Pharmacy Law

Emergency Contraception, Institutional Conscience, and Pharmacy Practice

Journal of Pharmacy Practice 2014, Vol. 27(2) 174-177 ª The Author(s) 2013 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0897190013515710 jpp.sagepub.com

Robert F. Card, PhD1, and Karl G. Williams, LLM, JD, BS Pharm2

Abstract ‘‘Emergency contraception’’ case law from the state of Washington is reviewed and analyzed. Important legal, social policy, and professional ethical questions are considered with focus on professional and institutional conscientious objection to participating in this therapy. Keywords ambulatory care, emergency medicine

Introduction Emergency contraception (EC) continues to be a controversial issue in our society with ethical, legal, and political dimensions. After years of bureaucratic process, judicial review, and often heated public debate, the Food and Drug Administration (FDA) has recently approved a supplemental new drug application (sNDA) for the Plan B One-Step1 version of levonorgestrel1 under pressure of a federal court order.2 The order required FDA ‘‘to make levonorgestrel-containing EC available without a prescription and without point-of-sale restrictions’’;that is, over-the-counter without age restrictions or limitation of sale only in pharmacies. In the judge’s memorandum opinion following FDA’s action, he urged FDA to expand approval to include available generic products including both the 1-dose and 2-dose versions of this medication.3 Most recently, FDA has published its decision4 to grant a 3-year exclusive right to market Plan B One-Step without age and context restrictions perhaps ensuring ongoing controversy. It is well known that some pharmacists morally object to EC since they think this involves taking a human life, given their belief that levonorgestrel has postfertilization effects. Termed conscientious objection, these are objections to providing this therapy based on genuine religious or moral reasons that are intended to preserve a provider’s integrity. In this article, we will review recent case law involving mandatory stocking policies that may well become a crucial area to watch in the evolution of pharmacy law and practice as it pertains to EC. This will become clear as we discuss the recent case of Stormans v Selecky and highlight the distinction between state conscience laws for individual pharmacists and policies that require pharmacies to stock Plan B.

Stormans v Selecky The central question in the Stormans case is whether the state of Washington can compel pharmacists and licensed

pharmacies to stock and dispense emergency contraceptives, despite their genuine religious belief (and associated objection) that this would involve participation in terminating a human life.5 There are 2 relevant Washington State rules. The first one (Washington Administrative Code 246-863-095) delineates pharmacist’s professional responsibilities and the second one (WAC 246-869-010) lays out pharmacies’ responsibilities. For our purposes, the latter is most important. One aspect of this second policy is the stocking rule, which demands that a pharmacy stock a ‘‘representative assortment of drugs in order to meet the pharmaceutical needs of its patients.’’ The other aspect of this second policy is the delivery rule; this rule explains that pharmacies have a duty to deliver lawfully prescribed drugs or devices to patients in a timely manner, except for the following or substantially similar circumstances: (a)

Prescriptions containing an obvious or known error, inadequacies in the instructions, known contraindications, or incompatible prescriptions or prescriptions requiring action in accordance with WAC 246-875-040. (b) National or state emergencies or guidelines affecting availability, usage, or supplies of drugs or devices; (c) Lack of specialized equipment or expertise needed to safely produce, store, or dispense drugs or 1 State University of New York, Department of Philosophy, Oswego, NY, USA; University of Rochester Medical Center, Department of Medical Humanities and Bioethics, Rochester, NY, USA 2 St John Fisher College, Wegmans School of Pharmacy, Department of Pharmacy Practice and Administration, Rochester, NY, USA

Corresponding Author: Karl G. Williams, St. Johns Fisher College, 3690 East Ave, Rochester, NY 14618, USA. Email: [email protected]

