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. 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.

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. 

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.

Reducing Maternal Mortality in the United States through Collaboration

Maternal Mortality Blog Post - Birth Control Pharmacist

Healthy childbirth requires education and action prior to conception and should continue throughout the gestation period to monitor for any changes that require immediate medical attention. Approximately 60% of maternal deaths are preventable and family planning has shown to decrease the number of maternal deaths related to pregnancy.1,2 Addressing the heightened rates in the United States requires the collaboration of medical expertise to maximize the health of mothers and their offspring.

California is one of the first states to take an initiative in the common complications that arise during childbirth. The California Maternal Quality Care Collaborative (CMQCC) has backed initiatives surrounding two common complications in childbirth: hemorrhaging and blood pressure. Since early prevention of these two serves as a crucial factor in the mother’s health, the team has created standard procedures through practicing these events through simulation, formulating a method for the measurement of blood loss, and creating an accessible toolkit to treat such events when they arise. The Pomona Valley Hospital Medical Center is laying the foundation for protocols that will save a woman’s life during childbirth. Utilizing this expertise has shown benefit based on efforts by the CMQCC and can further be supported by preventative care measures employed by the pharmacist.3

The Pharmacist’s Role in Reducing Maternal Mortality

The pharmacist’s scope of practice can have a significant impact on the rates of maternal mortality in the United States, ranging from preconception care, interventions during pregnancy, and patient education.2 The relationship between unintended pregnancies and maternal mortality suggests that reducing rates of unintended pregnancy would be beneficial in, too, reducing rates of maternal mortality. Pharmacists could also aid in the development of a reproductive life plan (RLP) with patients to firstly aid in pregnancy planning. RLPs involve both partners and “includes goals patients make personally about having or not having children and encourages intentional pregnancy planning.”4 Initiating a conversation about a RLP also serves as an opportunity to address a patient’s health needs. For people who are looking to prevent pregnancy, a pharmacist can aid a patient in choosing a contraceptive method that suits the patient’s lifestyle and preferences. For those who do have intentions to become pregnant in the near future, pharmacists can provide education and counseling on health behaviors that could be harmful to a potential pregnancy.4

The Significance of Collaboration

The role of the pharmacist is continually evolving. In collaboration with other healthcare professionals, pharmacists can lay the groundwork needed to reduce maternal morbidity in the United States. Pregnancy planning and education could allow for the formation of RLPs and reduce the number of unintended pregnancies as well as increase awareness for behaviors that could hinder or advance maternal-infant outcomes. Pharmacists’ intervention in conjunction with the initiatives such as the CMQCC could provide for significant breakthroughs in health and wellness before, during, and after parturition.

References

  1. “Maternal Mortality.” Centers for Disease Control and Prevention, 13 Aug 2020. Available at: http://www.cdc.gov/reproductivehealth/maternal-mortality/index.html.
  2. Tsui AO, McDonald-Mosley R, Burke A. Family Planning and the Burden of Unintended Pregnancies. Epidemiologic Reviews. 2010;32(1):152-174.
  3. Montagne, Renee. “To Keep Women from Dying in Childbirth, Look to California.” NPR, 29 July 2018. Available at: https://www.npr.org/2018/07/29/632702896/to-keep-women-from-dying-in-childbirth-look-to-california.
  4. Peters LM, DiPietro Mager NA. Pharmacists’ Provision of Contraception: Established and Emerging Roles. Innov Pharm. 2016;7(3):15.

About the Author

Courtney Smith Headshot
Courtney Smith, PharmD Candidate
is a pharmacy student in the Class of 2024 at Ohio Northern University.

Reviewed by Natalie DiPietro Mager, PharmD, PhD, MPH.

New Webinar Prepares Pharmacists to Provide Reproductive Health Services and Referrals

Pharmacists play a key role in providing health care to patients. Their scope is currently expanding into women’s health, specifically in prescribing birth control. As more states pass legislation to allow pharmacists to prescribe birth control, we are preparing pharmacy staff members with the appropriate knowledge and tools to best assist their patients.

We hosted an exciting webinar, “Meeting Reproductive Health Needs at the Pharmacy” with Provide. Provide is a nonprofit organization with a goal to provide healthcare and social services to patients without bias or judgement. They understand the lack of care for patients experiencing an unintended pregnancy and seek to provide a comfortable environment for people to explore their options. This webinar shed light and helped to educate pharmacists, student pharmacists, and pharmacy technicians about family planning services including birth control access, emergency contraception, and abortion. The program included myths and facts about reproductive health, best practices to combat stigma, and how to connect patients with local resources.

