Tag: pharmacist

Nextstellis®: A new drug update 

 

A new combined oral contraceptive was approved by the FDA (Nextstellis®) in April 2021.1 Nextstellis contains estetrol, an estrogen that can be manufactured from plants and that was originally derived naturally during pregnancy from the fetus liver, and drospirenone, a progestin found in other currently available contraceptives. Drospirenone has antiandrogenic and anti-mineralocorticoid activity.2 Estetrol differs from ethinyl estradiol in that has selective antagonistic and agonistic estrogen receptor activity, while ethinyl estradiol has exclusively agonist activity. With perfect use, Nextstellis is effective as a contraceptive for females between the ages of sixteen and fifty. These results are supported by data from two Phase III trials which obtained the drug’s safety and success over an extensive trial program. This research consisted of 3632 women between the ages of sixteen and fifty with 23% of patients having a BMI of 30-35 kg/m2. In the North American Phase III trial alone, 1524 women between the ages of sixteen to thirty-five years were tested over 12 months for 13 menstrual cycles and the clinical endpoint was that Nextstellis is 98% effective in preventing pregnancy when taken correctly.1

nextstellis packThe current recommended dosing is one tablet by mouth daily in the order provided by the blister pack for 28 days. The blister pack contains twenty-four active ingredient pills followed by four inert pills. The first active tablet should be taken on the first day of the menstrual cycle daily at the same time every day. If Nextstellis is not taken on the first day of menses an additional non-hormonal contraceptive method should be used for the first seven days.1 Nextstellis can be taken with or without food.2

 

Contraindications of Nextstellis

Patients should avoid use of Nextstellis prior to menarche or if they are postmenopausal.2 Nextstellis has a black box warning for women over the age of 35 who smoke.  Like other estrogen-containing contraceptives, this drug is contraindicated in women with a high risk, or current diagnosis, of thrombotic diseases. Nextstellis is also contraindicated in patients who have a history, or current diagnosis, of hormonal cancers such as breast cancer, renal impairment, adrenal insufficiency, and certain liver diseases: hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or decompensated cirrhosis. Additionally, this drug cannot be administered in conjunction with hepatitis C drugs that contain ombitasvir/ paritaprevir/ ritonavir. Drug interactions for Nextstellis include CYP3A inducers and the patient should use an alternative contraception method for up to 28 days after the last dose of a CYP3A inducer. 2 Lastly, Nextstellis should not be used when there is undiagnosed and abnormal vaginal bleeding.1  

 

Other warnings and precautions include gallbladder disease, cholestasis, and liver disease in which case the drug should be discontinued. If hypertension or hyperkalemia occurs, monitor periodically and discontinue if levels persist outside of normal parameters. Additionally, Nextstellis should be discontinued if migraines are new, persistent, and severe to the patient.1 Females with prediabetes and diabetes should monitor their blood glucose levels, and females with hypertriglyceridemia should consider a different birth control as this may increase the risk of pancreatitis.2

   

Limitations of Use

The limitations of Nextstellis is that it could be less effective in obese patients with a body mass index equal to or greater than 30 kg/ m2. Within the studied population, 23% accounted for women with a BMI between 30- 35 kg/ m 2. The Pearl Index for women with a BMI <30 was 2.57, and it was 2.94 for women with a BMI between >30 and 35. 1 The Pearl Index is equal to the number of women that get pregnant out of 100 women per year. As the BMI increased in the women participating in the study, the Pearl Index also increased. The lower the Pearl Index, the more effective the use of contraceptives. 2

 

Adverse Reactions

The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms.1 Mood disturbances were classified as irritability, anxiety, insomnia, panic disorder, restlessness and suicidal ideation. Breast symptoms included breast enlargement and sensitivity.2   These side effects are common in all combination oral contraceptives. Prescribers and dispensers should educate their patients that these symptoms are likely to occur, and most side effects will begin to resolve after three to five months of therapy when the body has adjusted to the hormonal changes. 3

 

Unique Features

While there are several other combination oral contraceptives on the market, Nextstellis has unique features that distinguishes it from other oral contraceptives. First, the estrogen component is estetrol, whereas most other contraceptives contain ethinyl estradiol. According to Grandi and colleagues  the selective actions of estetrol can lead to fewer side effect because the half-life of estetrol is 20- 28 hours, whereas other estrogens like estriol have a half-life of 10- 20 minutes and estradiol has a half-life of 1-2 hours. Estetrol is also minimally converted to estriol and estradiol. The longer half-life and the minimal metabolism to other estrogen forms, allows this drug to be  available for a longer period of time to bind at the receptor sites.4 Specifically, Nextstellis selectively binds to the nuclear estrogen receptor and it is described to be a native estrogen with selective action in tissues. 1 In pharmacologic studies, it was proven that estetrol acts as an estrogen in bones, uterus, and vagina. 5 

 

Clinical Trials

In addition to providing a contraceptive option for women who are unable to tolerate ethinyl estradiol, Nextstellis has demonstrated overall low rates of common side effects found in oral contraceptives such as acne, libido changes and breast pain in two Phase III studies (North American trial and the EU/Russian study).1 Animal data demonstrated that estetrol had a 100 times weaker effect on breast tissue proliferation in vitro human cells along with in vivo mouse mammary glands than estradiol.3 Although early animal studies have shown that estetrol has less of a damaging effect on breast tissue and may have a lower impact on the risk of breast cancer for humans, there needs to be more studies to solidify this data. 4

