The morning-after pill is the slang term for a hormonally effective preparation for post- coital contraception that can prevent unwanted pregnancy after sexual intercourse . The active substances are the progestin derivative levonorgestrel or the progesterone receptor modulator ulipristal acetate . The morning- after pill must be taken as early as possible after unprotected sexual intercourse within a period depending on the drug. These drugs are not suitable for regular contraception and interfere with the natural menstrual cycle .
The morning-after pill has been available in Germany without a prescription since March 14, 2015 . Over-the-counter emergency contraceptives can be purchased and used by adolescents aged 14 and over without the consent of their legal guardians . In the United States , such products are freely sold under trade names such as Plan B and take action not only in pharmacies and drug stores, but also in supermarkets.
“The pill” without the addition “afterwards”, on the other hand, is the most common slang term for the contraceptive pill , which must be taken daily from the beginning of the female cycle (from the 1st day of menstruation) in order to be effective.
The morning-after pill should not be confused with the so-called "abortion pill", which contains mifepristone as an active ingredient .
A subsequent IUD is possible up to five days after unprotected sexual intercourse at the latest.
Mode of action
The mode of action of the morning-after pill is dominated by its ovulation-inhibiting effect. In addition, other mechanisms such as sperm obstruction are also discussed. An inhibition of the nidation (implantation) of an already fertilized egg cell is discussed, especially with ulipristal acetate. The effect against already fertilized egg cells is essential for the ethical attitude of many people towards these preparations.
Mechanism of action
The effectiveness of levonorgestrel depends on when it is taken, which must follow no later than 72 hours (three days) after sexual intercourse. The earlier it is taken, the more likely it is to prevent a possible pregnancy. If the first dose is taken within 24 hours, the pregnancy rate is approximately 0.6%. If the morning-after pill is first taken on the second day after intercourse, the pregnancy rate is around 1.2% and 2.7% if taken on the third day.
The exact mechanism of action of the active ingredients is not fully understood. As the main action of the morning-after pill in the medical literature is the prevention of ovulation (ovulation) indicated, that is the ovulatory effect. If the effect is limited to that, it could not prevent pregnancy if the morning-after pill is taken after ovulation.
Ovulation is the prerequisite for fertilization of the egg by a sperm . The maturation of the egg cell and ovulation are controlled by hormones . A sudden increase in the concentration of luteinizing hormone (LH) in the blood triggers ovulation about 14 to 16 days before the next menstruation. Hormones from the group of progestins inhibit the release of LH. Levonorgestrel - the active ingredient in the morning-after pill - is an artificially produced gestagen that specifically prevents the release of LH and thus ovulation. If the LH surge has already occurred (12 to 24 hours before ovulation), levonorgestrel no longer has any influence on the final maturation of the follicle or on ovulation.
In addition to the effect on ovulation, a reduction in the mobility and functionality of sperm cells due to the active ingredients was experimentally determined. The administration of levonorgestrel leads to a reduced number of sperm in the uterus. Levonorgestrel causes the secretion of the glands of the uterine lining to become less acidic (the pH value of the secretion increases), which results in reduced mobility of the sperm. In addition, levonorgestrel causes a thicker secretion from the cervix . As a result, more sperm are less likely to migrate from the vagina into the uterus.
Whether levonorgestrel inhibits the implantation (nidation) of fertilized egg cells in the uterine lining is scientifically controversial. There are no direct indications for such an inhibition of nidation . Both confirmatory and negative studies exist for indirect indications, such as changes in the structure and function of the uterine lining due to the administration of the morning-after pill , which could possibly prevent the fertilized egg cell from implanting. Overall, those effects that can take place after the egg cell has been fertilized (post-fertilization effects) are considered to be of little relevance to the contraceptive effect of the morning-after pill . It is discussed whether the failures of post-coital contraception can be attributed to the fact that the morning-after pill may not have any effect on the implantation of a fertilized egg.
It is scientifically proven that levonorgestrel (as well as ulipristal acetate, see below) is ineffective if the fertilized egg has already implanted in the uterine lining. Taking levonorgestrel mistakenly too late does not have a negative effect on existing pregnancies.
