4/29/19 - cdn.ymaws.com

4/29/19

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©UNIVERSITY OF UTAH HEALTH ©UNIVERSITY OF UTAH HEALTH

Contraception Therapeutics 101: A Foundation for the Future

Karen Gunning, PharmD, BCPS, BCACP, FCCP Professor & Associate Dean of Community Engagement

Adjunct Professor of Family & Preventive Medicine University of Utah College of Pharmacy & School of

Medicine

©UNIVERSITY OF UTAH HEALTH

Disclosures

•  The speaker has no relevant conflicts or interests to disclose.

•  Off-label uses of contraceptive products will not be discussed in this presentation except for extended use of patch and ring

•  We will only be talking about therapeutics today, not the standing order, law, or workflow

•  This presentation does not meet the training requirements for pharmacist provision of self administered contraception in the State of Utah.


Pharmacist Objectives

1.  Explore the Centers for Disease Control and Prevention (CDC) Selected Practice Recommendations for Contraceptive Use (U.S. SPR) to identify and differentiate self-administered contraception, long acting reversible contraception, and resources for talking with patients about contraceptive method efficacy, use and adverse effects.

2.  Outline a plan to reasonably determine a woman is not pregnant prior to starting contraception; how to start the selected contraceptive method and subsequently identify appropriate follow up process and frequency depending on the contraceptive method chosen.

3.  Using the CDC Medical Eligibility Criteria for Contraception, evaluate patient medical histories in order to develop an initial and ongoing contraceptive plan.


Technician Objectives

1.  Define resources available for patient information on contraception.

2.  Outline the various contraceptive products available for contraception and categorize them as self-administered, over the counter, or long acting reversible contraception (LARC).

3.  Develop a system to reduce dispensing errors by understanding the subtle differences between oral contraceptive products


Outline

•  Selected Practice Recommendations –  Pregnancy determination, methods available,

efficacy, –  How to start and how to follow up on self

administered hormonal contraception –  Method associated adverse effects

•  Medical Eligibility Criteria –  What types of self administered contraception for

which patient?

•  Error Prevention •  Resources

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https://www.cdc.gov/reproductivehealth/contraception/contraception_guidance.htm


Selected Practice Recommendations – CDC 2016

https://www.cdc.gov/reproductivehealth/contraception/mmwr/spr/intro.html

SAHC

LARC

OTC

Utah


Efficacy – Typical vs Perfect Use

https://www.cdc.gov/mmwr/pdf/rr/rr6304.pdf ©UNIVERSITY OF UTAH HEALTH

Efficacy Pearls

•  Adherence, Adherence, Adherence –  Patients should know what to do if they miss a

pill ( or patch/ring change day)

•  Progestin only pills are not forgiving –  3 hours late counts as a missed pill

•  Does the patient know how to use the medication?

©UNIVERSITY OF UTAH HEALTH https://www.cdc.gov/reproductivehealth/contraception/pdf/Recommended-Actions-Late-Missed_508Tagged.pdf

ForPatchorRing:>48hours=“missed”


When to Start a Contraceptive Method

•  What are common barriers to starting? •  Filling a prescription •  Starting during menses •  Coming back for a second (or more) visit •  Pregnancy testing

•  Reduce barriers:

•  “Quick Start” – pills, patch, ring •  Start as soon as patient has medication •  Back up method for 7 days •  Pregnancy testing not required or recommended

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https://www.cdc.gov/reproductivehealth/contraception/pdf/When-To-Start_508Tagged.pdf

How Can You be Certain a Woman is NOT Pregnant ?

“The benefits of starting self administered hormonal

contraception likely exceed any risk of starting the method

if the patient is pregnant”

“No increased risk for adverse outcomes (congenital

anomalies, neonatal death, infant death) among infants exposed in utero to COCs “

©UNIVERSITY OF UTAH HEALTH https://www.cdc.gov/reproductivehealth/contraception/mmwr/spr/appendixb.html


Self Administered Contraceptive Methods

•  Combined Hormonal Contraceptives •  Progestin Only pills •  Contraceptive Ring •  Contraceptive Patch


Combined Contraceptive Pills

•  Estrogen (ethinyl estradiol) –  50, 35, 30, 25, 20, 10 mcg

+ •  Progestin

–  Levonorgestrel, drospirinone, norethindrone, norethindrone acetate, desogestrel, norgestrel, norgestimate, ethynodiol diacetate


Combined Contraceptive Pills: Types of pill products

•  Monophasic •  Biphasic •  Triphasic

–  Good to start with monophasic

•  28 day cycle pack (21 day active/7 placebo) –  Extended regimen

•  Could be 24 active, 4 placebo •  Could be 26 active, 2 placebo •  Could be 28 active, 0 placebo •  Could be 84 active, 7 placebo


