A Comprehensive Guide to Pharmacist Birth Control Services

February 12, 2024Leave a comment

In the ever-evolving landscape of healthcare, pharmacists are stepping into increasingly vital roles, particularly in the realm of reproductive health. Pharmacist-provided birth control services offer a convenient and accessible alternative for individuals seeking contraception. However, to deliver these services effectively, pharmacists require specialized training, clinical guidelines, billing resources, and patient education materials. In this compendium, we explore the essential components necessary to equip pharmacists with the knowledge and resources they need to provide comprehensive birth control services.

Pharmacists seeking to expand their scope of practice to include birth control services require specialized training to ensure they have the necessary knowledge and skills. Fortunately, several training programs cater to this need, offering comprehensive courses that cover contraceptive methods, counseling techniques, patient assessment, and more. By participating in such programs, pharmacists can enhance their expertise and confidence in providing birth control services, ultimately improving patient outcomes and satisfaction.

Clinical guidelines serve as invaluable resources for pharmacists, providing evidence-based recommendations for the provision of birth control services. These guidelines cover various aspects, including eligibility criteria for different contraceptive methods, screening protocols, counseling frameworks, and management of side effects and complications. Pharmacists can refer to established guidelines from reputable organizations such as the Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the American Pharmacists Association (APhA) to ensure that their practice aligns with current standards of care.

Navigating the complexities of billing and reimbursement is a crucial aspect of providing birth control services in a pharmacy setting. Pharmacists must be familiar with billing codes, insurance coverage policies, and documentation requirements to facilitate seamless transactions and ensure fair compensation for their services. Fortunately, numerous resources are available to assist pharmacists in this regard, including online guides, webinars, and training modules provided by professional organizations and billing experts. By leveraging these resources, pharmacists can optimize their billing practices and maximize revenue while providing essential birth control services to patients.

Effective patient education is essential for promoting informed decision-making and optimal contraceptive use. Pharmacists play a vital role in counseling patients on the benefits, risks, and proper usage of contraceptive methods, as well as addressing any concerns or misconceptions they may have. To support this effort, pharmacists can utilize a variety of educational materials, including pamphlets, brochures, visual aids, and digital resources. These materials should be clear, concise, culturally sensitive, and accessible to ensure that patients receive accurate information tailored to their needs and preferences.

Pharmacist-provided birth control services represent a significant advancement in expanding access to contraception and promoting reproductive health. By investing in training programs, clinical guidelines, billing resources, and patient education materials, pharmacists can enhance their capacity to deliver comprehensive and high-quality care in a pharmacy setting. As trusted healthcare professionals embedded within their communities, pharmacists have a unique opportunity to empower individuals to make informed choices about their reproductive health and improve overall health outcomes. This compendium serves as a convenient collection of the resources needed for pharmacists to provide birth control services to their patients.

Rebecca Exantus APPE About the Author

Rebecca Exantus, Pharm.D Candidate, is a 4th-year student pharmacist in the Class of 2024 at Shenandoah University Bernard J. Dunn School of Pharmacy. Rebecca completed an elective APPE rotation with Birth Control Pharmacist.

From Catholic School to Pharmacy School: My Journey to Learn About Reproductive Health

January 29, 2024January 28, 2024

Growing up in a conservative Catholic environment, discussions about reproductive health were often shrouded in secrecy and limited to the teachings of the Church. However, my curiosity and a deep-seated desire to understand the intricacies of reproductive health led me on a transformative journey from a Catholic school to pharmacy school.

My early education was deeply rooted in Catholic principles, where discussions about reproductive health were often reserved for religious contexts. While my school instilled strong moral values, I couldn’t ignore the gaps in my understanding of crucial health matters. This realization became the catalyst for my quest to learn more.

As I progressed through high school, I started questioning the limited information provided about reproductive health. We were educated about sexual health but were told not to engage in sexual intercourse because it was only allowed for married men and women. At the age of 16, I didn’t even know what a condom looked like. We did not have access to both male and female condoms at the nurse office at school. This is what began my quest for understanding the science behind it, the various methods of contraception, and the broader spectrum of sexual health. This curiosity became the driving force that led me to explore beyond the confines of my traditional education.

As I delved into my pharmacy school curriculum, I encountered a diverse range of subjects, one of which was Contraception Pharmacology & Counseling. I remember feeling a little uncomfortable hearing abortion being talked about so openly. However, this subject opened my eyes to the complexities surrounding this area of healthcare and ignited a curiosity to understand it in depth.

As I delved deeper into the world of healthcare on clinical rotations, I discovered the pivotal role that pharmacists play in reproductive health. Pharmacists serve as valuable resources for individuals seeking information about contraceptives, family planning, and sexual health. Recognizing the importance of this role, I made the decision to pursue a career in pharmacy to bridge the gap between religious beliefs and evidence-based reproductive health knowledge.

Pharmacy school proved to be both challenging and enlightening. I faced coursework that demanded a comprehensive understanding of reproductive health, including pharmacological interventions. Additionally, I engaged in open discussions that challenged my preconceived notions and allowed me to grow both personally and professionally.

