1. Managing Issues on Use of Hormonal Contraceptives

2. Methodology  Brainstorming  Group Discussion  Illustrated Lectures

3. Learning Objectives  At the end of the session, the participants will be able to resolve  Issues concerning hormonal contraceptives as to their:  Mechanism of action  Effectiveness  Advantages and disadvantages  Possible side effects  Clients’ Eligibility  Actual Provision  Follow-up Guidelines  Possible complications  Persistent myths and misconceptions

4. Brainstorming  What issues participants must have heard or known about hormonal contraceptive as to its:  Mechanism of action  Effectiveness  Advantages and disadvantages  Possible side effects  Clients’ Eligibility  Actual Provision  Follow-up Guidelines  Possible complications  Persistent myths and misconceptions

5. Hormonal Contraceptives  Types:  Combined contraceptives  Oral/Tablets (COCS)  Injectable (CICS)  Patch, Spray, Gel, Etc.  Progestin-only contraceptives  Oral/Tablet (POPS)  Injectable (POIS)  Implant (CIS)  Intra-uterine System (IUS)

6. Mechanism of Action  Prevents ovulation  Levels of the follicle stimulating hormone (FSH) and luteinizing hormone (LH) are lowered and an LH surge does not occur.  Thickens the cervical mucus, which makes it difficult for sperm to pass through.

7. Effectiveness Method Perfect Use (%) Typical Use (%) Implant99.95 Injectable99.797 Pills (COC)99.792 Pills (POP)99.599 IUD99.499.2 BTL99.5 Vasectomy99.999.85 Condom9885

8. Effectiveness  Factors affecting effectiveness:  Correct and consistent use  Proper storage, observance of shelf life and expiration date  Vomiting or Diarrhea  Drug Interaction

9. Combined Oral Contraceptives Known as pills or oral contraceptives; Contains hormones similar to the woman’s natural hormones –estrogen and progesterone. Preparations:  Monthly COCs:  21 pills - 21 active tablets taken everyday followed by 7 pill-free days;  22 pills – 22 active tablets taken everyday followed by 6 pill-free days  24 pills – 24 days active pills taken everyday followed by 4 pill-free days  28 pills - 21 "active" pills taken everyday followed by 7 "inactive or reminder" pills of a different color. The reminder pills do not contain hormones. No pill-free or rest days.  Extended-cycle Preparations – active pills are taken for 12 weeks followed by a one week pill-free period for withdrawal bleeding.  Continuous COCs – active pills are taken for 365 days of each year.

10. COCs Estrogen:  First generation - estrogen content of 50mcg or more  Second generation – estrogen content is less than 50 mcg  Current generation doses are now even lower, ranging from 20-35 mcg  The pregnancy rates for COCs with 20 mcg estrogen are comparable to those COCs with higher estrogen content. Progestin:  First generation oral contraceptives contain up to 10 times the dose of progestins compared to later generations:norethindrone, norethindrone-acetate, or ethynodiol diacetate.  Second generation: levonorgestrel (LNG) and norgestimate. They are more potent and at lower doses produce an anovulatory effect.  Third generation : gonane progestins, such as desogestrel or gestodene, and have reduced androgenic and metabolic side effects.  Fourth generation : drosperinone, dienogest, or nomegestrol acetate.

11. Another Classification of COCs Phasic pills were developed to reduce the total progestin per cycle without sacrificing the contraceptive efficacy or cycle control. Over time, the estrogen and progestin contents of COCs have been reduced remarkably to minimize the hormone-related adverse effects Types of Phasic Pills:  Monophasic pills provide the same amount of estrogen and progesterone in every hormonal pill.  Biphasic pills have the first 10 pills with one dosage and the next 11 pills having another level of estrogen and progestin.  Triphasic pills have the first 7 pills with one dosage, the next 7 pills have another dosage and the last 7 pills with yet another dosage.  Quadriphasic pills - a combination hormonal contraceptive tablet containing a bioidentical synthetic estrogen, estradiol valerate and dienogest. The product offers 4 progestin/estrogen dosing combinations during each 28-day cycle.

12. Combined Injectable Contraceptive Types:  25 mg DMPA + 5 mg Estradiol [CYCLOFEM],  50 mg NET-EN + 5 mg Estradiol, [MESIGYNA, NORIFAM]) - one brand is already available in the country but not yet part of the PFP Program.

