Attachment 6 - IHSC Sample Clinical Guidelines.pdf

Clinical Guidelines for the Diagnosis, Evaluation and Management of Adults with Asthma (≥ 12 years of Age)

Introduction:

As all Guidelines are intended to be flexible, they serve as recommendations, not rigid criteria. The guideline for asthma (reactive airway disease) should be followed in most cases, but depending on the patient, and the circumstances, the clinical practice guidelines for asthma may need to be tailored to fit individual needs. These guidelines are tied to the concept of severity, control and responsiveness and domains of impairment and risk.

1. Criteria that suggest the diagnosis of asthma:

Consider a diagnosis of asthma and perform spirometry if any of these indicators are present *:

The symptoms of dyspnea, cough and/or wheezing, especially nocturnal-difficulty breathing or chest tightness- With acute episodes: hyperventilation of thorax, decreased breath sounds, high pitched wheezing, and use of accessory muscles Symptoms worse in presence of exercise, viral infection, inhaled allergens, irritants, changes in weather, strong emotional expression, stress, menstrual cycles

Reversible airflow obstruction: FEV 1> 12% from baseline or increase in FEV 1 > 10 % of predicted after inhalation of bronchodilator, if able to perform spirometry

Alternative diagnoses are excluded.

* Eczema, hay fever, and/or a family history of asthma or atopic diseases are often associated with asthma, but they are not key indicators.

2. Goal of Therapy : Control of Asthma

A). Reduce Impairment

Prevent chronic and troublesome symptoms (e.g., coughing or breathlessness in the daytime, in night, or after exertion).

Require infrequent use (< 2 days a week) of inhaled Short-Acting Beta 2-Agonist (SABA) for quick relief of symptoms (not including prevention of exercise-induced bronchospasm [EIB])

Maintain (near) normal pulmonary function; Peak Expiratory Flow circadian variation < 20%

Maintain normal activity levels (including exercise and other physical activity and attendance at work)

Meet patients’ expectations under his/her detention environment regarding satisfaction with asthma care.

B). Reduce Risk

Prevent recurrent exacerbations of asthma and minimize the need for emergency department visits or hospitalizations.

Provide optimal pharmacotherapy with minimal or no adverse effects of therapy.

3). Refer to Asthma Specialist such as an allergist or pulmonologist when the following occurs:

A life-threatening asthma exacerbation Failure to meet the goals of asthma therapy after 3-6 months of treatment. An earlier referral or consultation is appropriate if the physician concludes that the patient is unresponsive to therapy.

Signs and symptoms are atypical, or there are problems in differential diagnosis.

Other conditions complicate asthma or its diagnosis, e.g., sinusitis;

nasal polyps; Bronchopulmonary aspergillosis (BPA) which is uncommon and results from an allergic pulmonary reaction to inhaled spores of Aspergillus fumigatus and occasionally from other Aspergillus species; severe rhinitis; vocal cord dysfunction; GERD;

chronic obstructive pulmonary disease.

Additional diagnostic testing is indicated (e.g., allergy skin testing, rhinoscopy, complete pulmonary function studies, provocative challenge, bronchoscopy)

Additional education and guidance is required on complications of therapy, problems with adherence, or allergen avoidance.

The detainee patient is being considered for immunotherapy.

The detainee patient requires step 4 care or higher.

The detainee patient has had more than two bursts of oral corticosteroids in one year or has an exacerbation requiring hospitalization.

Requiring confirmation of a history that suggests that an occupational or environmental inhalant or ingested substance is provoking or contributing to asthma. Depending on the complexities of diagnosis, treatment, or the intervention required in the detention environment, it may be appropriate in some cases for the specialist to manage the patients over a period of time or to co-manage with the IHSC provider.

Table 1 Classification of Asthma Severity ≥ 12 years of Age & Adults

Component of Severity Intermittent P E R S I S T E N T Mild Moderate Severe

Symptoms ≤ 2 days/week ≥ 2 days/week but Daily Throughout day not daily

Impairment Nighttime awakenings ≤ 2x/month 3-4x/ month ≥ 1x/week but Often 7x/week not nightly

Normal FEV1/FVC: Short-acting beta2-agonist use > 2 days/week but for symptom control ( not pre- ≤ 2 days/week not daily, and not Daily Several times

8-19 yr 85 %; vention of Exercise Induced more than 1x on any per day.

20-39 yr 80 %; Bronchospasm ) day 40-59 yr 75 %;

60-80 yr 70 %; Interference with normal activity None Minor limitation Some limitation Extremely limited

Lung Function Norm. FEV1 between FEV1 < 60% exacerbations. predicted FEV1> 80% FEV1≥ 80% FEV1> 60% but<80% FEV1/FVC reduced predicted predicted predicted 5% FEV1/FVC normal FEV1/FVC normal FEV1/FVC reduced

5% 0-1/year ( see note) ≥ 2 in 1 year ( see note)

R i s k Exacerbations requiring oral Consider severity & interval since last exacerbation. Frequency & severity may systemic corticosteroids fluctuate over time for patients in any severity category.

Relative annual risk of exacerbations may be related to FEV1

Recommended Step 1 Step 2 Step 3 Step 4 or Step 5 step for initial Rx. and consider short course of oral systemic corticosteroids ( see table 2 ) in 2-6 weeks, evaluate level of asthma control that is achieved and adjust therapy accordingly

Notes:

* Level of severity is determined by assessment of both impairment and risk. Assess impairment domain by patient's/ caregiver's recall of previous 2-4 weeks and spirometry. Assign severity to the most severe category in which any feature occurs.

* At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. In general ,more frequent and intense exacerbations (e.g.,requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity. For treatment purpose, patients who had ≥ 2 exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma.