Through my journey, I discovered that faith and science can coexist harmoniously. Instead of viewing them as conflicting entities, I learned to integrate my Catholic beliefs with evidence-based knowledge. This newfound perspective empowered me to contribute positively to conversations about reproductive health, fostering understanding and compassion within diverse communities.

My journey from Catholic school to pharmacy school has been a profound exploration of not only pharmaceutical sciences but also the intricacies of reproductive health. Embracing the challenges, questioning preconceived notions, and actively participating in the discourse surrounding this vital aspect of healthcare have defined my transformative journey. As I continue to learn and advocate, I hope to inspire others to approach reproductive health with an open mind, fostering a compassionate and informed approach to healthcare.

Rebecca Exantus APPE About the Author

Founder Reflections on 2023

December 31, 2023Leave a comment

As I reflect on this past year, 2023 finally brought us some wins in reproductive health. And I personally had the opportunity to contribute to landmark steps forward.

⭐️ The FDA made long awaited changes to the mifepristone REMS program to allow pharmacies to dispense the essential medication. I was part of the research team that conducted multi-site research studies demonstrating the safety and acceptability of pharmacy dispensing of mifepristone, led by Dr. Daniel Grossman at UCSF.

⭐️ The FDA also approved the first over-the-counter birth control pill, OPill, that we will see on the shelves soon. My supportive testimony at the FDA Advisory Committee meeting helped committee members vote unanimously to recommend approval.

⭐️ California is leading the country by investing in implementation of abortion and comprehensive reproductive health care by pharmacists. Birth Control Pharmacist, in partnership with the California Pharmacists Association and CPhA Foundation, will be providing training, technical assistance and pharmacy mini-grants to increase the number of pharmacies dispensing medication abortion care and other reproductive health services. I hope the Pharmacists CARE Initiative will be an inspiration to other states.

⭐️ Our highest leadership at HHS has recognized the value of pharmacists and pharmacy-based care. When I presented at the HHS Roundtable, Secretary Xavier Becerra agreed that pharmacists are an important part of delivering this care. I look forward to seeing pharmacist services incorporated into payment structures.

While this doesn’t balance the ongoing attacks on reproductive health, they are important milestones worth celebrating. It’s a privilege to engage in such meaningful work and partner with so many bright and dedicated individuals. I appreciate the partnership of organizations supporting this work and inviting me to speak at their programs – Association of State and Territorial Health Officials, Ibis Reproductive Health, NFPRHA, Reproductive Health Access Project, UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, UC Irvine School of Public Health/OC Women’s Health Project, UConn’s LKS Chapter, UCSF, UNC, University of Maryland/Johns Hopkins University, California State University, California Board of Pharmacy, AMIA Clinical Informatics Fellows (ACIF) Working Group, UCLA/USC, and others.

On the other hand, in addition to all the state policies removing and restricting peoples choices related to their own reproductive health and bodies, we are now seeing the first case threatening the availability of mifepristone on a national level. This case evaluating the validity of FDA approval of mifepristone is a new tactic against reproductive rights. We must use our voices and vote in 2024 to preserve and advance what matters.

We’re passing a mile marker but the long road to reproductive justice in this country continues.

Birth Control Pharmacist Founder, Dr. Sally Rafie, pictured with her Vital Contributions to Women’s Health Award from the ACCP Women’s Health PRN

Announcing the Pharmacists CARE Initiative to Increase Access to Reproductive Health Services in California

December 13, 2023December 13, 2023Leave a comment

$2 Million Contract Awarded to the Pharmacists CARE Initiative to Expand Medication Abortion Services in California

Birth Control Pharmacist, in partnership with the California Pharmacists Association (CPhA) and the CPhA Foundation, is proud to announce the receipt of a transformative $2 million grant from the California Department of Health Care Access and Information. Over the next five years, this grant will facilitate the development of the “Pharmacists Comprehensive Abortion and Reproductive Health Empowerment (Pharmacists CARE) Initiative,” aimed at significantly increasing access to medication abortion and reproductive health services in pharmacies across California.

Key Features of the Program:

Access Expansion: The initiative will extend medication abortion services to medically underserved communities by providing training and implementation support for pharmacists. This will enable pharmacies to provide a fuller range of reproductive health services at their practice site locations including directly providing services allowed by state policy and the pharmacists’ scope of practice, creating greater access to comprehensive reproductive health options.

Safe and Professional Services: All training adheres to the highest medical and ethical standards to guarantee patients receive quality care and information.

Mini Grants to Pharmacies: The program includes mini grants administered by the CPhA Foundation to support pharmacies in implementing abortion services.

The Pharmacists CARE Initiative was created through Assembly Bill 1918 (Petrie-Norris) and subsequently funded through Governor Newsom’s 2022 budget. AB 1918 was based on recommendations developed by the California Future of Abortion Council to respond to drastic changes in the abortion access landscape.

Statement from Dr. Sally Rafie, Founder of Birth Control Pharmacist:

“California is leading the way by recognizing pharmacists and pharmacies as an essential access point for reproductive health services and products. The Pharmacists CARE Initiative represents a milestone in our mission to provide access to quality and convenient reproductive healthcare, empowering pharmacists to make a difference in the lives of people in the communities they serve. We are excited to work collaboratively with the California Pharmacists Association and the CPhA Foundation to make this vision a reality.”

