Clinical Challenges in Contraception Kathleen Besinque, PharmD Sarah McBane, PharmD Disclosures Kathleen Besinque has nothing to disclose Sarah McBane has nothing to disclose Objectives Pharmacists Compare the current methods available for contraception Furnish hormonal contraception to women with complex medical conditions in California Generate a visit summary for reimbursement under AB1114 in California 1
Objectives Technicians Describe medications available for contraception List ways technicians can facilitate pharmacists provision of hormonal contraception Assist in completing a visit summary for reimbursement under AB1114 in California Got a Phone/Tablet? Download the app Hormonal Contraception Many states are enacting scope of practice changes California Oregon Colorado New Mexico Maryland Tennessee Washington State Washington DC Missouri South Carolina The scope of practice changes, as with EC, are pushing practice change. 2
Initiating Hormonal Contraception in the Pharmacy Setting Health History (required) Screening questionnaire Include the categories and conditions from the MEC Other information Measurement of Blood Pressure (required) Weight (optional) Physical Exam (not required) Laboratory Studies (not required) https://www.cdc.gov/reproductivehealth/contracept ion/contraception_guidance.htm http://www.pharmacy.ca.gov/publications/patient_screening_t ool_consumers_english.pdf Guidelines for providing hormonal contraceptives The Centers for Disease Control publish evidence based guidelines and practice recommendations for clinicians regarding contraceptive use. The Medical Eligibility Guidelines for Contraceptives (MEC) The Selected Practice Recommendations (SPR) https://www.cdc.gov/reproductivehealth/contraception/contraception_guidance.htm 3
How to Interpret the Medical Eligibility Criteria Criteria are organized according to: Contraceptive method Patient characteristics (age, smoking status, etc.) Preexisting conditions (hypertension, epilepsy, etc.) Criteria use a numeric scheme to provide the recommendations for contraceptives being used for contraceptive purposes only, not for treatment of medical conditions. Divided columns if recommendations differ: Initiation criteria (preexisting conditions) Continuation criteria (condition develops or worsens) Safety/Risk Categories 1 Method can be used without restriction 2 Advantages generally outweigh theoretical or proven risk 3 Method usually not recommended unless other, more appropriate methods are not available or not acceptable 4 Method not to be used 10 Contraceptive Methods in US Hormonal methods (prevent ovulation, alter endometrium and cervical mucous) Combined hormonal contraceptives Progestin only contraceptives Emergency contraceptive pills Progestin Intrauterine devices Implants Non hormonal methods Barrier contraceptive methods (condoms internal and external) Spermicides Fertility Awareness Based Methods Lactational Amenorrhea Method Coitus Interruptus Copper Intrauterine device Female and Male Sterilization 4
Indications for Hormonal Contraceptives Prevention of pregnancy Reduction in mild or moderate acne* Treat symptoms of premenstrual dysphoric disorder (PMDD)* Menstrual suppression (reduction in menstrual period frequency* Regulation of the menstrual cycle** Risk reduction for ovarian and endometrial cancer** Management of PCOS and endometriosis** Reduction in vasomotor symptoms** Reduce menstrual bleeding** Reduce menstruation induced exacerbations of seizures, headaches and other medical conditions** * Some HC products **Off label uses supported by evidence based literature Health Benefits: Combined Hormonal Contraception Menstrual related health benefits: Decreased dysmenorrhea Decreased menstrual blood loss and anemia May reduce PMS symptoms Decreased risk of: Ectopic pregnancies Endometrial and ovarian cancer Benign breast conditions PID Larsson G. Contraception. 1992. Parsey KS. Contraception 2000. Freeman EW. Fertil Steril. 2005. Davis A. Obstet Gynecol. 2005 Contraindications to estrogen (CHC) Estrogen contraindications: Migraine with aura Uncontrolled hypertension Postpartum < 6 weeks History of DVT Smokers age 35 and older Smoking: Is NOT a contraindication for women less than age 35 Counsel about smoking cessation 15 5