 

Interventional studies on Nextstellis have demonstrated less outcomes of deterrent side effects common to hormonal contraceptives such as breakthrough bleeding. Less than 2% of patients in the Phase III study experienced unscheduled bleeding episodes after cycle 2.1 In the FIESTA study it was shown that estetrol combined with drospirenone (E4/DRSP) compared with  quadriphasic estradiol valerate and dienogest (E2 V/DNG) had different frequencies for unscheduled bleeding. Breakthrough bleeding was present in 33.8% of the E4/DRSP group group versus 47.8% of the E2 V/DNG group. There was an additional study that showed overall satisfaction of being on E4/DRSP was higher than E2 V/DNG when patients took a self-reported Subject Satisfaction and Health-Related Questionare.4

 

Environmental Impact           

Estetrol is beneficial because it is less likely to contribute to water pollution and harm to the environment than estradiol (E2) or ethinyl estradiol (EE2).6 Nextstellis is metabolized in a unique way where less of the drug ends up being in the urine and therefore less of it ends up in our water system. This drug is made through a plant-based procedure, unlike other estrogens. Estrogens like ethinyl estradiol are not metabolized well, leading to build up in the body. Ethinyl estradiol is excreted in the urine and ends up in bodies of water, where it can lead to damage to marine life’s growth and ability to reproduce, whereas estetrol’s ability to be decomposed more quickly can be more environmentally friendly. According to Mirtha Women’s Health Pharmaceutics, levels as low as 1ng/L of E2 and EE2 in fish environments can lead to adverse effects and are far more potent than having 32,000 ng/L of estetrol. Adverse side effects, including reduced testicular growth, development of ova-testes in males, reduced egg production, delayed maturation, and the population ratio skewed towards females. are severely affecting the fishes reproductive health6.

 

In conclusion, Nextstellis is a recent FDA-approved oral contraceptive that offers patients another alternative for birth control. Nextstellis’ active estrogen is estetrol which is unique compared to other combination oral contraceptives. While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Overall, Nextstellis is a safe and effective contraceptive option. 

 

REFERENCES

  1. NEXTSTELLIS® (DRSP/E4): Now Available for Pregnancy Prevention. https://www.nextstellis.com/. Accessed June 25, 2021.
  2. Nextstellis (Drospirenone and Estetrol) [package insert]. U.S Food and Drug Administration website. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed April 2021. 
  3. Grossman Barr, Nancy. “Managing Adverse Effects of Hormonal Contraceptives.” American Family Physician, U.S. National Library of Medicine, 15 Dec. 2010, pubmed.ncbi.nlm.nih.gov/21166370/.
  4. Grandi G, Chiara Del Savio M, Lopes da Silva-Filho A, Facchinetti F. Estetrol (E4): the new estrogenic component of combined oral contraceptives. Taylor & Francis. https://www.tandfonline.com/doi/full/10.1080/17512433.2020.1750365. Published April 7, 2020. Accessed June 25, 2021.
  5. Singer, Christian F., et al. “Antiestrogenic Effects of the Fetal Estrogen Estetrol in Women with Estrogen-Receptor Positive Early Breast Cancer.” OUP Academic, Oxford University Press, 5 July 2014, academic.oup.com/carcin/article/35/11/2447/416699.
  6. Mithra Pharmaceuticals. “E4 Paves the Road towards a Revolutionary Era of Environmental FRIENDLY MEDICINES.” GlobeNewswire News Room, Mithra Pharmaceuticals, 10 Jan. 2020, http://www.globenewswire.com/news-release/2020/01/10/1968775/0/en/E4-Paves-the-Road-Towards-a-Revolutionary-Era-of-Environmental-Friendly-Medicines.html


About the Authors

AthinaAthina Herrera Ng, PharmD Candidate 2023, is currently in her third year of pharmacy school at Midwestern University College of Pharmacy-Downers Grove. She holds the Event Chair position for Pharmacy and Pediatrics and is invested in learning more about women and children’s health. She is passionate about creating art in her free time as well as helping others heal through expressive therapy.

 

KaylaKayla Mitzel, PharmD Candidate 2023, is currently in her second year of pharmacy school at Midwestern University College of Pharmacy – Downers Grove. She is serving as the President Elect for APhA-ASP, and the Member at Large for CPNP. Her hobbies include running and biking. 

Reviewed by Brooke Griffin, PharmD, BCACP.

Present and Future Pharmacist Roles in Medication Abortion Care

Medication Abortion Pharmacist

Educational programming for pharmacy students and practicing pharmacists on medication abortion is limited.

Twenty years ago, the FDA approved mifepristone. Since then, medication has transformed the accessibility of abortion. In 2017, about 39% of abortions in the United States were medication abortions, reflecting many people’s preference for this option.1 As reproductive health services are transforming, it is important that pharmacy services become adaptive to them.

What is medication abortion?