Table 2 Stepwise Approach for Managing Asthma in ≥ 12 years of Age and Adults Table 3-1 & 3-2

Intermittent Persistent Asthma ; Daily Medication Asthma ( Consult with asthma specialist if step 4 care or higher is required. Consider consult at step 3)

Step 6 Preferred:

Step 5 High-dose Preferred: ICS +LABA + Step up if needed

Step 4 High-dose ICS+ oral corticosteroids ( first, check adherence, Preferred : LABA environmental control, Step 3 Medium -dose and & comorbid conditions) Preferred: ICS+ LABA and Consider

Step 2 Low-dose ICS+LABA Consider Omalizumab Assess Control Preferred : or Medium-dose ICS Alternative: Omalizumab for patients who

Step 1 Low-dose ICS Medium-dose ICS+ for patients have allergeries Step down if possible Preferred : Alternative: either LTRA, who have allergies ( and asthma is SABA PRN Alternative: Low-dose ICS+either Theophylline, or well controlled at

Cromolyn, LTRA, LTRA,Theophylline, Zileuton least 3 months) Nedocromil, or or Zileuton Theophylline

Each Step : Patient education, environmental control, and management of comorbidities.

Step 2-4 : Consider subcutaneous allergen immunotherapy for patients who have allergic asthma.

* SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral syste,ic corticosteroids may be needed.

* Caution : Increasing use of SABA or use > 2 days a week for symptom relief ( not prevention of Exercise Induced broncho-spasm) generally indicates inadequate control and the need to step up treatment.

* ICS, Inhaled Cortocisteroids; LTRA, Leukotriene Receptor Antagonist; SABA, Short-Acting Beta2-Agonist; LABA, Long-Acting Beta2-Agonist

Table 3-1 LONG -Term Control Medications & QUICK-Relief Medications ( For ≥ 12 years of Age & Adults )

Usual Doses for Quick -Relief Medictions

Inhaled Short-Acting Beta2-Agonists ( SABA) Dosage

M Albuterol HFA MDI ( 90 mcg/puff; 200puffs/canister) 2 puffs every 4-6 hours, as needed for symptoms;

2 puffs 5 minutes before exercise

E Albuterol Nebulizeer Solution 1.25- 5 mg in 3 cc of saline q 4-8 hours, as needed

D Levalbuterol HFA ( 45 mcg/puff; 200 puffs/ canister) 2 puffs every 4-6 hours, as needed for symptoms;

I 2 puffs 5minutes before exercise

C Levalbuterol ( R-albuterol) Nebulizer Solution 0.63-1.25 mg, q 8hours, as needed

A For Asthma Exacerbations

T Albuterol MDI ( 90mcg/puff) 4-8 puffs every 20 minutes up to 4 hours, then every 1-4 hours as needed.

I Albuterol Nebulizer solution 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg

O every 1-4 hours as needed, or 10-15 mg/hour continuously.

N Anticholinergics

S Ipratropium HFA MDI (17mcgpuffs,200 puffs/canister) 2-3 puffs every 6 hours

Ipratropium HFA ( Nebulizer soultion) 0.25 mg every 6 hours

Ipratropium with albuterol MDI ( 18mcg/puff of Ipratropium bromide and 90mcg/puff of albuterol; 200puffs.canister) 2-3 puffs every 6 hours

Ipratropium with albuterol ( Nebulizer solution) 3 ml every 4-6 hours

Systemic Corticosteroids

Methylprednisolone ( 2,4,6,8,16,32 mg tablets) Prednisolone ( 5mg tablets,5mg/5cc,15mg/5cc) Short course "burst": 40-60 mg/day as single or 2 divided Prednisone ( 1,2.5,5,10,20,50mg tablets; 5mg/5cc,5mg/cc) doses for 3-10 days

Repository Injection ( Methylprednisolone acetate) 240mg IM once

Notes: HFA, hydrofluoroalkane; IM , intramuscular; MDI, metered-dose inhaler

Table 3-2 Usual Doses for LONG-Term Control Medications

Inhaled Corticosteroids Dosage

Beclomethasone HFA (40 or 80mcg/puff) 80 mcg - > 480mcg Budesonide DPI ( 90,180, or 200mcg/inhalation) 180mcg- 1,200mcg

M Flunisolide ( 250 mcg/puff ) 500mcg- > 2,000mcg Flunisolide HFA ( 80mcg/puff ) 320mcg- > 640mcg

E Fluticasone HFA/MDI ( 44,110,or 220 mcg/puff ) 88mcg-. 440mcg Fluticasone DPI ( 50,100, or 250 mcg/inhalation) 100mcg- >500mcg

D Mometasone DPI ( 200mcg/inhalation ) 200mcg-> 400mcg Triamcinolone acetonide ( 75 mcg/puff ) 300mcg- >1,500 mcg

I Oral Systemic Corticosteroids

C Methylprednisolone 7.5 -60 mg daily in a single dose in A.M. or

A Prednisolone qod as needed for control.

Prednisone

T Short course "burst": to achieve control, 40-60mg/day as single or two divided doses

I for 3-10 days.

Inhaled Long-Acting Beta2-Agonists ( LABAs)

O Salmeterol ( DPI: 50 mcg/blister ) 1 blister every 12 hours

N Formoterol ( DPI: 12 mcg/single-use capsule ) 1 capsule every 12 hours.

S Combined Medication

Fluticasone/ Salmeterol 1 inhalation bid, dose depends on level of severity or control

Budesonide/Formoterol 2 puffs bid, dose depends on level of severity or control

Cromolyn/Nedocromil

Cromolyn ( MDI: 0.8 mg/puff ) 2 puffs qid Nebulizer ( 20mg/ampule ) 1 ampule qid Nedocromil ( MDI: 1.75 mg/puff ) 2 puffs qid

Immunomodulators

Omalizumab ( Anti IgE) 150-375 mg SC q 2-4 weeks, depending on body weight & pretreatment serum IgE level

Leukotriene Modifiers ( Leukotriene Receptor Antagonists)

Montelukast 10mg qhs Zafirlukast 40mg daily ( 20 mg tablets bid) Zileuton ( 5-Lipoxygenase Inhibitor ) 2,400 mg daily

Methylxantines

Theophylline ( Liquid,sustained-release tablets, & capsules) Starting dose 10mg/kg/day up to 300 mg maximum; usual maximu 800mg/day

Note: DPI, Dry Powder Inhaler; IgE, immunoglobulin E; MDI, meter-dose inhaler.

