Tag: Pharmacy

Misoprostol-Only Medication Abortion Regimen

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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

  1. 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
  2. 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 
  3. 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

Mifepristone REMS Update for Pharmacies

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.

 

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 IdusuyiAbout 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

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:

  1. 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!
  2. Contact policymakers and advocate for them to support bills that allow. You can also look up your policy makers here: 
  3. 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:

  1. 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 AckershoekAbout 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

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.

 


MuscatAbout the Author

 

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

Nextstellis®: A new drug update 

 

A new combined oral contraceptive was approved by the FDA (Nextstellis®) in April 2021.1 Nextstellis contains estetrol, an estrogen that can be manufactured from plants and that was originally derived naturally during pregnancy from the fetus liver, and drospirenone, a progestin found in other currently available contraceptives. Drospirenone has antiandrogenic and anti-mineralocorticoid activity.2 Estetrol differs from ethinyl estradiol in that has selective antagonistic and agonistic estrogen receptor activity, while ethinyl estradiol has exclusively agonist activity. With perfect use, Nextstellis is effective as a contraceptive for females between the ages of sixteen and fifty. These results are supported by data from two Phase III trials which obtained the drug’s safety and success over an extensive trial program. This research consisted of 3632 women between the ages of sixteen and fifty with 23% of patients having a BMI of 30-35 kg/m2. In the North American Phase III trial alone, 1524 women between the ages of sixteen to thirty-five years were tested over 12 months for 13 menstrual cycles and the clinical endpoint was that Nextstellis is 98% effective in preventing pregnancy when taken correctly.1

nextstellis packThe current recommended dosing is one tablet by mouth daily in the order provided by the blister pack for 28 days. The blister pack contains twenty-four active ingredient pills followed by four inert pills. The first active tablet should be taken on the first day of the menstrual cycle daily at the same time every day. If Nextstellis is not taken on the first day of menses an additional non-hormonal contraceptive method should be used for the first seven days.1 Nextstellis can be taken with or without food.2

 

Contraindications of Nextstellis

Patients should avoid use of Nextstellis prior to menarche or if they are postmenopausal.2 Nextstellis has a black box warning for women over the age of 35 who smoke.  Like other estrogen-containing contraceptives, this drug is contraindicated in women with a high risk, or current diagnosis, of thrombotic diseases. Nextstellis is also contraindicated in patients who have a history, or current diagnosis, of hormonal cancers such as breast cancer, renal impairment, adrenal insufficiency, and certain liver diseases: hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or decompensated cirrhosis. Additionally, this drug cannot be administered in conjunction with hepatitis C drugs that contain ombitasvir/ paritaprevir/ ritonavir. Drug interactions for Nextstellis include CYP3A inducers and the patient should use an alternative contraception method for up to 28 days after the last dose of a CYP3A inducer. 2 Lastly, Nextstellis should not be used when there is undiagnosed and abnormal vaginal bleeding.1  

 

Other warnings and precautions include gallbladder disease, cholestasis, and liver disease in which case the drug should be discontinued. If hypertension or hyperkalemia occurs, monitor periodically and discontinue if levels persist outside of normal parameters. Additionally, Nextstellis should be discontinued if migraines are new, persistent, and severe to the patient.1 Females with prediabetes and diabetes should monitor their blood glucose levels, and females with hypertriglyceridemia should consider a different birth control as this may increase the risk of pancreatitis.2

   

Limitations of Use

The limitations of Nextstellis is that it could be less effective in obese patients with a body mass index equal to or greater than 30 kg/ m2. Within the studied population, 23% accounted for women with a BMI between 30- 35 kg/ m 2. The Pearl Index for women with a BMI <30 was 2.57, and it was 2.94 for women with a BMI between >30 and 35. 1 The Pearl Index is equal to the number of women that get pregnant out of 100 women per year. As the BMI increased in the women participating in the study, the Pearl Index also increased. The lower the Pearl Index, the more effective the use of contraceptives. 2

 

Adverse Reactions

The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms.1 Mood disturbances were classified as irritability, anxiety, insomnia, panic disorder, restlessness and suicidal ideation. Breast symptoms included breast enlargement and sensitivity.2   These side effects are common in all combination oral contraceptives. Prescribers and dispensers should educate their patients that these symptoms are likely to occur, and most side effects will begin to resolve after three to five months of therapy when the body has adjusted to the hormonal changes. 3

 

