TABLE OF CONTENTS

Leqembi: Approved for Alzheimer’s Disease

Treatment 2
FDA Approval of Over the Counter Naloxone Nasal
Spray 2
How to Compete and Succeed at the SSHP Clinical Skills
Competition 3
Supported and Unsupported Drug Price Increases 4
A December to Remember 5
Personalized Medicine Meets Antidepressants: A New
Dream Team? 6
A New Tool in the Substance Abuse Disorder Toolbelt:
Fentanyl Vaccine 7
Hospital Internship Experience: Sarasota Memorial
Hospital 7
Poliomyelitis - Making a Comeback? 8
Not Your Traditional Receptor Drug
Target – Sigma-1 10
Quarterly Capsule Word Search 12
About the Organization 13

1
Leqembi: Approved for Alzheimer’s
Disease Treatment
Stephanie Mourino
As of January 2023, the FDA granted accelerated
approval of Leqembi (lecanemab-irmb), classifying it as
second in the new monoclonal antibody category for
the treatment of Alzheimer’s Disease, the first being
Aduhelm (aducanumab).1 This treatment is indicated in
individuals diagnosed with early Alzheimer’s with mild
cognitive impairment and confirmation of elevated
beta-amyloid plaques.
Alzheimer’s disease is the most common
neurodegenerative disease and is the 6th leading cause
of death among US adults, affecting as many as 5.8
million Americans.2 It is a progressive brain disorder that
affects cognition, memory, and behavior, eventually
interfering with daily activities. Although the main cause
of Alzheimer’s is not fully understood, scientists believe
plaques, which are beta-amyloid protein deposits that
build up in spaces between nerve cells, and tangles,
which are twisted fibers of tau protein that build up
inside cells, play a major role in damaging and killing
nerve cells.2 Like Aduhelm, Leqembi targets
beta-amyloid located in the brain and removes it, which
helps to reduce the plaque size, and slows the cognitive
and functional decline in individuals with Alzheimer’s.
This allows the individual to be independent and
partake in their daily activities.
A randomized, multi-center, double-blind, phase 3 trial
was conducted for 18-months to study the effects
Leqembi had on cognition and function compared to
placebo.3 The trial analyzed the effects of Leqembi in
individuals with early Alzheimer’s disease and was not
tested in individuals with more advanced stages of
Alzheimer’s or those without clinical symptoms.
Participants in the treatment group received 10 mg/kg
every 2 weeks. As a result, there was moderately less
decline on measures of cognition and function, and
reduced markers of beta-amyloid than those in the
placebo group.3
For the treatment of Alzheimer’s disease, the
recommended dosage for Leqembi is 10 mg/kg and it
must be diluted before administration.4 The treatment is
then administered as an IV infusion, lasting between
45-60 minutes, once every two weeks. A brain MRI must
be obtained, within one year prior to initiating
treatment, to evaluate for any pre-existing Amyloid
Related Imaging Abnormalities (ARIA).4 It is
recommended to obtain an MRI prior to the 5th, 7th,
and 14th infusions and to remain vigilant for ARIA
during the first 14 weeks of treatment with Leqembi.
Clinical evaluation should be obtained for patients
experiencing symptoms suggestive of ARIA, such as
headache, confusion, dizziness, and nausea. Common
adverse effects of Leqembi are infusion-related
reactions, headaches, and ARIA-edema.4
Overall, the addition of Leqembi has given clinicians
another effective option in the treatment of Alzheimer’s
disease. It targets the potential underlying biological
cause of Alzheimer’s, whereas traditional/mainstream
pharmacotherapy, such as donepezil and memantine,
exclusively treat cognitive symptoms. The high cost of
the medication may be a barrier to patient accessibility
and should be a consideration for future use.
References:
1. Grant, A. (2023, January 06). FDA Grants Accelerated Approval for Alzheimer’s Disease
Treatment. U.S. Food and Drug Administration. Retrieved February 1, 2023, from
https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approv
al-alzheimers-disease-treatment
2. What is Alzheimer’s Disease? Alzheimer’s Association. Retrieved February 16, 2023, from
https://www.alz.org/alzheimers-dementia/what-is-alzheimers
3. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer's Disease. N Engl J
Med. 2023;388(1):9-21. https://doi.org/10.1056/NEJMoa2212948
4. Leqembi. Package Insert. Eisai Inc. and Biogen. 2023, from
https://www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf?hash=3d
7bf1a2-5db2-4990-8388-81086f415676.
FDA Approval of Over the Counter
Naloxone Nasal Spray
Almina Gomez
Narcan, a 4 mg naloxone hydrochloride nasal spray, is a
life-saving medication that has been approved for
over-the-counter (OTC), non-prescription use by the U.S.
