1. Amr Nadim, MD Professor of Obstetrics & Gynecology Ain Shams Faculty of medicine Barriers to Access to Quality: An Evidence Based look to Contraceptive Prescription

2. In February 2002, A Big event occurred in Cairo…

3. The Problem … “ There is lack of a mechanism to facilitate the exchange of MAQ principles and evidence-based lessons learned which can result in inadequate coordination, design and implementation of FP/RH programs. ”

5. MAQ Attributes:  Practical and realistic  Client-centered  Evidence-based  Impact-oriented  Field relevant  Drawing on international consensus  Prioritized ( “ first things first ” )  Collaborative

6. What is… QUALITY QUALITY?

7. Quality = Goodness Quality = Goodness

9. Good Access and Quality Increases Contraceptive Prevalence Rates Months of Follow-up CPR Percentages (All Methods) Source: Shelton et al, 1999. Pakistan 6 CBD Pilot Projects

10. Dimensions Of Quality Effectiveness Interpersonal Relations Interpersonal Relations Access To Service Access To Service Efficiency Technical Competence Technical Competence Amenities Continuity Safety

11. è Access to services è Contraceptive choice è Quality services provided Legal Time Socio-cultural norms Medical Cost Regulatory Gender Process Physical Appropriate eligibility criteria Poor CPI Provider bias Knowledge Location Barriers to Access and Quality

12. Medical Barriers  Medical barriers are “… practices derived at least partly from a medical rationale, that result in a scientifically unjustifiable impediment to, or denial of, contraception. ”  These include : eligibility restrictions, process barriers, contraindications and provider limitations/bias. Shelton, Angle, Jacobstein, The Lancet, Volume 340, November 28, 1992.

13. Anecdotes Intermediate Outcomes “ The Winds of Change ” Expertise Client values & concerns Best Evidence

15. Effectiveness Best Evidence Relevant Patient Centered Patient Centered Provider Expertise Provider Expertise Life Long learner Life Long learner Validity

16. Improving CPI Improving Knowledge Improving Knowledge Setting Medical Eligibility Criteria Setting Medical Eligibility Criteria Correction of Provider Bias Correction of Provider Bias Implementing Best Practices Implementing Best Practices Continuity

17.  Scientific studies of contraceptive products that NO longer exist.  OR on long-standing theoretical concerns that have NEVER been substantiated.  OR on the provider PERSONAL preferences.  OR on BIAS of service providers. Current Policies And Health Care Practices Are Based On:

18. How did they proceed … ?  1994~1996: The objective was : Improving the Access to quality care in family planning through breaking the medical barriers set against quality. The method was: An in-depth review of the epidemiological and clinical evidence relevant to the medical eligibility criteria of various contraceptive methods.

19. How did they proceed … ?  2000: New evidence from systematic reviews women of the literature for contraceptive use among women with certain pre-existing conditions.

20. Efficacy SafetyConvenience

21. Pills Have Changed Over Time  New pills are safer due to reduced hormonal dose  Typical dosages by year (approximate) - 1960s~1970s: 50 mcg of ethinyl estradiol - 1980s~ 1990s: 30 mcg of ethinyl estradiol - Present: 20 mcg of ethinyl estradiol (becoming available)

22. And … COCs Have Non-Contraceptive Benefits  Reduce the risk of: - benign breast disease - ovarian and endometrial cancer - functional ovarian cysts - ectopic pregnancy - symptomatic PID  Menstrual improvements

23. COCs … Ovarian Cancer Protection  COCs reduce risk by more than 50%  Protection develops after 12 months of use and lasts for at least 15 years COC users (8+ years of use) Costa RicaChina 1.7 0.7 0.6 0.2 0.6 0.2 Non COC users United States Lifetime risk of acquiring ovarian cancer Number per 100 women 0 0.5 1.0 1.5 2.0 100 Source: Petitti and Porterfield, 1992.

