Why Contraception? Why Over The Counter?

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Why Contraception? Why Over The Counter? Christopher M. Zahn, MD Vice President, Practice Activities American College of Obstetricians and Gynecologists July 17, 2015 About ACOG The American Congress of Obstetricians and Gynecologists (ACOG) is the nation s leading group of physicians providing health care for women. With more than 58,000 members, ACOG strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women s health care. 1

Benefits of Contraception Optimizes preconception health Allows for needed care prior to pregnancy to help improve birth outcomes (e.g. diabetes, folate deficiency) Lowers risk of unplanned pregnancy Reduces need for abortion Benefits of Contraception Optimizes inter-pregnancy interval (birth spacing) Too short of time between pregnancies associated with: Low birthweight Premature rupture of membranes Preterm birth Anomalies Stillbirth Placental abruption Autism 2

Other Considerations: Non-Contraceptive Benefits Decreased risk of endometrial and ovarian cancer Reduced anemia secondary to heavy menses (bleeding) Improvement in dysmenorrhea (painful menses) Decreased pain in women with endometriosis Decreased risk of ectopic pregnancy Decreased symptoms from premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) Effects on hirsutism and polycystic ovarian syndrome (PCOS) That s Why ACOG Supports Health Insurance Covering Full Range of Contraceptives Without Patient Cost-Sharing Title X Family Planning Programs 6 3

ACOG Guidance Several documents specifically address contraception and over-the-counter aspects Committee Opinion #544, Over-the-Counter Access to Oral Contraceptives Clinical guidance Safety Adherence and continuation Preventive services Committee Opinion #615, Access to Contraception Several separate statements Clinical guidance regarding contraceptives in general also applicable By prescription and OTC Background Unintended pregnancy rate estimated at 50% Huge economic impact $11.1 billion (or greater) annually Many factors associated with unintended pregnancy Access and cost are common contributing factors 4

Interest in OTC Several studies demonstrate interest among women at risk of unintended pregnancy Includes uninsured and low-income groups Pharmacists also interested in provision of contraceptives Safety Venous thromboembolism Increased risk, BUT overall risk very low even with OC use Lower than risk in pregnancy Screening for contraindications Data supports non-physicians, including patients and pharmacists, can effectively screen Patients self-screening: reports of accuracy approach 90% No significant differences between provider and non-provider screening 5

Adherence and continuation Data supports higher continuation rates among those with improved access Greater with multiple pill packs Use of preventive services Fear that preventive services will not be used STI and cervical cancer screening not required for contraception provision Data supports that OC users from clinical and out-ofcountry pharmacies both had higher screening rates than national screening rates 6

Cost Studies have evaluated out-of-pocket costs and use Also insurance coverage Out-of-pocket costs need to be considered due to effect on access ACOG Committee Opinion #615 From the Committee on Health Care for Underserved Women (January 2015) Addresses many issues surrounding contraception, including barriers Supports ACA implementation regarding insurance coverage Including funding for low-income women; adolescents Also addresses barriers regarding education, cost, insurance coverage Supports OTC access with full insurance coverage 7

Contraceptive Access: Fear of Sexual Activity Common misperception: increased access will result in greater prevalence of high risk sexual behavior Number of partners Risk of STI s Not using barrier methods Disproven with OTC emergency contraceptive access No increase in high-risk behavior No reason to think that OTC access should be any different ACOG Statements Support of FDA approval for OTC emergency contraception (May 2013) AOCG support of contraceptive coverage (November 2013) Employers should not interfere in women s access to contraceptive coverage ACOG Statement on OTC Access to Contraception (September 2014) Support OTC as strategy to increase access and use ACOG Position on Over-the Counter Access To and Insurance Coverage of Oral Contraceptives (June 2015) Supports ACA requirement for insurances to cover FDA-approved contraceptives Supports FDA approval of OTC availability Extend ACA provision to coverage of OTC OC without costsharing 8

ACOG Endorsement of CDC Recommendations US Medical Eligibility Criteria (US MEC) (2010): Patterned after WHO recommendations Guidance for counseling regarding safety Particularly in settings of specific characteristic and medical conditions Evidence-based list of contraindications that ACOG endorses Agreement on contraindications for non-provider screening US Selected Practice Recommendations (US SPR) for Contraceptive Use (2013): Addresses common and complex management issues related to contraceptive methods Addresses barriers and removal of barriers Adapted from WHO recommendations ACOG endorses and encourages its use OTC Access: Summary Safe? Interest? Non-physicians can screen? Adherence and continuation? No effect on preventive services? Interest? 9