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TABLE OF CONTENTS
Advancements in Sickle Cell Disease Treatment:
Enhancing Pediatric and Adult Outcomes 2
XacduroⓇ: Acinetobacters’ Biggest Enemy 3
Buprenorphine Dose in the Era of Fentanyl 5
Electronic Cigarettes, Safe or Not? CYP Enzymes May
Hold the Answer 6
A Breath of Progress: The Latest Advancements in
COPD Management 8
Pharmacy’s Top Priority: Medicare Provider Status
Recognition 8
Emerging Infectious Disease: Respiratory Syncytial
Virus 9
Zurzuvae: First and Only Oral Postpartum Depression
Treatment 10
Uncovering the Student Experience at the FSHP 57th
Annual Meeting 11
Expanding the Delivery of CAR T-cell Therapy to
Outpatient Settings and The Role of Pharmacists in
Ensuring Patient Safety 13
Recent Rise of Melatonin Ingestion in the United States
Pediatric Population 14
Value of JAK Inhibitors and Monoclonal Antibodies for
the Treatment of Atopic Dermatitis 15
Florida's Vaccine Stance: DeSantis vs. New COVID-19
Guidelines 16
Reblozyl: Novel First Line Anemia Therapy for Persons
with Lower-Risk Myelodysplastic Syndrome 17
Biopharma’s AI revolution is about more than
algorithms 18
Pralsetinib: RETribution for Patients with RET-gene
fusion Non-Small Cell Lung Cancer 19
Empowering Access: How Pharmacies Are Redefining
Birth Control Access 20
About the Organization 21
Editor’s Note 22