Rare, Serious Adverse Events Cardiovascular events Myocardial infarction: Elevated risk in oral contraceptives containing ethinyl estradiol Hypertension: Elevated risk in oral contraceptives Ischemic stroke: Elevated risk in oral contraceptives Venous thromboembolism: Elevated risk, particularly with certain types of progestin Cancer Unclear risk of cervical and breast cancer Ultimately a modest, non significant increase Cardiovascular events and cancer are typically associated with birth control that contains estrogen due to the transcriptional activity of this hormone. 1 Lidegaard Ø, et al, NEJM, 2012; 2 de Bastos M, et al, Cochrane Database Syst Rev, 2014; 3 Iversen L, et al, Am J Obstet Gynecol, 2017 Hormone options combined E and P progestin only Delivery options Oral Topical Injection Implant IUD Oral Regimen options Monphasic Triphasic Multi phasic 21 day, 28 day Extended cycle Hormonal Contraceptive Options How will you select HC products? Creating your own formulary What products are commonly prescribed to women in your practice? Are there formulary limitations (quantity, product) with your most common insurance plans? How many products will you comfortably be able to maintain in stock? Get comfortable with a handful of products that you can keep in stock. Select a monophasic and a triphasic product Select one product with each of the most commonly used progestins norethindrone, levonorgestrel, drospirenone Select a range of estrogen doses 10mcg to 35mcg 6
Hormonal Contraceptive Options Hormone options (type/dose) estrogen/progestin progestin only No hormones Method of Administration Pill (oral) Vaginal ring Patch Injection Implant* IUD* Dosing Frequency Options Daily Weekly Monthly Quarterly 3 10 years Other Considerations Cost Availability Past experience 19 Oral Contraceptive Options 1. Hormone options Estrogen and progestin (go to Step 2) Progestin only (go to Step 6) 2. Regimen options Type of regimen Monphasic Triphasic Multi phasic 3. Select estrogen and dose estrogens Estradiol 10 35mcg estradiol valerate 4. Select progestin and dose 1 st generation estranes norethindrone 2 nd generation gonanes levonorgestrel 3 rd generation desogen norgestimate Other: drospirenone 5. Select the cycle type Duration of a cycle Traditional 21 day, 28 day Extended cycle (91 day) 6. Insurance formulary issues What is covered? Cost Number of products Estrogen Progestin Monophasic CHC 8 EE 20 mcg levonorgestrel 0.1mg 9 EE 20 mcg norethindrone acetate 1mg 3 EE 25 mcg norethindrone 0.8mg 6 EE 30 mcg levonorgestrel 0.15mg 4 EE 30 mcg norgestrel 0.3mg 10 EE 30 mcg norethindrone acetate 1.5mg 7 EE 30 mcg desogestrel 0.15mg 6 EE 30 mcg drospirenone 3mg 2 EE 35 mcg ethynodiol diacetate 1mg 7 EE 35mcg norgestimate 0.25mg 2 mestranol 50 mcg norethindrone 1mg 8 EE 35 mcg norethindrone 0.4mg 5 EE 35 mcg norethindrone 0.5mg 8 EE 35mcg norethindrone 1mg 1 EE 50 mcg norgestrel 0.5mg 1 EE 50 mcg ethynodiol diacetate 1mg Biphasic CHC EE 20 mcg for 21 days, placebo for 2 days, EE 10mcg desogestrel 0.15mg for 21 days 4 for 5days norethindrone 0.5mg for 10 days then 1mg for 11 days 1 EE 35 mcg 7
