1. Medical Education Series © 2005 National Abortion Federation E A R L Y O P T I O N S A PROVIDER’S GUIDE TO MEDICAL ABORTION

2. E A R L Y O P T I O N S A PROVIDER’S GUIDE TO MEDICAL ABORTION Overview of Medical Abortion: Clinical and Practice Issues

3. Objectives Discuss mifepristone’s history Provide an overview of medical abortion agents and regimens. Review important components of medical abortion practice, including counseling, eligibility screening, side effects, and follow-up Discuss general administrative and legal issues related to medical abortion practice

4. Overview Mifepristone history Overview of medical abortion agents and regimens Medical abortion in practice Administrative and legal issues

5. Definition of Medical Abortion Early pregnancy termination, generally before 9 weeks’ gestation, resulting from abortion- inducing medications and without primary surgical intervention

6. Use of Mifepristone Worldwide Millions of women have used mifepristone for medical abortion. Year that mifepristone was licensed France-1988 China-1988 UK-1991 Sweden-1992 Austria-1999 Belgium-1999 Denmark-1999 Finland-1999 Germany-1999 Greece-1999 Israel-1999 Luxembourg-1999 Netherlands-1999 Spain-1999 Switzerland-1999 Norway-2000 Russia-2000 Taiwan-2000 Tunisia-2000 Ukraine-2000 US-2000 New Zealand-2001 South Africa-2001 Azerbaijan—2002 Belarus—2002 Georgia--2002 India--2002 Latvia--2002 Uzbekistan--2002 Vietnam—2002 Estonia—2003 Guyana—2004 Moldova--2004

7. The Path to FDA Approval 1993: Clinton executive order 1994: Roussel Uclaf donates US patent 1994-95: US clinical trials 1996: FDA grants “approvable” status 1999: Manufacturing and labeling information submitted 2000: FDA approves Mifeprex ®

8. Abortions by Gestational Age in U.S. Strauss et al. MMWR, 2004 Weeks of gestation

9. Overview Mifepristone history Overview of medical abortion agents and regimens Medical abortion in practice Administrative and legal issues

10. Rhythmic Uterine Contractions Progesterone Blockade Decidual Necrosis Cervical Ripening DetachmentExpulsion Abortion © Lisa Penalver Mechanism of Action: Mifepristone + Misoprostol Mifepristone-Induced Abortion

11. FDA-Approved & Evidence- Based Alternative Regimens FDA-Approved Regimen Evidence- Based Alternatives Mifepristone dosage600 mg (three 200-mg tablets) 200 mg (one 200-mg tablet) Misoprostol dosage400 µg PO800 µg PV Where misoprostol taken At office or clinicAt home When misoprostol taken 48 hrs later (Day 3) Timing of initial follow- up examination Approximately Day 14 Gestational limit49 days LMP 6-72 hrs later < 56 days 6-48 hrs later < 63 days From Day 4-14 Up to 63 days LMP ONLY in studies using 800µg VAGINAL miso

12. Evidence-Based Alternative Regimens 200-mg dose of mifepristone Vaginal administration of misoprostol –Lower incidence of side effects compared to oral misoprostol –More rapid expulsion compared to oral misoprostol –Increases efficacy of medical abortion for gestations up to 63 days –Decreases continuing pregnancy rate Home use of misoprostol Flexibility in day of vaginal misoprostol use Flexibility in initial follow-up evaluation

13. Contraindications Allergy to mifepristone, misoprostol, or other prostaglandin analogues Concurrent long-term systemic corticosteroid use Chronic adrenal failure Hemorrhagic disorder or concurrent anticoagulant therapy Intrauterine device in situ Possible ectopic pregnancy Inherited porphyria

14. Special Considerations Chronic medical conditions –Cardiovascular disease –Hypertension –Hepatic disease –Renal disease –Pulmonary disorders –IDDM –Severe anemia –Heavy smoking Breast-feeding Women over 35 who smoke > 10 cigarettes daily

15. Overview Mifepristone history Overview of medical abortion agents and regimens Medical abortion in practice -Features of medical abortion -Counseling -Eligibility screening -Expected side effects -Follow-up care Administrative and legal issues