A medication abortion is the use of medications to end a pregnancy. There are a couple of medication abortion regimens, but the only regimen approved by the FDA is a combination of mifepristone and misoprostol to end a pregnancy up to 70 days gestation.2

First, a patient takes 200 mg of mifepristone orally followed by 800 mcg of misoprostol buccally, 24-48 hours after the mifepristone dose. After 7-14 days, the patient must follow-up with a health care provider.2

Mifepristone works by binding competitively to the intracellular progesterone receptor, thus blocking the effects of progesterone that support the pregnancy.3 Misoprostol works by inducing contractions in the myometrium as well as relaxation of the cervix.4

According to a systematic review performed by the American College of Obstetrics and Gynecology (ACOG), medication abortion was 97% effective up to 70 days after gestation.5

Present pharmacist roles with medication abortion

Right now, the pharmacist role with medication abortion is minimal as patients receive their dose of mifepristone in the clinic to take either at that time or at home. A prescription for misoprostol may be filled at a pharmacy to be picked up by the patient. Pharmacists will counsel patients on how to take the misoprostol and what to expect with this medication.

Mifepristone is only able to be dispensed at a clinic as a result of restrictions in place as part of the Risk Evaluation and Mitigation Strategies, or REMS, with an exception allowing mail order during the pandemic. The purpose of REMS is to assure that a medication’s benefits outweigh its risks. Recently, there have been studies on the safety of mifepristone to determine whether the REMS requirements are necessary or not.

Future pharmacist roles with medication abortion

According to articles published in the New England Journal of Medicine and Journal of the American Pharmacists Association, the REMS restrictions on mifepristone use have been deemed medically unnecessary as the rates of adverse events and mortality are extremely low. Since its approval, only 19 deaths have been reported to the FDA out of over 3 million patients who had taken mifepristone giving it a mortality rate of 0.00063%.6 Additionally, analysis of data from studies of over 423,000 women, which demonstrated that nonfatal serious adverse events from mifepristone use ranged from 0.01-0.7% and were almost always able to be treated.6

There are research studies underway to evaluate no-test medication abortion protocols, medication abortion telehealth services, and pharmacy dispensing of mifepristone. As new information emerges, there will be more opportunities for pharmacists to have a role in medication abortion care.

Educational programming for pharmacy students and practicing pharmacists on medication abortion is limited. The University of California San Francisco’s Advancing New Standards in Reproductive Health (ANSIRH) recently released a home study continuing pharmacy education program titled “Pharmacists’ Role in Medication Abortion” that is free and open to all. Birth Control Pharmacist has an open access introductory curriculum that can be integrated into pharmacy curricula.

Conclusion

In summary, medication abortion is a critical and common component of women’s health and reproductive health services. Although there are currently restrictions on the ways that patients can obtain a medication abortion, this many soon change and pharmacists will be an important part of access.

This article was originally published in Pharmacy Times.

REFERENCES

  1. Jones RK, Witwer E and Jerman J, Abortion Incidence and Service Availability in the United States, 2017, New York: Guttmacher Institute, 2019, Accessed September 8, 2020. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017
  2. U.S. Food and Drug Administration (FDA), Mifeprex (mifepristone) information, 2018. Accessed September 20, 2020. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
  3. Mifeprex (mifepristone) [prescribing information]. New York, NY: Danco Laboratories, LLC; April 2019.
  4. Cytotec (misoprostol) [prescribing information]. New York, NY: Pfizer; February 2018.
  5. Chen, MJ, Creinin, MD. Mifepristone with buccal misoprostol for medical abortion: A systematic review. Obstetrics and gynecology, 2015;126(1), 12-21. Retrieved from https://escholarship.org/uc/item/0v4749ss.
  6. Mifeprex REMS Study Group, Sixteen years of overregulation: time to unburden Mifeprex, N Eng J Med, 2017;376(8):790-794,https://www.nejm.org/doi/full/10.1056/NEJMsb1612526.
  7. Raifman S, Orlando M, Rafie S, Grossman D. Medication abortion: potential for improved patient access through pharmacies. 2018;58(4):377-81.


About the AuthorBreanna Headshot

Breanna Failla is a pharmacy student in the Class of 2022 at Midwestern University in Illinois. Breanna completed a summer internship with Birth Control Pharmacist.

A Primer on Reproductive Justice for Pharmacy Professionals

Reprodutive Justice Pharmacy

What is reproductive justice?

Reproductive justice is “the human right to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities” as defined by SisterSong Women of Color Reproductive Justice Collective [1]. Reproductive justice exists in a trinity of frameworks also consisting of reproductive health and rights.

 

How does it apply to pharmacy practice?

All health care providers, including pharmacists, take oaths to serve their patients as ethically and professionally as possible. The concept of reproductive justice falls within the scope of this promise, especially as it pertains to women of color and other marginalized people.

Legislators, healthcare providers and communities can address the intersectionality of oppressive forces (e.g. racism, sexism, classism, and ageism) that influence care given and received [2]. Barriers to the realization of reproductive freedoms and choices have stood in the way of family planning and personal health for ages. If we value reproductive justice and recognize the injustices of the past and present, we can prepare providers to shape a revolutionized future for reproductive care.

