DEFINITION - SOM - State of Michigan



COMBINATION HORMONAL CONTRACEPTIVE METHODS: IDENTIFICATION OF CANDIDATE FOR INITIAL START, RESTART, or CONTINUATIONDEFINITIONCombination hormonal contraception with estrogens and progestins are available as daily oral contraceptives, once-a-week transdermal patches and once-a-month vaginal rings. This protocol is intended to describe the process for identifying women who may be eligible to use these methods. If used correctly and consistently, combined hormonal contraceptives have a first-year failure rates of 0.3%, but in typical use, the first-year failure rate for is 7%. Counseling is critical to successful use. Shortened hormone free intervals and more generous dispensing patterns are associated with high continuation rates and lower pregnancy rates.SUBJECTIVEHistory must include:LNMP and menstrual history.Medical, sexual, and contraceptive history (initial or update). Include Review of SystemReproductive Life PlanZika Risk Assessment- As per current CDC guideline- and partner(s)Past travel – where and whenPlans for future travel –where and whenReview of contraindications and risks:All CDC category 4 conditions- (Unacceptable risk for method use)Use caution with CDC category 3 conditions- (Risks outweigh advantages for method use) individualized management must be based on protocols and /or consult with Medical Director or clinic physician.Post-partum (non-breastfeeding or breastfeeding) <21 days (CDC 4)Multiple cardiovascular risk factors (older age, smoking, diabetes, hypertension, low HDL, high LDL, high triglycerides) (CDC 3 for initiation, CDC 4 for continuation)Medically Diagnosed Migraine with aura-any age (CDC 4) Smoking including E-Cigarettes ≥35 years of age<15 cigarettes/day (CDC 3) including E-Cigarettes≥15 cigarettes/day (CDC 4) including E-CigarettesHypertension Adequately controlled (CDC 3)systolic ≥ 160 or diastolic ≥ 100 (CDC 4)systolic ≥ 140-159 or diastolic of 90-99 (CDC 3) With associated vascular disease (CDC 4)History of or current deep vein thrombosis (DVT)/pulmonary embolism (PE), not receiving anticoagulant therapy(CDC 4)Stroke (history of cerebrovascular accident) (CDC 4)Known thrombogenic mutations (e.g. Factor V Leiden, Prothrombin mutation, Lupus Anticoagulant, Protein C, Protein S, Antithrombin deficiencies) (CDC 4)History of, or current, ischemic heart disease (CDC 4)History of superficial venous thrombosis (acute or history) (CDC 3)Diabetes mellitus with nephropathy, retinopathy, neuropathy (CDC 3,4)With Vascular disease or diabetes of >20 years duration (CDC 3,4) Viral hepatitis (acute or flare) (CDC 3,4 initiation) Liver tumor (adenoma or hepatoma) (CDC 4) Cirrhosis-severe (decompensated) (CDC 4) Solid organ transplant (complicated) (CDC 4) Breast cancer (current CDC 4); or (Past and no evidence of current disease for 5 yrs. (CDC 3) Major surgery with prolonged immobilization (CDC 4) Valvular heart disease- complicated (pulmonary hypertension, history of sub-acute bacterial endocarditis, risk of atrial fibrillation) (CDC 4) Peripartum cardiomyopathy (CDC 3,4) Normal or mildly impaired cardiac function:<6 months (CDC 4) 6 months or greater (CDC 3)Moderately or severely impaired cardiac function (CDC 4)Multiple Sclerosis with prolonged immobility (CDC 3)Gallbladder disease –symptomatic (current or medically treated) (CDC 3) History of Cholestasis -(past COC related) (CDC3) Post-partum (non-breast feeding or breastfeeding) 21 – 42 days with other risk factors for VTE (age ≥35 y.o., previous VTE, thrombophilia, immobility, transfusion at delivery, BMI 30 or >, post-partum hemorrhage, post cesarean delivery, preeclampsia, or smoker)(CDC 3) Post-partum (breastfeeding) 21-30 days without VTE risk factors (CDC 3)Systemic Lupus Erythematous—with positive (or unknown) antiphospholipid antibodies (CDC 4)Inflammatory bowel (ulcerative colitis, Crohns) (CDC 2,3)Bariatric surgery (history of)-malabsorption procedures (CDC 3 for COC only)Potential drug interactions: Antiretroviral therapy: Ritonavir-boosted protease inhibitors (CDC 3) Note: May decrease effect of contraceptive Fosamprenavir (FPV) Anticonvulsant therapy: Certain anticonvulsants (phenytoin, carbamazepine, oxcarbazepine, primidone, topiramate, barbiturates) (CDC 3) Note: May decrease effect of contraceptiveLamotrigine (CDC 3) Note: May decrease effect of lamotrigine (i.e. potential increase seizure activity)Antimicrobial therapy: Rifampicin or rifabutin therapy (CDC 3) Note: May decrease effect of contraceptive.