24. COCs… Endometrial Cancer Protection Lifetime risk of acquiring endometrial cancer Number per 100 women COC users (8+ years of use) Costa Rica 3.1 0.7 0.3 0.4 0.1 United States China Non COC users 2 0 1 3 4 100 Source: Petitti and Porterfield, 1992; CASH Study, 1987. COCs reduce risk by more than 50% Protection develops after 12 months of use and lasts for at least 15 years 1.2

25. Relative Risk with 95% Confidence Intervals 0.1 1.0 10.0 Significantly elevated RR Nonsignificantly elevated RR Significantly decreased RR Increased risk Equal risk Decreased risk Relative Risk (RR) 95% Confidence Interval Relative Risk = Medical condition in exposed population Medical condition in non-exposed population

26. Risk of Breast Cancer, By Duration of COC Use Source: WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception, Contraception 1998. 0.1 0.5 1.0 5.0 10.0 1.01.071.091.051.16 Increased risk Equal risk Decreased risk Relative Risk 1.081.07 Nonusers < 1 yr 1-4 yrs 5-9 yrs 10-14 yrs 15 yrs Ever

27. Risk of CVD and Use of Hormonal Contraceptives Source: WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception, Contraception 1998; 57: 315-324 0.1 0.5 1.0 5.0 10.0 1.0 Non- users Oral combined Progestin-only injectable Combined injectable 1.14 0.95 1.02 Increased risk Equal risk Decreased risk Relative Risk

28. Return to Fertility After Stopping DMPA Use Source : Tieng, 1982. 0 20 40 60 80 100 04812162024 Oral Contraceptives (0=last pill taken) IUD (0=device removed) DMPA (0=15 weeks after last injection) Months After Stopping Contraceptive Percent of Women Having Conceived

30. Eligibility Criteria WHO (1996 Classifications) (known conditions) Classification of known Conditions Definitions 1No restriction of use 2Benefits generally outweighs the risk 3Risks generally outweighs the benefits 4Unacceptable health risks

32. Women Who Can Use COCs Without Restriction  Adolescents  Nulliparous women  Postpartum (3 weeks, if not breastfeeding)  Immediately Postabortion  Women with varicose veins  Any weight (including obese) Source: WHO, Medical Eligibility Criteria for Contraceptive Use. Second Edition, 2000. ( Selected examples )

33. Women Who Should Not Use COCs  Breastfeeding (<6 weeks postpartum).  Smoke heavily AND are over age 35.  At increased risk of cardiovascular disease.  Have certain pre-existing conditions (breast cancer, liver tumors or cancer).  Pregnant*. Source: WHO, Medical Eligibility Criteria for Contraceptive Use. Second Edition, 2000. *No proven effects on the fetus, if taken accidentally during pregnancy (Selected examples)

34. What Procedures Do You Need To Do Before Prescribing Contraceptive Methods?

35. Clinical Procedures to Be Done Before Providing a Method of Contraception Class A essential and mandatory in all circumstances for safe and effective use of the contraceptive method Class B Contributes substantially to safe and effective use, but implementation may be considered within the public health and/or service context. The risk of not performing an examination or test should be balanced against the benefits of making the contraceptive method available Class C does not contribute substantially to safe and effective use of the contraceptive method.

36. How Can You Be Reasonably Sure A Woman is Not Pregnant  has had no intercourse since last normal menses, or  is correctly and consistently using another method, or  is within first 7 days after onset of normal menses, or  is within 4 weeks postpartum (non-lactating women), or  is within first 7 days postabortion, or  is amenorrheic, fully breastfeeding and less than 6 months postpartum Source: Recommendation for Updating Selected Practices in Contraceptive Use, 1994. You can be reasonably sure if she has no symptoms or signs of pregnancy, and:

37. Clinical Procedures Before Providing A Hormonal Method Of Contraception No examination or tests are considered essential and mandatory in all circumstances for safe and effective use of any of the hormonal contraceptive methods (excluding LNG-IUD) It is desirable to have blood pressure measurements taken before initiation. However, in settings where pregnancy morbidity and mortality are high women should not be denied use of hormonal methods simply because their blood pressure can not be measured. Source: Selected Practice Recommendations for Contraceptive Use.

38. Clinical Procedures Before Providing A Non-hormonal Method The only clinical procedures considered essential and mandatory in all circumstances are a.Pelvic and genital examination before providing IUDs, diaphragm/cervical cap, female and male sterilization b.STI assessment before providing IUDs c.Blood pressure screening before female sterilization Source: Selected Practice Recommendations for Contraceptive Use

39. u WHO Eligibility Criteria u USAID Recommendations for Updating Selected Practices in Contraceptive Use u JHPIEGO Infection Prevention reference manual u CPI guidance documents Evidence Based and Updated Guidelines

42. Thank you