Food and Drug Administration (FDA). It was initially
approved for prescription use in 2015 but has since
undergone an extensive process to receive OTC
approval. Naloxone’s manufacturer provided data
showing the safety and efficacy of its use as directed in
its proposed labeling and showed that consumers can
understand how to use the drug without the supervision
2
of a healthcare provider. Ultimately, approval of patient populations.3 Despite this, naloxone’s approval
naloxone for OTC use was granted priority review status OTC will undoubtedly save lives moving forward.
and was unanimously voted in for use without a
prescription. This approval is recognized as a “landmark
approval” as naloxone is essential in combating the
opioid epidemic affecting the U.S today.1 Its approval for
OTC use will increase its accessibility tremendously, and
will allow for not only first responders, but also friends,
family, and other bystanders to save lives.2

The opioid epidemic has led to countless opioid-related

deaths in the U.S. since the early 1990s. Just in a
12-month period ending October 2022, the CDC
reported 101,751 fatal overdoses.3 These deaths are
driven largely by synthetic opioids, such as illicit
fentanyl, which in some cases are up to 10,000 times
more potent than morphine.4 Overdose can be
characterized by pinpoint pupils, loss of consciousness, References:
1. FDA approves first over-the-counter naloxone nasal spray. U.S. Food and Drug
bluish lips, and respiratory failure that may lead to Administration.
death.4 In the event of an overdose, naloxone is https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-count
er- naloxone-nasal-spray. Published March 29, 2023. Accessed April 6, 2023.
essential to reverse the effect of the opioid and restore 2. NIDA. Naloxone for Opioid Overdose: Life-Saving Science. National Institute on Drug
Abuse website.
normal breathing and consciousness in patients http://nida.nih.gov/publications/naloxone-opioid-overdose-life-saving-science. March
30, 2017 Accessed April 7, 2023.
affected. 3. Hernandez J. The FDA approves the overdose-reversing drug narcan for over-the-counter
sales. NPR.
https://www.npr.org/2023/03/29/1166750095/narcan-fda-approval-naloxone-over-the-
counter-otc. Published March 29, 2023. Accessed April 7, 2023.
Naloxone acts as an antagonist at the opioid receptor, 4. Lifesaving naloxone. Centers for Disease Control and Prevention.
https://www.cdc.gov/stopoverdose/naloxone/index.html. Published January 25, 2023.
meaning it binds to the same receptor as opioids and Accessed April 7, 2023.
blocks their effects. As a result, the opioid overdose can
be rapidly reversed, and normal breathing can be
restored.2 Naloxone is considered a safe drug with no
evidence of significant adverse effects. Although
administration of the drug can cause opioid withdrawal
How to Compete and Succeed at the
symptoms in those recovering from an overdose, the SSHP Clinical Skills Competition
discomfort is not life threatening, and the life-saving
benefits outweigh the risks.2 Additionally, naloxone has Cheryl Wood
no harmful effect on a patient if given in the absence of
For the last 3 years, Melissa Cuevas and I have
overdose, making it an ideal treatment for opioid
competed in SSHP’s Clinical Skills Competition as a
overdose.2
team, or as we call it “the dynamic duo”. As a 1PD, I
volunteered for the event which allowed me to see how
Before OTC approval, access to naloxone came with
it was run: teams of 2 receive a case and work up the
significant barriers such as inability to see a doctor, cost,
patient over 2 hours, and then present their assessment
stigma, or general distrust of healthcare providers.
and plan to the panel of judges. As 2PDs, we were faced
These barriers prevented many people from receiving
with a patient with an NSTEMI before we had even
this life-saving medication in time. The new FDA
gotten to cardiac emergencies in Patient Care 3, so we
approval has addressed this by increasing accessibility of
used our clinical resources to put together the best plan
naloxone. Patients can now purchase the medication
that we could for our patient. As 3PDs, I joked before
with no worry of stigma or burden of multiple doctors
opening the case that I hoped it was a “brain case”
appointments. While this change is significant, overdose
despite the fact we hadn’t officially learned neurology.
prevention advocates warn that cost may still be a
Naturally, the case was about a newborn with viral
barrier for patients purchasing over the counter. In the
meningitis: a brain case with a pediatric twist to suit
years to come, it will be necessary to advocate for
Melissa’s pediatric interests. This year, having completed
lower-cost and increased accessibility of naloxone for all
the PharmD didactic curriculum and several APPE
rotations, we were ready! We were able to redeem our
3
2PD selves with a case about an NSTEMI in a patient
with heart failure and diabetes. As always, we made a
list of patient problems and split them according to our
strengths. We ended up as the second-place overall
finishers in the tri-campus competition, behind Jade
Nanan and Charles Burke who represented UFCOP at
the ASHP Midyear conference.
In a few short weeks, Melissa and I will be graduating,
so I wanted to share some advice for the upcoming
Orlando Clinical Skills Competition competitors. First, I’d
recommend competing with someone you have worked
with before. Melissa and I made a very strong team
because we knew each other’s strengths and played our
strategy with those in mind. For instance, Melissa is very
good at the details while I am great at looking at the
whole picture. Do you need someone to tell you in
intricate detail the dosing regimen for neonatal
abstinence syndrome? Melissa is likely your best
resource. However, if you need someone to recognize
missing medications, vaccinations, or the need for
smoking cessation, I’ll be ready.
While playing to each other’s strengths is important, a
large portion of the rubric is prioritizing your problems
correctly. It is better to think a problem is more
important than it is, but you can only have one #1
priority problem. Within the first 15 minutes of each
patient case, we would read over the case and identify
any problems we could find. Then, we would prioritize
them together. To identify our #1 problem, we would
ask ourselves, “which of these will kill the patient first?”.
It seems like a simple question, but it’s an important
one. An HbA1c of 15% won’t kill the patient tomorrow,
but a serum glucose of 40 mg/dL might kill the patient
today. By working as a team to prioritize your problems,
you will present as a united front to the judges.
