Pharmacies and Conscience Clauses: Overview

Introduction

Emergency contraception (EC), also known as postcoital contraception or the morning-after pill, is a drug taken after unprotected sex to prevent pregnancy. This drug uses hormones to prevent the ovaries from releasing eggs, prevent sperm from fertilizing an egg, or chemically alter the lining of the uterus to prevent fertilized eggs from implanting. When taken within seventy-two hours of unprotected sex, EC is believed to be 90-percent effective at preventing pregnancy.

Although EC meets the legal and medical definition of a contraceptive (as opposed to an abortifacient, or a drug that induces abortion), some opponents believe that it constitutes a form of abortion, as the pills may potentially be taken after fertilization. Progestin-only EC is legal in the United States for unrestricted over-the-counter sale, while EC containing ulipristal acetate, an antiprogestogen, is only available with a prescription. Pharmacists may decline to dispense medication if sufficient evidence exists to suggest that a patient’s prescription is invalid or that the drug in question could prove harmful to the patient.

In some cases, physicians and pharmacists have refused to dispense EC for moral or ethical reasons. This practice was previously protected under several amendments collectively known as the Federal Health Care Provider Conscience Protection Laws. These amendments, examples of a form of law popularly known as a “conscience clause,” were enacted by President George W. Bush in 2008 to allow pharmacists and physicians to refuse to dispense medications that they consider to be in violation of their personal beliefs. In 2011, the administration of President Barack Obama repealed those laws and replaced them with a different conscience clause, narrower in scope, which maintains federal protection for health-care workers who refuse to perform abortions or sterilizations but no longer protects refusal to dispense contraception.

The debate on this issue is between those who believe that pharmacists who have moral objections to EC and other forms of contraception should not be required to dispense them and those who believe that pharmacists should be legally prohibited from using their position to impose their personal morals and ethics onto others.

Understanding the Discussion

Abortifacient: A drug or other substance that induces abortion. The most common abortifacient in the United States is mifepristone, also known as RU-486, which is used in combination with misoprostol in chemical abortion procedures. The hormones used in emergency contraceptive pills are not abortifacients.

Contraceptive: A device or chemical agent used to prevent pregnancy. Typical contraceptive methods include condoms, birth-control pills, and emergency contraception.

Pharmacist: A person licensed to dispense drugs and medicines.

Postcoital Contraception: A combination of hormones that acts to prevent ovulation, fertilization, and/or the implantation of a fertilized egg in the uterus.

History

The legal and ethical responsibilities of pharmacists were first established as part of the larger field of medical ethics and law. Pharmaceutical organizations eventually developed a specific set of ethics for pharmacists. The Philadelphia College of Pharmacy developed its first ethical code in 1848; some historians consider this the first official pharmacists’ ethics code in the United States. Prior to that time, pharmacists were bound by the same ethics and laws that applied to physicians.

In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act, which, after several amendments and revisions, formed the basis of modern federal policy regarding pharmaceuticals. The Food and Drug Administration (FDA) determines the legal status of pharmaceutical products and also plays a major role in determining the legal policies that apply to pharmacists.

The Code of Ethics for Pharmacists was created by the American Pharmaceutical Association (APhA), later renamed the American Pharmacists Association, in 1852. The code requires that pharmacists follow federal and state laws and that they take precautions to avoid causing harm to patients during the course of their work. Though the ethical code is not legally binding, many pharmacies require adherence to certain ethical standards as a condition of employment. The code was revised and updated in 1922, 1952, 1969, 1981, and 1994.

Some pharmaceutical organizations include a conscience clause as part of their ethical code. Conscience clauses are legal clauses that allow health-care workers to refuse to provide certain services to which they have a religious or moral objection. Most conscience clauses that apply to pharmacists were originally created for use in situations where they have reason to believe that patients might use medications to cause harm to themselves or others.

Conscience clauses became a significant issue during the 1960s, after the development of hormone contraceptives, also known as birth-control pills. Some pharmacists were reluctant to distribute birth-control medication for religious or moral reasons, leading several pharmaceutical companies and organizations to develop guidelines specific to contraceptives.