 

What historical injustices should we be aware of?

In contrast to reproductive justice, reproductive oppression is the control and manipulation of people through their bodies, sexuality, labor, and reproduction, according to Forward Together [3]. The goals of reproductive justice become clear when the injustices of the past are studied and acknowledged as reproductive oppression. They are stark by today’s standards, but they also remind us of a time when such acts were considered appropriate.

Just a few examples of historical injustices:

  • Rape and forced breeding of black slaves (1700s-1800s) [4]
  • Sterilization of the “hereditarily diseased” in Nazi Germany (1934-1945) [5]
  • Experimentation on low-income, imprisoned, and/or women of color for birth control research without informed consent (mid-1900s) [6]
  • Sterilization of Native Americans (1960s-1970s) [7]
  • China’s one-child policy (1979-2015) [8]

 

Are reproductive injustices still occurring now?

Although not as extreme, reproductive injustices still exist and hide in plain sight, including [9]:

  • Promotion of abstinence
  • Propagation of social “taboos” like teen and premarital pregnancies
  • Refusal of service (denying OTC emergency contraception sales or prescription medications)
  • Low access and availability of services to immigrants
  • Providing access to reproductive and contraceptive resources but limiting their feasible attainability through scarcity, geographical distance, and cost (lack of insurance)
  • Long-acting reversible contraception (e.g. implants and IUDs) as first-line birth control methods
  • The Hyde Amendment, which restricts the use of federal funds for abortions
  • Targeted Regulation of Abortion Providers (“TRAP”) laws, which shut down abortion clinics and effectively reduce access to abortion services

 

What can pharmacy professionals do?

The changes needed to achieve reproductive justice are easier said than done but not impossible. Widespread change depends on political decisions made at state and federal levels, but each health care provider can do their part in enacting progress in their workplaces. Putting aside personal beliefs in favor of patients’ best interests is key. Pharmacists in one-quarter of U.S. states are prescribing birth control with other states following suit [10].

Pharmacists can adopt practices that align with reproductive justice like the following:

  1. Be aware of personal biases. It is normal to have them, but recognition is key to avoid acting on them. Imagine serving a patient who has a different racial or socioeconomic background from you. How would your care and demeanor differ (if at all)?
  2. Do your research. Don’t fall prey to industry claims and monetary influences. For instance, with contraception consider all methods equally initially and narrow down the choices throughout the course of the patient interview and assessment.
  3. Share decision-making. Do not assume that your patient has the same values as you when making healthcare decisions. For instance, with contraception we cannot assume that effectiveness is the most important factor for patients. There are many other values and preferences that influence their choices, such as side effects, frequency of use, return to fertility, invasiveness/discomfort, and confidentiality. In one study, 28% of black women reported feeling pressured to use a method that was not their preferred [11]. Pharmacists should educate patients on all the various options available to them and give people the freedom to make their own decisions; this will improve patient satisfaction and outcomes. Always be mindful of their values, goals, and lifestyles.

Remember that what we now view as outrageous was once normal, and always try to think years ahead of the present to lead and be better prepared for inevitable change.

References

  1. “Reproductive Justice.” Sister Song, www.sistersong.net/reproductive-justice. 
  2. McIntosh, J. “Reproductive Justice: A Practice Framework.” ACSAP 2018 Book 2: Women’s and Men’s Care, ACCP, May 2018, 171–89.
  3. Forward Together, forwardtogether.org/. Accessed on 29 August 2020.
  4. Foster, Thomas A. “The Sexual Abuse of Black Men under American Slavery.” Journal of the History of Sexuality 2011;20(3):445–64.
  5. “German Law Authorizes Sterilization for Prevention of Hereditary Diseases.” United States Holocaust Memorial Museum, newspapers.ushmm.org/events/german-law-authori- zes-sterilization-for-prevention-of-hereditary-diseases. 
  6. Blakemore, Erin. “The First Birth Control Pill Used Puerto Rican Women as Guinea Pigs.” History.com, A&E Television Networks, 9 May 2018, www.history.com/news/ birth-control-pill- history-puerto-rico-enovid.
  7. Blakemore, Erin. “The Little-Known History of the Forced Sterilization of Native American Women.” JSTOR Daily, 25 August 2016, daily.jstor.org/the-little-known- history-of-the-forced-sterilization-of-native-american-women/. 
  8. Connett, Wendy. “Understanding China’s Former One-Child Policy.” Investopedia, 28 August 2020, www.investopedia.com/articles/investing/120114/understanding-chinas-one -child-policy.asp. 
  9. McDonald-Mosley, Raegan, MD, MPH, FACOG. “Reproductive Justice and Patient- Centered Care.” Maryland Department of Health Reproductive Health Roundtable Virtual Series. 2 July 2020.
  10. “Pharmacist Prescribing of Hormonal Contraception.” Birth Control Pharmacist, https://birthcontrolpharmacist.com/policies/. 
  11. Thorburn S, Bogart LM. African American women and family planning services: perceptions of discrimination. Women Health. 2005;42(1):23-39. 


