Call for Articles
North Carolina Pharmacist (NCP) is currently accepting articles for publication consideration. We accept a diverse scope of articles, including but not limited to: original research, quality improvement, medication safety, case reports/case series, reviews, clinical pearls, unique business models, technology, and opinions.
NCP is a peer-reviewed publication intended to inform, educate, and motivate pharmacists, from students to seasoned practitioners, and pharmacy technicians in all areas of pharmacy.
Articles written by students, residents, and new practitioners are welcome. Mentors and preceptors – please consider advising your mentees and students to submit their appropriate written work to NCP for publication.
Don’t miss this opportunity to share your knowledge and experience with the North Carolina pharmacy community by publishing an article in NCP.
Click on Guidelines for Authors for information on formatting and article types accepted for review.
For questions, please contact Tina Thornhill, PharmD, FASCP, BCGP, Editor, at tina.h.thornhill@ gmail.com
North Carolina Pharmacist is the official journal of the North Carolina Association of Pharmacists
Located at: 1101 Slater Road, Suite 110 Durham, NC 27703
Phone: (984) 439-1646
Fax: (984) 439-1649
www.ncpharmacists.org
Official Journal of the North Carolina Association of Pharmacists
1101 Slater Road, Suite 110
Durham, NC 27703
Phone: (984) 439-1646
Fax: (984) 439-1649
www.ncpharmacists.org
EDITOR-IN-CHIEF
Tina Thornhill
LAYOUT/DESIGN
Rhonda Horner-Davis
EDITORIAL BOARD MEMBERS
Anna Armstrong
Jamie Brown
Lisa Dinkins
Jean Douglas
Brock Harris
Amy Holmes
John Kessler
Angela Livingood
Bill Taylor
BOARD OF DIRECTORS
EXECUTIVE DIRECTOR
Penny Shelton
PRESIDENT Bob Granko
PRESIDENT-ELECT
Tom D’Andrea
PAST PRESIDENT
Ouita Gatton
TREASURER
Ryan Mills
SECRETARY
Beth Caveness
Cassey Zendarski, Chair, SPF
Micaela Hayes, Chair, NPF
Lisa Dinkins, Chair, Community
Tyler Vest, Chair, Health-System
Kimberly Hayashi, Chair, Chronic Care
Mackie King, Chair, Ambulatory
Angela Livingood, At-Large
Elizabeth Locklear, At-Large
Macary Weck Marciniak, At-Large
North Carolina Pharmacist (ISSN 0528-1725) is the official journal of the North Carolina Association of Pharmacists. An electronic version is published quarterly. The journal is provided to NCAP members through allocation of annual dues. Opinions expressed in North Carolina Pharmacist are not necessarily official positions or policies of the Association. Publication of an advertisement does not represent an endorsement. Nothing in this publication may be reproduced in any manner, either whole or in part, without specific written permission of the publisher.
North Carolina Pharmacist
A Few Things Inside
I am sure there must be some fans of The Flintstones or James Dean among our members. Whether you are a lover of classic films or a cartoon aficionado, hopefully, this column’s title evokes a few nostalgic memories for you.
During 2024, there has been much that our state pharmacists and fellow North Carolinians have had to endure, none greater than the devastation of Hurricane Helene. Even with the worst that Mother Nature can throw at us, I have been amazed at the herculean efforts of pharmacists, other health professionals, and neighbors helping neighbors. In times like these, it is heart-warming to see that our humanity is not lost. The rubble left behind by Helene is massive, and the landscape of western North Carolina has forever changed. This event has single-handedly and within a matter of hours generated ‘a cause’ for our state that will no doubt take years, and the emotional scars left behind are likely to remain for a lifetime.
As your Executive Director, I have been asked to share what this year has produced for the Association. When I look back at the year, I see a plethora of initiatives, resources, programming, and services.
Penny S. Shelton, PharmD, FASCP, FNCAP
Rubble With A Cause
The very ‘things’ we do that truly demonstrate the diversity of the Association’s cause, influence, value, and success. Members can take great pride in not only knowing but also having witnessed the very work your state pharmacy association produces each year on behalf of the profession. Often, we think of all these individual ‘things’ as pieces that form a collective picture for the Association. However, unlike a jigsaw puzzle, familiarity with just one piece or aspect of NCAP does not reveal the Association’s full impact or value. For instance, if you only read our journal and never participate in our programming, or only attend our live-stream programs and never follow our advocacy work, or only attend our annual convention but are unfamiliar with our online resources, then even as a member, although you find value in the Association, you may not be fully apprised or aware of the full strength of the organization.
When looking back over the year and thinking about all of the individual ‘things’—forays and accomplishments—I like to put a bit of a different spin on the above pieces-analogy. Instead of viewing the pieces as coming together to form a complete picture, I suggest we view the pieces as scattered components, essentially a sort of rubble. Now, many hear the word ‘rubble’
and immediately envision destructive forces and debris. Although not wrong, it is also true that in both construction and gardening, rubble serves to create a base upon which strong foundations are built and yield flourishes. Similarly, if we look at the totality of all the ‘things’ that NCAP leads, supports, creates, provides, and does as the very foundation upon which our strength and the impact of the association arises, then our membership organization is most certainly an effective, influential and valuable ‘rubble with a cause’!
Last fall, I wrote that in the midst of all the doing, with heads down and working hard, we can sometimes lose sight of the best path forward. I mentioned time is elusive, and when we look up, another year has passed us by. Life rushes at us, as does work, and even with the running of an Association, we can often get swept up in the doing and forget how important it is to pause, reset, and reorient ourselves. When I wrote this, I promised you that NCAP would be spending time in the coming year to reexamine our operations, partnerships, programming, and resources and adjust our strategic plan, with the intent to ensure our organization is still on a path to success.
Your elected officials and the NCAP staff have worked collaboratively to
conduct this assessment. We have continued to maintain our primary operations of advocacy, professional development, resource development, and communications while also doing a deep dive into our strategic partnerships and operational efficiencies. Your Board of Directors has been exploring and refining a number of tactics designed to improve membership and membership engagement. This work has been done with the sole premise of a ‘members-first’ philosophy. Everything we do should have our members in mind.
As part of this work, we conducted a series of short online polls with our members. Although most members did not participate, we were pleased with the number and diversity of respondents. These polls were seeking member impressions and feedback primarily related to our media (i.e., special alerts via email, weekly news, journal, and social media). The feedback was overwhelmingly positive, but through the open-ended questions, we were also able to glean a number of helpful suggestions.
This past week, your Board of Directors met for their 2024 year-end meeting. Since October, they have spent time working on a review of the current strategic plan. As of late September, 90% of the 20232025 strategic plan objectives had been completed, a pace well ahead of schedule, and at last week’s yearend meeting, the Board approved a number of new items and updates for the plan. We want you to know that the governing body for the Association consistently strives for organizational progress.
In the coming weeks and months,
the NCAP staff and I will share the revised strategic plan and introduce our members to several exciting changes. In closing, I want to share with you that during these first few months following the Hurricane Helene devastation, we have been directing people to give to the general North Carolina Disaster Relief Fund. NCAP has never had a pharmacy-related, specific disaster relief fund in place, but we are working to create an enduring charitable fund to help with the long recovery process for western North Carolina and to be in place for future disasters that may impact pharmacies, pharmacy personnel, and their families.
On behalf of the NCAP Board of Directors and staff, I thank you for helping to make 2024 another successful year for the Association. I wish you a warm, safe, and joyous holiday season, and I look forward to our work together in 2025.
Pharmacy Proud
Penny
Discounts on Home, Travel, and Entertainment
All NCAP members can unlock the best life has to offer with exclusive savings on: Theme Parks, Attractions and Shows; Hotels, Flights and Rental Cars; Concerts, Sports and Live Events; Movie Tickets; Electronics and much more. Visit the Membership Benefits tab at ncpharmacists.org to find out more!
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The Power to Choose
Why Relexxii?
References: 1. RELEXXII® (methylphenidate hydrochloride extended-release tablets) package insert. Vertical Pharmaceuticals, LLC; 2023. 2. Data on file, Osmotica Pharmaceuticals.
*Co-pay assistance is applicable to prescription coverage for eligible commercially insured patients. O er void where prohibited. No income restrictions apply. Other restrictions may apply. O er e ective 04/2024. Alora Pharmaceuticals, LLC reserves the right to rescind, revoke, or amend this o er without notice. For full terms and conditions visit relexxii.com/savings. The individuals depicted are models used for illustrative purposes only.
INDICATION & IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
RELEXXII is a central nervous system (CNS) stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older.
WARNING: ABUSE, MISUSE, AND ADDICTION
See full prescribing information for complete boxed warning.
RELEXXII has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including RELEXXII, can result in overdose and death.
• Before prescribing RELEXXII, assess each patient’s risk for abuse, misuse, and addiction.
• Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.
• Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
relexxii.com/pi or scan here
Respiratory syncytial virus (RSV) is a major cause of acute respiratory infections and lower respiratory tract diseases, which can lead to clinical complications, including but not limited to exacerbation of underlying diseases, hospitalizations, and death in older adults. In 2019, there were 5.2 million cases of RSV reported, with 470,000 hospitalizations and 33,000 inpatient deaths among the older adult population (age greater than or equal to 60 years old)1,2. RSV is most prevalent during the months of October to May in temperate climates across the United States and can extend over a period of 20 weeks or more. During this time, RSV can produce a major burden of infections, leading to increased healthcare utilization and cost.
