetal health, premature birth, LBW, language developmental delays

#Rx Summit www.NationalRxDrugAbuseSummit.org

Special Characteristics

Initiate later than men Lower educational attainment Lower employment rates Lower average age at admission More likely to have using partner More likely to have major psychological

diagnosis- Major depression- Predates substance use

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Telescoping

Well established with alcohol Progress faster than in men to alcoholism, to

consequences, from 1st use to dependence, from regular use to problematic use 50-100% higher rate of premature death More circulatory and hepatic disease Comparable incidence of ulcer, GI bleeds, fatty

liver, obesity, anemia, malnutrition

#Rx Summit www.NationalRxDrugAbuseSummit.org

Alcohol and Telescoping Theories

- Lower free body water leads to higher BAC at same rates of consumption

- Lower alcohol dehydrogenase with lower metabolism and higher absorption

Socio-cultural rituals and protective factors- Binge rates 28 to 34% from 1995 to 2007- Senior drinking over 5 per session point

difference dropped from 23 to 7 from 1975 to 2006

- Single sex settings

#Rx Summit www.NationalRxDrugAbuseSummit.org

Conditions Liver: mortality 2x greater for men over women but

cirrhosis develops at faster rates for women v. men Cirrhotic threshold at half the rates for women v.

men (7-13 v. 14-27 drinks per week) -Becker Cardiovascular disease: 35% of U.S. women with

disease, heavy drinking increases risk- Saremi- moderate drinking is protective but >

3/day raises TG, cardiomyopathy, HTN, and stroke

- Ikehara- 3500 men and 4900 women studied increased risk of coronary disease; in men 69 gm, in women 23-46 grams. 3x increased if > 46 grams/day

#Rx Summit www.NationalRxDrugAbuseSummit.org

AHA Recommendations

To protect against cardiac disease, drinking is not as effective as:- Decreasing cholesterol- Decreasing BP- Balancing diet- Regularly exercising- Controlling weight

#Rx Summit www.NationalRxDrugAbuseSummit.org

Endocrine

Alcohol increases cortisol, which increases HTN and metabolic disturbances, decreases immune function, and disturbs the HPA axis In 2005, > 60% women were overweight or

obese- 80% NHB women- 70% H women- Associated with cardiac disease, HTN, Type

II DM, and respiratory cancers

#Rx Summit www.NationalRxDrugAbuseSummit.org

Endocrine, continued

Schroder: > 3 drinks/day associated with abdominal obesity (Type II DM) DM: 9.5 million women with diagnosis, 2.5

million undiagnosed, 23 million pre-diabetic Women > men with diagnosis, especially NHB

women (106/1000 v. 69/1000 NHW women)- Abstinence and high consumption increases

risk

#Rx Summit www.NationalRxDrugAbuseSummit.org

Endocrine, continued

Osteoporosis: 8 million in U.S. (80% of cases) Felson et al- 7 oz./week increases risk of hip

fracture- Women (54% increase) v. men (26%)

Kanis- Review of 3 studies (6,000 men v. 11,000 women)- With moderate and large amounts consumed,

increase risk of fracture, osteoporotic fracture, and hip fracture

Diaz- decreased risk of vertebral deformity if alcohol consumed > 5 day/week in > 65 y/o

#Rx Summit www.NationalRxDrugAbuseSummit.org

National Osteoporosis Foundation Recommendation

Do not drink for benefit Weight bearing exercise to increase bone

density Prevention with family history

#Rx Summit www.NationalRxDrugAbuseSummit.org

Cancer

Lung- 219,000 per year- Bandera et al- research inconclusive- Pollack- if > 40 ounces/month see 2x incidence- Djousee- 2 drinks/day is associated with 2x

incidence lung CA Breast- 2.5 million women with diagnosis, > 40,000

die annually- Irrespective of what is consumed, alcohol

increases risk of CA- Allen et al- 1.28 million women studied, for every

10 gm increase/day, risk of CA increases 12%

#Rx Summit www.NationalRxDrugAbuseSummit.org

Cancer, continued

Breast, continued- Longnecker- with increasing age, risk

increases with increasing consumption (if over 30 y/o)

GU CA- endometrial CA is most common in reproductive tract; 554,000 - Studies inconclusive, but suggestive

