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

DMPA Outreach Study Infographic

Why Expand Access to DMPA

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

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

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

Approach to Patient Outreach 

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

Clinical Implications

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

 

Check out the full study here

References

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

Birth Control Pharmacist Sara Strome Headshot
About the Author

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

Webinar Introduces Pharmacists to New Hormonal Contraceptives

New drugs are constantly being approved by the FDA, and it is important for practicing pharmacists to stay up to date on new contraceptives. There are now over 50 unique contraceptives available, and pharmacists need to be aware of these and incorporate them into their practices. Birth Control Pharmacist recently hosted a webinar that aimed to educate pharmacists, pharmacy staff members, and other healthcare providers to feel more comfortable with the new contraceptive options they could prescribe or dispense.

The faculty speaker, Shareen El-Ibiary, PharmD, BCPS, FCCP, is a professor and chair of the Department of Pharmacy Practice at Midwestern University, College of Pharmacy. She is also a consultant for Birth Control Pharmacist.

The program focused on three new hormonal contraceptives – Annovera, Twirla, and Slynd – along with one new nonhormonal contraceptive – Phexxi.

What is Annovera?

Annovera is a new contraceptive vaginal ring that contains segesterone and ethinyl estradiol. It is different from NuvaRing because it is used for 13 consecutive cycles, as opposed to just one cycle. It is not refrigerated.

What is Twirla?

Twirla is a new contraceptive patch that contains levonorgestrel and ethinyl estradiol. It is very similar to Xulane in terms of application, but Twirla has lower rates of headache, nausea, and breast tenderness.

What is Slynd?

Slynd is a new progestin-only oral contraceptive that contains drospirenone. In each pack of 28 tablets, there are 24 active tablets and four inactive tablets. The main benefit of Slynd over norethindrone is less opportunity for missed doses. Unlike norethindrone’s 3-hour window to take a dose, patients on Slynd have up to a 24-hour window to take a dose before it is considered a missed dose. Pharmacists need to be aware of the unique drug interactions associated with Slynd.

What is Phexxi?

Phexxi is a new prescription-only contraceptive gel that does not contain nonoxynol-9. Instead, it contains lactic acid, citric acid, and potassium bitartrate. Phexxi should be applied vaginally within one hour before each episode of intercourse. It should not be used by patients who have recurrent urinary tract infections or urinary tract abnormalities.

Dr. El-Ibiary wrapped up the program by reviewing patient cases, and she even demonstrated a patient interaction within a pharmacy. This helped bring the concepts from the lecture portion to life and allowed participants to practice incorporating these new hormonal contraceptive into their counseling and other practices.

Fortunately, if you missed the webinar, the video recording and materials are available for home study online at https://birthcontrolpharmacist.com/newhc/. The course material is available to all, with pharmacists having the opportunity to obtain Continuing Pharmacy Education credit. This material provides education to participants to increase their comfort in prescribing, dispensing, or counseling patients on the new contraceptive options available.

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

 “As a P1, I appreciate how Dr. El-Ibiary explained everything clearly. It helped me better understand the content and I now have a much better understanding of contraceptives.”

“Very practical, real-life patient case scenarios were used as effective teaching points.”

“Amazing presentation. Very informative and easy to follow.”

“Thank you for providing this CE! It was both helpful & thorough.”

New Hormonal Contraceptives Home Study CPE


Katie HoodAbout the Author

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

Webinar Equips Pharmacists to Provide Contraception Care During COVID-19

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

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

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

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

How can pharmacists prescribe birth control safely?

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

What are some best practices within the pharmacy?

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

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

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

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

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

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

“Loved the topic, very timely for COVID.”

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

pharmacy-based-contraception-care-during-covid-19-online-cpe-program-1


About the Author

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

Putting Policy into Practice: Contraception Care in San Francisco Pharmacies

Contraception Care in San Francisco Pharmacies

What makes some pharmacies more successful than others at implementing pharmacist-prescribed contraception care? To answer this question, we conducted a study to determine the extent of hormonal contraceptive prescribing, also referred to as furnishing in California, among San Francisco community pharmacies, and identify the factors that led to successful implementation.