(Note: If a potential drug interaction exists yet it is determined by the ordering clinician that the combined contraceptive method remains an option, the client must be informed of the potential drug interactions, other contraceptive options available, and the need for consistent back-up contraception when contraceptive efficacy may be diminished.)OBJECTIVEMust include:Blood pressure. Evaluate if BPS ≥ 140 or BPD ≥ 90.Weight, height and BMI.No additional physical exam is needed for routine initiation of combined hormonal methods. Exam only required as indicated.LABORATORYNo routine screening labs are required for healthy women.Laboratory tests may be needed for well woman care or to evaluate problems raised by client’s history or current complaints, but unless they represent a significant US MEC condition, they should not delay pill initiation.Pap screening and clinical breast exam (based on current recommendations for timing and testing components).Offer annual CT and GC for female clients <25 years old (and older clients at high risk).ASSESSMENTCandidate for combination hormonal methods, initial start, restart or continuation. PLANIf client has no contraindications to combination hormonal contraceptive method use, provide the delivery system that best meets client’s needs for contraception and maximizes her non-contraceptive benefits.If oral contraceptive pills are selected:Provide at least one year prescription of pills, unless she is planning pregnancy sooner. Follow- up visits may be scheduled earlier, but the need for follow-up should not influence the number of cycles provided.Determine if client prefers cyclic or extended cycle use of oral contraceptives.If she desires monthly scheduled bleeding, select a formulation, considering client preference, cost, and non-contraceptive benefits.If using low dose formulations or the client suffers estrogen withdrawal symptoms, consider shortening the placebo pill interval to 3-4 days. Triphasic formulations have no advantage, in general, over monophasic formulations.There is no strong, consistent evidence that one progestin is associated with clinically significantly higher risks of VTE than other progestins. All estrogen-containing pills have lower VTE risks than VTE risks of pregnancy and the postpartum period.If the client prefers to avoid scheduled bleeding, offer extended cycle combined OC use. Provide supplies of active pills to meet her contraceptive needs for 12 months (unless she is planning pregnancy sooner). Her schedule of follow-up visits should not affect dispensing protocols. This can be done in one of the following ways:Select a branded extended cycle pill product.Provide supplies of monophasic cyclic pills sufficient to provide uninterrupted active pill use.Establish fixed intervals of pill use to mimic branded products - 84 active pills (first 21 pills in 4 packs) followed by 4-7 days of placebo pills.Discuss pill initiation options.Quick start (Same day start) is preferred approach.If the client is within 5 days of the beginning of her last menses, she should take the first pill today. No back-up method is needed.If the woman is later in her cycle, initiation depends upon whether she has had any unprotected intercourse.If she has had no unprotected intercourse in last 5 days, she should take her first pill today. Advise her to use abstinence or a backup method for the next 7 days.If the client has had any unprotected intercourse in last 5 days, provide offer appropriate hormonal emergency contraceptive (See Emergency Contraception (EC) protocol). If EC provided was LNG: take the first pill in her pill pack tonight or tomorrow. Advise her to use abstinence or backup method for the first 7 days of pill use. If EC provided was UPA: have client take the first pill no sooner than 5 days after UPA use. Advise her to use abstinence or backup method for 14 days. First day start is also an option.Offer client another contraceptive method and EC for her to use until the beginning of her next period.Tell her to start her first pack of birth control pills on the first day of her next menses. She will need no back-up method once she starts her pills.Sunday start is the least preferred method of pill initiation. Offer client another method of contraception and EC to use until her next normal menses starts.Tell her to start her first birth control pill on the first Sunday of her next menses. Make sure she understands that she should count from the first day of bleeding, not the last day.If she takes her first pill >5 days since menstrual bleeding started (i.e., her period started on Monday, six day before Sunday), she should abstain from sexual intercourse or use additional contraceptive protection for the next 7 days, otherwise no back-up is needed.Recommend pregnancy test now or in the first cycle of pill use if client has symptoms of pregnancy or if her scheduled bleeding is delayed or abnormal.Counsel client about missed pills (see Client Education).Provide a 12-month supply of pills. For extended cycle users, a 12-month supply requires 17 packets of cyclic pills.A prescription may be extended beyond 12 months in order for client to schedule annual visit.Advise client to return to the clinic if needed (side effects, method utilization, method change desired) OR if provider feels it is clinically indicated. No routine follow up visit is required. (U.S. SPR.) If vaginal contraceptive ring preferred,Determine if client prefers cyclic or extended cycle use of vaginal contraceptive ring.If she desires monthly