RSV isolates can be classified into antigenically distinct groups, A and B. The two major groups differ in that they have a different sequence of proteins (G, F, and/ or SH). During RSV season, both strains, A and B, circulate. The severity of RSV in older adults is
Review of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults
By: Dr. Hailey Bass and Morgan Hall, PharmD Candidate
attributed to reduced RSV-specific T-cell responses. To bolster this response, RSV vaccines for older adults target the RSV F glycoprotein, which mediates viral fusion and host-cell entry, elicits neutralizing antibodies, and is highly effective in both subtypes of RSV (A and B). Previously, vaccines for RSV targeted the G protein, which mediates the virus’s attachment to host cells. The most recent vaccine studied, GSK RSVPreF3 OA, contains an F protein that targets neutralizing antibodies in older adults. Formulations of the vaccine containing the F protein have shown in phase 1 and 2 studies to increase RSV-specific CD4+ T-cell frequencies in older adults1
Multiple rapid direct antigen detection tests are widely available and used by most laboratories. However, the reverse transcriptase polymerase chain reaction (RT-PCR) assay, in terms of diagnosis, has consistently demonstrated much higher specificity and sensitivity rates than the rapid antigen diagnostic assays. Current treatment for RSV-associated
illness is supportive care for older adults. Aerosolized ribavirin is used to treat RSV in highly immunocompromised patients, with or without anti-RSV immunoglobulin, but the efficacy is not currently well established. Based on the most recent Centers for Disease Control and Prevention (CDC) recommendation, adults 60 years of age and older may receive a single dose of the RSV vaccine, Abrysvo (Pfizer) or Arexvy (GSK), utilizing shared clinical decision-making with healthcare professionals3.
Study Design
This ongoing, randomized, international, placebo-controlled, phase 3 trial was conducted in 17 African and Asian countries, Australia, Europe, and North America over at least two consecutive RSV seasons. The trial data reveals data from the first RSV season in the Northern Hemisphere. Patients were included if they were 60 years or older, not enrolled in another RSV vaccine trial (previous or current), and had medically stable chronic conditions as
determined by the investigator. Patients were excluded if they were immunocompromised or had a history of vaccine hypersensitivity. The intervention was completed before the RSV season, and participants were assigned 1:1 to receive the RSVPreF3 OA vaccine or placebo.
Outcome Measures
The primary outcome measured in this study was the efficacy of a single dose of the RSVPreF3 OA vaccine for preventing RSV-related lower respiratory tract diseases (LRTD) during one RSV season, confirmed by PCR testing in adults 60 years of age or older. Adverse effects (graded from mild to severe) efficacy against RSV-related respiratory infections according to all RSV subtypes (A or B) confirmed by RT-PCR testing, safety, and coexisting conditions at baseline were recorded as secondary outcomes.
Statistical Analysis
Patient characteristics were outlined using percentages or other means as appropriate. Type 1 error was adjusted to maintain an overall significance level, and noninferiority for the primary endpoint was determined using a 96.95% confidence interval1. No adjustments for multiplicity were made in the analysis of the secondary endpoints1.
Results
A total of 26,664 participants were enrolled in the trial between May 25, 2021, and January 31, 2022,1 and received a dose of either the vaccine or placebo. Base-
line and demographic characteristics between the two groups were overall similar. Patients included in the exposed population were 24,966, with 24,690 participants in the modified exposed population, defined as participants in either group that did not report an RSV-related acute respiratory infection within the first 15 days following injection1.
Seven of the 12,466 participants in the vaccine group and 40 of the 12,494 in the placebo group, a total of 47 participants in the modified exposed population, reported an episode of an RSV-related lower respiratory tract disease during a 6.7-month median follow-up1. Vaccine efficacy was 82.6% (96.95% confidence interval [CI], 57.9 to 94.1), meeting the primary objective with a lower limit of the confidence interval being >20%1. Results were similar in the exposed population.
Efficacy against severe RSV-related lower respiratory disease was 94.1% (95% CI, 62.4 to 99.9), with 1 case reported in the vaccine group and 17 cases in the placebo group1. A total of 122 participants between the two groups had at least one RSV-related episode, with vaccine efficacy being 71.7% (95% CI, 56.2 to 82.3)1. No deaths related to RSV were reported in the trial. A single dose of the vaccine had an acceptable safety profile and prevented RSV-related complications in adults 60 years or older, regardless of the subtype and presence of underlying conditions. Cumulative incidence curves for either RSV-related lower respiratory infections or acute respiratory infections indicated efficacy in follow-up1. Two-thirds
of the reported RSV-related infections were associated with RSV subtype B, and the efficacy of both RSV A- and RSV B-specific vaccines was evaluated based on incidences of lower respiratory disease and acute respiratory infection1. Efficacy against lower respiratory tract diseases related to RSV was more than 80% in participants aged 60-69 and 70-791. Among patients with coexisting conditions, efficacy was reported to be 94.6%1.
Discussion
In this study, the RSVPreF3 OA vaccine was efficacious against RSV with no difference between A and B subtypes. It was shown to provide additional benefits in patients of older age (60 to 79) with other comorbid conditions. The median follow-up of 6.7 months showed efficacy in preventing RSV-related lower respiratory tract infections, representing vaccine data over an entire RSV season. Reactogenicity was higher in the vaccine population; however, most reactions were mild to moderate and transient in nature.
Although this study successfully showed the efficacy of the RSVPreF3 OA vaccine in older adults, it has some limitations. First, there was a relatively small patient population above 80 years old despite being completed internationally in over 17 countries. Additionally, the trial was conducted during the second year of the COVID-19 pandemic when public health measures were in place to prevent COVID-19. These measures, in turn, likely reduced the spread of RSV and altered the timing of RSV season, with most
cases occurring early in the season. Mitigation to these limitations was addressed, and one attempt was made in the Northern Hemisphere region to start the trial in May, several months before RSV season.
This data can aid in the shared decision-making process between providers, clinicians, and patients regarding the efficacy and benefit of the RSVPreF3 OA vaccine in older adults. Future studies could consider utilizing this data beyond one RSV season to assess the need for re-vaccination. Another option for future studies is the inclusion of more participants with frailty and above the age of 80 years to ensure the results remain consistent.
This trial showed that a single dose of the RSVPreF3 OA vaccine was efficacious in adults over the age of 60 years old against RSV-related lower respiratory tract infections (mild to severe) during one RSV season regardless of RSV subtype, coexisting comorbidities, or frailty status.
Authors: Hailey Bass, PharmD; PGY-1 Acute Care Pharmacy Resident; Harnett Health System, Campbell University College of Pharmacy and Health Sciences Email: hebass240@gmail.com; Morgan Hall, PharmD Candidate Class of 2026; Campbell University College of Pharmacy and Health Sciences
L, Dezutter N, Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrom V. Respiratory Syncytial Virus Perfusion F Protein Vaccine in Older Adults. N Engl J Med. 2024 Feb 11;388(7): 595-608.
2. RSV Surveillance and Research. Centers for Disease Control and Prevention. Last reviewed July 17, 2023. https://www.cdc.gov/rsv/research/index.html
3. Respiratory Syncytial Virus (RSV) Immunizations. Centers for Disease Control and Prevention. Last reviewed March 01, 2024. https:// www.cdc.gov/vaccines/vpd/rsv/index.html
4. RSV in Older Adults and Adults with Chronic Medical Conditions. Centers for Disease Control and Prevention. Last reviewed March 01, 2024. https://www.cdc.gov/rsv/highrisk/older-adults.html
5. Walsh EE, Hall CB. Respiratory Syncytial Virus (RSV). Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, Elsevier. 2015;1948-1960.e3.