Implementation in San Francisco pharmacies 

After calling all 113 community and independent pharmacies located in San Francisco, we identified 21 locations (19%) that furnished hormonal contraception. Only one of these was an independent pharmacy; the rest were chain community pharmacies. Half or more of Costco, CVS, and Safeway locations furnished hormonal contraception, while less than 5% of Walgreens and independent pharmacies did so. 

Factors associated with successful adoption

Within the control of pharmacies

We identified three main factors that led to successful implementation that were within pharmacy control. The first was a company protocol—respondents stated that having an established precedent and administrative support, and paying for pharmacists’ training, was crucial for successful implementation. The second was advertising, due to the community’s limited awareness of this service. Lastly, the accessibility of pharmacists played a role in increasing access to services and to hormonal contraception. 

Relating to the setting or larger community

We also identified factors leading to successful implementation outside the control of pharmacies. These included the location of the pharmacy and its patient population, as well as collaboration with local clinics. Pharmacies in proximity to students and other younger and short-term residents found there was more need for hormonal contraceptive furnishing services. One pharmacy had an existing collaboration with a local clinic and its providers that acted as a bridge to the service. 

Barriers to service adoption 

Respondents also reported several barriers to successful implementation. The cost of consultation for patients was a widespread concern. Lack of time was another barrier reported by many pharmacists, which could be resolved through scheduled appointments or more overlaps of pharmacist shifts. The last identified barrier was patient privacy. Many respondents expressed a need for a private consultation room in order to provide a confidential service, and those that had a private consultation room acknowledged this as a benefit. 

Effect of COVID-19 on furnishing 

Our data collection began in April 2020, shortly after the introduction of San Francisco’s shelter-in-place order. We asked study participants to comment on whether practices or demand for hormonal contraception had changed under the shelter-in-place order and responses were mixed. While some pharmacies reported an increase in demand for hormonal contraceptive furnishing, others reposted a decrease. 

Implications for the future

We found an increase in participation among pharmacies in San Francisco that were furnishing hormonal contraception than previously reported in California overall; 19% in San Francisco in 2020 versus 11% statewide in 2017. This finding could reflect either pharmacies adding this service gradually over time or a local phenomenon. However, CVS pharmacists reported that a new corporate protocol was initiated in 2020, suggesting the higher rate of furnishing we identified could be reflected statewide. Our results detailed successful strategies used by San Francisco community pharmacies that could serve as a model for expanding this service to other pharmacies. In the words of one respondent:

“The pharmacist is the most overtrained and underutilized health care professional we have.”

With more widespread implementation of this service, community pharmacists can increase their scope of practice, improve quality and continuity of care for patients, and expand access to hormonal contraception to improve reproductive health.

Link to the full paper.

References

  1. California Board of Pharmacy 1746.1: Protocol for pharmacists furnishing self- administered hormonal contraception. Link.
  2. Chen L, Lim J, Jeong A, & Apollonio D. Implementation of hormonal contraceptive furnishing in San Francisco community pharmacies, 2020. Journal of American Pharmacists Association. doi:https://doi.org/10.1016/j.japh.2020.07.019
  3. Gomez AM. Availability of pharmacist-prescribed contraception in California, 2017. JAMA. 2017;318(22):2253e2254. 

Chen Lim Jeong ApollonioAbout the Authors

Lauren Chen, Julie Lim, and Asher Jeong are third-year doctoral students at the University of California San Francisco (UCSF) School of Pharmacy. Dorie Apollonio is a professor in the UCSF Department of Clinical Pharmacy.