Unique Features

While there are several other combination oral contraceptives on the market, Nextstellis has unique features that distinguishes it from other oral contraceptives. First, the estrogen component is estetrol, whereas most other contraceptives contain ethinyl estradiol. According to Grandi and colleagues  the selective actions of estetrol can lead to fewer side effect because the half-life of estetrol is 20- 28 hours, whereas other estrogens like estriol have a half-life of 10- 20 minutes and estradiol has a half-life of 1-2 hours. Estetrol is also minimally converted to estriol and estradiol. The longer half-life and the minimal metabolism to other estrogen forms, allows this drug to be  available for a longer period of time to bind at the receptor sites.4 Specifically, Nextstellis selectively binds to the nuclear estrogen receptor and it is described to be a native estrogen with selective action in tissues. 1 In pharmacologic studies, it was proven that estetrol acts as an estrogen in bones, uterus, and vagina. 5 

 

Clinical Trials

In addition to providing a contraceptive option for women who are unable to tolerate ethinyl estradiol, Nextstellis has demonstrated overall low rates of common side effects found in oral contraceptives such as acne, libido changes and breast pain in two Phase III studies (North American trial and the EU/Russian study).1 Animal data demonstrated that estetrol had a 100 times weaker effect on breast tissue proliferation in vitro human cells along with in vivo mouse mammary glands than estradiol.3 Although early animal studies have shown that estetrol has less of a damaging effect on breast tissue and may have a lower impact on the risk of breast cancer for humans, there needs to be more studies to solidify this data. 4

 

Interventional studies on Nextstellis have demonstrated less outcomes of deterrent side effects common to hormonal contraceptives such as breakthrough bleeding. Less than 2% of patients in the Phase III study experienced unscheduled bleeding episodes after cycle 2.1 In the FIESTA study it was shown that estetrol combined with drospirenone (E4/DRSP) compared with  quadriphasic estradiol valerate and dienogest (E2 V/DNG) had different frequencies for unscheduled bleeding. Breakthrough bleeding was present in 33.8% of the E4/DRSP group group versus 47.8% of the E2 V/DNG group. There was an additional study that showed overall satisfaction of being on E4/DRSP was higher than E2 V/DNG when patients took a self-reported Subject Satisfaction and Health-Related Questionare.4

 

Environmental Impact           

Estetrol is beneficial because it is less likely to contribute to water pollution and harm to the environment than estradiol (E2) or ethinyl estradiol (EE2).6 Nextstellis is metabolized in a unique way where less of the drug ends up being in the urine and therefore less of it ends up in our water system. This drug is made through a plant-based procedure, unlike other estrogens. Estrogens like ethinyl estradiol are not metabolized well, leading to build up in the body. Ethinyl estradiol is excreted in the urine and ends up in bodies of water, where it can lead to damage to marine life’s growth and ability to reproduce, whereas estetrol’s ability to be decomposed more quickly can be more environmentally friendly. According to Mirtha Women’s Health Pharmaceutics, levels as low as 1ng/L of E2 and EE2 in fish environments can lead to adverse effects and are far more potent than having 32,000 ng/L of estetrol. Adverse side effects, including reduced testicular growth, development of ova-testes in males, reduced egg production, delayed maturation, and the population ratio skewed towards females. are severely affecting the fishes reproductive health6.

 

In conclusion, Nextstellis is a recent FDA-approved oral contraceptive that offers patients another alternative for birth control. Nextstellis’ active estrogen is estetrol which is unique compared to other combination oral contraceptives. While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Overall, Nextstellis is a safe and effective contraceptive option. 

 

REFERENCES

  1. NEXTSTELLIS® (DRSP/E4): Now Available for Pregnancy Prevention. https://www.nextstellis.com/. Accessed June 25, 2021.
  2. Nextstellis (Drospirenone and Estetrol) [package insert]. U.S Food and Drug Administration website. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed April 2021. 
  3. Grossman Barr, Nancy. “Managing Adverse Effects of Hormonal Contraceptives.” American Family Physician, U.S. National Library of Medicine, 15 Dec. 2010, pubmed.ncbi.nlm.nih.gov/21166370/.
  4. Grandi G, Chiara Del Savio M, Lopes da Silva-Filho A, Facchinetti F. Estetrol (E4): the new estrogenic component of combined oral contraceptives. Taylor & Francis. https://www.tandfonline.com/doi/full/10.1080/17512433.2020.1750365. Published April 7, 2020. Accessed June 25, 2021.
  5. Singer, Christian F., et al. “Antiestrogenic Effects of the Fetal Estrogen Estetrol in Women with Estrogen-Receptor Positive Early Breast Cancer.” OUP Academic, Oxford University Press, 5 July 2014, academic.oup.com/carcin/article/35/11/2447/416699.
  6. Mithra Pharmaceuticals. “E4 Paves the Road towards a Revolutionary Era of Environmental FRIENDLY MEDICINES.” GlobeNewswire News Room, Mithra Pharmaceuticals, 10 Jan. 2020, http://www.globenewswire.com/news-release/2020/01/10/1968775/0/en/E4-Paves-the-Road-Towards-a-Revolutionary-Era-of-Environmental-Friendly-Medicines.html


