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.

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.