Reducing Maternal Mortality in the United States through Collaboration

Maternal Mortality Blog Post - Birth Control Pharmacist

Healthy childbirth requires education and action prior to conception and should continue throughout the gestation period to monitor for any changes that require immediate medical attention. Approximately 60% of maternal deaths are preventable and family planning has shown to decrease the number of maternal deaths related to pregnancy.1,2 Addressing the heightened rates in the United States requires the collaboration of medical expertise to maximize the health of mothers and their offspring.

California is one of the first states to take an initiative in the common complications that arise during childbirth. The California Maternal Quality Care Collaborative (CMQCC) has backed initiatives surrounding two common complications in childbirth: hemorrhaging and blood pressure. Since early prevention of these two serves as a crucial factor in the mother’s health, the team has created standard procedures through practicing these events through simulation, formulating a method for the measurement of blood loss, and creating an accessible toolkit to treat such events when they arise. The Pomona Valley Hospital Medical Center is laying the foundation for protocols that will save a woman’s life during childbirth. Utilizing this expertise has shown benefit based on efforts by the CMQCC and can further be supported by preventative care measures employed by the pharmacist.3

The Pharmacist’s Role in Reducing Maternal Mortality

The pharmacist’s scope of practice can have a significant impact on the rates of maternal mortality in the United States, ranging from preconception care, interventions during pregnancy, and patient education.2 The relationship between unintended pregnancies and maternal mortality suggests that reducing rates of unintended pregnancy would be beneficial in, too, reducing rates of maternal mortality. Pharmacists could also aid in the development of a reproductive life plan (RLP) with patients to firstly aid in pregnancy planning. RLPs involve both partners and “includes goals patients make personally about having or not having children and encourages intentional pregnancy planning.”4 Initiating a conversation about a RLP also serves as an opportunity to address a patient’s health needs. For people who are looking to prevent pregnancy, a pharmacist can aid a patient in choosing a contraceptive method that suits the patient’s lifestyle and preferences. For those who do have intentions to become pregnant in the near future, pharmacists can provide education and counseling on health behaviors that could be harmful to a potential pregnancy.4

The Significance of Collaboration

The role of the pharmacist is continually evolving. In collaboration with other healthcare professionals, pharmacists can lay the groundwork needed to reduce maternal morbidity in the United States. Pregnancy planning and education could allow for the formation of RLPs and reduce the number of unintended pregnancies as well as increase awareness for behaviors that could hinder or advance maternal-infant outcomes. Pharmacists’ intervention in conjunction with the initiatives such as the CMQCC could provide for significant breakthroughs in health and wellness before, during, and after parturition.

References

  1. “Maternal Mortality.” Centers for Disease Control and Prevention, 13 Aug 2020. Available at: http://www.cdc.gov/reproductivehealth/maternal-mortality/index.html.
  2. Tsui AO, McDonald-Mosley R, Burke A. Family Planning and the Burden of Unintended Pregnancies. Epidemiologic Reviews. 2010;32(1):152-174.
  3. Montagne, Renee. “To Keep Women from Dying in Childbirth, Look to California.” NPR, 29 July 2018. Available at: https://www.npr.org/2018/07/29/632702896/to-keep-women-from-dying-in-childbirth-look-to-california.
  4. Peters LM, DiPietro Mager NA. Pharmacists’ Provision of Contraception: Established and Emerging Roles. Innov Pharm. 2016;7(3):15.

About the Author

Courtney Smith Headshot
Courtney Smith, PharmD Candidate
is a pharmacy student in the Class of 2024 at Ohio Northern University.

Reviewed by Natalie DiPietro Mager, PharmD, PhD, MPH.

New Webinar Prepares Pharmacists to Provide Reproductive Health Services and Referrals

Pharmacists play a key role in providing health care to patients. Their scope is currently expanding into women’s health, specifically in prescribing birth control. As more states pass legislation to allow pharmacists to prescribe birth control, we are preparing pharmacy staff members with the appropriate knowledge and tools to best assist their patients.