About the Authors

AthinaAthina Herrera Ng, PharmD Candidate 2023, is currently in her third year of pharmacy school at Midwestern University College of Pharmacy-Downers Grove. She holds the Event Chair position for Pharmacy and Pediatrics and is invested in learning more about women and children’s health. She is passionate about creating art in her free time as well as helping others heal through expressive therapy.

 

KaylaKayla Mitzel, PharmD Candidate 2023, is currently in her second year of pharmacy school at Midwestern University College of Pharmacy – Downers Grove. She is serving as the President Elect for APhA-ASP, and the Member at Large for CPNP. Her hobbies include running and biking. 

Reviewed by Brooke Griffin, PharmD, BCACP.

Present and Future Pharmacist Roles in Medication Abortion Care

Medication Abortion Pharmacist

Educational programming for pharmacy students and practicing pharmacists on medication abortion is limited.

Twenty years ago, the FDA approved mifepristone. Since then, medication has transformed the accessibility of abortion. In 2017, about 39% of abortions in the United States were medication abortions, reflecting many people’s preference for this option.1 As reproductive health services are transforming, it is important that pharmacy services become adaptive to them.

What is medication abortion?

A medication abortion is the use of medications to end a pregnancy. There are a couple of medication abortion regimens, but the only regimen approved by the FDA is a combination of mifepristone and misoprostol to end a pregnancy up to 70 days gestation.2

First, a patient takes 200 mg of mifepristone orally followed by 800 mcg of misoprostol buccally, 24-48 hours after the mifepristone dose. After 7-14 days, the patient must follow-up with a health care provider.2

Mifepristone works by binding competitively to the intracellular progesterone receptor, thus blocking the effects of progesterone that support the pregnancy.3 Misoprostol works by inducing contractions in the myometrium as well as relaxation of the cervix.4

According to a systematic review performed by the American College of Obstetrics and Gynecology (ACOG), medication abortion was 97% effective up to 70 days after gestation.5

Present pharmacist roles with medication abortion

Right now, the pharmacist role with medication abortion is minimal as patients receive their dose of mifepristone in the clinic to take either at that time or at home. A prescription for misoprostol may be filled at a pharmacy to be picked up by the patient. Pharmacists will counsel patients on how to take the misoprostol and what to expect with this medication.

Mifepristone is only able to be dispensed at a clinic as a result of restrictions in place as part of the Risk Evaluation and Mitigation Strategies, or REMS, with an exception allowing mail order during the pandemic. The purpose of REMS is to assure that a medication’s benefits outweigh its risks. Recently, there have been studies on the safety of mifepristone to determine whether the REMS requirements are necessary or not.

Future pharmacist roles with medication abortion

According to articles published in the New England Journal of Medicine and Journal of the American Pharmacists Association, the REMS restrictions on mifepristone use have been deemed medically unnecessary as the rates of adverse events and mortality are extremely low. Since its approval, only 19 deaths have been reported to the FDA out of over 3 million patients who had taken mifepristone giving it a mortality rate of 0.00063%.6 Additionally, analysis of data from studies of over 423,000 women, which demonstrated that nonfatal serious adverse events from mifepristone use ranged from 0.01-0.7% and were almost always able to be treated.6

There are research studies underway to evaluate no-test medication abortion protocols, medication abortion telehealth services, and pharmacy dispensing of mifepristone. As new information emerges, there will be more opportunities for pharmacists to have a role in medication abortion care.

Educational programming for pharmacy students and practicing pharmacists on medication abortion is limited. The University of California San Francisco’s Advancing New Standards in Reproductive Health (ANSIRH) recently released a home study continuing pharmacy education program titled “Pharmacists’ Role in Medication Abortion” that is free and open to all. Birth Control Pharmacist has an open access introductory curriculum that can be integrated into pharmacy curricula.

