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Blame the Hormones!A Review of Hormonal ContraceptivesErin Carson, PharmD, UIC COP at Rockford | SwedishAmerican Health System

Speaker declares no conflicts of interest, real or apparent, and no financial

interests in any company, product, or service mentioned in this program,

including grants, employment, gifts, stock holdings and honoraria.

Disclosures and Conflict of Interest

At the conclusion of the program, the pharmacists will be able to:

1. Review the physiologic functions of estrogen and progesterone.

2. Describe types of hormonal contraceptives and the CDC’s evidence-based

practice recommendations regarding the differences in safety and efficacy

between products.

3. Discuss regulations and procedures in states which have enacted legislation

allowing pharmacists to prescribe or furnish hormonal contraceptives and the

associated legal requirements.

Pharmacist Objectives

At the conclusion of this program, the pharmacy technician will be able to:

1. Discuss regulations and procedures in states which have enacted legislation

allowing pharmacists to prescribe or furnish hormonal contraceptives and the

associated legal requirements.

2. Review workflow considerations, including the pharmacy technician’s role and

how this works functionally in a community pharmacy.

3. Recognize and discuss different types of hormonal contraceptives.

Technician Objectives

For which patient would the preferred hormonal contraceptive be the

progesterone only tablet, also known as the mini-pill?

A. Otherwise healthy patient 28 days postpartum who has elected not to

breastfeed

B. Patient who started the mini-pill 2 years ago postpartum and prefers

to continue taking it

C. Patient with a newly diagnosed hepatocellular adenoma

D. Patient who is 21 days postpartum after an unintended pregnancy

secondary to poor compliance with previous OCP

Pre-Test Question #1

In which states can pharmacists legally prescribe hormonal contraceptives?

A. Colorado

B. Oregon

C. New Mexico

D. A & B

E. All of the above


Which of the following is universally required in states where pharmacists can

legally prescribe hormonal contraceptives?

A. Pharmacists must bill for services

B. Pharmacists cannot bill for services

C. Pharmacists can only prescribe hormonal contraceptives for patients over 18

years old

D. Patients must have a normal blood pressure prior to receiving a prescription

E. Patients must have a negative pregnancy test prior to receiving a prescription


What are hormonal contraceptives?

Percentage of women who have ever used:

Any method of contraception: 99.3%

Oral contraceptive pill: 79.3%

Long-acting injectable: 25.4%

Intrauterine device: 15.0%

Patch: 10.6%

Emergency contraception: 20.0%

CDC’s National Survey of Family Growth

National Center for Health Statistics. 2013-2015 National Survey of Family Growth.

https://www.pexels.com/photo/silhouette-of-four-people-against-sun-background-862848/

CHC: Combined Hormonal Contraceptive (estrogen + progesterone)

OCP: Oral contraceptive pill

COC: Combination oral contraceptive

Transdermal patch

Intravaginal ring

Progesterone Only

POP: Progestin-only pills

LARC: Long-acting removable contraceptive

Intramuscular injectable

Subcutaneous implant

IUD: Intrauterine device

Types of Hormonal Contraceptives

Pharmacotherapy: Principles & Practice. New York, NY: McGraw-Hill; 2010;2:841-854.

Follicular phase:

Hypothalamus releases gonadotropin-releasing hormone (GnRH)

GnRH stimulates release of follicle-stimulating hormone (FSH) & luteinizing hormone (LH) from anterior pituitary

Estrogen and progesterone suppress release of GnRH

Ovulation:

Mature follicle ruptures due to surge in FSH & LH

Luteal phase:

FSH & LH return to pre-ovulation levels

Ovary hormone levels peak

Menstruation:

As ovary hormone levels fall, endometrial growth sheds if implantation has not occurred

Four Phases of the Menstrual Cycle


Pharmacotherapy: Principles & Practice.

Primary Mechanism

Mimics physiologic changes that occur during pregnancy to suppress ovulation

Consistent levels of estrogen and progesterone suppress release of FSH and LH via a

negative feedback loop

Estrogen: FSH

Progesterone: LH

Secondary Mechanisms

Reduces penetration of egg by sperm

Reduces implantation of fertilized eggs

Thickens of cervical mucus

Slows tubal mobility

Hormonal Contraceptives:

Mechanism of Action


Side EffectsEffect Estrogen Progesterone

Breakthrough bleeding: early in cycle

Breakthrough bleeding: late in cycle

Menstrual irregularities

Acne / oily skin

Hirsutism

N/V

Bloating

Breast tenderness

Weight gain

Decreased libido

Headache

Hypertension ()

Dyslipidemia

Decrease lactation


MMWR Recomm Rep 2016;65(No. RR-4):1–66.

US Pharm. 2006;6:62-70.

