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

5 Pearls from the 2020 States Forum on Pharmacist Birth Control Services

The second annual States Forum on Pharmacist Birth Control Services recently was held by the Birth Control Pharmacist project in partnership with the National Alliance of State Pharmacy Associations (NASPA). Due to the coronavirus disease 2019 (COVID-19) pandemic, this year’s meeting was held virtually as representatives from across the United States, as well as Canada, discussed advances in pharmacist birth control services.

Following a brief overview of the current landscape from the 2019 report, representatives shared updates on pharmacist birth control services in their respective states. The implementation status among the states ranged from fully implemented, in progress, and under consideration, to not being considered at this time.

Each representative was able to provide insight on their successes, challenges, and tips on obtaining state-wide authorities to provide contraception services. Attendees also participated in breakout sessions to brainstorm ideas to improve public awareness, research and evaluation, payment for pharmacist services and advance policy.

Here are 5 pearls to take away from the 2020 States Forum:

  1. Exercise authorities granted by emergency regulations due to COVID-19. As the global pandemic continues to unfold, many states are allowing pharmacists to dispense emergency refills and extended supply quantities. This provision includes refills for hormonal contraception. This unique circumstance can highlight the benefits of implementing contraceptive services within the pharmacy and pave the way for expanded access to birth control.
  2. Identify champions to build a coalition for planned policy proposals. A common barrier expressed in the states forum was legislation halts due to COVID-19. It is important to use this time as an opportunity to expand our outreach to pharmacists and physicians to gain support on pharmacist contraceptive services in the meantime. By identifying pharmacist and physician champions to reach out to medical associations and organizations, states can hopefully overcome and alleviate apprehension from groups opposed to proposed legislation. By educating pharmacist colleagues of the value of providing these services and providing educational resources, we can mitigate pharmacist opposition to legislation. Consider reaching out to obstetrician-gynecologist colleagues, particularly those who are members of the American College of Obstetricians and Gynecologists or have completed a family planning fellowship, to aid in coalition building and policy planning for pharmacist birth control services.
  3. Encourage fellow pharmacists to partake in providing contraceptive services. Pharmacists are key health care members and well equipped to provide these clinical services. There are currently more than 3000 participating pharmacies on the Birth Control Pharmacies map. However, there is still room to expand our reach to more communities as pharmacists. Many pharmacy schools have, or are in the process of implementing, curriculum to complement the implementation of birth control services within pharmacies throughout the US. In some states, legislation has grandfathered pharmacy school graduates to remove additional training barriers. Encourage your colleagues, preceptors, and teams to complete continuing education on contraception services, particularly if practicing in a state with a protocol or other authority available that allows pharmacists to prescribe contraception.
  4. Promote pharmacy services on different platforms to raise public awareness. Although a handful of states have implemented pharmacist birth control services, patients remain widely unaware. By promoting this pharmacy service via signs, social media platforms, partnerships, and through word of mouth, we can expand our impact within the community. Seek partnerships with local student pharmacists and student pharmacy organizations to further promote birth control services.
  5. Join the next States Forum on Pharmacist Birth Control Services. This forum is an opportunity to participate in valuable discussion, and share experiences and strategies to advance pharmacist contraception services in your state. This session was especially helpful for states that are in the process of, or are considering, pharmacy birth control legislation.

If you missed the 2020 States Forum, you may view the meeting recording.

Join the Birth Control Pharmacist email list to be notified of details for the next States Forum. 

The Birth Control Pharmacist project was established to provide training and education, implementation assistance, resources, and clinical updates for pharmacists prescribing contraception. Beyond service implementation, this project engages in advocacy, research and policy efforts within the community to expand the role of pharmacists in family planning.

The mission of NASPA is to provide support and to facilitate collaboration between state pharmacy associations to advance the profession of pharmacy.

This article was co-written by Kailey Hifumi, a student pharmacist at the Pacific University School of Pharmacy.

This article was originally published in Pharmacy Times.

Contraception During COVID: California’s Medi-Cal and FamilyPACT Programs Cover Depo-SubQ Provera

We recently wrote about the importance of offering patients subcutaneous depot medroxyprogesterone acetate (DMPA-SQ) as a contactless form of contraception during the COVID-19 public health emergency. California pharmacists can prescribe DMPA-SQ under statewide protocol upon completing the required training program and obtain payment for the visit for Medi-Cal patients.

