Tag: birth control

A Comprehensive Guide to Pharmacist Birth Control Services

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

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

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

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

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

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


Rebecca Exantus APPEAbout the Author

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

Founder Reflections on 2023

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

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

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

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

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

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

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

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

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

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

Why Over-the-Counter Birth Control?

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

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

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

How Do We Get an OTC Birth Control Option?

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

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

What is Opill?

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

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

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

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

When Can We Expect a Decision from the FDA?

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

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

References

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

Photo credit: Image from FreethePill.org


MatissaAbout the Author

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

Updated Report on State Policy Efforts to Expand Access to Contraception in Pharmacies

Free 22-page report describing the current landscape of direct pharmacy access to contraception in pharmacies, state policy approaches and experiences, as well as implementation.

The 2020 report includes information for policy efforts in 2020, along with emphasis on definitions of reimbursement vs. payment and a new appendix with model bill elements. 

Subscribe and download PDF report

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.

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.

Contraception During COVID-19: Pharmacy Best Practices

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Pharmacists should not allow postponed or cancelled appointments to keep patients from accessing birth control. It’s important that patients understand how their pharmacy can continue to meet their contraceptive needs during the coronavirus disease 2019 (COVID-19) pandemic.

Pharmacists should inform patients that even though clinics and providers’ offices might be closed, their pharmacy is still able to facilitate refills, provide emergency contraception, and, in some states, prescribe hormonal contraception.

The following tips can help ensure your pharmacy is meeting patients’ contraceptive needs during COVID-19, while keeping your patients and pharmacy staff safe.

1. Encourage Contactless Communications and Dispensing 

Prevent patients from missing doses or going without contraception by preemptively contacting them via texts, emails, and calls to assess their needs. Encourage patients to utilize contactless communication to get in touch with the pharmacy for prescriptions or other items they want to order.

Pharmacies can provide contactless contraceptive care during COVID-19 by encouraging patients to obtain birth control prescriptions and products via mail, drive-through, or curbside pick-up services.1 


2. Promote and Supply Over-the-Counter Products

Visits to the pharmacy may be very limited for patients because of stay-at-home orders, social distancing, and other COVID-19-related barriers. Preemptively supplying prescriptions for emergency contraception can avert out of pocket costs while mitigating stress for patients that experience method failure and are unable to access the pharmacy in a timely manner.2 Encourage patients to have a pregnancy test on hand, in addition to over-the-counter contraceptive options, to ensure that patients’ contraceptive needs are met when routine visits to the pharmacy are not feasible.


3. Optimize Prescriptions and Anticipate Patient Needs

To maintain social distancing and the health of patients and employees, encourage providers to transmit new prescriptions electronically or via telephone.1 

Prescriptions for birth control should include maximum quantities and refills for a full year’s supply.2 Some states require health plans to cover dispensing a 12-month supply of birth control.3 Dispense the maximum amount allowed by the patient’s insurance and share the cash price if a patient desires paying out-of-pocket to limit visits to the pharmacy or clinic.

Pharmacy staff can proactively review patients’ profiles to anticipate upcoming refills and ensure the pharmacy’s birth control inventory is adequate to fulfill patient needs.2 

Check with your state’s COVID-19 pharmacy executive orders to ensure permitted emergency refills are being authorized.


4. Adapt Pharmacist Prescribing

Utilize Telehealth for Birth Control Visits

Patients are turning to telehealth services to access contraception during COVID-19. Transitioning your contraception service to telehealth wherever possible will ensure continuity of care while protecting the health and safety of patients and employees. Pharmacists can utilize telehealth to initiate contraception, assess and switch current methods, and adjust therapy as needed.

Due to COVID-19, some telehealth HIPAA regulations have loosened and health insurance plans are beginning to cover telehealth services.4 

Offer Methods that Don’t Require Blood Pressure Screening

Encourage patients to consider a progestin-only contraceptive if they’re unable to visit the pharmacy for a blood pressure screening.

Progestin-only contraceptive methods do not require a blood pressure screening in order to be safely prescribed, making them a feasible option when prescribing birth control via telehealth. Progestin-only options that can be prescribed by pharmacists and dispensed at the pharmacy include progestin-only pills (containing norethindrone or drospirenone) and depot medroxyprogesterone acetate injections (subcutaneous or intramuscular formulations).

Blood pressure measurement is required prior to initiating combined hormonal contraceptives—containing both estrogen and progestin hormones—due to the increased risk of stroke and myocardial infarction in patients with hypertension or without blood pressure measurements.