1
Advancements in Sickle Cell Disease
Treatment: Enhancing Pediatric and
Adult Outcomes
Alexandra Chizmar and Julia Nguyen
Sickle Cell Disease (SCD) is an inherited disorder
presented at birth, occurring when the infant receives
two genes, one from each parent, that codes for
abnormal hemoglobin.1 SCD is diagnosed using a blood
test. In the US, diagnosis can occur before or at birth, but
more often it occurs at birth. Complications of SCD can
occur throughout an individual’s lifespan, from infancy
through adulthood. The most notable complications of
SCD include anemia, vaso-occlusive pain crisis,
infections, and acute chest syndrome. Unfortunately,
SCD is a condition that degenerates over time.1
Management of SCD focuses on the prevention and
treatment of pain episodes while also extending the life
expectancy of those affected by this condition.
According to the 2014 Sickle Cell Disease Guidelines,
the only cure is allogeneic hematopoietic stem cell
transplant.2 This method, however, is often underused
due to the lack of ideal donors.3 Another possible cure
being investigated is gene therapy, however, there is no
conclusive data to date. In terms of disease-modifying
treatments, one option is chronic blood transfusion
therapy.2
Pharmacologically, the mainstay of treatment up until
2017 was hydroxyurea. Hydroxyurea is an
antimetabolite which selectively inhibits ribonucleoside
diphosphate reductase, the rate-limiting enzyme of DNA
synthesis, effectively halting DNA synthesis and repair.4
In SCD, hydroxyurea is used to increase red blood cells
(RBC), improve the deformability of sickle cells, and
decrease the expression of adhesion molecules. These all
lead to decreased vaso-occlusive pain crises, acute chest
syndrome, and the need for blood transfusions.3
Since 2017, three new disease-modifying therapies have
been FDA-approved for various age groups.
L-Glutamine is an amino-acid oral powder that received
FDA approval in 2017 for reducing acute complications
of reactive oxygen species (ROS) and hemolysis and
thus, decreasing inflammation.5 Currently, this
medication is expensive and can only be obtained
through a specialty pharmacy. The second new therapy
for SCD is Crizanlizumab-tmca.3 Crizanlizumab is a
humanized IgG2 kappa monoclonal antibody that binds
to P-selectin and blocks interaction with ligands.6 It is
FDA approved for adolescents 16 years and older to
reduce the frequency of vaso-occlusive crisis. The final
new therapy for SCD is Voxelotor.2 Voxelotor, a
hemoglobin S (HbS) polymerization inhibitor, increases
the affinity of hemoglobin for oxygen. The increased
affinity for oxygen may lead to inhibition of RBC
sickling, improvement in RBC deformability, and
reduction in whole blood viscosity.7 Similar to
L-Glutamine, Crizanlizumab can only be dispensed
through a specialty pharmacy and is costly.
L-glutamine, crizanlizumab, and voxelotor are three of
the newest FDA approved treatments for SCD.3 While
L-glutamine and crizanlizumab have been seen to
demonstrate a statistically significant reduction in pain
crises compared to placebo, voxelotor showed a
significant increase in hemoglobin. Each medication can
be used concurrently with hydroxyurea, but to date, no
studies have been conducted using these combinations.
These promising FDA-approved therapies, while not yet
incorporated into current SCD guidelines, offer
substantial and statistically significant improvements in
symptom management across all age groups and enhance
the overall quality of life for both pediatric and adult
patients battling this challenging condition.
References:
1. Centers for Disease Control and Prevention. (2023, July 6). What is Sickle Cell Disease?.
Centers for Disease Control and Prevention.
https://www.cdc.gov/ncbddd/sicklecell/facts.html
2. Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014.
Pediatrics December 2014; 134 (6): e1775. 10.1542/peds.2014-2986
3. Tara Higgins, Melissa A. Menditto, Stephanie Katartzis, Kelly L. Matson; Advances in
the Management of Sickle Cell Disease: New Concepts and Future Horizons. The
Journal of Pediatric Pharmacology and Therapeutics 1 March 2022; 27 (3): 206–213.
4.
doi: https://doi.org/10.5863/1551-6776-27.3.206
Hydroxyurea (hydroxycarbamide): Drug information. UpToDate. (n.d.).
https://www.uptodate.com/contents/hydroxyurea-hydroxycarbamide-drug-information?se
arch=hydroxyurea&source=panel_search_result&selectedTitle=1~148&usage_type=pane
l&kp_tab=drug_general&display_rank=1#F180986
5. Glutamine (including L-glutamine [pharmaceutical grade] and supplements): Drug
information. UpToDate. (n.d.-a).
https://www.uptodate.com/contents/glutamine-including-l-glutamine-pharmaceutical-gra
de-and-supplements-drug-information?search=l+glutamine&source=panel_search_result
6.
&selectedTitle=1~148&usage_type=panel&kp_tab=drug_general&display_rank=1
Crizanlizumab: Drug information. UpToDate. (n.d.-a).
https://www.uptodate.com/contents/crizanlizumab-drug-information?search=crizanlizum
ab&source=panel_search_result&selectedTitle=1~14&usage_type=panel&kp_tab=drug_
general&display_rank=1#F53886340
7. Voxelotor: Drug information. UpToDate. (n.d.-d).
https://www.uptodate.com/contents/voxelotor-drug-information?search=voxelotor&sourc
e=panel_search_result&selectedTitle=1~16&usage_type=panel&kp_tab=drug_general&
display_rank=1#F53917142
2
XacduroⓇ: Acinetobacters’ Biggest of tigecycline for the treatment of HAP/VAP caused by
Acinetobacter species.5 It is crucial to mention that these
Enemy treatments are listed as weak recommendations with
Gisselle Halabi-Molli and Ralitza Gradeva low-quality evidence which poses a need for higher
quality evidence targeting this complex strain associated
Acinetobacter species are gram-negative bacteria
with HAP/VAP.
commonly found in water, soil, and sometimes skin that
can dangerously affect health with illness and “serious
Xacduro is the brand name of sulbactam/durlobactam
disease of various systems and organs.”1 More
which is a new drug approved by the Food Drug
specifically, Acinetobacter baumanii accounts for the
Administration (FDA) in 2023 for the treatment of
majority of infections. “Outbreaks of Acinetobacter
HAP/VAP caused by susceptible isolates of
infection typically occur in hospital intensive care units
Acinetobacter baumannii-calcoaceticus. Xacduro was
(ICUs) and healthcare settings” in the geriatric
approved by the FDA through fast track and priority
population that are disabled or presenting with severe
review processes which are both used to expedite the
illness.2 Acinetobacter does not pose a major threat to
development, evaluation and marketing of new drugs.
healthy individuals but when compromising vulnerable
The purpose of fast track review is to accelerate the
populations, it can cause bacteremia, lung infections
review of drugs used to treat serious conditions and
(such as pneumonia), urinary and wound infections.2
drugs that have the possibility to address unmet medical
Common lung infections that this bacteria causes are
needs.6 There is an unmet medical need for the treatment
hospital-acquired pneumonia (HAP) and
of HAP/VAP associated with complex Acinetobacter
ventilator-acquired pneumonia (VAP). HAP is defined as
species due to the low evidence and weak
pneumonia not present at admission but occurring 48
recommendation in the current IDSA guidelines. A
hours after hospital admission; in contrast, VAP is a
priority review was enacted under the Prescription Drug
subset of HAP seen in the ICU setting where it is defined
User Act (PDUFA) and it requires the FDA to take
as pneumonia caused by tracheal intubation within 48-72
action on an application within 6 months. A priority
hours.3 In terms of diagnosis, it is recommended to use
review is granted when a new drug can lead to
noninvasive methods such as inducing sputum for HAP
significant improvements or significant preventions of
and nasotracheal suction or endotracheal aspiration for
serious conditions compared to the standard.7
VAP to perform respiratory secretions culture.4
In reference to the package insert, the only indication for
Acinetobacter baumanii continues to develop
which Xacudro has been approved for currently is the
mechanisms of resistance to currently approved
treatment and prevention of HAP/VAP associated with
antibiotics, causing around 8500 cases in hospitalized
the complex Acinetobacter species.8 The mechanism by
patients and 700 deaths in 2017.3 “Carbapenem-resistant
which Xacduro exerts its effects is by the ability for
Acinetobacter are usually multidrug-resistant”
“sulbactam to act as a beta-lactam antibacterial and
demonstrating resistance to multiple antibiotics. Studies
Ambler Class A serine beta-lactamase inhibitor that has
continue to expand on the development of new drugs to
bactericidal activity due to its inhibition of Acinetobacter
target carbapenem-resistant Acinetobacter to optimize
baumannii-calcoaceticus complex (ABC)
outcomes in these healthcare settings.
penicillin-binding proteins PBP1 and PBP3, which are
essential enzymes required for bacterial cell wall
According to the Infectious Diseases Society of America
synthesis.”8 Additionally, Xacduro’s second ingredient,
(IDSA) guidelines on antibiotics used for the treatment
durlobactam, “is a diazabicyclooctane non-beta-lactam,
of patients with HAP/VAP due to complicated
beta-lactamase inhibitor, that protects sulbactam from
Acinetobacter species, the first-line agents which are
degradation by certain serine-beta-lactamases.”8
currently recommended include carbapenem or
Durlobactam and sulbactam are manufactured together
ampicillin/sulbactam.5 Patients sensitive to polymyxins
as durlobactam alone does not have antibacterial activity
are recommended to use intravenous polymyxin. Inhaled
against ABC isolates.
colistin can also be used as an adjunct to the intravenous
polymyxin treatment.5 IDSA guidelines advise against
the use of rifampicin as an adjunct to colistin or the use
3
Common adverse effects included liver test
abnormalities, diarrhea, anemia, and hypokalemia seen
in more than 10% of the participants in clinical trials.8
Xacduro has precautions for hypersensitivity reactions as
it is administered as a beta-lactam injection and a
warning for Clostridioides difficile-Associated Diarrhea
(CDAD) which is common with antibacterial agents.
Xacduro has reported drug interactions with organic
anion transporter 1 (OAT1) drugs. OAT1 inhibitors may
increase the plasma concentration of sulbactam.8 The
normal recommended dosage for Xacduro is 1g
sulbactam/1g durlobactam intravenously every 6 hours
for 7-14 days, but adjustments should be made regarding
renal impairment. If patients’ creatinine clearance is over
130mL/min then the drug should be administered every
4 hours; if it falls between 30-44 mL/min then it should
be administered every 8 hours; if it falls between 15-29
mL/min then it should be administered every 12 hours;
and if it is under 15 mL/min then it should be
administered every 24 hours.8 There are currently no
evaluations in regards to hepatic impairment.
Xacduro’s clinical trial during Phase 3 of the NDA
process was randomized, in a multicenter,
active-controlled, and unblinded (for investigators).9
There was a total of 177 adult (age over 18) hospitalized
patients.9 The patients were either given Xacduro (1g
sulbactam/1g durlobactam) intravenously over 3 hours
every 6 hours or colistin 2.5 mg/kg intravenously over
30 minutes every 12 hours after an initial loading dose
(2.5→5mg/kg).9 Both treatment groups received 1g
imipenem and 1g cilastatin intravenously every 6 hours
for potential HAP/VAP pathogens other than
Acinetobacter species in addition to address preventative
needs. Durations on these treatment regimens was up to
14 days.9 The primary endpoints for this study were to
evaluate the 28-day-all-cause mortality in patients who
had the infection. The results evaluated patients who did
not withdraw from the trials which resulted in 63
patients in the Xacduro group and 62 patients in the
colistin group.9 According to inclusion statistics, “64%
of patients had been in the ICU ≥ 5 days, 26% of patients
had been in the ICU for >14 days, and 75% were
mechanically ventilated.”11 Although Xacduro showed
non-inferiority when compared to colistin, the results
showed, in addition, that Xacduro had an
all-cause-mortality of 19% compared to colistin which
was 32.3%.9
Infections caused by tough-to-beat multidrug resistant
organisms especially in the hospital setting continues to
pose a threat to patients.10 There are limited resources
and efficacious treatment options that target these
pathogens which result in higher unmet medical needs
posing a threat to patient’s lives. Acinetobacter species
of bacteria are known to be ‘difficult-to-treat’ which tops
