World Health Organization Medical Eligibility for Contraceptive Use. Connie Kraus, PharmD, BCACP Professor (CHS) Director Office of Global Health

Transcription

1 World Health Organization Medical Eligibility for Contraceptive Use Connie Kraus, PharmD, BCACP Professor (CHS) Director Office of Global Health

2 Objectives After this session, learners should be able to: 1. Interpret information obtained from the World Health Organization s Medical Eligibility for Contraceptive Use wheel and text. 2. Create a list of safe options for patients seeking hormonal contraception taking into account comorbid conditions and other medication use.

3 World Health Organization s Medical Eligibility for Contraceptive Use Medical Eligibility for Contraceptive Use Website Text Wheel

4 World Health Organization s Medical Eligibility for Contraceptive Use Text In the text, each chapter contains a table representing a specific type of contraceptive method: Combined hormonal contraceptives (CHC) oral, injectable, patch and ring Progestin-only contraceptives (POCs) pills, implants and depot medroxyprogesterone acetate, injectable Emergency contraceptive pills (ECPs) Intrauterine devices (IUDs) copper and progestin-containing

5 World Health Organization s Medical Eligibility for Contraceptive Use Text (continued) Copper IUD for emergency contraceptive (E-IUD) Barrier methods (BARR) Fertility awareness-based methods (FAB) Lactational amenorrhea method (LAMM) Coitus interruptus (CI) Surgical sterilization procedures (STER) including female and male surgical sterilization

6 World Health Organization s Medical Eligibility for Contraceptive Use Text For our purposes, we will refer to the following for information on use of hormonal contraceptives: Combined hormonal contraceptives (CHC) oral, patch and ring Progestin-only contraceptives (POCs) pills, implants and depot medroxyprogesterone acetate Intrauterine devices (IUDs) copper and progestin-containing A useful comparison table can be found on p of part 2.

7 World Health Organization s Medical Eligibility for Contraceptive Use Text Each chapter is broken down into health-related categories in the same order: Personal characteristics and reproductive history Cardiovascular disease Rheumatic diseases Neurologic conditions Depressive disorders Reproductive tract infections and disorders HIV/AIDS Other infections Endocrine conditions Gastrointestinal conditions Anemias Drug interactions

8 World Health Organization s Medical Eligibility for Contraceptive Use Every 3-4 years, World Health Organization convenes an Expert Working Group Four categories are used to classify conditions affecting eligibility for use of various methods ons/family_planning/ex-summ-mec-5/en/ Category Implication 1 A condition for which there is no restriction for the use of the contraceptive method 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks 3 A condition where the theoretical or proven risks usually outweigh the advantages of using the method 4 A condition which represents an unacceptable health risk if the contraceptive method is used.

9 Medical Eligibility for Combined Hormonal Contraceptives (CHCs) and Smoking Text Smoker less than 35 years = Category 2 Smoker (<15 cigarettes/day) and 35 years = Category 3 Smoker ( 15 cigarettes/day) and 35 years = Category 4

10 Medical Eligibility for Progestin-only Contraceptives (POC) and Smoking Text Smoker less than 35 years = Category 1 Smoker (<15 cigarettes/day) and 35 years = Category 1 Smoker ( 15 cigarettes/day) and 35 years = Category 1

11 Combined Hormonal Contraceptives Category 4 World Health Organization (WHO) Classification (Category 4) Less than 6 weeks postpartum (breastfeeding) Less than 21 days postpartum with other risks for VTE (non-breastfeeding) Age 35 years and smoking 15 cigarettes/day Systolic BP 160 or diastolic BP 100 mm Hg Vascular disease History of DVT/PE, acute DVT/PE or DVT/PE and established on anticoagulation therapy Known thrombogenic mutations Major surgery with prolonged immobilization

