New Contraceptive Options in Primary Care

1. New Contraceptive Options in Primary Care Kelly Kruse Nelles MS, RN-C, NP Clinical Associate Professor UW School of Nursing UW Women’s Health Center

2. Learning Objectives: • 1. Recognize the role of family planning as an important part of primary health care. • 2. Identify 3 new methods of contra-ception and the correct use for each. • 3. Select candidates that may benefit from new contraceptive methods.

3. Statement of Financial Disclosure: • This talk has not been sponsored by any organization.

4. Why Family Planning in Primary Care? • A typical woman in the U.S. spends about 36 years – almost half of her lifespan at potential biological risk of pregnancy. • Nearly half of pregnancies in the US are still unintended – 3.2 million • Among industrialized countries, the US still has the highest rate of teenage pregnancies, unintended pregnancies, and abortions • Of women aged 15-44, 49% will experience unintended pregnancy

5. Impacts • Preconception care • Maternal and child morbidity • Maternal and child mortality • Resulting consequences for the family and society

6. Dissatisfaction with Contraceptive Methods • Plays a large role in unintended pregnancy • As many as 60% of women starting OCs stop within the first 6 months resulting in >1 million unintended pregnancies • Most stop current contraception due to side effects • 20% of women selecting sterilization at age 30 years or younger later express regret

7. Contraceptive Properties Desired by Women • Highly effective • Prolonged duration of action • Rapidly reversible • Privacy of use • Protection against STI • Easily accessible

8. Perfect vs Typical Use • Typical Use – pregnancy rates during typical use reflect how effective methods are for the average person who does not always use methods correctly or consistently. • Perfect Use – predicts the probability of method failure (pregnancy) during the first year of use when a method is used perfectly and consistently • Typical use reflects the user while perfect use reflects the method

9. Current Trends in Contraception • Development of new delivery systems • Increased access to a full range of options • Emphasis on greater success • Decreased side effects • Wider use of emergency contraception

10. Recognition of Health Benefits of Hormonal Contraception • Menses related benefits • Cycle regulation • Decreased blood loss with resulting decreased iron deficiency anemia • Improved dysmenorrhea • Benefits of inhibiting ovulation • Decreased incidence of ovarian cysts • Decreased incidence of ectopic pregnancy

11. Other health benefits • Decreased benign breast disease and fibroadenomas • Decreased incidence of acute PID • Protection against Endometrial and Ovarian cancers • Maintains bone mass • Possible decreased risk of Colorectal cancer • Often improves Rheumatoid Arthritis

12. Candidate Selection for Hormonal Contraception • Art vs Science • Helpful to assess the woman’s body type when selecting hormonal contraceptive options • Determine if she can safely use estrogen

13. Determining if Estrogen Can Safely Used • Ask yourself: • Is this person a good candidate for a method with estrogen?

14. Absolute Contraindications to Estrogen Use • Thrombophlebitis or thromboembolic disorder • Family history of hereditary thrombophilia in a first degree relative • Cerebrovascular disease • Coronary artery or ischemic heart disease • Known or suspected breast cancer • Known or suspected estrogen-dependent neoplasia • Known or suspected pregnancy • Benign or malignant liver tumor • Current impaired liver function • Undiagnosed vaginal bleeding

15. Relative Contraindications (exercise caution): • Vascular or migraine headaches, especially if they began or worsened with the use of combined hormones • Hypertension • Acute mononucleosis or recent hepatitis • Presence of factors predisposing to thromboembolic disorder: illness or surgery requiring immobilization, long leg cast, trauma to lower leg

16. Relative Contraindications (exercise caution): • Cardiac or renal dysfunction (or hx of) • Diabetes mellitus • Obesity (>20% ideal weight) • Lactation • Age over 50 • Age over 35 for a smoker • Psychic depression • History of MI in an immediate family member before age 50 – especially a mother or sister