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References
1. Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, Zyl-Smit RN, Campora
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Assessing Adults’ Willingness to Receive the Influenza Vaccine
By: Christina J. Ricker, Lisa M. Jones, Deborah O. Adebisi, Pokou JM. Kouassi, Meredith P. Hatchell, and Dr. Edward T. Chiyaka
Introduction
Influenza, commonly referred to as flu, is a respiratory illness caused by a contagious virus that primarily affects the upper and lower respiratory tracts.1 This community-based infection is spread through close contact with individuals and usually circulates throughout the United States between the fall and spring seasons.2,3 Although it has been found that the majority of individuals who contract influenza will recover without significant complications and long-term sequelae, it can be associated with severe illness, hospitalization, and death.4 Influenza-related complications are more common in groups with a diminished immune response, pregnant women, people with chronic medical conditions, children under the age of 5 years, and those over 65 years.5,6,7
Empirical estimates of the total burden of influenza have historically been difficult to obtain both within the United States and globally.8 This difficulty can be attributed to healthcare-associated costs, including the direct costs of healthcare services, costs associated with lost
productivity during illness, and overall socioeconomic costs secondary to the burden on public health.9 Globally, influenza-related illnesses are estimated at 1 billion cases per year, accounting for a substantial global economic burden and upwards of 650,000 deaths yearly.10,11 It has been estimated that the United States alone has an annual economic burden of roughly $11 billion in influenza-related burdens, stemming from the estimated 3-11% of the population contracting the virus yearly.12,13
Influenza vaccine recommendations have remained a mainstay, given its vital role in preventing illness and reducing the healthcare burdens associated with influenza-related illness.14,15 Despite the high variability in the efficacy of the influenza vaccination, it has remained the most important method of protection from influenza-related illness and complications.16 Given the risk of complications and other associated burdens of the influenza virus, the Advisory Committee on Immunization Practices (ACIP) recommends routine annual influenza vaccination for all individuals at least six months old who have no contrain-
dications to the flu vaccine.3
Although vaccination is the mainstay for influenza protection, vaccination rates vary significantly between local and global levels. From a global perspective, it is estimated that 24.9% of individuals are immunized against influenza.17 In the United States, influenza immunization rates are estimated at 46.9%.18 State estimates show North Carolina (NC) reports above the national average at 50.6%.2 However, the vaccination rate in Union County, NC, is below the national average at 45.2%.2
The relatively high national vaccination rates are attributed to a large population group with a broad mixture of racial groups, education levels, and metropolitan and rural areas.19 Research demonstrates that the variation in vaccination rates among high-risk individuals for influenza complications in the United States is correlated with the wealth gap between racial groups. Specifically, among white individuals, the vaccination rate is 59.9%; among black individuals, it is 48.5%; and among Hispanic individuals, it is 48.6%.20 Furthermore, it has been
reported that rural communities have lower health literacy rates and less access to healthcare than metropolitan areas.21 Although Union County has become more suburban, the majority is rural, with a population per square mile of 376.6; lower vaccination rates are expected compared to more populated metropolitan areas.1,17
Vaccination hesitancy, the delay in the acceptance or refusal of vaccination despite the availability of vaccination services, threatens global health because it contributes to preventable diseases.22,23 Hesitancy has been found to vary depending on the type of vaccine as well as individual demographics, political affiliation, and religion.24 Additionally, lack of awareness of recommended vaccines, lack of confidence in the flu vaccine, and perceived benefits and risks have been shown to impact hesitancy.25
Influenza vaccination is key in preventing and controlling the influenza virus. Individuals’ willingness to vaccinate, however, is influenced by attitudes as well as social, economic, and geographical barriers.26 Some challenges can be addressed by implementing initiatives that increase awareness, provide access, and are affordable.27 The purpose of this study is to explore the factors that influence willingness to vaccinate in the community of Union County, NC. We hypothesize that knowledge of the safety and benefits of influenza vaccination increases adults’ willingness to receive the influenza vaccine.
Methods
We conducted a cross-sectional study to investigate the factors in-
fluencing the willingness of adults in Union County, North Carolina (NC), to receive the influenza vaccine. Study locations in Union County were selected using convenience sampling, including the Wingate Farmers Market and the Community Health and Wellness Fair. Additionally, participants were recruited using social media posts in several community-based Facebook groups. The data collection period spanned four months, from September 2023 to December 2023. Participants had to be 18 years or older and live in a zip code in Union County.
Data was collected using a printed and an online survey hosted on Google Forms. We used two data collection forms to enhance participants’ accessibility. The survey asked participants to indicate their beliefs on vaccination, answer knowledge assessment questions, and provide their demographic information. The knowledge assessment consisted of seven true/false questions to assess an individual’s knowledge of the influenza virus (Appendix A). Each participant’s average knowledge score was derived as a percentage of correctly answered knowledge assessment questions. The Research Review Board at Wingate University approved the study (Protocol #: CR091123).
Data Analysis
Data analysis was performed using Microsoft Excel version 2403. For our analysis, participants who indicated that they strongly agreed or agreed that they planned on being vaccinated were reclassified as willing to vaccinate. Likewise, those who indicated they strongly disagreed, disagreed, or were neutral
on planning to vaccinate were reclassified as not willing.
We used bivariate analysis to compare those willing to vaccinate with those who were not. Additionally, we used Chi-Square tests and T-tests to assess variations between different groups. Statistical significance was established using an alpha value of p <0.05.
Results
A total of 124 individuals completed the survey. However, three participants were excluded from further analysis due to being under 18, not providing consent, and not completing the entire survey. Table 1 shows a summary of the demographic characteristics of participants. The majority of participants were females (74.4%), between the ages of 18 and 39 years old (70.2%) and had some college education but no degree (38.8%). There were 103 (85.1%) participants who stated they chose to receive an influenza vaccine at least once in the past. Of those, 85 (70.2%) stated they chose to receive an influenza vaccine in the past 5 years.
About half of the participants (49.6%) indicated they were willing to receive the influenza vaccine for the upcoming flu season. When categorized by age, adults aged 60 years and above were more willing to receive the influenza vaccine than those under 60. Similarly, individuals who indicated having at least a graduate degree were more willing to receive the influenza vaccine (62.5%) than those with an undergraduate degree or less (46.4%). An individual’s zip code also appeared to be associated with willingness to vaccinate, as seen with one zip code, 28173, having 93.8% of participants
willing to vaccinate compared to the average of the other zip codes included in the study reporting 46.8% willingness.
The results of this study found an association between willingness to receive the influenza vaccine and participants’ age, level of education, and zip code. Table 2 shows the distribution of the participant’s willingness to vaccinate based on different socio-demographic characteristics and the associated p-values. Compared to other age groups, the 18-39 age group has the highest number of individuals not willing to receive the influenza vaccine. Among genders, females showed a slightly higher willingness to receive the influenza vaccine than males, with gender-variant individuals showing a lower willingness overall. Overall, the results showed that participants with no college education tend to
exhibit lower influenza vaccine hesitancy (13%) compared to those with some college or undergraduate education (at least 15%). Additionally, one zip code, 28173, stood out as having a higher percentage of those willing to receive the vaccine. Although these associations were not statistically significant, they identified trends that warrant further evaluation.
We assessed the participants’ knowledge of influenza and influenza vaccines. Overall, the participants’ average knowledge score was 71%. When categorized by willingness to vaccinate, individuals who were willing to vaccinate had an average score of 73.6% compared to 69.6% for those who were not willing to vaccinate. An independent sample 2-tailed T-test was performed to examine the hypothesis that knowledge of the safety and benefits of in-
Table 1: Demographic characteristics of participants
fluenza vaccination increases adult’s willingness to receive the influenza vaccine. We found no significant relationship between participant knowledge score and willingness to receive the influenza vaccine in the current flu season (p=0.23).
We assessed individuals’ perceptions of trust in healthcare and their perception of vaccine benefits compared to risks. Table 3 shows a summary of the findings. Among participants surveyed, 52.1% agreed that vaccine benefits outweighed the risks, 53.7% believed vaccination beneficial, and 49.6% expressed trust in healthcare system recommendations. Most participants were willing to receive the influenza vaccine, and among those willing to receive the vaccine, 90% believed that vaccine benefits outweighed risks, 88% considered the vaccine beneficial, and 82% trusted the healthcare system. Additionally, there were significant differences between the willing and not willing groups in all categories (p < 0.05). Among those who believed vaccine benefits outweighed risks, a higher proportion were willing to receive the vaccine compared to those who did not hold this belief (90% vs. 10%). Similarly,
participants who had trust in the healthcare system were more likely to be willing to receive the vaccine compared to those who did not (82% vs. 18%).
Discussion
This study aimed to explore the factors influencing willingness to vaccinate in the Union County, North Carolina community. The findings indicate variations in willingness to receive the influenza vaccine based on the highest level of education and geographic location as assessed using the Zip code, age group, and gender of participants. Participants from specific Zip codes were more willing to receive the influenza vaccine. Similarly, older age groups were more willing to receive the vaccine than younger ones. Additionally, female participants showed slightly higher willingness than males, with gender-variant individuals displaying lower willingness overall. While these findings show an observable trend for specific subgroups, the associations were not statistically significant. On the other hand, statistically significant differences were observed between willingness to receive the influenza
vaccine and trust in the healthcare system, perceived benefits of the influenza vaccine, and belief that the influenza vaccine benefits outweigh the risks within this population.
Despite the lack of data demonstrating statistically significant differences in influenza vaccine hesitancy based on individuals’ demographic characteristics, further analysis does reveal some important correlations within these areas. The study results show the highest percentage of willingness to vaccinate is among those over 60 years. Additionally, the group with graduate-level education had a greater percentage of willingness to vaccinate than other education levels. While the overall education level did not reach statistical significance, it is theorized that the level of education needed to develop sufficient health literacy that extends beyond a simple understanding of the basics of influenza and vaccines may be a factor in grasping the overall impact of vaccination programs.
Given the current data available aimed at understanding factors contributing to vaccination hesitancy, this study anticipated significant
Table 3: Survey responses among participants assessing their perceptions of trust in healthcare and vaccine benefits compared to risks
findings related to influenza vaccination hesitancy and the individual demographics, as well as the level of knowledge of influenza and vaccinations calculated for the participants.24 In addition to these factors, previous studies have shown that the perceived benefits of vaccination and trust in the healthcare system contribute to vaccine willingness.25 As such, this study expected these factors to contribute significantly to the overall findings.
This study hoped to provide insight into factors contributing to the low influenza vaccination rates among adults in Union County, North Carolina. The findings can be used to improve the rate of influenza vaccination by guiding future outreach projects to use a holistic approach rather than placing the project’s main focus on education alone. For example, a project could target participant’s beliefs rather than education. Additionally, projects can use our results to target the projects toward the populations most hesitant to receive the influenza vaccination, allowing their work to lead to higher vaccination rates.28 This project may have broader implications and rep-
Appendix
licability for use within the county and on larger scale populations that demonstrated similar demographic characteristics as our study population.
