THIS UPDATE COVERS THE EFFICACY AND SAFETY, AVAILABILITY, AND PHARMACY REFUSALS

 

Effectiveness and safety

Emergency contraception (EC), (also known as “Plan B” or “the morning after pill”) can prevent a pregnancy from occurring if taken shortly after unprotected sex or contraceptive failure.[1] EC is most effective when taken within the first 12 -24 hours after unprotected sex[2], but it has also been shown to be up to 89% effective when taken up to 72 hours after unprotected sex,[3] and can even work up to 120 hours after unprotected sex.[4] However, the sooner EC is taken following unprotected sex, the more successful it is in preventing pregnancy.[5]

 

The form of EC that is approved for use in the United States by the Food and Drug Administration is a concentrated dose of the same hormones found in ordinary birth control pills, and consists of two pills (0.75 mg Levonorgestrel in each pill) that are taken by mouth after unprotected sex.[6]

 

Studies have found that EC is safe and effective and repeated use of EC does not pose any health risks.[7] EC cannot interfere with an established pregnancy[8] and should not be confused with a different drug known as mifepristone (RU-486)[9], which is taken to induce abortion during the first nine weeks of a pregnancy.

 

Availability

In 2006, the FDA approved EC for over-the-counter sale to people aged 18 and older. Women aged 17 and younger still need a doctor’s prescription to get EC,[10] although they can get it directly from many family planning clinics and some doctors’ offices. (For a directory of providers, visit www.not-2-late.com). As a result and to ensure fast access to EC, many professional health organizations urge doctors to provide minor patients with advance prescriptions.[11] FDA conditions require that EC be kept behind the counter rather than on store shelves and hence a customer would need to ask for it from the pharmacist or an employee, who is permitted to check the person’s identification for proof of age. Acceptable forms of identification in New York include government issued identification that shows a birthdate, like a driver’s license, school ID or passport. If the identification card does not include a photograph, it should include identifying information.[12] No one should be asked to sign a special form or record their name or address in a log in order to receive EC.

 

Additionally, EC is available to minors as well as adults at federal Title X family planning and reproductive health clinics.[13]

 

EC is also part of the standard of care in treating victims of sexual assault. New York State Public Health Law and New York City municipal law require that every hospital providing emergency treatment to a rape survivor must promptly offer written and oral information about EC and must provide the EC when requested.[14] This is true for minors as well as adults. The New York State Departments of Health and Social Services have instructed hospital emergency rooms to offer EC to rape survivors within 72 hours of unprotected sex where medically appropriate.[15]

 

Both prescription and over-the-counter EC are covered by New York State Medicaid for minors as well as adults.[16]

 

Pharmacy Refusals

Unfortunately, there have been cases where pharmacists have refused to fill prescriptions for EC or regular birth control in New York.[17] Pharmacists have a professional responsibility to ensure that their patients obtain properly ordered and therapeutically appropriate medications in a timely manner with appropriate counseling from a pharmacist.[18] New York State law governing pharmacy practice as well as policy guidelines prohibit pharmacists from obstructing patient access to medication without a medical justification, or from refusing to transfer prescriptions to another pharmacy.[19] Even pharmacists who have a religious, moral or ethical reason for refusing to fill a prescription have a professional obligation to avoid abandoning the patient. Pharmacy owners must find a way to balance the individual beliefs of their employees with the delivery of services to patients in need, without compromising their ability to conduct business.[20]

 

If a patient is having trouble getting or filling a prescription, several resources are available:

  • Visit www.not-2-late.com or call 888-NOT-2-LATE for a list of local providers who will write a prescription for EC or locations selling EC over the counter.
  •  Call a local Planned Parenthood clinic. Call 800-230-PLAN to find a clinic near you.
  • If you are having trouble getting your prescription for EC or birth control filled, fill out the NYCLU’s Pharmacy Refusal form here

 

 

 



[1] See David A. Grimes & Elizabeth G. Raymond, Emergency Contraception, 137 Annals of Internal Med. E-180, E-183 (2002); David Weismiller, Emergency Contraception, 70 Am. Fam. Physician 707, 709 (2004).

[2] Am. Acad. Of Pediatric Comm. On Adolescence, Emergency Contraception 116(4) Pediatrics 1038-47 (Oct. 2005).

[3] Carton Text, Plan B, http://www.fda.gov/cder/foi/label/1999/21045lbl.pdf (package label). There are also studies showing that a single dose of 1.5 mg of levonorgestrel can substitute for two 0.75 mg doses 12 hours apart. See ICEC, Policy Statement Regimen Update (July 2003).