Statement from Susan Bonilla, CEO of the California Pharmacists Association:

“The California Pharmacists Association is pleased to be part of this groundbreaking initiative. This grant will empower pharmacists with the skills and resources they need to expand and ensure access to essential reproductive health services for all Californians. We believe this initiative will have a lasting, positive impact on the lives of those who need these services.”

Statement from Dr. Rajan Vaidya, Executive Director of the CPhA Foundation:

“At the CPhA Foundation, we are dedicated to supporting initiatives that enhance public health and well-being. This grant from the California Department of Health Care Access and Information is a significant step in ensuring that pharmacists are equipped to provide vital reproductive health services, ultimately improving access to healthcare for people throughout California.”

More information about the Pharmacists CARE Initiative and its mission to expand medication abortion services and comprehensive reproductive health care in pharmacies across California can be found at https://birthcontrolpharmacist.com/care/. For more information on the Pharmacists CARE Initiative or to arrange interviews with project leaders, please contact mail@birthcontrolpharmacist.com.

About Birth Control Pharmacist
Birth Control Pharmacist provides education and training, implementation assistance, resources, and clinical updates to pharmacists prescribing contraception and key stakeholders, as well as leading and stimulating advocacy, research, and policy efforts to expand the role and realize the potential of pharmacists in reproductive health and justice. They also maintain the Birth Control Pharmacies directory for people across the country to find a participating pharmacy where they can access contraception directly from a pharmacist.

About the California Pharmacists Association (CPhA)
The California Pharmacists Association is a leading advocate for the pharmacy profession in California representing all areas of pharmacy practice. They are dedicated to promoting the health of Californians through pharmacy practice.

About the CPhA Foundation
The CPhA Foundation is a non-profit organization committed to improving healthcare through innovation, research, and educational programs, with a particular focus on the role of pharmacists in patient care.

Over-the-Counter Birth Control Pills: FDA Considering HRA Pharma’s Opill

April 18, 2023April 18, 2023

Why Over-the-Counter Birth Control?

Oral contraceptives have been around since 1960, and their risks and safety profiles have been well-studied throughout the years. According to the Guttmacher Institute, unplanned pregnancies account for 45% of all pregnancies in the US. Furthermore, nearly one-third of individuals who have tried to obtain a prescription for hormonal contraception report difficulty doing so. Polling from Data for Progress in 2022 shows that the majority of Americans, regardless of political affiliation, support making birth control available over the counter.

The push for over-the-counter (OTC) birth control is driven by the need to expand access to safe and effective contraception. Research shows that women and teens who are uninsured, currently use a less effective contraceptive method, or tried to get a birth control prescription in the past year are more likely to use OTC birth control. Being able to acquire birth control over the counter would especially benefit marginalized communities and individuals who face healthcare barriers, such as transportation, cost, language, and lack of physician access.

Over 100 countries worldwide have approved OTC birth control options, but as of April 2023 the United States is not one of them. The American College of Obstetricians and Gynecologists, American Medical Association, and American Academy of Family Physicians concur that oral contraceptives should be approved for OTC use. In June 2022, the AMA urged the FDA to approve an OTC contraceptive method with no age restriction.

How Do We Get an OTC Birth Control Option?

In order for a drug to be approved for OTC use by the FDA, certain criteria must first be met. The drug must be safe, treat a condition that patients can diagnose by themselves, have a low potential for abuse or misuse, and be available for use without supervision of a healthcare provider. Oral contraception checks all of these boxes.

The next step is having a pharmaceutical company manufacture a product that can be FDA-approved for OTC use. HRA Pharma, a French pharmaceutical company acquired by Perrigo, is working with Ibis Reproductive Health to bring the product Opill to the US market.

What is Opill?

Opill, the product manufactured by HRA Pharma, is a progestin-only pill for which Ibis and HRA Pharma are seeking FDA approval. If approved, Opill will become the first oral contraceptive available over the counter in the US.

There are two types of oral contraceptives: combination pills (containing both estrogen and progestin) and progestin-only pills. Progestin is a form of the endogenous hormone progesterone, and it plays a key role in the menstrual cycle. Progestin, along with other hormones, helps start and stop the menstrual cycle. Low progestin levels in the body cause shedding of the uterus lining, signaling the start of menstrual bleeding. High progestin levels in the body (i.e., when you’re taking a progestin-only pill) cause the cervical mucus to thicken, making it harder for sperm to enter the uterus and fertilize an egg.

Progestin-only pills are deemed safer than combination oral contraceptives. Due to estrogen’s pro-coagulatory nature, combination oral contraceptives carry the risk of adverse effects related to thromboembolism, or blood clotting. The lack of estrogen in progestin-only pills means it is preferred in individuals who smoke, have high blood pressure, experience migraines with aura, or are otherwise at risk of blood clots.

On July 11, 2022, HRA Pharma submitted their application for FDA approval of Opill. The FDA review process is expected to take about 10 months. Opill has been approved for prescriptive use since 1973, so its safety data has stood the test of time. Traditionally, progestin-only pills must be taken at the same time each day, with only a three-hour window of tolerance before requiring back-up contraception (e.g., male condom). However, recent research has found that there is a larger margin of error than previously believed. Because different progestin-only pills contain different types of progestin, they act on the body through different mechanisms. Thus, some progestin-only pills (including norgestrel-only formulations such as Opill) may not adhere to the strict three-hour window of administration.