* Dosages are provided for those products that have been approved by the U.S. Food and Drug Administration or have sufficient clinical trial safety & efficacy data in the ≥12 years of age and adults to support their use.

Figure 1. Diagnosis, Evaluation, and mangement of Adults-detainees with Asthma

Detainee with symptomatic or History of reactive airway disease

SYMPTOMATIC Table 1

YES NO

Assess detainee for Bronchial Asthma exacerbation Does detainee have own medications or are

1. O2 Saturations ( < 90%) they familiar with his/her medications regimen?

2. Peak flow X 3 ( average < 200 )

3. breath sounds ( excessive wheezing)

4. Respiratory rate ( > 30/min.) YES NO

Does detainee meet 1 of the above criteira ? IF afterhours;

NO 1. Give albuterol from Night Pharmacy YES 2. Have detainee place medications in

"personal property & document.

Ensure no contraindication to albuterol and start rebulizer treatment

If known patient, refer this finding/ results to primary care physician.provider.Figure 2

Figure 2

Notify to a Provider !!!

( Should consider an immedaite referaal to the Hospital E.R. via an ambulance service.)

Figure 2 Sensible approaches to patient with Asthma Table 1

Complete history includes patient’s & family history of atopy (C/c. dyspnea on exertion, cough, wheezing) Trigger symptoms (e.g. , exercise, cold air, upper respiratory tract infections, animal dander, pollen, mold, tobacco smoke)

Physical examination (Often completely normal. A triad; nasal polyps and aspirin sensitivity, Cobblestoning, Wheezing or stridor)

Spirometry with bronchodilator test

Obstruction ( FEV1/FVC < 70 % or Normal † Or response to bronchodilator)

Initial step Rx Table 2

In addition to pharmacological intervention, Environmental controls, Smoking cessation ( essential!!).

“ Action Plans” with patients based on Peak Flow measurements with thresholds for increasing Rx and seeking a referral.

Note : † ; The American Thoracic Society criteria for “ responsiveness “ require an increase 200ml and 12 % in either FEV1 or FVC. A key aspect of asthma is variability in airflow obstruction. Spirometry testing can often be effort dependent. After being instructed in appropriate technique, patients should obtain peak flows at different times of day, when asymptomatic and when dyspneic or wheezy. Variability in peak flows > 20 % is consistent with asthma. Although useful diagnostically, the peak flow meter is generally more useful as a way to monitor for control of established disease.

ICE Health Service Corps

Clinical Guidelines for the Treatment of Gender Dysphoria (formerly Gender Identity Disorder, GID)

Introduction

Gender, that is the essence of male and female, is not a clear cut distinction, but rather a spectrum on which an individual perceives themselves and is perceived by others. Transgender individuals identify with a gender which is different than their sex assignment at birth. This gender identity often manifests early in childhood but may emerge in adolescence or even adulthood.

Transgender individuals may identify with the opposite sex (e.g. male to female or transwoman/girl, female to male or transman/boy) or somewhere along the gender spectrum identifying with characteristics of both genders (gender non-conforming).

Discordance between self-perception, perception of and treatment by others, and gender assignment at birth lead to conflict regarding gender identity, the most extreme of which is Gender Dysphoria (GD). Gender dysphoric individuals do not identify with their birth-assigned gender which in turn generates distress from internal discord as well as external (family and social) misunderstanding and rejection which may culminate in neglect and/or abuse.

Many patients with GD have a strong desire to modify their appearance to match the gender they identify with, and this may be achieved through hormonal supplementation as well as a vast array of surgical procedures. Both hormone treatment, as well as gender affirming (reassignment) surgery (most conservatively referring to genital reconstruction only), are covered as necessary medical treatment by major health plans as long as appropriate medical evaluation has occurred and been documented.

Basic Tenets of Managing Patients with Gender Dysphoria

1. Evaluation and treatment of detainees with GD should involve a multidisciplinary team including medical, mental health, pharmacy, nursing and administrative staff.

2. Treatment of GD is not cosmetic; denial of treatment may lead to worsening mental health and self-harm by distressed detainees.

3. Use of the pronoun corresponding to the desired gender should be utilized; slang terms

(“tranny”, “he-she”, etc.) are derogatory and are not permissible.

4. Instituting treatment for ICE detainees with GD does not require previous hormone treatment. Newly diagnosed and/or previously untreated GD will be managed with the same liberality as newly diagnosed and/or previously untreated hypertension or diabetes – if treatment is clinically indicated, is desired by the patient and no medical/mental health contraindications exist, it will be initiated. Initiation of treatment does, however, require 1) evaluation by a mental health provider to officially establish the diagnosis of GD as well as evaluation for comorbid mental health illness and 2) counseling by a trained medical provider regarding the risks and benefits of treatment as well as reasonable expectations of hormone treatment. Gender affirming surgery will be considered, on a case-by-case basis, consistent with applicable medical standards.

5. Laboratory values are utilized to guide your treatment plan; corresponding physiologic changes are slow and variable amongst individuals and “failure to see changes” should not prompt an increase in dosage without supportive laboratory data. In addition, laboratory monitoring, pertinent review of systems, extensive counseling and physical examinations are all necessary to optimize patient safety. See Appendix A and B for the current treatment protocols and Appendix E and F for the informed consent documents which will be utilized as a counseling tool as well as documentation of the patient’s understanding of the risks and benefits of hormone treatment.