As of April 9, 2020, California’s Medi-Cal, FamilyPACT, and managed Medi-Cal health plans are covering DMPA-SQ under pharmacy benefits.

To facilitate compliance with state and federal guidelines for sheltering in place and physical distancing, DHCS will temporarily allow for pharmacy dispensing of DMPA-SQ directly to patients for self-administration at home. This is in addition to current Medi-Cal policy that allows administration by a health care professional. Self-administration of DMPA-SQ would be at the option of the Medi-Cal recipient after individualized discussions and decision-making between the prescriber and the recipient. The prescribing provider is responsible for ensuring proper training of the recipient in administering the drug, potential side effects, and proper disposal of the pre-filled syringe.

The FamilyPACT system updates to allow for claim reimbursement of DMPA-SQ will not be implemented until May 15, 2020 for pharmacy dispensing, with a retro-effective date on or after April 9, 2020.  Pharmacies may re-process their denied claims after the implementation date and it should process successfully at that time. FamilyPACT always recommend that pharmacies validate eligibility, process the claim, get the denial, dispense the medication, and reprocess the claim after May 15 for payment. The reprocessed claim will show payment for the actual date of service as long as it is not before April 9.

Additionally, a reminder that a Medi-Cal beneficiary should not be required to pay for a covered medication until all avenues of successful processing have been explored and the department denies the service (for example the provider tries obtaining a TAR) and only if the patient requests to purchase the medication out of pocket. 

The full policy document is published on the COVID-19 webpage at: Direct-to-Patient Dispensing of Subcutaneous Depot Medroxyprogesterone Acetate – COVID-19 Emergency. This temporary policy change is effective immediately and remains in effect until further notice.

Clinical Considerations for Contraception During COVID: Patient Self-Administration

During the COVID-19 pandemic and beyond, patients may desire a contactless method of contraception. The subcutaneous (SQ) formulation of depot medroxyprogesterone acetate (DMPA), Depo-SubQ Provera, is an important option to offer patients. This may be of particular interest among patients who currently come in to the pharmacy or go to a clinic for their intramuscular (IM) injection.

Formulation Differences

While patients are able to self-administer both subcutaneous and intramuscular injections for a variety of purposes (e.g., insulin, fertility medications), patients may prefer the SQ formulation of DMPA since it is associated with less pain and higher continuation rates than the IM formulation.

Differences between the two formulations are summarized in the table below.

Intramuscular (IM)Subcutaneous (SQ)
Dose150 mg104 mg
Duration13 weeks
(up to 15 weeks)
12-14 weeks
Generic AvailabilityYesNo
Cost at Pharmacy$70-100>$200

Another important consideration is insurance coverage of these products. Some health plans cover the IM formulation as a medical benefit but have not yet included it as a pharmacy benefit. Some health plans are now covering the SQ formulation as a pharmacy benefit due to COVID-19, while others cover it as a pharmacy benefit but require a prior authorization.

How to Initiate or Switch

There is no physical assessment or blood pressure measurement required for eligibility of DMPA.

If your patient is not currently using a method of hormonal contraception, they can begin using either the IM or SQ at any time during the menstrual cycle if it is reasonably certain that patient is not pregnant. A backup method of contraception should be used for 7 days.

If your patient is currently using IM DMPA, the SQ DMPA can be administered when she is due for her next injection. No backup contraception is needed.

If your patient is currently using any other hormonal contraception (i.e., progestin only-pill, hormonal IUD, combination hormonal pill, patch or ring) or a copper IUD, the DMPA should be administered 7 days before stopping the other method. No backup contraception is needed.

References

2020 CDC Update for Contraceptive Use in Women at High Risk for HIV

What is the significance?

Women who have unprotected sex or have multiple partners have not only an increased the risk of sexually transmitted infections (STIs also known as STDs) but also have a risk of pregnancy. Aside from condoms, other contraceptive methods do not protect against HIV and other STIs but can effectively prevent an unintended pregnancy with potential complications and perinatal transmission associated with HIV infection.  Based on the new 2019 recommendations by the World Health Organization (WHO), the CDC published updated guidelines to the 2016 U.S. Medical Eligibility Criteria (US MEC) for Contraceptive Use regarding women at high risk for HIV infection in April 2020.