This article was co-written by Whitney Russell, a student pharmacist at University of Kentucky College of Pharmacy, and Kailey Hifumi, a student pharmacist at the Pacific University School of Pharmacy.

This article was originally published in Pharmacy Times.

Click image to view and download our COVID guide.

Find out more about providing contraceptive care during COVID-19 on our COVID resource page

References

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

Clinical Considerations for Contraception During COVID: Extended Duration of IUDs and Implants

Contraceptive care should not be compromised during this global pandemic. As many providers transition to contactless care methods via telehealth, patients that utilize long-acting reversible contraception may be worried if their intrauterine device (IUD) or implant has reached its expiration and needs to be removed or replaced. Pharmacists play an important role in educating patients about birth control, including what options are available to them when in-person appointments are not available at their regular clinic or doctor’s office. 

Expiration Dating 

The expiration date listed on the IUD and implant packaging should not be confused with the duration of use. The date stated on the packaging refers to the date by which the implant and IUD should be inserted.  Therefore, as long as the contraceptive device is inserted before the expiration date listed on the package, the IUD or implant will be effective for the entire duration indicated for each method. If the expiration date listed on the package has passed, the device is considered expired so it should not be used for a patient and should be discarded.  

Duration

Studies have demonstrated that IUDs and implants are effective past the FDA-approved duration. This evidence can help minimize concerns about ineffective devices that cannot be replaced due to cancelled doctor’s appointments due to COVID-19 or patient inability to go in due to exposure concerns, insurance loss, or any challenges. See table below to view extended evidence-based durations. 

Table modified from Reproductive Health Access Project

If the IUD or implant usage extends beyond the evidence-based duration, the patient should utilize an alternative birth control method until she is able to resume in-person visits with their provider to remove the device and possibly replace it with a new one if the patient desires. Providers should inform patients that leaving an IUD or implant in place past the evidence-based duration will not cause harm. While there are no safety concerns, there is no benefit as the device is not expected to be effective.

Pharmacists Roles

Pharmacists cannot prescribe or insert IUDs or implants, however, pharmacists have the ability to prescribe self-administered hormonal contraceptives in some states and can always provide over-the-counter barrier and emergency methods. If patients want an implant or IUD, pharmacists are able to initiate an alternative method in the meantime until patients are able to visit their clinic or doctor’s office for IUD or implant insertion. See our COVID page for more on providing contraceptive care during COVID-19. 

For patients not satisfied with their current birth control regimen who are interested in switching to an IUD or implant, pharmacists can refer the patient to a provider and educate the patient on proper bridging methods to prevent pregnancy during the transition to an IUD or implant. 

It is important that pharmacists stay up to date on birth control recommendations and clinical updates in order to provide guidance for patients and providers during a public health emergency. Pharmacists play an integral role in providing patients with the resources and education needed to make informed decisions on their contraceptive options. See the ACCP Women’s Health PRN Opinion Paper on the pharmacist’s role in safe and effective use of long-acting reversible contraceptive methods. 

If a patient is having symptoms related to their IUD or implant, they should be seen for this at a local clinic or doctor’s office. To find a clinic that provides contraceptive devices, visit Bedsider’s clinic finder.

References

About the Author

Kailey Hifumi is a student pharmacist at the Pacific University School of Pharmacy.

Photograph of Kailey Hifumi

5 Pearls from the 2020 States Forum on Pharmacist Birth Control Services

The second annual States Forum on Pharmacist Birth Control Services recently was held by the Birth Control Pharmacist project in partnership with the National Alliance of State Pharmacy Associations (NASPA). Due to the coronavirus disease 2019 (COVID-19) pandemic, this year’s meeting was held virtually as representatives from across the United States, as well as Canada, discussed advances in pharmacist birth control services.

Following a brief overview of the current landscape from the 2019 report, representatives shared updates on pharmacist birth control services in their respective states. The implementation status among the states ranged from fully implemented, in progress, and under consideration, to not being considered at this time.

Each representative was able to provide insight on their successes, challenges, and tips on obtaining state-wide authorities to provide contraception services. Attendees also participated in breakout sessions to brainstorm ideas to improve public awareness, research and evaluation, payment for pharmacist services and advance policy.

