Role of the Pharmacist in

Transgender Healthcare

Jan S. Redfern, PhD

President, Redfern Strategic Medical Communications, Inc
Adjunct Assistant Professor, Department of Pharmacotherapy,
University of North Texas System College of Pharmacy, Fort Worth, TX

jan@redfernstrategic.com
 Pharmacists’ Role In
1

TG Healthcare
 Pharmacists are increasingly part of integrated team
delivering healthcare to TG or gender non-conforming people
— General practitioner, endocrinologist, psychiatrist, social
worker

 Pharmacists can be accessible, trusted providers for TG

patients
— Feel safer opening up with pharmacist vs. physician

 However, pharmacists may feel inadequately equipped to

understand and interact with TG individuals

 No public policy statement from American Pharmacists’

Association on role of pharmacists in caring for TG patients
 2

Rowan, TG man

“I think pharmacists play an incredibly vital role in my healthcare.

They help me manage my health, offer a wealth of information,
and are key in my overall well-being.

Walking into a pharmacy and having the people behind the

counter validate my identity as a TG man and walk me through
my testosterone prescription as easily as they would penicillin
makes the entire experience truly positive.

Knowing my pharmacist is educated about my community and is

invested in my care is invaluable. ”
 Pharmacy Residents’ Perceptions
3

 2015 survey of US community pharmacy residents’ perceptions

of TG healthcare (N=63)

TG patients deserve same care

98%
as cisgender patients

Responsibility to treat TG patients 98%

Pharmacists play important role in

83%
TG care

Not educated about TG patients

71 %
in pharmacy school

Confident to treat TG patients 36%

Leach C Layson-Wolf C. J Am Pharm Assoc 2016; 56:441-445

 Cultural Competency in TG Healthcare

Challenge messages from

Understand terminology
cultures, families, religions,
about gender, sex, and
and peers influencing our
sexual orientation
beliefs or actions

Cultural
Competence

Promote sensitive,
Understand transphobia in
responsive, and affirming TG
our society
healthcare
 Transgender People
 Wide spectrum of individuals whose gender identity,
gender expression, or behavior does not conform to that
typically associated with the sex assigned to them at birth

 Some undergo surgeries or take hormones, many do not

Transman (FtM) Gender non-conforming Transwoman (MtF)

Male gender Genderqueer, two-spirit, Female gender
identity and a and third gender identity and male
female birth- birth-assigned sex
assigned sex
 How Many TG People Are There?

 CDC’s Behavioral Risk Factor Surveillance System

estimates of prevalence of TG in adult population
— 1.4 million (0.6%) in US

Roughly the population of Hawaii

— 125,000 (0.7%) of adults in Texas

Flores AR et al. 2016. How Many Adults Identify as Transgender in the United States? Los Angeles, CA: The Williams Institute.
 TG Etiology

 Biologic, environmental, and cultural factors are all believed

to play a role in the evolution of gender identity
— Prenatal/postnatal sex hormone effects
— Infant, adolescent experiences
— Genetic influences
— Neurodevelopmental differences:
 Bed nucleus of stria terminalis
 Corpus callosum
 Uncinate nucleus
 Is Being TG a Mental Illness?
 Gender nonconformity
— “Not in itself a mental disorder” (APA)

 Gender dysphoria DSM-5 (formerly GID)

— Marked difference between gender identity and birth sex
— Desire to be treated as other gender and change sex
characteristics
— Causes clinically significant distress
— Impairs social, occupational, or other important areas of
functioning

 ICD-11 proposal: Transsexualism (mental health and disorders)

 gender incongruence (conditions related to sexual health)

 Being transgender does not imply any specific sexual orientation

ICD = International Classification of Diseases, DSM = Diagnostic and Statistical Manual of Mental Disorders,
APA = American Psychiatric Association
Evolution of Diagnostic Criteria

 GID in DSM-IV changed to gender dysphoria in DSM-5

— Depathologize the condition
— Focus more on distress experienced by individuals (while
preserving a diagnosis for insurance coverage)

 Trend of depathologization mirrored in proposed changes to

ICD-11
Archaic ICD-10 designation of transsexualism (F64.0) in mental
health and behavioral disorders section

Gender incongruence in conditions related to sexual health in ICD-11 (2018)

 DHHS: Legal Definition of Sex

 DHHS spearheading an effort to establish a legal definition

of sex under Title IX
— Bans discrimination on the basis of sex in education
programs that receive government financial assistance

