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Emergency Contraception: Law & Ethics

Jesse C. Vivian, RPh, JD
Professor, Department of Pharmacy Practice
College of Pharmacy and Health Sciences
Wayne State University
Detroit, Michigan



11/20/2012

US Pharm
. 2012;37(11):60-62.

A recent decision from the Illinois Court of Appeals could have the potential to change the ethos of the profession of pharmacy.1 The Pharmacist Code of Ethics and the Oath of a Pharmacist tell us that the pharmacist’s primary concern is the welfare and dignity of the patient.2,3 The decision states the opposite: When it comes to emergency contraception, the right of a pharmacist with a conscientious objection to dispensing the drug takes precedence over the ethical duties embodied in the code and oath. The decision is only valid in Illinois for now, and it was decided under existing state laws. While extrapolating its impact to other states might not be legally required, the reasoning by the judges deciding the case could be influential, if not persuasive, throughout the country. As it stands, Illinois pharmacists are no longer required to dispense emergency contraception when their own religious beliefs are opposed to its use.

Facts of the Case

In April 2005, then-Governor Rod Blagojevich signed an “emergency rule” requiring pharmacists to dispense emergency contraceptives upon receipt of a valid prescription without delay.4,5 Upon its adoption, the governor warned pharmacists who refused to fill emergency contraception prescriptions that they could face sanctions ranging from a fine up to the loss of their license to practice pharmacy. He also stated that pharmacies should not engage in making moral judgments.

Litigation

Two individual pharmacists, both Christians, and their wholly owned three corporate pharmacies filed a complaint in September 2005 against the state asking for an injunction to prevent the rule’s enforcement. They claimed the rule was in contradiction to Illinois statutes (the Conscience Act and the Religious Freedom Act).6,7 They also claimed that the rule violated their First Amendment rights to the free exercise of religion and forced them to participate in “abortions” to which they were conscientiously and religiously opposed. During a tortuous trail through the Illinois court system that resulted in multiple prior decisions, the plaintiffs were unable to sustain their burden of showing any actual damages. While their case was pending before the Illinois Supreme Court, the rule was modified by the Illinois Department of Financial and Professional Regulation (the Department) to read, in essential importance, that a retail pharmacy use its “best efforts to maintain adequate stock of emergency contraception to the extent that it continues to sell contraception.”8

The rule also required that if a pharmacist objected to the dispensing of emergency contraception and a “nonobjecting pharmacist” was not present at the pharmacy, the “dispensing pharmacy” must sell the emergency contraceptive through “remote medication order processing,” which involved having a non-objecting pharmacist at another location authorize a nonpharmacist employee at the dispensing pharmacy to dispense the drug.9 In addition, the amendment mandated that retail pharmacies ensure that a nonobjecting pharmacist was scheduled to work when the pharmacy was open or that a licensed pharmacist was available to perform the remote medication order processing procedure when no nonobjecting pharmacist was available at the dispensing pharmacy.10

In December 2008, the Supreme Court of Illinois reversed the majority’s decision in an earlier Court of Appeals decision,11 finding that the plaintiffs’ claims complaint stated a valid cause of action that should be decided in a court of law.12

In August 2009, the circuit court granted the plaintiffs a preliminary injunction, prohibiting the defendants from enforcing the amended rule against the plaintiffs. In response, the Department amended the rule again in April 2010 to state: “Pharmacies have a duty to deliver lawfully prescribed drugs to patients and to distribute nonprescription drugs approved by the [FDA] for restricted distribution by pharmacies, or to substitute a generic drug in a timely manner, or to contact the prescriber to obtain authorization to dispense a different drug that produces a similar clinical effect in a timely manner.”13 Note that emergency contraception is not referenced in the revised current rule. While there were exceptions included in this version, no mention of conscience- or religious-based objections was listed.