#Rx Summit www.NationalRxDrugAbuseSummit.org

Other Cancers

Allen et. al Million Woman Study (1.28 million middle-aged women followed 7 years)

69,700 cancers during f/u- 10% rectum- 24% liver- 12% breast increased with every 10 gm

increase/day - 29% H and N, oral cavity, pharynx- 22% esophagus- 44% larynx

#Rx Summit www.NationalRxDrugAbuseSummit.org

Work Up

CAGE TWEAK T-ACE AUDIT Apply when woman has

- Vague c/o- Stressful life events- Partner who uses- Quasi-legitimate use as a medicine

#Rx Summit www.NationalRxDrugAbuseSummit.org

Social Consequences

Intimate partner violence HIV/AIDS STDs

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The more we know about the complexity of addiction, the more effectively we can treat it and advocate for those with the disease.

#Rx Summit www.NationalRxDrugAbuseSummit.org

IOM, Broadening the Base of Treatment for Alcohol Problems, Washington, D.C.: National Academy Press, 1990a.

“The overall goal of treatment is to reduce or eliminate the use of alcohol [and/or other drugs] as a contributing factor to physical, psychological, and social dysfunction and to arrest, retard, or reverse the progress of any associated problems.”

#Rx Summit www.NationalRxDrugAbuseSummit.org

Treatment is…

Identification Brief intervention Assessment Diagnosis Counseling Medical, psychiatric, psychological, and social

services Follow-up

Treatment Gap

Did not feel need for treatment5,938,000

Received treatment1,400,000

Sought but did not get treatment88,000

Felt need but did not seek treatment274,000

#Rx Summit www.NationalRxDrugAbuseSummit.org

Current Knowledge

Some is better than none More is better than less Treatment is best when driven by

assessment, buttressed with case management, and completed with follow up care in the community

#Rx Summit www.NationalRxDrugAbuseSummit.org

Motivation to Enter/Sustain Tx

Need not be voluntary Sanctions/enticements can increase

entry/retention Similar outcomes no matter the cause

#Rx Summit www.NationalRxDrugAbuseSummit.org

Non-Medication Treatments

May be effective for some people May work only to a certain point Need to target the non-rational survival brain,

not just the cortex

#Rx Summit www.NationalRxDrugAbuseSummit.org

Medication Targets

Facilitate treatment- Restore homeostasis- Co-morbid conditions

Relapse prevention- Stress reduction- Cues/craving/withdrawal- Cognitive/decision pause (thought to action)- Block action of drugs

#Rx Summit www.NationalRxDrugAbuseSummit.org

Combination Treatments

Medications in combination with counseling and psychotherapies may be the best addiction treatment we have at this point- Treat the survival/pleasure system

abnormalities with medications to facilitate abstinence and prevent relapse

- Treat the cortical decision-making system with counseling and therapies

#Rx Summit www.NationalRxDrugAbuseSummit.org

The Disease is Addressed With…

Non-medical treatment Medications Peer support Professional guidance Exercice Diet Ritual

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Twelve Step Facilitation Brain Recovery

Supports abstinence- Tones down the drive of the pleasure-reward

pathway Retrains the brain

- Provides healthier structure and ritual- Offers specific suggestions on a new way of

living and behaving Retools the emotions

- Modulates emotions- Works through connections with others- Provides safe structure for expression

#Rx Summit www.NationalRxDrugAbuseSummit.org

TSF Brain Recovery, cont.

Offers a range of interventions- Simple (slogans) to complicated (in-depth Step

work) for different stages of brain healing and recovery

Builds responsibility and better judgment- Provides a blueprint for living sober (Steps)- Exercises the prefrontal cortex - Provides constant reminders of needed behavior

changes and reinforcement of changes Is (almost) always available

#Rx Summit www.NationalRxDrugAbuseSummit.org

Mature Recovery

Well-learned habits of avoiding dangers Ample social networks Solid intimate relationships Healthy recreation and relaxation Employment and career development Philosophy of life Key activities or interests Acceptance of the past

#Rx Summit www.NationalRxDrugAbuseSummit.org

Gender Differences

Most research until recently was gender neutral Missed opportunities for prevention, incorrect

diagnoses, misinformed treatments, sickness, and death- 8 of the 10 prescription drugs withdrawn from the

market from 1997 to 2001 posed greater health risks for women than for men

- In 2013, FDA recommended first sex-specific dose (zolpidem)