Anna Pfaff and Dr. Sally Rafie led the discussion. Each touching on different subject material and bringing some diverse perspectives to the topic, Dr. Rafie as a pharmacist who also runs Birth Control Pharmacist and Anna as a patient educator who coordinates Provide’s Referrals Program. There are many barriers for different populations, further magnified during the COVID-19 pandemic and Title X restrictions, to obtain family planning services.

One very important objective of the program was preparing pharmacists and pharmacy teams to combat stigma surrounding these services. Pharmacy best practices were provided to address individual, environmental, and structural stigmas. The presenters raised awareness around these issues and shared new practical pharmacy communication guides that pharmacists and pharmacy team members can use in their everyday practices. As an example, Dr. Rafie and Monica Sliwa (a UCSD pharmacy student intern with Birth Control Pharmacist) performed a role play activity to show different approaches to assisting a patient find an emergency contraception method in the pharmacy. They also demonstrated the steps to refer patients for other services using online directories.

Fortunately, if you missed the webinar, the video recording and materials are available for on-demand home study online at https://birthcontrolpharmacist.com/referrals/. The course material is available to all, with pharmacists and pharmacy technicians having an opportunity to obtain Continuing Pharmacy Education credit. This material provides education to pharmacy staff members in reducing stigma in access to reproductive health services.

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

“Though not having a place of practice due to being in my 4th year of pharmacy school, I appreciated having these materials that can be utilized in whatever area of practice I’m in. I am interested in a career in women’s health and know that these resources will be valuable to me when transitioning into my career.”

“I love the handout provided, and I learned more about abortion clinics. I feel so much more comfortable about discussing options with patients now.”

“I plan on promoting this initiative and educating my colleagues on reproductive health competencies so that patients in my practicing state will have more options for accessibility.”

Meeting Reproductive Health Needs at the Pharmacy On-Demand Webinar


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.

Meet Phexxi – A New Non-Hormonal Contraceptive Gel

Image from https://hcp-phexxi.com

About the Product

Lactic acid, citric acid, and potassium bitartrate (Phexxi, Evofem Biosciences) is a prescription combination, non-hormonal contraceptive gel approved by the FDA in May 2020. The vaginal gel was found to be 86.3% effective with typical use when inserted up to 1 hour before vaginal intercourse.1

The gel acts as a contraceptive by maintaining the vaginal pH within its normal range of 3.5 to 4.5, an environment too acidic for sperm to survive. This pH regulating mechanism decreases sperm viability and supports bacteria integral to the vaginal microbiome.1

The gel is supplied in a package of twelve, single dose (5 grams), pre-filled applicators with an attachable plunger. The applicator should be inserted into the vagina immediately before or up to 1 hour before vaginal intercourse, with a new dose needing to be administered prior to each act of intercourse.2

What Patients Can Expect

The most common adverse events (AEs) were vulvovaginal burning (20%) and vulvovaginal itching (11.2%). Of local AEs, 23.9% were mild, 18.7% were moderate, and 2.3% were severe. Rates of these reactions mostly decreased over time.1

Women with a history of recurrent urinary tract infections or urinary tract abnormalities should not use the gel due to the 0.36% incidence of cystitis or pyelonephritis in clinical trials.2

Male partners of women using the gel might also experience local AEs such as burning, itching, and pain. However, the local AEs experienced by male partners were generally mild (74.7%), while 21.4% were moderate and 3.9% were severe.2

Offering This New Option to Patients

The contraceptive gel is an option for women who are seeking a non-hormonal or on-demand method of birth control. Women preferring to use multiple methods of contraception can combine the gel with diaphragms and latex, polyurethane, and polyisoprene condoms. However, it should not be used with vaginal rings.2

Spermicide is also available as a vaginal gel, but it is only about 72% effective with typical use.3 Like the non-hormonal contraceptive gel, it can be used on-demand. Nonoxynol-9, the active ingredient in most spermicides, can cause vaginal irritation and increase the risk of HIV transmission.4 In a clinical trial comparing nonoxynol-9 to the , incidences of vulvovaginal itching, burning, and irritation were similar, with the non-hormonal contraceptive gel having a slightly higher incidence of vulvovaginal burning.5

The contraceptive gel’s novel pH modulating mechanism is currently being studied for prevention of gonorrhea and chlamydia in the phase 2B clinical trial AMPREVENCE. Preliminary results from the 4-month study period showed a 50% relative risk reduction of chlamydia and a 78% relative risk reduction of gonorrhea. The clinical trial will move on to phase 3 later in 2020.6

Although the gel will be available as a prescription only treatment in September 2020, patients may face barriers to accessing the gel during COVID-19. Evofem Biosciences plans to launch a telemedicine program to support patient and provider access to the contraceptive gel.7 Additionally, barriers to contraception access could be further mitigated by enabling pharmacists to prescribe birth control.