 DHHS memo: Government agencies need to adopt an

explicit and uniform definition of gender
— “Sex means a person’s status as male or female based on
immutable biological traits identifiable by or before birth”
— Any dispute about one’s sex to be clarified using genetic
testing
 Stages of Transition: MtF
Hormone Real-life
therapy
Experience – surgeons require 2 years real life experience
(GnRH blocker)
Gender
Coming
Name affirmation
out
change surgery

decisions
Electrolysis
Fertility
Laser therapy

Cosmetic
surgery
Diagnostic assessment Clothing, Change
Psychotherapy voice legal sex,
Counseling body language birth certificate

 Meet individuals at various stages of transition

— Unexpected combinations: breasts and penis or beard and pregnancy
Medical Care Sought by TG Patients
 Cross-sex hormone therapy or surgery to alter secondary
sexual characteristics of the body

 Psychotherapy or counseling

 Preoperative evaluations with procedures and medications

 Routine postoperative care and management of surgical

complications (e.g. pain mgt., antibiotics)

 Facial hair removal (e.g. laser, electrolysis); topical analgesics

 Chronic disease management

 Speech language pathology and culture (e.g. FTM - what do

men/women typically do?)
 Surgical Treatment Sought by
Transwomen (MtF) Patients
 Breast augmentation

 Orchiectomy

 Penectomy

 Vaginoplasty/vuvloplasty

 Facial feminization surgery

 Tracheal cartilage shave

 Vocal feminization (endoscopic glottoplasty for vocal

chord shortening)

 Liposuction and body contouring

 Surgical Treatment Sought by
Transmen (FtM) Patients
 Mastectomy

 Hysterectomy/salpingo-oophorectomy

 Chest reconstruction

 Metoidioplasty - Testosterone replacement therapy gradually enlarges

the clitoris to an average size of 4–5 cm. In a metoidioplasty, the urethral
plate and urethra are completely dissected from the clitoral corporeal
bodies, then divided at the distal end, and the testosterone-enlarged
clitoris straightened out and elongated

 Urethroplasty

 Clitoral free-up

 Phalloplasty, vaginectomy

 Scrotoplasty, implants
 15
Procedures in TG Individuals

Transwomen Transmen
Hair removal 48% Chest surgery 36%

Voice therapy 14% Hysterectomy 14%

Vaginoplasty 12% Metoidioplasty 2%

Mammoplasty 11% Phalloplasty 3%

Facial surgery 7%

Silicone injections 3%
Emergence of Gender Dysphoria

 Gender dysphoria may occur as early as 2 years (early onset) or

around puberty or in adulthood (late-onset)

 In children, manifests in several ways

— Preference for clothes/toys typically associated with other sex
— Predilection to play with other-sex peers
— Unhappy with physical sex characteristics

 Gender dysphoria may disappear by puberty or persist and

intensify in adolescence and adulthood
— Strong wish for hormones/surgery, puberty suppression
— Begin living in desired gender role
— Link to anxiety, depression, oppositional defiant disorder

DSM V, American Psychiatric Association, 2013

 Gender Dysphoria: Child vs. Adolescent

TG Children (<12 yr) TG Adolescents (12-18 yr)

Referral rate 3-6 boys for each girl 1 boy for each girl
Persistence of gender
dysphoria into adulthood
Boys 2% to 23% 67% to 100%
Girls 12% to 50% 50%

 Greater fluidity in gender identity in prepubertal children

 Feminine behavior in boys more indicative of later sexual orientation than

cross-gender identity

Drummond et al. Dev Psychol 2008;44:34-45. Wallien et al. J Am Acad Child Adolesc Psychiatry 2008; 47:1413.
De Vries et al. J Sex Med 2011;8:2276. Zucker Child and Adolescent Psychiatry Clin NA 2004;13:551. Cohen-Kettenis
Transgenderism and intersexuality in childhood and adolescence: Making choices. Sage: Thousand Oak, CA
 Managing Gender Dysphoric Children

Involves counseling to No attempt to lessen gender

reinforce gender dysphoria or cross-gender
stereotypes Reparative Watchful behavior
waiting
Premise: Gender Premise: For many children,
dysphoria is reinforced gender dysphoria does not
if cross-gender persist into adolescence and
behavior allowed to beyond
continue
Intervention
Controversial Actively affirm cross-gender identity

Premise: Early transition and pubertal

suppression optimizes outcome

 Overall approach—early individual/family therapy to encourage acceptance of

child’s budding gender development yet remain open to fluidity of gender
identity
Zucker KJ. J Am Acad Child Addolesc Psychiatry 2008; 47:1361. Edwards-Leeper L, Spack N. J Homosex 2012;
59:321
 Benefits of Pubertal Suppression

