History of Emergency Contraceptives. In 1974, Doctor Albert Yuzpe (Canada) came up with the Yuzpe regimen, in which progestin-only emergency-contraception was investigated. In 1975, the copper intrauterine device (IUD) was then studied for use before the pills of Danazol, a low-side effect emergency-contraception was tested in the 1980s. However, Danazol was found to be less effective. Therefore, the Yuzpe regimen was then adopted as the standard, emergency contraception, in many countries. The combined, oral contraceptive, which was in the form of pills, were less expensive and were easily available in many countries; therefore, they were also prescribed for the Yuzpe regimen. The use of progestin-only emergency-contraception then gradually increased prompting organizations such as the Special Program on Human Reproduction (HRP) to play a crucial role in determining the effectiveness of Levonorgestrel contraceptive pill, in comparison with the Yuzpe regimen, in 1998. This led to the withdrawal of combined estrogen-progestin emergency contraceptives from some markets. The Mifepristone emergency contraception was first registered in China in the year 2002 (Lakhan, Hamlat, McNamee & Laird, 2009).
In 2012, with the aid of the internet, the online prescription was made possible with the first one being done by an online doctors’ practice, which started a courier service emergency-contraception service in London. This was developed to help women, who shied off from seeking emergency-contraception aid or those who could not find time to visit the pharmacy shops to receive services at their doorstep. The development of emergency contraception was initially concentrated in the United States of America and Canada. For instance, in 1971, the studies on the use of Diethylstilbestrol (DES) at the Yale University were first published in a medical journal and later in the University of Michigan. This led to a rise in the use of emergency contraception in most of university health facilities. The use of Diethylstilbestrol (DES) was challenged in May 1973, prompting the approval of its use in instances like rape cases. This led to its restricted application under federal authority conditions (Güldal, 2000).
In September 1973, new terms and conditions for specifying labeling and required standards, including the distinctive packaging of DES by manufacturers, were published by the FDA. This was meant to set market standards for DES as emergency contraception. Subsequently, there was the withdrawal from the market of the 25mg pill DES emergency-contraceptives, by a leading manufacturer in the United States, following recommendations by pharmacists and physicians. During the month of February in 1975, the approval of DES as an emergency contraceptive treatment was revoked by the FDA. This was changed after March 8, 1975, whereby it’s marketing for use in cases of emergency, for example, rape cases or incest was allowed. Its use in other, normal circumstances had to be regulated by putting into place several measures, such as the withdrawal of 25mg and higher DES pills from the market, as well as placing conspicuous warning messages, like “This drug product should not be used as a post-coital contraceptive”, on the drug packages (Güldal, 2000).
This was further reiterated in March 1978, following a bulletin sent to all U.S. physicians and pharmacists by the FDA, which stated its disapproval for the manufacture or marketing of the DES contraceptive but did not effectively rule out its application in emergency situations, such as rape or incest. This, however, required that manufacturers should provide patient labeling and distinctive packaging for their products. In the following years of the 1980s, the use of the Yuzpe regimen passed the off-label use of DES, as an emergency-contraception treatment, which led to the eventual phasing out of the commercial use of DES, in the United States. The Food and Drug Administration authorities in the United States approved the use of the Yuzpe regimen as a safe and effective emergency contraception treatment on February 25, 1997. One year later, on the month of September, the approval of a prescription kit called the Yuzpe regimen Prevent Emergency Contraception Kit was passed by the Food and Drug Administration. However, it was not until May 2004 before its use was discontinued (Lakhan, Hamlat, McNamee, and Laird, 2009).
In the late nineties, the prescription of a progestin-only Plan B was approved, by the Food and Drugs Administration (FDA). The Plan B was made up of two 750 microgram Levonorgestrel pills, meant as emergency contraceptives. Its prescription over-the-counter by licensed pharmacies was not approved for women above eighteen years. Another form of prescription-only for Plan B was for women under eighteen years, which was also made available. This took effect as from 28th July, 1998, following FDA directions. However, this has been subjected to changes following court rulings in the U.S. In 2009 which permitted the “behind the counter” acquisition of Plan B contraceptives even by seventeen year old males and females (Güldal, 2000).
Importance of Emergency Contraception. Emergency contraception plays a particularly influential role in reproductive health especially in women. It is an underused means of contraception that has, however, proved to be immensely valuable in preventing unwanted pregnancies. This happens in situations such as when an alternative contraception fails, for example, when a condom breaks during sexual intercourse. Other instances may include when a woman is raped or faces other health risks owing to pregnancies, for example, ectopic pregnancies. Emergency contraception may also be necessary if a woman does not or is not ready to have a pregnancy, at a definite moment. This can be backed by statistics showing that out of 210 million women all over the world that become pregnant each year, it is estimated that 80 million of those pregnancies are unplanned. On the other hand, these unintended pregnancies result in 19 million unsafe abortions every year worldwide, and pregnancy-related causes kill 530,000 women annually. These deaths can be prevented if the pregnancies are not allowed to develop, in the first place, and this can be made possible through the use of emergency contraception (Güldal, 2000).
