Emergency contraception

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]

Emergency contraception (EC), or emergency postcoital contraception, refers to contraceptive measures that, if taken after sex, may prevent pregnancy. As its name implies, EC is intended for occasional use, when primary means of contraception fail. Since EC methods act before implantation, they are medically and legally considered forms of contraception. Some pro-life groups define pregnancy as beginning with fertilization, and consider EC to be an abortifacient.

Interest in synthetic hormones as postcoital contraceptives originated several decades ago, with the first published study on the subject appearing in 1967.^[1] A few different drugs were studied, with a focus on high-dose estrogens, and it was originally hoped that postcoital contraception would prove viable as anongoing contraceptive method.^[2]

Emergency contraceptive pills (ECPs)—sometimes simply referred to as emergency contraceptives (ECs) or the morning-after pill —are drugs that act both to preventovulation or fertilization and possibly post-fertilization implantation of a blastocyst (embryo). Emergency contraceptive pills (sometimes referred to as emergency hormonal contraception (EHC) in the U.K.) may contain higher doses of the same hormones (estrogens, progestins, or both) found in regular combined oral contraceptive pills. Taken after unprotected sexual intercourse, such higher doses may prevent pregnancy from occurring.Mifepristone is another kind of ECP, but is considered an anti-hormonal drug, and does not contain estrogen or progestins. The phrase “morning-after pill” is figurative; ECPs are licensed for use up to 72 hours after sexual intercourse. ECPs are distinct from medical abortionmethods that act after implantation.^[3]

Intrauterine devices are usually used as a primary contraception method, but sometimes used as emergency contraception. The copper-T intrauterine device (IUD) can be used up to 5 days after unprotected intercourse to prevent pregnancy. Insertion of an IUD is more effective than use of Emergency Contraceptive Pills – pregnancy rates when used as emergency contraception are the same as with normal IUD use. IUDs may be left in place following the subsequent menstruation to provide ongoing contraception (3-10 years depending upon type).^[4]

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]

Interest in synthetic hormones as postcoital contraceptives originated several decades ago, with the first published study on the subject appearing in 1967.^[1] A few different drugs were studied, with a focus on high-dose estrogens, and it was originally hoped that postcoital contraception would prove viable as an ongoing contraceptive method.^[2]

• The first widely used methods were five-day treatments with high-dose estrogens, using diethylstilbestrol (DES) in the US and ethinyl estradiol in the Netherlands.^[3][4]

• In the early 1970s, the Yuzpe regimen was developed by AA Yuzpe (1974);^[5] progestin-only postcoital contraception was investigated (1975);^[6] and the copper IUD was first studied for use as emergency contraception (1975).^[7] Danazol was tested in the early 1980s in the hopes that it would have fewer side effects than Yuzpe, but was found to be ineffective.
• The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s.
• The first prescription-only combined estrogen-progestin dedicated product, Schering PC4 (ethinylestradiol and norgestrel), was approved in the UK in January 1984 and first marketed in October 1984. Schering introduced a second prescription-only combined product, Tetragynon (ethinylestradiol and levonorgestrel) in Germany in 1985.[3] By 1997, Schering AG dedicated prescription-only combined products had been approved in only 9 countries: the UK (Schering PC4), New Zealand (Schering PC4), South Africa (E-Gen-C), Germany (Tetragynon), Switzerland (Tetragynon), Denmark (Tetragynon), Norway (Tetragynon), Sweden (Tetragynon) and Finland (Neoprimavlar); and had been withdrawn from marketing in New Zealand in 1997 to prevent it being sold over-the-counter.[4][5][6]
• Regular combined oral contraceptive pills (which were less expensive and more widely available) were more commonly used for the Yuzpe regimen even in countries where dedicated products were available. Certain combined oral contraceptives for use as postcoital emergency contraception.
• Over time, interest in progestin-only treatments increased. The Special Program on Human Reproduction (HRP), an international organization whose members include the World Bank and World Health Organization, “played a pioneering role in emergency contraception” by “confirming the effectiveness of levonorgestrel.”^[8]
• After the WHO conducted a large trial comparing Yuzpe and levonorgestrel in 1998,^[9][10] combined estrogen-progestin products were gradually withdrawn from some markets (Preven in the United States discontinued May 2004, Schering PC4 in the UK discontinued October 2001, and Tetragynon in France) in favor of progestin-only EC, although prescription-only dedicated Yuzpe regimen products are still available in some countries.
• In 2002, China became the first country in which mifepristone was registered for use as EC.