Conclusion

In summary, medication abortion is a critical and common component of women’s health and reproductive health services. Although there are currently restrictions on the ways that patients can obtain a medication abortion, this many soon change and pharmacists will be an important part of access.

This article was originally published in Pharmacy Times.

REFERENCES

  1. Jones RK, Witwer E and Jerman J, Abortion Incidence and Service Availability in the United States, 2017, New York: Guttmacher Institute, 2019, Accessed September 8, 2020. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017
  2. U.S. Food and Drug Administration (FDA), Mifeprex (mifepristone) information, 2018. Accessed September 20, 2020. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
  3. Mifeprex (mifepristone) [prescribing information]. New York, NY: Danco Laboratories, LLC; April 2019.
  4. Cytotec (misoprostol) [prescribing information]. New York, NY: Pfizer; February 2018.
  5. Chen, MJ, Creinin, MD. Mifepristone with buccal misoprostol for medical abortion: A systematic review. Obstetrics and gynecology, 2015;126(1), 12-21. Retrieved from https://escholarship.org/uc/item/0v4749ss.
  6. Mifeprex REMS Study Group, Sixteen years of overregulation: time to unburden Mifeprex, N Eng J Med, 2017;376(8):790-794,https://www.nejm.org/doi/full/10.1056/NEJMsb1612526.
  7. Raifman S, Orlando M, Rafie S, Grossman D. Medication abortion: potential for improved patient access through pharmacies. 2018;58(4):377-81.


About the AuthorBreanna Headshot

Breanna Failla is a pharmacy student in the Class of 2022 at Midwestern University in Illinois. Breanna completed a summer internship with Birth Control Pharmacist.

A Primer on Reproductive Justice for Pharmacy Professionals

Reprodutive Justice Pharmacy

What is reproductive justice?

Reproductive justice is “the human right to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities” as defined by SisterSong Women of Color Reproductive Justice Collective [1]. Reproductive justice exists in a trinity of frameworks also consisting of reproductive health and rights.

 

How does it apply to pharmacy practice?

All health care providers, including pharmacists, take oaths to serve their patients as ethically and professionally as possible. The concept of reproductive justice falls within the scope of this promise, especially as it pertains to women of color and other marginalized people.

Legislators, healthcare providers and communities can address the intersectionality of oppressive forces (e.g. racism, sexism, classism, and ageism) that influence care given and received [2]. Barriers to the realization of reproductive freedoms and choices have stood in the way of family planning and personal health for ages. If we value reproductive justice and recognize the injustices of the past and present, we can prepare providers to shape a revolutionized future for reproductive care.

 

What historical injustices should we be aware of?

In contrast to reproductive justice, reproductive oppression is the control and manipulation of people through their bodies, sexuality, labor, and reproduction, according to Forward Together [3]. The goals of reproductive justice become clear when the injustices of the past are studied and acknowledged as reproductive oppression. They are stark by today’s standards, but they also remind us of a time when such acts were considered appropriate.

Just a few examples of historical injustices:

  • Rape and forced breeding of black slaves (1700s-1800s) [4]
  • Sterilization of the “hereditarily diseased” in Nazi Germany (1934-1945) [5]
  • Experimentation on low-income, imprisoned, and/or women of color for birth control research without informed consent (mid-1900s) [6]
  • Sterilization of Native Americans (1960s-1970s) [7]
  • China’s one-child policy (1979-2015) [8]

 

Are reproductive injustices still occurring now?

Although not as extreme, reproductive injustices still exist and hide in plain sight, including [9]:

  • Promotion of abstinence
  • Propagation of social “taboos” like teen and premarital pregnancies
  • Refusal of service (denying OTC emergency contraception sales or prescription medications)
  • Low access and availability of services to immigrants
  • Providing access to reproductive and contraceptive resources but limiting their feasible attainability through scarcity, geographical distance, and cost (lack of insurance)
  • Long-acting reversible contraception (e.g. implants and IUDs) as first-line birth control methods
  • The Hyde Amendment, which restricts the use of federal funds for abortions
  • Targeted Regulation of Abortion Providers (“TRAP”) laws, which shut down abortion clinics and effectively reduce access to abortion services

 

What can pharmacy professionals do?