Emergency contraception also plays a vital role in helping to serve women’s health needs. For instance, if a woman is being held in a refugee camp and is not able to take care of pregnancy or receive proper prenatal healthcare besides planning for the baby’s future. She can then avoid getting pregnant immediately after having unprotected sexual intercourse by using emergency contraceptive pills (ECPs). Emergency contraception helps prevent pregnancy after unprotected sexual intercourse immensely, since it has the potential to reduce the risk of conceiving an unintended pregnancy, effectively; thus, eliminating the consequent need for abortion of the pregnancy. However, they do not offer protection against sexually transmitted diseases during unprotected sexual intercourse (Kelly, 1979)
Relevant Statutory Laws. The state of Massachusetts became one of the first few states to allow pharmacists to dispense contraceptives without having to wait for doctors’ prescription. The Bill dubbed “Providing Timely Access to Emergency Contraception” required that all public hospitals provide victims of sexual offenses with adequate information regarding the use of contraception, besides providing them with the drugs. This was in acknowledgment that women in the United States needed to take full control of their lives and determine when they wanted to get pregnant. According to the Center for Disease Control and Prevention, about 10% of women in the US use emergency contraceptive pills. Although health scientists rate their effectiveness at around 80%, these drugs have found use in the United States, especially due to various cases of sexual assault and rape related cases. In the state of Illinois, “The Sexual Assault Emergency Treatment Act” clearly defined, what should be done during cases of sexual assault. In this act, public hospitals were supposed to draw a clear plan on how they intend to serve patients of sexual assaults and submit their plans to the Department of Public Health, so that they can be approved. Indeed, the Law acknowledged that some of the emergency contraceptives had some severe side effects that could interfere with patients’ quality of life. Thus, by this law, hospital staffs were obliged to provide survivors of sexual assault with adequate information regarding these side effects and how to obtain the right drugs. In 2005, the state of New Hampshire established legislation, “The Collaborative Practice for Emergency Contraception Act”, which stipulated how sexual assault victims should be handled. According to this law, pharmacists were given the responsibility to start emergency contraceptive therapy as soon as the patients reported to their facilities. However, this was supposed to comply with the provisions of the procedures set out by the New Hampshire Pharmacy Board (Brody, 1988).
Ethical issues related to the use of emergency contraceptives have sharply risen to the public arena in several states. The whole idea began, when pharmacists in Illinois declined to transfer any emergency contraception prescriptions after Governor Rod gave a directive to that effect. According to the pharmacists, this was a moral issue, and no one should have been forced to engage in it. In their opinion, it amounted to violation of the rights of the pharmacists when the state tried to force them to dispense emergency contraception. They agreed with Mitt Romney’s idea that prevention of implantation amounted to abortion, and thus should have been considered an immoral act. However, it was the church and all hospitals run by the church that had been persistent in as far as opposing the Law is concerned. According to Catholics, life starts at the point of conception and any acts aimed at terminating life between conception and natural death is immoral and sinful. It is the reason why there has been a standoff between the church and the state, as the two seem to favor different ideas. In addition, the fact that most people in the United States are of the Catholic faith has made it difficult for the state to implement this law. While they try to educate the public on its importance, the Church and various civic organizations have been eroding the hard work that they do. However, people seem to be embracing the idea with the rise of cases of sexual assault and teen pregnancy. They believe that victims of assault should not be victimized into early parenthood because it was not their wish to get pregnant and that the state must uphold the freedom of self-determination in these cases (Berlant, 1975).
The wide acceptance of the use of emergency contraceptives has necessitated the Department of Justice to establish “The Sexual Assault Emergency Medical Response Fund”, as this would help victims to access medical facilities and emergency contraceptives in a timely manner. Essentially, this would ensure that no citizens of the United States are denied access to free emergency contraceptives from public and private hospitals. The state of Oregon is particularly harsh on this law, considering that it has previously imposed severe penalties on health facilities, which do not treat patients according to the law. Moreover, the information availed to patients should not just be timely, but it should be unbiased and based on oral or written medical literature. A similar medical scheme has been set up in South Carolina “Crimes Victims Compensation Fund” is used to pay for medical bills of patients who happen to be victims of sexual assault. Besides the hospitalization bill, the fund caters for the cost of seeking termination of pregnancy or prevention of implantation if the patient so desires. According to the state, implementation of the law provides the right of self-determination, and the legal requirements are not extraordinary. In some states, controversy usually arises only on the clause that gives the pharmacist the sole responsibility to dispense these drugs. The argument is in that pharmacists should contact physicians on the need, so as to protect the patient’s safety related to the administration of emergency pills. Nonetheless, several private hospitals have opted to withdraw from implementing the law entirely, arguing that they will always stick to the earlier statute of Massachusetts that allowed for moral or religious considerations in deciding what to do. This was popularly known as “the conscious clause” and has significantly changed the social dynamics of the United States, till today (Lakhan, Hamlat, McNamee and Laird, 2009).