12 Combined Hormonal Contraceptives Category 4 World Health Organization (WHO) Classification (Category4) Current and history of ischemic heart disease Stroke Complicated valvular heart disease (pulmonary hypertension, risk of atrial fibrillation, history of subacute bacterial endocarditis) Positive antiphospholipid antibodies (SLE) Migraine headache with aura (any age) Continuation in patients with migraine without aura ( 35 years) Severe cirrhosis, hepatocellular adenoma or malignant hepatoma Current breast cancer h

13 Combined Hormonal Contraceptives Category 3/4 World Health Organization (WHO) Classification (Category 3/4) Multiple risk factors for arterial cardiovascular disease (older age, smoking, diabetes and hypertension) Diabetes with nephropathy/retinopathy/neuropathy Acute or flare of viral hepatitis Other vascular disease or diabetes of greater than 20 years duration

14 Combined Hormonal Contraceptives Category 3 World Health Organization (WHO) Classification (Category 3) 6 weeks to <6 months postpartum primarily breastfeeding < 21 days postpartum without other risk factors for VTE (non-breastfeeding) 21 days to 42 days postpartum with other risk factors for VTE (non-breastfeeding) Age 35 years and smoking < 15 cigarettes per day History of hypertension where blood pressure can not be evaluated Adequately controlled BP where BP can be evaluated Elevated BP systolic or diastolic mm Hg Initiation of COC in women 35 years who have migraine without aura or continuation of COC in women < 35 years who begin to have migraine without aura while on COC Past breast cancer and no recurrence in 5 years

15 Combined Hormonal Contraceptive Category 3 World Health Organization (WHO) (Category 3) Current symptomatic or medically-treated gall bladder disease Past COC-related cholestasis Use of certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate or oxcarbazepine) (may decrease efficacy of COC) Lamotrigine (decreased efficacy of antiepileptic agent) Rifampicin or rifabutin therapy (may decrease efficacy of COC) (Please note that broad-spectrum antibiotics, antifungals and antiparasitics are category 1)

16 Progestin-only Pills Categories 3 and 4 WHO category 4 risk : current breast cancer WHO category 3 (risk usually outweighs benefits): acute DVT/PE, continuation of use with ischemic heart disease or stroke, positive (or unknown) antiphospholipid antibodies, continuation of use with migraine with aura (any age), past breast cancer and no evidence of current disease for 5 years, severe cirrhosis, hepatocellular adenoma, malignant hepatoma WHO category 3 unique to progestin-only pills vs. other progestin-only methods: certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine), and rifampicin or rifabutin therapy) where a decrease in POC efficacy expected (Unlike COCs, POPs do not appear to affect levels of lamotrigine)

17 Progestin Injection Categories 3 and 4 Less likely to be influenced by drug interactions than COCs or progestin-only tablets WHO category 4: current breast cancer WHO category 3: acute DVT/PE, continuation of use with migraine with aura at any age, positive or unknown antiphospholipid antibodies (SLE), continuation migraine with aura (any age), past breast cancer and no evidence of current disease for 5 years, severe cirrhosis, hepatocellular adenoma, malignant hepatoma. WHO category 3 unique to injectable form vs. oral: less than 6 weeks postpartum (breastfeeding), multiple risks for arterial cardiovascular disease (age, smoking, hypertension, dyslipidemias), systolic BP 160 or diastolic 100, vascular disease, current and history of ischemic heart disease or stroke, initiation in severe thrombocytopenia, unexplained vaginal bleeding, diabetes more than 20 years or retinopathy, nephropathy or neuropathy

18 Progestin Implants For most part same profile as progestin-only pills Exception: category 3 for unexplained vaginal bleeding and less likely to be affected by drug interactions (category 2) 5/en/

19 Progestin-containing Intrauterine System Category 4 World Health Organization Category 4 Puerperal sepsis Immediate post-septic abortion Persistently elevated beta-hcg levels or malignant disease in patients with gestational trophoblastic disease Current breast cancer Unexplained vaginal bleeding (initiation) Cervical cancer (initiation) Endometrial cancer (initiation) Uterine fibroids with distortion of uterine cavity or other anatomical abnormalities with distortion Pelvic inflammatory disease or current STI (initiation) Pelvic tuberculosis (initiation)