About the AuthorGayane Kechechyan Headshot

Gayane Kechechyan, PharmD Candidate is a pharmacy student in the Class of 2023 at University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. Gayane completed a summer internship with Birth Control Pharmacist.

Updated Report on State Policy Efforts to Expand Access to Contraception in Pharmacies

Free 22-page report describing the current landscape of direct pharmacy access to contraception in pharmacies, state policy approaches and experiences, as well as implementation.

The 2020 report includes information for policy efforts in 2020, along with emphasis on definitions of reimbursement vs. payment and a new appendix with model bill elements. 

Subscribe and download PDF report

Sex & Gender 101

Sex and Gender 101 Katie Hood

I recently had the opportunity to attend the Sex & Gender 101 webinar designed to help anyone in the healthcare field learn more about creating trans inclusive care. It is crucial to create an environment that is inclusive because trans people – especially trans people of color – face many barriers to healthcare.

We have all had doctor’s appointments where we were required to fill out a form and check one of two boxes to describe our gender: male or female. For someone who is not cisgender, or someone whose sense of personal identity and gender does not correspond with their birth sex, this can immediately cause feelings anxiety and mistrust before the appointment even starts.

When we look at gender beyond the binary, we find that there are many identities that comprise a person. The first identity that should be recognized is a person’s pronouns; most commonly, we might think of she/her and he/him pronouns, but there are other pronouns like they/them, ze/zir, or others that someone may decide most accurately represents them. It is important to respect and use a person’s preferred pronouns and to understand that we cannot infer other aspects of a person’s identity based on their pronouns.

Another identity that may be important to recognize in the healthcare setting is sex assigned at birth. Like gender, sex assigned at birth is also commonly thought of as binary: male or female. However, people could also be intersex, meaning their genetics and/or anatomy may not fit into the traditional male or female boxes.

Coming back to gender, the typical male and female boxes should be expanded to include, at a minimum, nonbinary. The term nonbinary is a specific gender identity label and an umbrella term. Whether specific or general, this word refers to anyone whose gender is somewhere outside of a strict gender binary. Not all nonbinary people consider themselves to be transgender, but the definition of transgender used here does include nonbinary people.

Gender expression is an identity that may align with someone’s gender but does not have to. People belonging to any gender have the freedom to present themselves in manners that are feminine, masculine, both, or neither. Like pronouns, we cannot assume the other identities of a person based on their gender expression.

The last two identities are sexual attraction and romantic attraction, which, like gender and gender expression, could be the same or different.

I hope that like me, you were able to learn something about gender identities. If you are a healthcare professional, I challenge you to make changes to your practice that will create a more inclusive space for people of all identities.

 

For more information about this training program, visit https://www.innovating-education.org/course/gender-inclusive-care/.


About the AuthorKatie Hood

Katie Hood, PharmD Candidate is a pharmacy student in the Class of 2021 at Shenandoah University Bernard J. Dunn School of Pharmacy and Pharmaceutical Sciences. Katie completed an elective APPE rotation with Birth Control Pharmacist.

Levonorgestrel Intrauterine Device for Emergency Contraception

Levonorgestrel IUD for EC

A New Emergency Contraception Option

A recent study set out to assess the one-month pregnancy risk with the levonorgestrel 52-mg intrauterine device (IUD, Liletta®) as compared with the copper IUD (Paragard®) for emergency contraception (EC). The study included adults up to 35 years old who requested EC after unprotected sexual intercourse. Unprotected sexual intercourse must have occurred within the previous five days, but participants were not excluded if unprotected sexual intercourse also occurred up to 14 days prior. Participants were instructed to follow-up one month after IUD insertion for a urine pregnancy test, but even if they did not follow-up, their medical records for the following six months were reviewed to verify if a pregnancy was ever detected.1

 

Why the Levonorgestrel IUD?

Although not currently approved by the FDA for EC, the copper IUD, has substantial evidence supporting its use for EC. The failure rate of the copper IUD as EC is much lower than that of oral EC options.2-4 However, when compared to the copper IUD, the levonorgestrel IUD is more popular for long-term contraception, likely due to its other benefits, including decreased menstrual bleeding and pain.5-7

 

Failure Rates and Adverse Events

Of 638 total participants who received an IUD, only one patient experienced an EC failure. The patient had received a levonorgestrel IUD and the pregnancy ended in a spontaneous abortion at ten weeks with the IUD still in place. Statistical analysis of the data showed that the levonorgestrel 52-mg IUD was non-inferior to the copper IUD as EC. Rates of adverse events that required medical attention during the first month of IUD use were similar among both groups and very low overall.1

 

What Does This Mean for Patients?

This evidence means there is a new highly effective option for patients seeking EC and ongoing long-term contraception within five days of unprotected sexual intercourse. Although Liletta® was the levonorgestrel IUD used in this study, Mirena® is another levonorgestrel 52-mg IUD that releases the same daily dose of levonorgestrel. Other levonorgestrel IUDs release varying amounts of levonorgestrel, so we cannot necessarily expand these results to other options at this time. It is also possible the levonorgestrel IUD could be effective in preventing pregnancy when used up to 14 days after unprotected sexual intercourse, but more research is needed in this patient population.1

 

What Does This Mean for Pharmacists?

