Presentation on theme: "The “Morning After Pill” should not be readily available over the counter. Natalie Vander Kelen Jere Whitbred Lindsey Yunck."— Presentation transcript:
The “Morning After Pill” should not be readily available over the counter. Natalie Vander Kelen Jere Whitbred Lindsey Yunck
Defining our terms: Birth Control – the use of any practices, methods, or devices in order to prevent pregnancy. – Condoms – Birth control pills, patches, shots – Emergency Contraception – Abortion
Defining our terms continued: Abortion – the removal of an embryo or fetus from the uterus in order to end a pregnancy – Abortion pill: taken up to 9 weeks after first day of a woman’s last period (COST: $350-$650) – In-clinic abortion: most common is aspiration (use of a medical vacuum), preformed no later than 16 weeks (COST: $350-$900) – D&E (Dilation and Evacuation): preformed no later than 16 weeks, after 24 weeks this procedure is only preformed for serious health risks
Defining our terms continued: “Morning-after-pill” –an oral drug usually containing high doses of estrogen (birth control) that interferes with pregnancy by blocking implantation of a fertilized egg in the human uterus – Plan B – Preven
History of Women’s Heath Biblical Book of Genesis – oldest recorded reference to birth control. Coitus interrupts also know as the “withdraw method” or “pull-out method” 384-322 B.C. – Aristotle is the first person to mention the use of spermicides 1839 – Charles Goodyear invents the technology, “to vulcanize rubber and puts it to use manufacturing condoms (American Experience)
Fertilization of the Sea Urchin In 1875 Oscar Hartwig observed the fertilization of the Sea Urchin (208 Bullough ).
Fertilization of a Human Egg A year after Oscar Hartwig observed the fertilization of the Sea Urchin, Herman Fol observed a human egg being fertilized (208 Bullough).
History of Women’s Health Continued: In 1876, “Scientists conclude defiantly that for human fertilization to occur there must be a union of the egg and the sperm” (American Experience). In 1954 the birth control that we still use today was developed (American Experience).
History of Women’s Health Continued: September 1998: the U.S. Food and Drug Administration approved Pre-vent, the first emergency contraception product. The kit contained: – A detailed patient information booklet – Pregnancy test – Emergency contraception pills
History of women’s health continued: After the release of Pre-vent in 1998 many companies and governments pushed for more options of emergency contraception There are over 100 versions of the “morning after pill” – Ranging from taking 1 pill to over 50 pills – Plan B is most common form of emergency contraception in the United States
History of Plan B in the United States May 1999 - Plan B approved as Rx (prescription) drug by the U.S. Food and Drug Administration (FDA) April 2003 – application submitted to switch Plan B from Rx to over the counter (OTC) May 2004 – application rejected by FDA for lack of data of females younger than 16 June 2004 – Congress requests that FDA does not make the switch
History of Plan B in the United States continued: August 2005 – FDA announced that Plan B is safe for OTC use for women 17 and older, but still has three main concerns: 1.Can Plan B be both Rx and OTC depending upon age? 2.Can Rx and OTC versions of Plan B be marketed in the same package? 3.Can an age restriction for Plan B be enforced?
History of Plan B in the United States continued: August 24, 2006 – FDA approves making Plan B available OTC to women 18 and older and Rx to women aged 17 and younger November 2006 – Plan B begins shipping to pharmacies April 22, 2009 - The FDA announces that Plan B may be sold OTC to women and men aged 17 and younger without a prescription
Plan B One-Step Most common today in the United States “The only single tablet, single dose emergency contraception available in just one pill. It can help prevent pregnancy up to 72 hours (3 days) after unprotected sex or contraceptive failure” (Plan B One Step).
Plan B One-Step Molecular Structure The Plan B One-Step tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18, 19-Dinopregn-4-en-20- yn-3-one-13-ethyl-17-hydroxy-, (17a)-(-)-], a totally synthetic progestogen. The inactive ingredients are colloidal silicon dioxide, cornstarch, lactose monohydrate, magnesium stearte, potato starch, and talc. Levonorgestrel has a molecular weight of 312.45, and the following structural molecular formulas: VIDEO
Plan B One-Step’s Effectiveness FDA and Plan B claim Plan B One-Step is 89% effective in preventing pregnancy if used correctly Many obstetricians and gynecologist disagree with their percent of effectiveness. – “When you base effectiveness on use throughout the month, without considering the day of the cycle, the results are misleading,” (Dr. Hager).