We hosted an exciting webinar, “Meeting Reproductive Health Needs at the Pharmacy” with Provide. Provide is a nonprofit organization with a goal to provide healthcare and social services to patients without bias or judgement. They understand the lack of care for patients experiencing an unintended pregnancy and seek to provide a comfortable environment for people to explore their options. This webinar shed light and helped to educate pharmacists, student pharmacists, and pharmacy technicians about family planning services including birth control access, emergency contraception, and abortion. The program included myths and facts about reproductive health, best practices to combat stigma, and how to connect patients with local resources.

Anna Pfaff and Dr. Sally Rafie led the discussion. Each touching on different subject material and bringing some diverse perspectives to the topic, Dr. Rafie as a pharmacist who also runs Birth Control Pharmacist and Anna as a patient educator who coordinates Provide’s Referrals Program. There are many barriers for different populations, further magnified during the COVID-19 pandemic and Title X restrictions, to obtain family planning services.

One very important objective of the program was preparing pharmacists and pharmacy teams to combat stigma surrounding these services. Pharmacy best practices were provided to address individual, environmental, and structural stigmas. The presenters raised awareness around these issues and shared new practical pharmacy communication guides that pharmacists and pharmacy team members can use in their everyday practices. As an example, Dr. Rafie and Monica Sliwa (a UCSD pharmacy student intern with Birth Control Pharmacist) performed a role play activity to show different approaches to assisting a patient find an emergency contraception method in the pharmacy. They also demonstrated the steps to refer patients for other services using online directories.

Fortunately, if you missed the webinar, the video recording and materials are available for on-demand home study online at https://birthcontrolpharmacist.com/referrals/. The course material is available to all, with pharmacists and pharmacy technicians having an opportunity to obtain Continuing Pharmacy Education credit. This material provides education to pharmacy staff members in reducing stigma in access to reproductive health services.

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

“Though not having a place of practice due to being in my 4th year of pharmacy school, I appreciated having these materials that can be utilized in whatever area of practice I’m in. I am interested in a career in women’s health and know that these resources will be valuable to me when transitioning into my career.”

“I love the handout provided, and I learned more about abortion clinics. I feel so much more comfortable about discussing options with patients now.”

“I plan on promoting this initiative and educating my colleagues on reproductive health competencies so that patients in my practicing state will have more options for accessibility.”

Meeting Reproductive Health Needs at the Pharmacy On-Demand Webinar


About the Author

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

Meet Phexxi – A New Non-Hormonal Contraceptive Gel

Image from https://hcp-phexxi.com

About the Product

Lactic acid, citric acid, and potassium bitartrate (Phexxi, Evofem Biosciences) is a prescription combination, non-hormonal contraceptive gel approved by the FDA in May 2020. The vaginal gel was found to be 86.3% effective with typical use when inserted up to 1 hour before vaginal intercourse.1

The gel acts as a contraceptive by maintaining the vaginal pH within its normal range of 3.5 to 4.5, an environment too acidic for sperm to survive. This pH regulating mechanism decreases sperm viability and supports bacteria integral to the vaginal microbiome.1

The gel is supplied in a package of twelve, single dose (5 grams), pre-filled applicators with an attachable plunger. The applicator should be inserted into the vagina immediately before or up to 1 hour before vaginal intercourse, with a new dose needing to be administered prior to each act of intercourse.2

What Patients Can Expect

The most common adverse events (AEs) were vulvovaginal burning (20%) and vulvovaginal itching (11.2%). Of local AEs, 23.9% were mild, 18.7% were moderate, and 2.3% were severe. Rates of these reactions mostly decreased over time.1

Women with a history of recurrent urinary tract infections or urinary tract abnormalities should not use the gel due to the 0.36% incidence of cystitis or pyelonephritis in clinical trials.2

Male partners of women using the gel might also experience local AEs such as burning, itching, and pain. However, the local AEs experienced by male partners were generally mild (74.7%), while 21.4% were moderate and 3.9% were severe.2