 Arrest development of secondary sex characteristics

 Leads to easier transition later on by preventing difficult to

reverse anatomical changes

 Buys time for adolescent to work with psychotherapist to

determine whether full transition is appropriate

 Allows adolescent to explore gender identity without distress of

puberty

 Reversible intervention shown to decrease behavioral/emotional

problems and depression and improve general functioning

Edwards-Leeper L et al. J Homosexuality 2012;59:321. de Vries ALC et al. J Sex Med 2011;8:2276-2283.
 20
American College of Pediatricians

 Urges healthcare professionals, educators and legislators

to reject all policies that condition children to accept as
normal a life of chemical and surgical impersonation of
the opposite sex

 Facts – not ideology – determine reality

http://www.acpeds.org/the-college-speaks/position-statements/gender-ideology-harms-children
 Treatment Interventions: Reversibility

 Patients are recommended to fully dress as and assimilate

to the gender they desire to become
Fully Reversible Partially Reversible Irreversible
• Use of GnRH • Hormonal therapy to • Surgical procedures:
analogues to delay masculinize or • Mastectomy
puberty feminize the body • Genital
• Progestins except reassignment
(medroxyprogestero • Testosterone to
ne to decrease deepen the voice
androgen secretion (irreversible)
• Spironolactone to • Estrogens to induce
decrease androgen gynecomastia
secretion (reversible but
• Oral contraceptives residual tissue may
to stop menses need surgery)
Wilczynski C and Emanuele MA. PostGrad Med 2014; 126: 121-128
 22
Treatment Guidelines TG MtF

 Oral estradiol: 2.0–6.0 mg/d

 Estradiol transdermal patch (New patch every 3–5 d): 0.025–0.2

mg/d

 Estradiol valerate/cypionate: 5–30 mg IM q 2 wk, 2–10 mg IM q

week

 Spironolactone: 100–300 mg/d

 Cyproterone acetate: 25–50 mg/d

 GnRH agonist (e.g., leuprolide): 3.75 mg SQ (SC) monthly

Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, November 2017,
 23
Treatment Guidelines TG FtM

 Testosterone enanthate or cypionate: 100–200 mg SQ (IM)

every 2 wk or SQ (SC) 50% q week

 Testosterone undecanoate: 1000 mg q 12 wk

 Transdermal testosterone gel 1.6%: 50–100 mg/d

 Testosterone transdermal patch: 2.5–7.5 mg/d

Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, November 2017,
 24
Masculinizing Effects in TG FtM
Effect Onset Maximum
Skin oiliness/acne 1–6 mo 1–2 y
Facial/body hair growth 6–12 mo 4–5 y
Scalp hair loss 6–12 mo continuous
Increased muscle mass/strength 6–12 mo 2–5 y
Fat redistribution 1–6 mo 2–5 y
Cessation of menses 1–6 mo Continuous
Clitoral enlargement 1–6 mo 1–2 y
Vaginal atrophy 1–6 mo 1–2 y
Deepening of voice 6–12 mo 1–2 y

Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, November 2017,
 25
Feminizing Effects in TG MtF
Effect Onset Maximum
Redistribution of body fat 3–6 mo 2–3 y
Decrease in muscle mass and strength 3–6 mo 1–2 y
Softening of skin/decreased oiliness 3–6 mo Unknown
Decreased sexual desire 1–3 mo 3–6 mo
Decreased spontaneous erections 1–3 mo 3–6 mo
Male sexual dysfunction Variable Variable
Breast growth 3–6 mo 1–2 y
Decreased testicular volume 3–6 mo 1–2 y
Decreased sperm production Unknown 1–2 y
Decreased terminal hair growth 6–12 mo >3 yr
Scalp hair Variable -
Voice changes None -

Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, November 2017,
 26
Medical Risks of Hormone Therapy
TG MtF receiving estrogen
 Very high risk:
— Thromboembolic disease

 Moderate risk:
— Macroprolactinoma, breast cancer, CAD, cerebrovascular
disease, cholelithiasis, hypertriglyceridemia

TG FtM receiving testosterone

 Very high risk:
— Erythrocytosis (hematocrit > 50%)

 Moderate risk:
— Severe liver dysfunction (transaminases >3xULN), CAD,
cerebrovascular disease, hypertension, breast or uterine cancer

Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, November 2017,
 27
Psychosocial and Quality of Life
Benefits of Transitioning
100  Meta-analysis of 28 studies
80% 78% 80%
80 72%  Subjects with GID undergoing
gender reassignment that
60 included hormone therapy
40 — 1093 MtF, 801 FtM

20
 Psychological functioning after
0 reassignment comparable to
non-TG population

 Evidence poor
— No controls, not randomized
— Patient self-reporting
— Limited follow-up

Murad MH et al. Clin Endocrinol 2010; 72:214-231.