When Can We Expect a Decision from the FDA?

Previously, the FDA planned to hold a joint meeting on November 18, 2022 with the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) to review HRA Pharma’s Opill application. This joint meeting was put off indefinitely until March 28th of this year, when the FDA announced that it has rescheduled the advisory committee meeting for May 9-10, 2023. May 9th is also Free the Pill Day, which celebrates the anniversary of the first birth control pill in the US becoming FDA-approved in 1960.

Currently, the nationwide movement involving pharmacists prescribing hormonal contraceptives helps circumvent healthcare barriers and make birth control more accessible. The approval of Opill would further aid in the removal of these barriers and see a monumental expansion of contraceptive access, bringing us one step closer to providing patients with the healthcare they deserve. We look forward to the FDA’s decision as May 2023 draws near.

References

Abrams A. First U.S. application for over-the-counter birth control pill. Time. https://time.com/6195124/birth-control-pill-over-the-counter-fda/. Published July 14, 2022. Accessed April 13, 2023.
Data For Progress. Files For Progress. Data For Progress. https://www.filesforprogress.org/datasets/2022/5/dfp_22_cai_tabs.pdf. Published 2022. Accessed April 14, 2023.
Finer L, Zolna M. Declines in unintended pregnancy in the United States. 2008–2011, New England Journal of Medicine, 2016, 374(9):843–852, doi:10.1056/NEJMsa1506575.
Grindlay K, Grossman D. Interest in Over-the-Counter Access to a Progestin-Only Pill among Women in the United States. Womens Health Issues. 2018;28(2):144-151. doi:10.1016/j.whi.2017.11.006
Grindlay K, Grossman D. Prescription Birth Control Access Among U.S. Women at Risk of Unintended Pregnancy. J Womens Health (Larchmt). 2016;25(3):249-254. doi:10.1089/jwh.2015.5312
Wollum A, Zuniga C, Blanchard K, Teal S. A commentary on progestin-only pills and the “three-hour window” guidelines: Timing of ingestion and mechanisms of action [published online ahead of print, 2023 Feb 19]. Contraception. 2023;109978. doi:10.1016/j.contraception.2023.109978.

Photo credit: Image from FreethePill.org

Matissa About the Author

Matissa Peng, Pharm.D Candidate, is a 3rd-year student pharmacist in the Class of 2023 at the University of the Pacific Thomas J. Long School of Pharmacy. Matissa completed an elective APPE rotation with Birth Control Pharmacist.

Misoprostol-Only Medication Abortion Regimen

March 23, 2023

Political Climate

After the U.S. Supreme Court’s decision to eliminate the constitutional protections for abortion in Dobbs v. Jackson Women’s Health Organization in June 2022, access to mifepristone and abortion services in general are being threatened across the country.

An ongoing anti-abortion lawsuit in Texas seeks to reverse mifepristone’s FDA approval and remove it from the market, even in states where abortion is legal.

This won’t shut down medication abortion altogether, but it will limit treatment options. In the unfortunate case that mifepristone is taken off the market, we need to be prepared to use other regimens such as misoprostol-only.

Background

Misoprostol can safely be used alone for medication abortion if mifepristone is not available. It is used off-label for abortion because it is effective at inducing uterine contractions and cervical ripening.

Evidence from a range of sources including randomized control trials, a meta-analysis, a retrospective review and others, shows that misoprostol-only successfully terminates around 80-100% of pregnancies without needing procedural intervention.¹

Safety

Side effects for the misoprostol-only regimen are similar to the combined mifepristone and misoprostol regimen, however they may last longer due to the multiple doses.

Beyond vaginal bleeding, other common side effects of misoprostol include nausea, abdominal pain and cramping, diarrhea, and fever/chills. Major complications requiring hospital admission, blood transfusions, or surgery are rare and occur in <1% of cases.¹ Patients should seek medical attention if they experience heavy bleeding that soaks 2 full-size pads per hour for 2 consecutive hours, a persistent fever over 100°F that lasts more than 4 hours, severe abdominal pain that is unresponsive to pain medications, or general malaise that lasts over 24 hours after the last misoprostol dose.

It’s critical to acknowledge that self-managed abortions occur and that they may increase, especially in states with severe abortion bans. Available data on self-managed abortions suggest a low prevalence of serious adverse outcomes.²

Pharmacists have been publicly deemed as some of the most trusted healthcare professionals, and it’s important to think about how we can be a safe resource for patients who do seek support for adverse events while protecting them and ourselves from legal repercussions.

Sample Protocol

The following sample protocol is endorsed by the Society of Family Planning.³ Providers may use it for guidance when screening patients in-person or through telehealth. Of note, the buccal route of administration is not included in this protocol, but is commonly used as well.