The plaintiffs filed another complaint in May 2010 seeking to declare the current rule in violation of the Conscience Act and the Religious Freedom Act as well as the First Amendment. The trial court found that the current rule is invalid on its face and as applied under the Conscience Act, the Religious Freedom Act, and the First Amendment. The injunction against enforcement of the rule that had been granted earlier remained intact, and the parties were granted a right to make an immediate appeal.14

Appeals Decision

It is this appeal that forms the basis for the decision at hand. After an extensive review of the statutes at issue, the Court of Appeals found that the current rule does violate the state’s Conscience Act and the Religious Freedom Act at least insofar as the rule applies to emergency contraception and conscientious objection based on religious beliefs. The injunction against enforcement of the current rule was upheld only to the extent that it enjoins the state from enforcing the current rule against these plaintiffs, who have conscience-based objections to this rule.15

Analysis

This case was decided based on the interpretation and application of two state statutes that afford conscientious objectors freedom from persecution versus an opposing administrative regulation that would remove the right of conscientious objection when applied to a pharmacist’s receipt of a legitimate prescription. To the judges deciding the matter, the legislative enactments trumped the executive branch rule, at least when applied to a religious objection against dispensing an emergency contraception.

Other states and courts have issued both similar and opposing points of view on whether pharmacists may legally refuse to dispense emergency contraceptives based on religious and/or moral grounds. In the state of Washington, a comparable case has already gone to a federal court of appeals.16 The vital importance of this and similar decisions suggests the issue could be appealed up to the U.S. Supreme Court. If that happens, it’s going to be a fair amount of time before any final conclusions can be made.

In the meantime, the question that the profession of pharmacy must address, sooner rather than later, is whether the rights of one individual pharmacist should have priority over those embodied in the Pharmacist Code of Ethics and the Oath of a Pharmacist. Put another way, do the personal values expressed by a pharmacist override the decisions of patients and/or prescribing physicians?

It is much too easy to tell pharmacists who have a real, honest objection to dispensing emergency or other contraceptives to find another job, career, or profession.17 The argument that these pharmacists choose their profession and are therefore obligated to follow a physician’s orders or the requests of patients without regard to personal values ignores the reality of pharmacy practice. The debate would not be taking on the “hot button” level of scrutiny were the issue to involve a pharmacist who resists dispensing an addictive controlled substance to a patient who is believed to be taking “too much” for his or her own good. Nor would it be a problem if the issue was selling laxatives to a bulimic person. Pharmacists refuse to dispense and sell other products every day without being constrained by religious values in meeting their obligations to patients. Or is there something very different when it comes to contraception, of any sort?

The 62,000-strong American Pharmacists Association (APhA),18 out of approximately 275,000 pharmacists in the U.S.,19 takes a sort of “sitting-on-the-fence” position. Passing the patient-centered Code of Ethics in 1994,20 the organization added an amended “conscience clause” in 1998 stating: “1) APhA recognizes the individual pharmacist’s right to exercise conscientious refusal and supports the establishment of systems to ensure patient access to legally prescribed therapy without compromising the pharmacist’s right of conscientious refusal,” and “2) APhA shall appoint a council to serve as a resource for the profession in addressing and understanding ethical issues.”21 There seems to be an obvious contradiction here. Recall that in Dante’s Inferno it warns that there is a special place in hell for those who remain neutral when questions of moral dimensions are being debated.22

In contrast, take note that the American Public Health Association’s (sometimes also confusingly referred to as the APHA) stand on emergency contraception is much clearer23:

“When a health professional such as a physician or nurse practitioner has prescribed contraception, the patient must be able to obtain the contraceptive in a timely manner at a pharmacy, without interference from those pharmacists who have personal objections to contraception. Similarly, patients need timely access to nonprescription emergency contraception. Any delay in access can endanger the patient’s health by increasing the risk of unintended pregnancy or exacerbating the other medical conditions for which contraceptives are sometimes prescribed.”

It goes on to state that: “As the nation’s oldest and largest public health organization, APHA has the responsibility and expertise to address this critical health access issue from the perspective of public health protection. Thus, APHA takes the position that the patient’s health and well-being must come first in health care delivery and in the formulation of health policy. Therefore, APHA recommends that any policies or standards to address the desire of some pharmacists or pharmacy employees to refuse to dispense contraceptives should advance the following three principles:

1) If the contraceptive is in stock the medication should be made available on the premises in the customary time frame, through such methods as having a nonobjecting pharmacist or pharmacy employee step in to provide the medication;