Card and Williams devices, such as certain drug compounding or storage for nuclear medicine; (d) Potentially fraudulent prescriptions; or (e) Unavailability of drug or device despite good faith compliance with WAC 246-869-150. After this rule was adopted, the Pharmacy Board in Washington interpreted the regulations in a letter. In this document, the Board explained that there was no right of conscientious objection, since ‘‘the pharmacy business must meet the patient’s needs onsite unless one or more of the exceptions described in the rule are present.’’6 In other words, on the Board’s interpretation, ‘‘the rule does not allow a pharmacy to refer a patient to another pharmacy to avoid filling the prescription due to moral or ethical objections.’’ The upshot is that even a standard policy of ‘‘refuse and refer’’ was insufficient to satisfy the regulations; the pharmacy must dispense the requested medications, although a narrow right of conscience is permissible for individual pharmacists if there was another pharmacist on shift at that pharmacy who would dispense the requested medication instead of the conscientious objector. After a series of legal maneuvers and a bench trial, findings of fact and a ruling were rendered by the US District Court, Western District of Washington at Tacoma in February 2012. We will briefly detail the court’s reasoning for this conclusion and then use this case as a lens to focus the debate. The heart of the controversy in Stormans has to do with the claim by the plaintiffs that their constitutionally guaranteed first Amendment rights to the free exercise of religion are improperly impinged upon by the Washington State rules. It would be wise, therefore, to first briefly elaborate on a few of the precedent-setting cases relating to the free exercise clause of the First Amendment decided upon by the US Supreme Court. As a form of religious exercise, do conscience-based refusals to dispense EC pass the traditional test for earning a religious accommodation? The answer to this question depends in significant part on the level of scrutiny applied to the law in question. Some laws implicating religious freedoms are considered to be directed laws. This means that it is reasonable to believe that their passage was intended to impact the religious exercise of a certain group and such laws attract the highest level of suspicion or ‘‘strict scrutiny’’ in legal parlance. Other laws are considered to be laws of general applicability. These laws are those that are deemed not to be directed at suppressing the religious behavior of others. These general laws instead garner a lower level of scrutiny, although the law in question may place a burden on some who wish to exercise their religious beliefs. As long as this is simply an ‘‘incidental effect’’ of the law it is acceptable, and the regulation in question must simply have a rational basis in order to be constitutional. The US Supreme Court expounds upon these tests in Employment Division, Department of Human Resources of Oregon v. Smith (494 US 872 [1990]). In this case, 2 men were terminated from their jobs with a private drug rehabilitation organization because of their use of peyote and as a result were denied unemployment benefits by the state of

175 Oregon. They contended that this drug was taken as part of a religious ceremony in the Native American Church and as such their free exercise rights had been violated. In his discussion of the case, Justice Scalia imagines a law that required the payment of a tax even of those who believed this supported the sinful activities of an organized government. Such a law would be of general applicability and would be constitutional; as Scalia says in his opinion: ‘‘ . . . if prohibiting the exercise of religion . . . is not the object of the tax but merely the incidental effect of a generally applicable and otherwise valid provision (then), the First Amendment has not been offended.’’ To make this analysis concrete and applicable to pharmacy law, consider a rule (which eventually became permanent and attained the status of law) put in place in April 2005 in Illinois that required that pharmacies must dispense contraceptive drugs or devices ‘‘without delay’’ upon receiving a valid, lawful prescription (68 Ill Admin Code §1330.91 [29 Ill Reg 5586]). Would this be a directed law or a general law? Supporters of CO would likely state that this is a directed law by citing the burdens placed on medical providers who must engage in activities that are inconsistent with their religiously inspired moral beliefs but this statement does not prove the point. Since a law may acceptably place a burden on the religious exercise of some and still be constitutional, the question is whether or not the burden is an incidental effect of the law or whether the religious beliefs of the medical providers were targeted in the passage of the law. Is there reason to believe that this is true? In order for this to be proven, one must be able to point to outward signs that ‘‘ . . . the object of a law is to infringe upon or restrict practices because of their religious motivation . . . ’’ The US Supreme Court case of Church of the Lukumi Babalu Aye v. City of Hialeah7 provides an example of a case in which citizens’ rights to freely exercise their religion were improperly restricted. In this case, the city of Hialeah, Florida, passed a set of regulations that impacted the religiously inspired animal sacrifices performed by members of the Santeria religion. These laws were put in place after an emergency public session of the city council. The court reviewed the minutes and taped excerpts of the city council session and found ‘‘ . . . significant hostility exhibited by residents, members of the city council, and other city officials toward the Santeria religion and its practice of animal sacrifice’’ as well as statements that Santeria was ‘‘a sin, ‘‘foolishness,’’ ‘‘an abomination to the Lord,’’ and the worship of ‘‘demons.’’ This led the court to hold that the ordinances in question ‘‘ . . . had as their object the suppression of religion’’ and to ultimately conclude that the laws were not neutral and ran afoul of the Free Exercise Clause. Therefore, these laws were deemed unconstitutional and struck down by the court. If there was similar significant evidence that the Illinois law was put in place to target or condemn those who engage in religiously inspired refusals to dispense Plan B, then this law would likely be held to be unconstitutional. The most demanding test of a law burdening religious exercise would be the strict scrutiny test, which holds that a state law restricting religious practice is constitutional if the restriction (1) furthers a compelling interest and (2) is narrowly