scheduled bleeding,Advise her to place the vaginal ring as discussed below and remove it in 21 days. During the 7 ring-free days, she will have a scheduled bleed.She should place a new ring 7 days after she removed the first ring, regardless of whether or not she has finished bleeding.If she prefers less frequent bleeding episodes, she should use one ring for 21-30 days and immediately replace it with a new ring.Discuss ring initiation options.Quick start (Same day start) is preferred approach.If the woman has had no unprotected intercourse in prior 5 days, she should place the contraceptive ring in her vagina today. Advise her to use abstinence or a back- up method for the next 7 days,If the client has had any unprotected intercourse in last 5 days, offer appropriate hormonal emergency contraceptive (See Emergency Contraception (EC) protocol).If EC provided was LNG: have her place the first ring in her vagina today or tomorrow. Advise her to use abstinence or backup method for the first 7 days. If EC provided was UPA: have client place ring in vagina no sooner than 5 days after UPA use. Advise her to use abstinence or backup method for 14 days.Recommend pregnancy test now or in the first cycle of ring use if client is symptomatic or if her withdrawal bleeding is delayed or abnormal.First day start is also an option.Offer client another contraceptive method and EC to use until her next menses.Tell her to place the first contraceptive ring in her vagina on the first day of her next menses. Tampons can be used with the ring, but the client must check to ensure that the ring is not lost whenever a tampon is removed. No back-up method is needed.Sunday start may not be preferred option because the vaginal ring must be started on the first day or within the first 5 days of the woman’s cycle. If she inserts a ring >5 days since menstrual bleeding started (i.e., her period started on Monday, six day before Sunday), she should abstain from sexual intercourse or use additional contraceptive protection for the next 7 days, otherwise no back-up is needed.Recommend pregnancy test now or in the first cycle of ring use if client has symptoms of pregnancy or if her scheduled bleeding is delayed or abnormal.Provide the client with instructions about how to place vaginal ring in upper aspect of her vagina, flat against the vaginal wall. Blunt tipped tampon applicators can be used to place the contraceptive ring easily in the vault.Tell the client to remove vaginal ring 21-30 days later. Place ring into the original pouch it came in and dispose of it in routine trash. Do not flush ring down toilet or press through trash compactor.The ring does not need to be removed for any activity but can be out for up to 3 hours without compromise in effectivenessIf ring is expelled or removed for >3 hours but <48 hours, reinsert as soon as possible and continue wearing until scheduled removal day. No additional contraceptive is needed, offer EC with LNG if unprotected intercourse occurred during the first week of the cycle (see appendix B)If the ring has been out >48 hoursReinsert the ring as soon as possibleUse additional contraception or abstinence until ring has been in for 7 daysIf the ring was out/removed in the third week of the cycle or later:Omit the hormone-free week by finishing the third week of ring use and starting a new ring immediatelyIf unable to start a new ring immediately, use back-up contraception or abstinence until a new ring has been worn for 7 daysProvide a 3 to 12-month supply of rings. Note: If more than a 3-month supply is provided, advise client to store the rings in the refrigerator as shelf life outside of refrigeration is limited to 4 months.A prescription may be extended beyond 12 months in order for client to schedule annual visit.Advise client to return to the clinic if needed (side effects, method utilization, method change desired) OR if provider feels it is clinically indicated. No routine follow up visit is required. (U.S. SPR).If transdermal patch preferred Discuss patch initiation options. Quick start (Same day start) is preferred approach.If the client is not on the first day of her cycle, recommendations depend upon whether she has had any unprotected intercourse since her LMP.If the woman has had no unprotected intercourse in prior 5 days, client should place her patch today. Advise her to use abstinence or a backup method for the next 7 days.If the woman has had any unprotected intercourse in last 5 days, offer appropriate hormonal emergency contraceptive (See Emergency Contraception (EC) protocol). If EC provided was LNG: have her place the first patch today or tomorrow. Advise her to use abstinence or backup method for the first 7 days. If EC provided was UPA: have her place the first patch no sooner than 5 days after taking UPA. Advise her to use abstinence or backup method for 14 days.Recommend pregnancy test now or in the first cycle of patch use if client is symptomatic or if her scheduled bleeding is delayed or abnormal. First day start