Ulipristal acetate (trade name ellaOne ) has been available as an emergency contraceptive in Germany since the end of 2010. It prevents ovulation up to a few hours before the point in time, even if there has already been an LH surge. It must be taken within 120 hours (five days) after intercourse; However, as with LNG, the earlier the drug is taken after unprotected sexual intercourse, the greater the safety. Ulipristal acetate is a selective progesterone - receptor modulator (SPRM): It prevents the docking of the body's own sex hormone progesterone, so this can not work. Ovulation is prevented or delayed. The formation of proteins, which are necessary for the beginning and maintenance of a pregnancy, is suppressed.
Ulipristal acetate was designated by the German Society for Gynecological Endocrinology and Reproductive Medicine in February 2013 as a standard drug for emergency contraception.
Very common (more than 10%) undesirable effects after taking levonorgestrel are nausea, headache and pelvic pain. Irrespective of menstruation, bleeding can occur (intermenstrual bleeding). The subsequent menstrual bleeding may start late; however, a pregnancy test should be carried out if menstruation has not started one week after the expected time or if it is weaker than usual. If vomiting up to three hours after taking the morning-after pill, it is recommended that you take levonorgestrel again. Metoclopramide can be used to treat nausea and vomiting . Even after administration of ulipristal acetate, the most common side effects are abdominal pain, menstrual irregularities, nausea and headache.
Women who are at risk of fallopian tube infections, fallopian tube or ectopic pregnancies must check with their doctor whether the morning-after pill is an option for them as an emergency contraceptive.
Requirements for levonorgestrel
The World Health Organization (WHO) recommends, because levonorgestrel is relatively well tolerated and because a medical examination is not necessary before taking it, to make the morning-after pill available without a prescription , because this avoids unwanted or unwanted pregnancies and abortions . Levonorgestrel for postcoital contraception is available without a prescription in almost all European countries. Exceptions are Poland, Italy and Hungary. The German Society for Gynecology and Obstetrics and the professional association of gynecologists spoke out against a release from the prescription requirement in 2013. The National Association of Statutory Health Insurance Physicians doubted an improvement in the care of affected women. Other German associations and experts spoke out in favor of an exemption from prescriptions. Advocacy came in 2014 from the Austrian AGES , which described the prescription exemption in Austria (end of 2009) as a success story.
|Germany||without a prescription since March 2015||On March 14, 2015, the morning-after pill with the active ingredient levonorgestrel became available without a prescription. In the same month , prompted by the decision of the EU Commission in January 2015 to make the ulipristal-containing emergency contraceptive EllaOne prescription-free, the Federal Ministry of Health submitted a draft ordinance to amend the drug prescription regulation , whereby emergency contraceptives with both Ulipristal and levonorgestrel should be released from the prescription requirement. On March 6, 2015, the Federal Council approved the draft ordinance.
Years of debate preceded this. As early as 2003, the responsible committee of the Federal Institute for Drugs and Medical Devices (BfArM) spoke out in favor of releasing levonorgestrel for post-coital contraception from the prescription requirement. Pro familia was involved in a campaign for approval (2012), while the Professional Association of Gynecologists (BVF) and the German Society for Gynecology and Obstetrics (DGGG) spoke out against the prescription-free regime (2012).
In 2012, the SPD and the Left had asked the government in two motions in the Bundestag Committee on Health to release it from the prescription requirement, Union parties and FDP rejected them in May 2013 - four months before the Bundestag election .
In November 2013, the Federal Council approved the joint Federal Council proposal of the state governments of Baden-Württemberg and North Rhine-Westphalia with the aim of dispensing over the counter and free of charge, but Federal Health Minister Hermann Gröhe subsequently did not issue a corresponding ordinance .
|Austria||without a prescription since 2009||Efforts began in 2005 to make levonorgestrel available as a morning-after pill without a prescription . In 2007 the Greens and the SPÖ spoke out clearly in favor of liberalization; the FPÖ was against the abolition of the prescription requirement and the ÖVP without a clear position. One point of contention was that abandoning the prescription requirement would also remove the advertising ban.
