Understanding Menstrual Hormones and Oral Contraceptive Choices



Similar documents
Combination Birth Control Pills - FAQ

PILLS & RING INFORMATION AND INSTRUCTIONS ON COMBINED HORMONAL CONTRACEPTION INCLUDING BIRTH CONTROL PILLS & NUVA RING

FDA-Approved Patient Labeling

The Challenges, Risks, and Benefits of Oral Contraceptives

Hormonal Oral Contraceptives: An Overview By Kelsie Court. A variety of methods of contraception are currently available, giving men and

WOMENCARE A Healthy Woman is a Powerful Woman (407) Birth Control Pills

Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/ 0.03 mg

Anatomy and Physiology of Human Reproduction. Module 10a

FDA-Approved Patient Labeling IMPLANON (etonogestrel implant) Subdermal Use

progestog progestogen stogen-only pill progestogen progestogen-only pill he progestogen-only pill progestogen-onl progestogen-o the progestogenonly

What s New in Contraception? Evelyn Kieltyka, Maine Family Planning, ekieltyka@mainefamilyplanning.org

CYCLESSA Tablets (desogestrel and ethinyl estradiol tablets USP)

All methods of birth control are MUCH SAFER than being pregnant! If 100 women use each method for a year, how many of them get pregnant?

CONSUMER INFORMATION IMPORTANT: PLEASE READ

PROVERA (medroxyprogesterone acetate) Product Monograph Page 34 of 38

Combined Oral Contraceptives

Post-Coital Hormonal Contraception Instructions for Use of Plan B, Plan B One-Step, Next Choice One Dose, My Way, Generic Levonorgestrel and Ella

Birth Control Options

Quick Guide to Contraception

A REVIEW OF FEDERAL PHARMACY LAW DONALD SULLIVAN, PH.D

STANDARD APRN PROTOCOL FOR IUD INSERTION: Levonorgestrel (LNG) Releasing Intrauterine System

Young Women and Long-Acting Reversible Contraception. Safe, Reliable, and Cost-Effective Birth Control

Dr. Friedman s Guide to Estrogen Replacement

Effective long-lasting strategy to prevent unintended pregnancy. The intrauterine system for contraception after abortion.

implant contraceptiv contraceptive contraceptive raceptiv contraceptive implant contraceptive contraceptive ontraceptive implant ontraceptive im

Management of Abnormal Uterine Bleeding in Adolescents

Hull & East Riding Prescribing Committee

Menopause and Hormone Replacement Therapy

INFORMATION FOR THE PATIENT PATIENT PACKAGE INSERT CLÉO -35 Acne Treatment

This is Jaydess. Patient Information. What is Jaydess? How does Jaydess work?

injections injections injections injections injections injection injections injections injections tions njections injections injections injections

What Athletic Trainers Need to Know About Gynecology

PREVENTING MEDICATION ERRORS IN PHARMACY PRACTICE DR. SULLIVAN S SUPPLEMENTAL HANDOUT

TESTOSTERONE REPLACEMENT THERAPY FOR THE AGING MALE: COUNSELING INSIGHTS FOR THE PHARMACIST TIM DRAKE, PHARM.D.

Risk Management Plan

Plan B (Levonorgestrel) Tablets, 0.75 mg

patient education Fact Sheet PFS003: Hormone Therapy APRIL 2015

Heavy menstrual bleeding and what you can do about it!

Polycystic Ovary Syndrome

Abnormal Uterine Bleeding FAQ Sheet

Now that your Doctor has prescribed Livial for you

POLYCYSTIC OVARY SYNDROME

Polycystic Ovarian Syndrome

Women s Preventive Services

WOMENCARE A Healthy Woman is a Powerful Woman (407) Hormone Therapy

HEALTH UPDATE. Polycystic Ovary Syndrome (PCOS)

WOMENCARE A Healthy Woman is a Powerful Woman (407) Endometriosis

Abigail R. Proffer, M.D. October 4, 2013

Why is Cerazette used? To prevent pregnancy.

