Christine Blank

After the United States Supreme Court overturned it’s the longstanding Roe v. Wade decision on June 24,1 retail pharmacies are experiencing a marked increase in patients looking to purchase Plan B emergency contraception and are placing limits on the medication.

Meanwhile, the American Medical Association (AMA) is encouraging the FDA to approve OTC access to oral contraceptives without an age restriction.

On Monday, CVS Health, Walmart, and Rite Aid began limiting purchases of the Plan B pills, which were out of stock or in short supply on their web sites, according to 

Although Walgreens does not have purchase limits in place currently, Fraser Engerman, senior director of external relations for the chain, told 

, the retailer is “working to restock online inventory for ship-to-home.”

“Walgreens is still able to meet demand in-store, including leveraging digital-first solutions like curbside pickup. Plan B is being shipped to our stores and also restocked online in the next day or 2,” Engerman added.

 the company has implemented temporary purchase limits to ensure equitable access, but it has ample supply of the pills in stores and online.

And according to Catherine Carr, manager of public relations and external communications at Rite Aid, “Due to increased demand, at this time we are limiting purchases of Plan B contraceptive pills to 3 per customer.”

Walmart did not respond to the publication’s requests for comment.

Meanwhile, the AMA’s new policy, adopted the policy at its 2022 Annual Meeting of the AMA House of Delegates in Chicago, June 10 to 15, is particularly timely given the Roe v. Wade ruling.

“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” said AMA Board Member David H. Aizuss, MD, in a news release.3 “Access is one of the most cited reasons why patients do not use oral contraceptives, use them inconsistently, or discontinue use. Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies.”

There is a regulatory pathway at the FDA for converting oral contraceptives from prescription products to OTC products and a required manufacturer application for a switch is expected to be submitted before the end of 2022, AMA said.

When considering manufacturer applications, the FDA should consider that OTC birth control pills are safe and “a common-sense, science-based approach to addressing an important health equity and reproductive justice issue facing our communities,” the OCs OTC Working Group said in a recent letter4 to FDA Commissioner Robert Califf, MD.

“Over 60 years of research and data show that oral contraception is safe and effective. However, due to pervasive and systemic inequities, significant barriers to access remain for communities who bear the greatest share of these inequities: people of color, particularly Black, Latinx, AAPI, and Indigenous peoples, people who live in rural areas, those working to make ends meet, immigrSants, LGBTQ+ folks, and young people,” the Working Group wrote. "Increasing access to over-the-counter birth control would allow people to make decisions with dignity and respect—about their own bodies, lives and reproductive health and well-being, including when and whether to have children.”

Although the National Community Pharmacists Association (NCPA) does not have an established position on the issue currently, “we expect to have more insight after the NCPA House of Delegates meets during our annual convention in October to install new officers and consider legislative, regulatory, or policy resolutions,” Andrea Pivarunas, director of public affairs for NCPA, told 

“We anticipate discussions among delegates around options that would support patients having the choice to access oral contraceptives at pharmacies while also having a healthcare provider readily available to consult with on subjects including possible drug interactions, choosing between the dozens of oral contraceptives available in the marketplace, and their uses beyond contraception (acne, headaches, etc.),” she added.

Representatives from the American Pharmacists Association and the National Association of Chain Drug Stores did not respond to requests for comment.

Meanwhile, the AMA “will work with expert stakeholders to advocate for the availability of hormonal contraception as an OTC medication and continue to study issues relevant to OTC access including full insurance coverage without cost sharing of an OTC oral contraceptive,” the organization said.