Finally, it is important to take some time to determine
how you will present the case to the judges. The
follow-up questions in the judge’s panel often come
directly from your case presentation, so it is important
to be concise, thorough, and accurate. Make sure you
list all the patient’s disease states and clearly indicate
your #1 priority problem. Finally, you should only
present the plan for the #1 priority problem, so do not
waste time talking about the details of the other
problems unless the judges ask about them.
I am confident that the Orlando campus has the
potential to produce the next Clinical Skills competition
tri-campus winner, and I wish you all the very best as
you develop into clinicians through all the wonderful
opportunities provided to you by the Orlando campus
chapter of SSHP!
Supported and Unsupported Drug
Price Increases
Ashley Stultz
On December 6th, 2022, the Institute for Clinical and
Economic Review (ICER) published its yearly,
“Unsupported Price Increases Report” concerning drug
price increases in 2021 in the United States (US).
Narrowed down from a list of 250 drugs, the report
found three drugs with price increases supported by
clinical evidence and seven drugs with price increases
unsupported by clinical evidence.
ICER is a nonprofit research organization that aims to
evaluate all available evidence to help align a
treatment’s price with how well it improves the lives of
patients.1 In 2019, ICER started publishing its yearly
report to determine whether the pricing of the top
revenue-generating drugs in the US are “supported by
clinical evidence” or “unsupported by clinical evidence.”
Supported by clinical evidence was defined as, “[drugs
with] new clinical evidence in the prior two years that
demonstrated ‘moderate/high-quality new evidence or
analyses of a substantial improvement in net health
benefit compared with what was previously believed.’”
Unsupported by clinical evidence is defined as, “drugs
that have no new evidence or analyses,” or not meeting
the criteria mentioned above.2 ICER gave each
manufacturer the opportunity to respond to ICER’s
available evidence to justify the price increases and
included their responses in the final report.
4
Using data provided by SSR Health LLC, an independent
research firm, ICER narrowed down a list of the top 250
drugs with the highest revenue in 2021 in the US to a list
of 10 drugs. ICER’s method utilized a five-step process.
The first four steps resulted in 10 final drugs to be
reviewed via a fifth step to evaluate clinical evidence
amongst the remaining drugs. The four steps in
sequential order are as follows: 1) identify prescription
drugs with the largest net sales revenue in 2021; 2)
exclude drugs whose wholesale acquisition cost (WAC)
was not more than 2% greater than the increase in the
medical consumer price index (CPI); 3) estimate the
increase in spending due to increases in net price as
opposed to increases in volume; 4) confirm pricing data
from manufacturer input, and apply corrections.3 For
the fifth and final step, ICER determined if there was any
substantial clinical evidence that had been published
from January 2020 to December 2021. Consequently,
ICER concluded that out of the 10 remaining drugs,
three had price increases backed by new evidence,
whereas seven had price increases unsupported by new
evidence.
The three drugs with price increases backed by new
evidence included Cosentyx (Secukinumab, Novartis), a
human interleukin-17a antagonist; Tremfya
(Guselkumab, Janssen), an interleukin-23 blocker; and
Jakafi (Ruxolitinib, Incyte), a kinase inhibitor. Conversely,
the seven drugs with price increases not backed by new
evidence include Xifaxan (Rifaximin, Bausch Health), a
rifamycin antibacterial; Invega Sustenna/Invega Trinza
(Paliperidone, Janssen), a long-acting antipsychotic;
Prolia (Denosumab, Amgen), a monoclonal antibody;
Entyvio (Vedolizumab, Takeda), a humanized
monoclonal antibody; Promacta (Eltrombopag,
Novartis), a small molecule thrombopoietin receptor
agonist; Rexulti (Brexpiprazole, Otsuka), an atypical
antipsychotic; and Lupron (Leuprolide, AbbVie), a
gonadotropin-releasing hormone agonist.
Unlike past reports, ICER added a new section with the
purpose of highlighting therapies from Medicare B with
the highest increases in total population-based spending
by the Centers for Medicare and Medicaid Services
(CMS) from 2019-2020 due to increases in unit prices.2
Concerns regarding list price changes greatly affecting
patients were brought to ICER by patient groups. The
three therapies ICER highlighted include Somatuline
Depot (Lanreotide, Ipsen), a somatostatin analog;
Adcetris (Brentuximab Vedotin, Seagen), a monoclonal
antibody; and Krystexxa (Pegloticase, Horizon
Therapeutics), a PEGylated uric acid specific enzyme. All
three therapies were concluded to have price increases
unsupported by clinical evidence.
In September 2022, the Assistant Secretary for Planning
and Evaluation (ASPE) issued a brief to the Department
of Health & Human Services (HHS) on prescription drug
spending from 2016-2021 and reported that spending
on prescription drugs has increased due to growth in
spending per prescription, not because there were more
prescriptions.4 Recent legislation, such as the Inflation
Reduction Act, has attempted to combat rising drug
prices.
References:
1. About us: Institute for clinical & economic review. ICER. https://icer.org/who-we-are/.
Published September 13, 2022.
2. Unsupported price increases occurring in 2021. ICER.
https://icer.org/assessment/upi-2022/#timeline. Published December 6, 2022.
3. Unsupported price increase assessment.
https://icer.org/wp-content/uploads/2022/04/ICER_UPI_2022_National_Protocol_0414
22.pdf. Published April 14, 2022.
4. Parasrampuria S, Murphy S. Trends in prescription drug spending, 2016-2021. ASPE.
https://aspe.hhs.gov/reports/trends-prescription-drug-spending. Published September
30, 2022.