• In 1971, a New England Journal of Medicine editorial calling attention to previously published studies on the use of DES as a postcoital contraceptive at Yale University, and a large study published in JAMA on the use of DES as a postcoital contraceptive at the University of Michigan, led to off-label use of DES as a postcoital contraceptive becoming prevalent at many university health services.
• In May 1973, in an attempt to restrict off-label use of DES as a postcoital contraceptive to emergency situations such as rape, a FDA Drug Bulletin was sent to all U.S. physicians and pharmacists that said the FDA had approved, under restricted conditions, postcoital contraceptive use of DES. (In February 1975, the FDA Commissioner testified that the only error in the May 1973 FDA Drug Bulletin was that the FDA had not approved postcoital contraceptive use of DES.)
• In September 1973, the FDA published a proposed rule specifying patient labeling and special packaging requirements for any manufacturer seeking FDA approval to market DES as a postcoital contraceptive, inviting manufacturers to submit abbreviated new drug applications (ANDAs) for that indication, and notifying manufacturers that the FDA intended to order the withdrawal of DES 25 mg tablets (which were being used off-label as postcoital contraceptives).
• In late 1973, Eli Lilly, the largest U.S. manufacturer of DES, discontinued its DES 25 mg tablets and in March 1974 sent a letter to all U.S. physicians and pharmacists telling them it did not recommend use of DES as a postcoital contraceptive.
• Only one pharmaceutical company, Tablicaps, Inc., a small manufacturer of generic drugs, ever submitted (in January 1974) an ANDA for use of DES as an emergency postcoital contraceptive, and the FDA never approved it.
• In February 1975, the FDA said it had not yet approved DES as a postcoital contraceptive, but would after March 8, 1975 permit marketing of DES for that indication in emergency situations such as rape or incest if a manufacturer obtained an approved ANDA that provided patient labeling and special packaging as set out in a FDA final rule published in February 1975. To discourage off-label use of DES as a postcoital contraceptive, in February 1975 the FDA ordered DES 25 mg (and higher) tablets removed from the market and ordered the labeling of lower doses (5 mg and lower) of DES still approved for other indications be changed to state: “THIS DRUG PRODUCT SHOULD NOT BE USED AS A POSTCOITAL CONTRACEPTIVE” in block capital letters on the first line of the physician prescribing information package insert and in a prominent and conspicuous location of the container and carton label.
• In March 1978, a FDA Drug Bulletin was sent to all U.S. physicians and pharmacists which said: “FDA has not yet given approval for any manufacturer to market DES as a postcoital contraceptive. The Agency, however, will approve this indication for emergency situations such as rape or incest if a manufacturer provides patient labeling and special packaging. To discourage ‘morning after’ use of DES without patient labeling, FDA has removed from the market the 25 mg tablets of DES, formerly used for this purpose.”
• In the 1980s, off-label use of the Yuzpe regimen superseded off-label use of DES for postcoital contraception.
• DES is no longer commercially available in the U.S.; Eli Lilly, the last U.S. manufacturer, ceased production in spring 1997.

• On February 25, 1997, the FDA posted a notice in the Federal Register saying it had concluded that the Yuzpe regimen was safe and effective for off-label use as postcoital EC, was prepared to accept NDAs for COCPs labeled as ECPs, and listed 6 then available COCPs (there are now 22) that could be used as ECPs.
• On September 1, 1998, the FDA approved the prescription Yuzpe regimen Preven Emergency Contraception Kit (which contained a urine pregnancy test and 4 COCPs). Preven was discontinued in May 2004.^[11]

• On July 28, 1999, the FDA approved the prescription progestin-only Plan B (two 750 µg levonorgestrel pills) emergency contraceptive.
• On August 24, 2006, the FDA approved nonprescription behind-the-counter access to Plan B from pharmacies staffed by a licensed pharmacist for women 18 or older; a prescription-only form of Plan B will remain available for young women aged 17 and younger.
• On November 6, 2006, Barr Pharmaceuticals announced that its subsidiary, Duramed Pharaceutials, had initiated shipment of dual-label Plan B OTC/Rx and it would be available in pharmacies across the U.S. by mid-November 2006.