16. Medical High success rate (about 95-99%) Usually avoids surgical procedure Requires at least two visits Abortion occurs within 24 hours of second medication, for most women May be used in early pregnancy Oral pain medication can be used Some of the process may happen at home Medications cause a process similar to a miscarriage Vacuum Aspiration High success rate (99%) Instruments inserted into the uterus Can be done in one visit Procedure is completed in 5-10 minutes May be used in early pregnancy Anesthesia/Sedation can be used Procedure is done in a medical office or clinic Health care provider performs the procedure Features of Medical Abortion and Vacuum Aspiration

17. Methods of Abortion

18. Features of Medical Abortion

19. Why Women Choose Medical Abortion Avoids surgery, noninvasive Perceived by some women as: –“Better” or “easier” than vacuum aspiration –More natural, like a miscarriage

20. Medical Abortion: Acceptability Generally well-accepted by providers and patients Patient attitudes towards mifepristone/misoprostol –“Satisfactory” or “very satisfactory”: 88%–97% –% of eligible women choosing mifepristone varies –More than half of eligible women choose mifepristone in France, Scotland & Sweden –Patients dislike multiple-visit requirements Winikoff, et al. Int Fam Plann Perspect 1997 Winikoff, et al. Arch Fam Med 1998 Ngoc, et al. Int Fam Plann Perspect 1999 Jones, et al. Perspect Sexual Reprod Health 2002

21. Counseling and Eligibility Screening

22. Counseling for Medical Abortion The quality of counseling correlates with the level of patient satisfaction with abortion care Abortion can be an emotional issue for patients and providers Clarify provider values Assumes a large role in medical abortion services Requires adequate time

23. Challenges Specific to Medical Abortion Counseling Greater patient autonomy Patients must be knowledgeable and prepared to participate in the process Preparing women for side effects is a critical component of counseling Patients may not acknowledge process as an abortion Patients must understand importance of vacuum aspiration completion, if needed

24. Protocol: Special Issues Home administration of misoprostol Viewing products of conception Anxiety about participating in the abortion process Support person, child care, time off from job Privacy issues

25. Common Questions About the Medical Abortion Protocol Efficacy Safety Side effects –Pain –Bleeding –Other Timeline for the process

26. Completion of Medical Abortion Timing varies somewhat depending on mifepristone regimen Onset of bleeding –Bleeding after mifepristone can occur –80-92% bleed within 4 hours of misoprostol –Average onset 2-4 hours post misoprostol –98% of women bleed within 24 hours of misoprostol Expulsion –60-93% abort within 5 hours of misoprostol –~90% abort within 24 hours after misoprostol Schaff, et al. Contraception 1999 Wiebe, et al. Obstet Gynecol 2002 Creinin, et al. Obstet Gynecol 2004

27. Eligibility Screening Patient certain about abortion decision Gestational age Able to follow treatment protocol and follow up Willing to have vacuum aspiration if needed Able to give informed consent Phone access Access to emergency care

28. Patient Instruction Sheet Given to patients at initial visit Covers: –Misoprostol administration –Use of analgesics with medication restrictions –Symptoms and side effects –24-hour contact number –When to call for help or medical advice –When to return for follow-up

29. Expected Side Effects: Patient Preparation and Management

30. Definitions Side Effect Effect of treatment, other than the intended outcome, that might include physiological or psychological consequences Complication Effect resulting from treatment that has potentially serious clinical consequences and requires medical intervention

31. Expected Side Effects of Medical Abortion Pain Bleeding Nausea, vomiting, diarrhea Short-term temperature elevation or chills Headache, dizziness

32. Management of Common Side Effects: Pain Cramping occurs in > 90% of patients 1 - Variable in intensity - Generally peaks after misoprostol Provide pain medications with initiation of treatment Discuss additional comfort measures Counseling and reassurance crucial to pain management 1 Spitz IM, New Engl J Med, 1998

33. Management of Common Side Effects: Bleeding Usually exceeds typical menstrual bleeding –If patient saturates 2 maxipads/hour for 2 consecutive hours, contact provider –Surgical intervention to control bleeding: 0.4% to 2.6% 1,2 –Transfusion required: 0.2% 2 Longer duration than with vacuum aspiration No significant difference in total blood loss between medical abortion & vacuum aspiration 1 Ashok, et al. Hum Reprod 1998 2 Spitz, et al. New Engl J Med 1998

34. Management of Common Side Effects: GI, Temperature Elevation Nausea, vomiting, and diarrhea –Usually short in duration –Rarely needs medication Short-term fever and chills –Result of misoprostol or the abortion process –Antipyretics as appropriate –Suspect infection with: Sustained fever > 100.4°F Fever 24 hours or more after misoprostol

