- Email: [email protected]
Should Emergency Contraception be Sold Over the Counter?
POINT
counter-point
Regarner H. Thompson
Regarner H.Thompson received her bachelor of science in nursing degree from Our Lady of the Lake College in Baton Rouge, LA, and her master of nursing at Louisiana State University Health Science Center School of Nursing in New Orleans. She has extensive experience in oncology nursing, and has worked as a staff nurse and as an oncology clinical specialist for most of her nursing career. For several years, she served in a management position as director of operations for Amedisys Hospice Care Division.
Antiqua N. Smart
Antiqua N. Smart received her bachelor of science in nursing degree from Southern University and A & M College in Baton Rouge, LA, and her master of nursing at Louisiana State University Health Science Center School of Nursing in New Orleans. She has worked as a nurse specialist in low-risk neonatal nursing. She also served as a relief charge nurse/staff nurse in the mother/baby department at Woman’s Hospital in Baton Rouge. She holds certification as a family nurse practitioner and continues to practice in Baton Rouge.
Should Emergency Contraception be Sold Over the Counter? Two emergency regimens of hormonal contraception are available in the United States today. The first to be approved by the Food and Drug Administration (FDA) was the Yuzpe regimen, which consists of an initial dose of 2 combination oral contraceptives (0.5 mg levonorgesterel plus 100 µg ethinyl estradiol), followed 12 hours later by 2 more. The second regimen is levonorgestrel alone or Plan B: one 0.75-mg tablet followed 12 hours later by another dose. On August 24, 2006, Plan B was approved by the FDA for nonprescription sales to individuals aged 18 years and older. Over the past decade, increasing attention has been focused on emergency contraceptive pills (ECPs) as an important means to reduce rates of unintended pregnancy and abortion. Because of the potential public health benefit and the safety and simplicity of this method of contraception, prominent medical and public health organizations have supported efforts to maximize access to ECPs by making them available over the counter (OTC). However, concerns have been raised by activists, health care providers, and women themselves, that easy availability of ECPs could undermine use of more effective contraceptive methods, particularly condoms. To comment on this matter, e-mail section editor Jacqueline Rhoads at [email protected].
Online Poll: What is your view on this topic? Go to www.npjournal.org to register your preference. 282
The Journal for Nurse Practitioners - JNP
April 2008
Support
Rationale
for
Against
Emergency Contraceptive Pills Available Over the Counter
Emergency Contraceptive Pills Available Over the Counter
Regarner H. Thompson
Antiqua N. Smart
believe ECPs should be readily available for OTC use to reduce the risk of an unwanted pregnancy that may occur from consensual, unprotected, and nonconsensual sexual intercourse. The sooner ECPs are administered after unprotected intercourse, the better they work. For every 12 hours of delay, ECP efficacy is reduced in half. An ECP prescription can be hard for a woman to obtain without delay. Opponents of ECPs as an OTC medication cite concerns such as the chance that women will use ECPs as a method of contraception, coupled with the possible lack of medical surveillance that could increase the risk for adverse effects and possible threat to life. Studies have indicated that easier availability of ECPs neither promotes risky sexual behavior nor undermines consistent contraception use. Medical studies have also suggested that repeat ECP use has not been a major problem, as few women needed ECPs more than once or twice a year. The FDA has declared ECPs to be safe and effective for the prevention of an unwanted pregnancy and meet criteria for OTC status, in that ECP treatment is self-diagnosable, ECPs are safe and effective when self-administered, and ECP labeling is clear for selfadministration. The most commonly reported side effect associated with ECP use are nausea or vomiting; however, this can be prevented by taking them with food. Requests for ECPs often arise on weekends when offices are closed. The costs associated with a visit to a clinic may be prohibitive. Many other factors may deter women from seeking prescriptions, such as embarrassment, fear of discovery of sexual activity, and the inability to take time off from school or work. By having OTC availability of ECPs in drugstores that are open evenings and weekends, many of these obstacles are removed.
I
do not think ECPs should be available over the counter for several important reasons. There is a significant lack of data about long-term outcomes for women who take the excessively high doses of hormones that are required to prevent pregnancy in this manner. OTC access precludes examination by and discussion with the woman’s primary health care provider about how ECPs work, appropriate dosage and administration, potential side effects, and information about other aspects of unplanned sexual encounters such as lack of consent, the risk of sexually transmitted infections (STIs), and strategies for prevention. Advocates of OTC availability of ECPs insist that women can read information provided by the pharmacy prior to self-administration. There are very few patients who actually read package inserts, which are usually written in fine print at high literacy levels. How could this teaching method alone be beneficial to the millions of Americans who are illiterate? Although pharmacists are trying to improve patient education about medications, there are not many private areas available for the patient to ask questions to his/her pharmacist without other customers being able to hear the conversation. This could result in women taking ECPs incorrectly because they are too embarrassed to ask imperative questions in the presence of other customers. Some proponents suggest that OTC ECP availability is essential because condoms can break or sexual intercourse may be forced upon a woman. It would be better for the woman who underwent this experience to discuss the situation with her health care provider to ensure that follow-up care and education about STIs will occur. This opportunity is missed with OTC availability. Although the intention of OTC availability is to make ECPs more accessible to women, it actually denies women the basic care they deserve.