 Long-Term Follow-Up After Sex- 28

Reassignment
 Population-based cohort study in Sweden

 324 sex-reassigned persons and birth

year/sex matched controls (appropriate?)
Short-term
studies  SRS had higher rate of
— Overall mortality (HR 2.8)
— Suicidal death (HR 19.1)

 Is this SOC really the best we can do?

 Causes:
— Internalizedtransphobia persisting
regardless of therapy
— Social forces repressing gender
nonconformity and creating psychosocial
Dhejne C et al PloS One 2011; 6:e16885
stress (minority stress model)
 Gender-Affirmative Healthcare for
TG People
 TG peoples’ physical, mental, and social health needs
involves respectfully affirming their gender identity

Preferred name, Gender identity Puberty blockers, Name change,

pronoun respected, hormones, surgery sex marker
validated change

Reisner SL, et al. J Acquir Immune Defic Syndr 2016;72:S235–S242

 30
Conscience and Religious Freedom
 Trump Administration plans to form Conscience and Religious
Freedom Division within its Office for Civil Rights

 “The Conscience and Religious Freedom Division has been

established to restore federal enforcement of our nation’s
laws that protect the fundamental and unalienable rights of
conscience and religious freedom”

 Unclear whether this new Division would make it easier for

healthcare providers and hospitals to deny treatment to TG
patients if it conflicts with their individual beliefs

www.hhs.gov/about/news/2018/01/18/hhs-ocr-announces-new-conscience-and-religious-freedom-division.html
 How Pharmacists Can Help 31

TG Patients
 Help TG patients understand their medications
— Goals, expectations, risks and benefits
— Typical for physical outcomes of HT and GnRH analogs
— Prevent and treat AEs

 Help coordinate care, prescription assistance programs and

provider referrals

 Know biologic sex

— Creatinine clearance for dosing protocols
— Avoid teratogenic agents (transmen of childbearing potential)

 Provide culturally sensitive care

— Foster TG-inclusive, welcoming environment
Redfern, JS, Jann M. The evolving role of the pharmacist in healthcare. Transgender Health. 2019 (in press).
 How Pharmacists Can Help 32

TG Patients
 Avoid assumptions about gender identity or sexual orientation

 Use preferred gender identity, name, pronouns

— If unsure, use gender neutral language or politely ask

 Consider adding a name and pronoun-in-use option on intake

forms and in pharmacy records

 Make pharmacy forms inclusive beyond male/female binary

 Be aware that some TG people have insurance and

identification documents that do not accurately reflect their
current name or gender identity

 Provide single occupancy gender-neutral restrooms

Redfern, JS, Jann M. The evolving role of the pharmacist in healthcare. Transgender Health. 2019 (in press).
 Burgeoning HIV in TG People 33

 TG women carry a heavy burden of HIV/AIDS

 HIV prevalence 20% (as high as 44% in India)

 Odds of HIV infection 49-fold greater vs. general population

 Less likely to access and utilize HIV services

Baral SD et al Lancet Infect Dis 2013; 13:214-222; Poteat T et al. Acquir Immune Defic Syndr 2016;72:S210–
S219; Herbst JH et al AIDS Behav 2008; 12:1-17; Neumann MS et al. AJPH Transgender Health; 2017; 107
p207-212.
 Drug-Drug Interactions

 Many complex DDIs between hormonal therapy and HIV drugs

 Further complicated with presence of comorbid diseases (e.g.,

epilepsy) in TG persons
— HIV medications, antiepileptics, and hormones co-prescribed

 Ethinyl estradiol ± progestins in contraceptive pills interact with

NNRTIs and protease inhibitors boosted with ritonavir

 Extent of DDIs with higher estradiol doses used in hormone

therapy in TG individuals remains unclear

 Perception among many HIV-infected TG women is that

antiretroviral therapy may impact feminizing effects of estrogen
Robinson JA et al. Infect Dis Obstet Gynecol 2012;2012:890160.
 35
Patient Concern That ART Impacts
Estrogen Therapy
 Cross-sectional survey of TG women (n = 87) in Los Angeles, CA

Living with HIV and on ART 54%

Used hormone therapy 64%

Discussed ART-HT interactions with
provider
49%
Not taking ART, HT, or both as directed
due to DDI concerns
40%

 Raises concerns regarding

— Sub-optimal adherence to antiretroviral therapy

— Increased risk of resistance to ART, virologic failure

— Increased transmission to partners, especially drug-resistant HIV

Braun HM et al. LGBT Health 2017;4:371-375.

 36
Summary

 Many TG patients experience bias in the healthcare system,

which leads to numerous healthcare disparities as well as barriers
to care

 Pharmacists play an important role in the healthcare system and

can take positive steps to promote the health of their TG patients
by examining
— Their patient interactions
— Pharmacy environments, policies and staff training