17. Relative Contraindications (exercise caution): • Hyperlipidemia • Active gallbladder disease • Sickle cell or Sickle cell C Disease • Completion of a term pregnancy in the past 10-14 days • Ulcerative colitis • Asthma

18. If Yes, base your selection on: • Body type – estrogenic vs androgenic • Monophasic vs triphasic method • Number of micrograms of ethinyl estradiol • Availability of the method • Ability to understand and use the method correctly • Cost • Prior experience with other methods

19. Acronym of Contraceptive Counseling • BRAIDED: • Benefits of the method • Risks of the method • Alternatives to the method • Inquiries about the method are the patients right and responsibility • Decision to withdraw from the method without penalty • Explanation of the method that is understandable • Documentation that the hcp has ensured understanding of each of the proceeding points

20. Hormonal Side Effects • Estrogen Sensitivity • Progesterone Sensitivity

21. The Contraceptive Patch • Ortho Evra transdermal system • Combination hormonal method releasing 20 mcg ethinyl estradiol/150 mcg norelgestromin daily • 20 cm square applied to abdomen, buttocks, upper outer arm or upper torso – not breast.

22. Use is based on a 28 day cycle • On the first day of each of the first three weeks, a new patch is applied and worn 7 days, then discarded • During the 4th week, no patch is worn and withdrawal bleeding occurs

23. Ideally, first patch should be applied on the first day of menses and is considered immediately protected • If patch is applied at any other time in the cycle, a back up method should be used for 7 days • The patch should be applied on the same day of each week (patch change day)

24. Apply to clean, dry, healthy skin free of creams or lotions • May bathe, shower, swim, exercise while wearing • Partial or complete detachment has been shown to occur in <5% of cases • If it does fall off, immediately apply a new patch and then replace it on her regular patch change day

25. When prescribing the patch, write for a single replacement patch as well. • If the patch is off for longer than 24 hours, a new cycle must be initiated with a new patch, and back up for the next 7 days.

26. Effectiveness: • An analysis of pooled data from studies involving >3,300 women showed that the overall probability of pregnancy in patch users was 0.8% • Comparable to OCs

27. Ideal for women who find it difficult to remember to take a pill at the same time daily • Among patch users, the mean proportion of cycles with perfect compliance is 88.2% as compared with 77.7% among OC users

28. 97-98% women stay with the patch • Easy and convenient • Break through bleeding less with the patch vs the pill • If worn on buttocks, BTB is even less as absorption is better

29. Adverse effects similar to OCs although breast tenderness is more prevalent (19% patch vs 6% pill) • Resolves after 1-2 months • Application site reactions (1-2.4%) • Women weighing 198 lbs or > may experience a higher failure rate • Inform that risk of pregnancy is higher • Counsel on use of combined methods

30. No significant impact on LDL/HDL ratios • Drug interactions reported with OCs are assumed to pertain to patch • Contraceptive effectiveness may be reduced when coadministered with some antibiotics, anitfungals, anticonvulsants, and other drugs that increase metabolism of contraceptive steroids • Barbiturates, griseofulvin, rifampin, phenylbutazone, phenytion, carbamazepine, felbamate, oxcarbazepine, topiramate, and possibly ampicillin

31. Contraindications similar to OCs • Valvular heart disease with complications • Severe hypertension • Diabetes with vascular involvement • Headaches with focal neurological symptoms • Acute or chronic hepatocellular disease with abnormal liver function • Hypersensitivity to any component of the product

32. The Vaginal Ring • The NuvaRing is a flexible transparent device made of ethylene vinyl that is inserted into the vagina • It is a combination contraceptive releasing 15 mcg ethinyl estradiol/120 mcg etonogestrel daily over 3 weeks of use • It is removed for week 4 during which time withdrawal bleeding occurs • A new ring is then inserted

33. Requires lower hormone doses than OCs as administration vaginally precludes hepatic or GI interference • Effectiveness similar to combined OCs, the ring offers more uniform plasma hormone concentrations

