Pharmacists and Emergency Contraception

Abstract & Commentary

Synopsis: Personal beliefs should not be imposed on others.

Cantor and Baum, lawyers from the Yale University School of Medicine, have written an op-ed piece in the New England Journal of Medicine focusing on the central role of pharmacists in providing emergency contraception. The recent decision by the Food and Drug Administration not to grant over-the-counter availability for emergency contraception has ensured that for a while there will continue to be the problem of a patient needing to obtain and fill a prescription within the narrow window of treatment associated with emergency contraception. There are now 6 states that allow pharmacists to provide emergency contraception without a prescription, but the collaboration of pharmacists is essential, and individual pharmacists do not always cooperate. Indeed, there are reports in the literature of pharmacists refusing to provide emergency contraception, even following a rape, citing personal moral grounds as a legitimate reason for this refusal. These examples are not new, but there is concern that the frequency may be increasing. There are 3 states (Arkansas, Mississippi, and South Dakota) that have legislated legal protection for pharmacists who cite "conscientious objection" as a reason to refuse to dispense emergency contraception. Similar legislation has been proposed in many other states.

They review 3 arguments supporting a pharmacist’s right to object: 1) The exercise of independent judgment; 2) Employment should not require a change in personal morals; and 3) Conscientious objection is a personal right in a democracy. Independent judgment is inherent in the practice of a profession, and the courts have established that pharmacy is a profession and a part of health care services. The choice to serve a patient is a component of most, if not all, professions; and it is argued that professionals should have the right to be consistent with their morals. In addition, professionals have a right of refusal by virtue of a democracy that protects against conflicts with personal ethical, moral or religious convictions.

There are also arguments against a pharmacist’s right to object: 1) Entering a profession creates obligations; 2) Emergency contraception is not an abortifacient; 3) Pharmacists’ refusals have an adverse effect on patients’ health; and 4) Refusing service has no clear-cut limitations. Pharmacists themselves have argued that a patient’s interests come first, and that willingly entering the profession is a choice that carried with it fiduciary obligations. Science and organizations have concluded that emergency contraception is not the same thing as an induced abortion and, therefore, this should not be a reason to refuse services to a patient. It is argued that a pharmacist’s objection imposes personal religious beliefs on another, and forces an unwanted burden on the patient, especially because the timing of the treatment is an urgent consideration. Personal moral objections can be used as a reason to refuse service in other categories such as treatment for HIV infection.

Cantor and Baum reject the alternatives of either an absolute right to object or no right to object, and believe that "state efforts to provide blanket immunity to objecting pharmacists are misguided." But they also believe that it is not appropriate for refusal to be illegal for 3 reasons: emergency contraception is not a true, absolute emergency; other options exist; and personal morals deserve consideration. At the same time, it is not appropriate to leave patients to solve the problem themselves. It is appropriate, ethically and legally, in the presence of an objection, to require referral to another resource. Cantor and Baum argue that pharmacists who object to providing emergency contraception should arrange for another pharmacist to provide this service, and that pharmacies should strive to have at least one nonobjecting pharmacist. A nonprescribing pharmacy could display a sign referring the patient to Planned Parenthood or the emergency contraception web site and hotline. These policies have been endorsed by the American Pharmacists Association. Appropriate referral maintains a standard of professional responsibility, and Cantor and Baum conclude that when pharmacists "pledge to serve the public, it is unreasonable to expect those in need of health care to acquiesce to their personal convictions." Finally, there is a need to educate pharmacists about the mechanism of action for emergency contraception and that the use of emergency contraception is safe (Cantor J, Baum K. N Engl J Med. 2004;2008-2012).

Comment by Leon Speroff, MD

The mechanism of action for emergency contraception is not known with certainty, but it is believed with justification that this treatment combines delay of ovulation with a local effect on the endometrium and prevention of fertilization.1-6 How much a postfertilization effect contributes to efficacy is not known, but it is not believed to be the primary mechanism.4,7 Indeed, an experiment in monkeys could detect no effect of a high dose of levonorgestrel administrated post-coitally once fertilization had occurred.8 Clinicians, pharmacists, and patients can be reassured that treatment with emergency contraception is not an abortifacient.

Levonorgestrel in a dose of 0.75 mg given twice, 12 hours apart, is more successful and better tolerated than the combination oral contraceptive method.9,10 In many countries, special packages of 0.75 mg levonorgestrel (Plan B, Norlevo, Vikela) are available for emergency contraception. Greater efficacy and fewer side effects make low-dose levonorgestrel the treatment of choice.

Clinicians have an important role to play in this problem. There are 2 recommended procedures: 1) To identify local pharmacies that will provide emergency contraception; and 2) To directly provide treatment as well as education about this method before it is needed.

Clinicians should consider providing emergency contraceptive kits to patients (a kit can be a simple envelope containing instructions and the appropriate number of oral contraceptives) to be taken when needed. It would be a major contribution to our efforts to avoid unwanted pregnancies for all patients without contraindications to oral contraceptives to have emergency contraception available for use when needed. This would be much more effective in reducing the need for abortion than waiting for patients to call. In studies of advanced provision and self-administration, adult women in Scotland and Hong Kong and younger women in San Francisco, Pittsburgh, and Mexico increased the use of emergency contraception without adverse effects such as increasing unprotected sex or changing the use of other contraceptive methods.11-17

Information for patients and clinicians, including the latest available products and clinicians who provide emergency contraception, can be obtained from the web site and hot line maintained by the Office of Population Research at Princeton University: http://ec.princeton.edu

Telephone hotline: 1-888-NOT-2-LATE or (1-888-668-2528)

References

1. Young DC, et al. Obstet Gynecol. 1994;84:266.

2. Swahn ML, et al. Acta Obstet Gynecol Scand. 1996;75: 738-744.

3. Trussell J, Raymond EG. Obstet Gynecol. 1999;93: 872-876.

4. Marions L, et al. Obstet Gynecol. 2002;100:65-71.

5. Croxatto HB, et al. Contraception. 2002;65:121-128.

6. Durand M, et al. Contraception. 2001;64:227-234.

7. Trussell J, et al. Contraception. 2003;67:167-171.

8. Ortiz M, et al. Hum Reprod. 2004;19:1352-1356.

9. Ho P, et al. Hum Reprod. 1993;8:389-392.

10. Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998;352:428-433.

11. Glasier A, et al. N Engl J Med. 1998;339:1-4.

12. Raine T, et al. Obstet Gynecol. 2000;96:1-7.

13. Jackson R, et al. Obstet Gynecol. 2003;102:8-16.

14. Gold M, et al. J Pediatr Adolesc Gynecol. 2004;17: 87-96.

15. Walker DM, et al. J Adolesc Health. 2004;35:329-334.

16. Lo SS, et al. Hum Reprod. 2004;19:2404-2410.

17. Raine T, et al. JAMA. 2004;in press.

Leon Speroff, MD, Professor of Obstetrics and Gynecology, Oregon Health Sciences University, Portland, is Editor for OB/GYN Clinical Alert.