ORAL CONTRACEPTION (OC) - OVER THE COUNTER (OTC)?

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 - OTCPROS

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 …..

Reduction in: Ovarian cancer Endometrial cancer PID Ectopic pregnancy Anemia Dysmenorrhea Functional ovarian cysts Benign breast disease Acne Hirsutism Irregular menses Menorrhagia NON-CONTRACEPTIVE BENEFITS OF OC

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)

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 Should Oral Contraceptives Be Sold Over the-Counter?

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

ORAL CONTRACEPTION (OC) - OVER THE COUNTER (OTC)?