Eligibility Criteria

Pregnancy confirmed by urine, serum test, or ultrasound
Gestational age ≤ 12 weeks
None of the following risk factors or symptoms of ectopic pregnancy:
- Vaginal bleeding or spotting within the past week
- Pelvic pain within the last week
- Prior ectopic pregnancy or tubal surgery
- IUD currently in uterus or at time of conception
No history of hemorrhagic disorder or concurrent anticoagulant therapy
No history of allergy to misoprostol or other prostaglandin
Patient has made an informed decision to use misoprostol-only for abortion

Treatment

Misoprostol 800 mcg sublingually or vaginally every 3 hours for at least 3-4 doses per clinician judgment
- Sublingual route: put all 4 pills under the tongue and leave them there for 30 minutes, then swallow what’s left with water
- Vaginal route: wash hands, lie down, and use finger to insert 4 pills as high up into the vagina as able to and stay lying down for 30 minutes. Moistening each tablet with a few drops of water before insertion may improve effectiveness
Analgesics, antipyretic, antiemetics, antidiarrheals as indicated or needed per the clinician

Follow-up

Confirm abortion completion by one of the following:
- Urine pregnancy test 4 weeks after misoprostol use
  - If positive, evaluate with ultrasound or serum HCG tests
- Ultrasound or pelvic examination 1-2 weeks after misoprostol use
- Serial serum HCG testing
  - First test on the day of initial misoprostol ingestion
  - Second test 1-2 weeks later

References

Society of Family Planning. (2023). Misoprostol Only is Safe and Effective [fact sheet]. Retrieved from https://societyfp.org/wp-content/uploads/2023/02/SFP_ScienceSays_misoprostol.pdf
Aiken ARA, Romanova EP, Morber JR, Gomperts R. Safety and effectiveness of self-managed medication abortion provided using online telemedicine in the United States: A population based study. Lancet Reg Health Am. 2022;10:100200. doi:10.1016/j.lana.2022.100200
Raymond EG, Mark A, Grossman D, et al. Medication abortion with misoprostol-only: A sample protocol [published online ahead of print, 2023 Feb 26]. Contraception. 2023;109998. doi:10.1016/j.contraception.2023.109998

michelle (2) About the Author

Michelle Chung, Pharm.D Candidate, is a 4th-year student pharmacist in the Class of 2023 at the University of Washington School of Pharmacy. Michelle completed an elective APPE rotation with Birth Control Pharmacist.

Pharmacists Can Now Dispense Mifepristone Under Updated REMS Program

January 19, 2023

What Does the January 2023 Update Mean for Mifepristone Dispensing?

Mifepristone is a medication that is used to end an early pregnancy. It has been available in the United States since 2000 and is widely used as a safe and effective option for ending a pregnancy during the first 10 weeks.

As of January 2023, the US Food and Drug Administration (FDA) announced an update to the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. One of the most notable changes is the ability for pharmacists to dispense the drug to patients in the community retail setting. Pharmacies must become certified before they can order and dispense mifepristone. Pharmacies can become certified by choosing a designated representative to fill out the Pharmacy Agreement Form and oversee the implementation of the REMS program.

This only affects the dispensing aspect of mifepristone use. The requirements associated with the safe prescribing of this medication remain the same. This update is expected to alleviate the burden on patients and make medication abortion care more accessible. This revision to the REMS program is a step in the right direction for reproductive health access.

The other component of the medication abortion regimen is misoprostol. Pharmacies have been dispensing misoprostol for medication abortion as well as other indications, so they can continue to do so without any changes.

Certification Requirements

Here are some of the most important steps to the certification process that pharmacists should know about.

Decide who will become the authorized representative(s). This individual(s) will oversee compliance with the REMS program.

Choose one Pharmacy Agreement Form from either Danco Laboratories or GenProBio to complete. You should pick the form that corresponds to the product — brand or generic — you plan to dispense most often.

Develop a record-keeping system for prescriber agreement forms. You can keep a binder with the physical forms or create a digital folder on the pharmacy computer. You will need a Prescriber Agreement Form (for either manufacturer) from each prescriber prior to filling the first prescription issued by them.

Record the NDC and lot number from each medication package dispensed in the patient’s record.

Mifepristone must be dispensed to the patient within four calendar days of the date the pharmacy receives the prescription.
- If patients are set to receive the drug >4 days after the pharmacy received the prescription, confirm the appropriateness of dispensing with the prescriber.
- If the pharmacy is mailing mifepristone, they must use a shipping service that provides tracking information.

How Should Pharmacists Counsel Patients?

Learn about the side effects, contraindications, counseling strategies, and follow-up needs related to mifepristone and misoprostol.

Utilizing a continuing education course can help pharmacists counsel patients effectively and answer any questions they may have.

Why Is This Important?

Pharmacists play an integral role in medication abortion by ensuring that patients receive the correct medications in a timely manner and providing education on the proper use of the drugs. By providing guidance on other aspects of the abortion process, such as follow-up care and contraception options, pharmacists help to ensure that patients have a safe and successful abortion experience. It is important for pharmacists to be aware of these changes to ensure that they are providing their patients with the best care possible and following the requirements for dispensing mifepristone.

Frequently Asked Questions

Can mifepristone be processed through prescription drug insurance?

There is no information yet on whether it is covered as a pharmacy benefit with the various health plans. Pharmacies should process the claims in hopes of coverage, and if not it will put the need for coverage on the radar for these health plans. For now, explain to patients it may be an out-of-pocket expense until their health plans align with the update. If any pharmacists have connections with health plans, this is an important issue to advocate for.