is also an option.Offer client another contraceptive method and EC to use until the first day of her next period.Tell her to place her first patch on the first day of her next menses. No backup method is needed.Sunday start is the least preferred method of patch initiation.Offer client another method of contraception and EC to use until her next normal menses starts.Apply your first patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first patch that day, and no back-up birth control is neededIf she applies patch>5 days since menstrual bleeding started (i.e., her period started on Monday, six day before Sunday), she should abstain from sexual intercourse or use additional contraceptive protection for the next 7 days, otherwise no back-up is needed.Discuss patch placement instructions. Patch is placed on lower abdomen, buttocks, back, or upper arm.Instruct the client to remove her current patch and place new patch on different location on appropriate body areas every 7 days until she has used a total of 3 patches. After she has removed her 3rd patch, she should delay placement of another patch for 7 days, during which time she should experience a scheduled bleed. Tell her to place a new patch at end of 7 day patch free period.Long-term risks of extended cycle use of the patch have no published data; the safety of this practice is unproven. Occasional use of more than 3 consecutive patches is permitted for special circumstances Use abstinence or a back-up method for 7 days, and consider use of EC if any intercourse occurs around the time of any of the following patch problems occurs:Patch separated from skin for more than 24 hours,Patch placed late,Patches used longer than 9 days, especially for first patch in the cycle.Provide 12 months’ supply of patches. Schedule of follow-up visits should not influence dispensing protocols.A prescription may be extended beyond 12 months in order for client to schedule annual visit.Advise client to return to the clinic if needed (side effects, method utilization, method change desired) OR if provider feels it is clinically indicated. No routine follow up visit is required. (U.S.SPR).CLIENT EDUCATIONOffer hormonal EC by advance prescription Provide back-up and interval method, if necessary.Advise client that hormonal contraception is safer for her than pregnancy would be.Discuss Method Effectiveness (see QFP pg. 9, ref. #31).Counsel client that most women do not experience any significant side effects when they use hormonal contraception but that she may experience unscheduled spotting or bleeding or may have other changes in her menstrual periods with hormonal contraceptives. Skin pigment changes are also possible with estrogen-containing contraceptives. The client should be advised that there is a chance that she may experience (at least transiently) some other symptoms that may or may not be due to her contraceptives, including nausea, vomiting, breast tenderness, headache, mood changes, nervousness, hair loss, acne, hirsutism or change in appetite. It is very uncommon to have significant changes in weight or in sex drive that are attributable to hormonal contraceptives.Using the ACHES mnemonic, reinforce danger signs for rare serious complications with combination birth control methods. Advise client to seek immediate medical care if any of the following occurs to her: A - Abdominal pain.Blood clot in the pelvis or liver.Benign liver tumor or gallbladder disease. C - Chest pain.Blood clot in lungs.Heart attack.Angina (heart pain)Breast lump.H – Headache.StrokeMigraine headache with neurological problems (blurred vision, spots, zigzag lines, weakness, difficulty speaking).Other headaches caused by pillsHigh blood pressureE - Eye problemsStrokeBlurred vision, double vision, or loss of visionMigraine headache with neurological problems (blurred vision, spots, and zigzag lines)Blood clots in the eyesChange in shape of cornea (contacts don’t fit)S - Severe leg pain.Inflammation and blood clots of a vein in the legRemind client that hormonal contraceptives do not protect against sexually transmitted infections, including HIV/AIDS and Zika Virus.Advise client that there are significant health benefits with hormonal contraception, including less menstrual bleeding, less menstrual cramping and reduction in the risk of ovarian and endometrial cancer. Tell women who are concerned about side effects of hormonal contraception that long-term studies have shown that women who have used birth control pills live longer and have less cancer than women who never use pills.Encourage healthy lifestyles, including safer sex practices.Zika virus education and prevention strategiesAvoid traveling to impacted areasAvoiding mosquito bites if traveling to impacted areasUsing condoms to prevent transmission of virusAvoiding pregnancy if infected or partner infectedRisk to unborn fetusIf OCs given, reinforce education with particular emphasis on:Initiation instructions for pills. The preferred method is Quick Start (same day as visit) or