Combined Oral Contraceptive Pills (COCs) Session II: Who Can and Cannot Use COCs? Illustration credit: Salim Khalaf/FHI

COCs Are Safe for Nearly All Women Almost all women can use COCs safely, including women who: Have or have not had children Are not married Are of any age Smoke (if under age 35) Have anemia now or had it in the past Have varicose veins Have an STI or HIV/AIDS Most health conditions do not affect safe and effective use of COCs Use slides to show women who can safely use COCs: • Nearly all women can use COCs safely and effectively. • Most health conditions do not affect safe and effective use of COCs and only few conditions or situations may affect a woman’s eligibility to use COCs. • The WHO medical eligibility criteria were developed to reassure providers about conditions that do not interfere with safe use of contraceptives and highlight all the conditions that affect a woman’s eligibility to use any given contraceptive method.

Who Can and Cannot Use COCs Most women can safely use the pill. But usually cannot use the pill if: Adapted from WHO’s Decision-making tool for family planning clients and providers. Explain that most women can safely use the pill as mentioned in the previous slide. Use slides to show who should not use COCs High blood pressure Smoke cigarettes AND age 35 or older Breastfeeding 6 months or less May be pregnant Gave birth in the last 3 weeks Some other serious health conditions

Who Should Not Use COCs (part 1) 5/25/2012 My period is late… Breast feeding a baby less than 6 months old Breast feeding a baby less than 6 months old Are pregnant Think they may be pregnant Are pregnant Think they may be pregnant Illustration credit: Ambrose Hoona-Kab. Adapted from WHO’s Decision-making tool for family planning clients and providers. Smoke and are age 35 or older Had a heart attack or stroke Had blood clots in legs or lungs Have or had breast cancer Had a heart attack or stroke Had blood clots in legs or lungs Source: WHO, 2010.

Who Should Not Use COCs (part 2) 5/25/2012 Have rheumatic disease, such as lupus Take pills for TB, seizures (fits), or HIV Have high blood pressure I cannot eat sweets. Have diabetes (high sugar in blood) Have serious liver disease or gall bladder disease Have bad headaches with nausea or vision problems Gave birth in last 6 weeks Breast feeding a baby less than 6 months old Think they may be pregnant Illustration credit: Ambrose Hoona-Kab. Adapted from WHO’s Decision-making tool for family planning clients and providers. Had a heart attack or stroke Had blood clots in legs or lungs Source: WHO, 2010; Chu, 2005. Source: WHO, 2010.

Medical Eligibility Criteria 5/25/2012 Medical Eligibility Criteria What are medical eligibility criteria? Define the categories. Review the job aid. Brainstorming (10 min.) This activity has two purposes: To give participants an opportunity to share what they know about the eligibility criteria used in their national family planning guidelines or the WHO medical eligibility criteria (WHO MEC) so that the facilitator can determine whether the participants understand the criteria and how they are used or whether they need additional background information before proceeding. To introduce job aids that help participants understand eligibility criteria (and that they may also use at their worksites), such as the WHO Medical Eligibility Criteria Wheel for Contraceptive Use, or the Quick Reference Chart for the WHO Medical Eligibility Criteria for Contraceptive Use. Explain the 4 categories: Category 1: For women with these conditions or characteristics, the method presents no risk and can be used without restrictions. Category 2: For women with these conditions or characteristics, the benefits of using the method generally outweigh the theoretical or proven risks. Women with Category 2 conditions generally can use the method, but careful follow-up may be required. Category 3: For women with these conditions or characteristics, the theoretical or proven risks of using the method usually outweigh the benefits. Women with Category 3 conditions generally should not use the method. However, if no better options for contraception are available or acceptable, the provider may judge that the method is appropriate, depending on the severity of the condition. In such cases, ongoing access to clinical services and careful follow-up will be required. Category 4: For women with these conditions or characteristics, the method presents an unacceptable health risk and should not be used. In some cases, a particular condition or characteristic is assigned to one category for initiation and another for continuation of the method. In other words, the category may depend on whether a woman with the condition wishes to initiate the contraceptive method or was already using that method when she developed the condition.

