Overview of the PRN

The Women’s Health (WH) PRN aims to lead in patient care, education, training, and scholarship pertaining to women’s health while advocating women’s health issues in the public policy arena to ensure access to safe and effective health care services and medications. The WH PRN embraces health care for all genders, including obstetric and gynecologic care and transgender care. The WH PRN also promotes advances in health care related to women and transgender care and advocates health care access for these populations.

The WH PRN consists of over 220 pharmacists and trainee members (students, residents, and fellows) from around the globe. Members practice in a variety of settings, including obstetrics and gynecology, family practice, geriatrics, ambulatory care, internal medicine, public health, and academia.

Residents, fellows, and graduate student members are encouraged to get involved in the WH PRN by participating in its committees (e.g., Advocacy and Scholarship, Communications, Programming), writing for its newsletter, and attending its business meetings and programming. The WH PRN also has a committee composed of residents, fellows, and students.

PRN Leadership

Chair: Sarah Kain, Pharm.D., BCACP

Chair-Elect: Regina Arellano, Pharm.D., BCPS

Past Chair: Jaini Patel, Pharm.D., BCACP

Secretary: Kassandra Bartelme, Pharm.D., BCACP

Treasurer: Marina Maes, Pharm.D., BCACP, BCPS

Public Policy Liaison: Lalita Prasad-Reddy, Pharm.D., M.S., FCCP, BCACP, BCPS, CDE

Student Liaison: Amanda Lackey

Board Liaison: Elizabeth Farrington, Pharm.D., BSPharm, FCCP, FCCM, FPPA, BCNSP, BCPPS, BCPS

Recent Publications by Members of the WH PRN

• Westberg SM, Arellano R, Cieri-Hutcherson NE, et al. Pharmacotherapy of chronic neuropsychiatric conditions during pregnancy. Nurs Womens Health 2024;28:227-41.
• Vernon VP, Cieri-Hutcherson NE, Arellano R, Collins O, Lodise NM. Contraception for transgender and gender-diverse individuals in pharmacy education: a cross-sectional survey and select resources. Curr Pharm Teach Learn 2023;15:715-21.
• Bartelme KM, Cieri-Hutcherson NE, Anderson L, Barnes KN, Karaoui LR, Meredith AH. Survey of colleges and schools of pharmacy to determine restrictions for teaching, research, and advocacy related to contraception. Curr Pharm Teach Learn 2023;15:551-8.
• Vernon V, Patel J, Cieri-Hutcherson NE, et al. The impact of COVID-19 on select considerations in patients of reproductive age: brief talking points for pharmacists. J Am Pharm Assoc (2003) 2023;63:720-4.
• Barnes KN, Leader LD, Cieri-Hutcherson NE, et al. Peripartum pharmacotherapy: a pharmacist’s guide. J Pharm Pract 2024;37:467-77.
• Rafie S, Sandoval AM, Vernon VP, Cook EA. A report on pharmacists with the NCMP credential. Menopause 2022;29:599-605.

Women’s Health PRN Spring 2024 Newsletter Excerpt

The following is an article written by a student member of the WH PRN for the WH PRN spring 2024 newsletter. Since writing the article, Carmela Ruiz graduated from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences in May 2024 and will be completing postgraduate residency training at Lt. Col. Luke Weathers, Jr. VA Medical Center in Memphis, Tennessee.

New Advances in RSV Protection of Newborns and Infants

By: Dr. Carmela Ruiz

Respiratory syncytial virus (RSV) is a lower respiratory virus that commonly affects infants and young children.¹ Respiratory syncytial virus typically causes mild, cold-like symptoms; however, infants and children are at an increased risk of severe disease leading to hospitalizations and death.² Virtually all children younger than 2 years will contract RSV, though all infants are at risk of developing severe RSV disease.² In children younger than 5 years in the United States, RSV results in around 58,000–80,000 hospitalizations and around 100–300 deaths annually.² In 1998, Synagis (palivizumab) was approved for infants and children at high risk to protect against severe RSV-associated lower respiratory tract infection (LRTI). In 2023, two new options for RSV protection were made available on the market for all newborns and infants.