Strengths and Limitations
While our study provided valuable insights into understanding factors associated with influenza vaccine uptake, our research has several limitations. One limitation is our project’s scope, as we could only feasibly gather data in one county. Our limited sample size did not provide enough participants to allow for a true representation of the population data. Another limitation is that our survey was short and had limited demographic questions. We intended for the short survey to be more manageable to complete. However, significant demographic information may be missing, affecting willingness to vaccinate. A potential source of bias for the project is believed to be a fear of answering honestly due to participants viewing the authors’ involvement as a part of the healthcare workforce.
An avenue that requires further ex-
ploration includes factors driving individuals’ reasons for unwillingness to vaccinate. This study found that many individuals who were unwilling to vaccinate performed well on the administered knowledge assessment. This indicates that there might be other tertiary reasons leading to unwillingness to vaccinate in our study population. A 2022 study identified cultural reasons, perceived lack of need for vaccinations, concerns over the safety of vaccines, and lack of trust as reasons for vaccine hesitancy.23 Furthermore, additional demographic information such as culture, religion, and political affiliation may help us close the gaps of why individuals are unwilling to obtain the vaccine. For future research, it is important to include a larger sample size to ensure external validity. Additionally, broadening the areas targeted for data collection would increase the probability of gathering data from subgroups that may have outside factors influencing their stance on vaccination.
Conclusion
In summary, this study found a statistically significant association be-
Table 4: Participants were asked to mark if each statement was true or false in the knowledge assessment section of the survey.
Influenza is transmitted primarily by coughing and sneezing.
Influenza is more serious than a “common cold.”
People can spread influenza even when they are feeling well.
People with influenza can transmit the infection only after their symptoms appear.
Influenza is transmitted primarily by contact with blood and body fluids.
The flu shot contains live viruses that may cause some people to get influenza.
Symptoms typically appear 8 -10 days after a person is exposed to influenza.
tween adults’ desire to receive the influenza vaccine and their perceptions of its advantages, conviction that those advantages exceed the risks, and level of trust in healthcare. This study could not find a significant association between adult’s willingness to vaccinate and their demographic data. This emphasizes the necessity of addressing the public health issue of vaccine uptake with a multimodal strategy that considers different characteristics.
Authors: Christina J. Ricker, PharmD Candidate; Lisa M. Jones, PharmD Candidate; Deborah O. Adebisi, PharmD Candidate; Pokou JM. Kouassi, PharmD Candidate; Meredith P. Hatchell, PharmD Candidate; and Edward T. Chiyaka, PhD, Assistant Professor. Wingate University School of Pharmacy; Wingate, NC 28174; Email: e.chiyaka@wingate.edu
References
1. Centers for disease control and prevention [Internet]. New York: U.S. department of health and human services. c2022 - [cited 2023 Oct]. Available from: https://www.cdc. gov/flu/about/keyfacts.htm
2. Centers for disease control and prevention [Internet]. New York: U.S. department of health and human services. c2021- [cited 2023 Oct]. Available from: https://www.cdc. gov/flu/professionals/infectioncontrol/healthcaresettings.htm
3. Grohskopf LA, Blanton LH, Ferdinands JM, Chung JR, Broder KR, Talbot HK. Prevention and control of seasonal influenza with vaccines: recommendations from the advisory committee on immunization practices—United States, 2023-24 influenza season. MMWR [Internet] 2023 Aug 25 [cited 2023 Oct];72(2):125. Available from: https://www. cdc.gov/mmwr/volumes/72/rr/ rr7202a1.htm
4. Javanian M, Barary M, Ghebrehewet
S, Koppolu V, Vasigala V, Ebrahimpour S. A brief review of influenza virus infection. Journal of medical virology [Internet] 2021 Apr 1 [cited 2023 Oct];93(8):4638-4646. Available from: https://onlinelibrary.wiley.com/doi/10.1002/jmv.26990
5. Coleman BL, Fadel SA, Fitzpatrick T, Thomas SM. (2018). Risk factors for serious outcomes associated with influenza illness in high- versus low- and middle-income countries: Systematic literature review and meta-analysis. Influenza and other respiratory viruses [Internet]. 2018 Jan [cited 2023 Oct];12(1), 22–29. Available from: https://onlinelibrary.wiley.com/doi/10.1111/ irv.12504
6. Poehling KA, et al. The underrecognized burden of influenza in young children. N Engl J Med [Internet] 2006 Jul 6 [cited 2023 Oct];355:3140. Available from: https://www. nejm.org/doi/full/10.1056/NEJMoa054869
7. Wilhelm, M. Influenza in older patients: a call to action and recent updates for vaccinations. the American journal of managed care [Internet] 2018 Mar 2 [cited 2023 Oct];24(2 Suppl), S15–S24.Available from: https://www.ajmc.com/view/influenza-in-older-patients-a-call-to-action-and-recent-updates-for-vaccinations
8. Macias AE, McElhaney JE, Chaves SS, Nealon J, Nunes MC, Samson SI, Seet BT, Weinke T, Yu H. The disease burden of influenza beyond respiratory illness. Vaccine [Internet]. 2021 Mar 15 [cited 2023 Oct];39(1):A6-A14. Available from: https://www.sciencedirect.com/science/article/ pii/S0264410X20312093?via%3Dihub
9. De Francisco (Shapovalova) N, Donadel M, Jit M, Hutubessy R. A systematic review of the social and economic burden of influenza in low- and middle-income countries. Vaccine [Internet] 2015 Nov 27 [cited 2023 Oct];33(48):6537-6544. Available from: https://www.sciencedirect. com/science/article/abs/pii/ S0264410X15014954?via%3Dihub
10. World Health Organization. (2019). Global influenza strategy 2019–2030. World Health Organization. https:// www.who.int/publications-de -
tail-redirect/9789241515320
11. Bresee J, Fitzner J, Campbell H, Cohen C, Cozza V, Jara J, Lee V. Progress and remaining gaps in estimating the global disease burden of influenza. Emerging infectious diseases [Internet]. 2018 Jul [cited 2023 Oct];24(7):1173-1177. Available from: https://www.ncbi.nlm.nih. gov/pmc/articles/PMC6038739/
12. Putri WCWS, Muscatello DJ, Stockwell MS, Newall AT. Economic burden of seasonal influenza in the United States. Vaccine [Internet] 2018 Jun 22 [cited 2023 Oct]; 36(27):3960-3966. Available from: https://www.sciencedirect. com/science/article/abs/pii/ S0264410X18306777?via%3Dihub
13. Tokars JI, Olsen SJ, Reed C. Seasonal incidence of symptomatic influenza in the United States. Clinical infectious diseases [Internet]. 2018 May 15 [cited 2023 Oct];66(10):15111518. Available from: https:// academic.oup.com/cid/article/66/10/1511/4682599?login=false
14. Nypaver C, Dehlinger C, Carter C. Influenza and influenza vaccine: a review. J midwifery womens health [Internet]. 2021 Jan-Feb [cited 2023 Oct];66(1):45-53. Available from: https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC8014756/
15. Rondy M, EI Omeiri N, Thompson MG, Leveque A, Moren A, Sullivan SG. Effectiveness of influenza vaccines in preventing severe influenza illness among adults: a systematic review and meta-analysis of test-negative design case-control studies. Journal of infection [Internet] 2017 Nov [cited 2023 Oct];75(5):381394. Available from: https://www. journalofinfection.com/article/ S0163-4453(17)30299-2/abstract
16. Buchy P, Badur S. Who and when to vaccinate against influenza. International journal of infectious diseases [Internet]. 2020 Feb 25 [cited 2023 Oct];93:375-387. Available from: https://www.ijidonline.com/article/S1201-9712(20)30098-9/fulltext
17. C, et al. Global influenza vaccination rates and factors associated with influenza vaccination. International journal of infectious diseases [Internet]. 2022 Oct 31 [cited 2023
Oct];125:153-163. Available from: https://www.ijidonline.com/article/S1201-9712(22)00574-4/fulltext
18. Centers of disease control and prevention [Internet]. New York: U.S. Department of Health and Human Services c2023- [cited 2023 Oct]. Available from: https://data.cdc. gov/Flu-Vaccinations/Influenza-Vaccination-Coverage-for-All-Ages-6-Mont/vh55-3he6
19. Granade CJ, Lindley MC, Jatlaoui T, Asif AF, Jones-Jack N. Racial and ethnic disparities in adult vaccination: a review of the state of evidence. Health equity [Internet]. 2022 Mar 7 [cited 2023 Oct];6(1):206223. Available from: https://www. ncbi.nlm.nih.gov/pmc/articles/ PMC8985539/
20. Lu D, Qiao Y, Brown NE, Wang J. Racial and ethnic disparities in influenza vaccination among adults with chronic medical conditions vary by age in the United States. PIoS One [Internet]. 2017 Jan 12 [cited 2023 Oct];12(1):e0169679. Available from: https://www.ncbi.nlm.nih. gov/pmc/articles/PMC5231366/
21. Davis TC, Arnold CL. Health literacy research in rural areas. Studies in health technology and informatics [Internet]. 2020 Jun 25 [cited 2023 Oct];269:241-247. Available form: https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC8590389/
22. MacDonald NE. Vaccine hesitancy: definition, scope and determinants. Vaccine [Internet]. 2015 Aug 14 [cited 2023 Oct];33(34):4161-4164. Available from: https://www.sciencedirect.com/science/article/
pii/S0264410X15005009?via%3Dihub
23. Kumar S, Shah Z, Garfield S. Causes of vaccine hesitancy in adults for the influenza and COVID-19 vaccines: a systematic literature review. Vaccines [Internet] 2022 Sept [cited 2023 Oct];10(9): 1518. Available from: https://www.ncbi.nlm.nih. gov/pmc/articles/PMC9503596/
24. Zhang V, Zhu P, Wagner AL. Spillover of vaccine hesitancy into adult COVID-19 and influenza: the role of race, religion, and political affiliation in the United States. International journal of environmental research and public health [Internet]. 2023 Feb [cited 2023 Oct];20(4):3376. Available from: https://www. ncbi.nlm.nih.gov/pmc/articles/ PMC9966756/
25. Nowak GJ, Evans NJ, Wojdynski BW, Ahn SJG, Len-Rios ME, Carera K, Hale S, McFalls D. Using immersive virtual reality to improve the beliefs and intentions of influenza vaccine avoidant 18-to-49-year-olds: considerations, effects, and lessons learned. Vaccine [Internet]. 2020 Jan 29 [cited 2023 Oct];38(5):1225-1233. Available from: https://www.sciencedirect.com/science/article/abs/pii/ S0264410X19315166?via%3Dihub
26. Welch VL, Metcalf T, Macey R, Markus K, Sears AJ, Enstone A, Wiemken TL. Understanding the barriers and attitudes toward influenza vaccine uptake in the adult general population: a rapid review. Vaccine [Internet]. 2023 Jan [cited 2023 Oct];11(1):180. Available from: https://www.ncbi.nlm.nih. gov/pmc/articles/PMC9861815/
27. Eiden AL, Barratt J, Nyaku MK. A review of factors influencing vaccination policies and programs for older adults globally. Human vaccines and immunotherapeutics [Internet]. 2023 Jan 19 [cited 2023 Oct];19(1):2157164. Available from: https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC9980618/
28. Williams BE, Kondo KK, Ayers CK, Kansagara D, Young S, Saha S. Preventing unequal health outcomes in COVID-19: a systematic review of past interventions. Health equity [Internet] 2021 [cited 2023 Oct];5(1):856-871. Available from: https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC8742307/
Effect of Parent Education on the Willingness to Enforce Screen Time Limitations on Children to Increase Physical Activity and Combat Childhood Obesity
By: Alyssa Bland, Jasmine Gibson, Alexis Howard, Rylee Williams, Charlie Yang, and Dr. Lisa Dinkins
Objective
This study aimed to assess the change in the willingness of parents/ guardians to alter their children(s) physical activity or monitor screen time following a brief educational encounter.