Form ### Transgender Hormone Therapy - Estrogen Informed Consent SAMPLE

ON PENS AND NEEDLES A PRIMER ON INSULIN PENS AND PROPER INJECTION TECHNIQUES PETE KRECKEL, RPH

Abnormal Uterine Bleeding

BE WISE, IMMUNIZE: AN UPDATE ON IMMUNIZATION PRACTICES GRETCHEN KRECKEL GAROFOLI, PHARMD

Menstruation and the Menstrual Cycle

Menopause Guidance on management and prescribing HRT for GPs based on NICE guidance 2015

vagina vaginal r vaginal ring vaginal vaginal ring aginal ring vaginal ring vaginal ring vaginal ring the contraceptive vaginal rin vaginal ring

OVERVIEW OF RECENT PHARMACY LAW CASES DAVID BRUSHWOOD, JD, RPH

USER PACKAGE LEAFLET: INFORMATION FOR THE USER Exluton, tablets 0.5 mg Lynestrenol

WHEN THE STARS ALIGN AND YOUR PATIENT IS IN SYNC: ADHERENCE RISES MARK GAROFOLI, PHARMD, MBA, CGP PETE KRECKEL, RPH

Birth Control Methods

The menopausal transition usually has three parts:

Polycystic ovary syndrome (PCOS)

Overview of Existing State Distribution Mechanisms and Barr s Proposed Educational Program and Distribution for Plan B

ANTIBIOTICS FROM HEAD TO TOE: PART 5 - URINARY TRACT INFECTIONS LAUREN HYNICKA, PHARM.D.

REVIEW OF FEDERAL LAW FOR PHARMACY TECHNICIANS DR. SULLIVAN S MONOGRAPH

patch contracep raceptiv contraceptive patch contraceptive patch contraceptiv patch contraceptive patch tch ontraceptive atch contraceptive p

MOVEMENT BEYOND LAXATIVES: EVOLVING PHARMACOLOGIC OPTIONS FOR IBS-C AND CIC PETE KRECKEL, RPH

From Menses to Menopause: How Hormones Can Affect Blood Glucose Levels. Christine Day, RN, MS, CNS-BC Lake Superior College

contraception contraception contraception contracepti contraception contraception contraception aception contraception contraception contraception

Diary Card. Cerazette. Keeping a record. For women prescribed Cerazette. How do I find out more?

ency emergency contra-

Menstruation and the Menstrual Cycle

Accurate Answers. to Questions About Birth Control Pills. Rick Jelovsek MD From BackupMD.net. Table of Contents

MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules. What is the most important information I should know about POMALYST?

BACKGROUNDER CONTRACEPTION

SHOULD WE ALL TAKE OMEGA-3 FATTY ACID SUPPLEMENTS? GENEVA BRIGGS, PHARMD, BCPS

Medical criteria for IUCD s Based on the WHO MEC (2004- Annexure 3) system a woman s eligibility for IUCD insertion falls in 4 categories. These categ

FACT SHEET. The Polycystic Ovary Syndrome (PCOS) Introduction

OVARIAN CYSTS. Types of Ovarian Cysts There are many types of ovarian cysts and these can be categorized into functional and nonfunctional

PRS 103 CONTEMPORARY ISSUES IN PHARMACY REGULATION PRS 103.6: LICENSURE AS ASSURANCE OF COMPETENCE DR. BRUSHWOOD S MONOGRAPH

Ovarian Cyst. Homoeopathy Clinic. Introduction. Types of Ovarian Cysts. Contents. Case Reports. 21 August 2002

MHRI IUD Protocol. Migraine with aura Current DVT or PE History of or current breast cancer Active viral hepatitis Severe cirrhosis or liver tumors

Emergency Contraceptive Pills

ALL IN THE FAMILY 75 YEARS OF DIABETES TREATMENT OPTIONS FROM GLASS SYRINGES TO SGLT2 INHIBITORS PETER A. KRECKEL, R.PH.

Lakeview Endocrinology and Diabetes Consultants N Halsted St C-1. Chicago IL P: F:

The Morning-After Pill: The Dangers of Over-the-Counter Availability

RHEUMATOID ARTHRITIS: PRIMARILY AN AUTOIMMUNE DISEASE JOHNATHON DUFTON, MD

PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES

MEDICATION GUIDE. SORIATANE (sor-rye-uh-tane) (acitretin) Capsules

Transcription:

Understanding Menstrual Hormones and Oral Contraceptive Choices ACTIVITY DESCRIPTION Pharmacists should be aware of the various types of oral contraceptives that are currently available and how to choose among them. They should also be aware of the warnings, contraindications and potential side effects of this class of medication. TARGET AUDIENCE The target audience for this activity is pharmacists, pharmacy technicians, and nurses in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist will be able to: Summarize the pathway of the normal menstrual cycle and its relation to the mechanism of action of oral contraceptives. Compare and contrast the oral contraceptives that are currently available Explain the health benefits and risks associated with oral contraceptive use. List the potential drug-drug interactions associated with oral contraceptive Counsel a patient on oral contraceptive use including missed doses and adherence issues. After completing this activity, the pharmacy technicians will be able to: Summarize the menstrual cycle List oral contraceptives currently available ACCREDITATION Pharmacy PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Nursing PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number 50-3515). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit: http://www.nursecredentialing.org/renewalrequirements.aspx Universal Activity No.: 0798-0000-15-154-H01-P Credits: 1.0 Release Date: 7/05/2016 freece Expiration Date: 7/05/2018 ACPE Expiration Date: 1/05/2019 ACTIVITY TYPE Knowledge-Based Live Webinar FINANCIAL SUPPORT BY PharmCon

Brooke Fidler Assistant Professor, LIU Pharmacy, Arnold & Marie Schwartz College of Pharmacy and Health Sciences ABOUT THE AUTHOR Dr. Brooke Fidler joined the faculty in 2000 as assistant professor of pharmacy practice. In 1999 Dr. Fidler completed a Pharm.D. at the University of Rhode Island and went on to complete a PGY-1 residency at URI the following year. Currently Dr. Fidler s practice site is Kings Specialty Pharmacy where she precepts APPE students completing their MTM elective experience. At Kings Pharmacy Dr. Fidler is also the residency director for the PGY-1 Community Residency. Dr. Fidler s primary didactic responsibilities including teaching and coordinating the physical assessment course at the college. Dr. Fidler has published in Pharmacy and Therapeutics Journal and Journal of Nurse Practitioners. She has also presented numerous webinars for Drug Store News and FreeCE related to community practice and nonprescription medications. FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. Brooke Fidler reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, faculty may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not intended as a substitute for the participant s own research, or for the participant s own professional judgement or advice for a specific problem or situation. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this activity and other unrelated sources. Neither freece/pharmcon nor any content provider intends to or should be considered to be rendering medical, pharmaceutical, or other professional advice. While freece/pharmcon and its content providers have exercised care in providing information, no guarantee of it s accuracy, timeliness or applicability can be or is made. You assume all risks and responsibilities with respect to any decisions or advice made or given as a result of the use of the content of this activity.

Understanding Menstrual Hormones and Oral Contraceptive Choices Understanding Menstrual Hormones and Oral Contraceptive Choices Activity Universal Activity Number Activity Faculty ACCREDITATION 0798-0000-15-154-L01-P INSTRUCTION Credits Brooke Fidler, PharmD 1.0 contact hour(s) Assistant Professor of Pharmacy Practice, LIU Pharmacy Faculty Disclosure Dr. Fidler has no actual or potential conflicts of interest in relation to this activity. Learning OBJECTIVES Review the pathway of the normal menstrual cycle and its relation to the mechanism of action of oral contraceptives (OCs) Compare and contrast the oral contraceptives that are currently available Explain the health benefits and risks associated with oral contraceptive use List the potential drug-drug interactions associated with oral contraceptives Describe the key counseling points for a patient taking oral contraceptives including missed doses and adherence issues Legal DISCLAIMER The material presented here does not necessarily reflect the views of PharmCon, Inc. or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. FACULTY: Brooke D Fidler, PharmD 7/5/2016 2 Learning Objectives Review the pathway of the normal menstrual cycle and its relation to the mechanism of action of oral contraceptives (OCs) Compare and contrast the oral contraceptives that are currently available Explain the health benefits and risks associated with oral contraceptive use List the potential drug-drug interactions associated with oral contraceptives Describe the key counseling points for a patient taking oral contraceptives including missed doses and adherence issues Background According to the CDC between 2011-2013 62% of 60.9 million women aged 15-44 in the US use a method of contraception OCs (16%), female sterilization (15.5%), male condom (9.4%), long acting reversible contraceptives (7.2%) Approximately 15% of OC users show poor compliance Failure to fill prescription or late refills Incorrect administration and missed doses Discontinuing the OC with no or poor backup method 7/5/2016 3 7/5/2016 4 1