Federal Medicaid funding only pays for abortions when the pregnancy is a result of rape or incest or a threat to the pregnant person’s life. Sixteen states have opted to use their own state funds to pay for medication abortions, for Medicaid enrollees.

Alaska, California, Connecticut, Hawaii, Illinois, Maine, Maryland, Massachusetts, Minnesota, Montana, New Jersey, New Mexico, New York, Oregon, Vermont, and Washington

Private insurance coverage of abortion services is variable and depends on the type of insurance plan, the policyholder’s state of residence, and employer coverage decisions. Pharmacists should encourage patients to contact their insurance provider if they have questions about whether a particular insurance provider will cover the cost of the drug.

Can a pharmacist refuse to dispense mifepristone or misoprostol?

Pharmacists can legally refuse to fill prescriptions due to religious or personal values in most states that have conscience laws. However, some states require that pharmacists avoid neglecting or abandoning the patient’s needs. In other words, you have to ensure the patient is still able to get the medications elsewhere in a timely fashion if you are not going to fill the prescription. Check your state policy.

Are there any special storage or handling requirements for mifepristone?

No, but it is important to note that:

MIFEPREX is supplied as light yellow, cylindrical, and bi-convex tablets imprinted on one side with “MF.” One tablet is individually blistered on one blister card that is packaged in an individual package.
The generic mifepristone is light yellow, circular, and is also packaged individually.
Both should be stored at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).

Where can pharmacists receive training to dispense medication abortion tablets?

Located on our website is a continuing pharmacy education course that can help teach pharmacists about everything they need to know about medication abortion and the dispensing implications. It is a 1-hour home-study activity with no charge to participate, complements of UCSF’s ANSIRH, and it has received no commercial support.

How can a pharmacist support patients seeking medication abortion tablets, particularly in areas where access to such services may be limited?

If a pharmacy is not yet certified to dispense mifepristone, they can refer their patients to mail-order pharmacies. Here are three safe online options they can utilize: Honeybee Health, American Mail Order Pharmacy, and ManifestRx.

How will state bans affect pharmacy dispensing?

While pharmacies in any state may complete the pharmacy agreement for Danco or GenBioPro, they would not be able to legally dispense mifepristone for medication abortion if they are in a state that has banned medication abortion. Check your state policies.

How to know if a pharmacy is certified to dispense?

Pharmacies can inform their local providers when they’re enrolled to let them know about their certification. Pharmacies can consider proudly displaying signage in stores and on their social media to raise awareness about the availability of medication abortion care. We have some social media graphics that you are welcome to use. Patients are encouraged to call ahead to ask about a pharmacy’s status.

Some chains, like CVS and Walgreens, have stated they are in the works of becoming certified, but this doesn’t ensure every location will implement the program at the same rate.

Amanda Idusuyi About the Author

Amanda Idusuyi, Pharm.D Candidate, is a 4th-year student pharmacist in the Class of 2023 at the University of Connecticut School of Pharmacy. Amanda completed an elective APPE rotation with Birth Control Pharmacist.

How Pharmacy Students Can Advocate for Pharmacist Prescribing of Hormonal Contraception

March 14, 2022March 13, 2022

Can pharmacy students advocate for pharmacists prescribing hormonal contraceptives? YES, that is exactly what Wilson Pace, a graduate of the University of Utah College of Pharmacy did. When Wilson heard about the barriers and costs that women experience when accessing contraceptives. His perseverance and dedication to advocacy as a pharmacy student allowed him to take action in his leadership class. Wilson drafted a “dream bill” which became Bill 184 in Utah. Bill 184 was passed in 2019 and allowed women in Utah to receive birth control prescriptions from their pharmacist.

Fast forward to 2022; we now have 26 states + D.C that have either statewide protocols or collaboration practice agreements that allow pharmacists to prescribe birth control. But as pharmacy students we can do more! As of early 2022, the map below shows where pharmacists can prescribe hormonal contraceptives.

As future pharmacists we know that pharmacists are the most accessible healthcare providers (9 out of 10 Americans living within five miles of a pharmacy). The benefits pharmacists can offer women who are seeking hormonal contraceptives include accessibility, limiting barriers as well as reduced costs.

Here are three easy ways pharmacy students can advocate for pharmacists to prescribe hormonal contraceptives if their state has not passed legislation yet:

Research to see if any bills have been introduced in your state. If a bill has not been introduced you can help advocate for one to be started or start your own!
Contact policymakers and advocate for them to support bills that allow. You can also look up your policy makers here:
Speak up and educate others by using your voice on social media such as LinkedIn, Facebook and Instagram. Share why it is important to you that pharmacists are able to provide access to contraceptives. To help spread your message to a larger audience use hashtags such as #advocacy #pharmacystudents #birthcontrol #birthcontrolpharmacies

What if you currently live in a state that allows pharmacists to prescribe contraceptives, can you still make an impact? The answer is YES! Even if your state has allowed pharmacists to prescribe contraceptives you can still advocate here are 3 ways you can help:

Check the Birth Control Pharmacies map to see if your pharmacy is listed. If your state allows pharmacists to prescribe hormonal contraceptives, encourage your pharmacist to fill out this form. This will help women be able to find a pharmacy near them.

https://www.birthcontrolpharmacies.com/addpharmacy

Educate yourself by taking Birth Control Pharmacist’s free home study course to learn how to provide contraceptive care during the COVID-19 public health emergency. It is important to stay up to date on the ways you facilitate access to over-the-counter and prescription contraceptives.
Promote brainstorm ways that your pharmacy can promote contraceptive services. Maybe this is by creating a private area for counseling or developing ideas on how you can promote birth control services at your pharmacy.