Methods
This study included parents/guardians of children ages 5-13 years. It was conducted in various locations across Union County, North Carolina, targeting areas such as health fairs, parks/playgrounds, local children’s museums, and neighborhoods. Participants were given introductory information followed by a 3–5-minute education session and educational pamphlet. Educational material included information on obesity prevalence in children, along with recommendations on physical activity and screen time. Participants completed a 4-question Likert scale survey after receiving educational material, which asked them to compare their willingness to monitor screen time or alter their child(ren)’s physical activity before and after the educational encounter.
Results
There were 28 participants in the study. Prior to the educational encounter, the majority of parents were “likely” (32.1%) or “very likely” (28.6%) to monitor their child’s physical activity, which increased to 46.4% and 32.1%, respectively, after the educational intervention. For screen time, prior to education, 39.2% of parents were “likely” to monitor screen time, which increased to 60.7% of parents being “very likely” after the educational intervention.
Conclusions
Parents/guardians were more willing to monitor their child(ren)’s screen time and alter their physical activity following a brief educational encounter. Future studies could increase the number of community partners, such as parent-teacher association meetings and collaboration with local organizations for wider outreach.
Introduction
The effects of increased screen time
and decreased physical activity with the advancement of modern technology have contributed to increased rates of childhood obesity. Technology is rapidly becoming more accessible, leading to an increase in screen time in childhood, which contributes to a sedentary lifestyle.1 A sedentary lifestyle leads to decreased physical activity, poorer metabolic health, shorter sleep duration, higher adiposity, and poorer mental health outcomes.2
Ten years ago, the Centers for Disease Control (CDC) reported roughly 1 in 6 American children were obese.3 In 2022, the CDC reported that number increased to 1 in 5 American children.4 Increased prevalence of childhood obesity can increase demands on healthcare resources and costs. The CDC states that $173 billion dollars a year is spent on obesity healthcare costs.4 Key stakeholders on this issue include health insurance companies, government and community assistance, and parents/guardians. Health insurance company interests are to ensure that individuals are receiving affordable and adequate healthcare, while government and community assistance play a role in ensuring needed health services are provid-
ed. Parents/guardians are the direct stakeholders to their children. Various interventions involving these stakeholders have been conducted to find ways to decrease childhood obesity rates, lower healthcare costs, and increase quality of life.
A study conducted in 2021 on people 10-24 years of age focused on the gap between physical activity surveillance and actual physical activity in adolescents. It evaluated three intervention components: supportive schools, social and digital environment, and multi-utility urban environment. The study discussed the need for a multi-level intervention to combat the issue of deceased physical inactivity in children. This study showed the importance of interventions in schools through their curriculum, such as physical education and health classes, and how the impact of technology and screen time correlates with the lack of physical activity and education in urban environments. The study also reviewed an article that concluded that after two years of multi-level interventions, including educational classes, students averaged seven more minutes of mild to moderate-intensity exercise per day.5 Another study conducted in 2021 on children aged 2-5 years focused on the impact of an obesity intervention and measured children’s hours of TV viewing, BMI, and waist circumference over 35 weeks. This study showed a correlation between parental involvement and screen time limitations. When parents limited or monitored screen time, weekly screen time decreased by 1.79 hours, BMI z-score (standard deviation from normal BMI in children based on age, sex and BMI percentiles) decreased by 0.16 (indicating a decrease in overall BMI,
approaching 0 which represents the average BMI z-score and 50th percentile) indicating a further BMI reduction beyond the average for the participants, and waist circumference decreased by almost half a centimeter.6 A 2022 systematic review evaluated interventions, including nutrition education, physical activity assessment, and daily screen time measurements. A correlation was found between sedentary behavior and screen time totals. It included over 50 studies that analyzed the public health programs in place, such as healthier school lunches and wellness policies in the community, along with other programs. Overall, the review concluded that most interventions are conducted in higher-income communities, and further research and interventions should be focused on lower-income communities that may not have access to the intervention methods.7 As stated, surveillance of adolescents is the key to encouraging exercise and decreasing screen time. Parental education is a necessary step to ensuring that children understand the impact and benefit of exercise on their health and wellbeing.
In 2007, the percentage of children aged 6-17 years with less than 2 hours or no daily screen time ranged from 70.3% in black non-Hispanics, 80.8% in Hispanics, to 84.6% in white non-Hispanics. At the time of this study, a majority of children were not using screens, but this data was collected during a time when technology was not as prevalent as it is today.8 North Carolina has taken a multitude of initiatives to combat the issue of childhood obesity by promoting healthy eating habits and exercise, but there are fewer programs emphasizing screen time
limitations.9 In 2006, a CHAMP survey was administered to parents asking about physical activity and screen time limits for their children. Of the 2,796 respondents, 1,177 (42.6%) stated yes, they were trying to encourage both. Only 222 (7.7%) said yes to only encouraging more physical activity and 385 (14.1%) said yes to only limiting screen time. Overall, this means 64.4% of parents were encouraging their children to adopt more healthy habits.10
The aim of this study is to investigate the impact of education on parental involvement in increasing physical activity and monitoring screen time for their children ages 5-13 years. Following an educational intervention, it is hypothesized that parents will increase their involvement in screen time and physical activity in their child, ultimately decreasing rates of childhood obesity.
Methods
This study was conducted by thirdyear student pharmacists in various locations across Union County, North Carolina, targeting areas such as health fairs, parks/playgrounds, local children’s museums, and neighborhoods where it would be likely to encounter parents/guardians of children ages 5-13 years. As a demographic, children ages 5-13 are important, as these children likely live in their childhood homes with more parental oversight than those over 13 years old. Children over the age of 13 have more autonomy when it comes to engaging in extracurricular sports and free time, especially those over the age of 16 who can drive.
Potential participants were approached and given introductory
information about the study and eligibility requirements. Inclusion criteria for this study were parents/ guardians with children ages 5-13 who have access to electronic devices at home. Adults with no children, parents with no children between ages 5 and 13 years, or parents who have no access to electronic devices at home were excluded from the study. After eligibility was determined, participants were provided with a 3–5-minute education session and given an educational pamphlet. Educational material included information on obesity prevalence in children, along with recommendations on physical activity and screen time. The participants were then asked to complete a survey (Table 1).
Data was collected from parents using a QR code that was linked to the four-question survey utilizing Qualtrics Experience Management*, with two questions regarding the child’s previous physical activity levels and monitored screen time and two questions regarding willingness to modify the child’s physical activity and screen time. Data was imported into Microsoft Excel software**. A statistical analysis, a
T-test, range, mean, and standard deviation calculations were performed using Microsoft Excel [Table 3]. Values (1,2,3,4) were assigned for the answers (not at all likely (1), somewhat likely (2), likely (3), very likely (4)) of the Likert scale survey and transferred to a pivot table [Table 2]. Two-tailed paired T-tests were utilized to compare participants’ willingness before and after intervention education sessions.