Number of Estrogen Progestin products Triphasic CHC EE 20 mcg x 5 days, 30 norethindrone acetate 2 mcg x 7 days, 35 mcg x 9 1 mg x 21 days days norgestimate 0.18 mg x 7 days, 2 EE 25 mcg x 21 days 0.215 mg x 7 days, 0.25 mg x 7 days. desogestrel 0.1 mg x 7 days, 3 EE 25 mcg x 21 days 0.125 mg x 7 days, 0.15 mg x 7 days. levonorgestrel EE 30 mcg x 6 days, 40 0.05 mg x 6 days, 4 mcg x 5 days, 30 mcg x 10 0.075 mg x 5 days, days. 0.125 mg x 10 days. norgestimate 0.18 mg x 7 days, 7 EE 35 mcg x 21 days 0.215 mg x 7 days, 0.25 mg x 7 days. norethindrone 0.5 mg x 7 days, 3 EE 35 mcg x 21 days 1 mg x 9 days, 0.5 mg x 5 days. norethindrone 0.5 mg x 7 days, 7 EE 35 mcg x 21 days 0.75 mg x 7 days, 1 mg x 7 days. Number of products Estrogen Progestin Four phase CHC Estradiol valerate 3 mg dienogest x 2 days, then 2 mg x 22 none x 2 days, then 1 days, then 1 mg x 2 2 mg x 5 days, then days, then 2 day pillfree 3 mg x 17 days, then interval none x 4 days Extended cycle products 1 norethindrone acetate 1 mg x 24 days EE 10 mcg x 26 days 3 norethindrone acetate 1 mg x 24 days EE 20 mcg x 24 days 4 EE 20 mcg x 84 days, 10 levonorgestrel 0.1 mg x 84 days mcg x 7 days. 4 levonorgestrel 0.15 mg x 84 days EE 30 mcg x 84 days 4 EE 30 mcg x 84 days, levonorgestrel 0.15 mg x 84 days 10 mcg x 7 days. 1 6 1 10 EE 20 mcg x 42 days, 25 mcg x 21 days, 30 mcg x 21 days, then 10 mcg x 7 days EE 20 mcg x 24 days levonorgestrel 0.15 mg x 84 days drospirenone 3 mg x 24 days EE 20 mcg levonorgestrel 90 mcg Progestin only pills ************ norethindrone 0.35 mg Factors to Consider When Selecting a Contraceptive Method Safety Efficacy Past experience with contraception Reversibility Non contraceptive benefits Sexual acceptability Effort & convenience Cultural and religious alignment Barriers Effectiveness Highly effective birth control options may be less likely to result in unintended pregnancy Discuss typical use versus perfect use with clients Do not assume effectiveness is the most important factor for clients Elicit client preferences for effectiveness by asking a question such as, How important is it to you that you prevent pregnancy (until you are ready to be pregnant)? 8
Tier Based Counseling More effective How to make your method most effective Less than 1 pregnancy per After procedure, little or nothing to do or 100 women in one year remember Vasectomy: Use another method for first 3 months Implant Vasectomy Female IUC Sterilization Injections: Get repeat injections on time Pills: Take a pill each day Patch, ring: Keep in place, change on time 6-12 pregnancies per Injectable Pills Patch Ring Diaphragm 100 women in one year Diaphragm: Use correctly every time you have sex Male Condoms Less effective 18 or more pregnancies per 100 women in one year Female Condoms Spermicides Sponge Withdrawal Fertility Awareness- Based Methods Condoms, sponge, withdrawal, spermicides: Use correctly every time you have sex Fertility awareness based methods: Abstain or use condoms on fertile days. Newest methods (Standard Days Method and TwoDay Method) may be the easiest to use and consequently more effective CDC, US Selected Practice Recommendations for Contraception, 2013 CDC s 5 Steps of Quality Contraceptive Counseling Establish and maintain rapport with the client Step 1 Obtain clinical and social information from the client Step 2 Work with client interactively to select the most effective and Step 3 appropriate contraceptive method Conduct a physical assessment related to contraceptive use, Step 4 when warranted Provide the contraceptive method along with instructions about correct Step 5 and consistent use, help the client develop a plan for using the selected Gavin L, et al., MMWR, 2016 method and for follow up, and confirm client understanding Gavin L, et al., MMWR, 2016 Eliciting Client Preferences Ask open ended questions Rephrase Discuss past methods Discuss menses Examples: What is the most important factor to you when selecting birth control? I hear you saying that you would prefer a birth control method that is discreet. Is that correct? What did you like about the pill? What didn t you like? Can you tell me about your period right now? What about in the past? 9
Brandie Condition Cu-IUD LNG-IUD Implant DMPA POP CHC DVT/PE and established anticoagulant therapy for at least 3 months Higher risk for recurrent DVT/PE Lower risk for recurrent DVT/PE 2 2 2 2 2 4 2 2 2 2 2 3 Isabel 10
