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Session II: Who Can and Cannot Use Progestin-Only Injectables

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1 Session II: Who Can and Cannot Use Progestin-Only Injectables
Progestin-Only Injectable Contraceptives Session II: Who Can and Cannot Use Progestin-Only Injectables Photo credit: FHI (packaging from socially marketed DMPA in Kenya and Uganda) Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

2 Progestin-Only Injectables Are Safe For Most Women
Almost all women can use progestin-only injectables safely, including women who: Have or have not had children Cannot do or do not want to use other methods Are breastfeeding a baby who is at least 6 weeks old (WHO/MEC) Smoke (regardless of age or number of cigarettes) Have an STI, HIV or AIDS Just had a miscarriage or abortion Are taking medicines, including ARVs to treat AIDS Most health conditions do not affect safe and effective use of injectables Illustration credit: Ambrose Hoona-Kab Most women can use progestin-only injectables safely and effectively, including women who: Have or have not had children Are not married Are of any age, including adolescents and women over 40 years old Smoke cigarettes, regardless of a woman’s age or number of cigarettes smoked Are infected with an STI or HIV, or have AIDS, including those on antiretroviral therapy Are postabortion This slide represents the international consensus on the initiation of progestin-only injectables and breastfeeding as reflected in the WHO MEC. For further information on the initiation of implants and breastfeeding, see slide 10.  This consideration should be more fully discussed at that time. Source: CCP and WHO, 2011 Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

3 Who Should Not Use Injectables (part 1)
Source: WHO, 2010. Had a heart attack or stroke or has blood clots Has breast cancer Has serious liver disease I cannot eat sweets. Has diabetes Has very high blood pressure Hmm… that is high. Who Should Not Use Injectables (part 1) Illustration credit: Ambrose Hoona-Kab Although injectables are safe for the majority of women, a small number of women with certain characteristics or medical conditions should not use DMPA or NET-EN. In addition, women who have two or more conditions that increase their risk of a heart attack or a stroke, such as old age, smoking, obesity, high blood pressure, or diabetes should not be given DMPA or NET-EN. In special circumstances, when other methods are not available or acceptable to her, a qualified provider who can carefully assess the woman’s situation and condition may decide that she can use progestin-only injectables. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

4 Who Should Not Use Injectables (part 2)
Source: WHO, 2010. Is pregnant Thinks she may be pregnant My period is late… Is breastfeeding a baby less than six weeks old (WHO/MEC) Has abnormal vaginal bleeding Has systemic lupus Illustration credit: Ambrose Hoona-Kab This slide represents the international consensus on the initiation of progestin-only injectables and breastfeeding as reflected in the WHO MEC. For further information on the initiation of implants and breastfeeding, see slide 10.  This consideration should be more fully discussed at that time. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

5 Medical Eligibility Criteria
What are medical eligibility criteria? Define the categories. Review the job aid. Review the WHO Medical Eligibility Wheel for Contraceptive use and The Quick Reference Chart for the WHO Medical Eligibility Criteria for Contraceptive Use. Explain how to use them. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

6 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 Introduce the concept of medical eligibility and determine whether participants have an adequate foundation. Explain the 4 categories. List 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. 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. Category 3: For women with these conditions or characteristics, the theoretical or proven risks of using the method usually outweigh the benefits. In settings where clinical judgment is limited, Category 3 conditions are treated in the same manner as Category 4 conditions. This means that women with Category 3 or Category 4 conditions should not use progestin-only injectables. Category 4: For women with these conditions or characteristics, the method presents an unacceptable health risk and should not be used. Current breast cancer is the only Category 4 condition for injectables. Source: WHO, 2010. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

7 When clinical judgment is limited
WHO’s Medical Eligibility Criteria Categories for IUDs, Hormonal and Barrier Methods Category When clinical judgment is limited 1 Use the method (Yes) 2 3 Do not use the method (No) 4 In settings where clinical judgment is limited, Category 3 conditions are treated in the same manner as Category 4 conditions. This means that women with Category 3 or Category 4 conditions should not use progestin-only injectables. Categories 1 and 2 are combined to mean Use the method. Source: WHO, 2010. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