Data Analysis And Results
There were 28 participants in the education session and survey. All participants were parents/guardians of children ages 5-13 years residing in Union County, North Carolina. As shown in Table 2, before the education session, the majority of parents noted they were “likely” (32.1%) to monitor their child’s physical activity, with the rating staying the same, being “likely” (46.4%) after the educational intervention. For the screen time questions, before education, the majority (39.2%) of parents stated they were “likely” to monitor screen time, which shifted to the majority (60.7%) being “very likely” after the educational intervention. A two-tail paired T-test was
performed to show the difference between Q1 and Q2 on physical activity and between Q3 and Q4 on screen time. The p-value between Q1 and Q2 was 0.18, and the p-value between Q3 and Q4 was 0.00003.
Discussion
Table 1: Survey Questions: Options for response: “Not at all likely,” ”Likely,” “Somewhat likely,” or “Very likely.”
This study investigated parents’ willingness to enforce screen time limitations on children to increase physical activity and combat childhood obesity. In this study, parents’ willingness to make changes to physical activity was not significantly impacted by the educational intervention. This could be due to several factors, including parents’ lack of knowledge on indoor exercises or engagement with children, difficulty consistently enforcing exercise due to a busy work schedule, or potentially thinking that no big changes can be made. There was a statistically significant difference in willingness to make changes in screen time. This result could be from factors including education on recommended amounts of daily screen time, parents being more aware of the impact of screen time on children’s health in the presence of increasing technology, and easy implementation of monitoring applications requiring less supervision.
Question 1 (Q1) Before today, how likely were you to make changes to your child’s physical activity?
Question 2 (Q2) After today, how likely were you to make changes to your child’s physical activity?
Question 3 (Q3) Before today, how likely were you to make changes to your child’s screen time?
Question 4 (Q4) After today, how likely were you to make changes to your child’s screen time?
In the study by Neshteruk et al., 2021, the association between parents’ personal screen time habits and their 2-5-yearold children’s TV viewing and weight status was investigat-
Table 2: Percentages Breakdown Per Question: 28 Responses were evaluated. Values (1,2,3,4) were assigned for the answers not at all likely (1), somewhat likely (2), likely (3), very likely (4).
Response to Questions 1-4
ed. This study concluded that limiting TV screen time was associated with decreased BMI z-score and waist circumference over the study period. The other study group had parents use TV screen time as a reward, which was associated with increased weekly TV viewing over the follow-up of 59 weeks and led to an increased BMI z-score.
Researchers agree that optimizing parenting limitations on screen time can help with pediatric obesity prevention, and different strategies can be utilized to provide guidance to parents on their children’s screen time and media use.6 While the scope and sample size of our study is small, it can serve as a pilot, providing one of many strategies to help guide a parent’s decision on limiting screen time through a brief educational intervention. Our results show that an educational intervention can motivate parents to monitor and be more proactive about limiting screen time. Further investigation should be completed using different interventions that can be implemented to encourage parents to monitor screen time and increase physical activity.
This study assessed parents’ willingness to modify their child’s physical activity and screen time when presented with an educational intervention. Our study adds to the broader field of study by showing that parental involvement in children’s lifestyle practices at an early age is important. Our study could be improved by targeting a larger population and different communities to have more evidence to compare, which in turn has the potential to impact the field by creating public health initiatives to encourage and teach parents how to keep their children physically active. Our research question focused on parental involvement in children’s exercise before and after an educational intervention. Although the intervention did not lead to a change in parental involvement in children’s exercise, there was a statistically significant increase in parents’ willingness to monitor screen time following the educational intervention. Overall, this study contributes to parents’ awareness of screen time and how it can affect physical activity and its relationship to children’s health.
Strengths & Limitations
The educational intervention and survey were relatively simple and required only a few minutes of time commitment from parents. This allowed more participants to be actively engaged and decide based on the education provided to them. Utilizing a booth with candy and small toys was an effective way to entice children to come over and bring their parents with them.
The Union County area had a variety of options when selecting a location that would be populated with parents and children to conduct the intervention. Despite having multiple locations to select from, the target population was spread out, making data collection challenging. A lack of study participants can provide unreliable and biased results that are not representative of the whole population of focus. To mitigate this, future strategies could include outreach via social media and collaboration with local organizations, such as a Parent Teacher Association (PTA) meeting. These methods would require additional networking but would yield greater results in terms of data collection. The lack of demographic data allowed for the survey to be more easily and quickly filled out by parents
Table 3: Data analysis : P-value was calculated using paired T-test comparing Q1 and Q2 and Q3 and Q4
but failed to provide insight into how race/ethnicity, socioeconomic status, age, or other demographic factors impact the participants’ willingness to monitor screen time or increase their child(ren)’s physical activity.
Conclusion
The purpose of this study was to assess the impact of education on parental involvement in increasing physical activity and monitoring screen time for their children ages 5-13 years. After educational materials were provided, significantly more parents were willing to monitor their child(ren)’s screen time. Parents did not convey a significant difference in willingness to increase physical activity when compared to monitoring screen time before and after educational materials were provided. Pharmacists play a vital role in the community and are equipped to educate parents on the harmful effects of increased screen time and decreased physical activity that may move the needle in a positive direction.
*Qualtrics Experience Management, November - December 2023
Provo, Utah
**Microsoft Excel 2021, November - December 2023, Redmond Washington
Authors: Alyssa Bland B.S., Jasmine Gibson B.S., Alexis Howard B.S., Rylee Williams, Charlie Yang B.S., and Lisa Dinkins PharmD, BCACP; Wingate University School of Pharmacy
References
1. Sahoo K, Sahoo B, Choudhury AK, Sofi NY, Kumar R, Bhadoria AS. Childhood obesity: causes and consequences. J Family Med Prim Care. 2015;4(2):187192. doi:10.4103/2249-4863.154628
2. Shenoi RP, Linakis JG, Bromberg JR, et al. Association of Physical Activity, Sports, and Screen Time With Adolescent Behaviors in Youth Who Visit the Pediatric Emergency Department. Clin Pediatr (Phila). 2022;61(4):335=doi:10. 1177/00099228221075094
3. Prevalence of Overweight and Obesity Among Children and Adolescents: United States, 1963–1965 Through 2011–2012. Centers for Disease Control and Prevention. November 6, 2015. Accessed October 5, 2023. https://www. cdc.gov/obesity/about-obesity/why-itmatters.html.
4. Why it matters. Centers for Disease Control and Prevention. July 14, 2022. Accessed October 5, 2023. https://www. cdc.gov/obesity/about-obesity/why-itmatters.html.
5. Van Sluijs EMF, Ekelund U, Crochemore-Silva I, et al. Physical activity behaviours in adolescence: current evidence and opportunities for intervention. Lancet. 2021;398(10298):429-442. doi:10.1016/S0140-6736(21)01259-9
6. Neshteruk CD, Tripicchio GL, Lobaugh S, et al. Screen Time Parenting Practices and Associations with Preschool Children’s TV Viewing and Weight-Related Outcomes. Int J Environ Res Public Health. 2021;18(14):7359. Published 2021 Jul 9. doi:10.3390/ijerph18147359
7. Oh C, Carducci B, Vaivada T, Bhutta ZA. Interventions to Promote Physical Activity and Healthy Digital Media Use in Children and Adolescents: A Systematic Review. Pediatrics. 2022;149(Suppl 5):e2021053852I. doi:10.1542/ peds.2021-053852I
8. North Carolina state factsheet prevalence of obesity among low ... - NICHQ (2008) North Carolina state factsheet prevalence of obesity. Available at: https://static.nichq.org/obesity-factsheets/North%20Carolina/NC_State_ Factsheet.pdf (Accessed: 11 October 2023).