6. Screening for concomitant medical conditions

• Mental Health (MH) conditions (mood disorders, anxiety disorders, PTSD etc.) are more common in transgender individuals than the general population. All transgender individuals will be referred to a MH professional for the initial evaluation of GD as well as other concomitant MH conditions; the care plan including frequency of MH appointments will follow as deemed clinically appropriate by the MH provider. In addition, the patient should be assessed for readiness to start/continue treatment: consolidation of gender identity (if time in custody allows), progress in stabilizing mental health, and is deemed likely to take hormone treatment responsibly.

• Blood borne pathogens and sexually transmitted infections (STIs) – HIV, syphilis, hepatitis B and C, chlamydia and gonorrhea - are common infections among transgender patients and should be actively screened for at the initial provider evaluation. Failure to diagnose may lead to untoward clinical outcomes and/or spread of infection both within and outside of the correctional environment.

7. For additional staff training and resources, see Appendix B.

Special Issues for Transgender Individuals in Custody

1. Housing determination

Segregation is not required nor encouraged unless the detainee self-identifies as feeling vulnerable or at risk of harm because of their gender identity. Such concerns will be addressed during custody processing and should also be queried at the time of intake, as well as during periodic medical and mental health evaluations. Automatic assignment to administrative segregation for simple disclosure of gender dysphoria without perceived risk of harm/vulnerability may lead to the well-recognized risk of prolonged isolation, including significant self-harm and suicide.

In facilities which have adopted or implemented best practices found in the “ICE Detention Facility Contract Modification for Transgender Care,” transgender detainees may initially be placed in administrative segregation for a maximum of 72 hours (not counting weekends and holidays) to allow for the Transgender Classification and Care Committee to convene and determine a detention plan which includes housing. Housing options include: 1) general population male or female, 2) special unit housing (e.g., Gay-Bisexual-Transgender (GBT) or transgender only), or

3) in rare cases, administrative segregation.

Housing of transgender detainees in facilities which have not adopted or implemented this contract’s best practices will be left to the discretion of the medical and custody staff.

Several factors should be considered including the degree of gender expression of the detainee, comfort and safety of the detainee and the layout of individual units including privacy factors. Medical staff are encouraged to assist custody staff in establishing housing assignment.

2. Gender Specific Undergarments

Undergarments which reflect the gender identity of the individual should be provided.

Special needs forms should suffice as medical orders which custody staff shall honor.

3. Additional support and resources

A correctional setting poses many challenges for a transgender person given the lack of privacy, targeted discrimination and abuse which may be amplified in close quarters and the risk of sexual assault. Resources are available to help these detainees share common experiences for support and encouragement. See Appendix C.

Continuity of Care Referrals

If a transgender detainee is released to the U.S., there are many regional centers of excellence as well as independent practitioners where the detainee may continue their care. See Appendix D.

In the case of deportation, in country resources for transgender care may be limited and IHSC-directed referrals won’t usually be possible. However, transgender detainees will be provided with two weeks of medication (in line with standard IHSC guidelines) to provide them with a chance to establish care once they have repatriated.

References

1. http://transhealth.ucsf.edu/trans?page=protocol-00-00

2. Tom Waddell Health Center. (2006, revised May 2013). Protocols for Hormonal

Reassignment of Gender. Accessed online January 28, 2014 from:

http://www.sfdph.org/dph/comupg/oservices/medSvs/hlthCtrs/TransGendprotocols1220 06.pdf

3. Hembree et al. Endocrine treatment of transsexual persons: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2009; 94(9):3132-54

4. VA Pharmacy Benefits Management Services, Medical Advisory Panel and VISN Pharmacist Executives. Transgender Cross-Sex Hormone Therapy Use. February 2012

5. Guidelines for Psychological Practice with Transgender and Gender Nonconforming People. Retrieved from http://www.apa.org/practice/guidelines/transgender.pdf

Disclaimer – Clinical guidelines have been established to provide medical providers at IHSC facilities with general information regarding the management of patients. Guidelines are not statements of policy.

Medical providers should consider each case individually, in the context of good clinical judgment and within the provider’s experience and comfort level. This guidance is not intended to, does not, and may not be relied upon to create any right or benefit, substantive or procedural, enforceable at law by any party in any administrative, civil, or criminal matter.

http://transhealth.ucsf.edu/trans?page=protocol-00-00 http://www.sfdph.org/dph/comupg/oservices/medSvs/hlthCtrs/TransGendprotocols122006.pdf http://www.sfdph.org/dph/comupg/oservices/medSvs/hlthCtrs/TransGendprotocols122006.pdf http://www.sfdph.org/dph/comupg/oservices/medSvs/hlthCtrs/TransGendprotocols122006.pdf http://www.sfdph.org/dph/comupg/oservices/medSvs/hlthCtrs/TransGendprotocols122006.pdf http://www.apa.org/practice/guidelines/transgender.pdf

Appendix A – Male to Female (MTF) Transgender Treatment Protocol

Initiating MTF transgender treatment:

Visit 1 – assessment, referral to BH if not already done, order blood work (HIV serology, RPR, GC/chlamydia nucleic acid test, hepatitis B surface antigen, hepatitis C serology, testosterone, estradiol, lipids, cmp prolactin*), general counseling including completion of eCW informed consent document.

Visit 2 (1 week later)– if baseline lab work is normal and confirmed GD by BHP then start estradiol 2 mg / spironolactone 50 mg / aspirin 81 mg daily. Order bmp for the next visit.

Visit 3 (1 month later) – if bmp (potassium and creatinine) is normal, increase spironolactone to 100 mg daily. Order lab work (testosterone, estradiol, prolactin, cmp, lipids) for next visit.

Visit 4 (2 months later) – review lab work, PE assessment; if testosterone is not fully suppressed (<50) would increase spironolactone to 150 mg daily**; if estradiol is not at female pre-menopausal (100-200) level, increase estradiol by 2 mg daily.