The changes needed to achieve reproductive justice are easier said than done but not impossible. Widespread change depends on political decisions made at state and federal levels, but each health care provider can do their part in enacting progress in their workplaces. Putting aside personal beliefs in favor of patients’ best interests is key. Pharmacists in one-quarter of U.S. states are prescribing birth control with other states following suit [10].

Pharmacists can adopt practices that align with reproductive justice like the following:

  1. Be aware of personal biases. It is normal to have them, but recognition is key to avoid acting on them. Imagine serving a patient who has a different racial or socioeconomic background from you. How would your care and demeanor differ (if at all)?
  2. Do your research. Don’t fall prey to industry claims and monetary influences. For instance, with contraception consider all methods equally initially and narrow down the choices throughout the course of the patient interview and assessment.
  3. Share decision-making. Do not assume that your patient has the same values as you when making healthcare decisions. For instance, with contraception we cannot assume that effectiveness is the most important factor for patients. There are many other values and preferences that influence their choices, such as side effects, frequency of use, return to fertility, invasiveness/discomfort, and confidentiality. In one study, 28% of black women reported feeling pressured to use a method that was not their preferred [11]. Pharmacists should educate patients on all the various options available to them and give people the freedom to make their own decisions; this will improve patient satisfaction and outcomes. Always be mindful of their values, goals, and lifestyles.

Remember that what we now view as outrageous was once normal, and always try to think years ahead of the present to lead and be better prepared for inevitable change.

References

  1. “Reproductive Justice.” Sister Song, www.sistersong.net/reproductive-justice. 
  2. McIntosh, J. “Reproductive Justice: A Practice Framework.” ACSAP 2018 Book 2: Women’s and Men’s Care, ACCP, May 2018, 171–89.
  3. Forward Together, forwardtogether.org/. Accessed on 29 August 2020.
  4. Foster, Thomas A. “The Sexual Abuse of Black Men under American Slavery.” Journal of the History of Sexuality 2011;20(3):445–64.
  5. “German Law Authorizes Sterilization for Prevention of Hereditary Diseases.” United States Holocaust Memorial Museum, newspapers.ushmm.org/events/german-law-authori- zes-sterilization-for-prevention-of-hereditary-diseases. 
  6. Blakemore, Erin. “The First Birth Control Pill Used Puerto Rican Women as Guinea Pigs.” History.com, A&E Television Networks, 9 May 2018, www.history.com/news/ birth-control-pill- history-puerto-rico-enovid.
  7. Blakemore, Erin. “The Little-Known History of the Forced Sterilization of Native American Women.” JSTOR Daily, 25 August 2016, daily.jstor.org/the-little-known- history-of-the-forced-sterilization-of-native-american-women/. 
  8. Connett, Wendy. “Understanding China’s Former One-Child Policy.” Investopedia, 28 August 2020, www.investopedia.com/articles/investing/120114/understanding-chinas-one -child-policy.asp. 
  9. McDonald-Mosley, Raegan, MD, MPH, FACOG. “Reproductive Justice and Patient- Centered Care.” Maryland Department of Health Reproductive Health Roundtable Virtual Series. 2 July 2020.
  10. “Pharmacist Prescribing of Hormonal Contraception.” Birth Control Pharmacist, https://birthcontrolpharmacist.com/policies/. 
  11. Thorburn S, Bogart LM. African American women and family planning services: perceptions of discrimination. Women Health. 2005;42(1):23-39. 


About the AuthorGayane Kechechyan Headshot

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

Sex & Gender 101

Sex and Gender 101 Katie Hood

I recently had the opportunity to attend the Sex & Gender 101 webinar designed to help anyone in the healthcare field learn more about creating trans inclusive care. It is crucial to create an environment that is inclusive because trans people – especially trans people of color – face many barriers to healthcare.

We have all had doctor’s appointments where we were required to fill out a form and check one of two boxes to describe our gender: male or female. For someone who is not cisgender, or someone whose sense of personal identity and gender does not correspond with their birth sex, this can immediately cause feelings anxiety and mistrust before the appointment even starts.

When we look at gender beyond the binary, we find that there are many identities that comprise a person. The first identity that should be recognized is a person’s pronouns; most commonly, we might think of she/her and he/him pronouns, but there are other pronouns like they/them, ze/zir, or others that someone may decide most accurately represents them. It is important to respect and use a person’s preferred pronouns and to understand that we cannot infer other aspects of a person’s identity based on their pronouns.