• A great deal of controversy accompanied the FDA approval of over-the-counter (OTC) access to Plan B. Supporters of over-the-counter access believe that easier access will reduce unintended pregnancy and abortion rates; some pro-life opponents believe that EC itself is a form of abortion. The American Medical Association, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and other leading U.S. medical organizations all supported OTC access. An advisory committee to the FDA recommended that Plan B be made available over the counter in 2003. In 2004, the FDA refused the advisory board’s recommendation and prohibited over-the-counter sale, citing insufficient evidence that ECPs could be used safely by adolescents without medical supervision. Reproductive rights supporters accused the FDA of basing the decision on political pressure from the pro-life lobby. The Center for Reproductive Rights filed a lawsuit regarding the approval process, which has not been resolved as of December 2006. In the legal proceedings, two senior FDA officials have alleged in depositions that the decision to reject the OTC application was made on political, rather than scientific, grounds to “appease the administration’s constituents”. Depositions taken from other FDA officials do not indicate White House involvement. In 2006, the FDA approved over-the-counter access to Plan B for women 18 years of age and older.

• A Massachusetts law that went into effect on 14 December, 2005, requires all hospitals in the state to provide emergency contraception to any “female rape victim of childbearing age”^[12] including Catholic Hospitals who oppose the provision of emergency contraception. In a letter criticizing the joint UN/WHO Inter-agency Field Manual on Reproductive Health in Refugee Situations, the Catholic Church explains its belief that emergency contraception, along with IUDs and hormonal contraception, cannot be considered “solely contraceptive because in the case of effective fertilization a chemical abortion would be carried out during the first days of pregnancy. The Catholic position on family planning is explained further in Ethical and Religious Directives for Catholic Health Care Services.

• In isolated instances across the United States, pharmacists have refused to dispense emergency contraception even when presented with a legal prescription. In addition, Wal-Mart, the nation’s fifth-largest distributor of pharmaceuticals, refused to stock EC, beginning with Preven in 1999. However, Wal-Mart reversed this position when it was announced that stores would sell Plan B in March of 2006.^[13]

In 1995, the Rockefeller Foundation convened a meeting to discuss emergency contraception. After the meeting, a group of seven international organizations formed The International Consortium for Emergency Contraception (ICEC) to promote EC as a part of mainstream reproductive health care worldwide. Dedicated products for EC were “virtually unknown” in 1995, there was little awareness of EC as an option, and EC was not used as public health measure.

The seven founding member organizations were the Concept Foundation, the International Planned Parenthood Federation (IPPF), the Pacific Institute for Women’s Health, the World Health Organization (WHO), the Population Council, Population Services International, and the Program for Appropriate Technology in Health (PATH).

The Concept Foundation is the distribution arm of ICEC; its funding for the development of Postinor-2 came from the Rockefeller Foundation and the David and Lucile Packard Foundation, as well as the other ICEC organizations.

The Consortium helped promote the availability of EC by:

• Manufacturing an EC product. The ICEC worked with the Hungarian pharmaceutical firm Gedeon Richter to repackage its contraceptive Postinor as an emergency contraceptive, called Postinor-2. Distributing Postinor-2, principally in developing countries, was the primary work of the ICEC.
• Facilitating product registration in two ways. First, the ICEC encouraged interest in EC products through meetings with public-sector agencies and non-governmental organizations (NGOs) who they perceived would benefit from adding EC to the products they distribute. Second, by helping organizations applying for EC registration through the country-specific approval process, including lobbying of local leaders who may be influential in the registration decision.
• Negtiotiating a public-sector price. The ICEC’s agreement with Gedeon Richter provided a discount price at which EC could be obtained by public-sector agencies in developing countries.
• Marketing and social marketing.

An ICEC member organization, the International Planned Parenthood Federation (IPPF), has launched its own dedicated levonorgestrel EC product, Optinor.