34. Women report: • Easy to use • Does not require fitting • Convenient – needs to be administered only once each month • Can be left in place during swimming, bathing and intercourse

35. Combined data from 1,950 North American and European women who use the ring for at least 3 months: • 96% of those who completed 13 cycles of use were satisfied or very satisfied • 85% of women and 71% of their sexual partners said they never or rarely felt the ring during intercourse • 85% of women reported menses of the same or shorter durations • 85% reported menstrual pain as unchanged or reduced

36. Of 821 women (35%) who did not complete the study: • 52% gave reasons not related to the device (ex: wishing to become pregnant) • 43% referred to adverse effects (ex: tendency for the ring to fall out) • 2.6% said they were pregnant • 2.3% complained of irregular bleeding

37. Ring specific adverse effects include vaginal irritation, infections and discharge • Vaginal medications (such as antifungal creams) can be used while the ring is in place

38. Mirena Intrauterine System • Like the copper T IUD, Mirena is inserted by the clinician into the uterine cavity to prevent pregnancy • Also T shaped it is the size of a quarter and made of a soft flexible plastic containing 52 mg of levonorgestrel in a release controlling membrane with a monofilament string

39. Levonorgestrel is released at 20mcg/day • Thickens cervical mucus • Suppresses ovarian function • Inhibits sperm movement • Thins uterine lining making it an unfavorable environment for implantation

40. Approved for 5 years of continuous use • Is appropriate for women in whom estrogen is contraindicated • Can be an effective treatment for women with dysmenorrhea, menorrhagia, and anemia • Low maintenance – only need to check strings after each menstrual period to ensure device is in place

41. For women who choose to become pregnant • Device can be removed at any time • No waiting period is required before conception • Mirena is not associated with decline in fertility

42. Women need to be counseled that complete or temporary amenorrhea is likely to occur within 1 year of use (20-56%) • Bleeding irregularities rarely contributed to discontinuation of use

43. Combined Oral Contraceptives • Popular method since introduction in the 1960s • Initial doses contained as much as 150 mcg of estrogen thus posing significant health threats (DVT, PE, CVA, MI) • Today 98% of all pills contain less than 35mcg of estrogen

44. Ethinyl Estradiol • 20, 25, 30, 35 mcg (low dose) • 50mcg (high dose) • Pills with low estrogen are considered safer for certain patients • Perimenopausal women • Those with a family history of heart disease • Smokers younger than 35 (although risk of MI and stroke due to OC-associated changes in coagulation factors remain)

45. Progestins have changed as well • Today’s combined OCs contain about 10% of amount found in OCs manufactured in the 1970s • Decreased progesterone related side effects: nausea, breast tenderness, bloating

46. Progestins • Norethindrone • Levonorgestrel • Norgestrel • Desogestrel • Drospierone

47. Yasmin • FDA approved in 2000 • Contains drospirone (DRSP) with antiandrogenic and anitmineralocorticosteriod properties • Associated with less water retention, less negative emotional affect, less appetite increase after 6 months of use • Women who took this pill did not experience statistically significant changes in weight or BP after 13 months of use

48. DRSP contains spironolactone and may benefit women with androgenic presentation (acne, hirsutism, obesity) • Should not be used by women with: • History of hyperkalemia secondary to renal insufficiency • Hepatic dysfunction • Adrenal insufficiency

49. Consider prescribing a different type of OC for women who take medications that affect serum potassium levels • Monitor potassium levels in the first cycle with these drugs • Angiotensin-converting enzyme inhibitors • Angiotensi II receptor antagonists • Other potassium-sparing diruetics, heparin, aldosterone antagonists, NSAIDs

50. 25mcg Pills • Triphasic with desogestrel (Cyclessa) • Triphasic with norgestimate (Ortho Tri-cyclen Lo) • Monophasic with norgestimate (Ortho Cyclen Lo)