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.
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
About 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.
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
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.
Pharmacists should not allow postponed or cancelled appointments to keep patients from accessing birth control. It’s important that patients understand how their pharmacy can continue to meet their contraceptive needs during the coronavirus disease 2019 (COVID-19) pandemic.
Pharmacists should inform patients that even though clinics and providers’ offices might be closed, their pharmacy is still able to facilitate refills, provide emergency contraception, and, in some states, prescribe hormonal contraception.
The following tips can help ensure your pharmacy is meeting patients’ contraceptive needs during COVID-19, while keeping your patients and pharmacy staff safe.
1. Encourage Contactless Communications and Dispensing
Prevent patients from missing doses or going without contraception by preemptively contacting them via texts, emails, and calls to assess their needs. Encourage patients to utilize contactless communication to get in touch with the pharmacy for prescriptions or other items they want to order.
Pharmacies can provide contactless contraceptive care during COVID-19 by encouraging patients to obtain birth control prescriptions and products via mail, drive-through, or curbside pick-up services.1
2. Promote and Supply Over-the-Counter Products
Visits to the pharmacy may be very limited for patients because of stay-at-home orders, social distancing, and other COVID-19-related barriers. Preemptively supplying prescriptions for emergency contraception can avert out of pocket costs while mitigating stress for patients that experience method failure and are unable to access the pharmacy in a timely manner.2 Encourage patients to have a pregnancy test on hand, in addition to over-the-counter contraceptive options, to ensure that patients’ contraceptive needs are met when routine visits to the pharmacy are not feasible.
3. Optimize Prescriptions and Anticipate Patient Needs
To maintain social distancing and the health of patients and employees, encourage providers to transmit new prescriptions electronically or via telephone.1
Prescriptions for birth control should include maximum quantities and refills for a full year’s supply.2 Some states require health plans to cover dispensing a 12-month supply of birth control.3 Dispense the maximum amount allowed by the patient’s insurance and share the cash price if a patient desires paying out-of-pocket to limit visits to the pharmacy or clinic.
Pharmacy staff can proactively review patients’ profiles to anticipate upcoming refills and ensure the pharmacy’s birth control inventory is adequate to fulfill patient needs.2
Check with your state’s COVID-19 pharmacy executive orders to ensure permitted emergency refills are being authorized.
4. Adapt Pharmacist Prescribing
Utilize Telehealth for Birth Control Visits
Patients are turning to telehealth services to access contraception during COVID-19. Transitioning your contraception service to telehealth wherever possible will ensure continuity of care while protecting the health and safety of patients and employees. Pharmacists can utilize telehealth to initiate contraception, assess and switch current methods, and adjust therapy as needed.
Due to COVID-19, some telehealth HIPAA regulations have loosened and health insurance plans are beginning to cover telehealth services.4
Offer Methods that Don’t Require Blood Pressure Screening
Encourage patients to consider a progestin-only contraceptive if they’re unable to visit the pharmacy for a blood pressure screening.
Progestin-only contraceptive methods do not require a blood pressure screening in order to be safely prescribed, making them a feasible option when prescribing birth control via telehealth. Progestin-only options that can be prescribed by pharmacists and dispensed at the pharmacy include progestin-only pills (containing norethindrone or drospirenone) and depot medroxyprogesterone acetate injections (subcutaneous or intramuscular formulations).
Blood pressure measurement is required prior to initiating combined hormonal contraceptives—containing both estrogen and progestin hormones—due to the increased risk of stroke and myocardial infarction in patients with hypertension or without blood pressure measurements.
This article was co-written by Whitney Russell, a student pharmacist at University of Kentucky College of Pharmacy, and Kailey Hifumi, a student pharmacist at the Pacific University School of Pharmacy.
This article was originally published in Pharmacy Times.
Click image to view and download our COVID guide.
Find out more about providing contraceptive care during COVID-19 on our COVID resource page
References
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.
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.
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:
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.
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) | |
| Dose | 150 mg | 104 mg |
| Duration | 13 weeks (up to 15 weeks) | 12-14 weeks |
| Generic Availability | Yes | No |
| 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
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.
The following updates were made to the US MEC for Contraceptive Use, 20161:
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).
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.
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
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
About 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.
Navigating through a discussion about gender and sexuality with the many terms used today can be confusing. Here is a brief introduction to terminology regarding the multifaceted gender spectrum.1
Now let’s review contraception for transgender patients…with a focus on transgender men (male gender identity and female assigned gender at birth)…
Gender affirmation therapy does not take the place of contraception.
