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Emergency Contraception

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Transcript of Emergency Contraception

Formulations Foundational Concepts Objectives

(T1): Appreciate the role of pharmacists in assisting patients and the public with respect to emergency contraception

(C1): Describe the mechanisms of action of various formulations of emergency contraception (c)

(CII): Define both local and national legal requirements relating to emergency contraception (c)

(CIII): Demonstrate approaches to counseling patients and the public about the use of emergency contraception (d)

(CIV): Appraise ethical principles, conflicts, and social controversy surrounding the use of emergency contraception (a). Legally Speaking... The Controversy Anti-implantation = Abortive mechanism?
-Definition of pregnancy (fertilization vs. implantation)

Sale to males vs. females

Pharmacists' right to refuse dispensing

Emergency contraceptive vending machines

Sexual assault, abuse of minors Perceptions in Puerto Rico "18 years old and older, with valid ID"

Study: Knowledge, attitudes and practices in a group of pharmacists in Puerto Rico regarding emergency contraception (Fuentes EC, Azize-Vargas Y, et al. 2007).
First study regarding EC in Puerto Rico
Questionnaire at CFPR Convention in 2006
51.4% supported OTC dispensing of ECs
Average number of knowledge-based questions answered correctly: 1.8 out of 6
Those who answered correctly were more comfortable dispensing.
Understanding the "Morning-After Pill" Emergency Contraception Upon completion of this educational activity, participants will be able to: Progestin-only (levonorgestrel)
Next Choice, Plan B, Plan B One-Step, Ovrette

Estrogen and Progestin ("the Yuzpe method")
Ovral, Levora, Nordette, Seasonale, Triphasil, Alesse

Progesterone Agonist/Antagonist
ella (ulipristal acetate)

Intrauterine Device
Copper-T 1974: The "Yuzpe Method" introduced

1997: FDA approves use of oral contraceptives using the Yuzpe Method

1998: First emergency contraceptive approved in US (Preven: Estrogen-Progestin)

1999: Plan B (Progestin-only) approved

2007: FDA makes Plan B OTC for 18 years +

2009: FDA makes Plan B OTC for 17 years + Historical Background "The only contraceptive method designed to prevent pregnancy after intercourse."
-American Academy of Pediatrics

"The use of a drug or device within 72 to 120 hours after unprotected intercourse for the purpose of preventing unintended pregnancy."
-Association of Reproductive Health Professionals, as quoted by APhA Emergency Contraception
Defined: Rx-only OTC for 17+ (except One-Step: 15+)
...all OTC as of 5/5/13, unless federal appeal... Prevention of Pregnancy Progestin-Only Mechanisms of Action Estrogen-Progestin
Combinations Progesterone
Agonists/Antagonists The Statistics According to the CDC's 2006–2010 National Survey of Family Growth:

1 in 9 sexually experienced women aged 15–44 (11% or 5.8 million) women had ever used emergency contraception, up from 4.2% in 2002.

Most women who had ever used emergency contraception had done so once (59%) or twice (24%).

Young adult women aged 20–24 were most likely to have ever used emergency contraception; about one in four had done so (23%).

Almost 1 in 5 never-married women (19%), 1 in 7 cohabiting women (14%), and 1 in 20 currently or formerly married women (5.7%) had ever used emergency contraception.

About one in two women reported using emergency contraception because of fear of method failure (45%), and about one in two reported use because they had unprotected sex (49%). Ethical Considerations Ethical principles (eg, autonomy, beneficence, non-maleficence)

Oath of a Pharmacist

Questioning vs. Assuming

Legal requirement to not obstruct appropriate use of medications

*Emphasis on Patient Counseling!* Abortifacients VS Termination of
Existing Pregnancy VS VS Levonorgestrel (0.75 mg x 2 doses/ 1.5 mg x 1)
-Generic, or Next Choice, Plan B, Plan B OneStep

Prevents ovulation and fertilization; *may* inhibit implantation, but only if it has not yet been initiated.
*~89-95% effective*
*Take within 72 hours* Levonorgestrel and ethinyl estradiol
-2-5 active tablets x 2 doses
(0.1-0.3 mg levonorgestrel, 0.15-0.5 mcg EE per tablet)

Prevents ovulation and fertilization; *may* inhibit implantation, but only if it has not yet been initiated.
*~75% effective*
*Take within 72 hours* Ulipristal acetate (30 mg x 1 dose)
-Available only as ella

Inhibits or delays ovulation

May inhibit implantation (Category X in pregnancy)
-Pregnancy should be excluded before prescribed
-The only oral EC approved for use between
72 and 120 hours. Mifepristone (RU 486)- used along with misoprostol

Blocks progesterone receptors, leading to endometrial deterioration and death of implanted embryo; cervical dilation, and uterine contraction.

