Outreach Initiative to Expand Access to Depot Medroxyprogesterone Acetate (DMPA)

DMPA Outreach Study Infographic

Why Expand Access to DMPA

The novel coronavirus 2019 (COVID-19) presented many downstream challenges in healthcare throughout 2020. An area of particular interest was the impact COVID-19 had on access to hormonal contraception, specifically DMPA intramuscular (DMPA-IM). Prior to the pandemic, patients who used DMPA-IM would attend approximately four clinic visits per year (every 12 weeks) to obtain their injection from a medical professional.

As public health risks continued to be a primary concern and shelter-in-place orders were issued, the Centers for Medicare & Medicaid Services (CMS) issued waivers under section 1135 of the Social Security Act, which permitted state governments to adjust their public health responses to the pandemic as they deemed fit. One way Medi-Cal used this waiver was to cover self-administered DMPA subcutaneous (DMPA-SC) without a prior authorization so patients could continue using their preferred method of hormonal contraception while decreasing exposure to COVID-19 until further notice.

Our study explored interest in at-home, self-administered DMPA-SC among patients who had been on DMPA-IM at an urban, hospital-based safety-net primary care clinic in San Francisco. 

Approach to Patient Outreach 

Our team consisted of medical and pharmacy students, pharmacists, and medical doctors. We identified patients who had been on DMPA-IM within the last nine months (August 2019-May 2020) by searching the clinic’s electronic medical records. Through this process, we identified 90 patients and successfully reached 70 patients (78%) by telephone. Our patients were all on Medi-Cal or Family PACT. Additionally, our patient base was largely non-English speaking, so interpretative services were utilized for effective, patient-preferred communication. Once each patient’s identity was confirmed, we explained self-administered DMPA-SC and answered any questions posed by the patient. If the patient expressed interest in DMPA-SC, we ordered a prescription to their community pharmacy and offered telehealth appointments to answer any further questions, demonstrate how to self-inject, and/or observe the patient as they self-administered. Of the 70 patients reached, 26 patients (37%) were interested in learning more about DMPA-SC. By the end of our study, 15 patients (21%) successfully self-administered DMPA-SC or had a family member or friend do it for them.  

Clinical Implications

Feedback received from patients previously utilizing DMPA-IM suggests at-home administration of DMPA-SC is a viable option when selecting a hormonal contraceptive. By continuing to advocate for at-home administration, the medical community can help expand access to hormonal contraception for all patients.  

 

Check out the full study here

References

  1. Depo-SubQ Provera 104 prescribing information. Pfizer, December 2020. Link. Accessed February 25, 2021. 
  2. Katz M, Newmark RL, Aronstam A, O’Grady N, Strome S, Rafie S, et al. An implementation project to expand access to self-administered depot medroxyprogesterone acetate (DMPA). Contraception. 2020;102(6):392-5. DOI

Birth Control Pharmacist Sara Strome Headshot
About the Author

Sara Strome, PharmD Candidate is a pharmacy student in the Class of 2022 at the University of California San Francisco School of Pharmacy.

Webinar Equips Pharmacists to Provide Contraception Care During COVID-19

During the COVID-19 worldwide pandemic it has been quite the adjustment to deliver safe and quality patient care. Specifically, for contraception care, pharmacists have been working extra hard to continue their direct patient care with how accessible they are. Birth Control Pharmacist recently hosted a webinar that facilitated an educational program and discussion for pharmacy staff members to feel more equipped to deliver contraception and emergency contraception services during COVID-19.

We had multiple speakers of diverse backgrounds in order to give different perspectives on the effects of COVID-19 on contraception care and how pharmacists can best help their patients. The panel speakers were Jennifer Karlin, MD, PhD an attending physician in Family & Community Medicine at UC Davis and Sonya Frausto, PharmD who is the pharmacist-in-charge at Ten Acres Pharmacy, an independent community pharmacy.

What is the healthcare landscape during the COVID-19 pandemic?

Laying out the landscape during the COVID-19 pandemic helped paint a picture to participants about the extensive effects on contraception care. Whether that be loss of insurance or fear of infection from going to healthcare facilities, it highlighted how important it can be for pharmacists to assist their patients with contraception while following national guidelines.

How can pharmacists prescribe birth control safely?

National guidelines covered prescribing birth control and also social distancing to reduce the risk of spreading the virus. Telehealth has been a useful service in adhering to social distancing, while also maintaining face-to-face encounters. This helps patients maintain a personal relationship with their pharmacist.

What are some best practices within the pharmacy?

There are many useful suggestions throughout the webinar, but a useful tool they referenced is the Contraceptive Care Best Practices During COVID-19 best practices guide for pharmacies created by Birth Control Pharmacist.

Dr. Frausto wrapped up the program by reviewing useful tools and resources to use while in the pharmacy. Then she demonstrated a patient interaction within a pharmacy. This helped really bring the whole webinar together with a real-world example and solidified that this webinar is well worth the watch.

Fortunately, if you missed the webinar, the video recording and materials are available for home study online at https://birthcontrolpharmacist.com/careduringcovid/. The course material is available to all, with pharmacists having an opportunity to obtain Continuing Pharmacy Education credit. This material provides education to participants to increase their comfort in providing contraception care, including prescribing hormonal contraception, in community pharmacies during the COVID-19 public health emergency.

Participants provided feedback at the conclusion. Keep reading to see their positive reviews and gain a better idea of what to expect from the online course:

“I loved this CE. Very informative, the speakers were great and passionate about the topic!

“As a newer pharmacist, this type of information helps me to feel better prepared to provide these kinds of services to patients.

“Loved the topic, very timely for COVID.”

“I was coming from a state where pharmacists did not prescribe birth control so this was a new perspective for me.”

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About the Author

Samantha ThompsonSamantha Thompson, PharmD Candidate is a pharmacy student in the Class of 2023 at University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. Samantha completed a summer internship with Birth Control Pharmacist.

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