the charts of critical bacterial pathogens that must be
addressed causing major concern specifically
carbapenem-resistant Acinetobacter baumanii (CRAB)
to immunocompromised patients, according to the World
Health Organization.11 Xacduro’s approval opens up
opportunities to meet a higher standard for treatments to
target this bacterial species as it is “the first and only
treatment targeting HABP/VABP caused by susceptible
isolates, which can include multidrug-resistant strains of
Acinetobacter baumannii‑calcoaceticus complex.”12 This
new drug will play a major role in our healthcare system
with a focus on preventing the spread of CRAB
infections as there was a 78% increase in cases found in
US hospitals in 2020.13 We are eager to witness the
difference this new drug causes in improving mortality
and morbidity rates related to Acinetobacter infections.
References:
1. Mehta, P. (2022, October 13). What to know about acinetobacter baumannii. WebMD.
https://www.webmd.com/a-to-z-guides/what-to-know-about-acinetobacter-baumannii
2. Virginia Department of Health. (2023, September 7). Acinetobacter infection. Epidemiology.
https://www.vdh.virginia.gov/epidemiology/epidemiology-fact-sheets/acinetobacter-infection/
3. Shebl E, Gulick PG. Nosocomial Pneumonia. [Updated 2023 Jun 26]. In: StatPearls [Internet]. Treasure Island (FL):
4.
StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK535441/
Kalil AC, Metersky ML, Klompas M, et al. Management of adults with hospital-acquired and ventilator-associated
pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic
5.
Society. Clin Infect Dis. 2016;63(5):e61-e111.
Andre C. Kalil, Mark L. Metersky, Michael Klompas, John Muscedere, Daniel A. Sweeney, Lucy B. Palmer, Lena M.
Napolitano, Naomi P. O'Grady, John G. Bartlett, Jordi Carratalà, Ali A. El Solh, Santiago Ewig, Paul D. Fey, Thomas
M. File, Marcos I. Restrepo, Jason A. Roberts, Grant W. Waterer, Peggy Cruse, Shandra L. Knight, Jan L. Brozek,
Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines
by the Infectious Diseases Society of America and the American Thoracic Society, Clinical Infectious Diseases,
Volume 63, Issue 5, 1 September 2016, Pages e61–e111, https://doi.org/10.1093/cid/ciw353
6. FDA. (2018, January 4). Fast track. U.S. Food and Drug Administration.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
7. FDA. (2018, January 4). Priority review. U.S. Food and Drug Administration.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
8. Xacduro [package insert]. Waltham, MA:Entasis Therapeutics,Inc.; 2023
9. Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With
Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (ATTACK), NCT03894046 Clinicaltrial.gov,
2023.https://clinicaltrials.gov/study/NCT03894046 (accessed 2023-09-24).
10. Center for Drug Evaluation and Research. (2023, May 23). FDA approves new treatment for pneumonia caused by
certain difficult-to-treat bacteria. U.S. Food and Drug Administration.
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficu
11.
lt-treat-bacteria
WHO publishes list of bacteria for which new antibiotics are urgently needed. World Health Organization.
Published February 27, 2017. Accessed June 19, 2023.
https://www.who.int/news/item/27-02-2017-who-publishes-list-ofbacteria-for-which-new-antibiotics-are-urgently-need
ed.
12. XACDURO® (Sulbactam for injection; durlobactam for injection). For Healthcare Professionals | XACDURO®
(sulbactam for injection; durlobactam for injection), co-packaged for intravenous use. (2023, September).
https://www.xacduro.com/
13. CDC. COVID-19: U.S. Impact on Antimicrobial Resistance, Special Report 2022. Atlanta, GA: U.S. Department of
Health and Human Services, CDC; 2022
4
Buprenorphine Dose in the Era of
Fentanyl
Kyle DePalma
According to a study done at Brown University,
individuals with opioid use disorder (OUD) who
received a lower buprenorphine dose were around 20%
more likely to discontinue treatment compared to those
that were prescribed a higher dosage.1 Buprenorphine is
an opioid partial agonist that produces euphoria or
respiratory depression effects when taken at moderate
doses.2 In patients who were recently prescribed
buprenorphine for OUD, 59% of those who were given
the recommended dose of 16 mg by the FDA and 53% of
those given a higher dose of 24 mg, stopped their
treatment within 180 days.1 After an analysis that
considered various factors and compared the two dosage
groups, it revealed that patients who were prescribed the
recommended dose were notably more likely to
discontinue their treatment over the course of 180 days
compared to those given the 24 mg dose.1 Medications
used to treat OUD, such as buprenorphine, have been
proven safe and effective in reducing opioid use,
preventing overdoses, and aiding in recovery. These
findings have supported the evidence in the safety and
efficacy of higher doses of buprenorphine.2 Studies have
shown that doses above the FDA recommended 16 mg
are well-tolerated and safe for individuals with OUD, in
both the emergency room and outpatient setting.3
In 2021, the majority of drug overdose deaths were
mainly attributed to fentanyl, an extremely potent
synthetic opioid. Out of the 107,000 reported overdose
deaths in 2021, nearly 70,000 were primarily attributed
to fentanyl.2 The growing presence of fentanyl in the
drug supply has resulted in an increase of overdose
deaths, leading many to question if dosing guidelines for
buprenorphine need adjustment to address the challenges
of such a potent opioid. Currently, FDA-approved
labeling states maintenance doses of 4 mg to 24 mg, with
a target dose of 16 mg per day for most patients.3
The study previously mentioned involved a retrospective
analysis of data of patients who began buprenorphine
treatment for OUD during 2016-2020, a period during
which the prevalence of fentanyl was increasing rapidly.
The aim was to assess the patient’s daily dosage of
buprenorphine and their retention of treatment over 180
days. At the initiation of treatment, 21% were prescribed
8 mg, 50% received 16 mg, and 10% were prescribed 24
mg. As previously mentioned, the results of the study
revealed that patients receiving a 24 mg dose of
buprenorphine stayed in treatment longer than those
prescribed with 16 mg.2 One of the study’s principal
investigators, Dr. Rachel Wightman, pointed out that the
current FDA target dose of 16 mg was established before
the high availability of fentanyl.2 People now show
higher levels of opioid tolerance, and the findings
suggest a higher dose, up to 24 mg, could improve
retention in treatment for many patients. To further the
research done in the study, scientists plan to conduct a
randomized clinical trial to assess the impact of daily
buprenorphine doses up to 24 mg in enhancing treatment
retention and reducing overdoses and death. Researchers
will explore other factors associated with treatment
retention as well as patient socio-demographic and life
circumstances. The results from these clinical trials
could conclude that updates to treatment standards for
OUD need to be made.
References:
1. Chambers, L. C., Hallowell, B. D., & Zullo, A. R., et al. (2023, September 18).
Buprenorphine dose and time to discontinuation among patients with opioid use disorder.
JAMA Network Open.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809633
2. Substance Abuse and Mental Health Services Administration. (n.d.). Buprenorphine.
SAMHSA. https://www.samhsa.gov/medications-substance-use-disorders/medications-
counseling-related-conditions/buprenorphine
3. NIDA. 2023, September 18. Higher buprenorphine doses associated with improved
retention in treatment for opioid use disorder. Retrieved from https://nida.nih.gov/news-
events/news-releases/2023/09/higher-buprenorphine-doses-associated-with-improved-ret
ention-in-treatment-for-opioid-use-disorder on 2023, September 24
5
Electronic Cigarettes, Safe or Not?
CYP Enzymes May Hold the
Answer
Anjali Paragji and Rachel Jarvis
Electronic cigarette smoking is a growing national
phenomenon. The National Institute on Drug Abuse
states, in individuals 12 years of age or older, 22% report
using tobacco products or vaping nicotine within the last
30 days.1 As future pharmacists, we are concerned about
the growing impact that electronic cigarette usage can
have on our patients and their treatments.
Pharmacokinetics encompasses the way in which a
medication is absorbed, distributed, metabolized, and
finally excreted from the body. A vital component of
drug metabolism in our body is through CYP enzymes.
These enzymes not only metabolize medications but also
nicotine and other harmful ingredients found in
electronic cigarettes (e-cigs). Mutations in these
enzymes can induce or inhibit their activities leading to
toxicities or ineffective drug therapies within our bodies.
This article aims to summarize recent research on
electronic cigarette usage and the effects on CYP
enzymes in the body, with mentions of the impact on
medication therapy and the comparison with traditional
cigarette smoking.
Cytochrome P450 (CYP450) describes the superfamily
of enzymes which are responsible for the metabolism of
xenobiotics within the body. CYP450 contributes to the
therapeutic effect of drugs in the form of activation or
deactivation. There are numerous CYP enzymes, and
they are predominantly located hepatically. There are a
few members within the superfamily that are affected by
the use of electronic cigarettes. One important member is
CYP1A2, which is responsible for the metabolism of
approximately 9% of the drugs on the market currently.2
Additionally, many of the drugs that are metabolized by
this enzyme have a narrow therapeutic range
contributing to the importance of the proper function of
these enzymes. Studies have shown that continuous
exposure to cigarette smoke has led to the up regulation
of CYP1A2 enzymes.2,3 CYP2A5 is a crucial component
in the metabolism of nicotine, lipopolysaccharides,
nitrosamines, and cotinine.4 A study done on mice
showed the increased enzymatic activity of CYP2A5 and
the increased probability of organ toxicity either in the
lungs or liver .4 The effects were not as prominent when
compared to cigarette smoke; however, when compared
to placebo, the difference was distinguishable. CYP1A1
is another enzyme that has shown a direct correlation
with lung disease progression when activated, and the
expression of this enzyme increases with the use of
e-cigarettes.4 These are just some of the highly regulated
members of the CYP450 family that play an extensive
role in the metabolism of xenobiotics.
The alteration of the enzymatic expression leads to
changes in the metabolism of drugs. This could increase
or decrease metabolism and cause modified effects
compared to the traditional dosing of a medication.
Studies have shown continuous exposure to cigarette
smoke leads to the down regulation of CYP1A2
enzymes and leads to complications associated with the
narrow therapeutic windows of medications including
warfarin, clozapine, olanzapine, and theophylline.2
CYP2A5 is an enzyme that is seen to be a metabolizer
with many of the chemical components that are found in
nicotine containing compounds. This interaction leads to
the intermediate reactive oxidative species (ROS) and
consequently oxidative stress on the body 2. CYP2D6 is
an enzymatic family that has shown altered effects after
prolonged exposure to nicotine products. This CYP
enzyme is known for its metabolism on antidepressant
drugs. 3 Nicotine products have resulted in up-regulation
of the enzyme which alters the therapeutic effects of
many highly used antidepressants. Some key problems
include the medication being ineffective to the patient,
increased side effects, and toxic levels of the drug
remaining in the body for an unwarranted amount of
time due to the modified metabolism.3 These are just
some highlighted impacts CYP enzymes can make on
the body relating to drug therapies that include nicotine
products, including electronic cigarettes.
There are significant negative effects that are a result of
the chronic use of electronic cigarettes and additional
nicotine containing products. One prominent enzyme of
discussion is CYP1A2. Studies have shown that the
effects of CYP1A2 inducement have been much higher
with cigarette smoking than the use of electronic
cigarettes or placebos. However, increased enzymatic
effects are still seen with e-cigs.2 Smoking cessation
allows this enzyme to return to normal activity a few
days after smoking is stopped.2 This can be a promising
6
reason for patients who are willing to quit smoking. It is
advised that the patient consults with their primary care
physician to make adequate dose adjustments to their
medications.