Additional Risks (and Benefits)



US Pharm. 2006;6:62-70.

Effect Estrogen Progesterone

Endometrial cancer ☺

Ovarian cancer ☺ ☺

Ovarian cysts ☺ ☺

Breast cancer ? ?

Benign breast disease ☺ ☺

Decreased BMD ☺

Cardiovascular disease ? ?

Ischemic stroke

Venous thromboembolism

Glucose intolerance ()

Gallbladder disease

☺ = Potentially protective

= Potentially harmful

Progesterone Androgen Qualities Progesterone Qualities

Drospirenone - +/-

Ethynodiol diacetate + +++

Norethindrone ++ ++

Norgestimate ++ ++

Desogestrol ++ ++++

Norgestrel +++ +++

Levonorgestrel ++++ +++++

Estrogen & Progesterone

in Hormonal ContraceptivesEstrogen Dosing

Ethinyl estradiol 10-50mcg

Mestranol 35mcg (=50mcg ethinyl estradiol)


CDC’s U.S. Selected Practice Recommendations for Contraceptive Use, 2016

Adapted from WHO guidelines

Guidance on differences between options, how to start contraceptives, what is

required prior to initiation, and when a back-up method is suggested

User-friendly and APP formats

Effectiveness

Availability (accessibility and affordability)

Acceptability

Safety

Contraceptive Method Choice


Effectiveness


U.S. Medical Eligibility Criteria for Contraceptive Use, 2016 (MEC)

Specific recommendations for >120 conditions and characteristics

Focus is on safety of various methods

Includes drug interactions

Additional (free!) CE, APP format, and documents for use in practice available:

https://www.cdc.gov/reproductivehealth/contraception/mmwr/mec/summary.html

Safety


MMWR Recomm Rep

2016;65(No. RR-3):1–104.

MEC: Key Points for Pharmacists

COC, Patch, Ring + POP – Avoid use:

Current breast cancer

History of breast cancer

Severe cirrhosis

Liver cancer

Malabsorption concerns

Ischemic heart disease

Drug interactions

***NOT comprehensive***

COC, Patch + Ring (ESTROGEN) – Avoid use:

< 21 days post-partum

< 42 days postpartum if risk factors for VTE

Breastfeeding

Any history of VTE

Complicated valvular disease

Major surgery with prolonged immobilization

Any history of CVA/TIA

Migraine with aura

Diabetes with complications

HTN

Multiple risk factors for ASCVD (older age, smoking, DM, HTN, low HDL, high LDL, high triglycerides)

Age > 35 + smokingMMWR Recomm Rep 2016;65(No. RR-3):1–104.

CHC: Combined Hormonal Contraceptive (estrogen + progesterone)

OCP: Oral contraceptive pill

COC: Combination oral contraceptive

Transdermal patch

Intravaginal ring

Progesterone Only

POP: Progestin-only pills

LARC: Long-acting removable contraceptive

Intramuscular injectable

Subcutaneous implant

IUD: Intrauterine device

Types of Hormonal Contraceptives


Monophasic, biphasic, triphasic, quadriphasic

21 day vs 24 day active pills

28 day vs 84 day cycle

Additional ingredients

Iron

Folic acid

Obtain baseline blood pressure

Consider baseline weight and BMI

Combination Oral Contraceptive Pill

(COC; OCP)


https://www.powertodecide.org

Timing of Initiation

Quick start: Today

Day 1 start: First day of menses

Sunday start: First Sunday after menses begins

No difference in bleeding patterns, side effects, and risk of pregnancy

Take at same time each day

Placebo pills

Missed dose

1 pill: take 2 the next day

2 pills: 2 tabs/day x 2 days + backup x 1 week

More than 2 pills: varies depending on type


Combination Oral Contraceptive Pill

(COC; OCP)

Ortho Evra®, Xulane ® (ethinyl estradiol/norgestimate)

Less effective in patients weighing >198lb

Application sites: buttock, abdomen, upper outer arm,

upper torso

Transdermal Patch


Intravaginal Ring

NuvaRing ® (ethinyl estradiol/etonogestrel)

Higher incidence of local infection and irritation

Timing of initiation

Traditional Start: Within 5 days of menses

Quick Start: Todayhttps://www.powertodecide.org


Alternative for lactating women or women with contraindication to estrogen

AKA mini-pill, norethindrone, Camila, Erinn, Jolivette, Ortho Micronor, etc.

