Keeping up with the latest developments regarding age restrictions on purchase of emergency contraceptives has been a real chore over the past few months. The situation continues to change, leaving pharmacists with a number of questions. One thing is for sure: the community pharmacist plays an important role in the appropriate assessment and education of consumers regarding contraceptive choices.
As described in this month’s OTCs Today (page 22), FDA in late April approved the lower age of 15 years for purchase of Teva’s Plan B One-Step (levonorgestrel), and a federal judge in New York this spring ruled that all consumers should be able to purchase such products without a prescription. The federal government has appealed the ruling.
These are important decisions. Almost half of pregnancies in the United States are unplanned, and one can generally assume that few girls younger than 15 intend to get pregnant. Intended or not, teen pregnancy has lit up the television and movie screens with popular hits such as “16 and Pregnant” and Juno. The reality of teen births is far more discouraging. “Only about 50% of teen mothers receive a high school diploma by 22 years of age, versus approximately 90% of women who had not given birth during adolescence,” CDC reported.
To simplify a complex situation, here are five questions on pharmacists’ minds and the best answers currently available.
Lowering or eliminating age restrictions on Plan B calls into question whether younger adolescents have adequate knowledge and information for making contraceptive decisions. In fact, that is one of the main criteria FDA uses in approving Rx-to-OTC switches: can consumers make correct decisions regarding purchase and use of medications based on the Drug Facts labeling on a nonprescription drug product?
Cynthia Harper, PhD, headed a team that was asked by FDA to assess whether young adolescents could make such decisions about taking Plan B and use the drug in a responsible manner. Harper, Associate Professor with the Bixby Center for Global Reproductive Health at the University of California, San Francisco, and her team reported in 2012 that young women are very capable of using this product correctly.
The Teva-sponsored study, published in Obstetrics & Gynecology, included 279 girls aged 11 years to 17 years who requested emergency contraception at teen reproductive health clinics. Participants using the single-tablet Plan B One-Step product, labeled for OTC use, did so correctly 93% of the time, and no unusual adverse events occurred.
Some pharmacists would agree with these researchers that age should not be the biggest concern.
“I think we need to take age out of the equation,” Amy Rudenko, PharmD, BCACP, Associate Professor with the Virginia Commonwealth University School of Pharmacy, told Pharmacy Today. “Currently, men enter our pharmacies and could be purchasing these products for potentially underage females.”
“There isn’t a large number of teens younger than 14 who are seeking contraceptive care,” Harper said. In fact, even though FDA had asked her team to study girls aged 11 years to 13 years in the Obstetrics & Gynecology study, they were not able to enroll enough to analyze.
Harper believed that the reason emergency contraceptive products are currently “behind the counter” is not due to issues in safety but rather that people are “nervous” about them.
“Nobody seems to worry that a young boy is going to buy condoms from a pharmacy,” said Harper. “I think some of our fears and worries about girls and their sexuality are counterproductive to our health care.” Rather than the age restriction, Harper feels that the larger issue is how we create access to health care. This access, Harper proposes, can be increased by OTC status of emergency contraception, without consideration of age or perhaps gender.
The fear that pharmacists or society at large may have about emergency contraception is a challenge. “Tylenol is certainly not harmless but I don’t think, as a nation, that’s something we’re scared about,” Harper said.
Adverse effects of emergency contraceptives include nausea, vomiting, and disruptions in menstrual cycles. Harper stressed that there is no risk of overdose with these products, unlike the dangers associated with acetaminophen or other OTC medications.
“It is obviously an individual pharmacist’s choice to dispense emergency contraception,” Rudenko said. If a pharmacy does not stock such products or the pharmacist on duty does not provide them for conscience reasons, she said, “we need to know where to send our patients and we need to give our patients good options for care.”
“They’ve come to the pharmacy seeking care,” Rudenko noted. “If we can’t provide [contraceptive] services and products due to a personal conflict or we’re simply out of stock, we still need to let them know where they can go for these products.”
Community pharmacists should avoid being fearful about providing guidance and education to their patients seeking emergency contraception, regardless of the patient’s age. Counseling points that should be considered by pharmacists include an assessment of appropriate timing of emergency contraceptives with regard to when the sexual encounter took place, and education on preventing future pregnancies. Plan B One-Step should be taken within 72 hours (3 d) after unprotected sex or birth control failure.
Patient counseling tips should also include potential adverse effects of the drugs, such as nausea and vomiting. Rudenko recommended advising patients to eat a small snack before taking the medication and, if timing allows, take the medication at bedtime to decrease gastrointestinal adverse effects. She also recommended that pharmacists educate patients that these products are intended to be used as primary contraception and do not protect against HIV or other sexually transmitted infections.
Pharmacists should also be prepared to direct women to appropriate community support resources if the sexual encounter involves an abusive relationship or rape. Deborah Beazley, NCC, MA, LGSW, works at West Virginia University’s Carruth Center for Psychological and Psychiatric Services and provides sexual assault counseling for students at that college. She told Today, “I would ask pharmacists to place near their phones the information for their local domestic violence and sexual assault agency and local rape crisis center.”
Rudenko suggested that pharmacists include the following counseling points for all women seeking emergency contraceptives:
Patients who are in danger or have been victims of domestic violence should also be directed to call 911 or the U.S. National Domestic Violence Hotline at 800-799-7233 and TTY 800-787-3224.