Dobbs, State Health Officer of the Mississippi Department of Health, et al. v. Jackson Women’s Health Organization, et al. US Supreme Court opinion. June 24, 2022. Accessed June 27, 2022. 

https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf

Terlep S. CVS, Walmart, Rite Aid limit purchases of Plan B pills as demand surges following Roe ruling. MarketWatch. Published June 27, 2022. Accessed June 28, 2022. https://www.marketwatch.com/story/cvs-walmart-rite-aid-limit-purchases-of-plan-b-pills-as-demand-surges-following-roe-ruling-11656377178

AMA urges FDA to make oral contraceptive available over-the-counter. News Release. American Medical Association. June 15, 2022. Accessed June 15, 2022. 

https://www.ama-assn.org/press-center/press-releases/ama-urges-fda-make-oral-contraceptive-available-over-counter

OCs OTC Working Group letter to Robert Califf, FDA. April 4, 2022. Accessed June 24, 2022. 

https://ocsotc.org/wp-content/uploads/2022/05/OCs-OTC-letter_Califf_FINAL-4.4.2022.pdf

Articles

The American Medical Association is urging the FDA to approve OTC access to oral contraceptives.

Pharmacies limiting Plan B purchases after Roe v. Wade reversal

When pharmacists are helping patients fill out forms or are in counseling sessions, they should ask patients their preferred name and pronouns, said Kelsea Gallegos Aragon, PharmD,BCACP, assistant professor of Pharmacy Practice and Administration at the University of New Mexico College of Pharmacy and pharmacist clinician at Truman Health Services, during her presentation at the American Pharmacists Association 2022 Annual Meeting & Exposition. A patient may, for example, come in for hormone therapy, but do not want to use the pronoun for the sex they are in transition to currently.

Front desk and registration staff should also address patients by the proper pronouns. “If they use the wrong pronouns—called ‘deadnaming’ in the community—are they going to be happy or feel safe?” Aragon said. “They may leave.”

“We want to make sure everyone knows it is a safe place. You want to ensure that patients understand—whatever their gender, whatever their orientation—discrimination will not be tolerated,” Aragon said.

Another way to do this is by using only gender-neutral pronouns, such as “they,” and avoiding terms such as “guys” and “gals.”

Creating a safe, comfortable environment is vital, as the LGBQT community faces more health care disparities than the average population, according to Aragon. A 2015 study found that 1 of 3 transgender people have a negative experience at a medical visit, and 23% don’t engage in medical care due to fear of mistreatment. Additionally, 50% of LGBQT individuals said they had to educate their health care provider on how to provide care to them.

During her presentation, Aragon also clarified important definitions that pharmacy staff should know.

Sex is based on the genitalia an individual was born with, while gender is “much more complex,” she noted. “It’s how you feel about who you are, your internal sense of self, and how you fit into the world and society.”

“Gender non-binary” is used for individuals who may not feel like identifying as a male or a female, while “transgender” is an umbrella term for people whose gender identity and/or expression is different from cultural expectations.

Aragon also educated APhA 2022 attendees on feminizing hormones and masculinizing hormones.

Advise patients using estrogen—including estradiol, transdermal patches, and compounded creams—that they will experience softer, less oily skin; body fat redistribution (less in the center area of the body and more towards the hips); and decreased muscle mass—even if they are exercising the same amount of time.

Patients taking estrogen will also have thin or slow growth of body or facial hair and breast growth, an A or B cup at the most, Aragon noted.

Meanwhile, testosterone monotherapy adds more fat in the center of the body, which increases patient’s risks of higher blood pressure and developing diseases such as non-alcoholic fatty liver disease.

“This is a great time to talk [with the patient] about healthy lifestyle and…exercise,” Aragon added.

Aragon concluded her presentation by sharing helpful resources, including the Office of Disease Prevention and Health Promotion 

Healthy People 2020 Report on LGBT Health

National LGBTQIA+ Health Education Center

Aragon KG. How to provide high quality care for LGBTQ patients. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX

This article originally appeared on Drug Topics®.

Understanding gender terms and addressing patients using the right pronouns is vital to decreasing health disparities in the LGBQT community.

Simple steps toward reducing care disparities in the LGBTQ community

Understanding the sex differences in cardiovascular disease presentation and outcomes remains a major research priority, according to the American Heart Association (AHA).