Here are 5 pearls to take away from the 2020 States Forum:

  1. Exercise authorities granted by emergency regulations due to COVID-19. As the global pandemic continues to unfold, many states are allowing pharmacists to dispense emergency refills and extended supply quantities. This provision includes refills for hormonal contraception. This unique circumstance can highlight the benefits of implementing contraceptive services within the pharmacy and pave the way for expanded access to birth control.
  2. Identify champions to build a coalition for planned policy proposals. A common barrier expressed in the states forum was legislation halts due to COVID-19. It is important to use this time as an opportunity to expand our outreach to pharmacists and physicians to gain support on pharmacist contraceptive services in the meantime. By identifying pharmacist and physician champions to reach out to medical associations and organizations, states can hopefully overcome and alleviate apprehension from groups opposed to proposed legislation. By educating pharmacist colleagues of the value of providing these services and providing educational resources, we can mitigate pharmacist opposition to legislation. Consider reaching out to obstetrician-gynecologist colleagues, particularly those who are members of the American College of Obstetricians and Gynecologists or have completed a family planning fellowship, to aid in coalition building and policy planning for pharmacist birth control services.
  3. Encourage fellow pharmacists to partake in providing contraceptive services. Pharmacists are key health care members and well equipped to provide these clinical services. There are currently more than 3000 participating pharmacies on the Birth Control Pharmacies map. However, there is still room to expand our reach to more communities as pharmacists. Many pharmacy schools have, or are in the process of implementing, curriculum to complement the implementation of birth control services within pharmacies throughout the US. In some states, legislation has grandfathered pharmacy school graduates to remove additional training barriers. Encourage your colleagues, preceptors, and teams to complete continuing education on contraception services, particularly if practicing in a state with a protocol or other authority available that allows pharmacists to prescribe contraception.
  4. Promote pharmacy services on different platforms to raise public awareness. Although a handful of states have implemented pharmacist birth control services, patients remain widely unaware. By promoting this pharmacy service via signs, social media platforms, partnerships, and through word of mouth, we can expand our impact within the community. Seek partnerships with local student pharmacists and student pharmacy organizations to further promote birth control services.
  5. Join the next States Forum on Pharmacist Birth Control Services. This forum is an opportunity to participate in valuable discussion, and share experiences and strategies to advance pharmacist contraception services in your state. This session was especially helpful for states that are in the process of, or are considering, pharmacy birth control legislation.

If you missed the 2020 States Forum, you may view the meeting recording.

Join the Birth Control Pharmacist email list to be notified of details for the next States Forum. 

The Birth Control Pharmacist project was established to provide training and education, implementation assistance, resources, and clinical updates for pharmacists prescribing contraception. Beyond service implementation, this project engages in advocacy, research and policy efforts within the community to expand the role of pharmacists in family planning.

The mission of NASPA is to provide support and to facilitate collaboration between state pharmacy associations to advance the profession of pharmacy.

This article was co-written by Kailey Hifumi, a student pharmacist at the Pacific University School of Pharmacy.

This article was originally published in Pharmacy Times.

Clinical Considerations for Contraception During COVID: Patient Self-Administration

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During the COVID-19 pandemic and beyond, patients may desire a contactless method of contraception. The subcutaneous (SQ) formulation of depot medroxyprogesterone acetate (DMPA), Depo-SubQ Provera, is an important option to offer patients. This may be of particular interest among patients who currently come in to the pharmacy or go to a clinic for their intramuscular (IM) injection.

Formulation Differences

While patients are able to self-administer both subcutaneous and intramuscular injections for a variety of purposes (e.g., insulin, fertility medications), patients may prefer the SQ formulation of DMPA since it is associated with less pain and higher continuation rates than the IM formulation.

Differences between the two formulations are summarized in the table below.

Intramuscular (IM)Subcutaneous (SQ)
Dose150 mg104 mg
Duration13 weeks
(up to 15 weeks)		12-14 weeks
Generic AvailabilityYesNo
Cost at Pharmacy$70-100>$200

Another important consideration is insurance coverage of these products. Some health plans cover the IM formulation as a medical benefit but have not yet included it as a pharmacy benefit. Some health plans are now covering the SQ formulation as a pharmacy benefit due to COVID-19, while others cover it as a pharmacy benefit but require a prior authorization.

How to Initiate or Switch

There is no physical assessment or blood pressure measurement required for eligibility of DMPA.

If your patient is not currently using a method of hormonal contraception, they can begin using either the IM or SQ at any time during the menstrual cycle if it is reasonably certain that patient is not pregnant. A backup method of contraception should be used for 7 days.

If your patient is currently using IM DMPA, the SQ DMPA can be administered when she is due for her next injection. No backup contraception is needed.

If your patient is currently using any other hormonal contraception (i.e., progestin only-pill, hormonal IUD, combination hormonal pill, patch or ring) or a copper IUD, the DMPA should be administered 7 days before stopping the other method. No backup contraception is needed.

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