A December to Remember
Talia LaSpina
Tens of thousands of pharmacists, from all over the
world, gathered all in one place to attend the year’s
most anticipated event. ASHP Midyear is full of
networking, leadership seminars, continuing education
courses and poster presentations. Everyone meets here
with the main intention to improve patient care. After
attending a few seminars and speaking with some
residency programs, I obtained some insight on the
fields of pharmacy that I want to spend my life as a
pharmacist practicing in. I learned how to be an
advocate for my patients and to provide the best care
possible. Events, such as this one, amplifies the
perspective of what a pharmacist is and how we can be
a huge and impactful member of the healthcare team.
Attending this conference as a 3rd year pharmacy
student was the best decision, because there is a ton to
take in and much to do. Doing this before applying for
residency taught me many pearls to carry with me,
which will help me navigate it as a 4th year student to
get the most out of the plethora of opportunities. There
were so many networking opportunities that I was not
able to reach them all due to poor planning. When
booking my trip for the 2023 season, I will now have a
laid-out plan to best take advantage of everything I want
5
to attend, and meet all of the programs that I plan on
applying to. Being around professionals and pharmacy
student peers showed me the number of opportunities
and different career paths available to take with a
PharmD degree.
Going into this conference, I had prepared a poster
presentation, and was told by many people that there
would not be many viewers coming by to see the
posters; that I would only talk to 1-2 people. I was
shocked and very excited when in the 1 hour of
presenting all my hard years' worth of work, there were
many people interested in vitamin C’s place in reducing
the occurrence of methemoglobinemia. Creating this
poster was one of the most beneficial things that I have
done in my time at the UF College of Pharmacy. It has
set me up for success in residency, as posters are a
common event done during residency years. This poster
presentation solidified the importance of conducting
research, the applicability to and interest from many
professionals in the field, and how many people are
impacted by such a rare disease occurrence. ASHP
Midyear in Las Vegas was an experience to be reckoned
with.
Personalized Medicine Meets
Antidepressants: A New Dream Team?
Gisselle Halabi-Molli and Makenzee Smith
Pharmacogenomics is on the rise to revolutionize
patient-centered care. By coordinating an individual’s
genetic makeup with drug effectiveness and toxicity,
personalized medicine can assess the impact of genetic
variation on drug response.1 This, in turn, enhances
establishing a safe and efficacious medication regimen
to prevent adverse events and optimize patient
outcomes.
One area in which personalized-medicine can be
beneficial is antidepressants as first-line treatments for
depressive disorders. Commonly, patients fail to notice
positive response to antidepressants on their initial
regimen due to inappropriately selected treatment,
accompanying mental health disorders, or changes in
drug metabolism.2 “Remission occurs in only one-third
of the patients after a trial with an adequately dosed
single drug, and remission rates further decline
following successive treatment failures”.3 This
demonstrates an opportunity to utilize
pharmacogenomics to personalize antidepressant
therapy.
Drug transporters such as efflux pumps play a major role
in reaching physiological targets, such as the central
nervous system, which potentially explains the
phenomenon of lack-of-response to antidepressants in
certain individuals. Specifically, the ABCB1 gene (or
MDR1) encodes for the efflux pump product
P-glycoprotein (P-gp), which regulates various
compounds passing through the blood brain barrier. The
P-gp transporter has an extended responsibility to
maintain therapeutic and nontoxic concentrations in the
brain to achieve clinical response.3 ABCB1 is a highly
polymorphic gene, meaning there is high potential for
variances called single-nucleotide polymorphisms
(SNPs), which influence the level of expression and
function of the transporter. This showcases why it is an
“important source in inter-individual variability in
pharmacokinetics and pharmacodynamics” in
psychiatric drugs.1,2
Efficacy of antidepressants that use the
ABCB1-transporter to cross the blood-brain barrier can
be affected by patients’ ABCB1 genotype. While
studying patients with recurrent depressive disorder,
Jeleń et al. uses the Hamilton Depression Rating Scale to
assess patients’ depression symptoms.2 They identified
three SNPs that were significantly associated with lower
response to antidepressant therapy: C1236T, G2677T/A,
and C3435T. However, more research needs to be done
to determine the functional implications of these
mutations.
Nevertheless, these polymorphisms may still have
important implications on clinical outcomes. In addition
to declined response to therapy, these SNPs were
associated with more fatal drug intoxications involving
venlafaxine.4 These findings show that the ABCB1
transporter mutations might have an important role in
antidepressant efficacy and toxicities. Currently, there
are no clinical dosing guidelines for antidepressant
therapies based on ABCB1 genotype. More research
should be executed in order to properly guide treatment
decisions and optimize patient response to therapy.