Role of the Pharmacist Choosing the appropriate oral hormonal contraceptive based on patient characteristics Counseling on potential side effects Educating patients on risks vs benefits Counseling on proper administration and missed doses Identifying issues of non-adherence Identifying potential drug interactions History of Oral Contraceptives 1960 s First combined oral contraceptive (COC) marketed Production of high and fixed dose of E/P 1970 s First progestin-only pill (POP) marketed Production of lower dose E/P in COC Recognizing COC use for postcoital contraception (Yuzpe regimen) 1980 s First COC marketed with varied dose of either or both E/P 7/5/2016 5 7/5/2016 6 History of Oral Contraceptives Late 1980 s Non-contraceptive benefits of OCs are recognized 1990 s Continued production of low-dose COC 1997 FDA identifies certain COCs safe and effective to use as EC Some COCs approved for treatment of acne History of Oral Contraceptives 1999 Approval of Plan B emergency contraceptive (EC) 2003 and 2006 Extended duration COC (I.e., Seasonale and Seasonique ) 2013 Unrestricted OTC sale for oral emergency contraception 7/5/2016 7 7/5/2016 8 2

Normal Menstrual Cycle Normal Menstrual Cycle The first day of menses is Day 1 of the menstrual cycle Average cycle is 28 days, between 21-35 days Average menses is 5 days, between 3-10 days 3 Phases: follicular, ovulation, luteal 3 Cycles: pituitary, ovarian, endometrial Hormones: follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrogen, progesterone Phases Follicular (preovulatory) Ovulatory Luteal (postovulatory) Cycles Pituitary Ovarian Endometrial Hormones FSH LH Estrogen Progesterone 7/5/2016 9 7/5/2016 10 Normal Menstrual Cycle Release of FSH and LH, increase production of estrogen (thinning of cervical mucus) Release of egg, production of progesterone OCs and Menstrual Cycle Suppress LH and FSH Inhibit ovulation Increased production of progesterone and thickening of uterine lining 7/5/2016 11 Thicken cervical mucus and prevents thickening of endometrial lining Lighter menstrual flow 7/5/2016 12 3

Hormonal Birth Control Options Progestin-only Progestin-only pill (POP or minipill) Injection IUD Estrogen + Progestin Combination Oral Contraceptive (COC) Vaginal ring Transdermal POP Mechanism of Action Only contains progestin as active ingredient Thickens cervical mucus to inhibit sperm penetration Prevents thickening of the endometrium lining to inhibit fertilized egg from implanting in the uterus Suppresses ovulation in half of users Lowers mid-cycle LH and FSH peaks Slows movement of ovum through fallopian tube 7/5/2016 13 7/5/2016 14 COC Mechanism of Action Contains estrogen and progestin (E+P) as active ingredients Inhibition of ovulation by suppressing LH and FSH Thickens cervical mucus to increase the difficulty of sperm entering into the uterus Thinning of the endometrium lining to prevent a fertilized egg from implanting in the uterus Progesterone First generation (estrane) Norethindrone, norethindrone acetate, ethynodiol diacetate Second generation (gonane) Levonorgestrel, norgestrel Third generation (newer gonane) Desogestrel, norgestimate Fourth generation Drospirenone (spironolactone derived), dienogest 7/5/2016 15 7/5/2016 16 4

Estrogen Ethinyl estradiol (EE) is the synthetic estrogen used in COCs Daily EE doses in COC have greatly decreased over the years 50mcg, 35mcg, 30mcg, 20 mcg, 10mcg Due to risk of venous thromboembolism patients should not take more than 50 mcg/day of ethinyl estradiol Estradiol valerate/dienogest (Natazia ) approval for contraception and heavy menstrual bleeding 7/5/2016 17 Commercially Available Products * POP Norethindrone (Errin, Nor-QD ) COC (P+EE) Norethindrone ** (Junel, Loestrin, Microgestin, Necon ) Ethynodiol diacetate (Zovia, Kelnor ) Levonorgestrel^ (Camrese, Lessina, Seasonale ) Norgestrel (Cryselle, Low-Ogestrel ) Desogestrel (Apri, Kariva ) Norgestimate ** (Ortho Tri-Cyclen, Tri-Sprintec, Previfem ) Drospirenone ** (Ocella, Yasmin, Yaz, Beyaz ) * List is not comprehensive; **Can be used for acne treatment; ^Can be used for EC 7/5/2016 18 Progestin Properties Potency (relative to 1mg of norethindrone) Desogestrel, levonorgestrel, norgestrel Estrogenic activity Ethinyl estradiol >35 mcg Progestational activity (relative to 1mg of norethindrone) Desogestrel, levonorgestrel, norgestrel Androgenic activity Low: desogestrel, norgestimate, norethindrone (<1mg), drospirenone Moderate: levonorgestrel, ethynodiol, norethindrone (1mg) High: norgestrel, norethindrone (>1mg) Oral Contraceptive Properties Too much estrogen Nausea, bloating, breast tenderness, increased BP and headache, weight gain, heavy menstrual flow, cardiovascular events (MI, VTE) Too little estrogen Early-cycle spotting or breakthrough bleeding (BTB), vaginal dryness, amenorrhea Too much progestin Breast tenderness, headache, weight gain, hirsutism, mood changes Too little progestin Late BTB, heavy menstrual flow, amenorrhea Too much androgen Increased appetite, weight gain, acne, oily skin, decreased libido, increase cholesterol, hirsutism, fatigue 7/5/2016 19 7/5/2016 20 5