• Medication on market 20 years

#Rx Summit www.NationalRxDrugAbuseSummit.org

Gender Differences

Biology - Fat storage – antipsychotics, antidepressants,

and antianxiety - Digestion/gastric acid – antifungals

(ketoconazole), antibiotic (tetracycline)- Other sex-related factors – heart medications,

pain medication Estrogen

- Fluctuations- Liver - Kidney

#Rx Summit www.NationalRxDrugAbuseSummit.org

Barriers to Women Seeking Treatment

Greater risk of arrest and criminalization - 24 states & DC consider substance use during pregnancy

to be child abuse; 3 consider it grounds for civil commitment

- 23 states & DC require health care professionals to report suspected prenatal drug use

Lack of Access - Only 10 states prohibit publicly funded drug treatment

programs from discriminating against pregnant women- Only 19 states have treatment programs specifically

designed for pregnant women Lack of childcare

#Rx Summit www.NationalRxDrugAbuseSummit.org

Recent Setbacks and Progress

Setbacks - States continue introducing new legislation criminalizing

women with SUD (e.g., MT & MO) Progress

- KY – PATHways, a one-stop shop for pregnant women in recovery, offering counseling, MAT, prenatal care, and parenting classes.

- MD – Launching coalitions to help women in recovery by providing supportive housing that welcomes children

- NJ – Allocated funding for gender-specific addiction plans that include family-centered treatment and trauma-informed care

#Rx Summit www.NationalRxDrugAbuseSummit.org

Federal Initiatives FDA – Diverse Women in Clinical Trial Initiative

- Office of Women’s Health, in collaboration with the NIH Office on Research in Women’s Health, launched the initiative to raise awareness about the importance of participation of diverse groups of women in clinical research, and to share best practices about clinical research design, recruitment, and subpopulation analyses

Improving Treatment for Pregnant and Postpartum Women- Authorizes $100 M to provide substance use treatment for pregnant

and postpartum women through programs in which, during the course of receiving treatment, (1) the women reside in facilities provided by the programs; (2) the minor children of the women reside with the women in such facilities, if the women so request; and (3) certain services are available to or on behalf of the women

#Rx Summit www.NationalRxDrugAbuseSummit.org

SAMHSA Grant Proposals 13 states proposed programs that refer to pregnant or parenting

women as a priority or target population (AZ, AK, IN, KY, ME, MA, MN, MS, MT, NH, TN, TX, WV)

AZ: increase the likelihood of recovery success by expanding peer support services, recovery homes, and recovery supports to pregnant and parenting women

AK: expand availability of MAT for pregnant and parenting women WV: increase access to OUD treatment; supplement evidence-

based prevention, treatment, and recovery activities pertaining to opioids currently undertaken; and support a comprehensive response to the opioid epidemic statewide. Anticipates that program will serve 520 pregnant/postpartum women with prevention, early intervention, treatment, and recovery support services for SUD

#Rx Summit www.NationalRxDrugAbuseSummit.org

Policy Recommendations

Substance-related education and prevention Eliminate laws and other institutionalized forms of

discrimination Advance laws, policies, and programs that improve

access to treatment Advancing legislation to provide access to health

care in jails through private or public insurance Eliminating economic sanctions levied against

people whose SUDs are managed as a chronic disease

#Rx Summit www.NationalRxDrugAbuseSummit.org

Women’s Influence

Women are positioned to influence health care policies and practices Health care utilization Health care decision making FORCE: advocacy and activism

#Rx Summit www.NationalRxDrugAbuseSummit.org

Gender Differences and Substance Abuse: Eliminate Discrimination,

Improve Treatment and Save LivesAndrea Barthwell, MD, DFASAM, Founder and Director

Two Dreams Treatment CentersShruti Kulkarni, JD, Policy Director,

Center for Lawful Access and Abuse DeterrenceBehshad Sheldon, Chair, Board of Directors,

Female Opioid-Addiction Research and Clinical Experts

Advocacy Track

Moderator: Michael Barnes, JD, Chairman, Center for Lawful Access and Abuse Deterrence, and Member, National Rx

Drug Abuse & Heroin Summit Advisory Board

THANK YOU#RxSummit

www.NationalRxDrugAbuseSummit.org

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