Reproductive Health During COVID: Eliminating FDA’s Burdensome Barriers to Mifepristone

What is Mifepristone? 

Mifepristone is the primary component in the FDA-approved regimen taken to terminate pregnancies through 10 weeks gestation and is seen as an alternative to a surgical procedure.1 Many patients view this as less invasive, allowing for more privacy and control over a personal situation. The standard oral regimen includes mifepristone 200mg followed by misoprostol 800mcg 24-48 hours later. There are alternative doses available depending on medication availability and gestational window.2 mifepristone and misoprostol work in tandem to halt the pregnancy from developing and induce cramping to evacuate the contents of the uterus. Following the administration of these medications, women typically report back to their healthcare provider one to two weeks later to ensure the medications were fully effective and that the pregnancy has been terminated. Women can expect heavy bleeding and strong abdominal cramps that are most severe during the first few hours post-treatment but typically subside over the next day or two.1,3

Current Practice of Mifepristone Prescribing

The protocol for women pursuing medication abortion counseling and treatment often begins in a doctor’s office. Patients undergo a series of health screenings including laboratory testing, an ultrasound assessment to determine gestational age, and contraindication evaluations.2,4 

Additionally, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) prior to prescribing mifepristone, stating this is necessary to ensure safe use of the medication by patients.1,4 REMS programs are typically employed when prescribing medications with major safety concerns or the potential for serious adverse effects. Beyond this program, there are numerous stipulations to prescribing and dispensing mifepristone. Patient agreement forms, healthcare provider supervision and policies that restrict dispensing this medication anywhere outside of clinics, medical offices, and hospitals, make mifepristone unnecessarily difficult for patients to obtain.

How Has the Pandemic Impacted this Process? 

Cue the COVID-19 pandemic and reproductive health becomes infinitely harder. Once the country began shutting down in March, schools, businesses, and many other public entities were at a standstill as nonessential services. While many healthcare facilities were faced with overwhelming numbers of potential patients with coronavirus, other health related surgeries and appointments were postponed to mitigate infection risk in the general population. Access to abortion is time-sensitive, so when it is unavailable it leaves many women without fundamental choices for their family planning and reproductive outcomes. 

Reproductive care, including abortion, has been regarded as nonessential in many states across the United States, barring women from access to vital medical services. Governors in Texas, Louisiana, Mississippi, Alabama, and Oklahoma have made efforts towards ending both medical and surgical abortions.5 These states, among others, have aimed to restrict access to reproductive health processes by deeming them elective rather than essential procedures. As of April 8th 2020, Temporary Restraining Orders (TROs) have impeded certain state bans on abortions while litigation remains ongoing in Ohio, Alabama, and Oklahoma.5 While certain states continue to debate reproductive health legislation, congressional lawmakers contested the FDA on behalf of their constituents earlier this month. On June 16th 2020, the FDA received a letter on behalf of over 100 members of congress urging them to ease restrictions surrounding reproductive care during the pandemic.

ACOG’s Efforts to Ease Reproductive Care Restrictions 

In response to certain states’ stringent limitations and the overdue revisions to modern reproductive care, the American College of Obstetricians and Gynecologists (ACOG) filed a lawsuit petitioning the FDA to remove restrictive barriers to obtaining mifepristone during the COVID pandemic. The civil rights action was officially filed May 27th, 2020 to challenge the FDA to alter the multitude of requirements to prescribing mifepristone as nationwide efforts shift towards telemedicine.7,8 Both the CDC and the FDA have encouraged the use of telehealth to allow flexibility for doctors to safely meet with their patients while foregoing unnecessary in-person appointments. Thus far, women seeking mifepristone to end an early pregnancy or manage a miscarriage have been an exception to the highly enforced transition to telemedicine.7 Likewise, women are still required to travel to their doctor’s medical office or hospital to pick up the medication rather than a contactless option like mail order. ACOG pointed out the incongruence of the FDA’s standards which require patients to be seen in person to obtain mifepristone, yet allows them to take it in their homes without medical supervision. To emphasize their point, ACOG continues by noting that out of more than 20,000 drugs regulated by the FDA, mifepristone is the only medication that has such specifications, while allowing patients to self-administer in a location of their choosing.7 

When utilized for reasons other than abortion or miscarriage, the FDA allows mailing mifepristone to patients’ homes without the barriers imposed upon women pursuing reproductive care.7 This caveat exclusively hinders women in need of reproductive care from easily obtaining the required medications without bearing the unnecessary risk of COVID-19 infection from visiting a medical clinic. Many women who refuse this option are left with less effective options which may necessitate consequential procedures, thereby increasing exposure risk for patients and healthcare workers; the very circumstance all facets of medicine are trying to avoid.7

