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

Arie Yeshaya, M.D.Arie Yeshaya, M.D.Pediatric Adolescent ClinicPediatric Adolescent Clinic

Schneider Children’s HospitalSchneider Children’s Hospitalandand

Department of Obstetrics and GynecologyDepartment of Obstetrics and GynecologyRabin Medical Center, Petah Tikva, IsraelRabin Medical Center, Petah Tikva, Israel

OC - OTC ?OC - OTC ?

The pill off prescription? (The pill off prescription? (Lester, 1974Lester, 1974))

The pill without prescription (The pill without prescription (Winaver,Winaver, 19751975))

OC without prescription (OC without prescription (Houghton, 1993)Houghton, 1993)

Making OC available over the counter Making OC available over the counter

( (Youngkin et al. 1996Youngkin et al. 1996))

POSTCOITAL EMERGENCY POSTCOITAL EMERGENCY CONTRACEPTIONCONTRACEPTION

((Yuzpe, 1974Yuzpe, 1974))

A prescription drug should be switched toover the counter Status if:

The drug is safe for self medicationThe drug is effective when self administeredThe condition to be treated is self diagnosableThe drug’s labeling is tailored to self administration

Should Oral Contraceptives Be Sold Over the-Counter?

OC - OTCOC - OTCPROSPROS

OC - OTCOC - OTC

Easier to achieveEasier to achieve

More usersMore users

Less unwanted pregnanciesLess unwanted pregnancies Less abortionsLess abortions

Lower maternal morbidity and mortalityLower maternal morbidity and mortality

WORLDWIDE STATISTICSWORLDWIDE STATISTICS

>1 of 2 pregnancies >1 of 2 pregnancies are unwantedare unwanted

Induced abortions Induced abortions >50x10>50x1066/year/year

Maternal mortality - Maternal mortality - 600,000/year600,000/year

GYNECOLOGICAL EXAMINATION -GYNECOLOGICAL EXAMINATION -

INCONVENIENT EXPERIENCEINCONVENIENT EXPERIENCE

DR. OC-OTCDR. OC-OTC

On vacation until …..On vacation until …..

NON-CONTRACEPTIVENON-CONTRACEPTIVE BENEFITS OF OC BENEFITS OF OC

Reduction in:Reduction in: Ovarian cancerOvarian cancer Endometrial cancerEndometrial cancer PIDPID Ectopic pregnancyEctopic pregnancy AnemiaAnemia DysmenorrheaDysmenorrhea

Functional ovarian cystsFunctional ovarian cysts Benign breast diseaseBenign breast disease AcneAcne HirsutismHirsutism Irregular mensesIrregular menses MenorrhagiaMenorrhagia

Various OC - no differencesVarious OC - no differences Deleterious effect - Deleterious effect - minimal/reversibleminimal/reversible Follow-up - limitedFollow-up - limited

SEVERE COMPLICATIONS SEVERE COMPLICATIONS WITH OC ARE RAREWITH OC ARE RARE

Venous thrombosis - 6/10,000Venous thrombosis - 6/10,000 (Without OC - 3/10,000)(Without OC - 3/10,000)

UnavoidableUnavoidable

THE ROLE OF THE PHYSICIANTHE ROLE OF THE PHYSICIAN

ExpensiveExpensive Sex is not a diseaseSex is not a disease

OC - OTC — CONSOC - OTC — CONS Counseling for reproduction and Counseling for reproduction and

sexual healthsexual health Avoidance of counseling for Avoidance of counseling for

family planning, reproduction family planning, reproduction and sexual health and sexual health

OC - OTC — CONSOC - OTC — CONSNo counseling - No counseling - Higher dropoutHigher dropout

OC CONTRAINDICATIONSOC CONTRAINDICATIONS

ThrombophlebitisThrombophlebitis Breast cancerBreast cancer Cervical, endometrial and ovarian Cervical, endometrial and ovarian

cancercancer Focal migraineFocal migraine Smokers >35 years of ageSmokers >35 years of age

OC - DIFFERENT EFFECTSOC - DIFFERENT EFFECTS

EstrogensEstrogensProgesteronesProgesteronesAndrogensAndrogens

Gynecological counselingGynecological counseling

Gynecological examination Gynecological examination can be avoided, can be avoided,

especially especially in adolescentsin adolescents

OC FOLLOW-UP : OC FOLLOW-UP : IMPORTANCEIMPORTANCE

Over 35 years of ageOver 35 years of age SmokersSmokers HypertensionHypertension DiabetesDiabetes HyperlipidemiaHyperlipidemia

ATTITUDE OF FEMALE COLLEGE ATTITUDE OF FEMALE COLLEGE STUDENTS TOWARDS AVAILABILITY OF OC STUDENTS TOWARDS AVAILABILITY OF OC

OTC OTC Forman et al. (1997)Forman et al. (1997)

No. - 290No. - 290Age - 20 ± 3Age - 20 ± 384% - previous sexual 84% - previous sexual intercourseintercourseAge at first sexual encounter - Age at first sexual encounter - 16.6 ± 216.6 ± 252% used OC at first encounter52% used OC at first encounter

65% - against OC-OTC65% - against OC-OTC Side effects could be preventedSide effects could be prevented Users would not go for regular checkupsUsers would not go for regular checkups

35% - pro OC-OTC35% - pro OC-OTC Fewer unwanted pregnanciesFewer unwanted pregnancies

OC - OTC : PROS and CONSOC - OTC : PROS and CONS

Not significant:Not significant:–RaceRace–Previous OC usePrevious OC use–Previous sexual activityPrevious sexual activity

Significant:Significant:–A previous pregnancy (ProA previous pregnancy (Pro))

Should Oral Contraceptives Be Should Oral Contraceptives Be Sold Over the-CounterSold Over the-Counter??

Potential AdvantagesPotential Advantages Increased access to affective Increased access to affective

birth control for all womenbirth control for all women Increased access for younger Increased access for younger

women, the prime users of women, the prime users of OCs OCs

Reduced rate of unintended Reduced rate of unintended pregnanciespregnancies

Cost savings from reduction of Cost savings from reduction of physician and family planning physician and family planning clinic visitsclinic visits

Encouragement of the national Encouragement of the national trend toward self-caretrend toward self-care

Potential DisadvantagesPotential Disadvantages Increased rate of unintended Increased rate of unintended

pregnancies due to unproper pregnancies due to unproper use of OCsuse of OCs

Reduced OC compliance Reduced OC compliance because of lack of counseling because of lack of counseling and management of nuisance and management of nuisance side effectsside effects

Increase in liability due to errors Increase in liability due to errors in self-prescribingin self-prescribing

Possible cost increases for Possible cost increases for Medicaid and family planning Medicaid and family planning clinic patientsclinic patients

Possible price increases due to Possible price increases due to the costs of marketing to the costs of marketing to consumersconsumers

Reduced opportunities for Reduced opportunities for preventive medical carepreventive medical care

OC - OTCOC - OTC Population, social and Population, social and religious attitudereligious attitude Availability of local family Availability of local family planning service planning service Availability of providersAvailability of providers

ConclusionIn order to expand OCs use:Reinforce the activity of family planning ClinicsFacilitate public access to professionalsInstituting charge free visitsOrganizing visits to schools

ConclusionBetter access to physicians might be the best way toEstablish the OC as the main and most efficaciousContraceptive method

So….should it be prescribed, So….should it be prescribed, or OTC?or OTC?

THE END