8 Conditions (selected examples)
Category 1 Examples (not inclusive): Who Can Use DMPA or NET-EN WHO Category Conditions (selected examples) Category 1 Age years; any parity (including nulliparous); smoking (any amount, any age); breastfeeding after 6 weeks postpartum; postabortion; and acute or chronic hepatitis. NET-EN: Obesity of more than 30 kg/m2 body mass index in women younger than 18 ears of age. DMPA: Women who are using certain types of ARVs (non-nucleoside reverse transcriptase inhibitors or ritonavir-boosted protease inhibitors). DMPA: Women using specific anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone topiramate, or oxcarbazepine). Category 1: For women with these conditions or characteristics, the method presents no risk and can be used without restrictions. Use the MEC Quick Reference Chart (Handout # 5) to find other examples of Category 1 conditions that are not listed on this slide <non-migrainous headaches, at high risk for HIV, HIV infected, AIDS, superficial thrombophlebitis, complicated valvular heart disease, pelvic tuberculosis, iron-deficiency anemia and sickle cell disease, endometrial and ovarian cancer, mild cirrhosis, history of cholestasis related to pregnancy>. Source: WHO, 2010. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

9 Conditions (selected examples)
Category 2 Examples (not inclusive): Who Can Use DMPA or NET-EN WHO Category Conditions (selected examples) Category 2 Age <18 years or >45; mild hypertension (BP <159/99 mmHg); non-vascular diabetes; prolonged or heavy bleeding patterns; and history of DVT. DMPA: Obesity of more than 30 kg/m2 body mass index in women younger than 18 ears of age. NET-EN: Women who are using certain types of ARVs (non-nucleoside reverse transcriptase inhibitors or ritonavir-boosted protease inhibitors). NET-EN: Women using specific anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone topiramate, or oxcarbazepine). Category 2: For women with these conditions or characteristics, the benefits of using the method generally outweigh the theoretical or proven risks. Other examples of Category 2 conditions that are not listed on this slide <migraines without an aura; migraines with aura/to initiate use; history of deep venous thrombosis (DVT); known hyperlipidemias; cervical cancer; an undiagnosed breast mass; irregular bleeding patterns; cholestasis related to oral contraceptives>. Source: WHO, 2010. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

10 Conditions (selected examples)
Category 3 and 4 Examples (not inclusive): Who Should Not Use DMPA and NET-EN WHO Category Conditions (selected examples) Category 3 Breastfeeding before 6 weeks postpartum, severe hypertension (≥160/≥100 mmHg), unexplained vaginal bleeding (before evaluation) acute DVT/PE, complicated diabetes, severe liver disease Category 4 Current breast cancer Although progestin-only injectables are safe for most women, there are some exceptions. According to the WHO MEC, progestin-only injectables are not generally recommended for women with category 3 conditions. In these situations, the risks of using this method usually outweigh the advantages. Category 3 conditions include: Acute blood clot in deep veins of legs or lungs, unexplained vaginal bleeding, severe hypertension (≥160/≥100 mmHg),, severe liver disease and most liver tumors, complicated diabetes and breastfeeding before 6 weeks postpartum. The condition of breastfeeding before 6 weeks postpartum is a special case that merits further consideration. Based on theoretical (i.e. not proven) reasons having to do with the concern that progestogens may negatively affect the neonatal liver or brain, the WHO MEC has classified breastfeeding before 6 weeks postpartum as a category 3. WHO also notes that “in many settings pregnancy morbidity and mortality are high, and access to services is limited. Progestin-only contraceptives may be one of the few types of methods widely available and accessible to breastfeeding women immediately postpartum.”  Reflecting this consideration, after careful evaluation of the evidence and their own health systems and settings, some countries have made different classifications.  The United States Center for Disease control (CDC) gives the condition of breastfeeding at 0-4 weeks a Category 2 and from 4-6 weeks a Category 1. The United Kingdom’s Royal College of Obstetricians and Gynecologists: Faculty of Sexual and Reproductive Health Care give it a Category 1 from birth onward. This distinction has important programmatic considerations because it would mean that implants could be offered in the immediate postpartum setting to women who wanted to receive them.  The materials in this training package reflect the WHO classification, with room for discussion of the various options.  Women with category 4 conditions should not use implants. Current breast cancer is the only category 4 condition. Source: WHO, 2010. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