*95-98% effective at pregnancy termination*
*Taken within 63 days of last missed period* In December 2011, Plan B One-Step was approved for "all women of child-bearing age," though the Secretary of the US Department of Health & Human Services disagreed with this decision- Thus, was only made available OTC for women over 17 years old.

*On April 5, 2013, a US federal judge ruled that levonorgestrel-based emergency contraception must be available OTC for all ages, without point-of-sale restrictions, beginning "within thirty days."*

Many states have issued additional laws which increase access to emergency contraceptives References Daniels K, Jones J, Abma J. Use of Emergency Contraception Among Women Aged 15–44: United States, 2006–2010. National Center for Health Statistics Data Brief, No. 112, February 2013. Available online at http://www.cdc.gov/nchs/data/databriefs/db112.htm. Accessed April 2013.
Powell C. Hormonal Birth Control and Abortifacient Mechanisms. Senior Honors Thesis, Liberty University. Spring 2012. Available at: http://digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=1287&context=honors&sei-redir=1&referer=http%3A%2F%2Fwww.google.com.pr%2Fsearch%3Fhl%3Den-PR%26source%3Dhp%26q%3Dabortifacient%2Bmechanism%26gbv%3D2%26oq%3Dabortifacient%2Bmechanism%26gs_l%3Dheirloom-hp.3...547.5780.0.5905.25.14.2.5.0.0.281.1985.0j6j4.10.0...0.0...1ac.1.Gp1PZdKrZ4o#search=%22abortifacient%20mechanism%22.
Fuentes EC, Azize-Vargas Y. Knowledge, attitudes and practices in a group of pharmacists in Puerto Rico regarding emergency contraception. 2007.PRHSJ 263;3:191-197.
State Policies in Brief: Emergency Contraception. Guttmacher Institute; www. guttmacher.org. 1 April 2013.
FDA Approved Emergency Contraceptive Products Currently on the US Market. Reproductive Health Technologies Project.; www.rhtp.org December 2011.
The Emergency Contraception Website: Educational and Promotional Materials. Office of Population Research & Association of Reproductive Health Professionals. Available at: http://ec.princeton.edu/ecmaterials/index.html. Accessed April 2013.
Emergency Contraception State Laws. National Conference of State Legislatures. August 2012. Available at http://www.ncsl.org/issues-research/health/emergency-contraception-state-laws.aspx. Accessed April 2013.
Emergency Contraception: The Pivotal Role of the Pharmacist. American Pharmacists Association: APhA Special Report (A Continuing Education Program for Pharmacists). 2007.
Wilkinson TA, Fahey N, Shields C, et al. Pharmacy Communication to Adolescents and Their Physicians Regarding Access to Emergency Contraception. Pediatrics 2012; 129:624-629.
American Academy of Pediatrics Committee on Adolescence. Emergency Contraception. Pediatrics 2012;130:1174-1182.
Dominguez L, Downing DF, Jordan B, et al. Emergency contraception: Update for pharmacists. Pharmacy Today 2010;50(6):48-60. Intrauterine Devices Prevent fertilization (primary mechanism) due to creation of hostile environment for sperm

Inhibit implantation (secondary); ova development

*~99% effective at 120 hours* Side Effects Oral Formulations:
Nausea (50%), vomiting (20%)
-May use preventative antiemetics 30-60 minutes prior to emergency contraceptive use
-Estimated to be worse with Yuzpe method vs. progestin-only formulations
Menstrual bleeding (12.5-13.8% for Plan B)

Intrauterine Device:
Cramping
Abdominal pain
Bleeding
Menstrual changes (26%)
Nausea (43%)
Fatigue; Headache (both 17%) Understanding Contraception Preventing pregnancy
Fertilization (sperm + mature ovum)
Implantation (ovum into endometrial wall

Estrogen (ethinyl estradiol, or EE)
Suppresses FSH --> Suppresses follicular development

Progestin (levonorgestrel)
Ovulation "blocker" (cervical mucus, endometrial involution)
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