I was interested in learning more about pharmacists prescribing hormonal contraceptives so I reached out to Dr. Rafie who allowed me to complete a rotation with her at Birth Control Pharmacist. I learned so much about legislation and advocacy during my 4 weeks on rotation. I was even able to discuss upcoming legislation that impacts pharmacists in South Carolina with my school’s Dean. Taking action as a student is a great way to impact the future of pharmacy.

There are numerous ways pharmacy students can advocate for increased access to contraceptive services. As pharmacy students we have the power to advocate for legislation just like Wilson Pace and make an impact. Whether it is helping change an entire state’s contraceptive laws or helping a woman find a local pharmacy that provides contraceptive services it is important that we support everyone’s reproductive health and choices!

“If you want to make a difference in health care, you have to be involved…you have to advocate for your profession.” — Wilson Pace

Amy Ackershoek About the Author

Amy Ackershoek is a pharmacy student in the Class of 2022 at the Medical University of South Carolina College of Pharmacy.

Upcoming Changes to the Mifepristone REMS Program: Implications for Pharmacy Practice

January 24, 2022January 23, 2022

Mifepristone REMS Change

Pharmacists in the community setting may soon have the opportunity to ease access to medication abortion in the United States. In the coming months, mifepristone (Mifeprex) is anticipated to have an updated Risk Evaluation and Mitigation Strategy (REMS) Program that allows dispensing through local brick-and-mortar and mail-order pharmacies. This change will integrate pharmacists into abortion care and bring them to the forefront of the national discussion about reproductive rights. Staying up to date on new regulations and their legal implications is paramount for successfully navigating this new role pharmacists can play in reproductive health and providing the best patient care.

Background

Mifepristone (Mifeprex) and misoprostol (Cytotec) are used together for medication abortion, or drug-induced interuterine pregnancy termination. Since 2000, this medication combination has provided pregnant patients with a safe, noninvasive means to end an unwanted but otherwise uncomplicated pregnancy. Patients first take mifepristone, followed by misoprostol in 24 to 48 hours. While misoprostol is dispensed at the prescriber’s office or a local pharmacy, there have historically been strict dispensing regulations on mifepristone.

In order to access medication abortion, patients must first make an appointment with a reproductive healthcare provider to ensure that there are no contraindications to this method of pregnancy termination. Prior to the coronavirus-19 pandemic, the prescriber of mifepristone was the only individual allowed to dispense this medication. Patients were required to be physically present with the prescriber to obtain mifepristone. Appointments to receive this medication often occur after the initial pregnancy screenings, and barriers to abortion such as intimidation by protestors and geographical proximity to clinics severely limited patient access to this service.

During the coronavirus pandemic, enforcement of the in-person dispensing requirement has been relaxed with the condition that adherence to all other requirements included in the Patient Agreement Form be maintained, allowing for the utilization of mail to dispense mifepristone, either mailed to the patient from the clinic or a partner mail-order pharmacy. This temporary change has not only allowed greater access to medication abortion, but has led to increased calls for the permanent modification of the REMS Program associated with mifepristone.

More information on medication abortion can be found here.

Forthcoming FDA Update to the Mifepristone REMS Program

The success of the pandemic-spurred dispense by mail model emboldened advocacy for adjusting the provisions associated with mifepristone. Though no formal announcement was made, the FDA’s question and answer webpage on mifepristone was updated on December 16, 2021 to include upcoming changes. After a comprehensive review of the safety data collected through mifepristone’s REMS Program, the FDA indicated that an updated REMS is appropriate and should include pharmacy dispensing of this medication.

While this change brings a groundbreaking transformation to safe abortion access in the United States, there are limitations on its timely implementation into pharmacy practice. Customary with the FDA’s policies for updating REMS requirements, REMS modification notification letters have been sent to the manufacturers of Mifeprex and generic mifepristone. The manufacturers, Danco Laboratories and GenBioPro, will draft an updated REMS Program and submit it to the FDA for approval. Once approved, the modifications to the REMS Program will be in effect. Pharmacies will need to be certified to dispense mifepristone.

This change will only affect the dispensing aspect of mifepristone use. The requirements associated with the safe prescribing of this medication will likely remain the same.

How to Prepare for Changes to Pharmacy Practice

Though the details of the updated REMS Program are not yet public, there are steps that pharmacists can take in order to prepare for this change.