COC Products Monophasic (Ovcon, Necon, Loestrin, Desogen ) Constant dose of both E+P in each active pill throughout the entire cycle EE 20-50mcg/day Biphasic (Ortho-Novum,Kariva ) Contains 2 different progestin doses and estrogen remains constant Contain 2 different estrogen doses and progestin remains constant COC Products Triphasic (Ortho Tri-Cyclen, Tri-Sprintec ) Gradual increase of E and/or P throughout cycle Four-phasic (Natazia ) 4 progestin/estrogen dosing combinations throughout cycle 7/5/2016 21 7/5/2016 22 28 Day COC Formulation 21 active tablets with a 7 day inactive week Inactive week No tablets (21 day container) Placebo tablets (28 day container) Iron tablets (Estrostep Fe ) Folate tablets (Beyaz ) Imitates the normal menstrual cycle Withdrawal bleeding during the inactive week (1 period every 4 weeks) 84 Day COC Formulation Seasonale, Seasonique 84 active tablets with a 7 day inactive week (91 day container) Decreases withdrawal bleeding to 4 per year Eliminate or reduce PMS symptoms, dysmenorrhea and other symptoms associated with withdrawal period 7/5/2016 23 7/5/2016 24 6

POP Products Taken continuously with no inactive weeks (28 day container) Contains norethindrone 0.35mg Brand products include by not limited to Ortho Micronor, Camila, Errin, Jencycla, Nor-QD Bleeding using POP varies among women No bleeding, regular or irregular bleeding Noncontraceptive Benefits of OCs Reduce risk of ovarian cancer Treatment of endometriosis Treatment of PCOS Reduce risk of endometrial cancer Reduce risk of colorectal cancer Improvement in acne 7/5/2016 25 7/5/2016 26 Noncontraceptive Benefits of OCs Menstrual benefits (PMS, PMDD, anemia) Protection of pelvic inflammatory disease Reduce incidence of ectopic pregnancy Positive effects on bone mineral density and reduction in hip fractures Transition therapy for perimenopausal women Cardiovascular and OC Health Risks Venous thromboembolism (VTE) Increases risk by 3-6 fold Other risk factors include age >35, obesity, family history MI OC users and smoke >15 cigarettes/day OC users with HTN are 1.5 times more likely to have stroke Other risk factors include obesity, diabetes, hyperlipidemia and age >35 Stroke Risk is 3 times higher in OC users Risk increases to 7 times in OC users who smoke and have HTN 7/5/2016 27 7/5/2016 28 7

Cancer and OC Health Risks Breast cancer Increase risk initially and may decrease to that of a nonuser after discontinuation Risk was seen to be higher in those using triphasic OCs Caution in patients with a family history Liver disease May be associated with a duration of use for longer than 5-8 years but still remains unclear Cervical cancer Associated with a duration of use for longer than 5-8 years Risk is 4 times higher when used OC for longer than 10 years Metabolic and OC Health Risks Diabetes Does not seem to cause diabetes but can worsen DM Estrogen can increase glucose levels and suppresses insulin response Progestin stimulates insulin production Linked to more androgenic properties Lipids OCs can affect LDL, HDL, TG and HDL 7/5/2016 29 7/5/2016 30 Misc. OC Health Risks Gallbladder disease Associated with high dose estrogen Increase formation of gallstones and inflammation of gallbladder Migraine Associated with high dose estrogen Warning sign of stroke Visual changes (retinal thrombosis) Does not protect against HIV or other STDs Minor hormonal side effects COC Contraindications Thrombophlebitis or thromboembolic disease Past history of DVT or thromboembolic disorders CVD or CAD Known or suspected carcinoma of the breast Carcinoma of the endometrium or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas Known or suspected pregnancy Hepatic or renal dysfunction or adrenal insufficiency (drospirenone) 7/5/2016 31 7/5/2016 32 Guidance for Industry. Labeling for COC. FDA. 8