6
 antibodies which were able to neutralize
antinociception and decrease the level of fentanyl in the
References: brain. Additionally, the physiological effects, such as
1. T P, A., M, S. S., Jose, A., Chandran, L., & Zachariah, S. M. (2009). Pharmacogenomics: the
right drug to the right person. Journal of clinical medicine research, 1(4), 191–194. respiratory depression, were completely blocked by the
https://doi.org/10.4021/jocmr2009.08.1255
2. Jeleń, A., Świechowski, R., Żebrowska-Nawrocka, M., Sałagacka-Kubiak, A., vaccine. This vaccine is specific to fentanyl and does not
Szmajda-Krygier, D., Gałecki, P., & Balcerczak, E. (2023). Importance of selected ABCB1
SNPs for the level of severity of depressive symptoms and effectiveness of recurrent
react with other opioids. However, this study displayed
depressive disorder therapy.
https://doi.org/10.1016/j.gene.2022.147021
Gene, 851, 147021. differences among female and male rats. The male rats
3. Uhr, M., Tontsch, A., Namendorf, C., Ripke, S., Lucae, S., Ising, M., Dose, T., Ebinger, M., had a higher effectiveness rate than female rats. Despite
Rosenhagen, M., Kohli, M., Kloiber, S., Salyakina, D., Bettecken, T., Specht, M., Pütz, B.,
Binder, E. B., Müller-Myhsok, B., & Holsboer, F. (2008). Polymorphisms in the drug the differences, this study is promising.2 This trial may
transporter gene ABCB1 predict antidepressant treatment response in depression.
Neuron, 57(2), 203–209. https://doi.org/10.1016/j.neuron.2007.11.017 push researchers along to start clinical trials in humans
4. Karlsson, L., Green, H., Zackrisson, A. L., Bengtsson, F., Jakobsen Falk, I., Carlsson, B.,
Ahlner, J., & Kugelberg, F. C. (2013). ABCB1 gene polymorphisms are associated with in order to find a breakthrough adjuvant treatment in
fatal intoxications involving venlafaxine but not citalopram. International journal of legal
medicine, 127(3), 579–586. https://doi.org/10.1007/s00414-013-0849-0
opioid use disorder. With the number of opioid
overdoses on the rise, this vaccine is a major topic of
interest since it could potentially allow an addicted user
a second chance at life, if it works to block the
physiological side effects of fentanyl.
A New Tool in the Substance Abuse
Disorder Toolbelt: Fentanyl Vaccine Fentanyl has taken so many lives that the DEA has
worked to create an exhibit called “The Faces of
Hollyann Brown Fentanyl”. This exhibit allows loved ones to
commemorate lives lost to fentanyl overdose. If you
The opioid epidemic has been ongoing since 1999. In
have a loved one that you would like to commemorate,
the 24 years since then, we have seen 3 different trends.
you can send their name, age, and photograph to
Trend 1 involved an increase in the amount of
fentanylawareness@dea.gov or post a photo to social
prescription overdose deaths. This was the first clue to
media with the hashtag #JustKNOW.3 Furthermore,
the dangerous nature of these drugs. Trend 2 involved a
Fentanyl Awareness Day was recognized for the first
rise in heroin overdose deaths. This trend was indirectly
time in 2022 to educate individuals about the dangers of
related to the decrease in prescription opioid
fentanyl. In the coming years, a vaccine of this nature
availability, driving addicted individuals to heroin.
may allow us to change the fate of many.
Finally, trend 3 involved a rise in synthetic opioid
overdose deaths. A sharp incline in synthetic opioid
overdose deaths began in 2013, with a major spike in References:
2020.1 1. CDC. Understanding the Epidemic | CDC’s Response to the Opioid Overdose Epidemic |
CDC. www.cdc.gov. Published June 17, 2021.
https://www.cdc.gov/opioids/basics/epidemic.html
2. Haile CN, Baker MD, Sanchez SA, Lopez Arteaga CA, Duddupudi AL, Cuny GD, Norton EB,
These opioid overdose deaths particularly involve Kosten TR, Kosten TA. An Immunconjugate Vaccine Alters Distribution and Reduces the
Antinociceptive, Behavioral and Physiological Effects of Fentanyl in Male and Female
fentanyl, a synthetic opioid that is up to 100 times more Rats. Pharmaceutics. 2022; 14(11):2290.
https://doi.org/10.3390/pharmaceutics14112290
potent than morphine. Fentanyl is illicitly manufactured 3. Erowid. Erowid.org. Published 2019. https://www.erowid.org/
4. DEA. Fentanyl Awareness. www.dea.gov. Published 2022.
and found in combination with marijuana, heroin, https://www.dea.gov/fentanylawareness
counterfeit pills, and cocaine. A nonprofit organization,
Erowid Center, tests drugs bought on the street to bring
awareness to the fact that many drugs sold on the street
are not what they are portrayed to be.4 The fact is these
illicit drugs are continuing to be sold and they are
Hospital Internship Experience:
contributing to the high amount of overdose deaths. Sarasota Memorial Hospital
Luckily, some doctors are working on strategies to
decrease the number of overdoses and addiction. Sierra Parsons

A recent study shows the development of an I have worked in a hospital internship at Sarasota
immunoconjugate vaccine that reduces the effects of Memorial Hospital since my 1st year of pharmacy school.
fentanyl and alters its distribution. This is a preliminary The experience has been nothing short of rewarding
study proving the differences in the effects of fentanyl in and one of the best learning environments for
vaccinated and unvaccinated female and male rats. This pharmacy students. My internship is dynamic, and job
study showed that rats produced anti-fentanyl duties progress as students progress through pharmacy
7
school. As a 1st year student, interns will focus on
medication dispensing, central distribution, sterile
compounding preparation, medication safety and
regulatory requirements. Interns will become proficient
in Pyxis machine utilization and in the IV room.
Additionally, interns can work with central pharmacists
and even assist nurses with medication needs.