13. Progestin Only Pills  Contains a small amount of only one kind of hormone: Progestin  Does not contain estrogen Kinds of POPs Available: .5 mg lynestrenol (Exluton)  75 ug desogestrel (Cerazette)  Both are available in 28 tablet package.

14. Projestin Only Injectable  An injectable contraceptive containing a synthetic progestin, which resembles the female hormone progesterone  Available preparations:  DMPA(depot-medroxyprogesterone acetate) 150 mg. given every 3 months  Noristerat (norethisterone enanthate) 200 mg. given every 2 months

15. The Patch (Ortho Evra)  0.8 -1.3 pregnancies per 100 women per year of typical use  Release estrogen and progestin thru the skin  Require attention just once a week  Can be worn in four different spots on the body  Can be worn in the shower, while swimming or exercising  Change once a week  99% effective  Obesity (90 kgs or greater) – increased failure

16. Vaginal (Nuva) Ring  Hormone-releasing vaginal ring for 3 weeks or one year depending on formulation  1.2 – 1.5 pregnancies per 100 women per year of typical use  Progestin (etonogestrel) only or combined with estrogen absorbed thru the vaginal wall into the bloodstream  54 x 4 mm releasing hormones at the rate of 15 and 120 ug per day

17. Contraceptive Implant (Implanon®)  1 rod 40mm x 2mm  68 mg of etonorgestrel  Effective for 3 years  Placed in the medial surface of the upper arm

18. Intrauterine System (IUS)  Intrauterine system  Releases 20ug/day of Levonorgestrel  One single IUS provides 5 years of treatment/protection Indications:  Idiopathic menorrhagia  Contraception

19. Side EffectPossible CauseManagement Amenorrhea/scanty period Due to possible pregnancy and inadequate endometrial buildup due to low-dose COCs Reassurance Spotting/ breakthrough bleeding - Missed pills - More common with low-dose COCs - Taking pills at different times a day - Vomiting and/or diarrhea within two hours of intake - Drug interaction Encourage regular intake of pill at the same time each day; teach to make up for missed pills properly; Nausea - Possible flu or other infection - Possible pregnancy - Taking Low-dose COCs on empty stomach Suggest taking low-dose COCs at bedtime or with food Headaches - estrogen effects associated with use of low-dose COCs Suggest pain relievers (paracetamol, aspirin, etc) If get worse refer. Breast tenderness - Related to estrogen component of the COCRecommend to use supportive bra (including during strenuous activity and sleep); try hot or cold compress; pain relievers; rule out pregnancy Management Of Possible Side Effects (COCs)

20. Medical Eligibility Checklist for Hormonal Contraceptives Ask the client the questions below. If she answers NO to ALL of the questions, then she CAN use the hormonal contraceptives. If she answers YES to a question below, follow the instructions. No conditions restrict use of these methods, but some conditions can make them harder to use effectively. 1. Do you smoke cigarettes and are you 35 or older?  No  YES Urge her to stop smoking. If she is 35 or older and will not stop smoking, do not provide Hormonal Contraceptives esp. COCs. Help her to choose a method without estrogen. 2. Do you have high blood pressure?  No  YES If you cannot check blood pressure (BP) and she reports high BP, do not provide hiormonal contraceptives esp. COCs. Refer for BP check if possible or help her choose a method without estrogen. If there is no report of high BP, it is okay to provide hormonal contraceptives Check is feasible: If BP is below 140/90, it is okay to give COCs without further BP readings. If systolic BP is 140 or higher or diastolic BP is 90 or higher, do not provide COCs. Help her choose another method. (One BP reading in the range of 140-159/90-99 is not enough to diagnose high BP. Offer condoms or spermicide for use until she can return for another BP check, or help her choose another method is she prefers. If BP reading at next check is below 140/90, she can use COCs and further BP readings are not necessary.) If systolic BP is below 160 or higher or diastolic BP is 100 or higher, she also should not use DMPA or NETEN.