9. CS233917- Overweight and Obesity North Carolina State Nutrition, Physical Activity, and Obesity Profile.; 2012. https://www.cdc.gov/obesity/stateprograms/fundedstates/pdf/North-Carolina-State-Profile.pdf
10. CHAMP: (Are you trying to encourage more physical activity or limit TV/video/computer game time?*). schs.dph. ncdhhs.gov. Accessed October 4, 2023. https://schs.dph.ncdhhs.gov/data/ champ/trends/red_tv.html
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An aDAPTing Practice: Dual Antiplatelet Therapy (DAPT) after Percutaneous Coronary Intervention
By: Dr. Jahnavi Yetukuri, Dr. Manali Patel, Dr. Andrew Darkow, and Dr. Payal Desai
Background
Coronary artery disease (CAD) is the most common type of heart disease in the United States. CAD is initially caused by atherosclerosis in coronary artery walls, leading to gradual arterial narrowing and reduced cardiac perfusion. In severe cases, CAD can progress to acute coronary syndrome (ACS), which is a sudden reduction in blood supply to the cardiac muscle. This can be caused by rupturing plaque deposits, which can result in intracoronary thrombus formation and arterial occlusion. ACS is classified as ST-elevation myocardial infarction (STEMI), indicating complete vessel occlusion, or non-ST-elevation ACS (NSTE-ACS), a partial blockage. NSTE-ACS consists of non-ST-elevation myocardial infarction (NSTEMI) and unstable angina with the differentiating characteristic of myocardial damage. Some patients with ACS may require percutaneous coronary intervention (PCI) with coronary stent placement to relieve the arterial occlusion and restore blood flow to ischemic myocardial tissue.1
Stent thrombosis is a potentially fatal complication that can occur
following PCI. The risk of stent thrombosis varies with the type of stent placed. With bare metal stents, stent thrombosis risk is highest within 1 month, whereas drug-eluting stents (DES) risk occurs between 1 to 12 months. Second-generation DES has the lowest thrombosis risk due to improved design features and the use of different antiproliferative agents, including zotarolimus and
The risk of stent thrombosis can be reduced after PCI with dual antiplatelet therapy (DAPT). DAPT has also been shown to reduce the recurrence of cardiovascular ischemic events after PCI. DAPT consists of aspirin and a P2Y12 inhibitor, each with unique properties and considerations (Table 1). Compared to clopidogrel, pra-
Mechanism
Inhibition
Inhibits COX-1 and COX-2 activation, which prevents platelet aggregation
Clinical pearls Use with caution in patients with NSAID allergy
Binds to P2Y12 receptor on platelets to inhibit ADPstimulated platelet activation
Reduced efficacy with inhibitors and poor CYP2C19 metabolizers
Contraindicated with history of prior stroke or transient ischemic attack
May cause dyspnea and bradycardia; limit concomitant aspirin dose to 100 mg/day
Table 1: Antiplatelet Agent Characteristics 1
sugrel and ticagrelor are more effective at reducing major adverse cardiovascular events (MACE) but are associated with higher bleeding risk and increased cost.1 In addition, certain populations on DAPT may have increased bleeding or ischemic risks due to patient characteristics and comorbidities. As a result, the 2021 American College of Cardiology (ACC) and American Heart Association (AHA) Guideline for Coronary Artery Revascularization recommends assessing patient-specific factors to guide P2Y12 inhibitor selection and DAPT duration to reduce bleeding risk without increasing ischemic events.1 This review discusses current evidence evaluating DAPT strategies for PCI after ACS and their clinical applications in special patient populations with high bleeding risk or CYP2C19 genetic polymorphisms.
High Bleeding Risk
Many patients may have individual characteristics or comorbidities that notably increase their bleeding risk. Potential factors that can increase bleeding risk include advanced age, diabetes, prior bleeds, female sex, low body weight, anemia, and the need for chronic steroid or non-steroidal anti-inflammatory drug (NSAID) therapy.1 Advanced age and diabetes are also considered risk factors for increased ischemic risk, in addition to ACS presentation and prior history of myocardial infarctions. Considering a patient’s individual bleeding and ischemic risk factors will help formulate an optimal patient-centered DAPT regimen. Clopidogrel may be preferred in these patients due to possessing the lowest bleed risk
among the P2Y12 inhibitors.1
Available literature evaluates other strategies that can be implemented to mitigate bleeding and ischemic risks.
P2Y12 Inhibitor De-escalation
One DAPT strategy evaluated is de-escalation of the P2Y12 inhibitor agent, which involves initiating ticagrelor or prasugrel for at least 1 month before switching to clopidogrel. Since the risk of stent thrombosis is highest in the first month after PCI, switching to clopidogrel earlier than 1 month should be avoided.1 Two large randomized controlled trials (RCTs), TOPIC and TALOS-AMI, evaluated P2Y12 inhibitor de-escalation at 1 month in patients with ACS (Table 2).2,3 In TOPIC, prasugrel or ticagrelor was de-escalated to clopidogrel and compared to a control group of clopidogrel.2 In comparison, TALOS-AMI evaluated ticagrelor de-escalated to clopidogrel and utilized a control group with ticagrelor.3 Both studies concluded that P2Y12 inhibitor de-escalation was associated with greater net clinical benefit, driven by a reduction in bleeding risk. Notably, study populations were not limited to those at high bleeding risk and TALOS-AMI only included East Asian patients, which may limit generalizability. While this de-escalation strategy is not routinely recommended for most patients, it may be consid-
ered for those with high bleeding risk.
Shortened DAPT Duration
The recommended DAPT duration is at least 12 months for most patients undergoing PCI after ACS.1 More recently, the 2021 ACC/AHA Guideline for Coronary Artery Revascularization recommends considering shorter DAPT durations with transition to antiplatelet monotherapy.1 After 1 to 3 months of DAPT, patients may be switched to P2Y12 inhibitor monotherapy to reduce bleeding risk. For patients with high bleeding risk or overt bleeding on DAPT, the regimen may be changed to aspirin monotherapy.
Three large RCTs (SMART CHOICE, TWILIGHT, and TICO) compared incidences of bleeding and MACE between 3-month DAPT and 12-month DAPT (Table 2).4-6 These studies concluded that shortened DAPT regimens of 3 months followed by P2Y12 inhibitor monotherapy significantly reduced bleeding risk without increasing MACE. One important consideration is that study populations in SMART CHOICE, TWILIGHT, and TICO primarily presented with non-ST-elevation-ACS (NSTE-ACS).4-6 As a result, the clinical utility of the shortened three-month DAPT regimen is likely more applicable to patients who underwent PCI after NSTEACS rather than those with PCI af-
Data reported as hazard ratio (HR) (95% confidence interval)
*Not referenced in text: Valgimigli M, Frigoli E, Heg D, et al. Dual antiplatelet therapy after PCI in patients at high bleeding risk. N Engl J Med. 2021; 385:1643-1655.
¥Not referenced in text: Watanabe H, Domei T, Morimoto T, et al. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12 -Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI. JAMA. 2019; 321(24):24142427.
Trial Patients Interventio n
P2Y12 Inhibitor De-escalation TOPIC (2017)2
N = 646
ACS: 100% Deescalation at 1 month
Prasugrel or ticagrelor to clopidogrel
TALOSAMI (2021)3
N = 2697
ACS: 100% Deescalation at 1 month
Ticagrelor to clopidogrel
Shortened DAPT Duration SMARTCHOICE (2019)4
N = 2993 STEMI: 10% NSTEACS: 63%
TWILIGHT (2019)5
N = 9006
STEMI: 0% NSTEACS: 63%
TICO (2020)6
STOP DAPT2 (2019)¥
MASTERDAPT (2021)*
STOP DAPT-2 ACS (2022)7
T-PASS (2023)8
Clopidogr el DAPT
HR 0.39 (0.270.57), p < 0.01 HR 0.48 (0.34-0.68), p = 0.36 HR 0.48 (0.340.68), p < 0.01
Ticagrelor DAPT HR 0.52 (0.350.77), p = 0.0012 HR 0.69 (0.42-1.14), p = 0.15
HR 0.55 (0.400.76), p = 0.0001
3 months DAPT, then P2Y12 inhibitor only 12 months DAPT
0.58 (0.360.92), p = 0.02 2.9% in short DAPT vs 2.5% in
p < 0.001 for noninferiority
3 months DAPT, then ticagrelor only 12 months DAPT (ticagrelor )
0.56 (0.450.68), p < 0.001
N = 3056 STEMI: 36% 3 months DAPT, then ticagrelor only 12 months DAPT (ticagrelor )
NSTEACS: 64%
N = 3045
STEMI: 19%
NSTEACS: 20% 1-month DAPT with clopidogrel or prasugrel, then clopidogrel only
N = 4579
STEMI: 12%
NSTEACS: 37%
N = 4136
STEMI: 56%
NSTEACS: 20%
N = 2850
12 months DAPT with clopidogre l, then aspirin only
1-month DAPT, then either aspirin only or P2Y12 inhibitor only 6-month DAPT, then either aspirin only or P2Y12 inhibitor only
1- to 2month DAPT, then clopidogrel only
STEMI: 40% NSTEACS: 35% < 1 month of DAPT (ticagrelor), then ticagrelor only
12-month DAPT, then clopidogre l only
0.56 (0.340.91), p = 0.02
3.9% in short DAPT vs 3.9% in control, p < 0.001 for noninferior ity
2.3% in short DAPT vs 3.4% in control, p = 0.09
HR 0.26, (0.110.64), p = 0.004 2% in short DAPT vs 2.5% in control, p = 0.005 for noninferiority
HR 0.68 (0.550.84), p < 0.001
HR 1.02 (0.8-1.3), p = 0.001 for noninferiority
HR 0.97 (0.78-1.2), p < 0.001 for noninferiority
HR 0.46 (0.230.94)
ter ST-elevation myocardial infarction (STEMI).
In STOPDAPT-2 ACS, more than half of the study population presented with STEMI prior to PCI, which added to the previously limited evidence in this patient population (Table 2).7 The results of STOPDAPT-2 ACS demonstrated that one to two months of DAPT followed by clopidogrel monotherapy failed to demonstrate noninferiority to 12-month DAPT. Although major bleeding events were reduced, MACE was numerically higher with the shortened DAPT regimen group. Overall, STOPDAPT-2 ACS findings were inconclusive and unable to support shorter DAPT durations of one to two months in patients with ACS, particularly those who underwent PCI after STEMI and on clopidogrel.