Become familiar with the websites for Mifeprex and mifepristone from Danco Laboratories and GenBioPro. The current process for prescribers to certify to prescribe and dispense this product, the Prescriber Agreement Form, is relatively straightforward. It is likely that the certification process for pharmacies will be similar.
Complete a continuing pharmacy education program on medication abortion to get acquainted with the adverse events, contraindications, counseling points, and follow up requirements associated with mifepristone and misoprostol.
Develop pharmacy policies regarding the dispensing of this medication. If a pharmacist on staff is not willing to verify and dispense a mifepristone prescription, there should be reasonable alternatives in place to ensure patient access to this medication.
Identify local resources for patients. In states where abortion restrictions are in place, it is incredibly important to stay up to date on the options that patients have for safe and effective reproductive care.

Conclusions

Pharmacists have been and continue to be the most accessible healthcare providers to patients. With the upcoming modification to mifepristone’s REMS Program, pharmacists can play a larger role in patients’ reproductive health. Commitment to lifelong learning is an essential component of effective pharmacy practice. Regardless of personal beliefs, we as healthcare providers have a responsibility to practice in an educated way that is respectful of our patients’ autonomy and right to care within the law.

Muscat About the Author

Jacqueline Muscat is a pharmacy student in the Class of 2023 at University of Michigan College of Pharmacy.

Society of Family Planning Annual Meeting Highlights

November 2, 2021November 1, 2021

SFP Annual Meeting Highlights Quyen Nguyen The Society of Family Planning (SFP) annual meeting was held virtually on October 1^st and 2^nd this year with well over one thousand attendees. For those who are not familiar with SFP, it is a community of like-minded people including clinicians, academics, residents, fellows, and students who share the same interest for family planning. SFP values diversity, equity, and the science behind abortion and contraception for everyone. I had the privilege of attending the meeting as part of an APPE rotation with Dr. Sally Rafie at Birth Control Pharmacist.

There were some highlights at the meeting:

Health Disparities Among Asian Americans and Pacific Islanders

On the days of the meeting, the opening plenary was presented by a group of panelists from across the country on the history that led to health disparities among Asian American and Pacific Islanders (AAPIs) and how future generations of healthcare providers, researchers can help address this gap. My favorite part of this presentation was listening to the vulnerability of the children of immigrants, through the lens of the panelists, regarding their experience about sexual reproductive health, and how much of a taboo topic it is to talk with their parents or even healthcare providers. Coming from a family of immigrants, this presentation hit home and how much it resonated with me professionally and personally. It was, as if, they were telling my story, and I am positive many fellow AAPIs feel the same way. To tell you the least, this plenary made me feel seen and inspired me to advocate for equitable health care among fellow Asian American, Native Hawaiian and Pacific Islanders (AANHPIs) as an aspired ambulatory care pharmacist. As of now, the panelists are continuing to conduct more research to help AANHPIs in the near future regarding access to health care.

Impact of the Pandemic on Access to Care

The pandemic has changed the climate of healthcare delivery here in the United States. It was a challenge for patients, especially women and BIPOC, to visit their doctor’s office for appointments such as getting their birth control shot. Health care disparities also increased in women during the pandemic, and contraceptive visits have declined as well.

Evidence reviewed by Dr. Nguyen at the CDC and colleagues showed that the use of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in four studies with self-injection and provider-injection groups resulted in no differences in pregnancies and side effects, along with higher continuation rate in the self-administered DMPA-SC at 12 months, therefore DMPA-SC should be offered to patients to increase access to reproductive care.

Another group of panelists presented on the impact of tear gas used by law enforcement and reproductive health following the racial justice protests in 2020. What they found was 100% of the participants in their research had health problems due to tear gas, alarmingly, 54.5% had changes to menstrual health such as increased bleeding, cramping, and unusual spotting.

Innovations in Abortion Care

The closing plenary was nothing short of relatable to what is going on in the country at the moment; the panelists presented on self-managed medication abortion in the United States among providers, patients, and seekers. Due to strict state laws regarding abortion and increased distances to abortion clinics, a telemedicine service was used to deliver medication abortion saw an increase of more than 40% within the last two years and it resulted in 96% of successful abortion and only 1% resulted in any serious adverse events. Unrelated to this study, but if pharmacies are able to dispense medication abortion, pharmacists get to use their expertise to help ease the anxiety and panic patients are facing who want an abortion but cannot access care.

Apart from disseminating information about family planning, there were presentations on how to use oral hormonal contraceptives in other health conditions. Additionally, there was a plethora of presentations on relevant topics such as how to counsel transgender and nonbinary patients on emergency contraceptives, anti-Black racism in obstetrics and gynecology, and many more.

Movie Screening & Discussion

To close out the annual meeting, and in my opinion, one of the many amazing things that happened at this meeting was the community screening of HBO Max’s Unpregnant. This movie depicts the struggles of two girls who are minors and cannot find an abortion clinic in their state that would provide care without parental consent and how religion plays a role in hindering an abortion. So, they had to drive from Kansas to New Mexico with hardly any resources to get to the clinic.

I hope this article sparks some interests and encourages you to play a part in advocating for reproductive justice.

For more information about the Society of Family Planning, visit https://www.societyfp.org/.

About the Author

Quyen Nguyen Headshot

Quyen Nguyen, PharmD Candidate 2022, is currently attending St. John Fisher College Wegmans School of Pharmacy in Rochester, New York. She is a member of APhA and the Treasurer for Club for Advancing Interprofessional Practice and Education (CAIPE). In this role, she collaborates with other healthcare professional students to help underserved patients in her community.