Timing concerns

Counseling points: take at the SAME TIME each day

Missed dose: if more than 3 hours late, use backup x 2 days

No placebo pills

Irregular/infrequent menses

Progestin Only Pill (POP)



Depo-Provera® (medroxyprogesterone acetate 150mg)

Duration: 3 months


Traditional start: Within 7 days of menses

Quick start: Today

Intramuscular Injection


Subcutaneous Implant Nexplanon® (etonogestrel)

Duration: 3 years

Implanon removed from market


Within 5 days of menses



Copper-containing or levonorgestrel-releasing

ParaGard® copper IUD (10 years)

Mirena ® & Kyleena ® levonorgestrel IUDs (5 years)

Skyla ® & Liletta ® levonorgestrel IUDs (3 years)

Can be used all ages, including adolescents and nulliparous women

Bimanual examination and cervical inspection necessary before insertion

Intrauterine Devices (IUD)

MMWR Recomm Rep 2016;65(No. RR-4):1–66. https://www.powertodecide.org

Can pharmacists prescribe

hormonal contraceptives?

Pros and Cons: The Legal Perspective

Proponents claim:

Improved compliance

Reduction in unintended

pregnancies

Reduction in abortion rates

Pharmacists are capable of

screening for contraindications

Opponents claim:

Reduced opportunity to screen for

other disease states

Not universally safe

Liability concerns

Cannot bill for services

Privacy concerns

Methods

2003-2005

26 pharmacists in 8 pharmacies in the Seattle area

Screening form and blood pressure pre-assessment

Follow-up at 1, 6, and 12 months

Outcomes:

91% of patients were prescribed a hormonal contraceptive

87% of those prescribed had previously taken hormonal contraceptives

70% of those prescribed continued taking contraceptive at 12 months

Typical continuation rate: 50%

97.7% of patients reported satisfaction with the experience

96.8% of patients reported feeling comfortable with the service

Pharmacist prescribing of hormonal

contraceptives: the direct access study

J Am Pharm Assoc. 2008;48(2):212-21.

Current Legislation

California

Colorado

Hawaii

Maryland

New Mexico

Oregon

Tennessee

Washington DC (2019)

Considering:

Minnesota, Missouri,

New Hampshire, Illinois

Differences in state laws:

Verbiage: “furnish” vs “prescribe”

Pharmacist training requirements

Screening tools and other screening requirements

Types of hormonal contraceptives

Age of patient

PCP notification requirements

PCP visit requirements

Ability to bill for services

One year after law passed in CA, 11.1% of community pharmacies

offered contraception services

New infrastructure required

Training

Staffing

Consult room

Liability

Public awareness

Fee for services

67.9% of pharmacies had a specific fee requirement in CA

Median fee: $45

Barriers

JAMA. 2017;318(22):2253-2254.

Bill HB0274

Proposed amendment to the Pharmacy Practice Act

Pharmacist prescribing of hormonal contraceptive patches and self-administered oral hormonal contraceptives

Patients over 18 years old

Patients under 18 years old if previously prescribed

Tasks DFPR to develop standard procedures

Filed 12/29/2016

Readings, co-sponsors, amendments, postponements, etc. in interim

Re-referred to the Rules Committee 4/27/18

Previous similar bill (HB5809) died in the house in 2016-2017

Illinois

Bill Status of HB0274. Illinois General Assembly.

So, what does this look like in practice?

Standard Procedure Algorithm: CO & OR

Health & History Screen:

Questionnaire & Review MEC

Pregnancy Screen

Medication Screen:

Drug interactions (MEC)

Blood Pressure Screen:

Is BP < 140/90 mmHg?

Patient history, preference,

and current therapy

Counsel &

Dispense

Referrals &

Visit Summary

Refer

Refer

Refer

Refer

Contraindications

Poss. Pregnancy

BP>140/90

No Contraindications

Not pregnant


BP<140/90

Contraindications

3 CCR 719-1, Appendix A. 2017 HB 2527.

Article 5, Division 17, Sections 4052(a)(10)

3 CCR 719-1, Appendix A.

2017 HB 2527.

MEC: Key Points for Pharmacists

COC, Patch, Ring + POP – Avoid use:

Current breast cancer

History of breast cancer

Severe cirrhosis

Liver cancer

Malabsorption concerns

Ischemic heart disease

Drug interactions

***NOT comprehensive***

COC, Patch + Ring (ESTROGEN) – Avoid use:

< 21 days post-partum

< 42 days postpartum if risk factors for VTE

Breastfeeding

Any history of VTE

Complicated valvular disease

Major surgery with prolonged immobilization

Any history of CVA/TIA

Migraine with aura

Diabetes with complications

HTN

Multiple risk factors for ASCVD (older age, smoking, DM, HTN, low HDL, high LDL, high triglycerides)

Age > 35 + smokingMMWR Recomm Rep 2016;65(No. RR-3):1–104.