 

What changed?

The following updates were made to the US MEC for Contraceptive Use, 20161:

Women at high risk for HIV:

There are no restrictions for use (MEC Category 1) of all contraception methods, now including IUDs and depot medroxyprogesterone acetate (DMPA) injection. Previously, high risk for HIV was a condition for which copper-containing and progesterone-releasing IUD and DMPA use was MEC Category 2 (benefits generally outweigh the risks of the condition).

Women on antiretroviral (ARV) therapy:

The CDC has clarified that their recommendations for contraception in women taking nucleoside reverse transcriptase inhibitors (NRTIs) applies to all NRTI indications: prevention (PrEP) or treatment of HIV infection. Most contraceptive methods are MEC Category 1 except initiation of IUDs in women whose HIV viral loads are not controlled or are not ARV therapy due to the risk of pelvic inflammatory disease due to the risk of pelvic inflammatory disease with IUD insertion (MEC Category 2).

See Table 1 for a summary of recommendation changes.

 

Summary of Clinical Evidence

The US MEC recommendations are based on a review of clinical evidence, the WHO recommendations, and epidemiological information regarding unintended pregnancy, contraceptive use, HIV infection, and maternal morbidity and mortality in the US.2 In the previous 2017 US MEC update, intramuscular DMPA (DMPA-IM) use changed from a category 1 to a category 2 based on evidence of possible increased risk for HIV acquisition in women using DMPA who are already at high risk of infection.2,3 However, in August 2019, the WHO published the following updates regarding recommendations for contraceptive use in this population:

Women with high HIV risk are eligible to use all methods of contraception without restriction (category 1)4

    • All progestin-only methods, including progestin-only pills (POPs), intramuscular and subcutaneous DMPA, levonorgestrel (LNG) implants, and etonogestrel (ETG) implants
    • Copper and LNG intrauterine devices (IUDs)
    • All combined hormonal contraceptive methods, including combined oral contraceptives (COCs), combined contraceptive patches, and combined vaginal rings

These recommendations for this patient population have been made in light of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial, which aimed to determine the risk of HIV incidence with the use of DMPA-IM, copper IUD, and LNG implant contraceptives. The randomized, multicenter, open-label trial included 7,839 non-pregnant, HIV-seronegative African females aged 16 to 35 years seeking effective contraception who were placed into 3 groups of contraceptive methods: DMPA-IM, copper IUD, and LNG implant.3 After 18 months, 397 HIV infections were observed: 36% in the DMPA-IM group, 35% in the copper IUD group, and 29% in the LNG implant group with no significant statistical differences between each method.3 Therefore, DMPA-IM copper IUD, or LNG implant use does not further increase the risk of getting HIV in patients already at high risk for HIV. In addition, patients younger than 25 years were associated with higher HIV incidence than those 25 years or older, and herpes simplex virus-2 (HSV-2) seropositive patients were associated with higher HIV incidence than those who were HSV-2 seronegative.3 However, age and HSV-2 status did not significantly alter the relationship between contraceptive use and HIV acquisition.3

Although the ECHO trial did not assess other hormonal methods (e.g., COCs, subcutaneous DMPA, hormonal IUDs), WHO also made their recommendations based on low/low-to-moderate quality studies or extrapolation from other studies indicating no increased risk for HIV acquisition with these methods.3,4 A consensus was also made that “no biological or clinical reasons” were evident “that a lower hormonal dose, different delivery mechanism, or different progestin” would affect HIV risk.”3

 

References

  1. Tepper NK, Curtis KM, Cox S, Whiteman MK. Update to U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Updated Recommendations for the Use of Contraception Among Women at High Risk for HIV Infection. MMWR Morb Mortal Wkly Rep 2020;69:405–410. Available from:http://dx.doi.org/10.15585/mmwr.mm6914a3
  2. Tepper NK, Krashin JW, Curtis KM, et al. “Update to CDC’s U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Revised Recommendations for the Use of Hormonal Contraception Among Women at High Risk for HIV Infection.” MMWR Morb Mortal Wkly Rep. 2017;66(37):990-994.
  3. Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium. HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial. Lancet. 2019;394(10195):303-313.
  4. Contraceptive eligibility for women at high risk of HIV. Guidance statement: recommendations on contraceptive methods used by women at high risk of HIV. Geneva: World Health Organization; 2019. License: CC BY-NC-SA 3.0 IGO.