By decision of December 18, 2009 - one year after the Faymann I government took office - the morning-after pill was made available without a prescription. Until then, an "emergency regulation" had temporarily existed at federal state level: in the eastern federal states, pharmacists were free to hand over the preparation without a prescription.
|Switzerland||without a prescription since 2002||In Switzerland, the morning-after pill has been available without a prescription as a single 1.5 mg levonorgestrel tablet since November 2002. The drug may only be dispensed without a prescription after a detailed discussion with the pharmacist.|
|Belgium||without a prescription since 2001|
|Denmark||without a prescription since 2001|
|Estonia||without a prescription since 2003|
|Finland||without a prescription since 2002|
|France||without a prescription since 1999||Is given to female pupils in schools if required. 'pilule du lendemain'|
|Greece||without a prescription since 2005|
|Great Britain and northern Ireland||without a prescription since 2001||Is given to female pupils in schools if required. 'morning-after pill'.|
|Ireland||without a prescription since 2011|
|Iceland||without a prescription since 2006|
|Italy||prescription only||In Italy there is a prescription requirement. In addition, the doctor can refuse to prescribe the “pillola del giorno dopo” if he invokes his right to “conscientious objection”.|
|Latvia||without a prescription since 2003|
|Lithuania||without a prescription since 2005|
|Luxembourg||without a prescription since 2005|
|Netherlands||without a prescription since 2004|
|Norway||without a prescription since 2000|
|Portugal||without a prescription since 2000|
|Sweden||without a prescription since 2001|
|Slovakia||without a prescription since 2006|
|Spain||without a prescription since 2009|
|Czech Republic||without prescription|
|United States||without a prescription since 2013||The morning-after pill with the drug levonorgestrel had been available in the USA since April 2009, following a judicial order to the FDA , for women aged 17 and over to be available without a prescription. For younger women it was only available on prescription; In April 2013 this prescription requirement was also lifted.|
Due to new knowledge about interactions with other drugs, the Federal Institute for Drugs and Medical Devices (BfArM) will issue new instructions for dispensing, according to which pharmacists should inquire about existing medications, based on which the respective dosage is adjusted.
Eligibility requirements for ulipristal acetate
In November 2014 , the European Medicines Agency recommended that ulipristal acetate be released from the prescription requirement for use in emergency contraception for ulipristal acetate, which has been approved and prescription-only in EU countries since 2009 . On January 8, 2015, the EU Commission decided to abolish the EU-wide prescription requirement for ellaOne . The German Federal Ministry of Health announced the rapid implementation of the decision. In Hungary, ellaOne remains a prescription. In Poland , the EU recommendation was met at short notice, after which ellaOne was sold out after a short time. In June 2017, the drug became subject to prescription again following the creation of a corresponding law.
On February 26, 2015, the German Bundestag decided that the health insurance company would continue to assume the costs for patients under 20 years of age (under 22 years of age since March 29, 2019) despite being released from the prescription requirement; the application of the preparation compared to patients is further prohibited. On March 6, 2015, the German Federal Council also approved the release from the prescription requirement. As a result, “the finished medicinal product ellaOne for emergency contraception approved according to Article 3 Paragraph 1 of Regulation (EC) No. 726/2004 ” was exempted from the prescription requirement from March 14, 2015. Since January 8, 2016, drugs that contain "ulipristal acetate in preparations for oral use without the addition of other pharmaceutically active ingredients in a concentration of up to 30 mg of active ingredient per divided dosage form and in packs with a maximum active ingredient content of 30 mg for emergency contraception" have been in existence , without prescription.
In the United States, pharmacies are legally required to dispense medically prescribed ulipristal acetate. Individual pharmacists whose religious beliefs contradict the dispensing may only refuse to dispense the latter if another employee from the same pharmacy hands over the preparation to the patient promptly. The Supreme Court ruled this binding in July 2016. In most other cases, pharmacists in the USA can decide for themselves which products they carry.