Visit 5 (2-3 months later) and every 2-3 months thereafter for the first year until at goal; if 1 year of steady follow up, can reduce full blood work panel to every 6 months if hormone levels are at steady, physiologic level and no signs of end organ effects (LFTs, renal function, electrolytes).

If the patient is 60 yrs or older, please order a baseline bone mineral density scan. Perform age appropriate breast cancer screening if the patient has been on 10 years or more of hormone therapy (HT) (cumulatively).

Continuing MTF transgender treatment:

Visit 1 – assessment, referral to BH if not already done, order blood work (HIV serology, RPR, GC/chlamydia nucleic acid test, hepatitis B surface antigen, hepatitis C serology, testosterone, estradiol, lipids, cmp, prolactin), general counseling including completion of eCW informed consent document.

Continue outpatient oral dose (maximum of estradiol 8 mg daily, maximum spironolactone 150 mg daily) add aspirin 81 mg daily (if not already receiving), add spironolactone if not yet receiving, start at 50 mg daily

Visit 2 (2 weeks later)– confirm GD diagnosis as per by BHP, review laboratories with patient. If was not previously on spironolactone, can increase from 50 mg to 100 mg daily if potassium and creatinine are normal. Otherwise, no need to modify treatment at this point assuming labs are within normal limits. Order lab work (testosterone, estradiol, prolactin, cmp, lipids) for next visit.

Visit 3 (2 months later) – review lab work, PE assessment; if testosterone is not fully suppressed

(<50) would increase spironolactone to 150 mg daily; if estradiol is not at female pre-menopausal (100-200) level, increase the estradiol by 2 mg daily. Order lab work (testosterone, estradiol, prolactin, cmp, lipids) for next visit.

Visit 4 (2-3 months later) and every 2-3 months thereafter for the first year following labs above and making adjustments based on estradiol and testosterone levels (assuming monitoring labs are normal); after 1 year of steady follow up, can reduce full blood work panel to every 6 months if hormone levels are physiologic and no signs of end organ effects (LFTs, renal function, electrolytes).

If the patient is 60 yrs or older, please order a baseline bone mineral density scan. Perform age appropriate breast cancer screening if the patient has been on 10 years or more of HT (cumulatively).

*Prolactin levels are often mildly elevated and this is normal; prolactin levels should ideally be obtained in the early AM and fasting. If levels are above 50, consider decreasing the estrogen supplementation to see if prolactin declines as well as inquire about the symptoms of prolactinoma which may include galactorrhea, headaches and diplopia. If the level does not decline or rises regardless of the medication adjustment OR review of systems is positive, consider an MRI of the sella (pituitary gland) to exclude a prolactinoma.

**spironolactone can be increased to 200 mg daily if indicated, but please split dose as 100 mg 2x/day

Estrogen conversion¥

Estradiol (P.O.) daily Premarin (P.O.) daily 2 mg 1.8 mg 4 mg 2.7 mg 6 mg 3.75 mg 8 mg 5 mg

¥ Estimated values, please use serum estradiol to adjust accordingly

Appendix B – Female to Male (FTM) Transgender Treatment Protocol

Initiating FTM transgender treatment:

Visit 1 – assessment, referral to MH if not already done, to confirm GD diagnosis and to assess for readiness to start treatment. Order blood work (HIV serology, RPR, GC/chlamydia nucleic acid test, hepatitis B surface antigen, hepatitis C serology, testosterone, estradiol, lipids, lfts, and cbc), general counseling including completion of eCW informed consent document.

Visit 2 (1 week later)– if baseline lab work and confirmed GD and demonstrates readiness to start treatment by BHP, then start testosterone cypionate 100 mg IM every 2 weeks. Order lfts, lipids, testosterone, estradiol, and cbc for 8-12 weeks after treatment has begun (to be timed 1 week after an injection; e.g., injections are day 1 and 15 of each month, the lab draw should fall on ~ day 7 or 21 of the calendar month). If a family history of osteoporosis exists or the patient is 60 yrs or older, please order a baseline bone mineral density scan.

Visit 3 (2-3 months later) – review labs, if estradiol is not suppressed and testosterone is not above 350 ng/dL, increase testosterone dose to 200 mg every 2 weeks. The serum testosterone level should not exceed 700 ng/dL.

Visit 4 etc. (2-3 months later) and every 2-3 months thereafter for the first year until at goal; if 1 year of steady follow up, can reduce full blood work panel to every 6 months if hormone levels are at steady, physiologic level and no signs of end organ effects (LFTs, renal function, electrolytes). Note, once uterine bleeding stops, estradiol levels are not necessary to obtain.

If the uterus has not been removed, pap smears should be conducted per usual preventive guidelines; likewise if mastectomy has not been performed, mammogram cancer screening is per usual guidelines.

Continuing FTM transgender treatment:

Visit 1 – assessment, referral to BH if not already done to confirm GD diagnosis and to assess for readiness to continue treatment. Continue outpatient testosterone (maximum of testosterone cypionate 200 mg IM every 2 weeks), order blood work (HIV serology, RPR, GC/chlamydia nucleic acid test, hepatitis B surface antigen, hepatitis C serology, testosterone, estradiol, lipids, lfts and cbc), (to be timed 1 week after an injection; e.g. injections are day 1 and 15 of each month, the lab draw should fall on ~ day 7 or 21 of the calendar month).

Provide general counseling including completion of eCW informed consent document.

Visit 2 (2 weeks later)– confirm GD diagnosis/readiness as per by BHP, review laboratories with patient. If testosterone is not above 350 ng/dL, increase testosterone dose to 200 mg every 2 weeks. The serum testosterone level should not exceed 700 ng/dL.