176 tailored. Simply, this test requires that since the law implicates religious expression, the interest on the part of the state that the law promotes must be of substantial significance and the law must choose the least restrictive option possible to promote that compelling interest. With this background in mind, we can now turn to the central reasoning in Stormans. The court blocked the Washington state law as applied to pharmacies for 3 main reasons—reasons that follow the contour of the background and tests described previously. First, the court accepted the plaintiffs’ claim that the regulations were not neutral as regards religion. The court reached this conclusion after examining the object of the regulations and determining that the law’s aim was to burden religious expression. The defendants identified the object in terms of timely access to all lawfully prescribed medications, while the plaintiffs viewed the object of the regulations to be removing from the practice of pharmacy, so far as possible, pharmacists who for religious reasons objected to dispensing lawful medications, especially Plan B. The main line of argument here concerned the history of the enactment of the regulations and the fact that these laws were specifically tied to Plan B. Evidence for this claim was adduced, including a letter by the Washington State Human Rights Commission (WSHRC) in which the WSHRC states that the drug at the center of the controversy surrounding pharmacists who do not wish to fill legal prescriptions was Plan B. Also referenced were the public words and actions of Washington Governor Gregoire who threatened to remove the entire Pharmacy Board if they adopted a rule that allowed denial on the basis of religious and moral beliefs of certain lawful prescriptions (again, with a presumed focus on Plan B). The court concludes that these matters speak to the aim of the law and that pharmacists are placed in a position in which they must either dispense a drug that violates their religious teachings or leave their present jobs in the state of Washington. Therefore, the court held that the regulations targeted the religious practices of citizens and hence are not neutral. The second main argument is that the regulations are not laws of general applicability. The issue here is that the government cannot impose burdens in a selective manner only on conduct motivated by religiously inspired beliefs. The court interprets the relevant test in terms of means and ends; if the means of advancing the interests in question do not match the ends, then it is reasonable to think that the law in question targets religious expression and therefore is not generally applicable. The court argues that there is no evidence that anyone has ever failed to gain access to Plan B in the state of Washington as a result of a conscientious refusal. The argument, then, is that the means of achieving the goal of securing access to prescription medications (ie, not allowing pharmacies to condone conscientious refusals by pharmacists) do not match the end. Therefore, this law fails the test and is not generally applicable; as the court concludes, ‘‘ . . . the enforcement mechanism of the new law appears aimed only at a few drugs and the religious people who find them objectionable.’’ In fact, the court noted that in 40 years the Board has never enforced its stocking rule against any pharmacy and it seemingly would allow a pharmacy to not stock Plan B

Journal of Pharmacy Practice 27(2) due to a financial arrangement with another EC manufacturer but the pharmacy could not refuse to stock Plan B due to a moral objection. Due to this incongruity, the court concludes that the laws are not fairly and consistently applied and therefore are not laws of general applicability. The third and final argument given by the court concerns the strict scrutiny test. Since the court has determined that these regulations had as their object placing intentional burdens on those exercising religious beliefs, then the law in question must be subjected to the strict scrutiny test. The court argues that the interests promoted by the law in question do not represent a compelling interest, and as such, these interests do not justify the significant burden placed on the free exercise of religion. The interests that the defendants assert are promoted by the law are the following: (1) promoting health by ensuring access to Plan B (and other medications) in a timely manner and (2) preventing sex discrimination. The court rejects the first possible interest by noting that the state’s interest has mainly to do with values such as consumer convenience than with access to medications, and such values are not compelling enough to justify the burden these laws impose on pharmacists’ free exercise rights. One might reasonably argue that those who are refused Plan B are victims of sex discrimination, but the Stormans court rejects this point as well by saying that reasonable people may disagree over when life begins and that ‘‘ . . . the refusal to participate in an act that one believes terminates a life has nothing to do with gender or gender discrimination.’’8