In fact, the Go Red for Women special issue of AHA’s journal 

 includes numerous studies on the topic, after more than 100 manuscripts were submitted this year.

“Undeniably, cardiovascular disease remains the number 1 killer of women around the world, taking the lives of 1 in 3 women. Even 1 life lost is too many, because we know much of heart disease and stroke is preventable and treatable,” said Joseph A. Hill, MD, PhD, editor-in-chief of 

“Support for ongoing research, as well as female participation in pivotal clinical trials, are imperative to effectively address sex disparities in heart disease and stroke care as part of our effort to improve cardiovascular health for women,” Hill continued. “These are critical in our fight against heart disease and stroke in women.”

One of the important studies highlighted in the Go Red for Women issue was a comparison of the efficacy and safety outcomes of edoxaban (Lixiana) with warfarin in 8040 women versus 13,065 men with atrial fibrillation (AFib).

Researchers examined clinical trial data involving more than 21,000 patients (8040 women) with AFib and an elevated risk for stroke. They were randomized to a higher dose or a lower dose of the newer anticoagulant edoxaban or to warfarin, “which is an older anticoagulant that must be closely monitored and tends to carry some risks,” AHA said in its news release.2 Follow-up continued for around 3 years.

At baseline, women had a higher level of FXa activity—a critical protein in the clotting process—placing women at potentially increased risk of thrombosis relative to men. Treatment with high-dose edoxaban reduced FXa levels to a greater extent in women than in men, resulting in similar intensity of anticoagulation.

Compared to warfarin, the treatment effect of the higher dose of edoxaban on the risk of stroke or other major clotting events and on major bleeding was similar in women and men.

However, the high-dose edoxaban reduced the risk of severe bleeding outcomes, including hemorrhagic stroke, to a greater extent in women than in men, AHA said.

 “Researchers said the safety advantage of edoxaban in women is enhanced for multiple bleeding end points compared with men, suggesting that edoxaban is a particularly attractive option for the treatment of women with [AFib].”

y examined the association between sex and treatment outcomes of AFib ablation versus drug therapy.

Researchers randomized 2204 patients with AFib (37% women) who were 65 or older or were under age 65 but had at least 1 risk factor for stroke to receive treatment with either catheter ablation or drug therapy to control heart rhythm. There was no significant difference in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest in men versus women, they reported.

Adverse events related to either therapy were low in both men and women, without significant sex differences. Catheter ablation compared with drug therapy reduced AF recurrence in both men and women.

“Whereas prior nonrandomized data have suggested higher procedural complications in women compared with men, this was not seen in this randomized trial. Researchers said recommendations for ablation should not be discouraged based on concern for adverse events in women, and since ablation offers comparable benefits for women and men, sex should not be used as a basis for selecting a management strategy for treatment of AFib,” AHA said in its news release.

This article was originally published on Drug Topics®.

1. American Heart Association. AHA Journals Go Red for Women Collection.. https://www.ahajournals.org/go-red

2. Understanding heart disease, stroke in women remains a scientific research priority. News release. American Heart Association; February 15, 2021. Accessed March 2, 2021. 

https://newsroom.heart.org/news/understanding-heart-disease-stroke-in-women-remains-a-scientific-research-priority

3. Zelniker T, Ardissino M, Andreotti F, et al. Comparison of the efficacy and safety outcomes of edoxaban in 8040 women versus 13,065 men with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. 

. 2021. https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.052216

4. Russo A, Zeitler E, Giczewska A, et al. Association between sex and treatment outcomes of atrial fibrillation ablation versus drug therapy: Results from the CABANA Trial. 

https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.051558

The American Heart Association published a special issue to discuss current research in cardiovascular disease and outcomes in women.

Christine Blank

Articles

Pharmacies limiting Plan B purchases after Roe v. Wade reversal

Simple steps toward reducing care disparities in the LGBTQ community

Sex Disparities in Heart Disease, Stroke is a Major Research Priority