Pharmacists should be aware of this new option when counseling and referring patients who request EC after unprotected sexual intercourse. Of course, pharmacists should also know when it would be appropriate to utilize other EC options and if their state allows them to prescribe oral EC.

 

For more information: 

References

  1. Turok DK, Gero A, Simmons RG, et al. Levonorgestrel vs. copper intrauterine devices for emergency contraception. N Engl J Med. 2021; 384:335-44.
  2. Cleland K, Zhu H, Goldstuck N, et al. The efficacy of intrauterine devices for emergency contraception: a systematic review of 35 years of experience. Hum Reprod. 2012; 27:1994-2000.
  3. Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-inferiority trial and meta-analysis. Lancet. 2010; 375:555-62.
  4. von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicenter randomized trial. Lancet. 2002; 360:1803-10.
  5. Diedrich JT, Desai S, Zhao Q, et al. Association of short-term bleeding and cramping patterns with long-acting reversible contraceptive method satisfaction. Am J Obstet Gynecol. 2015; 212:50-8.
  6. Sanders JN, Myers K, Gawron LM, et al. Contraceptive method use during the community wide HER Salt Lake contraceptive initiative. Am J Public Health. 2018; 108:550-6.
  7. Peipert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011; 117:1105-13.


About the AuthorKatie Hood

Katie Hood, PharmD Candidate is a pharmacy student in the Class of 2021 at Shenandoah University Bernard J. Dunn School of Pharmacy and Pharmaceutical Sciences. Katie completed an elective APPE rotation with Birth Control Pharmacist.

Medication Abortion Curriculum: A Pharmacy Student Perspective

The topics of reproductive health and particularly abortion remains stigmatized in today’s society despite 1 in 4 women having an abortion in their lifetime. Pharmacy school curriculums across the nation reflect this predicament, since abortion is omitted in the standard curriculum of many, if not all, pharmacy schools. Which brings up a question of how knowledgeable are student pharmacists, future medication specialists, with this subject?

Medication Abortion Curriculum was developed by the expert pharmacy educators at Birth Control Pharmacist in an attempt to better familiarize pharmacy students with the topic of medication abortion. This open access curriculum is a PowerPoint deck that is intended to be added or incorporated within a standard, larger lecture such as contraception. The slides provide the basics on medication abortion and prepare pharmacy students to dispense medications and counsel patients appropriately.

Medication abortion with a regimen of mifepristone and misoprostol has been shown to be safe and effective for decades, and is becoming increasingly utilized and acceptable to women across the world.1 Despite the growing use of these medications to induce termination of early pregnancy, the U.S. pharmacist involvement in abortion care is currently limited due to FDA imposed restrictions on how mifepristone can be distributed and dispensed.2 However, in some countries both medications are allowed to be dispensed by pharmacies rather than being limited to clinics and doctor’s offices, improving accessibility for people in need.3,4 Current research has shown great benefits of expanding the types of clinicians providing services, which may eventually lead to FDA lifting unnecessary restrictions to increase access to medication abortion through pharmacies.5

Diversification of skills and areas of expertise is necessary for any future pharmacists who want to stay relevant in tomorrow’s healthcare. Pharmacists need to be prepared to dispense and counsel on misoprostol now and may be able to offer additional patient-centered care in the future. For these reasons, pharmacists should be capable of providing patients with sufficient information, education, and safe and convenient care.

If you’re a pharmacy educator or a student who wants to advocate for medication abortion to be included in your school’s curriculum, check out the slide deck on the Resources page under Pharmacist Education and Training. 

Medication Abortion Curriculum Open Access for Pharmacy Educators

References

  1. Beaman J, Prifti C, Schwarz EB, et al. Medication to Manage Abortion and Miscarriage. J Gen Intern Med. 2020;35(8):2398-2405. doi:10.1007/s11606-020-05836-9.
  2. Raifman S, Orlando M, Rafie S, et al. Medication abortion: Potential for improved patient access through pharmacies. J Am Pharm Assoc (2003). 2018;58(4):377-381.doi:10.1016/j.japh.2018.04.011.
  3. Tamang A, Puri M, Masud S, et al. Medical abortion can be provided safely and effectively
    by pharmacy workers trained within a harm reduction framework: Nepal. Contraception. 2018;97(2):137-143. doi:10.1016/j.contraception.2017.09.004.
  4. Rogers C, Sapkota S, Paudel R, et al. Medical abortion in Nepal: a qualitative study on women’s experiences at safe abortion services and pharmacies. Reprod Health. 2019;16(1):105. doi:10.1186/s12978-019-0755-0.
  5. Weaver G, Schiavon R, Collado ME, et al. Misoprostol knowledge and distribution in Mexico City after the change in abortion law: a survey of pharmacy staff. BMJ Sex Reprod Health. 2019;46(1):46-50. doi:10.1136/bmjsrh-2019-200394.


About the AuthorEugenia

Eugenia A. Haire, PharmD Candidate is a pharmacy student in the Class of 2021 at the Shenandoah University Bernard J. Dunn School of Pharmacy. Eugenia completed an elective APPE rotation with Birth Control Pharmacist.