Marjorie Valdez Student PharmacistAbout the Authors

Marjorie Valdez is a fourth-year pharmacy student at the UC San Diego School of Pharmacy and Pharmaceutical Sciences.

Cydnee Ng, PharmD completed her pharmacy training at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences in 2019. She is currently a community pharmacist at Walgreens in the San Francisco Bay Area.

Twirla: A New Contraceptive Patch

What is Twirla?

Twirla is a new contraceptive patch designed for patients who want freedom from the daily pill without committing to a longer acting method. This transdermal patch delivers 120mcg of levonorgestrel and 30mcg of ethinyl estradiol through Agile’s Skinfusion® patch, which consists of five layers and serve as the reservoir for the active and inactive ingredients, as well as a barrier to prevent accumulation of debris from daily wear. Twirla is designed to be applied once weekly for three weeks, followed by one patch free week for menstruation.

Currently there is only one hormonal contraceptive patch available for consumer use called Xulane (norelgestromin 150mcg/ethinyl estradiol 35mcg). Women who use this patch have higher blood serum concentrations of estrogen compared to oral methods (AUC0-∞ 37.7±5.6 vs. 22.7±2.8), which is associated with health concerns such as increased risk of blood clots in the legs and lungs. Agile Therapeutics, the women’s healthcare company behind Twirla, saw an unmet need in the market for a low-dose hormonal contraceptive patch. This market gap lead to the development of their newly formulated contraceptive patch, Twirla.

 

What are the pros and cons of Twirla?

This patch provides another option for women who desire an alternative from a daily pill, without the constraints of a longer acting method. Twirla is applied once weekly, meaning women only have to remember their birth control about three times a month rather than every day. With various daily activities and responsibilities, a weekly patch liberates women from one of those daily routines. There are other birth control options such as the Depo-Provera injection, IUDs, or implants that serve as alternatives to the pill but some women perceive these methods as more invasive compared to the patch. Additionally, given the lower dose of estrogen, Twirla appears to have a lower risk of blood clots as shown in comparator studies but remains equally effective in regulating menstrual cycles and preventing pregnancies as compared to the existing patch option.

Although the convenience of a patch is desirable, there are several noteworthy considerations with this product. As previously mentioned, Twirla’s formulation lowers the risk of blood clots, but there remains a risk of blood clots with hormonal patches compared to oral methods.  Additional side effects reported with Twirla include unscheduled vaginal bleeding, weight gain, headache, and abdominal cramps.  Women have also reported skin irritation when applying and removing the patch. Regarding size, Twirla is round and slightly larger (28cm2) than the Xulane (14 cm²) patch. Additionally, both Twirla and Xulane are currently only produced in one neutral shade of beige. For many women, this prevents the possibility of a discrete form of birth control which may make this a less desirable option.

 

Are there different considerations with a patch compared to other contraceptive methods?

Given the hormones in Twirla, the patch works just like the pill in terms of preventing pregnancy by delaying ovulation.  It can be applied on the upper arm, buttocks, back, or lower abdomen. The patch is designed to withstand activities such as exercising, swimming, showering, etc. If the patch does happen to fall off during the week, it can be reapplied or a new patch may be used in its place. If the patch has been off more than 24 hours, a back up method such as condoms should be used for the next seven days of the new patch cycle. Although it’s rare (<2% of the time), healthcare providers recommend daily checks to ensure the patch has not accidentally fallen off. Patches should not be worn longer than the week they are intended and consequences of doing so include bleeding, spotting, and increased risk for unintended pregnancy. If a patient is more than 48 hours late transitioning from the existing patch to a new patch, then a back up should be used for seven days. Like all other birth control methods, Twirla does not protect against sexually transmitted diseases or HIV.

 

Is Twirla a good option for everyone?