COC Black Box Warning Women >35 years of age who smoke Smoking increases the risk of CV events from COC use Risk increases with number of cigarettes smoked COC Warnings and Precautions Persistent high blood pressure (>160/100) History of diabetes History of dyslipidemia History of migraines History of gallbladder disease 7/5/2016 33 Guidance for Industry. Labeling for COC. FDA. 7/5/2016 34 Guidance for Industry. Labeling for COC. FDA. WHO Contraindications Those listed in the PI plus Lactation (<6 weeks postpartum) Age >35 and smokes > 15cigarettes/day Elevated BP (>160/>100) Chest pain (angina pectoris) CVD or CAD Major surgery with prolonged immobilization Complicated valvular heart disease Migraine without focal neurologic symptoms >35 years Migraine with focal neurologic symptoms at any age Complicated diabetes (microvascular disease or >20 years duration Severe cirrhosis 7/5/2016 35 POP Contraindications Pregnancy History or current breast cancer Undiagnosed abnormal genital bleeding Currently taking antiseizure or TB medications Allergic to product Benign or cancerous liver tumors Acute liver disease Thromboembolic disorders 7/5/2016 36 POP Package Inserts. FDA. 9

POP Warnings Breastfeeding within 6 weeks of postpartum Ovarian cysts Smoking (BBW due to risk of MI and stroke) Diabetes Which OC is right OC for me? Patient characteristics Age, weight, smoker, BP, lipids, history of cancers, history of CVD, history of migraines, menstrual history, post-partum, breastfeeding, other specific co-existing conditions Tests needed before initiation BMI, BP, clinical breast exam, cervical exam, glucose, liver enzymes, STD/HIV screening 7/5/2016 37 POP Package Inserts. FDA. 7/5/2016 38 Resources Medical Eligibility Criteria for Contraceptive Use 2006 (reaffirmed in 2013) ACOG published guidelines for use of hormonal contraceptives in women with comorbidities 2010 CDC adapted the WHO US Medical Eligibility Criteria for Contraceptive Use 2013 US Selected Practice Recommendations for Contraceptive Use 1 = A condition for which there is no restriction for the use of the contraceptive method. 2 = A condition for which the advantages of using the method generally outweigh the theoretical or proven risks. 3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method. 4 = A condition that represents an unacceptable health risk if the contraceptive method is used. 7/5/2016 39 7/5/2016 40 10

When are POP safer than COC? >35 years Smokers Poorly controlled HTN Obesity Migraines with neurological symptoms Diabetes with complications History of blood clots Any contraindication to COC Breastfeeding Postpartum Postpartum and Contraceptive Use Nonbreastfeeding <21 days should not use hormonal contraceptives (4) 21-42 days plus risk factors for VTE should not use hormonal contraceptives (3) 21-42 days without VTE risk factors (2) 21-42 or >42 days no restrictions (1) Breastfeeding <21 days should avoid use due to concerns of estrogen on breastfeeding and milk production (4) 21 to <30 days with or without other risk factors for VTE avoid use (3) 30-42 days with VTE risk factors (3) >42 days (2) 7/5/2016 41 7/5/2016 42 http://www.cdc.gov/mmwr/pdf/wk/mm6026.pdf COC Side Effects and Resolution COC Side Effects and Resolution Break-through bleeding Higher estrogen, higher progestin potency, less androgenic Menstrual related symptoms (tiredness, bloating, excessive bleeding) Use of extended cycles COC Acne Higher estrogen and less androgenic progestin Absent or light menstrual flow Lower progestin potency Headaches Lower estrogen, lower progestin potency Breast soreness Lower estrogen, lower progestin potency Weight gain Lower estrogen, lower progestin potency Severe menstrual cramps Higher progestin potency Endometriosis Lower estrogen, higher progestin potency, higher androgen potency 7/5/2016 43 7/5/2016 44 11