Conception of the churches
Roman Catholic Church
Basically, the Roman Catholic Church rejects the morning- after pill, both with regard to an ovulation-inhibiting and nidation-inhibiting effect. The former because of their position on contraception , the latter because this is already an abortion for them . The Congregation for the Doctrine of the Faith has justified this in its doctrinal instruction Donum Vitae of 1987 as follows: “From the moment the egg cell is fertilized, a new life begins, which is neither that of the father nor that of the mother, but that of a new human being that develops independently. It would never become human if it had not already been from that moment on. "The Church's teaching sees itself confirmed here in the" research results of human biology , which recognizes that the zygote resulting from fertilization is the biological identity of a new one human individual has already constituted. "
However , the Church makes exceptions to the rejection of the morning-after pill in the event of rape. In January 2013 it was reported that a raped woman had not been treated in two Catholic hospitals because doctors were unable to prescribe the morning-after pill . The responsible Archbishop of Cologne, Joachim Cardinal Meisner , then stated : “If, after a rape, a preparation whose principle of action is to prevent conception is used with the intention of preventing fertilization, then in my opinion this is justifiable. If a preparation whose principle of action is nidation inhibition is used with the intention of preventing the implantation of the already fertilized egg cell, this is still not justifiable because it actively deprives the fertilized egg cell, which protects human dignity, from its livelihood will. "With regard to the assessment of the central active principles of the individual preparations, he added:" The Church can only explain the moral principles. The individual doctor in a Catholic institution must then conscientiously familiarize himself with these principles and thus come to a responsible decision. "Regarding the church position, he explained:" The issue of rape is not about the holistic nature of a loving act, but about prevention a criminal fertilization. ”Afterwards, the general assembly of the German Bishops' Conference confirmed that“ in Catholic hospitals women who have been victims of rape naturally receive human, medical, psychological and pastoral help. This may include the administration of a morning-after pill, provided that it has a preventive rather than an abortive effect. Medical-pharmaceutical methods that cause the death of an embryo must still not be used. The German bishops trust that in Catholic institutions the practical treatment decision will be made on the basis of these moral theological guidelines. In any case, the decision of the woman concerned must be respected. ”The President of the responsible Pontifical Academy for Life then publicly supported this line by referring to the encyclicals Casti connubii and Humanae vitae . He recalled that Catholic hospitals had been administering contraceptives in certain circumstances for 50 years, following the rape cases on a massive scale during the Congo crisis . The permit was later also valid during the Bosnian War , when rape of Catholic nuns in particular was used as a targeted means of waging war. According to the president, some Catholic hospitals like the one in Cologne are apparently not aware of these criteria.
Accordingly, at the end of February 2013, the Spanish Bishops' Conference also declared the prescription of the morning-after pill for raped women permissible, provided that the drugs did not have an abortion effect. The Spanish bishops do not know whether a morning-after pill without an abortion effect has been developed: "If there is something like that in Germany, we don't know anything about it."
Evangelical Lutheran Churches
In the Protestant Church, the protection of life is also an important issue, but so is individual responsibility. Paul Metzger from the denominational institute Bensheim of the Evangelical Church emphasizes that there is no binding opinion in the Evangelical Church. The Evangelical Church also argues about the active ingredient ulipristal acetate, whose nidation-inhibiting effect has not yet been proven. For “radical evangelicals” this is a problem in Metzger's view.
According to Norbert Groß, Director of the Evangelical Hospital Association, there is emergency care in all Protestant hospitals, regardless of the general position of the house or the treating doctor for the protection of life. The morning-after pill has never been a dispute in the association.
Advertising and mail order
In Germany, direct advertising of the preparation to patients is prohibited, as is mail order.
Levonorgestrel : PiDaNa 1,5 (DE), Duofem, NorLevo (DK, CH), Vikela (AT), Postinor, Plan B (USA, CAN)
Most packs only contain one tablet with 1.5 mg levonorgestrel. Sometimes there are preparations containing 2 tablets, each with 0.75 mg levonorgestrel. For the effect it is irrelevant whether the necessary dose is divided into one or two tablets. Combination preparations from the hormone types progestin and estrogen (Yuzpe method, e.g. Tetragynon , four dragees with 0.25 mg levonorgestrel and 0.05 mg ethinylestradiol each ) are no longer used because of the considerable side effects.
Ulipristal acetate : ellaOne (EU)
The Stiftung Warentest has tested the two drugs PiDaNa and ellaOne available in Germany. They rated the preparation PiDaNa as suitable, Ellaone, however, as only suitable with restrictions.
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