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ORAL CONTRACEPTION (OC) OVER THE COUNTER (OTC)? Arie Yeshaya, M.D. Pediatric Adolescent Clinic Schneider Children’s Hospital and Department of Obstetrics and Gynecology Rabin Medical Center, Petah Tikva, Israel OC - OTC ?  The pill off prescription? (Lester, 1974)  The pill without prescription (Winaver, 1975)  OC without prescription (Houghton, 1993)  Making OC available over the counter (Youngkin et al. 1996) POSTCOITAL EMERGENCY CONTRACEPTION (Yuzpe, 1974) Should Oral Contraceptives Be Sold Over the-Counter? A prescription drug should be switched to over the counter Status if: The drug is safe for self medication The drug is effective when self administered The condition to be treated is self diagnosable The drug’s labeling is tailored to self administration OC - OTC PROS OC - OTC Easier to achieve More users Less unwanted pregnancies Less abortions Lower maternal morbidity and mortality WORLDWIDE STATISTICS  >1 of 2 pregnancies are unwanted  Induced abortions >50x106/year  Maternal mortality 600,000/year GYNECOLOGICAL EXAMINATION INCONVENIENT EXPERIENCE DR. OC-OTC On vacation until ….. NON-CONTRACEPTIVE BENEFITS OF OC Reduction in:       Ovarian cancer Endometrial cancer PID Ectopic pregnancy Anemia Dysmenorrhea       Functional ovarian cysts Benign breast disease Acne Hirsutism Irregular menses Menorrhagia  Various OC - no differences  Deleterious effect minimal/reversible  Follow-up - limited SEVERE COMPLICATIONS WITH OC ARE RARE  Venous thrombosis - 6/10,000 (Without OC - 3/10,000)  Unavoidable THE ROLE OF THE PHYSICIAN  Expensive  Sex is not a disease OC - OTC — CONS  Counseling for reproduction and sexual health  Avoidance of counseling for family planning, reproduction and sexual health OC - OTC — CONS No counseling Higher dropout OC CONTRAINDICATIONS  Thrombophlebitis  Breast cancer  Cervical, endometrial and ovarian cancer  Focal migraine  Smokers >35 years of age OC - DIFFERENT EFFECTS Estrogens Progesterones Androgens  Gynecological counseling  Gynecological examination can be avoided, especially in adolescents OC FOLLOW-UP : IMPORTANCE  Over 35 years of age  Smokers  Hypertension  Diabetes  Hyperlipidemia ATTITUDE OF FEMALE COLLEGE STUDENTS TOWARDS AVAILABILITY OF OC OTC Forman et al. (1997) No. - 290 Age - 20 ± 3 84% - previous sexual intercourse Age at first sexual encounter 16.6 ± 2 52% used OC at first encounter 65% - against OC-OTC  Side effects could be prevented  Users would not go for regular checkups 35% - pro OC-OTC  Fewer unwanted pregnancies OC - OTC : PROS and CONS  Not significant: –Race –Previous OC use –Previous sexual activity  Significant: –A previous pregnancy (Pro) Should Oral Contraceptives Be Sold Over the-Counter? Potential Advantages Potential Disadvantages       Increased access to affective birth control for all women Increased access for younger women, the prime users of OCs Reduced rate of unintended pregnancies Cost savings from reduction of physician and family planning clinic visits Encouragement of the national trend toward self-care      Increased rate of unintended pregnancies due to unproper use of OCs Reduced OC compliance because of lack of counseling and management of nuisance side effects Increase in liability due to errors in self-prescribing Possible cost increases for Medicaid and family planning clinic patients Possible price increases due to the costs of marketing to consumers Reduced opportunities for preventive medical care OC - OTC  Population, social and religious attitude  Availability of local family planning service  Availability of providers Conclusion In order to expand OCs use: Reinforce the activity of family planning Clinics Facilitate public access to professionals Instituting charge free visits Organizing visits to schools Conclusion Better access to physicians might be the best way to Establish the OC as the main and most efficacious Contraceptive method So….should it be prescribed, or OTC? THE END