Emergency contraceptives (EC)
Emergency contraceptives is a term that refers to methods of preventing pregnancy after unprotected sexual intercourse. “Plan B,” one brand of hormonal emergency contraceptive, was approved for OTC sales to women 18 and older on August 24, 2006. Women younger than 18 will still need a prescription to acquire the product. The FDA announcement follows:
FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older: Prescription Remains Required for Those 17 and Under
August 24, 2006
The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older. Plan B is often referred to as emergency contraception or the “morning after pill.” It contains an ingredient used in prescription birth control pills–only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under.
Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. In the CARE (Convenient Access, Responsible Education) program Duramed commits to:
- Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;
- Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;
- Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and
- Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.
Today’s action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with
the application to switch Plan B to OTC use. Duramed’s application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception,but for different populations, in a single package.
Additional information about emergency contraception:
It is important to emphasize to users that emergency contraceptives do not protect against sexually transmitted infections. Emergency contraception can be used when a condom breaks, after a sexual assault, or any time unprotected sexual intercourse occurs. Emergency contraceptives available in the United States include emergency contraceptive pills and the copper-T intrauterine device. (Contraceptive pills packaged specifically for use as EC are Preven and Plan B; however, other pills may be used as well.) The availability of these methods are not well known to women, nor to all providers of health care. There are several sites which provide information and referrals for emergency contraception. The Emergency Contraception World Wide Web server is operated by the Office of Population Research at Princeton University and funded through generous foundation support. This server is designed to provide accurate information about emergency contraception derived from the medical literature and a directory of clinicians willing to provide emergency contraceptives. More information on EC as well as other forms of contraception is offered by Planned Parenthood of America, which is running a public awareness campaign about EC. The announcements remind viewers that “accidents happen” and, in the case of unprotected sex, it may not be too late to prevent a pregnancy.
If you need to provide emergency contraception and have difficulty getting the pills packaged specifically for this purpose, you can use any of the following pills: the patient needs to take 2 doses of the number of pills below, 12 hours apart:
|Brand||Pills per dose||Ethinyl Estradiol /Levonorgestrel per dose|
|Ovral||2 white pills||100/0.50|
|Alesse||5 pink pills||100/0.50|
|Levlite||5 pink pills||100/0.50|
|Nordette||4 light-orange pills||120/0.60|
|Levlen||4 light-orange pills||120/0.60|
|Levora||4 white pills||120/0.60|
|LoOvral||4 white pills||120/0.60|
|Triphasil||4 yellow pills||120/0.50|
|Tri-Levlen||4 yellow pills||120/0.50|
|Trivora||4 pink pills||120/0.50|
|Ovrette||20 yellow pills||0/0.75|