When clinical judgment is available WHO’s Medical Eligibility Criteria Categories for IUDs, Hormonal and Barrier Methods Category Description When clinical judgment is available 1 No restriction for use Use the method under any circumstances 2 Benefits generally outweigh risks Generally use the method 3 Risks usually outweigh benefits Use of method not usually recommended, unless other methods are not available/acceptable 4 Unacceptable health risk Method not to be used Source: WHO, 2010.

When clinical judgment is available WHO’s Medical Eligibility Criteria Categories for IUDs, Hormonal and Barrier Methods WHO’s Medical Eligibility Criteria Categories for IUDs, Hormonal and Barrier Methods Category When clinical judgment is available 1 Use the method 2 3 Do not use the method 4 Explain that in situations where clinical judgment is limited, the four-category classification framework can be simplified into two categories. When simplified for these situations, categories 1 and 2 indicate that the method can be used, while categories 3 and 4 indicate that the woman is not medically eligible to use the method. Demonstrate how to use the WHO MEC Wheel or the Quick Reference Chart. Explain that COCs are safe for the overwhelming majority of women. Use slides 9-11 to provide an overview of the medical eligibility criteria for COCs. List 10-15 medical criteria on a flip chart. Ask participants to find the appropriate category on the WHO MEC Wheel or the Quick Reference Chart. If time allows, this exercise can be made into a game using teams to determine the correct answers. Ask several participants to share one thing that they know about the eligibility criteria in their national FP/RH guidelines (if they exist) or the WHO MEC. Answer any questions that participants have about general medical eligibility issues or how to use the Quick Reference Chart or MEC Wheel before moving on to medical eligibility for COCs. Source: WHO, 2010.

Conditions (selected examples) Category 1 and 2 Examples (not inclusive): Who Can Use COCs WHO Category Conditions (selected examples) Category 1 menarche to 39 yrs; nulliparous; endometriosis; endometrial or ovarian cancer; uterine fibroids; family history of breast cancer; varicose veins; irregular, heavy, or prolonged bleeding; anemia; STI/PID; hepatitis (chronic/carrier) Category 2 ≥40 yrs; breastfeeding ≥6 months postpartum; superficial venous thrombosis; dyslipidaemias without other cardiovascular risk factors; uncomplicated diabetes; cervical cancer; unexplained vaginal bleeding; undiagnosed breast mass Source: WHO, 2010.

Conditions (selected examples) Category 3 Examples (not inclusive): Who Should Generally Not Use COCs WHO Category Conditions (selected examples) Category 3 Postpartum: Breastfeeding between 6 weeks and 6 months Non-breastfeeding and less than 3 weeks if no additional risk factors for deep vein blood clots (VTE) Non-breastfeeding 3-6 weeks with additional risk of VTE Vascular conditions: Hypertension (history of or BP 140-159/90–99) Migraine without aura (older than 35 yrs) Gastrointestinal conditions: Symptomatic gall bladder disease (current and medically-treated) Drug interactions: Use of seizure medications or rifampicin or rifabutin Source: WHO, 2010.

Conditions (selected examples) Category 4 Examples (not inclusive): Who Should Not Use COCs WHO Category Conditions (selected examples) Category 4 Breastfeeding: <6 weeks postpartum Non-Breastfeeding:<3 weeks with risk factors for VTE Smoking: ≥15 cigarettes/day and ≥ 35 yrs old Vascular conditions: Hypertension (≥160/≥100) Migraines with aura Ischemic heart disease or stroke Diabetes with vascular complications Deep venous thrombosis (history or acute) Pulmonary embolism (history or acute) Liver conditions: Acute hepatitis Severe liver disease and most liver tumors Breast cancer: current or within 5 yrs Source: WHO, 2010; Sekar, 2008.