Offering This New Option to Patients

The contraceptive gel is an option for women who are seeking a non-hormonal or on-demand method of birth control. Women preferring to use multiple methods of contraception can combine the gel with diaphragms and latex, polyurethane, and polyisoprene condoms. However, it should not be used with vaginal rings.2

Spermicide is also available as a vaginal gel, but it is only about 72% effective with typical use.3 Like the non-hormonal contraceptive gel, it can be used on-demand. Nonoxynol-9, the active ingredient in most spermicides, can cause vaginal irritation and increase the risk of HIV transmission.4 In a clinical trial comparing nonoxynol-9 to the , incidences of vulvovaginal itching, burning, and irritation were similar, with the non-hormonal contraceptive gel having a slightly higher incidence of vulvovaginal burning.5

The contraceptive gel’s novel pH modulating mechanism is currently being studied for prevention of gonorrhea and chlamydia in the phase 2B clinical trial AMPREVENCE. Preliminary results from the 4-month study period showed a 50% relative risk reduction of chlamydia and a 78% relative risk reduction of gonorrhea. The clinical trial will move on to phase 3 later in 2020.6

Although the gel will be available as a prescription only treatment in September 2020, patients may face barriers to accessing the gel during COVID-19. Evofem Biosciences plans to launch a telemedicine program to support patient and provider access to the contraceptive gel.7 Additionally, barriers to contraception access could be further mitigated by enabling pharmacists to prescribe birth control.

REFERENCES

  1. Thomas MA, Chappel BT, Maximos B, Culwell KR, Dart C, Howard B. A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial. Contraception: X.2020; vol. 2 100031.
  2. Phexxi. Prescribing information. Evofem Biosciences; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208352s000lbl.pdf. Accessed June 17, 2020.
  3. HHS. Spermicide. https://www.hhs.gov/opa/pregnancy-prevention/birth-control-methods/spermicide/index.html. Accessed June 17, 2020.
  4. FDA. Code of Federal Regulations Title 21; April 1, 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.325. Accessed August 3, 2020.
  5. Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel; March 11, 2020. https://clinicaltrials.gov/ct2/show/results/NCT01306331. Accessed August 30, 2020.
  6. Evofem Biosciences Reports Positive Top-Line Results from Phase 2b Study of Amphora® for Prevention of Chlamydia and Gonorrhea in Women. Evofem Biosciences; December 2, 2020. https://evofem.investorroom.com/2019-12-02-Evofem-Biosciences-Reports-Positive-Top-Line-Results-from-Phase-2b-Study-of-Amphora-R-for-Prevention-of-Chlamydia-and-Gonorrhea-in-Women. Accessed August 3, 2020.
  7. U.S. FDA Approves Evofem Biosciences’ Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy. Evofem Biosciences; May 22, 2020. https://evofem.investorroom.com/2020-05-22-U-S-FDA-Approves-Evofem-Biosciences-Phexxi-TM-lactic-acid-citric-acid-and-potassium-bitartrate-the-First-and-Only-Non-Hormonal-Prescription-Gel-for-the-Prevention-of-Pregnancy. Accessed August 3, 2020.

About the Author

This article was co-written by Whitney Russell, a student pharmacist at University of Kentucky College of Pharmacy.

This article was originally published in Pharmacy Times.

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

What is Mifepristone? 

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

Current Practice of Mifepristone Prescribing

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

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

How Has the Pandemic Impacted this Process? 

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

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

ACOG’s Efforts to Ease Reproductive Care Restrictions 

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

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

Recent Updates to Gaining Mifepristone Access

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

How Pharmacists Can Play a Role

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

References

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

About the Author

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

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

Can Contraceptives be Vegan? Important Considerations for Vegan Patients

The Vegan Society defines veganism as “a way of living which seeks to exclude, as far as is possible and practicable, all forms of exploitation of, and cruelty to, animals for food, clothing or any other purpose”. Since veganism extends beyond just a diet for avoiding animal products, awareness of medication ingredients is also a component of this lifestyle, and patients may be curious at to where their contraceptives fit in.