Webinar Introduces Pharmacists to New Hormonal Contraceptives

New drugs are constantly being approved by the FDA, and it is important for practicing pharmacists to stay up to date on new contraceptives. There are now over 50 unique contraceptives available, and pharmacists need to be aware of these and incorporate them into their practices. Birth Control Pharmacist recently hosted a webinar that aimed to educate pharmacists, pharmacy staff members, and other healthcare providers to feel more comfortable with the new contraceptive options they could prescribe or dispense.

The faculty speaker, Shareen El-Ibiary, PharmD, BCPS, FCCP, is a professor and chair of the Department of Pharmacy Practice at Midwestern University, College of Pharmacy. She is also a consultant for Birth Control Pharmacist.

The program focused on three new hormonal contraceptives – Annovera, Twirla, and Slynd – along with one new nonhormonal contraceptive – Phexxi.

What is Annovera?

Annovera is a new contraceptive vaginal ring that contains segesterone and ethinyl estradiol. It is different from NuvaRing because it is used for 13 consecutive cycles, as opposed to just one cycle. It is not refrigerated.

What is Twirla?

Twirla is a new contraceptive patch that contains levonorgestrel and ethinyl estradiol. It is very similar to Xulane in terms of application, but Twirla has lower rates of headache, nausea, and breast tenderness.

What is Slynd?

Slynd is a new progestin-only oral contraceptive that contains drospirenone. In each pack of 28 tablets, there are 24 active tablets and four inactive tablets. The main benefit of Slynd over norethindrone is less opportunity for missed doses. Unlike norethindrone’s 3-hour window to take a dose, patients on Slynd have up to a 24-hour window to take a dose before it is considered a missed dose. Pharmacists need to be aware of the unique drug interactions associated with Slynd.

What is Phexxi?

Phexxi is a new prescription-only contraceptive gel that does not contain nonoxynol-9. Instead, it contains lactic acid, citric acid, and potassium bitartrate. Phexxi should be applied vaginally within one hour before each episode of intercourse. It should not be used by patients who have recurrent urinary tract infections or urinary tract abnormalities.

Dr. El-Ibiary wrapped up the program by reviewing patient cases, and she even demonstrated a patient interaction within a pharmacy. This helped bring the concepts from the lecture portion to life and allowed participants to practice incorporating these new hormonal contraceptive into their counseling and other practices.

Fortunately, if you missed the webinar, the video recording and materials are available for home study online at https://birthcontrolpharmacist.com/newhc/. The course material is available to all, with pharmacists having the opportunity to obtain Continuing Pharmacy Education credit. This material provides education to participants to increase their comfort in prescribing, dispensing, or counseling patients on the new contraceptive options available.

Participants provided feedback at the conclusion. Keep reading to see their positive reviews and gain a better idea of what to expect from the online course:

 “As a P1, I appreciate how Dr. El-Ibiary explained everything clearly. It helped me better understand the content and I now have a much better understanding of contraceptives.”

“Very practical, real-life patient case scenarios were used as effective teaching points.”

“Amazing presentation. Very informative and easy to follow.”

“Thank you for providing this CE! It was both helpful & thorough.”

New Hormonal Contraceptives Home Study CPE

Katie HoodAbout the Author

Katie Hood, PharmD Candidate is a pharmacy student in the Class of 2021 at Shenandoah University Bernard J. Dunn School of Pharmacy and Pharmaceutical Sciences. Katie completed an elective APPE rotation with Birth Control Pharmacist.

Webinar Equips Pharmacists to Provide Contraception Care During COVID-19

During the COVID-19 worldwide pandemic it has been quite the adjustment to deliver safe and quality patient care. Specifically, for contraception care, pharmacists have been working extra hard to continue their direct patient care with how accessible they are. Birth Control Pharmacist recently hosted a webinar that facilitated an educational program and discussion for pharmacy staff members to feel more equipped to deliver contraception and emergency contraception services during COVID-19.

We had multiple speakers of diverse backgrounds in order to give different perspectives on the effects of COVID-19 on contraception care and how pharmacists can best help their patients. The panel speakers were Jennifer Karlin, MD, PhD an attending physician in Family & Community Medicine at UC Davis and Sonya Frausto, PharmD who is the pharmacist-in-charge at Ten Acres Pharmacy, an independent community pharmacy.

What is the healthcare landscape during the COVID-19 pandemic?

Laying out the landscape during the COVID-19 pandemic helped paint a picture to participants about the extensive effects on contraception care. Whether that be loss of insurance or fear of infection from going to healthcare facilities, it highlighted how important it can be for pharmacists to assist their patients with contraception while following national guidelines.

How can pharmacists prescribe birth control safely?

National guidelines covered prescribing birth control and also social distancing to reduce the risk of spreading the virus. Telehealth has been a useful service in adhering to social distancing, while also maintaining face-to-face encounters. This helps patients maintain a personal relationship with their pharmacist.

What are some best practices within the pharmacy?

There are many useful suggestions throughout the webinar, but a useful tool they referenced is the Contraceptive Care Best Practices During COVID-19 best practices guide for pharmacies created by Birth Control Pharmacist.