Beyfortus

Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) was approved in July 2023 for the prevention of RSV-associated LRTI.³ Beyfortus is a recombinant neutralizing human IgG1κ long-acting monoclonal antibody to the prefusion conformation of the RSV F protein with three amino acid substitutions that extend half-life.⁴ It is indicated for the prevention of severe RSV-associated LRTI in infants younger than 8 months who are born during or are entering their first RSV season and in children up to 24 months of age who have comorbidities leaving them more vulnerable to an RSV infection.⁵ In most of the continental United States, it can be administered anytime between the beginning of October through the end of March.⁵ The dosing recommendation for infants weighing less than 5 kg is a fixed dose of 50 mg, and in infants weighing more than 5 kg, the dosing recommendation is a fixed dose of 100 mg.⁴ In children receiving Beyfortus during their second RSV season, the recommended dose is 200 mg administered as two separate intramuscular injections.⁴ This injectable monoclonal antibody provides passive immunity in recipients through direct supplementation of antibodies to RSV antigens.⁴

The three clinical trials referenced in the Beyfortus product monograph – Study 3, MELODY, and MEDLEY – studied the safety and effectiveness of Beyfortus.⁴ These trials indicated that Beyfortus is safe and effective for preventing severe RSV infections and RSV-associated death.⁵ Pooled data from these trials showed the efficacy (based on relative risk reduction compared with placebo) of Beyfortus in preventing medically attended RSV-associated LRTI to be 79% ([95% CI, 68.5%–86.1%]; 31 of 2579 in nirsevimab arm and 80 of 1293 in placebo arm).⁵ Its efficacy in preventing RSV-associated infection resulting in hospitalization was 80.6% ([95% CI, 62.3%–90.1%]; 12 of 2579 in nirsevimab arm and 33 of 1293 in placebo arm), and efficacy in preventing admission to the ICU because of RSV-associated infection was 90% ([95% CI, 16.4%–98.8%]; 1 of 2579 in nirsevimab arm and 6 of 1293 in placebo arm).⁵ The most common adverse effects were the development of a rash within 14 days of Beyfortus administration (0.9%) and an injection site reaction within 7 days of administration (0.3%).⁴ Although there was no incidence of an anaphylactic reaction in the clinical trials, this medication still carries the warning of a potential to cause a serious hypersensitivity reaction because this has been observed in other IgG1 monoclonal antibodies.⁵ Efficacy against RSV-associated LRTI was shown through 5 months of age.⁴ Beyfortus can be administered without regard to normal childhood vaccination schedules because it does not affect other vaccine safety or effectiveness.⁵ Unfortunately, however, the manufacturer reported that for the 2023–2024 RSV season, the supply of this medication is limited.⁵

Abrysvo

In May 2023, Pfizer released a new option for RSV protection in newborns: the bivalent RSV prefusion F protein-based vaccine (RSVpreF) or Abrysvo.⁶ Abrysvo is an unadjuvanted vaccine composed of a recombinant RSV F protein antigen in a perfusion conformation (preF) that protects against the RSV A and B strains.⁷ One dose (around 0.5 mL) of this vaccine is indicated in pregnant individuals at 32–36 weeks’ gestational age and is injected intramuscularly.^6,8 Pregnant patients should receive this vaccine during the RSV season (September – January in most of the United States).⁷ When administered, this vaccine provides passive immunity through the transfer of antibodies to RSV antigens transplacentally.⁸ Through this mechanism, it prevents RSV-associated LRTI and severe LRTI in infants younger than 6 months.⁸