11 Injectables Use by Women with HIV and AIDS
WHO Eligibility Criteria Condition Category HIV-infected 1 AIDS ARV therapy 1 or 2 Women with HIV or AIDS can use without restrictions Injectable dose provides wide margin of effectiveness Return for injections on time if on any type of ARV treatment Encourage dual method use According to the WHO MEC, DMPA and NET-EN can be used without restrictions by women whit HIV and women who have AIDS; these are all Category 1 for both DMPA and NET-EN. ARV therapy includes a variety of different treatments, but all regimens contain either NNRTI (non-nucleoside reverse transcriptase inhibitors) or PI (protease inhibitor). As noted earlier, NNRTIs and ritonavir or ritonavir-boosted PIs are Category 1 for DMPA and Category 2 for NET-EN. Research shows that these ARVs interact with both DMPA and NET-EN in a way that slightly reduces the blood concentration of progestin—but not to a degree that impairs contraceptive effectiveness. For more information, consult the WHO document, Medical Eligibility Criteria for Contraceptive Use. Providers should encourage all women on ARV therapy to receive their injections by their scheduled reinjection dates to ensure maximum effectiveness. Women with HIV who choose to use progestin-only injectables should be counseled about dual method use and advised to use condoms in addition to injectables. Condoms provide both additional protection from pregnancy in the event of late reinjection and protection from STI/HIV transmission between partners. Source: WHO, 2010; Nanda, 2008; Cohn, 2007 Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

12 Injectables Use by Postpartum Women
WHO Eligibility Criteria Characteristic/ Condition Category Non- breastfeeding 1 Breastfeeding <6 weeks 3 Breastfeeding ≥6 weeks Non-breastfeeding women can initiate immediately postpartum Breastfeeding women Generally should not use injectables before 6 weeks postpartum No restrictions after 6 weeks postpartum Ask participants: Let us take a closer look at the conditions and categories pertaining to postpartum clients. Use slide to present the following: Non-breastfeeding women can initiate injectables immediately postpartum. Note to facilitator: Present and discuss your country’s guidelines regarding postpartum initiation of injectables and adapt the slide if needed to reflect the guidelines. In a number of countries, national guidelines allow for earlier initiation of injectables because the risks of unwanted pregnancies outweigh the risks associated with initiation during the early postpartum period. Source: WHO, 2010. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II

13 Understanding the Injectables Checklist
Read questions 1–9 in the checklist and match them with the conditions and categories on the MEC quick reference chart. This set of questions identifies women who should not use injectables.  Distribute an injectables checklist to each participant. When introducing the checklist, mention 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 progestin-only injectables. 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 1–9, are at the top of the checklist. Ask participants to pair themselves with the person sitting next to them and take turns reading questions 1–9 on the checklist and finding the condition on the Quick Reference Chart for the WHO Medical Eligibility Criteria for Contraceptive Use. Ask the pairs to verify that all the category 3 and 4 conditions for progestin-only injectables on the MEC chart are represented in the questions on the checklist. Allow participants about three to four minutes to examine the checklist questions and compare them with the MEC chart. Ask participants: After examining the checklist and the MEC chart, are you confident that the checklist questions address the conditions that prohibit safe use of progestin-only injectables? Explain why. How have you determined a client’s medical eligibility for progestin-only injectables in the past and how might the checklist facilitate that process? Accept responses from several participants and discuss any concerns that participants may raise. Draw attention to questions and 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 require a pregnancy test to rule out pregnancy. Tell providers that the final set of instructions provides details about initiating the method, especially whether the client will need to use a backup method initially. This set of questions identifies women who are not pregnant. The checklist also gives instructions about initiating injectables. Training Resource Package for Family Planning Progestin-Only Injectable Contraceptives Module Basic Slide Set: Session II


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