As 2nd year students, interns will become skilled in
medication histories and reconciliations. Interns will be
a vital part of direct patient care and use patient
interviews to obtain a current, complete, and accurate
medication list, focusing on adherence and drug allergy
information. I completed over 150 medication histories
as a 2nd year intern and was able to use my interviewing
skills to help an older patient escape a neglectful home
situation.
As 3rd and 4th year students, interns will focus on clinical
consult management and services relating to the
appropriate use of medications following hospital
protocols and guidelines. Interns will become
experienced in several different clinical consults, such as
patient weight alerts, renal alerts, electrolyte alerts, IV
to PO conversions, non-formulary medication
management, patient’s own medication management,
carbidopa-levodopa follow-ups, and alcohol withdrawal
follow-ups. My favorite consult so far is renal alerts,
which require you to evaluate the patient’s renal
function, and all their medications, to ensure the proper
doses for their renal function. Interns will also have
other unique experiences such as helping with
toxicology and interviewing pharmacist candidates
when the opportunities arise.
In addition to the set job duties, interns at Sarasota
Memorial Hospital will be guided on at least two
longitudinal projects, such as quality improvement,
continuing education development, and clinical
evaluation projects. I have completed a project on
improving storage conditions for light-sensitive
medication, and I am currently working on a clinical
project to evaluate a treatment protocol for immune
thrombocytopenia. Interns will receive one or more
pharmacist mentors who are there to help guide them
through pharmacy career options, personal growth, and
professional development. Interns will develop their
career skills through dedicated CV review sessions,
residency application preparation, interview skill
workshops, presentations, project management, topic
discussions, and journal clubs hosted by pharmacists.
Interns can also become a formal leader within the
program as Chief, Co-Chief, or Social Chair for the
program. I had the opportunity to serve in the formal
role of Co-Chief and I now help with the recruitment
and retention of interns in the program.
Lastly, my internship has allowed me to experience a
very positive work environment and allow me to explore
many networking opportunities. Sarasota Memorial
Hospital is a 900-bed facility and has about 100
pharmacists. My internship has about 10-15 interns split
between the 4 years of pharmacy school. Our
supervisors personally check in with each intern often
and always ask how they can help. Each pharmacist is
very appreciative of the interns’ help and will often
invite interns to evaluate situations that present good
learning opportunities. Interns are frequently
recognized for their help within the department and
commended on jobs well done. Each intern is
encouraged to practice at the top of their license and
seek out every learning opportunity. Senior interns in
the program help train newer interns, and even
technicians. The senior interns also often offer guidance
in navigating different pharmacy school milestones,
such as rotations and applying to residency. We had two
interns in our most recent graduating class stay at
Sarasota Memorial to complete their PGY1 residency. I
encourage anyone looking for internship experience to
evaluate the different job duties within the internship
and the opportunities offered. The culture of the
institution can also greatly affect your experience.
Partaking in a good internship can prepare you with
both the knowledge and skills to be successful in your
career post-pharmacy school. I strongly encourage
everyone to look into internships and apply to Sarasota
Memorial as a pharmacy intern!
Poliomyelitis - Making a Comeback?
Colin O’Connor
Fresh after the Paris Peace Treaties were signed, ending
the catastrophic second world war, the years 1948 to
1955 were tumultuous for another reason entirely.
Parents would not let their children meet or play with
new friends, civilians locked themselves indoors, and a
relatively primordial healthcare system was being
pushed to its limits. During this timeframe, several
poliomyelitis, colloquially known as “polio”, epidemics
had occurred.1 Polio has existed since prehistoric times,
when it wreaked havoc under the guise of curses and
angry deities throughout. The first known clinical
description of polio was in 1789 by Michael Underwood
8
and it was formally recognized as a medical condition in
1840 by Jakob Heine.2 Despite evidence pointing to
polio being an ancient disease, epidemics began during
the latter part of the 19th century.3 One of the first
outbreaks in the United States occurred in Vermont in
1894 with 132 recognized cases. The United States saw
its peak in 1952 where a single outbreak claimed over
3,000 lives, and the country as a whole saw about
21,000 cases of paralytic polio.2,3 In 1955, the
inactivated polio vaccine (IPV) developed by Jonas Salk
was licensed, with the oral polio vaccine (OPV) by Albert
Sabin following suit in 1960.
Polio disease is caused by the poliovirus, a member of
the Enterovirus genus and Picornaviridae family.4 This
virus is a small, RNA virus that is stable at acidic pH,
allowing it to survive in the gastrointestinal tract.
Poliovirus only affects humans, being more common in
infants and young children, and spreads mainly through
the fecal-oral route. Most people who are infected are
asymptomatic, 25% will exhibit flu-like symptoms (sore
throat, fever, lethargy, nausea, etc.), 1-5% will develop
meningitis, and 1% or less will develop paralysis or
paralytic polio.4 There is no cure for polio and treatment
is only symptomatic care, such as physical or
occupational therapy for muscle weakness.4 Prevention
through vaccination with the IPV or OPV is the only
means of combating polio that we have. Due to
widespread vaccination efforts through the decades, the
United States went from thousands of wildtype polio
cases per year to zero in 2020.1
In the summer of 2022, the first case of polio in the
United States since 2013 appeared in Rockland County,
New York, rendering the patient partially paralyzed. This
has stimulated a newfound worry over the chances of
polio becoming epidemic – or worse, pandemic – since
the world was, and still is, dealing with the fallout of the
COVID-19 pandemic. Genetic signs of the virus were
detected in wastewater from both Rockland County and
New York City, indicating that human transmission had
occurred. However, there was a vital factor that
deserved attention. Polio vaccination rates in Rockland
County hover around 60%, versus 80% for the state of
New York, and over 90% for the United States as a
whole.6 The same areas dealing with this polio outbreak
have had issues with measles outbreaks in the recent
past, also due to low vaccination rates. However, polio is
significantly harder to detect due to the asymptomatic
nature of the disease, making the possibility of a greater
outbreak more precarious.