REFERENCES

  1. Thomas MA, Chappel BT, Maximos B, Culwell KR, Dart C, Howard B. A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial. Contraception: X.2020; vol. 2 100031.
  2. Phexxi. Prescribing information. Evofem Biosciences; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208352s000lbl.pdf. Accessed June 17, 2020.
  3. HHS. Spermicide. https://www.hhs.gov/opa/pregnancy-prevention/birth-control-methods/spermicide/index.html. Accessed June 17, 2020.
  4. FDA. Code of Federal Regulations Title 21; April 1, 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.325. Accessed August 3, 2020.
  5. Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel; March 11, 2020. https://clinicaltrials.gov/ct2/show/results/NCT01306331. Accessed August 30, 2020.
  6. Evofem Biosciences Reports Positive Top-Line Results from Phase 2b Study of Amphora® for Prevention of Chlamydia and Gonorrhea in Women. Evofem Biosciences; December 2, 2020. https://evofem.investorroom.com/2019-12-02-Evofem-Biosciences-Reports-Positive-Top-Line-Results-from-Phase-2b-Study-of-Amphora-R-for-Prevention-of-Chlamydia-and-Gonorrhea-in-Women. Accessed August 3, 2020.
  7. U.S. FDA Approves Evofem Biosciences’ Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy. Evofem Biosciences; May 22, 2020. https://evofem.investorroom.com/2020-05-22-U-S-FDA-Approves-Evofem-Biosciences-Phexxi-TM-lactic-acid-citric-acid-and-potassium-bitartrate-the-First-and-Only-Non-Hormonal-Prescription-Gel-for-the-Prevention-of-Pregnancy. Accessed August 3, 2020.

About the Author

This article was co-written by Whitney Russell, a student pharmacist at University of Kentucky College of Pharmacy.

This article was originally published in Pharmacy Times.

Clinical Considerations for Contraception During COVID: Extended Duration of IUDs and Implants

Contraceptive care should not be compromised during this global pandemic. As many providers transition to contactless care methods via telehealth, patients that utilize long-acting reversible contraception may be worried if their intrauterine device (IUD) or implant has reached its expiration and needs to be removed or replaced. Pharmacists play an important role in educating patients about birth control, including what options are available to them when in-person appointments are not available at their regular clinic or doctor’s office. 

Expiration Dating 

The expiration date listed on the IUD and implant packaging should not be confused with the duration of use. The date stated on the packaging refers to the date by which the implant and IUD should be inserted.  Therefore, as long as the contraceptive device is inserted before the expiration date listed on the package, the IUD or implant will be effective for the entire duration indicated for each method. If the expiration date listed on the package has passed, the device is considered expired so it should not be used for a patient and should be discarded.  

Duration

Studies have demonstrated that IUDs and implants are effective past the FDA-approved duration. This evidence can help minimize concerns about ineffective devices that cannot be replaced due to cancelled doctor’s appointments due to COVID-19 or patient inability to go in due to exposure concerns, insurance loss, or any challenges. See table below to view extended evidence-based durations. 

Table modified from Reproductive Health Access Project

If the IUD or implant usage extends beyond the evidence-based duration, the patient should utilize an alternative birth control method until she is able to resume in-person visits with their provider to remove the device and possibly replace it with a new one if the patient desires. Providers should inform patients that leaving an IUD or implant in place past the evidence-based duration will not cause harm. While there are no safety concerns, there is no benefit as the device is not expected to be effective.

Pharmacists Roles

Pharmacists cannot prescribe or insert IUDs or implants, however, pharmacists have the ability to prescribe self-administered hormonal contraceptives in some states and can always provide over-the-counter barrier and emergency methods. If patients want an implant or IUD, pharmacists are able to initiate an alternative method in the meantime until patients are able to visit their clinic or doctor’s office for IUD or implant insertion. See our COVID page for more on providing contraceptive care during COVID-19. 

For patients not satisfied with their current birth control regimen who are interested in switching to an IUD or implant, pharmacists can refer the patient to a provider and educate the patient on proper bridging methods to prevent pregnancy during the transition to an IUD or implant. 

It is important that pharmacists stay up to date on birth control recommendations and clinical updates in order to provide guidance for patients and providers during a public health emergency. Pharmacists play an integral role in providing patients with the resources and education needed to make informed decisions on their contraceptive options. See the ACCP Women’s Health PRN Opinion Paper on the pharmacist’s role in safe and effective use of long-acting reversible contraceptive methods. 

If a patient is having symptoms related to their IUD or implant, they should be seen for this at a local clinic or doctor’s office. To find a clinic that provides contraceptive devices, visit Bedsider’s clinic finder.

References


About the Author

Kailey Hifumi is a student pharmacist at the Pacific University School of Pharmacy.

Photograph of Kailey Hifumi