Combined Contraceptives – Rare yet Severe Adverse Effects - ACHES

•  Abdominal pain à Benign liver tumor, clot •  Chest pain à Pulmonary embolism, MI •  Headaches à stroke, clot •  Eye problems à stroke, clot •  Severe leg pain à Deep Venous Thrombosis

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Combined Contraceptives: Common Side Effects

•  Breakthrough bleeding/spotting – especially in the first three months

•  Nausea/vomiting – especially in the first three months

•  Breast tenderness ReassurePatients


Combined Hormonal Contraceptives:

Myths •  Weight gain •  Depression •  Only certain products help with acne •  Effect fertility •  Protect against STDs •  Women should take pill “holidays” •  Obese woman can’t use combined ocps •  Can’t be used by women over 35, 45, 50 •  Many antibiotics effect OCP efficacy •  Combined ocps cause birth defects •  Generics are less effective


Combined Contraceptive Ring 15 mcg EE/ 0.12 mg Etnogestrel •  Left in x 3 weeks, out for one week

–  Can be used continuously (i.e. old ring out, new ring in after 3 weeks)

–  Can be removed/reinserted within 3 hours – not a “miss”

•  Must be comfortable with insertion and removal process •  Additional side effects

–  Vaginal discharge •  No increased risk of clot •  No decreased efficacy with weight > 90 kg •  Annovera is a one year ring – different progestin/ EE 13

mcg/day


Combined Hormone Patch: norelgestromin 150 mcg + ethinyl estradiol 20 mcg

•  Similar in adverse effects to combined pills •  Can be used continuously (no off week) •  BUT….

–  Increased risk of VTE due to higher AUC vs pills –  Efficacy decreases with weight over 90 kg (198

lbs) –  Must remember to change weekly –  Can be sensitive to adhesive

•  Overall – not a great method – no reason to choose over ring


Progestin Only Pills

•  One progestin: Norethindrone •  One dose: 0.35 mg •  No estrogen J •  No placebo pills •  3 hours late in taking = missed pill

–  Must use backup x 48 hours

•  No clot risk, no MI or stroke risk •  Adverse effects:

–  Breakthrough bleeding and spotting –  Amenorrhea à 10% of patients


LARC: Long acting reversible

contraception

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Intrauterine Devices (IUD) – Non Hormonal

•  Copper IUD (Paragard) –  10 years of contraceptive efficacy –  Adverse effect: heavier bleeding/cramping –  Advantage: no hormones, long duration of

efficacy –  Can be used as emergency contraception if

inserted within 5 days of unprotected intercourse –  No delay to fertility with removal


Intrauterine Devices - Progestin

•  Levonorgestrel IUDs –  Skyla à 3 years, 14 mcg/day –  Lilleta à 5 years, 20 mcg à 10 mcg/day –  Kyleena à 5 years, 17.5 à 9.8 mcg/day –  Mirena à 5 years, 20 mcg/day

•  Side effects: –  Irregular bleeding/spotting, then amenorrhea

•  CDC does not recommend use of medications pre-insertion

•  No delay to fertility with removal


Contraceptive Implant Etnogestrel

•  No estrogen, progestin only •  One rod system •  3 years of contraception •  No delay to fertility after removal •  Adverse effects: irregularly irregular

bleeding, amenorrhea (but less than with progestin iud)


Other Contraceptive Methods


Injections: Depot Medroxyprogesterone

•  Subcutaneous formulation: 104 mg •  Intramuscular formulation: 150 mg •  Both: Every three months

–  Can administer anytime between 11 – 13 weeks

•  Adverse effects: Irregular bleeding and spotting, WEIGHT GAIN, eventual amenorrhea in about 50% of patients –  Reduction in bone density, rebound after d/c

•  Delayed return to fertility (average 10 months to ovulation)


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Follow Up after Method Start*****


Outline





which patient?



Conditions with increased risk for adverse events as a result of pregnancy

•  Breast cancer •  Complicated valvular heart disease •  Cystic fibrosis •  Diabetes: insulin dependent; with

nephropathy, retinopathy, or neuropathy or other vascular disease; or of >20 years’ duration

•  Endometrial or ovarian cancer •  Epilepsy •  Hypertension (systolic ≥160 mm Hg

or diastolic ≥100 mm Hg) •  History of bariatric surgery within the

past 2 years •  HIV: not clinically well or not

receiving antiretroviral therapy

https://www.cdc.gov/mmwr/volumes/65/rr/rr6503a1.htm?s_cid=rr6503a1_w#B-1-1_down

•  Ischemic heart disease •  Hepatocellular adenoma

and Peripartum cardiomyopathy

•  Severe (decompensated) cirrhosis

•  Sickle cell disease •  Solid organ

transplantation within the past 2 years

•  Stroke •  Systemic lupus

erythematosus •  Thrombogenic mutations •  Tuberculosis

http://www.cdc.gov/reproductivehealth/contraception/pdf/summary-chart-us-medical-eligibility-criteria_ 508tagged.pdf


CDC Medical Eligibility Criteria for Contraception - 2016

http://www.cdc.gov/reproductivehealth/UnintendedPregnancy/USMEC.htm

•  The “contraception guideline” •  Similar to WHO MEC but adapted to US needs

•  4 categories: •  A condition with no restriction for contraceptive

use •  A condition where benefits generally > risks •  A condition where risks usually > benefits •  A condition that represents an unacceptable

health risk if contraceptive method used.