Potential Uncertainties in Contraceptives

Two inactive ingredients commonly found in hormonal contraceptives which could be considered problematic for vegans are lactose and magnesium stearate. Lactose can act as a filler, a diligent powder, or as an acid in medications and magnesium stearate acts as a lubricant during tablet processing and improves medication solubility. The source of these ingredients, and the status of whether they are vegan can be cloudy. Traditionally, lactose is derived from cow’s milk via bovine rennet extraction, but it can also be produced synthetically. Similarly, magnesium stearate is typically rendered from the fat of cows, pigs, and sheep, however it can now be produced from vegetable matter. Although these ingredients can be found on the medication label, their source is not stated.

Authors of The BMJ article, Why Can’t All Drugs Be Vegetarian? found that differentiation between vegetarian and non-vegetarian lactose was poor as materials involved and the process of manufacturing was often not available. Upon contacting manufactures of lactose-containing products, they found there was uncertainty as to whether medications were suitable for vegetarians or vegans. Because of this, the authors point to clearer labeling requirements as a necessity for understanding animal content in medications.

Patient Considerations

If a patient feels that their personal definition of veganism involves avoiding ingredients such as lactose in their hormonal contraceptives, there are alternatives contraceptive options such as condoms (look for non-latex brands such as Glyde and Sir Richard’s), IUDs, the Ortho Evra patch, vaginal rings, the implant, or the Depo-Provera injection. However, it is important to note that hormones themselves are also often derived from animals. Additionally, all products, even the ones made without animal-sourced ingredients, are tested on animal subjects before they can progress to human testing and make it to market.

So, can a patient use contraceptives and still be considered vegan? The Vegan Society recommends avoiding medications that contain animal products but also re-emphasizes the ‘as far as practical and possible’ portion of their definition for what it means to be vegan. Since all oral contraceptives currently available contain lactose, most would agree that taking them falls under that category as there is no practical way that they can be completely vegan. “Sometimes, you may have no alternative to taking prescribed medication. Looking after yourself and other people enables you to be an effective advocate for veganism,” says The Vegan Society.

The Pharmacist’s Role

Lastly, the Vegan Society also reminds patients to “open up a conversation with your pharmacist or doctor” in regard to discussing the intersection of medications and veganism, and providers need to be prepared to have these conversations too. Initiating dialogue with patients about their dietary and lifestyle preferences can help with understanding what contraceptive methods they feel most comfortable and confident using and fitting into their vegan lifestyle. Pharmacists are in an optimal position to discuss the options relevant to veganism with patients by being knowledgeable about animal testing as well as active and inactive ingredients and their sources. Being proactive and having these conversations could prevent patients from stopping or changing medications that they feel do not align with their lifestyle, while helping improve adherence and satisfaction.

References:

  1. Tatham , Kate, and Kinesh Patel. “Why Can’t All Drugs Be Vegetarian?” BMJ, vol. 348, 8 Feb. 2014, pp. 18–20., (link).
  2. McKie, Joshua, and Sue Gough . “Is There a Lactose-Free Oral Contraceptive?” UK Medicines Information, 3 Aug. 2016, (link).
  3. Fry, Samantha. “Is My Medication Vegan?” The Vegan Society, 13 Oct. 2017, (link).
  4. “List of Animal-Free Medications.” The Vegan Society, (link).
  5. “Definition of Veganism.” The Vegan Society, (link).
  6. Barclay, Eliza. “Is Your Medicine Vegan? Probably Not.” NPR, NPR, 15 Mar. 2013, (link).