CYP450 enzymes are an essential component of the

body and play a vital role in the therapeutic effects of
drugs when it comes to metabolism. Cigarette smoking
has been studied in depth when it comes to the
detriments it causes to our health; however, with the
increase in popularity of electronic cigarettes little is
known about the true impact it has on the human body.
Looking into the enzymatic impact electronic cigarettes
have may provide greater information on why
individuals should steer clear of this fad. The
metabolism of medications such as antidepressants and
those with narrow therapeutic windows are just some
points of impact electronic cigarettes can target. The use
of e-cigs may be a middle point for helping a patient
quit, but long-term use can still have detrimental
implications.

References:
1. NIDA. What is the scope of tobacco, nicotine, and e-cigarette use in the United States?.
National Institute on Drug Abuse
website.https://nida.nih.gov/publications/research-reports/tobacco-nicotine-e-cigarettes/w
hat-scope-tobacco-use-its-cost-to-society. January 23, 2023 Accessed September 17,
2023.

2. Van Der Plas A, Pouly S, Blanc N, et al. Impact of switching to a heat-not-burn tobacco
product on CYP1A2 activity. Toxicol Rep. 2020;7:1480-1486. Published 2020 Oct 29.
doi:10.1016/j.toxrep.2020.10.017

3. Bautista M, Mogul AS, Fowler CD. Beyond the label: current evidence and future
directions for the interrelationship between electronic cigarettes and mental health. Front
Psychiatry. 2023;14:1134079. Published 2023 Aug 14. doi:10.3389/fpsyt.2023.1134079

4. Marshall K, Liu Z, Olfert IM, Gao W. Chronic electronic cigarette use elicits molecular
changes related to pulmonary pathogenesis. Toxicol Appl Pharmacol. 2020;406:115224.
doi:10.1016/j.taap.2020.115224

7
A Breath of Progress: The Latest
Advancements in COPD
Management
Makenzee Smith and Shelby Figueroa
Excellent pharmacists need to stay up to date on
practice guidelines in order to provide evidence-based
treatments to ensure the best health outcomes for their
patients. The Global Initiative for Chronic Obstructive
Lung Disease (GOLD) released new guidelines for
Chronic Obstructive Pulmonary Disease (COPD) in
November 2022 using an impressive 387 new references
published from January 2021 to July 2022. The primary
change that healthcare workers involved in COPD care
plans should be aware of is the change in the initial
classification and subsequent initial treatment
recommendations. In addition, minor additions were
made to more thoroughly represent the Centers for
Disease Control and Prevention (CDC) guidelines and
certain patient counseling points.
In regards to management of COPD, the ABCD
assessment tool for initial disease severity was revised to
an ABE assessment tool to put more emphasis on the
prevention of exacerbations.1 Patients with two or more
moderate exacerbations or one exacerbation leading to
hospitalization are now categorized into group E and are
recommended to receive a long acting beta agonist
(LABA) and long acting muscarinic antagonist (LAMA)
therapy regardless of their Modified Medical Research
Council (mMRC) Dyspnea Scale score or their COPD
Assessment Test (CAT) score, as shown in Figure 1.
Although there are multiple options for the treatment of
these group E patients, LABA and LAMA combination
therapy is preferred to reduce COPD exacerbations.2
Another option is LABA, LAMA, and inhaled
corticosteroids (ICS) triple therapy for patients with
eosinophils greater than 300 cells/µL, which is the only
pharmacotherapy treatment that has been shown to
decrease mortality.4-5 ICS and LABA combination
therapy is no longer encouraged for the treatment of
COPD. This differs significantly from the 2022 GOLD
guidelines, which lists ICS and LABA combination
therapy as the primary treatment for previous Group D
patients who have high eosinophils. This change was due
to multiple large clinical trials which failed to
demonstrate a reduction in mortality.6-7 As before, the
only other treatments to reduce mortality in COPD
patients are non-pharmacotherapy options such as
smoking cessation, pulmonary rehabilitation, long-term
oxygen therapy, and other procedures. A final change
that is important to note in regards to initial treatment, is
the change of recommended therapy in group B.
Although the classification of patients into group B
stayed the same, these patients should now be treated
with LABA and LAMA combination therapy rather than
choosing between LABA or LAMA therapy.
Figure 1. Initial Pharmacological Treatment from the 2022 GOLD Guidelines
(left) and the 2023 GOLD Guidelines (right).1,3
The guidelines were also updated to match the CDC
vaccination guidelines, so people with COPD should be
vaccinated to protect against influenza, pneumonia,
pertussis and COVID-19. The 2023 updates also include
sections about the choice of inhaler device and the
importance of inhaler device technique and adherence.
Community pharmacists can play an essential role to
provide vaccinations and patient education to ensure
these needs are met to optimize COPD management.
Pharmacists should be encouraged to stay up to date with
treatment guidelines for a variety of indications. By
being knowledgeable about the most appropriate
treatments, we will be well-equipped to evaluate
treatment plans, counsel patients, and act as drug experts
and resources for other healthcare providers. Up to date
pharmacists in all areas of practice can work towards
elevating pharmaceutical care and increasing positive
health outcomes for our patients.
References:
1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of
chronic obstructive pulmonary disease report; 2023. Available from: https://goldcopd.org/2023-gold-report-2/. Accessed September
25, 2023.
2. Oba Y, Keeney E, Ghatehorde N, Dias S. Dual combination therapy versus long-acting bronchodilators alone for chronic obstructive
pulmonary disease (COPD): a systematic review and network meta-analysis. Cochrane Database Syst Rev 2018;12(12):CD012620.
3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of
chronic obstructive pulmonary disease report; 2022. Available from: https://staging.goldcopd.org/2022-gold-reports-2/. Accessed
September 25, 2023.
4. Lipson DA, Crim C, Criner GJ, et al. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients
with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2020;201(12): 1508-16.
5. ​Rabe KF, Martinez FJ, Ferguson GT, et al. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very- Severe COPD.
6.
N Engl J Med 2020;383(1): 35-48
Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary
7.
disease. N Engl J Med 2007; 356(8): 775-89.
Vestbo J, Anderson J, Brook RD, et al. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur
Respir J 2013; 41(5): 1017-22.
8
Pharmacy’s Top Priority: Medicare
Provider Status Recognition
Keian Halls and Tasnim Haque
What is H.R. 1770?
The fight for provider status for pharmacists has been
long and arduous. With so much media attention, it
might be hard to understand what this ever-elusive
"provider status" really is. In its most basic sense, it is
the ability of a pharmacist to offer healthcare services to
patients in need and receive reimbursement for the
services provided. If you're thinking, "Isn't that what
pharmacists already do?" you would only have a small
piece of the story. Currently, pharmacists lack a federal
mechanism for reimbursement on a federal level. The
pharmacy profession has consistently lagged behind in
terms of what it's allowed to do, but we've demonstrated
time and time again that we can step up to the plate.
There is a portion of the population that, when they think
of a pharmacist, they simply imagine someone
transferring pills from one bottle to another. However,
pharmacists do so much more than that. A great example
of this is during the COVID-19 pandemic when
pharmacists and interns were finally permitted to
administer childhood and Covid vaccines to patients,
including those under the age of 18.1 While this may
seem like an obvious mainstay now, it wasn't as clear to
lawmakers back then.
H.R. 1770, also known as The Equitable Community
Access to Pharmacist Services Act (ECAPS)2, provides
for Part B reimbursement of certain pharmacist services.3
This includes services such as testing for illnesses like
COVID-19, influenza, RSV, and strep throat. It allows
for reimbursement of the treatment of COVID-19,
influenza, and strep throat, as well as reimbursement for
immunization services that pharmacists already provide
for free. ECAPS would enable pharmacists to be
recognized as healthcare proivders under the Social
Security Act and be appropriately reimbursed through
the physician fee schedule. This resolution is necessary
because it limits Medicare beneficiaries' access to
pharmacist services in an outpatient setting.
Pharmacists are the most accessible healthcare providers
that most individuals have access to. In fact, nearly 90%
of all Americans live within 5 miles of a pharmacy, and
unlike with physicians, you can visit a pharmacist almost
anytime.4 Opposition has come from the American
Medical Association (AMA), which claims that granting
provider status to pharmacists would infringe on their
scope of practice. However, it is quite the opposite.
Pharmacists would only be allowed to bill for services
that are already included in each state's scope of
pharmacy practice. Having a pharmacist as part of a
healthcare team is synergistic for all involved because of
the delegation of care and improved outcomes for
patients.
Pharmacists are highly trained and qualified individuals
who are long overdue for provider status. Many patients
already rely heavily on pharmacists for advice on
illnesses and medications. Receiving care from the same
person they have built a relationship with is the logical
next step. Any barrier that can be broken down to patient
care is one that should be taken.
References:
1. Florida Department of Health. (2020, October 2). Pharmacists and Interns May
Administer Childhood and COVID-19 Vaccines. Florida Board of Pharmacy.
https://floridaspharmacy.gov/latest-news/pharmacists-and-registered-pharmacy-interns-m
ay-administer-childhood-and-covid-19-vaccines/
2. American Pharmacists Association. (2021). Pharmacy Provider Status: Improving
Americans’ Access Life-Changing Health Care. Home.
https://www.pharmacist.com/Advocacy/Issues/Provider-Status/Equitable-Community-Ac
cess-to -Pharmacist-Services-Act-ECAPS%E2%80%99
3. Congressional Record, Volume 169 (2023) H.R.1770 - Equitable Community Access to
Pharmacist Services Act (2023). bill. Retrieved September 27, 2023, from
https://www.congress.gov/bill/118th-congress/house-bill/1770/text.
4. Berenbrok, L. A., Tang, S., Gabriel, N., Guo, J., Sharareh, N., Patel, N., Dickson, S., &
Hernandez, I. (2022). Access to Community Pharmacies: A nationwide geographic
information systems cross-sectional analysis. Journal of the American Pharmacists
Association, 62(6). https://doi.org/10.1016/j.japh.2022.07.003
9