There is no one-size fits all method that is right for all women. Some women might be at greater risk for adverse effects with the patch. Agile reported reduced efficacy in preventing pregnancy for women who weigh 202 pounds (92kg) or more, or who have a BMI of 30 kg/m2 or greater. As a result, the drug company initially issued a Limitation of Usestatement in their product labeling that documented this clinical outcome.  Since gaining FDA approval, this limitation has transitioned to a listed contraindication. Xulane’s package insert lists the same contraindication, yet is regularly prescribed in women with a BMI >30 kg/m2. Studies have shown that the decrease in efficacy does not preclude the use of these patches in obese women. To combat the associated risks, additional counseling to emphasize the importance of strict compliance with the patch for optimal protection is necessary. Studies have also shown an increased risk in blood clots in women who are overweight and those who smoke. Additional contraindications for using Twirla include women with a high risk of thrombotic disease, who experience migraine with aura, who have liver disease, or who have undiagnosed abnormal uterine bleeding.

 

Is Twirla available now?

Twirla was approved by the FDA earlier this month on February 14, 2020. As part of the approval process, the FDA is requiring Agile to conduct a long term, observational post-marketing study to further evaluate the risks of blood clots in new users of Twirla. With its recent approval, the manufacturer is now focusing their attention on commercializing Twirla for consumer use. They hope to complete the manufacturing process and expect to ship the initial product to wholesalers as early as the end of this year.

With patient needs and safety in mind, the approval of this medication further expands the range of contraceptive options available for women. Given that there have only been three non-daily combined hormonal contraceptive methods made available since 2001, this is a valuable and timely option for women who seek alternative methods.

References

  1. FDA Approves Agile Therapeutics, Inc.’s Twirla® (levonorgestrel and ethinyl estradiol) Transdermal System – A New Weekly Contraceptive Patch Delivering a 30 mcg Daily Dose of Estrogen and 120 mcg Daily Dose of Progestin. (2020, February 14). Retrieved February 23, 2020, from https://ir.agiletherapeutics.com/news-releases/news-release-details/fda-approves-agile-therapeutics-incs-twirlar-levonorgestrel-and
  2. Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System – Full Text View. (2017, September 25). Retrieved from https://clinicaltrials.gov/ct2/show/NCT02158572?term=AG200-15&draw=2&rank=1
  3. Therapeutics, A. (n.d.). Results From the SECURE Trial, a Phase 3 Study of the… : Obstetrics & Gynecology. Retrieved from https://journals.lww.com/greenjournal/Abstract/2017/05001/Results_From_the_SECURE_Trial,_a_Phase_3_Study_of.46.aspx
  4. Hatcher, R. A. et. al (2018). Contraceptive technology. New York, NY: Ayer Company Publishers, Inc.
  5. Van den Heuvel et. al, M. W. (2005). Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception72(3). Retrieved from https://www-sciencedirect-com.proxy-remote.galib.uga.edu/science/article/pii/S0010782405000971 

About the AuthorBirth Control Pharmacist Headshots

Savannah Gross is a third-year pharmacy student at the University of Georgia College of Pharmacy. 

Article reviewed by Rebecca Stone, PharmD, BCPS, BCACP

New APhA-ASP Women’s Health Campaign

In 2018, APhA-ASP launched its new Women’s Health Campaign to address the health educational needs of women across the country. One area of focus for ASP chapters is to “provide education on the pharmacist role in reproductive health, including hormonal contraceptive options and access to hormonal contraceptives.”

This year at the University of Michigan – College of Pharmacy, our APhA-ASP chapter is working to promote women’s health at our college and within the university.  Since women’s health pharmacy is a niche area within the profession, we wanted to provide a career development event for pharmacy students to be exposed to “The Pharmacist Role in Rxeproductive Health”.

On Monday, November 11th, our chapter hosted its first “Rxeproductive Health”  event focusing on pharmacist involvement in a variety of fields within reproductive health. We invited Dr. Lauren Leader, PharmD, BCPS of Michigan Medicine and Dr. Brooke Griffin, PharmD, BCACP of Midwestern University and Birth Control Pharmacist to educate our students on topics of peripartum health, pharmacist prescribing of hormonal contraception, and policy to expand the pharmacist profession in women’s health. The event began with phast phacts (“fast facts”) on women’s health and where in the United States pharmacists have prescribing authority for hormonal contraceptives, followed by a question and answer between our panelists and audience. The program ended with a collaborative reflection with our guest speakers on a policy brainstorming session, asking ourselves: “What role or roles do we want to see pharmacists to have in women’s health and reproductive health?” Despite an all-day snow storm in Michigan that day, we had a lot of students attend and participate, making for a memorable and meaningful event.