This type of polio outbreak is defined as vaccine-derived
polio. Vaccine-derived polio is when a patient is
administered the OPV, which is a weakened, or
attenuated, form of the virus. The fact that it is
technically a live virus means that there is a short period
of shedding post-vaccination, which can help
unvaccinated people build somewhat of an immunity
secondarily. However, during this short post-vaccination
period, there are extremely rare cases where the virus
can revert to a pathogenic form through mutations. This
becomes even more problematic in unvaccinated
populations, as the virus can be continually transmitted
between individuals, increasing the chance of viral
mutations. Since the OPV was discontinued in the
United States in 2000, the more recent cases are when
an unvaccinated traveler picks it up in another country
where OPV is used and brings it back. Since the majority
of Americans are vaccinated against polio, and this type
of polio affects only unvaccinated people, there is zero
risk for further transmission to the vaccinated.
In short, there is no cause for concern for the vast
majority of Americans, as polio vaccination rates are
incredibly high. These cases highlight the importance of
receiving the polio vaccine to prevent the wildtype virus
and vaccine-derived viral mutation(s). The polio vaccine
is exceptionally efficacious (99% to 100% after a
three-dose series) and extremely well tolerated, with
the most common effect being injection site soreness
with the intramuscular formulation.7 Polio vaccination is
one of the greatest global health achievements, saving
millions of lives from paralysis and death. It is something
that we in the 21st century should not take for granted.
References:
1. History of Polio: Outbreaks and Vaccine Timeline. Mayo Clinic.
https://www.mayoclinic.org/coronavirus-covid-19/history-disease-outbreaks-vaccine-ti
2.
meline/polio.
History of polio vaccination. World Health Organization.
https://www.who.int/news-room/spotlight/history-of-vaccination/history-of-polio-vacci
nation.
3. Polio Through History. Encyclopædia Britannica.
https://www.britannica.com/science/polio/Polio-through-history.
4. Polio: For healthcare providers. Centers for Disease Control and Prevention.
https://www.cdc.gov/polio/what-is-polio/hcp.html. Published August 10, 2022.
5. What is polio? Centers for Disease Control and Prevention.
https://www.cdc.gov/polio/what-is-polio/index.htm. Published August 11, 2022.
6. Willingham E. Everything you need to know about polio in the U.S. Scientific American.
https://www.scientificamerican.com/article/everything-you-need-to-know-about-polio-i
n-the-u-s/. Published September 29, 2022.
7. Polio Vaccine - StatPearls - NCBI Bookshelf.
https://www.ncbi.nlm.nih.gov/books/NBK526039/.
9
Not Your Traditional Receptor Drug
Target – Sigma-1
Ashton Hagen
What if I told you there is a receptor with the potential
to cure a wide range of neurodegenerative and
neuropsychiatric human ailments, from chronic pain and
depression to Parkinson’s and Alzheimer’s Disease?...
Too good to be true? Found in the
mitochondrial-associated endoplasmic reticulum
membrane of major organs and throughout the central
nervous system, the sigma-1 receptor, initially thought
to be an opioid receptor, is a ligand-regulated
transmembrane molecular chaperone protein. Sigma-1
has been found to regulate and modulate various
voltage-gated ion channels and ionotropic receptors
such as Na+, K+, Cl-, NMDA (glutamate) and IP3 (Ca2+).1,2
The chaperone activity of this protein regulates cellular
survival, oxidative stress, neuronal differentiation, as
well as protein folding and degradation, and
bioenergetics.3,4 Agonistic action at sigma-1 ultimately
inhibits the ligand-gated ion channels, and potentiates
the voltage-gated ion channels it interacts with. As such,
sigma-1 antagonism blocks this inhibition resulting in
the opposite effects.1 With its functionality being as
encompassing of cell physiology and signaling as it is,
the ligand-regulated agonist-antagonist nature of
sigma-1 makes it an exceptionally valuable potential
drug target.3 Investigations have linked the actions of
sigma-1 to the pathophysiology of depression, drug
abuse, pain, cancer, stroke, HIV, Alzheimer’s disease and
more.1,4
Figure 1. Sigma-1 ligand binding a. Cross-section view of
sigma-1 bound to PD144418 (ligand with high affinity and
selective antagonist activity). b. View of sigma-1 binding
pocket residue charge-charge, hydrogen bonding, and
extensive hydrophobic interactions with the PD144418 ligand.
c. Corresponding binding of 4-IBP (agonist or inverse agonist
activity).5
Utilizing the sigma-1 receptor as a drug target could
mean the start of a new post-monoamine hypothesis
era of pharmacotherapy for psychiatric conditions.
