1. Medical Abortion: Options in an Outpatient Setting

2. Objectives Pharmacology Eligibility for medical abortion Describe the process of consent, counseling, administration, complications, and follow-up of medication abortions. Understand the role of medical abortions in the context of Family Practice Clinics Describe the process taking place to increase access to medical abortions within CCRMC

3. Data from US Abortion Surveillance, 2005 Induced abortion rate peaked during the ’80’s, 23-24/1000, was 20-21/1000 in the ’90’s and in ’05, 15/1000. 2% decline from 2004 61% were less than 8 weeks EGA 87% were less than 12 weeks EGA 81% were known D&C/D&E 10% were MABs (increased from 1% in 2000) 94% of MABs were less than 8 weeks EGA There has been a steady increase in ABs <6 weeks, with a decrease in ABs 7-10 weeks. MMWR, 2008

4. Pharmacology Mifepristone –A progesterone blocker –Interferes with placental attachment –Causes uterus lining to thin –Stops growth of embryo Misoprostol –Also called Cytotec –A prostoglandin E1 analog –Stimulates uterine contractions –Causes cervical ripening

5. Mifepristone Regimens $270 for mifepristone $2.00 for misoprostol $90 for mifepristone $4.00 for misoprostol Cost of medications 32Minimum office visits Day 10-15Day 4-10Office follow-up visit 400 mcg. oral Office administration 48 hours later 800 mcg. vaginal Home self-administration 6 - 72 hours later Misoprostol dosing 600 mg. oral200 mg. oralMifepristone dose 49 days63 daysGestational Age Limit FDA Product LabelingEvidence-Based Protocol

6. Contraindications to Mifepristone + Misoprostol Confirmed or suspected ectopic pregnancy IUD in place (must be removed before treatment) Adrenal failure Current long-term systemic corticosteroid therapy Allergy to mifepristone Hemorrhagic disorder or current anticoagulation Inherited porphyria Allergy to misoprostol

7. Additional Screening The decision is uncoerced EGA is less than 63 days Patient has the time and resources for reliable follow-up Able to understand the instructions

8. Comparison of medical vs surgical abortion Offered up to 63 days EGA Approx. 2 office visits 95-99% effective Depending on facility, offered up to 12 weeks, or later Approx. 1 office visit 98% effective Safety and cost are similar between the two

9. Comparison of medical vs surgical abortion: Advantages May feel more natural No shots, anesthesia, instruments, or machines Can end pregnancy earlier Privacy of home Initiated by the woman Quick and over in a few minutes Slightly higher success rate Less bleeding Medical staff present The Access Project

10. Comparison of medical vs surgical abortion: Disadvantages Takes several days Not as predictable Heavier bleeding More severe cramping Slightly lower success rate Side effects of meds May need surgical follow-up Invasive Side effects of anesthesia Woman has less control over procedures Cannot be done as early The Access Project

11. Logistics of Administration Confirm pregnancy –Urine HCG and/or sonogram Confirm gestational age –LMP history –bimanual exam Lemon 5-6 weeks Orange 7-8 weeks Grapefruit 9-10 weeks –sonogram Rule out ectopic pregnancy

12. Counseling: What to Expect Preparation is the key to a successful outcome Pain Bleeding Side effects of medications Support There must be surgical back-up, readily available.

13. Follow Up Visit Schedule 1-2 weeks after initial visit Confirm completed abortion –Criteria #1: History Pelvic exam Falling HCG –Criteria #2 History Repeat ultrasonography

14. Indications for Aspiration Approximately 2-5% of patients treated with mifepristone+misoprostol will need a follow up aspiration. Aspiration is most often done to –Resolve an incomplete abortion –Terminate a continuing pregnancy –Control bleeding

15. The two key elements for successful outcomes are: 1)Appropriate screening 2)Thorough counseling Satisfaction depends on an informed choice NAF abortion textbook

16. Advantages of Primary Care Providers doing MABs Continuity Increase access to abortion, especially in underserved areas Expand options Safe and efficacious –In a retrospective case series, of 236 MABs performed in 4 community health centers (majority managed by family physicians) only 1 pt. required aspiration, a failure rate of.4%. (Prine et al.) MABs require key PCP skills: assessing a patient’s support system, emotional state and understanding of the process (Prine et al., 2005).

17. Integration of MABs in to FPC: Patient Support A survey of 148 urban women were surveyed –70% agreed their clinic should provide MABs –73% (of those who would consider abortion) would prefer to have it done by their family physician. Rubin et al, 2008

18. Integration of MABs in to FPC: Patient Choice What might women choose if they receive options counseling in a clinical setting that offers on-site MABs and referrals for off-site surgical TABs? –A retrospective, cohort study of 204 women, in a university setting, found 85% of eligible women chose medication abortion. The earlier the gestational age, the more likely a MAB. –Reasons: convenience if both options are acceptable, bias in physician counseling, self-selection of patients Leeman et al., 2007

19. MABs within the Contra Costa County Health Services Current Services Goals: –Increase number of providers who offer MABs –Establish an infrastructure and protocol to support providers –Model integration of MABs into FPC as part of resident training –Accomplish goals in a manner that is respectful of differences in values

20. Establish Support: Non-resident physicians/NP’s Identify interested providers, preceptors –Qualifications FDA: must be able to reliably determine gestational age. Need to be approved by OB/GYN to use US In-service training

21. Establish Support 1)Residents: 11 of 22 eligible residents would like to incorporate MABs into their FPCs. 2)Nursing: Organize values clarification workshops to discuss concerns, if needed. 3)Social Work: Entry way into the system

22. Clear, Accessible Protocol On-site info packets: medication guide, mifeprex patient agreement, CCRMC consent, provider note template, charting template Dictate a procedure note Notify back-up OB-Gyns On call responsibility Follow-up visits * Additional counseling resources available for provider reference.

23. References Comparison of the Two types of First Trimester Abortion. The Access Project. Chapter 3: Informed Consent, Counseling, and Patient Preparation. NAF Abortion Textbook. Gamble et al. “Abortion Surveillance --- United States, 2005.” MMWR. 2008; 57: 1-32. Leeman et al. “Can Mifepristone Medication Abortion Be Successfully Integrated into Medical Practices That Do Not Offer Surgical Abortion?” Contraception. 2007; 76: 96-100.

24. Prine et al. “Medication Abortion and Family Physicians’ Scope.” Journal of American Board of Family Medicine. 2005; 18: 304-306. Prine et al. “Medical Abortion in Family Practice: A Case Series.” Journal of American Board of Family Medicine. 2003; 16: 290-295. Rubin et al. “Patient Attitudes Toward Early Abortion Services in the Family Medicine Clinic.” Journal of American Board of Family Medicine. 2008; 21: 162-164.