first day start (first day of next menses). Sunday start is acceptable. OC initiation instructions:If starting OCs on days 1-5 of cycle, no abstinence or backup method needed for that cycle.If OCs started later than 5 days after LMP, use abstinence or backup method for 7 days. If history of unprotected intercourse within the last 5 days, advise EC now. (See Emergency Contraception (EC) protocol). Have client start OCs tonight or tomorrow and use 7 days of abstinence or a back-up method for 7 days following her first pill. Recommend pregnancy test if scheduled bleeding is absent, late or abnormal.Advise client to take OC’s at the same time of day each day and tell her what to do if she is late taking her pills.Recommended Actions after Late or Missed Combined Oral Contraceptives - See Appendix A Advise client to consult the Client Information from manufacturer’s package insert.If vaginal rings are selected:If first ring placed in vagina during first 5 days of menses, no backup method is needed. Instruct client who needed EC to return for repeat UCG if no menses in 3-4 weeks or if symptoms of pregnancy develop.Reinforce education about correct ring placement, timing and removal. Teach use of tampon inserter to place ring, if needed.Advise client to consult NuvaRing Client Information from manufacturer’s package insert.Suggest that client store unused rings in refrigerator, because rings have longer shelf life if they are refrigerated. Caution client not to store rings in freezer.Reinforce need to use rings continuously for 3 weeks at a time. Ring does not need to be removed during intercourse or during any treatments for vaginal infection. Advise client to store ring in its foil pouch if she does remove it temporarily.Recommended Actions after delayed insertion or reinsertion with combined Vaginal Ring - See Appendix B Women should not douche while using vaginal ring, but vaginal medications may be used.For women who want to have monthly bleeding, instruct them to remove their ring after 21 days of use. Their scheduled bleeding should start after the ring is removed. A new ring should be inserted vaginally 7 days after the old one is removed, regardless of whether her scheduled bleeding is over or not. For women who do not want to have monthly bleeding, advise them to remove the current ring after 28-31 days of use and to replace it immediately with a new ring. This extended cycle use may be continued for at least 12 months.Tell client to place used vaginal rings into foil pouch or other sealable bag. Dispose of used rings in solid trash, not in toilet or trash compactor.If the client selects a transdermal combination contraceptive patch:Reinforce with client the correct application process, correct patch location and timing of placement and removal.Remind client about patch initiation instructions. Quick start is preferred method. First day start is acceptable. Women switching from pills should place first patch on during the first day of scheduled bleeding.Advise client to consult Client Information from manufacturer’s package insert. Tell client that product labeling suggests that the risk of venous thromboembolism may be higher with the patch than with pill use, but that the risk of blood clots with the patch is less that the risk of blood clots if she gets pregnant. Advise about possible skin irritation. Tell her to stop patch use if she develops irritation and return promptly to get another method. Educate client about recommendations for management of patch detachment.Recommended Actions after Delayed Application or Detachment with Combined Hormonal Patch - See Appendix B Remind clients to avoid using any creams or lotions on the skin around the patch, since this will cause patch detachment.If the client notes a grey lint ring on her skin after removal of the patch, recommend she apply hand or body lotion or even cooking oil to remove it. Tell client to fold her used patch in half with adhesive sides together and place it in routine trash. Do not flush the patch down toilet or place it in trash compactor. Advise client that studies have shown a decrease in the effectiveness of the patch in client weighing 198 pounds or more (evidence is inconsistent).REFER TO MD/EDAny client who declines pelvic examination but has symptoms or signs indicating need for evaluation. Consider Zika screening referral if indicated by Zika Risk Assessment.REFERENCESCenters for Disease Control and Prevention (CDC). U.S. Selected Practice Recommendations 2016 available at Centers for Disease Control and Prevention (CDC). U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Available at for Disease Control and Prevention (CDC). Zika Virus Homepage - Hatcher RA, et al (editors). Contraceptive Technology, 21st Ed. New York: Ayer Company Publishers, Inc.2018:263-315.Centers for Disease Control and Prevention (CDC). Providing Quality Family Planning Services, 2014. MMWR; 59(RR-4):1-86. Available at 2020 ................
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