Special Populations and Recommendations Age COC or POP for >35 years, nonsmoker and no contraindications HTN 3 rd or 4 th generation COC or POP Obesity COC or POP, assess comorbidities Special Populations and Recommendations Smoker Risk vs benefit for <35 years COC considered a contraindication (WHO) and BBW (PI) Warning for POP Minimize risk of VTE Use low estrogen dose or POP Diabetes Use less androgenic progestin or POP 7/5/2016 45 7/5/2016 46 Special Populations and Recommendations Epilepsy or depressive disorders COC or POP and assess for drug interactions Lupus Do not use hormonal OC if positive antiphospholipid antibodies Headaches (with no neurological symptoms) Use low estrogen dose or POP Known hyperlipidemias Use less androgenic progestin Adolescents and OCs High rates of unintended pregnancies and STDs More likely to discontinue OC due to side effects More likely to have poor adherence Discuss barrier method plus OC to prevent STDs and HIV Long-acting injectables (Depo-Provera ) and implantables (Nexplanon ) may provide better adherence Use appropriate E:P ratio for OCs 7/5/2016 47 7/5/2016 48 12

OC Drug Interactions Mechanism of Action Liver metabolism Hormone metabolism via CYP 450 3A4 system 3A4 enzyme inducers metabolism of E/P hormone blood levels effectiveness of COC or POP Enterohepatic circulation Intestinal bacterial breakdown free estrogen for reabsorption via enterohepatic circulation Antibiotics alter intestinal bacteria interrupts reabsorption amount of circulating estrogen effectiveness of COC Drug Interactions with POP Hepatic enzyme-inducing drugs (i.e., phenytoin, carbamazepine, barbiturates and rifampin) No significant interaction with broad-spectrum antibiotics St. John s Wort and induce hepatic enzymes and p-glycoprotein transporters and reduce effectiveness of OCs Concurrent use of bosentan and norethindrone containing OCs may reduce effectiveness of OC 7/5/2016 49 7/5/2016 50 POP Package Inserts. FDA. Drug Interactions with COC Recommendations Reduced efficacy associated with concomitant use of rifampin Reduced efficacy suggested with barbiturates, phenylbutazone, phenytoin, carbamazepine Reduced efficacy possibly with griseofulvin, ampicillin and tetracyclines Short-term antibiotic therapy (less than 2 weeks) Use second method (i.e., condoms or abstinence) with OC during ANY antibiotic therapy and for at least 7 days thereafter Long-term antibiotic therapy Use different method of birth control Use a second method with OC for at least 2 weeks after starting antibiotic therapy 7/5/2016 51 COC Package Inserts. FDA. 7/5/2016 52 13

Special Populations Epilepsy May require higher dose of estrogen or minimum of 30mcg of estrogen in COC Second method in addition to COC or POP Progesterone only injectable and implant recommended Lamotrigine preferred HIV 1 Always use condoms regardless of contraceptive method May depend on what regimen the patient is taking Intrauterine devices may be most appropriate option Role of the Pharmacist Counseling Provide a private area for discussion Match counseling to individual risk factors (I.e., smoking, HTN) Develop a regular pill-taking regimen Discuss back-up methods of contraception and what to do if pills are missed Be aware of side effects A- abdominal pain (severe) C- chest pain (severe), cough, SOB, sharp pain upon breathing H- headache (severe), dizziness, weakness or numbness E- eye problems (vision loss or blurring), speech problems S- severe leg pain (calf or thigh) 1 Aidsinfo.nih.gov. Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents: Drug Interactions. 7/5/2016 53 7/5/2016 54 Initiation of OCs POP Day-1 start regimen (first day of the menstrual period) COC Day-1 start regimen (first day of the menstrual period) Sunday-start regimen (first Sunday after menstrual bleeding begins) POP Missed Pills If you are more than 3 hours late or you missed 1 or more pills Take a missed pill as soon as you remember Then continue your regular regimen Use a backup method every time you have sex for the next 48 hours 7/5/2016 55 7/5/2016 56 14