COC Use by Women with HIV WHO Eligibility Criteria Condition Category HIV-infected 1 AIDS ARV therapy (which does not contain ritonavir) 2 Ritonavir/ ritonavir-boosted PIs (as part of ARV regimen) 3 Women with HIV or AIDS can use without restrictions Women on ARVs can use COCs safely Should not be used by women who take medications for seizures or rifampacin or rifabutin for tuberculosis (may reduce effectiveness of COCs). Using low-dose COCs is appropriate Condom use should be encouraged in addition to COCs Summary: Can women taking antiretroviral (ARV) therapy use COCs? What advice would you give to women taking rifampicin or rifabutin ? What advice would you give women taking medications for seizures? Ask participants: Let us take a closer look at the conditions and categories pertaining to clients with HIV or AIDS. Use slides to present the following: Women with HIV who may or may not have AIDS can use COCs without any restrictions—category 1. According to WHO, women with AIDS who are on antiretroviral (ARV) therapy generally can use COCs. Women who are taking medicines for seizures (such as barbiturates, carbamazepine, lamotrigine, oxcarbazepine, phenytoin, primidone, topiramate) or medication for tuberculosis such as rifampicin, or rifabutin should not take COCs. These medications can make COCs less effective. A sensible approach may be to use condoms consistently as a backup method of contraception while taking low-dose COCs. Regardless of the method chosen, counseling on condom use should be an integral part of contraceptive counseling for women with HIV. Source: WHO, 2010; Sekar, 2008.

COC Use by Postpartum Women WHO Eligibility Criteria Condition Category Non-breastfeeding <3 weeks 3 Breastfeeding <6 weeks 4 Breastfeeding >6 weeks and < 6 months Breastfeeding ≥6 months 2 Non-breastfeeding women should not initiate COCs before 3 weeks postpartum (3-6 weeks postpartum with VTE risk factors) Breastfeeding women Should not use COCs before 6 weeks postpartum Should not use COCs from 6 weeks to 6 months postpartum unless no other method is available Can generally initiate COCs at 6 months postpartum • Ask participants: Let us take a closer look at the conditions and categories pertaining to postpartum clients. • Use slides to present the following: O Women who are not breastfeeding and less than 3 weeks since giving birth, without additional risk that she might develop a blood clot in a deep vein (VTE) generally should not use COCs O Women who are not breastfeeding and between 3 and 6 weeks postpartum with additional risk that she might develop a blood clot in a deep vein (VTE) generally should not use COCs O Women who are not breastfeeding and between 3 and 6 weeks postpartum without additional risk that she might develop a blood clot in a deep vein (VTE) can use COCs O Breastfeeding women should avoid COCs until six months postpartum. O It is particularly important not to use COCs during the first six weeks postpartum, the period when milk production is established, because COCs can reduce the amount of breastmilk produced. O Women can generally initiate COCs at six months postpartum when breastmilk is not the sole source of the infant’s nutrition. O Consider using this slide if the participants will be offering services to postpartum clients. It provides a concise overview of medical eligibility issues related to COC use by women during the postpartum period. O Refer participants to the 2015 WHO document, Medical Eligibility Criteria for Contraceptive Use, 5th Edition, for the latest WHO update on medical eligibility issues for COCs during postpartum Source: WHO, 2010.

Read questions 1–12 in the checklist. Group Activity Understanding the Checklist Read questions 1–12 in the checklist. How have you determined medical eligibility in the past? The checklist also gives instructions about initiating COCs. This set of questions identifies women who should not use COCs. This set of questions identifies women who are not pregnant. The purpose of this activity is to introduce participants to the Checklist for Screening Clients Who Want to Initiate Combined Oral Contraceptives, to provide an overview of its purpose, and to show how to use it. • Distribute a COC checklist to each participant. • When introducing the checklist, note that it should be used by providers to determine whether a client is medically eligible to use the method that she selected during an informed decision-making process. • The questions on the checklist identify women who have health conditions—WHO category 3 or 4—that make it unsafe for them to use COCs. The checklist also incorporates questions that allow a provider to determine with reasonable certainty that a client is not pregnant. • To use the checklist, providers ask the questions on the checklist and follow the instructions based on the client’s responses. Explain that the medical eligibility questions, questions 1–12, are at the top of the checklist. • Ask participants: O To pair up with the person sitting next to them and take turns reading questions 1–12 on the checklist as if they were asking a client each question. O How have you determined a client’s medical eligibility for COCs in the past? If so, how might the checklist facilitate that process? • Accept responses from several participants and discuss any concerns that participants may raise. • Ask participants to read questions 13–18. Emphasize that providers should follow the instructions for this set of questions to identify women who are not pregnant or those who might be pregnant and should either wait till next menses or have a pregnancy test in order to rule out pregnancy. Refer to Session Plan for Exercise on Using the Checklist