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.

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.

Interactions Between Emergency Contraception and Other Hormonal Contraceptives

The American Society for Emergency Contraception (ASEC) recently held their annual EC Jamboree in Washington, DC. Participants included health care providers, researchers, reproductive health advocates, and pharmaceutical stakeholders.

One highlight was the key clinical discussions centered on drug interactions between emergency and other hormonal contraceptives, including ulipristal acetate (ella, Afaxys Pharma).

A selective progesterone receptor modulator, ulipristal acetate binds the progesterone receptor, and has both antagonistic and partial agonistic effects. When ulipristal acetate is in the picture, along with another progestin hormone, there will be competition for the progesterone receptors. For this reason, the patient’s use of another progestin-containing hormonal contraceptive either before or after may impact its effectiveness [1]

This theory is based on the pharmacology of the drugs and was supported by a European study. The study looked at the impact of starting a desogestrel progestin-only pill the day after taking ulipristal acetate, compared to starting the same progestin-only pill without ulipristal acetate beforehand. The group that had taken ulipristal acetate showed a slower onset of action of the progestin-only pill in preventing ovulation and thickening the cervical mucus. This particular progestin-only pill is not available in the United States [1]

Following this study, Afaxys revised the ulipristal acetate label in March 2015 to include: “Hormonal contraceptives: Progestin-containing contraceptives may impair the ability of ella to delay ovulation … Avoid co-administration of ella and hormonal contraceptives. If a woman wishes to start or resume hormonal contraception after the intake of ella, she should do so no sooner than 5 days afterwards, and she should use a reliable barrier method until the next menstrual period.“ [2]

Last year, another study found that combined oral contraceptives containing estrogen and progestin hormones are expected to reduce efficacy of ulipristal acetate, as well. In this United States study, researchers evaluated the impact of initiating an ethinyl estradiol/levonorgestrel combined pill 2 days after ulipristal acetate use [3]. More participants experienced ovulation when the combined pill was initiated compared to those who did not initiate any hormones after ulipristal acetate.

Pharmacists and pharmacy staff can refer to a 1-page guide created by ASEC, available on the organization’s website at americansocietyforec.org, for additional information on FDA-approved emergency contraceptives.

References

  1. Brache V, Cochon L, Duijkers IJ, et al. A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception. Hum Reprod. 2015;30(12):2785-2793.
  2. Ulipristal acetate (ella) prescribing information. May 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=052bfe45-c485-49e5-8fc4-51990b2efba4
  3. Edelman AB, Jensen JT, McCrimmon S, Messele-Forbes M, O’Donnell A, Hennebold JD. Combined oral contraceptive interference with the ability of ulipristal acetate to delay ovulation: A prospective cohort study. Contraception 2018;98(6):463-466.

This article was originally published in Pharmacy Times.

FDA Updates on Birth Control

There have been some notable changes with birth control products, including three new product approvals and one product exiting the market.

1. New yearly birth control vaginal ring approved. This birth control ring is very different from the existing vaginal ring product since it works for 1 year. It is a combined hormonal product and contains ethinyl estradiol and a new progestin — segesterone acetate. The ring is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year. The brand name is Annovera. One advantage of this product is that it does not require refrigeration. It is expected to be available in 2019. For more info, FDA News Release and Manufacturer Press Release.

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2.  First direct-to-consumer birth control digital app approved. This is the first app approved by the FDA as a safe and effective method of contraception.  It is indicated for use by adults aged 18 years and older. The app must be used with a thermometer — a two decimal basal thermometer, which is not the same as a normal fever thermometer.

Users will measure their temperature first thing in the morning before they get up and out of bed (at least five mornings a week) and enter it into the app.  For the algorithm to calculate daily fertility, users will also need to add their period data each month. The Natural Cycles algorithm analyses the information entered into the app to detect ovulation, thereby identifying green days, when no protection is needed, or red days, when you should use condoms or abstain from sex to prevent a pregnancy. For more info, FDA News Release and Company Website.

Natural Cycles Birth Control App

3. Another generic levonorgestrel emergency contraceptive pill approved. New generic emergency contraception (EC) pill approved. Preventeza is the brand name and it is made by the makers of Vagisil. This is another Levonorgestrel 1.5 mg single-pill EC product that may be sold without a prescription to consumers of all ages — women and men. It is available online only from the manufacturer’s website.

Preventeza Emergency Contraception

4. Essure to be discontinued. Essure is a permanent birth control method that doesn’t requires surgery and is placed in an office-based procedure. In this procedure, a soft, flexible insert is delivered through the vagina and uterus and permanently placed in each fallopian tube. No incision is required to deliver or place the inserts and general anesthesia is not required. Over time, a natural barrier forms around the inserts and prevents sperm from reaching the eggs by occluding the fallopian tubes. During this time, the patient must continue using another form of birth control to prevent pregnancy until the confirmation test at 3 months post-procedure.

The manufacturer is discontinuing production and it will no longer be available at the end of 2018.  This may be due to complaints from users due to adverse effects, restrictions by the FDA in April of this year, and/or low utilization. For more info, FDA Press Announcement.

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This has been a busy time for birth control product changes. We always welcome new birth control options to fit patient needs, given they are safe and effective.