Condition Cu IUD LNG IUD Implant DMPA POP CHC Hypertension: adequately controlled 1 1 1 2 1 3 Condition Cu IUD LNG IUD Implant DMPA POP CHC Diabetes: No vascular disease, noninsulin dependent 1 2 2 2 2 2 Zoe Condition Cu IUD LNG IUD Implant DMPA POP CHC Certain anticonvulsants 1 1 2 1 3 3 11
Furnishing Contraception Workflow Pharmacists Collect patient history Clinical decision Patient education Technicians Inform patients of service Ensure self screening form is completed Billing Visit Summary Patient name Other identifiers (eg DOB) Date of service Medications PMH BP Product provided Education/counseling Referrals (if any) Time spent face to face with patient Thank You! Speaker Contact Information: Kathleen Besinque, PharmD, MSEd, FCPhA, FCSHP, FASHP, APh Chapman University besinque@chapman.edu Sarah McBane, PharmD, CDE, BCPS, FCCP, FCPhA, APh West Coast University smcbane@westcoastuniversity.edu 12
Combined Hormonal Contraceptive Pills Effectiveness 92% for typical use and 99% for perfect use Adverse Events nausea, vomiting, breast tenderness, change to menses, increased risk of VTE Effort daily pills, easy to initiate and discontinue Value & Preference Alignment convenience, flexibility Patient Population Considerations a convenient method with the predictability of a monthly period or the flexibility of skipping periods Vaginal Ring Brand name: NuvaRing Contains estrogen and progestin Non Oral Dosage Forms Flexible, unfitted ring placed in vagina Worn for 3 weeks, no ring for 1 week, new ring inserted 4 weeks of medication in ring Continuous use: change once every 4 weeks/month 38 Vaginal Ring Effectiveness 91% for typical use and 99% for perfect use Adverse Events nausea, vomiting, breast tenderness, change to menses, increased risk of VTE Effort monthly schedule for removal Value & Preference Alignment convenience, flexibility Patient Population Considerations a convenient method that doesn t require daily effort 13
Vaginal Contraceptive Ring: Insertion There is no wrong way to insert. If it lies comfortably in the vagina, it is in correctly. www.contraceptiononline.org Transdermal Patch ethinyl estradiol and norelgestromin (Xulane) or LNG (Twirla) Beige patch Applied once per week for 3 weeks Can be used for continuous dosing Transdermal Patch Applied to upper, outer arm, upper torso, abdomen, buttock 14
Options to Initiate Combined Hormonal Contraception Method How to start Protection begins Notes Sunday start First day of bleeding start Quick Start or Any time start Start pill/patch/ring on the first Sunday after bleeding from next menses Start pill/patch/ring on the first day of bleeding from next menses Start pill/patch/ring today after establishing the woman is not pregnant After 7 days of active pills or wearing patch/ ring. Back up method required for first 7 days of initial cycle. Protection immediate. No back up required during first cycle. After 7 days of active pills or wearing patch/ ring. Back up method required for first 7 days of initial cycle. Cycles always start on Sunday. Avoids weekend bleeding. Cycle begins on same weekday each month as when initiated (e.g., Wednesday) Cycle begins on same weekday each month as when initiated (e.g., Wednesday) Progestin only Contraceptives Progestin Only OCs AKA Mini pill Norethindrone 0.35 mg only POP available in USA Micronor Nor QD Camila Errin Heather Jolivette Nora BE DSP and LnG are not available in the USA OTC version in development (LNG) An OTC progestin only pill is under development 15
Progestin Only Pills Effectiveness 91% for typical use and 99% for perfect use Adverse Events nausea, vomiting, breast tenderness, breakthrough bleeding Effort daily pills, easy to initiate and discontinue Value & Preference Alignment convenience, flexibility, safety Patient Population Considerations a convenient method with a low risk of serious adverse events Progestin only Injection Medroxyprogesterone acetate 150 mg intramuscular 104 mg subcutaneous Provides contraception for 3 months 16