Emerging Infectious Disease:
Respiratory Syncytial Virus
Alexandra Adair and Rachel Peña
Respiratory Syncytial Virus (RSV) is a common respiratory
RNA virus that causes mild, cold-like symptoms and normally
resolves without medication within one to two weeks after
infection. Transmission of RSV mainly occurs from close
contact with an infected individual or by direct exposure to the
eyes, nose, or mouth.1 Generally, RSV is not considered
life-threatening but can be serious in high-risk pediatric and
geriatric patients. This virus is a major cause of upper and
lower respiratory tract infections among older children and
adults; targeting the lower respiratory tract specifically in
infants.1 During the first several years of life, virtually all
children will be exposed to RSV infections with the most
dangerous exposure being within the first year.6 A new
vaccine became available to the geriatric population for
protection against severe infection while a monoclonal
antibody is necessary for infants who contract the virus.
Arexvy is a newly approved immunization for the prevention
of lower respiratory tract disease (LRTD) in adults ages 60 and
older. The safety and efficacy of giving a single dose of
Arexvy to adults 60 years and older was analyzed based on an
ongoing randomized, placebo-controlled study; 12,500
participants received Arexvy, and 12,500 participants received
placebo. Participants of the study will remain enrolled through
three RSV seasons to assess the duration of effectiveness and
the safety and effectiveness of repeat vaccination.5 Among the
participants who received a dose of Arexvy and those who
received a placebo, the vaccine significantly reduced the risk
of developing LRTD that is associated with RSV by 82.6%
and reduced the risk of developing severe LRTD associated
with RSV by 94.1%.5 In a morbidity and mortality weekly
report by the CDC on the use of RSV vaccines in older adults,
a single dose of vaccination was shown to have moderate to
high efficacy in preventing symptomatic RSV-associated
LRTD over the course of two RSV seasons in adults aged 60
and above.3 “Although trials were underpowered to estimate
efficacy against RSV-associated hospitalization and death,
prevention of LRTD, including medically attended LRTD,
suggests that vaccination might prevent considerable
morbidity from RSV disease among adults aged ≥60 years”.3
Prior to the approval of nirsevimab (Beyfortus), a long-acting
monoclonal antibody for the prevention of RSV-associated
LRTD in infants and children 24 months old and younger, “the
only FDA-approved product to prevent severe RSV disease
among infants and young children was palivizumab, another
monoclonal antibody.”2 However, the use of palivizumab is
limited to children younger than 24 months old with certain
conditions that place them at an increased risk for developing
severe RSV disease.4 The use of palivizumab is further limited
due to its high cost and monthly dosing. The efficacy of
nirsevimab was evaluated in infants that were less than 8
months old who were born during or were entering their first
RSV season for 150 days after their single injection. The
pooled efficacy in preventing medically attended
RSV-associated lower respiratory tract infection (LRTI) was
79.0%, efficacy in preventing RSV-associated LRTI with
hospitalization was 80.6%, and efficacy in preventing
RSV-associated LRTI with ICU admission was 90.0%.2 No
deaths were reported in either trial related to RSV. The
Advisory Committee on Immunization Practices (ACIP)
recommends 1 dose of nirsevimab for all infants less than 8
months old that are born during or entering their first RSV
season at a dose of 50 mg for infants weighing less than 5 kg
and 100 mg for infants weighing more than 5 kg. For infants
and children aged 8–19 months at increased risk for
developing severe LRTD from RSV and entering their second
RSV season, ACIP recommends a dose of 200 mg (two 100
mg injections at the same time in different injection sites). One
dose of nirsevimab protects the infant or child for five months,
or the average length of an entire RSV season; this less
frequent dosing is less costly while also being just as or more
effective than palivizumab.
Both therapies are recommended in each population to
decrease the intensity of illness as well as the likelihood of the
patients requiring hospitalizations. Ensuring the well-being of
the general population is crucial when interacting with
vulnerable individuals. Prevention of transmission includes
hand washing for a duration of 20 seconds, covering coughs or
sneezes with your sleeves or tissues, maintaining the
cleanliness of frequently touched surfaces, and avoiding close
contact with other individuals if symptoms are occurring.6
Please talk to your healthcare provider if you experience any
of the symptoms or have had contact with anyone suspected or
known to have RSV.
References:
1. CDC – Respiratory Synovial Virus (RSV) – Homepage.
https://www.cdc.gov/rsv/index.html#print. September 29, 2023.
2. 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;72:920–925. DOI:
http://dx.doi.org/10.15585/mmwr.mm7234a4.
3. Melgar M, Britton A, Roper LE, et al. Use of Respiratory Syncytial Virus Vaccines in
Older Adults: Recommendations of the Advisory Committee on Immunization Practices
— United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:793–801. DOI:
http://dx.doi.org/10.15585/mmwr.mm7229a4.
4. National Center for Immunization and Respiratory Diseases. “RSV Vaccination: What
Parents Should Know.” Centers for Disease Control and Prevention, 20 Sept. 2023,
www.cdc.gov/vaccines/vpd/rsv/public/child.html#:~:text=There%20are%20two%20RSV
%20antibody,entering%20their%20first%20RSV%20season.
5. Office of the Commissioner. “FDA Approves First Respiratory Syncytial Virus (RSV)
Vaccine.” U.S. Food and Drug Administration, FDA, 3 May 2023,
www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial
-virus-rsv-vaccine.
i.
6. Walsh, E. E., & Hall, C. B. (2015). Respiratory Syncytial Virus (RSV). Mandell,
Douglas, and Bennett's Principles and Practice of Infectious Diseases, 1948–1960.e3.
https://doi.org/10.1016/B978-1-4557-4801-3.00160-0
10

Zurzuvae: First and Only Oral
Postpartum Depression Treatment
Jordan McIntire and Kelly Duignan
Zurzuvae (Zuranolone), manufactured by Sage
Therapeutics, was approved by the FDA in August of
2023.2 Zurzuvae is a neuroactive steroid that positively
modulates the gamma-aminobutyric acid (GABA) A
receptor.4 The mechanism of action of the drug is
related to the opening of channels, allowing chemicals to
adhere to the GABA binding sites.4 This prescription
medication is the first and only oral postpartum
depression (PPD) treatment option approved by the Food
and Drug Administration.2 Zurzuvae is a 14-day
treatment regimen that is taken orally once daily. The
only alternative treatment option available for PPD is
Zulresso (Brexanolone) that is administered by IV drip
over the course of 60 hours, leading to limited usage of
Zulresso.¹
As originally stated, Zurzuvae’s indication is for the
mentioned previously, Zurzuvae must be taken with fatty
foods.4 Without, it can accelerate the possibility of renal
and liver failure.4 After giving birth, there is often a lack
of confidence and self-esteem in physical appearance
that play a role in PPD which may deter the consumption
of fatty foods, leading to adverse events.
Rolling out Zurzuvae into the public market is
beneficial, targeting a demographic that has historically
been overlooked. Also, it allows for a more convenient
and accessible plan that does not involve prolonged
outpatient treatment, giving newborn parents a second
option to combat PPD. This will aid in ensuring bonding
with newborns, that can often be hindered due to PPD.
Though this is a step in the right direction to combat
PPD, continuous research must still be done in order to
mitigate side effects and reach a broader audience.
References:
1. Cornett, E. M., Rando, L., Labbé, A. M., Perkins, W., Kaye, A. M., Kaye, A. D.,
Viswanath, O., & Urits, I. (2021). Brexanolone to Treat Postpartum Depression in Adult
Women. Psychopharmacology bulletin, 51(2), 115–130.

treatment of postpartum depression. The exact cause of
PPD is still unknown, so this has made it challenging to
find a treatment.1 It’s estimated that about 15% of
mothers suffer from PPD.3 This is a very serious issue
as 20% of maternal mortality is due to suicide.1
Self-harm is not the only disparity seen in women who
have PPD, but so is the increased incidence of child
2. Deligiannidis, K.M., Meltzer-Brody, S., Gunduz-Bruce, H., Doherty, J., Jonas, J., Li, S.,
Sankoh, A.J., Silber, C., Campbell, A.D., Werneburg, B., Kanes, S.J., & Lasser, R. (2021)
Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial.
JAMA Psychiatry. 78 (9), 951–959. https://doi.org/10.1001/jamapsychiatry.2021.1559
3. Faisal-Cury, A., Tabb, K.M., Ziebold, C., & Matijasevich, A. The Impact of Postpartum
Depression and Bonding Impairment on Child Development at 12 to 15 Months After
Delivery. (2021). Journal of Affective Disorders Reports. 4, Article 100125.
https://doi.org/10.1016/j.jadr.2021.100125
4. Sage Therapeutics. (2023). Zurzuvae: Highlights of Prescribing Information. Cambridge,
MA: Sage Therapeutics.

abuse.1 With Zurzuvae, women with PPD will be able to

have some alleviation of their symptoms, which may
lead to a decrease in the aforementioned statistics.