Shortly after the development of the birth-control pill, scientists began developing hormonal treatments that could be taken after unprotected sex to prevent pregnancy. The first successful form of EC was called the Yuzpe regimen after its developer, obstetrician A. Albert Yuzpe. In 1997, the FDA approved EC for prescription use in the United States. Antiabortion groups protested this, arguing that they considered EC to be an abortifacient, or a form of chemical abortion.

Some pharmacies and companies have refused to distribute EC on moral and ethical grounds. One highly publicized case occurred in 1999, when Walmart decided not to distribute EC in its pharmacies. After appeals from medical organizations and women’s rights groups, the company altered its policy and began carrying EC in 2005; however, it also allowed any pharmacist working for Walmart to refuse to dispense it.

Pharmacies & Conscience Clauses Today

In 2004 and 2005, a number of cases involving pharmacist refusals occurred across the United States. In April 2005, the governor of Illinois ordered all pharmacists to dispense contraceptives regardless of their personal beliefs. This ruling was challenged by antiabortion pharmacists in December 2008, and in September 2012, the Appellate Court of Illinois ruled in favor of the pharmacists under the state’s Health Care Right of Conscience Act.

In 2006, the FDA approved emergency contraception for over-the-counter distribution. The FDA’s research had determined that EC is safe for adult women and that there is no reason to require women to obtain a prior prescription. The decision was based partially on medical evidence indicating that EC is more effective the sooner it is administered following unprotected sex.

In January 2009, the United States Department of Health and Human Services began prohibiting federally funded health-care facilities from discriminating against patients whose behavior the staff found morally offensive. This regulation, which affected nearly six hundred thousand pharmacies, hospitals, and physician offices, was enacted to protect patients’ rights to obtain EC, among other services.

In 2011, the FDA recommended that the progestin-only EC pill Plan B, which had previously been approved for over-the-counter sale to adults but required a prescription for women under seventeen, be made available without a prescription for all females of reproductive age. However, the Department of Health and Human Services, under the direction of Secretary Kathleen Sebelius, overruled the recommendation, prompting the Center for Reproductive Rights to reopen a lawsuit it had filed in 2005, when the FDA first refused to recommend unrestricted sale of EC. In April 2013, US District Court judge Edward R. Korman ruled in favor of the plaintiffs, ordering that the age restriction be lifted. The Obama administration ultimately chose not to appeal the decision.

Another controversy was sparked in January 2012, when, as part of the Patient Protection and Affordable Care Act of 2010, Sebelius announced a mandate requiring all health-insurance plans to provide coverage for all FDA-approved doctor-prescribed contraceptives at no cost. An exemption was made for certain religious organizations, including some nonprofit religious organizations such as hospitals and private universities. The contraceptives mandate caused significant uproar among Catholic groups, but a proposed amendment that would have allowed for-profit employers to deny such coverage on a religious basis was struck down by the Senate. However, in June 2014, the Supreme Court narrowly ruled in the case of Burwell v. Hobby Lobby Stores, Inc. that a “closely held corporation,” meaning one that is not publicly traded, can also be exempted from the mandate on religious grounds.

Critics of pharmacists who refuse to dispense contraceptives argue that they are violating patients’ rights. In extreme cases, pharmacists have refused to transfer contraceptive prescriptions or have withheld prescriptions for EC until the three-day period of effectiveness has passed. Some pharmacists have been dismissed or even faced legal charges for refusing to dispense contraceptives. Organizations such as Pharmacists for Life argue that forcing pharmacists to dispense contraceptives or to direct patients to another facility to obtain contraceptives violates religious freedoms. Some believe that pharmacists should be allowed to use any means at their disposal to prevent people from obtaining medication that will prevent pregnancy.

The official stance of the APhA, according to its policy manual, is that pharmacists may refuse to dispense medications that violate their beliefs, but they must not attempt to prevent the patient from obtaining the medication and must be willing to refer the patient or transfer the prescription elsewhere. Though the ethical code requires pharmacists to dispense all legally available medications, state governments are ultimately responsible for determining the legality of refusing to dispense medications on moral grounds.

These essays and any opinions, information or representations contained therein are the creation of the particular author and do not necessarily reflect the opinion of EBSCO Information Services.

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