Each patient may prefer different gender affirmation methods, which may affect their contraceptive needs.3 Methods include hormone therapy with testosterone, surgery, or no intervention. For patients undergoing testosterone therapy or no intervention who desire contraception, an additional contraceptive method becomes necessary. On the other hand, patients who undergo reaffirming surgery may or may not need additional contraception to reduce risk of pregnancy, depending on the extent of surgery performed.
There are knowledge gaps around fertility and contraceptive needs amongst transgender patients and their providers.
Some transgender men and providers have a lack of knowledge regarding their reproductive potential and risk of pregnancy if sexually active with a capable partner.3 Misperceptions include testosterone as effective contraception (may decrease fertility, but does not eliminate pregnancy risk) and midlife patients as infertile (presumed menopausal).3,4,5
A transgender man has reproductive potential if they have an intact uterus and ovaries and until menopause or surgical sterilization.3 In addition, testosterone use may not completely suppress ovarian function, causing irregular or suppressed periods, which should not be confused with perimenopause in midlife patients.3,5 It is important to note there is still a risk of pregnancy despite a lack of menstruation. In a study of 41 transgender men who had been pregnant and given birth, one-third of pregnancies were unintended.6 Contraception use prior to pregnancy was lower in patients who used testosterone compared to those who did not.6 Use of a contraceptive is still necessary even with testosterone therapy.
Transgender patients have barriers to care that may prevent provision of adequate sexual and contraceptive care
Examples of barriers include stigmatization and feeling unsafe in health care settings.3 Health care teams should provide a supportive, open, and safe environment for transgender patients by accepting their gender identity and sexual orientation and using their preferred name and pronouns. Providers should ask if patients have an intact uterus and ovaries, are sexually active with a partner that may result in pregnancy, have a history of sexual violence, are at risk of sexually transmitted infections (STIs), and use gender affirmation methods.3
There is a lack of research on pregnancy risk and fertility in transgender patients, and consequently, contraceptive guidelines for this patient population.3
All transgender men with reproductive potential should be offered contraception.5 Patients should decide which contraceptive they prefer to use, if any.
Reversible contraceptives
Reversible methods are most appropriate for patients who have not decided or do not want to make long-term or irreversible decisions regarding their reproductive potential.3
Progestin-only contraceptives
Progestin-only methods do not interfere with testosterone use. Regardless of testosterone use, patients who continue to have menstrual cycles may prefer this method due to high rates of amenorrhea and potential for masculinizing effects (e.g., increased hair growth).5,7
Traditional progestin-only pills (POP) containing norethindrone have a risk of low patient adherence due to its strict 3-hour window, which by missing correct timing of doses, may compromise contraceptive efficacy.8 However, the new POP, Slynd, allows for a 24-hour missed pill window.9 Irregular bleeding may occur, which patients may want to avoid.8
For patients seeking longer acting methods, the progestin-only injectable and long-acting reversible contraceptive devices — implant and IUDs — may be more convenient and have higher rates of amenorrhea.
Combination hormonal contraceptives
There is a lack of evidence regarding combined hormonal contraceptives including pills, patches, and vaginal rings) for transgender men as the estrogen may or may not interfere with testosterone therapy. At this time, there are no contraindications to concurrent use.5 Though patients can choose combination hormonal contraceptives, some may not prefer this method due to concerns about having estrogen in their system and the potential for female traits to appear.5,10 Other available and acceptable methods should be considered before considering combination hormonal contraceptives.5
Nonhormonal contraceptives
Although the copper IUD does not interfere with testosterone, there is a risk of increasing any existing menstrual bleeding.5 Patients with an intact uterus who want to avoid both progestins and estrogens and who are already amenorrheic may prefer this method.5
The contraceptive effectiveness of external and internal condoms is lower than hormonal methods and LARCs, however they are essential to prevent HIV and other STDs.3
Permanent surgical options are available for patients who do not want to get pregnant at all.3,7
For patients with a female gender identity and male sex assigned at birth taking estrogen, condoms may be used as well as permanent options, including orchiectomy (removal of testicles) and vasectomy (blockage of vas deferens tubes, preventing sperm from reaching testicles).7
For more information regarding transgender care and terminology, please visit the UCSF Transgender Care Navigation Program website at transcare.ucsf.edu/guidelines.
References
About the Author
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.
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
About the Author
Savannah Gross is a third-year pharmacy student at the University of Georgia College of Pharmacy.
Article reviewed by Rebecca Stone, PharmD, BCPS, BCACP
Birth Control Pharmacist 