About the Author

Niamh O’Grady, PharmD Candidate, is a pharmacy student in the Class of 2021 at the University of California San Francisco School of Pharmacy

Reviewed by Breanna Failla, PharmD Candidate and Brooke Griffin, PharmD, BCACP

Measuring Blood Pressure: An Important Prerequisite to Prescribing Hormonal Contraception

Why is it important to measure blood pressure before prescribing hormonal contraception?

Combined hormonal contraceptives (CHCs) are a relatively safe and effective method for your patients in preventing pregnancy and treating other disease states such as menorrhagia, endometriosis, PCOS and more. However, CHCs may increase the risk for a few serious cardiovascular events. This risk is increased if a patient has hypertension.

Screening for hypertension prior to staring CHCs is a class A recommendation for safe use according to the U.S. Selected Practice Recommendations for Contraceptive Use (SRC). In a systemic review, women who did not have their blood pressure checked prior to starting hormonal contraception had higher odds of having an acute myocardial infarction and ischemic stroke.

Also, in a small percentage of patients, CHCs can cause life-threatening hypertension, which can lead to irreversible damage to the kidneys and cause renal failure. This effect can last after the medication is discontinued.

Due to these severe adverse effects, all patients are screened for hypertension prior to starting CHCs. If a patient is hypertensive, they should be treated appropriately and have blood pressure well controlled prior to starting a hormonal contraceptive method.  

How do CHCs raise blood pressure?

The mechanism by which CHCs increase blood pressure is unknown. Regardless, CHCs can cause small increases in blood pressure in both normotensive patients and patients with hypertension which is significant enough to be recognized as a risk for hypertensive patients.

Who is at risk of complications from CHCs?

It is not advised to use CHCs in patients with severe hypertension (defined as systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg). However, in people with controlled and monitored hypertension and who are also under 35 years of age, CHCs may be appropriate as long as they are otherwise healthy and do not smoke (U.S. MEC 3). It is important to mention that even if a patient has hypertension that is under control, there is still a risk present for cardiovascular events and that other contraceptive options should be considered before initiating a CHC.

Patients are at a higher risk of cardiovascular complications if they are older than 35 years of age, have a familial history of hypertension, cardiovascular disease or preexisting occult renal disease, and if the patient is obese. Providers should use discretion in patients with these preexisting conditions before starting CHCs or consider more appropriate contraceptive options.

What other options are there for patients with hypertension?

Patients with uncontrolled hypertension, or who are at risk of malignant hypertension have other options for contraception. Progestin only contraceptives such as progestin only pills (POPS), the shot, or levonorgestrel-containing IUDs are recommended over CHCs according to the CDC MEC for women with hypertension. Non-hormonal options include the copper-containing IUD, condoms, or spermicides.

References

  1. Tepper NK, Curtis KM, Steenland MW, Marchbanks PA. Blood pressure measurement prior to initiating hormonal contraception: a systematic review. Contraception 2013;87:631–8.
  2. CDC. U.S. medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep (No. RR-X);2016.
  3. Development, updates, and future directions of the World Health Organization Selected Practice Recommendations for Contraceptive Use. Int J Gynecol Obstet 2017;136: 113–119 – 04 January 2017
  4. Armstrong, Carrie. Hormonal Contraceptives in Women with Coexisting Medical Conditions. Am Fam Physician. 2007 Apr 15;75(8):1252-1258.
  5. El-Ibiary SY, Shrader SP, Ragucci KR. Contraception. In: DiPiro JT, Yee GC, Posey L, Haines ST, Nolin TD, Ellingrod V. eds. Pharmacotherapy: A Pathophysiologic Approach, 11e. McGraw-Hill; Accessed July 22, 2020. https://accesspharmacy-mhmedical-com.mwu.idm.oclc.org/content.aspx?bookid=2577&sectionid=227710658

About the Author

Elizabeth Duxbury Pharm.D. is a recent graduate of University of California, San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences in 2019.

Article reviewed by Breanna Failla, PharmD Candidate and Brooke Griffin, PharmD, BCACP