Abrysvo was found to significantly reduce the risk of severe RSV, hospitalizations from RSV, and health care visits for RSV.⁹ In the phase III clinical trial MATISSE (Maternal Immunization Study for Safety and Efficacy), Abrysvo was compared with placebo. The study found that vaccination reduced the risk of hospitalization by 68% within 3 months and 51% within 6 months after birth compared with placebo.¹⁰ The risk of severe disease was reduced by 82% within 3 months and 69% within 6 months after birth.¹⁰ The most common adverse effects (10% or greater) of this vaccine included pain at the injection site (40.6%), headache (31%), muscle pain (26.5%), and nausea (20%).⁸ Preeclampsia occurred more often in the Abrysvo group than in the placebo group (1.8% [95% CI, 1.4, 2.3] vs. 1.4% [95% CI, 1.1, 1.9]). Low birth weight occurred more often in the Abrysvo group (5.1%) than in the placebo group (4.4%), as did jaundice (7.2% vs. 6.9%).⁸ In addition, the clinical trials showed more preterm births in the Abrysvo group than in the placebo group (5.7% [95% CI, 4.9, 6.5] vs. 4.7% [95% CI, 4.1, 5.5]); however, the results were not statistically significant and cannot exclude a causal relationship between preterm birth and Abrysvo.⁸ This vaccine was not studied in patients with an increased risk of preterm birth or other pregnancy complications.⁸ All pregnant patients who receive Abrysvo should be encouraged to participate in the CDC’s V-safe program, which monitors the safety of this vaccine.⁹

Guiding Patients

The American College of Obstetricians and Gynecologists recommends that either the pregnant individual receive Abrysvo or the infant receive Beyfortus.¹¹ Patient consideration factors when choosing between Abrysvo and Beyfortus include risk of pregnancy complications, availability of Beyfortus, and personal preference.¹¹ Both are effective, but Abrysvo provides immediate protection to the newborn when vaccination occurs at least 14 days before birth, whereas Beyfortus may provide longer protection.¹¹ During the 2023–2024 RSV season, the supply of Beyfortus has been limited, which should be discussed with patients making the decision of maternal RSV vaccination.¹¹ Finally, some patients may want to decrease the amount of injections their newborn receives by opting for maternal vaccination.¹¹

Abrysvo and Beyfortus are exciting advances in the protection against RSV-associated complications and death. Both have been found effective, so decisions should be based on patient preference, medication availability, and risk of preterm birth.

Scan to reach the CDC’s V-safe¹²

References

1. Cherry JD, Harrison GJ, Kaplan SL, et al. Respiratory syncytial virus. In: Feigin and Cherry’s Textbook of Pediatric Infectious Diseases. Elsevier, 2019:1780-97.
2. Centers for Disease Control and Prevention (CDC). RSV in Infants and Young Children. CDC, 2023. Available at https://www.cdc.gov/rsv/high-risk/infants-young-children.html.
3. U.S. Food and Drug Administration (FDA) Office of the Commissioner. FDA Approves New Drug to Prevent RSV in Babies and Toddlers. FDA, 2023. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers.
4. BEYFORTUS^TM [nirsevimab injection] [product monograph]. Sanofi and AstraZeneca, April 2023. Available at https://pdf.hres.ca/dpd_pm/00070439.PDF.
5. Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices – United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:920-5.
6. Pfizer. U.S. FDA Approves ABRYSVO^TM, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age. Pfizer, 2023. Available at https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-abrysvotm-pfizers-vaccine-prevention-0#:~:text=In%20May%202023%2C%20the%20U.S.,years%20of%20age%20or%20older.
7. Centers for Disease Control and Prevention (CDC). For Healthcare Professionals: RSV (Respiratory Syncytial Virus). CDC, 2023. Available at https://www.cdc.gov/rsv/clinical/index.html#:~:text=To%20protect%20infants%20from%20severe,new%20prevention%20product%20or%20vaccine.
8. ABRYSVO: Highlights of Prescribing Information. 2023. Available at https://labeling.pfizer.com/ShowLabeling.aspx?id=19589.
9. Centers for Disease Control and Prevention (CDC). Healthcare Providers: RSV Vaccination for Pregnant People. CDC, 2023. Available at https://www.cdc.gov/vaccines/vpd/rsv/hcp/pregnant-people.html.
10. Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med 2023;388:1451-64. Available at https://doi.org/10.1056/nejmoa2216480.
11. American College of Obstetricians and Gynecologists (ACOG). Maternal Respiratory Syncytial Virus Vaccination. ACOG, 2023. Available at https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination.
12. Centers for Disease Control and Prevention (CDC). V-safe. CDC, 2023. Available at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/v-safe/index.html.