1. 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

2. 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)

3. POSTCOITAL EMERGENCY CONTRACEPTION ( Yuzpe, 1974)

4. 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 Should Oral Contraceptives Be Sold Over the-Counter?

5. OC - OTC PROS

6. OC - OTC OC - OTC Easier to achieve More users Less unwanted pregnanciesLess abortions Lower maternal morbidity and mortality

7. WORLDWIDE STATISTICS  >1 of 2 pregnancies are unwanted  Induced abortions >50x10 6 /year  Maternal mortality - 600,000/year

8. GYNECOLOGICAL EXAMINATION - INCONVENIENT EXPERIENCE

9. DR. OC-OTC On vacation until …..

10. 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

11.  Various OC - no differences  Deleterious effect - minimal/reversible  Follow-up - limited

12. SEVERE COMPLICATIONS WITH OC ARE RARE  Venous thrombosis - 6/10,000 (Without OC - 3/10,000) (Without OC - 3/10,000)  Unavoidable

13. THE ROLE OF THE PHYSICIAN  Expensive  Sex is not a disease

14. OC - OTC — CONS  Counseling for reproduction and sexual health  Avoidance of counseling for family planning, reproduction and sexual health

15. OC - OTC — CONS No counseling - Higher dropout

16. OC CONTRAINDICATIONS  Thrombophlebitis  Breast cancer  Cervical, endometrial and ovarian cancer  Focal migraine  Smokers >35 years of age

17. OC - DIFFERENT EFFECTS EstrogensProgesteronesAndrogens

18.  Gynecological counseling  Gynecological examination can be avoided, especially in adolescents

19. OC FOLLOW-UP : IMPORTANCE  Over 35 years of age  Smokers  Hypertension  Diabetes  Hyperlipidemia

20. ATTITUDE OF FEMALE COLLEGE STUDENTS TOWARDS AVAILABILITY OF OC OTC Forman et al. (1997)

21. No. - 290 Age - 20 ± 3 84% - previous sexual intercourse Age at first sexual encounter - 16.6 ± 2 52% used OC at first encounter

22. 65% - against OC-OTC  Side effects could be prevented  Users would not go for regular checkups 35% - pro OC-OTC  Fewer unwanted pregnancies

23. OC - OTC : PROS and CONS  Not significant: –Race –Previous OC use –Previous sexual activity  Significant: –A previous pregnancy (Pro )

24. Should Oral Contraceptives Be Sold Over the-Counter? Potential Advantages  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 Potential Disadvantages  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

25. OC - OTC  Population, social and religious attitude  Availability of local family planning service  Availability of providers

26. 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

27. Conclusion Better access to physicians might be the best way to Establish the OC as the main and most efficacious Contraceptive method

28. So….should it be prescribed, or OTC? THE END