Another identity that may be important to recognize in the healthcare setting is sex assigned at birth. Like gender, sex assigned at birth is also commonly thought of as binary: male or female. However, people could also be intersex, meaning their genetics and/or anatomy may not fit into the traditional male or female boxes.

Coming back to gender, the typical male and female boxes should be expanded to include, at a minimum, nonbinary. The term nonbinary is a specific gender identity label and an umbrella term. Whether specific or general, this word refers to anyone whose gender is somewhere outside of a strict gender binary. Not all nonbinary people consider themselves to be transgender, but the definition of transgender used here does include nonbinary people.

Gender expression is an identity that may align with someone’s gender but does not have to. People belonging to any gender have the freedom to present themselves in manners that are feminine, masculine, both, or neither. Like pronouns, we cannot assume the other identities of a person based on their gender expression.

The last two identities are sexual attraction and romantic attraction, which, like gender and gender expression, could be the same or different.

I hope that like me, you were able to learn something about gender identities. If you are a healthcare professional, I challenge you to make changes to your practice that will create a more inclusive space for people of all identities.

 

For more information about this training program, visit https://www.innovating-education.org/course/gender-inclusive-care/.


About the AuthorKatie Hood

Katie Hood, PharmD Candidate is a pharmacy student in the Class of 2021 at Shenandoah University Bernard J. Dunn School of Pharmacy and Pharmaceutical Sciences. Katie completed an elective APPE rotation with Birth Control Pharmacist.

Levonorgestrel Intrauterine Device for Emergency Contraception

Levonorgestrel IUD for EC

A New Emergency Contraception Option

A recent study set out to assess the one-month pregnancy risk with the levonorgestrel 52-mg intrauterine device (IUD, Liletta®) as compared with the copper IUD (Paragard®) for emergency contraception (EC). The study included adults up to 35 years old who requested EC after unprotected sexual intercourse. Unprotected sexual intercourse must have occurred within the previous five days, but participants were not excluded if unprotected sexual intercourse also occurred up to 14 days prior. Participants were instructed to follow-up one month after IUD insertion for a urine pregnancy test, but even if they did not follow-up, their medical records for the following six months were reviewed to verify if a pregnancy was ever detected.1

 

Why the Levonorgestrel IUD?

Although not currently approved by the FDA for EC, the copper IUD, has substantial evidence supporting its use for EC. The failure rate of the copper IUD as EC is much lower than that of oral EC options.2-4 However, when compared to the copper IUD, the levonorgestrel IUD is more popular for long-term contraception, likely due to its other benefits, including decreased menstrual bleeding and pain.5-7

 

Failure Rates and Adverse Events

Of 638 total participants who received an IUD, only one patient experienced an EC failure. The patient had received a levonorgestrel IUD and the pregnancy ended in a spontaneous abortion at ten weeks with the IUD still in place. Statistical analysis of the data showed that the levonorgestrel 52-mg IUD was non-inferior to the copper IUD as EC. Rates of adverse events that required medical attention during the first month of IUD use were similar among both groups and very low overall.1

 

What Does This Mean for Patients?

This evidence means there is a new highly effective option for patients seeking EC and ongoing long-term contraception within five days of unprotected sexual intercourse. Although Liletta® was the levonorgestrel IUD used in this study, Mirena® is another levonorgestrel 52-mg IUD that releases the same daily dose of levonorgestrel. Other levonorgestrel IUDs release varying amounts of levonorgestrel, so we cannot necessarily expand these results to other options at this time. It is also possible the levonorgestrel IUD could be effective in preventing pregnancy when used up to 14 days after unprotected sexual intercourse, but more research is needed in this patient population.1

 

What Does This Mean for Pharmacists?

Pharmacists should be aware of this new option when counseling and referring patients who request EC after unprotected sexual intercourse. Of course, pharmacists should also know when it would be appropriate to utilize other EC options and if their state allows them to prescribe oral EC.