Does every woman need emergency contraception after unprotected sex? “You can only get pregnant on certain days of the month – around the time you ovulate. Typically, there are only about three to five days a month in which a woman can get pregnant. Unfortunately, most women looking for the morning-after-pill are panicked because they think the clock is ticking, and as a result they don’t take the time to evaluate their situation” (Option Line).
Unlimited Access to Emergency Contraception FDA states not to take Plan B more than twice a month, however they allow unlimited access to it. Women are using Plan B up to five times per month on a regular basis. Some insurance companies cover emergency contraception, however they do not cover birth control.
Emergency Contraception around the World: CountryAvailability IrelandRequires a visit to a doctor or family- planning clinic RussiaRequires a prescription SpainRequires a visit to the doctor CanadaConsultation with a pharmacist United KingdomAvailable OTC to women only 16 & older RomaniaRequires a medical prescription ItalyRequires a medical prescription FinlandAvailable without a prescription, but only 1 pack may be purchased at a time United StatesAvailable without prescription to men and women 17 and older with no limitations
Plan B One-Step’s Adverse Reactions Most Common Adverse EventsPlan B One-Step N = 1,359 (%) Heavier menstrual bleeding30.9 Nausea13.7 Lower abdominal pain13.3 Fatigue13.3 Headache10.3 Dizziness9.6 Breast tenderness8.2 Delay of menses ( > 7 days)4.5 U.S. Food and Drug Administration
Plan B One-Step’s Adverse Reactions Plan B One-Step should not be taken more than two times per month (FDA). FDA does not list adverse reactions that occur in less than 4% of women or that occur when taken more than the recommended usage. – Internal bleeding – Ectopic Pregnancy – Alter the endometrium
Plan B One-Step & Ectopic Pregnancy “Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic” (FDA).
FDA Warning: Ectopic Pregnancy “Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Plan B One-Step, in order to be evaluated for an ectopic pregnancy.”
Plan B One-Step and Altering the Endometrium The FDA claims Plan B One-Step is "not effective if a woman is pregnant", will not "harm an unborn fetus," and "is not an abortifacient.” However, they also state that Plan B may inhibit implantation by altering the endometrium [i.e. the lining of the womb]. – In other words, this may cause an embryo to be expelled, causing the embryo to die
Emergency Contraception and STD’s Statistics from the United Kingdom four years after the “morning after pill” was distributed without a prescription: Sexually Transmitted DiseasePercent ChlamydiaUp 76% GonorrheaUp 55% SyphilisUp 54% Genital WartsUp 20%
Emergency Contraception and Preventing Unplanned Pregnancy Teenage pregnancy in Scottish schools among 13- 15 year olds rose 10 percent in one year with increased access to the morning-after-pill Scotland reported the highest number of abortions in 2006 since abortion was legalized in 1967 in their country Abortions rose by 6,000 in a year after the morning after pill was made available without a prescription. The largest leap was among girls younger than 16 years old.
Emergency Conception and Pharmacists Knowledge In conjunction with Planned Parenthood of Nassau County, Save Our Services Long Island surveyed 176 pharmacists on their knowledge of the morning after pill – 24% of them could not full describe the effects of emergency contraception on the body – 52% of the 176 pharmacists could not even technically describe emergency contraception – 5% of them confused emergency contraception with RU- 486 or the abortion pill (a pill that induces an abortion once a female is already pregnant)
Emergency Conception and Pharmacists Knowledge Continued: “If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to discuss whether to take another tablet.” – Most likely the pill was received from a pharmacists who may have a limited knowledge of the pill
Emergency Conception and Pharmacists Views All pharmacies in the United States are required to stock and distribute emergency contraception to any one over the age of 17 without a prescription with no limitations – After many pharmacists refused to distribute emergency contraception due to religious beliefs the 9 th Circuit panel declared, “the right to freely exercise one’s religion does not relieve an individual of the obligation to comply with a valid and neutral law of general applicability”
Future of Emergency Contraception Several studies have found that prescribing emergency contraception in advance increases the likelihood of young women's and teens' use of emergency contraception when needed. – Limitations on bulk purchases of Plan B
Vivian M. Dickerson, MD, President of The American College of Obstetricians and Gynecologists “FDA leaders bear significant responsibility for public health failure to reduce these [unintended pregnancy and abortion] rates if they fail to consider sound scientific evidence. Given the accumulating sound scientific evidence that over the counter access to emergency contraception doesn’t impact unintended pregnancy or abortion rates, this accusation is simply reckless rhetoric and political grandstanding. Further, to continue to claim that over the counter access will cut unintended pregnancy rates and abortions in half, when sound scientific evidence exists to the contrary, is to betray public trust.”