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How to Use The MEC


Headaches


Postpartum


MEC Example – Postpartum Patient Which of the following is true about contraception for Mary?

•  Mary is a 24 year old post partum patient who comes to your pharmacy today to restart contraception after her pregnancy.

•  She has recently moved to Utah from California and had previously had a great experience getting her contraceptive from her pharmacist.

•  She gave birth 2 months ago, and was reminded to come in because she just started her first period after giving birth. She is breastfeeding and it is going well. She has no past medical history besides a healthy pregnancy.

A. Theonlyoptionforherisa“minipill”–progestinonlypill

B. Sheshouldbereferred,youwerewronginthinkingyoucouldprovidehercontraception

C. Shecansafelytakeestrogencontainingpills,patchorring

D. Sheshouldnotneedcontraceptionasthebreastfeedingisprotectiveagainstpregnancy.


MEC Example: Drug Interactions What do you decide to do for Sara? •  Sara is a 30 year old woman

with a history of a seizure disorder. She has been well controlled on carbamazepine for several years, with minimal seizure activity.

•  She has no other medical history and was previously on contraception (ethinyl estradiol/levonorgestrel pill ), but has recently had an insurance change and can’t get an appointment to see her new PCP for 3 months; and would like to start contraception today. She is not on any other meds.

A. RestartthepillshewastakingpreviouslyB. Referhertoherprovider/giveherresourcesforprovidersyouknowwhomightnothavesuchalongwait,andtalktoheraboutOTCcontraception

C. Prescribethevaginalcontraceptiveringforher

D. Tellherthatsheshouldseekinfoonpermanentcontraceptionduetotheriskofhermedicationtoanypregnancy


MEC: Drug Interactions

•  What is the only antibiotic that creates a contraindication with oral or implantable hormonal contraception (As per the MEC)? A. Penicillin B. Clarithromycin C. Rifampin / Rifabutin D. Sulfamethoxazole / Trimethoprim

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Think – Pair – Share

Turn to a person around you and identify category 4 MEC recommendations for each of

these, then brainstorm why there is a risk (i.e. what underlies or explains the risk)

A. Combined hormonal contraceptives B.  Progestin only pills C. Copper IUD D. Levonorgestrel IUD E.  Depot

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Outline





which patient?



Preventing Errors at the Pharmacy

•  Don’t memorize all the weird branded generic names – always go to dose/generic name

•  Example: Aubra EQ Aviane Balcoltrak Falmina Larissia Lessina Lutera Orsythia Sronyx Vienva

These are all: EE 20 mcg & Levonorgestrel 0.1 mg


SALA: Sound Alike/Look Alike

•  They all look alike! (packaging and pills) •  They often sound alike! •  Examples:

–  Loestrin-21 1/20 Loestrin Fe 1/20

–  Loestrin 1.5/30-21 Loestrin Fe 1.5/30

–  Ortho Tri-Cyclen Lo –  Ortho Tri-Cyclen

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Depo is not just Depo

https://www.ismp.org/resources/do-not-let-depo-medications-be-depot-mistakes


Outline





which patient?



Resources

•  CDC Contraception Guidance For Healthcare Providers https://www.cdc.gov/reproductivehealth/contraception/contraception_guidance.htm –  SPR, MEC and other patient education and training tools –  Sign up for updates, free trainings

•  Pharmacists Letter (subscription) –  https://pharmacist.therapeuticresearch.com/Home/PL –  Excellent charts

•  www.ManagingContraception.com (for purchase) –  Pocket book/ebook,some free downloads/pt education –  Also Contraceptive Technology book


Resources

•  American College of Obstetrics & Gyn (ACOG) resources –  https://www.acog.org/Womens-Health/Birth-Control-

Contraception?IsMobileSet=false

•  Family Planning Elevated Utah –  https://fpeutah.org/

•  Utah Department of Health Standing order and resources –  https://mihp.utah.gov/birthcontrol

•  Utah Board of Pharmacy –  https://dopl.utah.gov/pharm/index.html


Questions? Karen Gunning

[email protected]

4/29/19 - cdn.ymaws.com

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