[4] Helena von Hertzen et al., Low Dose Mifepristone and Two Regimens of Levonorgestrel for Emergency Contraception: a WHO Multicentre Randomised Trial, 360 The Lancet 1803 (2002).

[5] Ibid. See also Grimes, supra n.1, at E-183; Weismiller, supra n.1 at 709.

[6] See sources cited supra n.3.

[7] World Health Organization, Emergency Contraception: A Guide for Service Delivery, 22-23 (1998); Katrina Abuabara et al., As Often as Needed: Appropriate Use of Emergency Contraceptive Pills, 69 Contraception 339 (2004).

[8] See International Consortium for Emergency Contraception (ICEC) and International Federation of Gynecology & Obstetrics (FIGO), Statement on Mechanism of Action (October 2008); see also K. Gemzell-Danielsson & L. Marions, Mechanisms of Action of Mifepristone and Levonorgestrel When Used for Emergency Contraception, 10 Human Reproduction Update 341 (2004); H.B. Croxatto et al., Pituitary–Ovarian Function Following the Standard Levonorgestrel Emergency Contraceptive Dose or a Single 0.75-mg Dose Given on the Days Preceding Ovulation, 70 Contraception 442 (2004); Weismiller, supra n.1, at 709; Anna Glasier, Emergency Postcoital Contraception, 337 New Eng. J. Med. 1058, 1060 (1997).

[9] See ICEC Policy Statement, Emergency Contraception and Medical Abortion (July 2003).

[10] Food and Drug Admin., FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older -Prescription Remains Required for Those 17 and Under, available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01436.html.

[11] Providing advance access to EC is also the standard of care on a national level. For example, the American College of Obstetricians and Gynecologists (“ACOG”) has launched a campaign to encourage physicians to offer advance prescriptions for EC during routine gynecological visits. Am. Coll. Obstetricians & Gynecologists, Emergency Contraception, ACOG Practice Bulletin, Dec. 2005, at 1, 6-7. The American Academy of Pediatrics recommends that pediatricians consider offering advance EC prescriptions for teens and young adults. See Am. Med. Women’s Ass’n, Position Statement on Emergency Contraception (adopted Nov. 1996), http://www.amwa-doc.org/index.cfm?objectid=0EF88909-D567-0B25-531927EE4CC23EFB; American Academy of Pediatrics, Committee on Adolescence, Policy Statement, Emergency Contraception, 116 Pediatrics 1038, 1044 (2005). See also Guttmacher Institute, Issues in Brief, supra, at 1-3 (discussing standard favoring advance prescriptions for EC)., http://www.acog.org/from_home/publications/press_releases/nr04-30-01-1.cfm.

[12] Memorandum Re: Information for Pharmacy Staff on Plan B® from Lawrence H. Mokhiber, Executive Secretary for New York State Board of Pharmacy, to All New York State Pharmacies (February 2007) available at http://www.op.nysed.gov/pharm-planb.htm.

[13] Memorandum Re: Emergency Contraception from Thomas Kring, Acting Deputy Assistant Secretary for Population Affairs, U.S. Department of Health and Human Services, to Regional Health Administrators (April 23, 1997) available at http://www.hhs.gov/opa/familyplanning/toolsdocs/opa97-2.pdf.

[14] N.Y. Pub. Health Law §2805-p (McKinney 2008); N.Y.C., N.Y., Code § 6-125(b) (forbidding the City of New York from entering into contracts with hospitals that do not provide for the prompt counseling about and on-site administration of EC to rape survivors).

[15] DEPARTMENT OF HEALTH, DEPARTMENT OF SOCIAL SERVICES, CHILD AND ADOLESCENT SEXUAL OFFENSE MEDICAL PROTOCOL, 49. As of December 2008, this document is under review for edits by the Department of Health and other stakeholders.

[16] Letter from Deborah Bachrach, Medicaid Director, Deputy Commissioner, New York State Office of Health Insurance Programs, to Pharmacy Providers, January 23, 2007 (on file with NYCLU).

[17] National Women’s Law Center, Pharmacy Refusals: State Laws, Regulations, and Policies, http://www.nwlc.org/pdf/PharmacyRefusalPoliciesJanuary2008.pdf; National Women’s Law Center, The Pharmacy Refusal Project, http://nwlc.org/details.cfm?id=2185&section=health.

[18] N.Y.S. Edu. Dept. Office of the Professions, Current Issues in Pharmacy-Policy Guideline Concerning Matters of Conscience, www.op.nysed.gov/pharmconscienceguideline.htm.

[19] Id.

[20]See Religious Refusals and Reproductive Rights: Accessing Birth Control at the Pharmacy, http://www.aclu.org/images/asset_upload_file576_29402.pdf.