Court Decisions.The Illinois Supreme Court, in 2008, ruled on a case that challenged the law forcing pharmacists to dispense emergency contraceptive pills. According to the court ruling, pharmacists should strictly adhere to this legal provision and continue dispensing these drugs to the public. However, pharmacists have maintained that the law unlawfully denies them the right to chose what is morally right for them. The pills effectively destroy the fertilized egg or prevent it from implanting on the walls of the uterus. When a fertilized egg is not implanted, it cannot survive as it depends on the uterine walls for its food and nutrition. Thus, pharmacists felt that they will be unduly used to kill innocent babies against their wills. Indeed, they cited the state law that gave moral objections a significant consideration in making health care decisions. The controversy seems to have overwhelmed the state, forcing them to settle on a compromise. At the moment, the state has ceded some ground and allowed individual pharmacists to prescribe emergency contraceptives only when their religious beliefs allow them. However, it requires individual health facilities to ensure that there are enough pharmacists to help mothers who seek emergency contraception from their faculties. In Washington, women over 18 years can purchase the drugs over the counter while ladies below 18 must have a prescription to be given these drugs. However, this only partly solves the problem because the Church, particularly the Catholic Church, has vehemently opposed the idea and urged its faithful to withdraw their participation from the exercise. The public stand by the Catholic Church has had a tremendous impact considering that most citizens of the United States belong to the Catholic Church. The state will undoubtedly have to do more, so as to ensure that people embrace the idea and save women from unwanted pregnancies (Berlant, 1975).
In Washington, the court ruled that the state was contravening the pharmacists’ rights of self determination, by forcing pharmacists to sell emergency contraceptives to patients. Some time earlier, the attorneys of the pharmacists had argued that the state did not sincerely mean to give timely access to medical care to women, but essentially intended to suppress the influence of the Church on such moral issues as securing abortion. The judge seemed to have bought this argument in his final ruling, leaving the state in a precarious position. According to the state law, pharmacies are required to purchase all the drugs that the community need and keep enough stocks in their stores. This legal provision technically includes emergency contraceptives, which many practitioners find immoral and unethical to distribute. Although popularly adopted to prevent a scenario where pregnant women are denied access to these drugs on moral grounds, in 2007, the whole idea has been hard to implement, giving an impression that its provisions may just remain on paper. The argument by state attorneys, whereby the law should apply uniformly as a way of promoting the government policy of providing timely medical interventions to patients, certainly fell on deaf ears. This is because pharmacists found several loopholes in the law that effectively strengthened their legal argument. For example, the law allows pharmacies to avoid stocking certain drugs if they are likely to be stolen from their stores or for any other reasons that the pharmacies deem concrete enough to warrant the avoidance. According to lawyers for the pharmacists, the “other reasons” that were not explicitly stated in the law could include religious freedom and moral considerations. It is on this basis that the judge decided to side with the pharmacists and declare the forceful implementation of the law unconstitutional (Brody, 1988).
The timing of the ruling did not favor the state either, because it came at a time when religious groups were supporting massive demonstration, so as to protest the federal law that required all health facilities affiliated with the church provide emergency pills, without an extra counseling of the patient with church. The public outcry by the Church made President Obama take radical measures that effectively shifted the burden to the insurance industries. Nonetheless, it remained a delicate matter, with legislators from conservative state promising to challenge the decision by President Obama. However, the state has continued to implement the policy on pharmacies that have no religious boundaries on the matter. For example, most pharmacies that are not affiliated to any church have had no problem implementing the policy. In fact, they get enough money from the sale of drugs. They have significantly helped the state to ensure the provision of timely medical care to women in dire need of emergency contraceptives, as the state purports (Berlant, 1975).
In conclusion, healthcare ethics related to the use of emergency contraceptives have always pitted the church against the state. While the state views their moves as an attempt to help women to get timely and affordable medical attention, the church regards it as an attempt by the state to overstep the mandate of religion in matters of religious freedom. It has caused a series of contracted battles in the courts of law that in most cases leave a dented image on the state, and the church alike.