20 Progestin-containing Intrauterine System Category 3 World Health Organization Category 3: 48 hours to <4 weeks postpartum, acute DVT/PE, continuation of use with ischemic heart disease (stroke is WHO 2), positive or unknown antiphospholipid antibodies (SLE), continuation with migraine with aura (any age), decreasing or undetectable beta-hcg levels in patients with gestational trophoblastic disease, past breast cancer and no evidence of current disease for 5 years, ovarian cancer (initiation), severe or advanced HIV disease (initiation), pelvic tuberculosis (continuation), severe cirrhosis, hepatocellular adenoma, malignant hepatoma. Like injectable, low risk for drug interactions with anticonvulsants and inducer antibiotics.

21 World Health Organization Medical Eligibility for Contraceptive Use Wheel

22 Case #1 J.S. is a 20-year-old woman with a history of migraine headaches (without aura). She has tried a number of preventive therapies for migraine including propranolol, amitriptyline and diltiazem. She states that amitriptyline was somewhat effective, but caused weight gain. Her current BMI is 34. She is a non-smoker and uses alcohol rarely. She has no drug allergies. She started using topiramate 4 months ago for migraine control and weight loss. Her headaches have been better controlled and she has lost 4 pounds. J.S. has been considering use of hormonal contraception. Please address the following questions: 1. Which of the hormonal options would offer the best safety profiles for J.S. considering her other health conditions? 2. Which of the hormonal options would offer the best efficacy profile for J.S. considering her current medication?

23 Case #2 M.B. is a 45-year-old woman diagnosed with type 2 diabetes three years ago. She is currently taking metformin, a statin, hydrochlorothiazide and an ACE-inhibitor. Her HgA1C, cholesterol and blood pressure are well-controlled. Her serum creatinine is within the normal range, and she doe not have microalbuminuria. Her current BMI is 28. She does not smoke or use alcohol. M.B. is interested in exploring use of hormonal contraception. Please address the following questions: 1. Which of the hormonal options would offer the best safety profiles for M.B. considering her other health conditions? 2. Which of the hormonal options would offer the best efficacy profile for M.B. considering her current medications?

24 Case #3 P.K. is a 45-year-old woman with a history of osteoarthritis in both knees. She has used non-steroidal antiinflammatory agents for pain and is scheduled for a total right knee replacement in one month. Since both knees are affected by osteoarthritis, she anticipates a longer recovery period. She is currently using combined oral contraceptives for menstrual cycle regulation. Please address the following questions: 1. Are combined oral contraceptives safe for use during P.K s surgery and recovery? 2. Which of the hormonal options would offer the best safety profile?

25 Case #4 C.K. is a 35-year-old pharmacy professor who directs her school s global health programs. Four years ago during a trip to outer Mongolia, she experienced a deep vein thrombosis. She successfully completed three months of anticoagulation and is now taking no medication. She is overall in good health, does not smoke or use alcohol. She has no known drug allergies. C.K. is interested to consider use of hormonal contraceptives. Please address the following question: 1. Which of the hormonal options would offer the best safety profiles for C.K. considering her past health condition?

26 Case #5 S.L. is a 30-year-old woman with a diagnosis of hypertension. For the past 3 years, she has controlled her blood pressure with hydrochlorothiazide and amlodipine. She has no other diagnoses. Her BMI is 35. She smokes an average of 10 cigarettes per day. She does not use alcohol. She is interested to discuss use of hormonal contraceptives. Please address the following questions: 1. Which of the hormonal options would offer the best safety profiles for S.L. considering her other health condition? 2. Which of the hormonal options would offer the best efficacy profile for S.L. considering her current medication?