Dr. Frausto wrapped up the program by reviewing useful tools and resources to use while in the pharmacy. Then she demonstrated a patient interaction within a pharmacy. This helped really bring the whole webinar together with a real-world example and solidified that this webinar is well worth the watch.

Fortunately, if you missed the webinar, the video recording and materials are available for home study online at https://birthcontrolpharmacist.com/careduringcovid/. The course material is available to all, with pharmacists having an opportunity to obtain Continuing Pharmacy Education credit. This material provides education to participants to increase their comfort in providing contraception care, including prescribing hormonal contraception, in community pharmacies during the COVID-19 public health emergency.

Participants provided feedback at the conclusion. Keep reading to see their positive reviews and gain a better idea of what to expect from the online course:

“I loved this CE. Very informative, the speakers were great and passionate about the topic!”

“As a newer pharmacist, this type of information helps me to feel better prepared to provide these kinds of services to patients.”

“Loved the topic, very timely for COVID.”

“I was coming from a state where pharmacists did not prescribe birth control so this was a new perspective for me.”

pharmacy-based-contraception-care-during-covid-19-online-cpe-program-1

About the Author

Samantha ThompsonSamantha Thompson, PharmD Candidate is a pharmacy student in the Class of 2023 at University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. Samantha completed a summer internship with Birth Control Pharmacist.

Putting Policy into Practice: Contraception Care in San Francisco Pharmacies

Contraception Care in San Francisco Pharmacies

What makes some pharmacies more successful than others at implementing pharmacist-prescribed contraception care? To answer this question, we conducted a study to determine the extent of hormonal contraceptive prescribing, also referred to as furnishing in California, among San Francisco community pharmacies, and identify the factors that led to successful implementation.

Implementation in San Francisco pharmacies 

After calling all 113 community and independent pharmacies located in San Francisco, we identified 21 locations (19%) that furnished hormonal contraception. Only one of these was an independent pharmacy; the rest were chain community pharmacies. Half or more of Costco, CVS, and Safeway locations furnished hormonal contraception, while less than 5% of Walgreens and independent pharmacies did so. 

Factors associated with successful adoption

Within the control of pharmacies

We identified three main factors that led to successful implementation that were within pharmacy control. The first was a company protocol—respondents stated that having an established precedent and administrative support, and paying for pharmacists’ training, was crucial for successful implementation. The second was advertising, due to the community’s limited awareness of this service. Lastly, the accessibility of pharmacists played a role in increasing access to services and to hormonal contraception. 

Relating to the setting or larger community

We also identified factors leading to successful implementation outside the control of pharmacies. These included the location of the pharmacy and its patient population, as well as collaboration with local clinics. Pharmacies in proximity to students and other younger and short-term residents found there was more need for hormonal contraceptive furnishing services. One pharmacy had an existing collaboration with a local clinic and its providers that acted as a bridge to the service. 

Barriers to service adoption 

Respondents also reported several barriers to successful implementation. The cost of consultation for patients was a widespread concern. Lack of time was another barrier reported by many pharmacists, which could be resolved through scheduled appointments or more overlaps of pharmacist shifts. The last identified barrier was patient privacy. Many respondents expressed a need for a private consultation room in order to provide a confidential service, and those that had a private consultation room acknowledged this as a benefit. 

Effect of COVID-19 on furnishing 

Our data collection began in April 2020, shortly after the introduction of San Francisco’s shelter-in-place order. We asked study participants to comment on whether practices or demand for hormonal contraception had changed under the shelter-in-place order and responses were mixed. While some pharmacies reported an increase in demand for hormonal contraceptive furnishing, others reposted a decrease. 

Implications for the future

We found an increase in participation among pharmacies in San Francisco that were furnishing hormonal contraception than previously reported in California overall; 19% in San Francisco in 2020 versus 11% statewide in 2017. This finding could reflect either pharmacies adding this service gradually over time or a local phenomenon. However, CVS pharmacists reported that a new corporate protocol was initiated in 2020, suggesting the higher rate of furnishing we identified could be reflected statewide. Our results detailed successful strategies used by San Francisco community pharmacies that could serve as a model for expanding this service to other pharmacies. In the words of one respondent:

“The pharmacist is the most overtrained and underutilized health care professional we have.”

With more widespread implementation of this service, community pharmacists can increase their scope of practice, improve quality and continuity of care for patients, and expand access to hormonal contraception to improve reproductive health.

Link to the full paper.

References

  1. California Board of Pharmacy 1746.1: Protocol for pharmacists furnishing self- administered hormonal contraception. Link.
  2. Chen L, Lim J, Jeong A, & Apollonio D. Implementation of hormonal contraceptive furnishing in San Francisco community pharmacies, 2020. Journal of American Pharmacists Association. doi:https://doi.org/10.1016/j.japh.2020.07.019
  3. Gomez AM. Availability of pharmacist-prescribed contraception in California, 2017. JAMA. 2017;318(22):2253e2254. 

Chen Lim Jeong ApollonioAbout the Authors

Lauren Chen, Julie Lim, and Asher Jeong are third-year doctoral students at the University of California San Francisco (UCSF) School of Pharmacy. Dorie Apollonio is a professor in the UCSF Department of Clinical Pharmacy.