Recent Updates to Gaining Mifepristone Access

After deliberation in federal court, ACOG accomplished what they sought out to do when issuing their lawsuit to the FDA. On July 13th 2020,  a federal district court ruled in favor of a temporary suspension of the restrictions imposed upon obtaining mifepristone.9 The ruling sided with the notion that the barriers around  mifepristone subjected countless women to the unnecessary health risks of public exposure during the COVID-19 pandemic. While the preliminary qualifications and REMS testing still applies, the court’s order allows clinicians to mail mifepristone to eligible patients seeking abortion care under the U.S. Department of Health and Human Services’ COVID-19 Public Health Emergency. Although this has the potential to vastly expand access to mifepristone, ACOG continues to encourage clinicians to practice within their state’s laws which take precedence over this ruling.10 In response to the lifted restrictions, the president of ACOG, Eva Chalas, M.D., FACOG, FACS, hailed this decision as a “necessary step forward in our collective work toward health equity”.9  

How Pharmacists Can Play a Role

As the nation strives to adapt to telemedicine, pharmacists are becoming the sole in-person healthcare provider for many Americans. Pharmacists are often conveniently positioned in stores housing groceries or necessary supplies that people continued visiting during the pandemic. As one of few essential businesses that never closed, pharmacy dispensing of mifepristone would enable women to have more timely access to mifepristone and avoid the added risks of visiting additional clinic locations. In light of telemedicine, health disparities would be reduced for patients that have difficulty accessing medical abortions in their communities. Pharmacists may be able to help fill this gap and ensure safe use of mifepristone by counseling patients on how to take it and by answering questions that may arise.4 This shift in responsibility would continue to prioritize patient safety while employing trained healthcare professionals to aid in convenience, education and accessibility to a time-sensitive medication. 

References

  1. Center for Drug Evaluation and Research. (n.d.). Mifeprex (mifepristone) Information. Retrieved June 24, 2020, (link)
  2. (n.d.). Retrieved June 27, 2020, from (link)
  3. Center for Drug Evaluation and Research. (n.d.). Questions and Answers on Mifeprex. Retrieved June 24, 2020, (link)
  4. Raifman, S., Orlando, M., Rafie, S., & Grossman, D. (2018). Medication abortion: Potential for improved patient access through pharmacies. Journal of the American Pharmacists Association, 58(4), 377-381. doi:10.1016/j.japh.2018.04.011
  5. Bayefsky, M. J., Bartz, D., & Watson, K. L. (2020). Abortion during the Covid-19 Pandemic — Ensuring Access to an Essential Health Service. New England Journal of Medicine, 382(19). doi:10.1056/nejmp2008006
  6. Congress of the United States – degette.house.gov. (2020, June 16). Retrieved June 24, 2020, from (link)
  7. ACOG V. FDA Complaint Mifepristone COVID-19, retrieved June 24, 2020 (link).
  8. ACOG Suit Petitions Court to Remove FDA’s Burdensome Barriers to Reproductive Care During COVID-19. (2020, May 27). Retrieved June 24, 2020 (link)
  9. Federal Court Blocks FDA Restriction That Unnecessarily Imposes COVID-19 Risks on Patients Seeking Abortion Care. 27 May 2020, (link)
  10. “Court’s Order Lifting Burdensome FDA Restriction: What You Need to Know.” ACOG, 15 July 2020, http://www.acog.org/news/news-articles/2020/07/courts-order-lifting-burdensome-fda-restriction-what-you-need-to-know.

About the Author

Savannah Gross, PharmD Candidate, is a third-year pharmacy student at University of Georgia College of Pharmacy

Article Reviewed by: Sally Rafie, PharmD, BCPS, APH, NCMP, FCCP

Contraception During COVID-19: Pharmacy Best Practices

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.


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.

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.

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.

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

  1. CDC. Guidance for pharmacies during COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html; Published April 14, 2020. Accessed May 15, 2020.
  2. Family Planning National Training Center. What family planning providers can do to meet client needs during COVID-19. https://www.fpntc.org/resources/what-family-planning-providers-can-do-meet-client-needs-during-covid-19. Accessed May 15, 2020.
  3. Kaiser Family Foundation. Oral contraceptive pills. Available at: https://www.kff.org/womens-health-policy/fact-sheet/oral-contraceptive-pills/. Published May 23, 2019. Accessed May 15, 2020.
  4. Beyond the Pill. Contraceptive care during COVID-19. https://beyondthepill.ucsf.edu/contraceptive-care-during-covid-19. Accessed May 15, 2020.

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

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