Auvelity (dextromethorphan + bupropion) was approved
by the FDA in August of 2022 for the treatment of major
depressive disorder in adults. Dextromethorphan (yes,
the OTC cough medicine) is both an NMDA receptor
antagonist and sigma-1 receptor agonist which leads to
modulation of central nervous system glutamate
signaling. Dextromethorphan is subject to extensive
CYP2D6 metabolism and bupropion is a strong CYP2D6
inhibitor. Therefore, 105 mg of bupropion is added to 45
mg of the dextromethorphan to increase the
bioavailability and half-life to therapeutic levels. This
combination was very well tolerated with the most
common adverse events being dizziness, nausea,
headache, somnolence, and dry mouth.6 The GEMINI
phase 3 clinical trial, to assess safety and efficacy of this
product, revealed statistically significant rapid and
sustained clinical response in improvement of
depressive symptoms, starting at one week after
initiation. At one week, the intervention group
demonstrated a 7.3 point mean reduction in mean
Montgomery-Asberg Depression Rating Scale (MADRS)
as compared with the 4.9 point reduction for placebo
(p=0.007). At six weeks, remission was achieved by
39.5% of participants; a 22.2% absolute difference
compared with placebo or a Number Needed to Treat
(NNT) of 4.5.6
Another sigma-1 agonist to be on the lookout for is the
selective and potent investigational drug by Prilenia
Therapeutics, pridopidine, to treat Huntington’s disease
(PROOF-HD trial: NCT04556656) and Amyotrophic
Lateral Sclerosis (HEALEY ALS Platform Trial:
NCT04615923). Both of these debilitating conditions are
progressive and neurodegenerative. Pridopidine works
by activating the sigma-1 chaperone protein to
downstream facilitate TFEB-mediated upregulation of
autophagy genes that are essential for neuronal
function and survival. The autophagy process eliminates
toxic, dysfunctional proteins through lysosomes
resulting in a highly valuable neuroprotective effect.7,8
As we await clinical trial data, many are hopeful for the
potential this has for the treatment of other
neurodegenerative conditions, such as Alzheimer’s
disease and Parkinson’s disease.
As our understanding continues to evolve, progressive
research is being conducted to identify sigma-1 agonists
and antagonists to serve as therapeutic options in the
treatment of neurodegenerative and neuropsychiatric
human conditions. The chaperone protein serving as a
novel drug target is both exciting and scientifically
10
stimulating. While we still have a lot to uncover with
sigma-1, it will be very interesting to see how our
understanding progresses, and how it will play into our
ability to utilize the neuroprotective aspects of this
protein to treat, slow/stop the progression, or maybe
even prevent neurodegenerative and neuropsychiatric
conditions.

References:
1. Wu, Nh., Ye, Y., Wan, Bb. et al. Emerging Benefits: Pathophysiological Functions and
Target Drugs of the Sigma-1 Receptor in Neurodegenerative Diseases. Mol Neurobiol 58,
5649–5666 (2021). doi.org/10.1007/s12035-021-02524-5
2. Maurice T, Su T-P. The pharmacology of sigma-1 receptors. Pharmacology &
Therapeutics. 2009;124(2):195-206. doi:10.1016/j.pharmthera.2009.07.001
3. Hayashi T. Sigma-1 receptor: the novel intracellular target of neuropsychotherapeutic
drugs. J Pharmacol Sci. 2015;127(1):2-5. doi:10.1016/j.jphs.2014.07.001
4. Hayashi T. Sigma-1 receptor: The novel intracellular target of Neuropsychotherapeutic
Drugs. Journal of Pharmacological Sciences. 2015;127(1):2-5.
doi:10.1016/j.jphs.2014.07.001
5. Schmidt HR, Zheng S, Gurpinar E, Koehl A, Manglik A, Kruse AC. Crystal structure of the
human σ1 receptor. Nature. 2016;532(7600):527-530. doi:10.1038/nature17391
6. Iosifescu DV, Jones A, O'Gorman C, et al. Efficacy and Safety of AXS-05
(Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3
Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022;83(4):21m14345. Published
2022 May 30. doi:10.4088/JCP.21m14345
7. Wang SM, Wu HE, Yasui Y, et al. Nucleoporin POM121 signals TFEB-mediated autophagy
via activation of SIGMAR1/sigma-1 receptor chaperone by pridopidine. Autophagy.
2023;19(1):126-151. doi:10.1080/15548627.2022.2063003
8. Fleming A, Bourdenx M, Fujimaki M, et al. The different autophagy degradation
pathways and neurodegeneration. Neuron. 2022;110(6):935-966.
doi:10.1016/j.neuron.2022.01.017

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 Quarterly Capsule Word Search

Clinical Agonism ICER Antagonist

Sigma Fentanyl Poliomyelitis Polymorphism

Pyxis Cognition Midyear Naloxone

Alzheimers

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 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
The Quarterly Capsule publication is the culmination of
the hard work of many students at the University of
Florida College of Pharmacy, Orlando campus. Each
semester, several students devote their time to write an
article on a topic of their choosing; a topic they are
passionate about. Their love of pharmacy translates into
educating others to bolster and round out their pharmacy
knowledge. This is one of the many reasons why
pharmacy is great. This is why the students at the Orlando
campus are amazing.
This newsletter is composed of topics from novel
treatment plans to student experiences to new pharmacy
legislation. Each topic allows the student to practice their
research and appraisal skills, developing the necessary
traits a pharmacist must have to optimize
interprofessional communication and patient care.
SSHP and I would like to thank each student writer for
their hard work and dedication. Our writers truly made
the spring newsletter a fascinating read that shares
several aspects of pharmacy with many areas of interest.
Thank you!
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