Visit 3 etc. (2-3 months later) and every 2-3 months for the first year until at goal; if 1 year of steady follow up, can reduce blood work to every 6 months if hormone levels are at steady, physiologic level and no signs of end organ effects. Note, once uterine bleeding stops, estradiol levels are not necessary to obtain.

If the uterus has not been removed, pap smears should be conducted per usual preventive guidelines; likewise if mastectomy has not been performed, mammogram cancer screening is per usual guidelines.

Appendix C - Additional Provider and Patient Resources

1. Trans in Prison Journal, produced by the Gender Identity Center of Colorado; you can download a copy and give to your detainees; they can mail in the request form on the issue and they will receive the future publications gratis as long as they are in a correctional setting.

https://www.gic-colorado.org/programs/trans-in-prison/

2. “Cruel and Unusual”, documentary by Janet Baus and Dan Hunt, about transgender persons and the challenges they face in and out of the correctional System. ~ 1 hour long https://www.youtube.com/watch?v=5Yzy8oh5Fw0 www.fandor.com/films/cruel_and_unusual

3. Resources on children diagnosed with GD, Most of our detainees will receive their hormone treatment during adolescence or adulthood but to benefit the most from this treatment, diagnosis of GD and treatment should occur during childhood.

www.youtube.com/watch?v=YfqmEYC_rMI http://www.huffingtonpost.com/2014/05/30/whittington-family-ryland- transgender-son_n_5414718.html http://www.gic-colorado.org/programs/trans-in-prison/ https://www.youtube.com/watch?v=5Yzy8oh5Fw0 http://www.fandor.com/films/cruel_and_unusual http://www.fandor.com/films/cruel_and_unusual http://www.youtube.com/watch?v=YfqmEYC_rMI http://www.huffingtonpost.com/2014/05/30/whittington-family-ryland-transgender-son_n_5414718.html http://www.huffingtonpost.com/2014/05/30/whittington-family-ryland-transgender-son_n_5414718.html http://www.huffingtonpost.com/2014/05/30/whittington-family-ryland-transgender-son_n_5414718.html http://www.huffingtonpost.com/2014/05/30/whittington-family-ryland-transgender-son_n_5414718.html http://www.huffingtonpost.com/2014/05/30/whittington-family-ryland-transgender-son_n_5414718.html

Appendix D – Transgender Care Regional Centers of Excellence for Continuity of Care or Referring Challenging Cases

AOR Facility name Phone number Website

Washington DC Transgender Health Empowerment 202-636-1646 http://theincdc.org/

Boston Fenway Health 617-267-0900 http://www.fenwayhealth.org

New York The Center Transgender Resources

212-620-7310 https://gaycenter.org/wellness/gender-identity http://transgendercny.org/

Newark Callen Lorde 212-271-7200 http://callen-lorde.org/our-services/sexual-health-clinic/transgender-health-services/

City of Newark Dept of Child and Family Well Being 973-733-7635

Philadelphia Mazzoni Center 215-563-0658 http://mazzonicenter.org/content/transgender-services

Buffalo Endocrinology center of Western New York 716-887-4069

Detroit UMHS-CGCP 734-736-0465 http://www.med.umich.edu/transgender/index.htm

Chicago Howard Brown Health Center 773-388-1600 www.howardbrown.org

Atlanta In-town Primary Care 404-541-0944 http://www.intownprimarycare.com/glbt-health/transgender-health.html

Miami Care Resource 305-576-1234 http://www.careresource.org/programs/transgender-services/

New Orleans Louisiana Trans Advocates 337-580-4615 http://www.latransadvocates.org/resources.html http://theincdc.org/ http://www.fenwayhealth.org/ https://gaycenter.org/wellness/gender-identity http://transgendercny.org/ http://callen-lorde.org/our-services/sexual-health-clinic/transgender-health-services/ http://callen-lorde.org/our-services/sexual-health-clinic/transgender-health-services/ http://callen-lorde.org/our-services/sexual-health-clinic/transgender-health-services/ http://mazzonicenter.org/content/transgender-services http://www.med.umich.edu/transgender/index.htm http://www.howardbrown.org/ http://www.intownprimarycare.com/glbt-health/transgender-health.html http://www.intownprimarycare.com/glbt-health/transgender-health.html http://www.intownprimarycare.com/glbt-health/transgender-health.html http://www.careresource.org/programs/transgender-services/ http://www.latransadvocates.org/resources.html

Houston Dr. Hammill Transgender Health Clinic 713-799-8994 http://drhammill.transhouston.com/

Transgender Center 713-520-8586 http://www.transgend erctr org/ San Antonio SAGA sagacal09@gma http://www.sagender.com/local-resources/ il.com

Pride Center 210-370-7743 http://pridecentersa.org/resources/

Dallas Transgender Health Clinic 214-528-2336

Resource Center of Dalllas 214-528-0144 http://www.rcdallas.org/family/transgender

El Paso Trans Health Referral Line 915-532-7000 2301 N Oregon St, El Paso, TX 79902

Saint Paul Transgender Health Services University of MN 612-625-1500 http://www.med.umn.edu/fm/phs/clinic/transgender.html

Denver Gender Identity Center of Colorado 303-202-6466 http://www.gicofcolo.org

Salt Lake City Susan Chasson 801-357-7930

D. S. Burton 385-282-2750

LeAnne Swenson 385-282-2000

Phoenix Prime Medical Clinic 602-840-3584 http://www.myprimeclinic.com/

Seattle Gay City Health Project 206-323-5428 https://www.gaycity.org/resources/

San Francisco The San Francisco Center

(415) 865-5555 http://www.sfcenter.org/ http://drhammill.transhouston.com/ http://www.tgctr.org/ http://www.tgctr.org/ mailto:sagacal09@gmail.com http://www.sagender.com/local-resources/ mailto:sagacal09@gmail.com http://pridecentersa.org/resources/ http://www.rcdallas.org/family/transgender http://www.med.umn.edu/fm/phs/clinic/transgender.html http://www.gicofcolo.org/ http://www.myprimeclinic.com/ https://www.gaycity.org/resources/ http://www.sfcenter.org/