35. Emergency Preparedness Recognizing the need for emergency care Access to phone, transportation, acute care Instructions on when to call for help –Saturating > 2 maxipads/hour for 2 consecutive hours –Intractable pain Reassure patient that hemorrhage is rare

36. On-Call Services A clinician must be available around the clock Call volume compared to vacuum aspiration is variable –In one study, 2/3 report fewer or same number –May be associated with quality of counseling and patient preparation On-call duties can rotate among qualified staff members

37. Follow-Up Care

38. Follow-up Care Determine if abortion is complete Continuity of care preferable Provide emotional support and assistance, as needed Provide information, ask/answer questions, listen, and observe

39. Kahn, et al. Contraception 2000 Meta-Analysis: Various Regimens Mifepristone/Misoprostol (< 49 days) 96.0% 2.9% 1.1% 0% 25% 50% 75% 100% SuccessIncomplete Abortion Continuing Pregnancy

40. Successful Treatment Focus on patient experience –Emotional/physical –Management of side effects, feelings Concerns and questions Review contraceptive options Provide information on EC, STDs, and additional health services as appropriate

41. Unsuccessful Treatment Counsel patient regarding options –Observation –Repeat misoprostol –Vacuum aspiration Be open to patient concerns and potential feelings of disappointment Allow patient to regain some control

42. Vacuum Aspiration in Cases of Unsuccessful Medical Abortion Vacuum aspiration required in event of medical abortion failure Manual or Electric Vacuum Aspiration Often does not require dilation Rarely emergent

43. Overview Mifepristone history Overview of medical abortion agents and regimens Medical abortion in practice Administrative and legal issues -Ordering medications -FDA requirements -Malpractice insurance -Legal issues

44. Ordering Medications Mifepristone –Prescriber’s agreement –Order from specific distributors only –Not available from general pharmacies Methotrexate and Misoprostol –Order from pharmaceutical distributors –Also available from pharmacies

45. FDA Labeling Prescriber’s Agreement requires care be provided by or under the supervision of a physician able to: –Assess gestational age –Diagnose ectopic pregnancy –Perform vacuum aspiration or appropriate referral Counseling and informed consent includes: –Mifeprex ® medication guide –Mifeprex ® patient agreement Patient access to emergency care

46. Evidence-Based Use of Medications Package labeling –Approved by FDA –Gives detailed information to clinicians and patients about how to use the medication Clinicians can use approved medications in ways that are different from the package labeling (“off-label” use) as long as: –The use is evidence-based and consistent with current, accepted medical practice –The clinician receives informed consent from the patient

47. Malpractice Insurance Abortion may or may not be covered under current policy Notify insurer of “material change” in practice –Are steps of a medical abortion consistent with services in current practice? –Complex issue Consultation with individual insurance carriers may help clarify

48. Legal Issues Medical abortion generally regulated as much as other abortion methods Providers must –Be alert to federal, state, and local requirements –Consult with their own legal counsel

49. Legal Issues Role of advanced practice clinicians and scope of practice TRAP regulations Tissue examination and disposal Reporting requirements Parental involvement Waiting periods/ “Informed consent”

50. Conclusion FDA approved mifepristone in 2000 High efficacy (95-99%) and extremely safe Counseling and education: critical for success and patient satisfaction Common side effects: pain, bleeding, GI symptoms Medical abortion practice incorporates administrative and legal components

51. E A R L Y O P T I O N S A PROVIDER’S GUIDE TO MEDICAL ABORTION This educational program does not define a standard of care, nor does it dictate an exclusive course of management. It contains recognized methods and techniques of medical care that represent currently appropriate clinical practice. Variations in patient needs and available resources may justify alternative approaches. Laws governing abortion, informed consent, and medical malpractice vary among states. These materials are strictly for informational purposes, and do not constitute legal advice or representation. These materials are not intended as a substitute for the advice of a health care provider. Neither NAF nor its agents are responsible for adverse clinical outcomes that might occur where they are not expressly and directly involved in the role of primary caregiver. This educational program is protected by copyright. Any unauthorized duplication, reproduction, or alteration of the presentations or any part of the presentations contained therein is strictly prohibited. This educational program is intended for the use of the original recipient and his/her agents and cannot be sold, distributed, transmitted or transferred in any form without prior written authorization by the National Abortion Federation. © 2005 National Abortion Federation