2) If the contraceptive is not stocked by the pharmacy or is temporarily out of stock, the pharmacy should order the medication for the patient. Alternatively, the patient may be referred or a prescription transferred to another pharmacy that is known to have the medication in stock, if the referral or transfer would result in more prompt dispensing of the contraceptive and the patient prefers the referral or transfer; and  

3) An objecting pharmacist or pharmacy employee should not be permitted to admonish patients about contraception or abortion, violate the patient’s right to privacy, misrepresent whether the drug is in stock or can be ordered in a timely manner, or otherwise interfere with access to legally prescribed or marketed medications.”24

Conclusion

While the APHA’s statement might make sense from a public health perspective, it would not be supported by the Court of Appeals decision in Illinois. At this point, it comes down to the question of which side you are on in this important policy debate. Declaring your position, one way or the other, will certainly create controversy. Nevertheless, your patients should know in advance if you hold values that would prevent them from getting the medications they want or need.

REFERENCES

1. Morr-Fitz Inc. v Quinn, (Slip Op No. 05CH495, September 20, 2012), 2012 IL App (4th) 110398. www.state.il.us/court/opinions/AppellateCourt/2012/4thDistrict/4110398.pdf. Accessed September 30, 2012.
2. Pharmacist Code of Ethics & Oath—Pharmacy Pledge & Sworn Statement. www.uspharmd.com/pharmacist/pharmacist_oath_and_code_of_ethics/. Accessed September 30, 2012.
3. Code of Ethics for Pharmacists. Adopted by the membership of the American Pharmacists Association October 27, 1994. www.pharmacist.com/code-ethics. Accessed October 7, 2012.
4. This is the same Rod Blagojevich who tried to sell the U.S. Senate seat that President Obama once occupied. He was convicted, and as of February 3, 2012, will reside in a federal penitentiary for the next 14 years, albeit in a low security “country club” facility.
5. 68 Ill Admin Code ยง1330.91 (29 Ill Reg 5586).
6. 748 ILCS 70/1-14.
7. 775 ILCS 35/1-99.
8. 32 Ill Reg 7116, 7127 (effective April 16, 2008).
9. See Note 8, supra.
10. 32 Ill Reg 7116, 7132 (effective April 16, 2008).
11. Morr-Fitz Inc. v Quinn, 371 Ill App 3d at 1184, 867 NE2d at 1171.
12. Morr-Fitz Inc. v Quinn, 231 Ill 2d at 504-05, 901 NE2d at 392-93.
13. 68 Ill Adm Code 1330.500(e) (2010).
14. See Note 1, supra.
15. See Note 1, supra.
16. Griegoire supports appeal of Stormans v. Selecky ruling. The Island Guardian. March 25, 2012. www.islandguardian.com/archives/00004306.html. See also the Court’s decision in the Stormans case, No. 4-11-0398. www.ca9.uscourts.gov/datastore/opinions/2009/07/08/07-36039.pdf. Accessed October 4, 2012.
17. Debate: should pharmacists be forced to fill legal prescriptions they personally object to on moral grounds? Conservapedia. www.conservapedia.com.Accessed October 7, 2012.
18. About APhA. American Pharmacists Association. www.pharmacist.com/about. Accessed October 7, 2012.
19. Pharmacists. Occupational Outlook Handbook. U.S. Bureau of Labor Statistics (2010 data). www.bls.gov/ooh/Healthcare/Pharmacists.htm. Accessed October 7, 2012.
20. See Note 3, supra.
21. Brauer K. APhA delegates passed a conscience clause for pharmacists. In The News. April 20, 1999. www.gargaro.com/pharmacy/. Accessed October 7, 2012.
22. Josephson M. What Will Matter? November 24, 2011. http://whatwillmatter.com/2011/11/observation-the-hottest-places-in-hell-are-reserved-for-those-who-in-time-of-moral-crisis-preserve-their-neutrality-attributed-to-dante/. Accessed October 7, 2012.
23. Ensuring that individuals are able to obtain contraceptives at pharmacies. Policy Statement Database. Policy number 200611. November 8, 2006. American Public Health Association. www.apha.org/advocacy/policy/policysearch/default.htm?id=1335. Accessed October 7, 2012.
24. See Note 23, supra.

To comment on this article, contact rdavidson@uspharmacist.com.

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