San Francisco UCSF Center of Excellence 415-597-8198 http://www.transhealth.ucsf.edu/

Los Angeles Western Medical Center Anaheim 714-533-6220

UCLA LGBT Resource Center 310-206-3628 http://www.lgbt.ucla.edu

San Diego The Center 619-692-2077 http://www.thecentersd.org

General Resources http://www.transgenderlynnsplace.com/transgender-medical-resources.htm http://www.transhealth.ucsf.edu/ http://www.lgbt.ucla.edu/ http://www.thecentersd.org/ http://www.tglynnsplace.com/tg-medical-resources.htm http://www.tglynnsplace.com/tg-medical-resources.htm

Appendix E: Informed Consent Document for Hormone Therapy (male to female)

Estrogen/Antiandrogen Therapy Consent Form For Male to Female Transition

Informed Consent: Information about this form.

This form refers to the use of estrogen and antiandrogens by detainees who wish to become more feminized as part of a gender transitioning process.

Your agreement or disagreement of the various statements on this form indicate that the risks as well as the changes which may occur as a result of the use of estrogen and antiandrogens have been explained and that you understand them.

If you have any questions or concerns about this information, you are encouraged to take the time you need to ask for clarification, read, research, talk with staff and think about the potential effects of this treatment before signing.

IF YOU DO NOT UNDERSTAND THIS INFORMATION STOP AND ASK FOR CLARIFICATION

1. I understand that estrogen may cause or contribute to depression. If I have a history of depression I will discuss this with my provider to explore treatment/therapy options that are available to me.

AGREE DISAGREE

Some of these changes will be permanent including:

Breast development: Breast development may take years to reach full size.

There are natural variations in the size of breasts, and one person's breast development will not correlate with that of another person's.

If estrogen therapy is discontinued, there may be some breast shrinkage, but breast development will not completely disappear.

Brain structures are affected by testosterone and estrogen.

The long term effects of changing the levels of ones hormones through the use of estrogen therapy and testosterone suppressants have not been scientifically studied & are impossible to predict.

These effects may be beneficial, damaging, or both. Changes in fertility and sperm production (see information below in # 5).

These additional changes will not be permanent if I stop taking estrogen:

Decreased acne Male pattern balding stops or slows (no hair loss will be reversed once it occurs) Skin may become softer Facial and body hair growth may decrease (not stop) in thickness or quantity to a greater or lesser extent.

Redistribution of body fat to a more female pattern (i.e., abdominal fat may decrease while fat on the buttocks and thighs may increase)

2. I understand the effects of estrogen will not protect me from sexually transmitted diseases or HIV and that condoms or barrier methods should be used.

3. Due to breast development with estrogen therapy, I understand that I will need to do monthly breast self-examinations, have an annual medical exam, and, once I am 40 or older, I will need to have an annual mammogram.

4. I understand that estrogen therapy will decrease hormones that support the size and function of my testicles, which may then effect overall sexual functioning and fertility.

The changes that may occur include:

a. Up to 40% shrinkage in size of the testicles.

b. Decrease in testosterone production from the testicles

c. The amount and quality of erections and ejaculation may decrease or stop entirely.

d. Sperm will still be present in the testicles, but may stop maturing which may cause infertility.

e. If estrogen therapy is stopped, the ability to make sperm healthy, mature sperm may or may not ever come back.

f. Erections may no longer be firm enough for penetrative intercourse.

g. There may be a decrease or loss of morning and spontaneous erections. Sex drive or libido may decrease.

5. I understand that taking estrogen can significantly increase the risk of blood clots (thrombosis) This risk of blood clots can result in:

a. death

b. deep vein thrombosis (clots in large veins)

c. chronic leg vein problems

d. pulmonary embolism (blood clot in the lung, which can cause permanent lung damage or death)

e. cerebral vascular accident (stroke) which may result in permanent brain damage, blindness, paralysis, difficulty talking or death.

6. I understand that the risk of blood clots, heart attack, and stroke on estrogen therapy is increased further if I smoke tobacco, especially if I am over the age of 35.

7. I understand that estrogen can cause increased blood pressure. If I have existing high blood pressure it may not be controlled on my current regimen of medication and/or diet and exercise.

7a. I understand that I may be able to take estrogen safely with close medical monitoring.

8. I understand that estrogen use may lead to liver inflammation or liver disease. I agree that while I am on estrogen therapy I will be monitored for liver problems before and periodically during therapy.

8a. I understand that there is a slight risk of long-term estrogen use causing liver cancer.

9. I understand that estrogen may increase migraine headaches and that this may be a reason for me to choose to stop taking estrogen or may be a reason for estrogen to be discontinued by my provider.

9a. I also understand there is a very small risk of developing a tumor at the base of the brain (pituitary gland), but that my blood tests will be monitored regularly to detect this problem early.

9b. If I develop new headaches, double vision and/or breast milk production, I should inform my health care provider immediately.

10. I understand that estrogen may cause nausea and vomiting, similar to morning sickness in a pregnant woman. If I experience nausea and vomiting that are severe and/or prolonged.

11. I understand that the most dangerous side effects from estrogen therapy occur in connection with smoking cigarettes, being overweight, being over 40 years old & having a history of blood clots, high blood pressure, or prior estrogen dependent cancer.

12. I understand that estrogen therapy may be discontinued or adjusted at any time if concerns or complications arise which are threatening to my continued physical and/or psychological well-being.

13. I understand that estrogen may cause changes in my cholesterol. My HDL (good cholesterol) may go up and my LDL (bad cholesterol) may go down.

14. I understand that estrogen may prevent prostate problems. I have been informed that there is a slight chance that taking estrogen will cause overgrowth of the prostrate.