Zurzuvae is available in multiple dosage forms. The

recommended dose is 50 mg once daily.4 The renal dose
is 30 mg once daily.4 The peak concentration occurs
between 5-6 hours from consumption of the drug.4
Because of this, the effects of the drug will not be
immediate. It’s important to note that this drug must be
taken with fatty foods to ensure optimal absorption.4
Given the half-life, 19.7-24.6 hours, it is important to
note that each dose must be timed appropriately to
ensure minimal dosage overlap.4 Patients are not
expected to feel alleviation from their symptoms until 3
days after initiating therapy and are expected to feel the
effects for up to 45 days.2

Zurzuvae does have side effects that are important to

note, including dizziness, drowsiness, overall fatigue,
nasopharyngitis, and urinary tract infections.4 After
administration, machinery should not be operated for at
least 12 hours, thus it is recommended to be
administered at night.4 Due to impaired mental
cognition from the drug, mothers may not be able to
attend to their newborn to the fullest extent. As
11
Uncovering the Student Experience
at the FSHP 57th Annual Meeting
So Young Moon
In the ever-expansive field of pharmacy, it is imperative
to stay updated on the latest findings and share clinical
expertise amongst professionals within the field. The
Florida Society of Health-System Pharmacists (FSHP)
held its 57th Annual Meeting on August 4th - 6th, 2023
at the Gaylord Palms Resort in Kissimmee, Florida.
Pharmacists, student pharmacists, and pharmacy
technicians acknowledged their accomplishments
throughout the year and discussed areas for clinical
improvements. Over the course of the 3-day event, a
wide spectrum of pharmacy expertise was explored,
including Emergency Management, Pain Management,
Leadership, and Critical Care, among others. It was a
wonderful educational experience especially for the
student pharmacists, who had the opportunity to learn
about different aspects of pharmacy and explore their
interests.
This year, pharmacy students from the University of
Florida College of Pharmacy (UFCOP) Orlando Campus
had the opportunity to attend and actively participate in
this meeting. On the second day of the meeting, students
from the UFCOP clinched victory in the Student Chapter
Quiz Bowl Competition. This competition was designed
to test the clinical knowledge and the expertise of
pharmacy students using questions that cover a wide
range of subjects.
Thy Tran, a UFCOP student of the Class of 2024,
collaborated with fellow students from UFCOP in this
competition. She attributed their achievements to the
college’s effort to design the curriculum, which not only
includes basic concepts, but also intricate clinical
pharmacotherapy. She emphasized that student
pharmacists are exposed to a learning environment that
simulates real clinical practices. The college’s
commitment to staying current with the latest
developments in the field allowed its students to apply
the classroom knowledge into practice. The Quiz Bowl
challenged these student pharmacists to provide answers
to a diverse range of topics, including biostatistics, drug
delivery, pharmacology, pharmacokinetics, and clinical
pharmacotherapy. Thy remarked that the FSHP’s
educational events, workshops, and seminars, which
delved deeply into the clinical aspects of pharmacy,
contributed to their success at the competition.
“Attending these events allowed me to stay updated on
the latest advancements in these fields”, she commented.
The FSHP Annual Meeting also served as a platform for
residents and interns to showcase their research findings.
On the second day, Sierra Parsons, a UFCOP student of
Class of 2024, participated in the Poster Session. She
presented her project on the implementation of a
protocol to treat immune thrombocytopenia with two of
her peers. She conducted a retrospective chart review to
compare the medications patients received before and
after the protocol’s implementation. The results
demonstrated that similar clinical responses were
obtained with significantly fewer medications
post-implementation. The protocol led to a $2000
decrease in the average cost of medications per patient.
The Poster Session provided the opportunity to
disseminate the results of her longitudinal research to
pharmacists and to practice communicating clinical data
effectively. Sierra found this experience invaluable as
she prepares for her APPE projects and her upcoming
presentation at the ASHP Midyear Meeting. She stated,
“FSHP allowed me to experience a clinical conference in
a less intimidating setting than some of the bigger
national meetings.” Moreover, she applauded the UF
College of Pharmacy for strongly emphasizing
professionalism, which allowed a seamless transition
into APPEs. She believes that her experiences at the
meeting helped guide her next steps towards a residency.
The profound impact of this year’s FSHP Annual
Meeting on the development of the student pharmacists
is evident. Their accomplishments and active
participation at the event showcased not only their hard
work but also the quality of the education at the UFCOP.
The experiences of Thy and Sierra highlight the
significance of professional events and the importance of
student involvement. It is events like these that equip
student pharmacists to become pharmacists who make a
difference.
12
Expanding the Delivery of CAR
T-cell Therapy to Outpatient
Settings and The Role of
Pharmacists in Ensuring Patient
Safety
Mary-Pearl Ojukwu
There has been new discussion to make Chimeric
Antigen Receptor (CAR) T-cell Therapy more mobile.
Traditionally, patients have received CAR T-cells in the
hospital setting due to many reasons including the risks
of serious harms and side effects associated with the
therapy.1 Each CAR T-cells’ regimen is made specially
for the patient. It requires collection of T cells from the
patient which are then re-engineered artificially in the
laboratory to produce surface proteins known as
chimeric antigen receptors (CARs). The receptors then
bind to cell specific proteins or antigens that are present
on the surface of cancer cells.2 Like most other oncology
treatments, this regimen has serious side effects with the
main ones being cytokine release syndrome and
neurological effects.1 Hence, it habitually requires
administration under the supervision of a healthcare
team and this process usually entails about 10-14 days of
hospitalization.3
Figure 1: Image description of the process of CAR T cell therapy. Adapted
from © 2017 Terese Winslow LLC; the U.S. Government has certain rights.9
Like many other cancer treatments, outpatient delivery
has its own benefits as the need for hospitalization and
the cost has a clear impact on the treatment’s feasibility
and burden to the patient. CAR T-cell treatment’s
efficacy along with its limitations sparked the interests of
researchers to determine if outpatient delivery is
realistic, equally efficacious and most importantly, safe
for patients. Some research also suggests that outpatient
delivery may make it more accessible but more
investigation is needed on those claims.4 In their study,
Carlos R. Bachier et al. reported on patients with
relapsed/refractory B-cell non-Hodgkin lymphoma
(NHL) who were treated in the outpatient setting with
Lisocabtagene maraleucel (liso-cel) in two phase 2
studies assessing the safety and efficacy of the drug. The
research included elderly patients and patients with a
high tumor burden (TMB). They observed that the
number of early hospitalizations was low, and that 41%
of patients did not require hospitalization in the first
month post infusion.5
Since FDA approves drugs and not methods of infusion,
it is not clear if outpatient delivery would soon become
the preferred method. Nonetheless, there are many
policies and procedures required to be set in place before
embarking on this delivery method. Patient specific
factors must be assessed to determine eligibility for the
delivery method as well as the availability of
institutional resources. Round the clock support is
needed and healthcare professionals as well as patients
have to be trained on the process.6 All in all, if an
algorithm is created for safe and effective methods to
make this a possibility, patients would benefit from the
ease and reduced hospitalization this will offer. Issues
about inpatient capacity limits could also be addressed
with this expansion. More time is needed to determine if
the block-busting CAR T-cell therapy will be made
mobile like its name suggests.
As the most accessible healthcare professionals,
pharmacists have a vital role to play in the outpatient
delivery of oncology medications. We are essential in
patient education, resource navigation, managing prior
authorizations, assessing patient-reported outcomes, and
monitoring medication adherence.7 Some healthcare
facilities have begun the outpatient administration of
CAR T-cell therapy with pharmacists at the forefront to
ensure the safe delivery of this high-risk therapy.
American Pharmacists Association (APhA) highlights 8
different actions pharmacists can take in daily practice
that can improve patient safety in all healthcare settings.
Some of them include ensuring medication access,
coordinating care transitions, performing medication
management services, improving medication awareness,
etc.8 These actions can be applied to this field as we can
comprehensively review patients status to determine if
13
they are appropriate to receive their regimen as
outpatients, educating our patients and their caregivers to
improve their health literacy as well as delivering patient
care services and assisting with care transitions to
inpatient if needed.8 Our advocacy skills as well as our
training on therapeutic drug management and
personalization of pharmacotherapy emphasizes our vital
role to play. Hopefully, the new outpatient CAR T-cell
discussion will improve accessibility without
undermining its safety and efficacy.

References
1. Cleveland Clinic. (n.d.). Car T-cell therapy: Procedure, Prognosis & Side effects.
https://my.clevelandclinic.org/health/treatments/17726-car-t-cell-therapy#:~:text=CAR%20T%2Dcell%20t
herapy%20c
an%20cause%20significant%20or%20life%2Dthreatening,and%20manage%20any%20side%20effects.

2. National Cancer Institute. (n.d.). Car T cells: Engineering immune cells to treat cancer.
https://www.cancer.gov/about-cancer/treatment/research/car-t-cells#:~:text=They%20are%20made%20by%
20collectin g,the%20surface%20of%20cancer%20cells.

3. The University of Chicago Medical Center. (n.d.). Outpatient car T-cell therapy. UChicago Medicine.
https://www.uchicagomedicine.org/cancer/types-treatments/car-t-cell-therapy/outpatient#:~:text=During%2
0outpatient %20CAR%20T%2Dcell,non%2Dinvasive%20process%20called%20apheresis
4. Bansal, R. (n.d.). Hospital-Based Outpatient Approach to CAR T Therapy Is Safe, Feasible in Lymphoma
and Multiple Myeloma.
https://dailynews.ascopubs.org/do/hospital-based-outpatient-approach-car-t-therapy-safe-feasible-lymphom
a-and-multiple

5. Carlos R. Bachier, Maria Lia Palomba, Jeremy S. Abramson, Charalambos Andreadis, Alison R. Sehgal,
John Godwin, Gerhard C. Hildebrandt, Tanya Siddiqi, Don Stevens, Thalia Farazi, Ana Kostic, Nikolaus S.
Trede, Lei Wang, James Lymp, Tennille Thelen, Ken Ogasawara, David G. Maloney; (2019, November 13)
Outpatient Treatment with Lisocabtagene Maraleucel (liso-cel) in Three Ongoing Clinical Studies in
Relapsed/Refractory (R/R) B Cell Non-Hodgkin Lymphoma (NHL), Including Second-Line Transplant
Ineligible Patients: Transcend NHL 001, Outreach, and PILOT. Blood 2019; 134 (Supplement_1): 2868.
doi: https://doi.org/10.1182/blood-2019-127566

6. Myers, G. D., Verneris, M. R., Goy, A., & Maziarz, R. T. (2021). Perspectives on outpatient administration
of CAR-T cell therapy in aggressive B-cell lymphoma and acute lymphoblastic leukemia. Journal for
immunotherapy of cancer, 9(4), e002056. https://doi.org/10.1136/jitc-2020-002056

7. Seung, A. H., Palatine, J., & Merten, J. (n.d.). Oncology pharmacists bring value and contribute to cancer
care. Pharmacy Times.
https://www.pharmacytimes.com/view/oncology-pharmacists-bring-value-and-contribute-to-cancer-care

8. American Pharmacists Association. (n.d.). Pharmacists’ impact on patient safety.

https://waf.pharmacist.com/Portals/0/PDFS/Practice/PharmacistsImpactonPatientSafety_Web.pdf?ver=dYe
AzwlN3-PG9eSkMMsV-A%3d%3d

9. Winslow, T. (n.d.). CAR T cell therapy. Terese Winslow LLC Medical and Scientific Illustration. Retrieved
September
23, 2023, from https://www.teresewinslow.com/cellular-scientific/84xlny0c31aafqm6vw81qjubsianku.