Discussion The Stormans court concludes that the Washington rules violate the free exercise rights of the plaintiffs but take notice of the fact that the plaintiff is Stormans Inc as well as 2 individual pharmacists. This reasoning then applies not only to the free exercise rights of the individual pharmacists but also to the religious rights of Stormans Inc and its retail pharmacy. These arguments raise a large question: do institutions themselves have religious rights that can serve as a basis for lodging a conscience objection to providing a service or product? Notice that the conscience of a pharmacist and the conscience of an institution could be coextensional in the case of an individual proprietorship operated by a single licensed pharmacist. The Stormans court calls attention to such a case noting that these individual pharmacist owners would be forced to act against their conscience or close shop. But in the typical case, these are separate issues and this means the question of institutional conscience needs further examination. Does a pharmacy have a right of conscience in itself, over and above the consciences of the employees who carry out the everyday actions of the corporation/institution, so that it could conscientiously object to satisfying the stocking rule? This case raises the interesting ethical dimension of whether a pharmacy has a right of conscience in itself. The Stormans court unproblematically accepts this premise but this assumption itself raises further perplexing questions. The Oxford English Dictionary defines conscience as: ‘‘The

Card and Williams internal acknowledgement or recognition of the moral quality of one’s motives and actions; the sense of right and wrong as regards things for which one is responsible; the faculty or principle which judges the moral quality of one’s actions or motives . . . ’’ Yet do institutions acknowledge or recognize the morality or immorality of their decisions? No one disputes, of course, that humans are capable of such, yet institutions may lack the associated capacities. Further, the conscientious scruples in the Stormans case are religious in nature; do institutions have religious beliefs? It is puzzling since institutions may lack the relevant interests. After all, according to most religions, individuals face an awesome choice concerning what to believe and may be saved or damned, while it appears that businesses and corporations themselves do not face a similar choice or fate. If this is the case then institutions themselves may not possess the interests typically implicated in religiously inspired conscientious beliefs, or at the very least, do not do so in the same way as humans. Given the fact that Plan B One-Step1 is now available over the counter to persons of all ages and generic versions will soon follow, this will do more to decrease pharmacists’ participation in consumers’ choice to obtain the medication. As we have suggested, however, this precise circumstance in conjunction with the Stormans case calls for deeper consideration of the basis in law for conscience clauses as applied to institutions themselves. Regardless of the FDA’s final determinations about generic levonorgestrel-containing 1- and 2-dose products, consciencebased decisions will continue to pose an ethical dilemma for many pharmacists. Consider that the Code of Ethics for Pharmacists establishes a ‘‘covenantal relationship,’’ an implicit promise, ‘‘to help individuals achieve optimum benefit from their medications.’’9 The phrase does not distinguish prescription

177 from nonprescription medications such as Plan B One-Step and presumes that pharmacists will work directly with patients to a therapeutic goal. No doubt conscientious objectors will continue to have difficulty with this aspect of professional practice when it is confronted. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.

References 1. FDA News Release; June 20, 2013. www.fda.gov/NewsEvents/ Newsroom/Press/Announcements/ucm358082.htm. Accessed July 27, 2013. 2. Tummino v. Hamburg, 2013 WL 1348656 (April 5, 2013). 3. Tummino v. Hamburg, 2013 WL 2631163 (June 12, 2013). 4. FDA’s Drug Products with Therapeutic Equivalence Evaluations; July 22, 2013.http://www.accessdata.fda.gov/scripts/cder/ob/docs/ patexclnew.cfm?Appl_No¼021998&Product_No¼001&table1¼ OB_OTC. Accessed on August 20, 2013. 5. Stormans, Inc. v. Selecky, 854 F.Supp.2d 925, W.D. Wash. (2012). 6. Cited in decision on preliminary injunction at 524 F. Supp. 2d 1245 (2007). 7. Church of Lukumi Babalu Aye v. City of Hialeah, 508 US 520 (1993). 8. The case referred to in the opinion is Bray v. Alexandria Women’s Clinic, 506 U.S. 263, 271-74, 113S. Ct. 753, 122L. Ed. 2d 34 (1993). 9. APhA Code of Ethics for Pharmacists (1994).

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Emergency contraception, institutional conscience, and pharmacy practice.

"Emergency contraception" case law from the state of Washington is reviewed and analyzed. Important legal, social policy, and professional ethical que...
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