14a. Prostate cancer screening is recommended for people 50 years of age and older as well as in younger people if otherwise medically indicated.

15. I understand that antiandrogen side effects include dehydration, high potassium levels, breast enlargement, low blood pressure and kidney problems. My labs and blood pressure will be routinely monitored to detect changes.

16. I understand that everyone's bodies will respond differently to estrogen and that there is no way to predict what will be my response to hormones.

16a. I understand that the correct dosage for me may not be the same as for another person. I understand I must follow my prescribed regimen of estrogen treatment to continue to receive hormone therapy at this clinic.

17. I agree to take estrogen and all other transition related medications as prescribed and to inform my provider of any problems or dissatisfactions I may have with my treatment.

18. I will have a complete physical examination annually and lab tests periodically as required to make sure I am not having an adverse reaction to hormone treatment and to continue good health care.

19. I understand that there are medical conditions that could make taking estrogen either dangerous or physically damaging.

19a. I agree that if my provider suspects I may have any condition that could be dangerous to me, I will be evaluated for it before the decision to start or continue my hormones is made.

19b. I understand that if I do not agree to be evaluated, my prescription for estrogen may be cancelled or refused.

20. I understand that I can choose to stop taking estrogen at any time. I also understand that my provider can discontinue treatment for clinical reasons.

20a. I agree to follow a prescribed reduction plan if either of these situations occurs to reduce negative and potentially harmful side effects that may occur if I suddenly stop my hormone therapy.

Having considered all of the above counseling I would like to:

Begin Estrogen / Antiandrogen Therapy Defer Estrogen / Antiandrogen Therapy at this time

Patient Signature:

Patient Printed Name:

Provider Information:

Provider Signature:

Provider Printed Name:

Date:

CONSENT:

Date:

Appendix F: Informed Consent Document for Hormone Therapy (female to male)

Androgen Therapy Consent Form For Female to Male Transition Informed Consent: Information about this form.

This form refers to the use of androgens by detainees who wish to become more masculinized as part of a gender transitioning process.

Your agreement or disagreement of the various statements on this form indicate that the risks as well as the changes which may occur as a result of the use of androgens have been explained and that you understand them.

If you have any questions or concerns about this information, you are encouraged to take the time you need to ask for clarification, read, research, talk with staff and think about the potential effects of this treatment before signing.

IF YOU DO NOT UNDERSTAND THIS INFORMATION STOP AND ASK FOR

CLARIFICATION

1. Some changes will be permanent including:

• Brain structures are affected by testosterone and estrogen o The long term effects of changing the levels of one’s hormones through the use of androgen therapy have not been scientifically studied and are impossible to predict o These effects may be beneficial, damaging, or both

• Deepening of the voice, which occurs after 6 to 10 weeks of androgen administration, is irreversible

• Breast changes similar to menopausal women including loss of firmness, changed shape, smaller size, etc.

o There are natural variations in the size and changes of breasts, and one person’s breast changes will not correlate with that of another person’s These additional changes will not be permanent if I stop taking androgen:

• Development of sexual hair which follows the pattern of boys in puberty o First upper lip, then chin, then cheeks o The predicted pattern and degree of this hair growth can be predicted by the pattern and degree in male members of the same family.

o Hair loss, “male pattern baldness” occurrence can also be predicted from the degree and pattern of male members of the same family

• Menses (monthly period) will usually stop within a few months of treatment; however, sometimes bleeding may continue

• Increase in lean body mass (average of 4kg (~9 pounds)) and an even greater increase in body weight

• Reduction of subcutaneous fat overall but focally increased abdominal fat

• Occurrence of acne (occurs in ~40% of patients)

• Clitoral enlargement will occur, but the degree varies from patient to patient

• Increased libido in most patients

• Polycystic-like changes in ovaries

2. I understand the effects of androgen will not protect me from sexually transmitted diseases or HIV and that condoms or barrier methods should be used.

3. I understand that I will need to continue to do monthly breast self-examinations, have an annual medical exam, and, once I am 40 and older, I will need to have an annual mammogram

4. I understand that androgen therapy will decrease hormones that support the functioning of my reproductive organs which may then effect overall sexual functioning and fertility.

5. I understand that androgen use may lead to major adverse cardiovascular events. I agree that I will be monitored for cardiovascular risk factors and cardiovascular events before and periodically during therapy. These adverse events include:

a. death

b. myocardial infarction (heart attack)

c. cerebral vascular accident (stroke) which may result in permanent brain damage, blindness, paralysis, difficulty talking or death

6. I understand that the most dangerous side effects from androgen therapy occur in patients with a history of cardiovascular events or cardiovascular risk factors including high blood pressure, tobacco use, elevated blood glucose (including diabetes), physical inactivity, unhealthy diet, elevated cholesterol, being over 55 years old and overweight/obesity.

6a. I understand that androgen therapy may be discontinued or adjusted at any time if concerns or complications arise which are threatening to my current physical and/or psychological wellbeing.

7. I understand that androgen therapy can cause increased blood pressure. If I have existing high blood pressure and it is controlled with medication and/or diet and exercise:

7a. I understand that I may be able to take androgen safely with close medical monitoring

8. I understand that androgen therapy may cause changes in my cholesterol. I agree that while I am on androgen therapy I will be monitored for changes in my cholesterol

9. I understand that androgen therapy use may lead to liver inflammation or liver disease. I agree that while I am on androgen therapy I will be monitored for liver problems before and periodically during therapy.

10. I understand that there is a risk of androgen therapy causing an abnormal increase in circulating red blood cells and an increased number of red blood cells may be a reason to stop therapy.

11. I understand that there is a slight risk of long-term androgen causing breast cancer.

12. I understand that there is a slight risk of androgen causing ovarian cancer.

13. I understand that everyone’s bodies will respond differently to androgen therapy and that…