 

For more information: 

References

  1. Turok DK, Gero A, Simmons RG, et al. Levonorgestrel vs. copper intrauterine devices for emergency contraception. N Engl J Med. 2021; 384:335-44.
  2. Cleland K, Zhu H, Goldstuck N, et al. The efficacy of intrauterine devices for emergency contraception: a systematic review of 35 years of experience. Hum Reprod. 2012; 27:1994-2000.
  3. Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-inferiority trial and meta-analysis. Lancet. 2010; 375:555-62.
  4. von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicenter randomized trial. Lancet. 2002; 360:1803-10.
  5. Diedrich JT, Desai S, Zhao Q, et al. Association of short-term bleeding and cramping patterns with long-acting reversible contraceptive method satisfaction. Am J Obstet Gynecol. 2015; 212:50-8.
  6. Sanders JN, Myers K, Gawron LM, et al. Contraceptive method use during the community wide HER Salt Lake contraceptive initiative. Am J Public Health. 2018; 108:550-6.
  7. Peipert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011; 117:1105-13.


About the AuthorKatie Hood

Katie Hood, PharmD Candidate is a pharmacy student in the Class of 2021 at Shenandoah University Bernard J. Dunn School of Pharmacy and Pharmaceutical Sciences. Katie completed an elective APPE rotation with Birth Control Pharmacist.

Medication Abortion Curriculum: A Pharmacy Student Perspective

The topics of reproductive health and particularly abortion remains stigmatized in today’s society despite 1 in 4 women having an abortion in their lifetime. Pharmacy school curriculums across the nation reflect this predicament, since abortion is omitted in the standard curriculum of many, if not all, pharmacy schools. Which brings up a question of how knowledgeable are student pharmacists, future medication specialists, with this subject?

Medication Abortion Curriculum was developed by the expert pharmacy educators at Birth Control Pharmacist in an attempt to better familiarize pharmacy students with the topic of medication abortion. This open access curriculum is a PowerPoint deck that is intended to be added or incorporated within a standard, larger lecture such as contraception. The slides provide the basics on medication abortion and prepare pharmacy students to dispense medications and counsel patients appropriately.

Medication abortion with a regimen of mifepristone and misoprostol has been shown to be safe and effective for decades, and is becoming increasingly utilized and acceptable to women across the world.1 Despite the growing use of these medications to induce termination of early pregnancy, the U.S. pharmacist involvement in abortion care is currently limited due to FDA imposed restrictions on how mifepristone can be distributed and dispensed.2 However, in some countries both medications are allowed to be dispensed by pharmacies rather than being limited to clinics and doctor’s offices, improving accessibility for people in need.3,4 Current research has shown great benefits of expanding the types of clinicians providing services, which may eventually lead to FDA lifting unnecessary restrictions to increase access to medication abortion through pharmacies.5

Diversification of skills and areas of expertise is necessary for any future pharmacists who want to stay relevant in tomorrow’s healthcare. Pharmacists need to be prepared to dispense and counsel on misoprostol now and may be able to offer additional patient-centered care in the future. For these reasons, pharmacists should be capable of providing patients with sufficient information, education, and safe and convenient care.

If you’re a pharmacy educator or a student who wants to advocate for medication abortion to be included in your school’s curriculum, check out the slide deck on the Resources page under Pharmacist Education and Training. 

Medication Abortion Curriculum Open Access for Pharmacy Educators

References

  1. Beaman J, Prifti C, Schwarz EB, et al. Medication to Manage Abortion and Miscarriage. J Gen Intern Med. 2020;35(8):2398-2405. doi:10.1007/s11606-020-05836-9.
  2. Raifman S, Orlando M, Rafie S, et al. Medication abortion: Potential for improved patient access through pharmacies. J Am Pharm Assoc (2003). 2018;58(4):377-381.doi:10.1016/j.japh.2018.04.011.
  3. Tamang A, Puri M, Masud S, et al. Medical abortion can be provided safely and effectively
    by pharmacy workers trained within a harm reduction framework: Nepal. Contraception. 2018;97(2):137-143. doi:10.1016/j.contraception.2017.09.004.
  4. Rogers C, Sapkota S, Paudel R, et al. Medical abortion in Nepal: a qualitative study on women’s experiences at safe abortion services and pharmacies. Reprod Health. 2019;16(1):105. doi:10.1186/s12978-019-0755-0.
  5. Weaver G, Schiavon R, Collado ME, et al. Misoprostol knowledge and distribution in Mexico City after the change in abortion law: a survey of pharmacy staff. BMJ Sex Reprod Health. 2019;46(1):46-50. doi:10.1136/bmjsrh-2019-200394.


About the AuthorEugenia

Eugenia A. Haire, PharmD Candidate is a pharmacy student in the Class of 2021 at the Shenandoah University Bernard J. Dunn School of Pharmacy. Eugenia completed an elective APPE rotation with Birth Control Pharmacist.