Visit Summary: CO

3 CCR 719-1, Appendix A

Proposed Pharmacy Workflow

Questionnaire provided to

patient

Pharmacist chart review

Pharm-patient consultation,

BP screen, & counseling

Dispensing & (?) billing for

services

Provider communication &

documentation

Refer

Refer

Refer

Contraindications




Contraindications

Contraindications

Case Studies

Questions??

For which patient would the preferred hormonal contraceptive be the

progesterone only tablet, also known as the mini-pill?

A. Otherwise healthy patient 28 days postpartum who has elected not to

breastfeed

B. Patient who started the mini-pill 2 years ago postpartum and prefers

to continue taking it

C. Patient with a newly diagnosed hepatocellular adenoma

D. Patient who is 21 days postpartum after an unintended pregnancy

secondary to poor compliance with previous OCP

Post Test Question #1

In which states can pharmacists legally prescribe hormonal contraceptives?

A. Colorado

B. Oregon

C. New Mexico

D. A & B

E. All of the above


Which of the following is universally required in states where pharmacists can legally

prescribe hormonal contraceptives?

A. Pharmacists must bill for services

B. Pharmacists cannot bill for services

C. Pharmacists can only prescribe hormonal contraceptives for patients over 18

years old

D. Patients must have a normal blood pressure prior to receiving a prescription

E. Patients must have a negative pregnancy test prior to receiving a prescription


CDC’s U.S. Selected Practice Recommendations for Contraceptive Use

Guidance on differences between options, how to start contraceptives, what is

required prior to initiation, and when a back-up method is suggested

CDC’s U.S. Medical Eligibility Criteria for Contraceptive Use (MEC)

Specific recommendations for safety with >120 conditions and characteristics

Pharmacist are legally able to prescribe/furnish hormonal contraceptives in a

handful of states

Illinois is considering

This is a wonderful opportunity to expand pharmacy services, however

significant barriers to implementation exist and workflows must be considered

TAKE HOME POINTS

1. National Center for Health Statistics. 2013-2015 National Survey of Family Growth User’s Guide. U.S. Department of Health and Human Services, Hyattsville, MD (2018). https://www.cdc.gov/nchs/nsfg/nsfg_questionnaires.htm

2. Koehler JM, Haynes KB. Contraception. In: Chisholm-Burns MA, Schwinghammer TL, Wells BG, et al. Pharmacotherapy: Principles & Practice. New York, NY: McGraw-Hill; 2010;2:841-854.

3. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep 2016;65(No. RR-4):1–66.

4. Rice C, Thompson J. Selecting and Monitoring Hormonal Contraception: Overview of Available Products. US Pharm. 2006;6:62-70.

5. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep 2016;65(No. RR-3):1–104.

6. Gardner JS, Miller L, Downing DF, Le S, Blough D, Shotorbani S. Pharmacist prescribing of hormonal contraceptives: results of the Direct Access study. J Am Pharm Assoc. 2008;48(2):212-21.

7. Gomez AM. Availability of Pharmacist-Prescribed Contraception in California, 2017. JAMA. 2017;318(22):2253-2254.

8. Pharmacists Authorized to Prescribe Birth Control in More States. National Alliance of State Pharmacy Associations. Published May 4, 2017. Accessed May 17, 2018. https://naspa.us/2017/05/pharmacists-authorized-prescribe-birth-control-states/

9. California state. Article 5, Division 17, Title 16 of the California Code of Regulations, Business and Professions Code. California Board of Pharmacy website. http://www.pharmacy.ca.gov/laws_regs/1746_1_pt.pdf. Accessed May 17, 2018.

10. California State. Hormonal Contraception Self-Screening Tool. Article 5, Division 17, Sections 4052(a)(10) of the California Code of Regulations, Business and Professions Code. California Board of Pharmacy website. http://www.pharmacy.ca.gov/laws_regs/1746_1_pt.pdf. Accessed May 17, 2018.

11. Colorado State. 3 CCR 719-1, Appendix A of the State of Colorado Department of Regulatory Industries, State Board of Pharmacy Rules. Colorado Department of Regulatory Industries website. https://www.colorado.gov/pacific/dora/Pharmacy_Protocols. Accessed May 17, 2018.

12. Oregon State. 2017 HB 2527, Oregon Legislative Assembly. Oregon Board of Pharmacy website. http://www.oregon.gov/pharmacy/Pages/ContraceptivePrescribing.aspx#Laws_&_Rules. Accessed May 17, 2018.

13. Bill Status of HB0274. Illinois General Assembly. http://www.ilga.gov/legislation/BillStatus.asp?DocTypeID=HB&DocNum=274&GAID=14&SessionID=91&LegID=99308. Accessed May 18, 2018.

References

Speaker Contact InformationErin Carson, PharmD, [email protected]

session c hormones tablet - lecturepanda.app

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