I
1555-4155/$ see front matter © 2008 American College of Nurse Practitioners doi:10.1016/j.nurpra.2008.01.022
www.npjournal.org
The Journal for Nurse Practitioners - JNP
283
counter-point
Regarner H. Thompson
Regarner H.Thompson received her bachelor of science in nursing degree from Our Lady of the Lake College in Baton Rouge, LA, and her master of nursing at Louisiana State University Health Science Center School of Nursing in New Orleans. She has extensive experience in oncology nursing, and has worked as a staff nurse and as an oncology clinical specialist for most of her nursing career. For several years, she served in a management position as director of operations for Amedisys Hospice Care Division.
Antiqua N. Smart
Antiqua N. Smart received her bachelor of science in nursing degree from Southern University and A & M College in Baton Rouge, LA, and her master of nursing at Louisiana State University Health Science Center School of Nursing in New Orleans. She has worked as a nurse specialist in low-risk neonatal nursing. She also served as a relief charge nurse/staff nurse in the mother/baby department at Woman’s Hospital in Baton Rouge. She holds certification as a family nurse practitioner and continues to practice in Baton Rouge.
Should Emergency Contraception be Sold Over the Counter? Two emergency regimens of hormonal contraception are available in the United States today. The first to be approved by the Food and Drug Administration (FDA) was the Yuzpe regimen, which consists of an initial dose of 2 combination oral contraceptives (0.5 mg levonorgesterel plus 100 µg ethinyl estradiol), followed 12 hours later by 2 more. The second regimen is levonorgestrel alone or Plan B: one 0.75-mg tablet followed 12 hours later by another dose. On August 24, 2006, Plan B was approved by the FDA for nonprescription sales to individuals aged 18 years and older. Over the past decade, increasing attention has been focused on emergency contraceptive pills (ECPs) as an important means to reduce rates of unintended pregnancy and abortion. Because of the potential public health benefit and the safety and simplicity of this method of contraception, prominent medical and public health organizations have supported efforts to maximize access to ECPs by making them available over the counter (OTC). However, concerns have been raised by activists, health care providers, and women themselves, that easy availability of ECPs could undermine use of more effective contraceptive methods, particularly condoms. To comment on this matter, e-mail section editor Jacqueline Rhoads at [email protected].
Online Poll: What is your view on this topic? Go to www.npjournal.org to register your preference. 282
The Journal for Nurse Practitioners - JNP
April 2008
Support
Rationale
for
Against
Emergency Contraceptive Pills Available Over the Counter
Emergency Contraceptive Pills Available Over the Counter
Regarner H. Thompson
Antiqua N. Smart
believe ECPs should be readily available for OTC use to reduce the risk of an unwanted pregnancy that may occur from consensual, unprotected, and nonconsensual sexual intercourse. The sooner ECPs are administered after unprotected intercourse, the better they work. For every 12 hours of delay, ECP efficacy is reduced in half. An ECP prescription can be hard for a woman to obtain without delay. Opponents of ECPs as an OTC medication cite concerns such as the chance that women will use ECPs as a method of contraception, coupled with the possible lack of medical surveillance that could increase the risk for adverse effects and possible threat to life. Studies have indicated that easier availability of ECPs neither promotes risky sexual behavior nor undermines consistent contraception use. Medical studies have also suggested that repeat ECP use has not been a major problem, as few women needed ECPs more than once or twice a year. The FDA has declared ECPs to be safe and effective for the prevention of an unwanted pregnancy and meet criteria for OTC status, in that ECP treatment is self-diagnosable, ECPs are safe and effective when self-administered, and ECP labeling is clear for selfadministration. The most commonly reported side effect associated with ECP use are nausea or vomiting; however, this can be prevented by taking them with food. Requests for ECPs often arise on weekends when offices are closed. The costs associated with a visit to a clinic may be prohibitive. Many other factors may deter women from seeking prescriptions, such as embarrassment, fear of discovery of sexual activity, and the inability to take time off from school or work. By having OTC availability of ECPs in drugstores that are open evenings and weekends, many of these obstacles are removed.
I
do not think ECPs should be available over the counter for several important reasons. There is a significant lack of data about long-term outcomes for women who take the excessively high doses of hormones that are required to prevent pregnancy in this manner. OTC access precludes examination by and discussion with the woman’s primary health care provider about how ECPs work, appropriate dosage and administration, potential side effects, and information about other aspects of unplanned sexual encounters such as lack of consent, the risk of sexually transmitted infections (STIs), and strategies for prevention. Advocates of OTC availability of ECPs insist that women can read information provided by the pharmacy prior to self-administration. There are very few patients who actually read package inserts, which are usually written in fine print at high literacy levels. How could this teaching method alone be beneficial to the millions of Americans who are illiterate? Although pharmacists are trying to improve patient education about medications, there are not many private areas available for the patient to ask questions to his/her pharmacist without other customers being able to hear the conversation. This could result in women taking ECPs incorrectly because they are too embarrassed to ask imperative questions in the presence of other customers. Some proponents suggest that OTC ECP availability is essential because condoms can break or sexual intercourse may be forced upon a woman. It would be better for the woman who underwent this experience to discuss the situation with her health care provider to ensure that follow-up care and education about STIs will occur. This opportunity is missed with OTC availability. Although the intention of OTC availability is to make ECPs more accessible to women, it actually denies women the basic care they deserve.
I
1555-4155/$ see front matter © 2008 American College of Nurse Practitioners doi:10.1016/j.nurpra.2008.01.022
www.npjournal.org
The Journal for Nurse Practitioners - JNP
283