COC Missed Pills COC Missed Pills No. of COC pills missed Start regimen Time in cycle What to do? Counseling No. of COC pills missed Start regimen Time in cycle What to do? Counseling 1 Day 1 Anytime Take pill as soon as remembered Sunday Anytime Take pill as soon as remembered No backup method No backup method 2 Day 1 Week 1 or 2 Take 2 pills as soon as remembered. Take 2 pills the next day. Take 1 pill everyday until finished. Use backup method for 7 days Sunday Week 1 or 2 Same as above Same as above 7/5/2016 57 7/5/2016 58 COC Missed Pills No. of COC pills missed Start regimen Time in cycle 7/5/2016 59 What to do? 2 Day 1 Week 3 Discard the rest of pill pack. Start new pack that same day. Sunday Week 3 Take 1 pill everyday until Sunday. On Sunday, discard rest of pack. Start new pack same day. Counseling Use backup method for 7 days. May not have period. Use backup method for 7 days. May not have period. COC Missed Pills No. of COC pills missed Start regimen Time in cycle 7/5/2016 60 What to do? 3 or more Day 1 Anytime Discard the rest of pill pack. Start new pack that same day. Sunday Anytime Take 1 pill everyday until Sunday. On Sunday, discard rest of pack. Start new pack same day. Counseling Use backup method for 7 days. May not have period. Use backup method for 7 days. May not have period. 15

Additional Backup Method Patient Information Resources First 7 days after initially starting OC While taking an interacting medication and for 7 days thereafter Prevention of STDs and HIV Severe vomiting or diarrhea (use backup on first day and continue use until next period) The Association of Reproductive Health Professionals Office on Women s Health Food and Drug Administration: Office of Women s health Obstetrics, Gynecology, Infertility and Women's Health The Center for Young Women s Health www.arhp.org www.womanshealth.gov www.fda.gov/womens/default.htm www.obgyn.net www.youngwomenshealth.org 7/5/2016 61 7/5/2016 62 References Current Contraceptive Status Among Women Aged 15 44: United States, 2011 2013. Available at http://www.cdc.gov/nchs/data/databriefs/db173.pdf U.S. Selected Practice Recommendations for Contraceptive Use, 2013. Available at http://www.cdc.gov/mmwr/pdf/rr/rr6205.pdf U.S. Medical Eligibility Criteria for Contraceptive Use, 2010. Available at www.cdc.gov/mmwr/pdf/rr/rr5904.pdf The American Congress of Obstetricians and Gynecologists. Available at www.acog.org Bonnema RA et al. Contraceptive Choices in Women with Underlying Medical Conditions. Am Fam Physician. 2010;82(6):621-628. Available at http://www.aafp.org/afp/2010/0915/p621.pdf 7/5/2016 63 16

Exam Questions: 1. What is the maximum dose per day that women should take of ethinyl estradiol due to the risk of thromboembolism? a. 20mcg/day b. 30mcg/day c. 40mcg/day d. 50mcg/day 2. Which of the following progestins is approved for emergency contraception? a. Desogestrel b. Levonorgestrel c. Norgestimate d. Norethindrone 3. Progestin only pills contain which progestin ingredient? a. Desogestrel b. Levonorgestrel c. Norethindrone d. Norgestimate 4. Which of the following risk factors have been shown to further increase the health risks associated with oral contraceptives? a. Smoking b. Obesity c. >35 years of age d. All of the above 5. Which if the following is NOT a benefit of oral contraception? a. Decreased risk of breast cancer b. Reduced risk of ovarian cancer c. Decreased anemia d. Improvement in acne 6. Which of the following statements is TRUE regarding oral contraceptives

drug interactions? a. Short-term antibiotic therapy requires use of a second contraceptive method for the duration of treatment only b. Only need to use caution for those medications metabolized by the CYP450 system c. A second contraceptive method should be used during and 7 days after any antibiotic treatment d. Progestin only pills have no significant drug interactions 7. A patient who misses 1 COC pill anytime in their cycle should be counseled to do which of the following? a. Discard the rest of the pill pack and use a backup contraceptive method for 48 hours b. Take the pill as soon as they remember and no backup contraceptive is necessary c. Wait till the next day and take two pills and no backup contraceptive method necessary d. Discard the rest of the pill pack and start a new pack that same day 8. A 25-year-old patient who experiences migraines without neurological symptoms would benefit from which of the following OC profile? a. Lower estrogen dose b. Lower progestin potency c. A and B d. None of the above. OC s would be contraindicated in this patient. 9. Which of the following is a black box warning for COCs? a. Persistent high blood pressure b. History diabetes c. Women >35 years of age who smoke d. History of dyslipidemia 10. A woman who is postpartum, not breastfeeding and has no additional risks for VTE should wait how long before using COC with no additional risks? a. 14-21 days postpartum

b. <21 days postpartum c. 30 days postpartum d. >42 days postpartum