21. Medical Eligibility Checklist for Hormonal Contraceptives 3. Are you breastfeeding a baby less than 6 months old?  No  YES Can provide supplies (e.g., pills) now with instruction to start when she stops breastfeeding or 3 weeks (for POCs) or 6 months (for COCs) after childbirth – whichever comes first. IF she is not fully or almost fully breastfeeding, also give her condoms to use until her baby is 6 months old. Other effective methods are better choices than COCs when a woman is breastfeeding whatever her baby’s age. 4. Do you have serious problems with you heart or blood vessels? Have you ever had such problems? If so, what problems?  No  YES Do not provide hormonal contraceptives if she reports heart attack or heart disease due to blocked arteries, stroke, blood clots (except superficial clots), severe chest pain with unusual shortness of breath, diabetes for more than 20 years, or damage to vision, kidneys, or nervous system caused by diabetes. Help her choose another effective method. 5. Do you have or have you ever had breast cancer?  No  YES Do not provide hormonal contraceptives. Help her choose a method without hormones.

22. Medical Eligibility Checklist for Hormonal Contraceptives 6. Do you have jaundice, cirrhosis of the liver, a liver infection or tumor? (Are her eyes or skin unusually yellow?)  No  YES Perform physical exam or refer. If she has serious active liver disease (jaundice, painful or enlarged liver, active viral hepatitis, liver tumor), do not provide hormonal contraceptives. Refer for care as appropriate. Help her choose a method without hormones. 7. Do you often get severe headaches, perhaps on one side or pulsating, that cause nausea and are made worse by light and noise or moving about (migraine headaches)?  No  YES If she is 35 or older, do not provide hormonal contraceptives. Help her choose another method. If she is under age 35, but her vision is distorted or she has trouble speaking or moving before or during these headaches, do not use COCs. Help her choose another method. If she is under age 35 and has migraine headaches without distortion of vision or trouble or moving, she can use COCs.

23. Medical Eligibility Checklist for Hormonal Contraceptives 8. Are you taking medicines for seizures? Are you taking rifampin (rifampicin) or griseofulvin?  No  YES If she is taking phenytoin, carbamezaphine, barbiturates, or primidone for seizures or rifampin or griseofulvin, provide condoms or spermicide to use along with hormonal contraceptives or, if she prefers, help her choose another effective method if she is on long-term treatment. 9. Do you think you are pregnant?  No  YES Assess whether pregnant (see How to tell if a woman is not pregnant). If she might be pregnant, also give her condoms or spermicide to use until it is reasonably certain that she is not pregnant. Then she can start hormonal contraceptives.

24. Medical Eligibility Checklist for Hormonal Contraceptives 10. Do you have gall bladder disease? Ever had jaundice while using hormonal contraceptives? Planning surgery that will keep you from walking for a week or more? Had a baby in the past 21 days?  No  YES If she has gall bladder disease now or takes medicine for gall bladder disease, or if she has had jaundice while using hormonal contraceptives, do not provide hormonal contraceptives. Help her choose a method without estrogen. If she is planning surgery or she just had a baby, can provide supply of hormonal contraceptives with instruction on when to start them later. Be sure to explain the health benefits and risks and the side effects of the method that the client will use. Also, point out any conditions that would make the method inadvisable when relevant to the client.

25. Who Cannot Use (WHO MEC Categories 3 AND 4)  Pregnant  Breastfeeding an infant < 6 months old  Smoke cigarettes and > 35 years old  Hypertension  Migraine headaches  Breast cancer  Undiagnosed abnormal vaginal bleeding

26. J-A-C-H-E-S JJaundice AAbdominal pain, severe CChest pain, shortness of breath HHeadache, severe EEye problems, blurring of vision SSevere leg pains Advise to seek immediate consultation Warning Signs of Possible Complication

27. High Risk for Venous Thrombo-embolism  Protein C or S deficiency  Hypertension  Obesity  Diabetes  Smoking  Sedentary lifestyle  Major operative procedure  Within 3 weeks post-partum

28. Return Visits for POI  Clients return to the clinic for next injection:  Every three months for DMPA  Every two months for Noristerat for the next injection  Advise every client during counseling and during post- injection instructions about the importance of returning to the clinic on her scheduled date.  Come back no matter how late she is for the next injection.  The injection may be administered 2 weeks early or 2 weeks late (UP TO 4 WEEKS LATE; STILL UP TO 2 WEEKS LATE FOR NET-EN!)  Give her an appointment card or slip.

29. Key Messages  Compliance and continuation rates are high if clients are properly counseled;  They are safe, effective, reversible and have other health benefits;  Medical eligibility criteria should be adhered to for safe provision.

30. Key Messages  Importance of breastfeeding should be emphasized  Warning signs of possible complications should be recognized early for prompt management;  Does not afford protection against STI/HIV/AIDS