As I reflect on my first three years of pharmacy school and as my interests in women’s health continues to grow, I have started to notice the lack of women’s health events outside of the lecture room. APhA-ASP launching their campaign last year has given our organization the opportunity to advocate for women’s health to the community and to our college of pharmacy. “The Pharmacist Role in Rxeproductive Health” was our first focused women’s health event for ASP, providing our students with the knowledge and networking to advocate for this population in health care. Given the success of our first event, I am excited to see where our ASP chapter will go from here.

For more information about the APhA-ASP Women’s Health campaign, visit: https://www.pharmacist.com/apha-asp-womens-health-campaign 

Rxeproductive Health Event.PNG

Photo 1 from L to R: Dr. Lauren Leader and Dr. Brooke Griffin

Photo 2 from L to R: Tina Bednarz (APhA Policy Vice President), Dr. Brooke Griffin, Dr. Lauren Leader, Andy Van Waardhuizen (SNPhA Women’s Health Committee Chair), Lana Alhashimi (APhA Policy Liaison), Jacqueline Muscat (APhA Women’s Health Liaison)

 


About the Author:

Tina Bednarz, PharmD Candidate is a third-year pharmacy student at the University of Michigan – College of Pharmacy where she is the Policy Vice President of the chapter’s APhA-ASP organization.

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.

5 Pearls from the States Forum on Pharmacist Birth Control Services

States Forum on Pharmacist Birth Control Services

The inaugural States Forum on Pharmacist Birth Control Services was recently held in conjunction with the American Pharmacists Association (APhA) 2019 Annual Meeting in Seattle, Washington. This session was hosted by Birth Control Pharmacist. Most states were represented at the forum with over 60 participants, and there was meaningful discussion on how to make this service not only possible, but also impactful.

Sally Rafie, PharmD kicked off the program with a review of the current landscape. Sharon Landau MPH followed by facilitating brief updates from the states, including those that have implemented pharmacist birth control services, are in progress, and are considering this action. State representatives shared successes, challenges, and lessons learned. Don Downing, BSPharm then led a focused discussion on payment for pharmacist services.

Here are 5 pearls to take away from the States Forum:

1. Even states that tend to be conservative, particularly with women’s health, should consider pursuing policy. 
Legislation to allow pharmacist birth control services is a nonpartisan effort. While some of the early states had Democratic lawmakers sponsoring bills, more than half of those passed and under consideration are sponsored by Republican lawmakers.

2. Avoid certification because this is standard practice for pharmacists. 
Payment for pharmacist services is critical to success. Multiple states cited this as the biggest challenge they are currently facing. Health plans may look for “certification” to credential a pharmacist as a provider or pharmacists assessing a body system to determine the service is eligible for payment. Washington has had success with payment for pharmacist services by recognizing pharmacists as medical providers and using legislation to mandate payment for pharmacist services by all government and private health plans.

3. Provide education for pharmacists and identify pharmacist and physician champions in advance of proposed legislation.
Pharmacists are not the only stakeholders who champion initiatives for pharmacist birth control services in the states; legislation has even moved forward without necessarily engaging the state pharmacist associations or other pharmacists. In some states, pharmacists have more concerns than other stakeholders and may even testify in opposition of proposed legislation. Many of these concerns may be due to knowledge gaps and can be addressed with education opportunities in advance of legislation. Identifying physician champions is important, particularly for testifying in support of any proposed legislation. Check with local teaching hospitals for family planning fellows who will likely be enthusiastic about engaging in this work.

4. We need to promote our birth control services as a profession, as well as individual pharmacists and pharmacies that offer the service.
While pharmacists are getting trained and geared up to provide this service, the public remains largely unaware. Some pharmacies are seeing low patient demand for their birth control services. With over 1100 participating pharmacies on the birthcontrolpharmacies.com map, there is an opportunity to have a greater impact in serving communities.

5. Join us next year for the States Forum. 
Pharmacists valued sharing ideas, experiences, best practices, and strategies. Especially those in states who are considering legislation found the forum to be helpful. States that were farther along in implementing pharmacist birth control services were more than willing to share and help other states.

This article was originally published in Pharmacy Times.