14
Recent Rise of Melatonin Ingestion
in the United States Pediatric
Population
Jade Gallahair
In the United States, pediatric melatonin ingestion
reports to poison control have alarmingly increased over
the past decade; including reports of serious outcomes
and hospitalizations.1 Melatonin is an endogenous
neurohormone that plays a role in natural sleep
on possible behavioral interventions as first line therapy
for sleep before initiating melatonin. It is important to
increase knowledge on the recent rise in reports of
melatonin ingestions of the United States pediatric
population and utilize preventive measures to reduce
unnecessary ingestions among such a vulnerable
population.
References
1. Centers for Disease Control and Prevention. (2022, June 2). Pediatric melatonin
ingestions - United States, 2012–2021. Centers for Disease Control and Prevention.
https://www.cdc.gov/mmwr/volumes/71/wr/mm7122a1.htm

regulation. Melatonin is also a dietary supplement 2. Melatonin. In: Clinical Pharmacology [database on the Internet]. Orlando (FL): Elsevier;
2023 [cited 2023 Sept 25]. Available from: www.clinicalpharmacology.com. Subscription
available as an over the counter (OTC) sleep aid for both required to view.

children and adults. The exact mechanism of action of
how melatonin helps to induce sleep is not clear;
however it is not thought to be through a direct hypnotic
effect.2 The dietary supplement is regulated by the Food
and Drug Administration (FDA) and is often regarded as
“safe” and “natural” to the general public.3 The use of
melatonin in children (age ≤18 years) is typically
secondary to bedtime resistance, difficulty initiating
sleep, night wakings or combinations of these
symptoms.3 Although most sleep disturbances in both
children and adults can be treated with behavioral
therapy, interventions like melatonin can be viewed as a
quick fix and because of this its use has been on the rise.
3. Pharmacotherapy for insomnia in children and adolescents: A rational approach.
Off-campus access using the UF proxy server. (n.d.).
https://www-uptodate-com.lp.hscl.ufl.edu/contents/pharmacotherapy-for-insomnia-in-chil
dren-and-adolescents-a-rational-approach?sectionName=Melatonin&search=emergency+
medicine+drug+&topicRef=8365&anchor=H727571870&source=see_link#H727571870
4. Koopman-Verhoeff ME, van den Dries MA, van Seters JJ, Luijk MPCM, Tiemeier H,
Luik AI. Association of Sleep Problems and Melatonin Use in School-aged Children.
JAMA Pediatr. 2019;173(9):883–885. doi:10.1001/jamapediatrics.2019.2084
5. David D. Gummin , James B. Mowry , Michael C. Beuhler , Daniel A. Spyker , Alvin C.
Bronstein , Laura J. Rivers , Nathaniel P. T. Pham & Julie Weber (2021) 2020 Annual
Report of the American Association of Poison Control Centers’ National Poison Data
System (NPDS): 38th Annual Report, Clinical Toxicology, 59:12, 1282-1501, DOI:
10.1080/15563650.2021.1989785

In 2020, according to reports received by National

Poison Control Centers, melatonin was the most
consumed substance by children in the United States.4
The long term effects and toxicities of children ingesting
melatonin is not fully known and more studies need to
be conducted to fully understand the consequences. It is
important that healthcare providers inform parents how
to properly store and use of melatonin. If any adverse
effects are experienced or observed following melatonin
ingestion, it is advised for both healthcare professionals
and users to report the adverse effects to the FDA’s
medical product safety reporting program: MedWatch.

By reporting these adverse effects, it provides

documentation and evidence that can assist policymakers
in understanding the need and importance for
establishing public health initiatives to raise awareness
for the growing issue of melatonin ingestion in the
pediatric population to develop strategies to mitigate the
risk.1 Healthcare providers should first educate patients
and those interested in using melatonin for their children

15
Value of JAK Inhibitors and
Monoclonal Antibodies for the
Treatment of Atopic Dermatitis
Ashley Stultz and Julia Nguyen
In January 2022, the Institute for Clinical and Economic
Review’s (ICER) review on the effectiveness and value
of JAK inhibitors and monoclonal antibodies for the
treatment of atopic dermatitis was published by the
Journal of Managed Care Pharmacy.1 This review
evaluated the clinical effectiveness of tralokinumab and
three oral JAK inhibitors (abrocitinib, baricitinib, and
upadacitinib) compared with placebo and with
dupilumab in patients with moderate to severe atopic
dermatitis. Emerging therapies also contribute greatly to
this field. Tralokinumab is an IL-13 receptor antagonist
that is currently under review.
Researchers combined outcome data from all eligible
monotherapy randomized controlled trials (RCTs) and
used a Bayesian network meta-analysis (NMA) to
indirectly compare the interventions.1 The results of their
analysis suggest that tralokinumab and all three oral JAK
inhibitors improve skin outcomes when compared with
placebo. Improvements in itch, sleep, and quality of life
were also seen upon initiating these medications.
Furthermore, the NMA suggests that higher doses of
abrocitinib and upadacitinib are similar or better than
dupilumab.1
In relation to adverse effects, all three JAK inhibitors
were shown to have similar and low drug
discontinuation rates. However, other studies suggest an
increased risk of serious adverse effects when evaluated
for a longer period of time. Serious adverse effects
include reactivation of herpes zoster, malignancy,
thromboembolic events, and cardiovascular events. In
response to this safety data, the FDA placed black box
warnings for this class of medications.1
Results from the economic analysis of tralokinumab and
the three oral JAK inhibitors showed that the
incremental cost-effectiveness ratio was lowest for
baricitinib and highest for upadacitinib when compared
to standard of care ($71,600 per QALY vs $248,400 per
QALY).1 Compared with dupilumab, baricitinib and
tralokinumab were found to be both less costly and less
effective.
Limitations acknowledged during ICER’s review include
a lack of long-term safety data, a lack of evidence for
specific patient subgroups that are affected by atopic
dermatitis, and non-existent head-to-head comparisons
for these agents.1 Both tralokinumab and the three oral
JAK inhibitors evaluated are newer forms of drug
therapy so their long term safety status is currently
unknown. Moreover, there is limited evidence for use of
these new therapies in 12-17 year olds and
African-Americans, subgroups notably affected by
atopic dermatitis.1 The lack of head-to-head comparative
evidence for these agents warrant substantial uncertainty
behind these interpretations. In the future, tralokinumab
and the three oral JAK inhibitors will need to be further
evaluated when more evidence arises.
While JAK inhibitors and monoclonal antibodies have
demonstrated significant improvements in the treatment
of moderate to severe atopic dermatitis, it is essential to
remain cautious due to the potential for serious adverse
effects. It is essential to understand that the choice of
therapy for a patient should not solely be guided by cost
considerations, but also take into consideration
individual patient profiles, treatment goals, and side
effect profiles.
References
1. Agboola, F., Atlas, S. J., Brouwer, E., Carlson, J. J., Hansen, R. N., Herron-Smith, S.,
Nhan, E., Rind, D. M., & Pearson, S. D. (2022). JAK inhibitors and monoclonal
antibodies for the treatment of atopic dermatitis: effectiveness and value. Journal of
managed care & specialty pharmacy, 28(1), 108–114.
https://doi.org/10.18553/jmcp.2022.28.1.108
16
Florida's Vaccine Stance: DeSantis
vs. New COVID-19 Guidelines
Titilayo Ajibola and Yamilée H. Fioyale
Although the COVID-19 burden is considerably lower
than it was earlier in the pandemic, there are still many
hospitalizations and deaths in absolute terms. The risk of
developing a serious illness is greater among the elderly
and those with comorbidities.1 COVID-19 still causes
serious disease in the population even with no
underlying medical issues. People who received the
previous COVID-19 vaccine had better protection
against serious illness and hospitalization versus those
who did not receive it. The COVID-19 virus is still a
threat to mankind since it is constantly evolving and
creating new variations. Infection and protection from
COVID-19 vaccinations both deteriorate over time. A
newer COVID-19 vaccination offers improved defense
against the variations currently causing the majority of
hospitalizations in the United States.1
A committee within the FDA met to unanimously vote
that the new COVID-19 vaccine should be formulated
with the XBB lineage of the Omicron variant. The new
vaccines produced by Pfizer and Moderna are now
monovalent compared to the previous bivalent
formulation of the BA lineage.2 The CDC now
recommends everyone 6 months and older to receive the
updated vaccine, regardless of previous vaccination
status.3 The FDA authorized the new vaccines on the
basis that the vaccines will be effective against the
circulating variants and considering the benefit to risk
ratio of the past vaccines.
Governor Ron DeSantis and the head of the state's health
department advised citizens against receiving a new
COVID-19 vaccine booster. In a news release following
the panel discussion, DeSantis stated, "I will not sit
quietly by and allow the FDA and CDC [to] utilize
healthy Floridians as guinea pigs for new booster shots
that have not been proven to be safe or effective.”4 In an
email to supporters last week, his campaign stated that it
would "fight back against every bogus attempt to expand
government control" with regard to COVID-19 safety
measures. While some political figures have made
statements against the use of such boosters, one’s
decision should be based on personal beliefs and
scientific evidence.
In the face of evolving threats posed by COVID-19, the
recent unanimous FDA committee decision to authorize
new monovalent vaccines targeting the XBB lineage of
the Omicron variant marks a significant development in
the ongoing battle against the virus. The CDC's
recommendation for everyone aged 6 months and older
to receive the updated vaccine underscores the urgency
of collective action. However, the decision to take the
booster shot remains a personal one, influenced by
individual beliefs and scientific evidence. Amidst
political debates and conflicting opinions, it is essential
for individuals to rely on credible information and
consult healthcare professionals to make informed
choices, ensuring the safety and well-being of
themselves and their communities in these challenging
times.
References
1. “Updated Covid-19 Vaccine Recommendations Now Available.” Centers for Disease
Control and Prevention, Centers for Disease Control and Prevention, 12 Sept. 2023,
www.cdc.gov/respiratory-viruses/whats-new/covid-vaccine-recommendations-9-12-2023.
html.
2. “CDC Recommends Updated COVID-19 Vaccine for Fall/Winter Virus Season.” Centers
for Disease Control and Prevention, Centers for Disease Control and Prevention, 12 Sept.
2023, www.cdc.gov/media/releases/2023/p0912-COVID-19-Vaccine.html.
3. Commissioner, Office of the. “FDA Takes Action on Updated Mrna COVID-19 Vaccines
to Better Protect against Currently Circulating Variants.” U.S. Food and Drug
Administration, FDA, 11 Sept. 2023,
www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19
-vaccines-better-protect-against-currently-circulating.
4. Bendix, Aria, and Matt Dixon. “DeSantis Administration Advises against Covid Shots for
People under 65.” NBCNews.Com, NBCUniversal News Group, 13 Sept. 2023,
www.nbcnews.com/health/health-news/desantis-administration-advises-no-covid-shots-u
nder-65-rcna104912.
5. Askin, Jerry. “Florida CVS, Walgreens Locations Receive Shipments of New Covid-19
Vaccines.” Edited by Brandon Hogan, WKMG, WKMG News 6 & ClickOrlando, 18
Sept. 2023,
www.clickorlando.com/news/local/2023/09/17/florida-cvs-walgreens-locations-receive-s
hipments-of-new-covid-19-vaccines/.
17
Reblozyl: Novel First Line Anemia
Therapy for Persons with
Lower-Risk Myelodysplastic
Syndrome
Heather Reiss
Myelodysplastic syndrome is a specific variation of
leukemia which stimulates the bone marrow to generate
blood cells that are unable to mature.3 The prevention of
blood cell maturation long term causes types of
cytopenias including leukopenia, thrombocytopenia and
anemia.3,4
In August 2023, the FDA granted a third indication to
Bristol Myer Squibb’s Reblozyl (luspatercept-aamt) to
treat anemia in adults with lower-risk myelodysplastic
syndromes (LR-MDS) that have not previously used
erythropoiesis stimulating agents (ESA) and who
regularly need red blood cell (RBC) transfusions.1
Reblozyl has been FDA accepted as a first line therapy
for this indiction.5
Reblozyl is an injectable erythroid maturation agent
medication that was previously FDA approved in 2020
for two other indications:
(1) To treat anemia in adults with beta thalassemia who
need red blood cell (RBC) transfusions regularly and
(2) To treat anemia in adults with LR-MDS* who failed
prior treatment with an ESA and require 2+ units of
RBCs over 8 weeks.1,2
The phase 3, open-label randomized controlled trial
“COMMANDS” compared the safety and efficacy of
luspatercept-ammt to epoetin alfa (an ESA medication)
in treating anemia for patients with LR-MDS.6 Red
blood cell transfusion independence (RBC-TI) and
hemoglobin levels increased significantly with the use of
luspatercept in comparison to epoetin alfa, thus showing
advantage of luspatercept over an ESA medication.6
LR-MDS is treated on basis of whether or not the patient
is symptomatic for anemia or will eventually become
symptomatic; asymptomatic patients without signs they
will become symptomatic will not be treated.7 RBC
transfusions are initiated when hemoglobin decreases
considerably or bleeding occurs as these suggest the
possibility of future symptoms, and ESA medications are
initiated when serum erythropoeitin (EPO) is less than or
equal to 500mU/mL. 7 RBC transfusions pose many risks
with chronic use including hypervolemia, transfusion
reactions, excess iron, and others. 7 Epoetin alfa or
darbepoetin alfa, the two ESA medications indicated for
treatment of LR-MDS, may worsen hypertension and it
is recommended to assess thrombotic risk and to monitor
for the development of acute myeloid leukemia while on
these medications. 7
Reblozyl is dosed as 1mg/kg and injected subcutaneously
one time every 3 weeks in a provider’s medical
office/clinic into the upper arm, abdomen, or thigh.8 ESA
medications are injected subcutaneously ranging from
twice per week to every other week depending on the
agent used.7 Warnings for usage of Reblozyl include risk
of thrombosis, worsening hypertension, extramedullary
hematopoietic (EMH) masses, and this medication
should not be used while pregnant.9 It is necessary to
discuss with a healthcare provider in order to determine
which LR-MDS medication(s) would benefit each
individual patient. Reblozyl should be highly considered
to treat LR-MDS as it has efficacious advantages over
ESA medications in reducing the frequency of RBC
transfusions, has been proven relatively safe, and it is
labeled as first line therapy for this indication.
*Myelodysplastic syndrome with ring sideroblasts (MDS-RS) or
myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis
(MDS/MPN-RS-T).
References
1. University of Texas Southwestern Medical Center. (2023). Myelodysplastic Syndrome (MDS).
https://utswmed.org/conditions-treatments/leukemia/myelodysplastic-syndrome-mds/
2. Bristol Myers Squibb. (2023). MDS and anemia: How they work and what you can do. REBLOZYL®
(luspatercept-aamt) Patient Site. https://www.reblozyl.com/mds-rs/about-mds-and-anemia
3. Bristol Myers Squibb. (2023). MDS and anemia: How they work and what you can do. REBLOZYL®
(luspatercept-aamt) Patient Site. https://www.reblozyl.com/mds-rs/about-mds-and-anemia
4. Bristol Myers Squibb. (2023a, August 28). U.S. FDA approves Bristol Myers Squibb’sReblozyl®
(luspatercept-aamt) as first-line treatment of anemia in adults with lower-risk myelodysplastic syndromes
(MDS) who may require transfusions.
https://news.bms.com/news/details/2023/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Reblozyl-luspatercep
t-aamt-as-First-Line-Treatment-of-Anemia-in-Adults-with-Lower-Risk-
5. Myelodysplastic-Syndromes-MDS-Who-May-Require-Transfusions/default.aspx
6. Center for Drug Evaluation and Research. (2020, April 6). FDA approves luspatercept-aamt for anemia in
adults with MDS. U.S. Food and Drug Administration.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-luspatercept-aamt-anemia-
adults-mds
7. Berliner, N., & Roberts, A. (Eds.). (2020). The Commands Trial: A Phase 3 Study of the Efficacy and
Safety of Luspatercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low-, Low-,
or Intermediate-Risk MDS in Erythropoiesis Stimulating Agent-Naive Patients Who Require RBC
Transfusions. The American Society of Hematology , 136(Suplement 1).
https://doi.org/https://doi.org/10.1182/blood-2020-140284
8. Sekeres, M. A., & Platzbecker, U. (2023).Myelodysplastic syndromes/neoplasms (MDS): Management of
hematologic complications in lower-risk MDS. UpToDate. Retrieved September 23, 2023, from
https://www-uptodate-com.lp.hscl.ufl.edu/contents/myelodysplastic-syndromes-neoplasms-mds-manageme
nt-of-hematologic-complications-in-lower-risk-mds?search=LR-MDS&topicRef=5938&source=related_lin
k#references
9. Bristol Myers Squibb. (2023a). Reblozyl U.S. Prescribing Information - BMS.
https://packageinserts.bms.com/pi/pi_reblozyl.pdf
10. Bristol Myers Squibb. (2023a). Reblozyl® (luspatercept-aamt) dosing administration: For HCPS.
Reblozyl® (luspatercept-aamt) . https://www.reblozylpro.com/dosing-administration
18