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]

1. Emergency contraceptive pills

2. Intrauterine devices

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]

A number of studies in the 1970s and 80s concluded that emergency contraception could cause changes in the endometrium^[1] that would prevent implantation of an early-stage embryo in the uterus. This research led many pro-life advocates, who believe that pregnancy begins at fertilization, to oppose ECPs as an abortifacient.

In recent years–especially in light of U.S. ethical controversy over the research’s claims–the scientific community has begun to critically reevaluate the early studies, introducing doubt into the argument that ECPs prevent implantation. Recent studies in rats and monkeys have shown that post-ovulatory use of progestin-only and combined ECPs have no effect on pregnancy rates.^[2] Studies in humans have shown that the rate of ovulation suppression is approximately equal to the effectiveness of emergency contraceptive pills,^[3][4] suggesting that might be the only mechanism by which they prevent pregnancy.

However, these studies have also shown that, in women who ovulate despite taking ECP before ovulation, there are changes in certain hormones such as progesterone and in the length of luteal phase.^[3] These secondary changes might inhibit implantation in cases where fertilization occurs despite ECP use. Because of the difficulty of studying embryos inside the uterus and fallopian tubes prior to implantation, both sides of this debate concede that completely proving or disproving the theory may be impossible.

The Food and Drug Administration recently stopped its practice of referring to all three mechanisms in its publications on emergency contraception.

When used as a regular method of contraception, IUDs have been proven to act primarily through spermicidal and ovicidal mechanisms, but it is considered possible that these same mechanisms are also harmful to embryos that have not yet implanted.

Hormonal progestin-only and combined estrogen-progestin emergency contraceptives such as Yuzpe regimen or Plan B are different from the anti-hormonal drugmifepristone (also known as Mifeprex and RU-486), an abortifacient which can induce abortion if taken after implantation. Yuzpe and progestin-only emergency contraception will have no effect if taken after implantation.

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]

The current (October 2005) AAP Policy Statement on Emergency Contraception states: “The concern that widespread emergency contraception use would encourage unprotected coitus in teens is not supported in the literature.”

The current (December 2005) ACOG Practice Bulletin on Emergency Contraception states: “A prominent concern among both women and health care providers is that making emergency contraception more readily available could encourage irresponsible sexual behavior, which would increase the risks of both unintended pregnancy and sexually transmitted diseases. However, numerous studies have shown that this concern is unfounded.”

The latest (April 2007) review by emergency contraception experts Trussell and Raymond states: “Reported evidence demonstrates that making ECPs more widely available does not increase risk-taking^{[1][2][3][4][5][6][7][8][9][10]} and that women who are the most diligent about ongoing contraceptive use are those most likely to seek emergency treatment.”^[11]

However, the availability of ECPs has not been shown to lower abortion rates. In France, Sweden, and Britain—where Yuzpe-regimen EC had been available by prescription for more than a decade and progestin-only EC has been available without a prescription for 8, 6, and 2 years respectively—the abortion rate was stable or higher during that time period. Another study concluded that distribution of free, advance supplies of EC to large numbers of women in Scotland did not reduce abortion rates.^[12] A randomized controlled trial of 2000 women in China compared women with advance access to EC to women without access, and noted that the pregnancy rate was the same between the two groups. The study observed that “…providing EC in advance increases use, but there is no direct evidence that it reduces unintended pregnancy” and concluded that EC may not lower abortion rates.^[13]

In September 2006, emergency contraception expert Anna Glasier wrote a BMJ editorial entitled “Emergency Contraception. Is it worth all the fuss?” that said in closing: “So is emergency contraception worth the fuss? If you are a woman who has had unprotected sex then of course it is, because emergency contraception will prevent pregnancy in some women some of the time—and if you don’t want to get pregnant anything is better than nothing. If you are the CMAJ’s editor or FDA commissioner then yes, because scientific freedom is worth the fight. If you are looking for an intervention that will reduce abortion rates, emergency contraception may not be the solution, and perhaps you should concentrate most on encouraging people to use contraception before or during sex, not after it.”^[14]

Before EC was used in the general population or defined as “emergency contraception,” it was used, beginning in the 1960s and 70s, specifically as a treatment for victims of sexual assault.^[15][16] Although EC is in wide use as an option for victims of sexual assault, some researchers believe it is underutilized as a public health measure.^[17] Abortions because of rape account for less than one percent of all annual abortions.^[18]

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