Biopharma’s AI Revolution Is About
More Than Algorithms
Tasnim Haque
Artificial intelligence (AI) has an impactful potential in the
healthcare industry. However, more times then not, it has been
misunderstood by many, especially with the proliferation of AI
in many other industries and the emergence of ChatGPT. What
is not known is that AI can offer more promise than we think.
With the appropriate supportive framework and circumstances
in place, intelligent tools have the potential to not only
generate data but also significantly enhance diagnostic and
therapeutic decision-making right at the point of care. Because
of the collaboration with pharmaceutical companies, doctors
in different medical fields now have access to decision support
they did not have previously.
On a larger scale, pharma-sponsored AI solutions are
recognized for their ability to analyze large and varied data
sets, such as electronic health record (EHR) and medical
imaging data. This enables us to predict in real-time of
conditions including stroke, heart attack, and rare events that
may not be typically be considered by doctors or otherwise be
looked for.
AI may be the simulation of human intelligence that is
programmed to think and learn like human machines, however
clinicians are still required to take action. This can often be the
most challenging aspect. Consequently, the most effective AI
tools are those that blend the algorithm with care activation,
providing alerts to clinicians and seamlessly integrating care
recommendations into their clinical workflow. When executed
effectively, this dynamic combination can elevate AI beyond
mere analytics and algorithms, turning it into a far more
formidable force.
What is care activation and why is it important? Care
activation, in the context of AI, refers to the process of alerting
and prompting healthcare professionals or clinicians to take
specific actions based on the insights or recommendations
generated by artificial intelligence systems. In healthcare, AI
can analyze patient data and identify potential issues,
treatment options, or care interventions. Care activation
systems ensure that these findings are not just passive
information but actively engage healthcare providers by
alerting them to important information and seamlessly
integrating recommendations into their workflow. This helps
ensure that AI-driven insights lead to appropriate actions and
improvements in patient care.
Physicians involved in diagnosing are very skilled and
dedicated to their patients, but they often find themselves in
situations of excessive workload and overwhelming
responsibilities. Welcoming AI decision support may help to
close the gaps in care. This technology is most valuable in
disease areas where quickly identifying and locating the
disease is crucial for achieving positive outcomes which
includes areas of cardiology, neurology, oncology and even
rare disease, which have seen much traction with AI. In such
situations, the technology's capability to facilitate rapid patient
identification is highly appreciated because it can significantly
impact the success of medical interventions or treatments.
The more healthcare professionals witness the benefits of
using AI algorithms along with activation in clinical settings,
the more they depend on this combination as a helpful tool for
detection. For example, Viz.ai has a proven system for stroke
using their algorithm and activation program, resulting in
shorter hospital stays and reduced disability.1 They have also
gained approval for a program related to a rare heart condition
called hypertrophic cardiomyopathy (HCM). With this
technology, a 74-year-old patient with HCM finally received
the correct diagnosis within three months, even though her
condition had gone undiagnosed for a decade despite
extensive cardiac care. This is just the beginning, especially
for areas that have a need for improved care and early
detection.
Thanks to the collaboration with pharmaceutical companies,
doctors in various medical fields now have access to decision
support they did not have previously. Algorithms combined
with activation represent a powerful partnership capable of
expediting diagnostics and treatments, streamlining clinical
operations, and enhancing patient outcomes. Additionally, this
synergy can open up new opportunities for manufacturers to
explore in terms of market expansion. However, all of this is
meaningless without the role of the health care provider. The
real challenge is can we make AI a seamless process that can
be integrated into the daily workflow without requiring
significant effort to use or learn. In the ever-evolving
symphony of healthcare, AI stands as the conductor of
innovation, orchestrating a harmonious future where precision,
efficiency, and patient well-being take center stage.
References
1. Partner, Q. (2023, September 25). Biopharma’s Ai Revolution is about more than
algorithms. Fierce Pharma. https://www.fiercepharma.com/sponsored/biopharma
-ai-revolution-about-more-al gorithms
19
Pralsetinib: RETribution for
Patients with RET-gene fusion
Non-Small Cell Lung Cancer
Andre Zibner
Lung Cancer remains the leading cause of cancer deaths in the
United States. The incidence of lung cancer remains low in
patients younger than 40 years of age and slowly begins to
peak between ages 65 to 84 years old. In the U.S., the median
age for diagnosis of lung cancer is 71 years old with close to
90% of diagnoses and deaths occurring in patients older than
55 years of age. Non-Small Cell Lung Cancer (NSCLC) and
Small Cell Lung Cancer (SCLC) make up 85% and 15% of
diagnoses for this condition respectively.¹ RET fusions are
present in 1-2% of NSCLC cases, whereas most patients who
have this rearrangement tend to be younger than average and
have little to no smoking history. These RET rearrangements
(malignant genetic mutations) are detected through
comprehensive next-generation sequencing performed on
tumor tissue biopsy.²
Pralsetinib, a highly potent, oral, central nervous
system-penetrant, selective RET inhibitor was granted
accelerated approval for patients with metastatic RET gene
fusion-positive NSLC in September 2022, and more recently
was granted regular approval on August 9, 2023.³ Pralsetinib
is an oral tyrosine kinase inhibitor that selectively targets
oncogenic RET fusions, including V804 gatekeeper mutations
usually associated with resistance to multikinase inhibitors.⁴
ARROW, a multi-cohort, open-label study including adults
with locally advanced or metastatic solid tumors and an
Eastern Cooperative Oncology Group (ECOG) performance
status of 0-2, that spanned 71 sites in 13 countries, found that
Pralsetinib in 233 patients with RET-fusion positive NSCLC,
regardless of previous therapy, was well tolerated and showed
significant clinical activity.⁴A response rate of 61% was seen
in patients who had received previous platinum chemotherapy,
including 6% experiencing complete response, and 70% in
treatment-naive patients who were not candidates for standard
therapies.⁴ In an update to the ARROW trial, a more recent
study found that Pralsetinib produced an overall response rate
(ORR) (proportion of patients whose tumor is destroyed or
significantly reduced by the drug), of 72% in treatment-naive
patients with RET fusion-positive NSCLC, a remarkable
result, supporting use as a first-line agent in this setting.⁴
Until recently, there have been no specific guidelines for the
frontline treatment of RET-fusion positive NSCLC. Standard
platinum-based chemotherapy in the NSCLC setting is
associated with a moderate response rate and Short
Progression Free Survival (PFS).⁵ Immune checkpoint
inhibitor monotherapy or in combination with platinum-based
chemotherapy, although improving ORR in patients with no
actionable oncogenic mutations, provides poor ORR and PFS
for patients with RET-fusion positive NSLC.⁵ Along with data
from Selpercatinib (another RET gene fusion targeted TKI for
NSCLC), the clinical activity observed with Pralsetinib in
treatment-naive patients with RET-fusion positive NSCLC
further supports first-line use of selective RET inhibitors in
this patient population.⁵ The recommended dose of Pralsetinib
is 400mg orally once daily on an empty stomach (no food
intake for 2 hours before and 1 hour after). The most common
adverse reactions include musculoskeletal pain, constipation,
diarrhea, fatigue, pyrexia, cough, and similarly to other RET
inhibitors, may cause hypertension due to cross inhibition of
VEGF.⁶
Ongoing phase III AcceleRET Lung and LIBRETTO-431
studies will evaluate the effectiveness and safety of pralsetinib
and selpercatinib, respectively, versus standard of care in
treatment-naive advanced/metastatic RET fusion–positive
NSCLC.⁵ To reiterate, the results seen in recent trials provide
promising ramifications for patients with genetically targetable
RET-NSCLC. With recent Food and Drug Administration
(FDA) approval for this indication, and as the only once-daily
therapy designed to selectively target RET, it may provide
ample reason to inform healthcare decisions and use this agent
as a first-line treatment.⁵
References
1. Duma N, Santana-Davila R, Molina JR. Non-Small Cell Lung Cancer: Epidemiology, Screening,
Diagnosis, and Treatment. Mayo Clin Proc. 2019 Aug;94(8):1623-1640. doi:
10.1016/j.mayocp.2019.01.013. PMID: 31378236.
2. American Lung Association. (n.d.). RET and Lung Cancer.
https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-di
agnosis/biomarker-testing/ret
3. Research, C. F. D. E. A. (2023). FDA approves pralsetinib for non-small cell lung cancer with RET gene
fusions. U.S. Food And Drug Administration.
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pralsetinib-non-s
mall-cell-lung-cancer-ret-gene-fusions
4. Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, Doebele RC, Cassier PA, Lopes G, Tan
DSW, Garralda E, Paz-Ares LG, Cho BC, Gadgeel SM, Thomas M, Liu SV, Taylor MH, Mansfield AS,
Zhu VW, Clifford C, Zhang H, Palmer M, Green J, Turner CD, Subbiah V. Pralsetinib for RET
fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet
Oncol. 2021 Jul;22(7):959-969. doi: 10.1016/S1470-2045(21)00247-3. Epub 2021 Jun 9. Erratum in:
Lancet Oncol. 2021 Aug;22(8):e347. PMID: 34118197.
5. Griesinger F, Curigliano G, Thomas M, Subbiah V, Baik CS, Tan DSW, Lee DH, Misch D, Garralda E, Kim
DW, van der Wekken AJ, Gainor JF, Paz-Ares L, Liu SV, Kalemkerian GP, Houvras Y, Bowles DW,
Mansfield AS, Lin JJ, Smoljanovic V, Rahman A, Kong S, Zalutskaya A, Louie-Gao M, Boral AL,
Mazières J. Safety and efficacy of pralsetinib in RET fusion-positive non-small-cell lung cancer including
as first-line therapy: update from the ARROW trial. Ann Oncol. 2022 Nov;33(11):1168-1178. doi:
10.1016/j.annonc.2022.08.002. Epub 2022 Aug 13. PMID: 35973665.
6. Prescribing information | GAVRETO® (pralsetinib). (n.d.-b). Gavreto.
https://www.gavreto-hcp.com/?adobe_mc=MCMID%3D31358552983418306853500036
582011783782%7CMCORGID%3DDF784CF658BD66380A495D3E%2540AdobeOrg
%7CTS%3D1696019904
20
Empowering Access: How
Pharmacies Are Redefining Birth
Control Access
Tamia Thomas
In recent years, a significant shift has occurred that
grants pharmacists the right to prescribe contraceptives.
This change to allow pharmacist’s prescriptive authority
comes with both support and hesitation, and discussion
has sparked within the nation surrounding reproductive
access. As of right now, 24 states have embraced this
change and allow pharmacists to prescribe
self-administered hormonal birth control such as pills,
patches, vaginal rings, and injections. Although, some
states have not followed this new policy; in action it is
expected to allow women to plan their pregnancies and
reduce unintended pregnancies. As seen in Oregon, after
this protocol was implemented, the policy prevented an
estimated 51 unintended pregnancies and saved the state
$1.6 million.1
Pharmacists are often viewed as the most accessible
health care professionals, and they play a pivotal role in
the medication management of patients. The extensive
training pharmacists receive in pharmacology, drug
interactions and management aid them with the
confidence to make informed decisions on prescribing
contraceptives. In a survey response, the majority of
women believed pharmacists have the knowledge and
skills to prescribe birth control in a pharmacy setting.2
With this shift in their scope of practice they will
perform comprehensive patient assessments and review
patient histories before figuring out a patient’s
contraceptive needs.
A compelling reason behind this policy is the increased
accessibility that it will offer to reproductive healthcare.
Research from states that have already implemented this
plan suggests pharmacist prescribing fills a gap as
women receiving contraception from a pharmacist were
more likely to be younger, uninsured and have less
education than women seeing clinicians.3 Traditionally,
pharmacies are widespread and open longer than
healthcare provider offices which makes it easier for
individuals to seek advice, receive counseling and obtain
contraceptives. Patients will hopefully be able to
schedule appointments more conveniently with a
pharmacist and reduce barriers to access. The
requirement of a prescription can be an obstacle for
many women, but pharmacists having the ability to
prescribe birth control nationwide will increase access as
nine out of ten Americans live within five miles of a
community pharmacy.4
Furthermore, this could potentially empower individuals
to take control of their own reproductive health! Many
screenings done at a gynecologist office such as pelvic
exams, cervical cancer screening and sexually
transmitted infection screening are not necessary to
begin hormonal contraception. Studies have shown that
women are capable of completing a self-screening tool
to determine a patient’s eligibility or risk factors before a
pharmacist initiates discussion.5 Women across the
country will be able to make informed decisions
regarding effective family planning and reduction in
unplanned pregnancies.
In sum, the decision to allow pharmacists to prescribe
contraceptives in states has brought about positive
changes in reproductive healthcare. The scope of
practice for pharmacists will be expanded with the goal
of making significant strides in reducing unplanned
pregnancies and improving patient autonomy. With the
hope that the majority of states will be moving towards
this progressive approach, women have more options for
convenient, timely, and informed family planning.
Pharmacist prescribed contraceptives are a pivotal
advancement in reproductive healthcare access, and this
approach has the potential to guide the United States
towards a future where reproductive healthcare is a right,
not a privilege.
References
1. Director, S. N. A., Nadeau, S., Director, A., Shepherd, Director, M., Shepherd, M.,
Director, Director, E. L. A., Lofgren, E., Jones, K. B., Cohen, A., Kogan, B., McConville,
D., & Truong, T. Q. (2023, February 28). Advancing contraception access in states
through expanded pharmacist prescribing. Center for American Progress.
2. (2022, December 5). Pharmacists can now prescribe hormonal birth control in 20 states.
ASHP.
https://news.ashp.org/news/ashp-news/2022/12/05/pharmacists-can-now-prescribe-hormo
nal-birth-control-in-20-states?loginreturnUrl=SSOCheckOnly
3. A visual representation of pharmacist prescribing. Power to Decide. (2021, December 9).
https://powertodecide.org/what-we-do/information/resource-library/visual-representation
pharmacist-prescribing
4. Berenbrock, L. (2022, July 12). Access to Community Pharmacies: A nationwide
geographic information. JAPhA.
https://www.japha.org/article/S1544-3191(22)002333/fulltext
5. The American College of Obstetricians and Gynecologists. (2012). Over-the-counter
access to hormonal contraception. ACOG.
https://www.acog.org/en/Clinical/Clinical%20Guidance/Committee%20Opinion/Articles/
2019/10/Over-the-Counter%20Access%20to%20Hormonal%20Contraception
21
About the Organization
The Student Society of Health-System Pharmacists
(SSHP) is the student branch of FSHP (state) and ASHP
(national). SSHP’s mission is to educate and develop
student pharmacists to become innovators, leaders, and
passionate providers. SSHP creates and molds future
professionals that are capable of reaching their potential,
which will maximize their patient care.
As an organization, we hope to spark interest in different
areas of health-systems pharmacy within our members.
We achieve this goal by hosting guest speakers who
work in clinical pharmacy practice at our monthly
meetings. This allows our members the opportunity to
find out more about clinical practice, pharmacy
residency, and engage in Q&A sessions. Outside of
meetings, we offer our members opportunities such as
engaging with the community through volunteer service,
participating in mock pharmacy practice scenarios, and
writing for the Quarterly Capsule periodical, amongst
many other activities. We provide an environment where
students can put their pharmacy knowledge to the test in
a broad and constructive manner, in order to prepare
them for health-system pharmacies.
Editor’s Note
Thank you for reading this season’s edition of the
Quarterly Capsule! 1st, 2nd, and 3rd year pharmacy
students from the University of Florida College of
Pharmacy worked effortlessly to find a topic they were
passionate about and write an article here. This edition
we had 24 pharmacy student authors this season, which
was a significant increase in authors from the previous 2
editions (11 for Spring 2023 and 12 for Fall 2022).
It has been inspiring reading and editing each and every
one of these articles. SSHP and I would like to thank you
for reading the Fall 2023 Quarterly Capsule Newsletter,
and we also thank the student authors for their
commitment to up-and-coming events and discoveries in
pharmacy!
Heather Reiss -
Quarterly Capsule Editor-in-Chief
22