HR 1.50 (0.99-2.26)
(0.8-1.62), p = 0.06 for noninferiority
12-month DAPT (ticagrelor ) HR 0.35 (0.2-0.61), p < 0.001 HR 0.68 (0.39-1.18), p = 0.17 HR 0.54 (0.37-0.8), p = 0.002
ULTIMATE -DAPT (2024)9
N = 3400
STEMI: 28%
NSTEACS: 72%
< 1 month of DAPT (ticagrelor), then ticagrelor only
ACS: Acute coronary syndrome
12-month DAPT (ticagrelor )
HR 0.45 (0.3-0.66), p < 0.0001
HR 0.98 (0.69-1.39), p < 0.0001 for noninferiority
HR 0.68 (0.530.88), p = 0.007
More recently, T-PASS and ULTIMATE-DAPT compared a shorter duration of less than one month of DAPT with ticagrelor to 12 months of DAPT with ticagrelor (Table 2) 8,9 A larger proportion of patients in T-PASS presented with STEMI prior to PCI (40%) compared to those in ULTIMATE-DAPT (28%). Results from both studies demonstrated a significantly improved net clinical benefit with DAPT for less than one month, driven by a reduction in bleeding risk. T-PASS and ULTIMATE-DAPT augment existing data in this patient population. These new trials indicate the safe use of DAPT with ticagrelor for less than one month, followed by ticagrelor monotherapy.
Key Takeaways – High Bleeding
STEMI: ST-elevation myocardial infarction
NSTE-ACS: Non-ST-elevation acute coronary syndrome (NSTEMI and unstable angina)
Clopidogrel has the lowest bleeding risk of the P2Y12 inhibitors. P2Y12 inhibitor de-escalation to clopidogrel after 1 month of DAPT with ticagrelor or prasugrel may be considered to reduce bleeding risk. Shortened duration of DAPT and early discontinuation of aspirin (after 1 to 3 months) or P2Y12 inhibitor (after 6 months) may reduce bleeding risk without increasing ischemic risk in certain patient populations. There is insufficient evidence to support early aspirin discontinuation in patients who underwent PCI after STEMI and continued clopidogrel monotherapy. Newer data suggests shortened DAPT (< 1 month) with continuation of ticagrelor monotherapy as a potential option for patients who underwent PCI, even those who presented with STEMI.
Triple Therapy
Triple therapy involves the concurrent use of an anticoagulant with aspirin and a P2Y12 inhibitor. Indications that may warrant the use of triple therapy include atrial fibrillation, venous thromboembolism (VTE), and prosthetic heart valves. Patients requiring triple therapy have a two- to three-fold increased bleeding risk.1,10 Since most existing evidence focuses on patients with atrial fibrillation, this review discusses literature relevant to the use of triple therapy for this indication in the setting of PCI.
For patients with atrial fibrillation on anticoagulation after PCI, the 2021 ACC/AHA Guideline on Coronary Artery Revascularization recommends discontinuing aspi-
rin after one to four weeks of triple therapy to minimize bleeding risk without increasing the risk of stent thrombosis.1 Direct oral anticoagulants (DOACs) are generally preferred over warfarin due to lower associated bleeding risks. A 2020 ACC Expert Consensus Decision Pathway provides additional guidance on DAPT management after PCI for patients with atrial fibrillation requiring anticoagulation.10 In addition to an anticoagulant agent, the ACC Consensus Pathway recommends initiating aspirin (maximum dose of 81 mg/day) and a P2Y12 inhibitor for patients who underwent PCI after ACS. On discharge or for up to 30 days after PCI, aspirin may be stopped with the continuation of the P2Y12 inhibitor and anticoagulant agent.10 In patients with high bleeding risk, P2Y12 inhibitor therapy can be discontinued after 6 months with continuation of anticoagulant only.11 Clopidogrel is the preferred P2Y12 inhibitor choice due to its lower bleeding risk. Ticagrelor may also be considered as part of triple therapy for PCI after ACS. Prasugrel should be avoided due to the high bleeding risk.1,10
Several landmark trials compared a combination of an anticoagulant and P2Y12 inhibitor to triple therapy for patients with atrial fibrillation (Table 3).11-14 In WOEST, patients who received warfarin with clopidogrel had a lower incidence of bleeding and MACE compared to those on triple therapy with warfarin.11 Similarly, PIONEER AF-PCI and RE-DUAL PCI demonstrated a combination of P2Y12 inhibitors and rivaroxaban or dabigatran, respectively, had significantly lower bleeding
compared to triple therapy with warfarin.12,13 Differences in MACE were not statistically significant in both studies. ENTRUST AF-PCI had a similar study design and evaluated edoxaban in this context.13 Results met noninferiority for bleeding and no significant difference in MACE. Notably, in the trials of DOACs, the most commonly used P2Y12 inhibitor was clopidogrel.11-13 In summary, these trials exhibited that a combination with a P2Y12 inhibitor and DOAC, specifically rivaroxaban or dabigatran, significantly reduced bleeding without increasing MACE after PCI in patients with atrial fibrillation when compared to warfarin triple therapy.
Unlike prior studies, AUGUSTUS utilized a two-by-two factorial design (Table 3).15 Patients with atrial fibrillation and recent ACS or PCI on a P2Y12 inhibitor received one anticoagulant (apixaban or warfarin) with aspirin or placebo. Results demonstrated the most bleeding events occurred with the warfarin and aspirin combination. Notably, the use of aspirin was associated with a nearly two-fold increase in bleeding events.15 Compared to patients who received a placebo, aspirin use did not significantly reduce MACE, death, or hospitalizations compared to placebo. AUGUSTUS confirmed that apixaban with a P2Y12 inhibitor was associated with a lower bleeding risk without increasing MACE.15
Key Takeaways – Triple Thera-
py
This review focused on patients with atrial fibrillation and requiring anticoagulation after PCI.
Table 3: Findings of Studies Evaluating DAPT Strategies after PCI for Triple Therapy and CYP2C19 Genetic Polymorphisms
Trial Patient s Intervention
Triple Therapy in Atrial Fibrillation WOEST (2013)11
PIONEER AF-PCI (2016)12
N = 2124
N = 563 Warfarin + clopidogrel Warfarin triple therapy
Rivaroxaban 15 mg daily + clopidogrel
Rivaroxaban 2.5
mg BID + DAPT
RE-DUAL PCI (2017)14
ENTRUST AF-PCI (2019)13
AUGUSTUS( 2019)15
N = 2725
N = 1506
N = 4614
2x2 factorial design
Dabigatran 110 mg BID + clopidogrel
Dabigatran 150 mg BID + clopidogrel
Edoxaban 60 mg (or 30 mg) daily + clopidogrel
Apixaban 2.5 mg or 5 mg BID
Warfarin (Goal INR 2-3)
HR 0.36 (0.26-0.5), p < 0.0001
HR 0.59 (0.47-0.76), p < 0.001
HR 0.63
(0.5-0.8), p < 0.001
HR 0.52 (0.42-0.63), p < 0.001
HR 0.72 (0.58-0.88), p < 0.002
HR 0.83 (0.65-1.05), p = 0.001 for noninferiority
HR 0.69 (0.58-0.81), p < 0.001
Aspirin 81 mg daily Placebo HR 1.89 (1.59-2.24), p < 0.001
CYP2C19 Genotype-Guided Therapy
PHARMCLO (2018)18
N = 888
POPular Genetics
N = 2488
Genotype-guided LOF: ticagrelor or prasugrel
Non-LOF: clopidogrel, ticagrelor, prasugrel
Genotype-guided
Standard therapy (clopidogrel, ticagrelor, prasugrel)
Standard therapy
HR 0.62 (0.35-1.1), p = 0.1
HR 0.6 (0.38-0.94), p = 0.025
HR 1.08 (0.69-1.68), p = 0.75
HR 0.93 (0.59-1.48), p = 0.76
HR 1.04 (0.84-1.29), p = 0.25
HR 1.06 (0.71-1.69), Not significant
HR 0.93 (0.75-1.16), Not significant
HR 0.89 (0.71-1.11), Not significant
HR 0.58 (0.43-0.78), p < 0.001
HR 0.78 (0.61-0.98),
HR 0.87 (0.62-1.21), (2019)17 LOF: ticagrelor or prasugrel Non-LOF: clopidogrel (ticagrelor, prasugrel) p = 0.04 p = 0.4
TAILOR-PCI (2020)19
N = 1849
Beitelshees et al (2022)20
Genotype-guided LOF: ticagrelor Non-LOF: clopidogrel
Standard therapy (clopidogrel)
HR 1.22 (0.6-2.52), p = 0.58
HR 0.66 (0.43-1.02), p = 0.06
At 90 days: HR 0.21 (0.08-0.54), p = 0.001
N = 3342
Retrospective study design LOF: Alternative antiplatelet (prasugrel, ticagrelor, high dose clopidogrel 150 mg/day)
Non-LOF: Alternative antiplatelet (prasugrel, ticagrelor, high dose clopidogrel 150 mg/day)
Clopidogrel: LOF
LOF: CYP2C19 loss -of-function allele carrier
LOF: clopidogrel
Duration of aspirin as part of triple therapy is usually limited to 4 weeks. After 4 weeks of triple therapy, an oral anticoagulant and P2Y12 inhibitor are continued. Based on existing evidence, DOACs and clopidogrel are the most preferred agents, although ticagrelor may be considered for patients with ACS. Prasugrel is generally avoided with oral anticoagulation due to the high bleeding risk. In most patients with ACS who received a DES, the P2Y12 inhibitor is continued for 12 months. A shortened duration of 6 months may be considered for those at high bleeding risk.
CYP2C19 Genetic Polymorphisms
Non-LOF: clopidogrel
HR 1.15 (0.6-2.2), p = 0.685
HR 0.56 (0.39-0.82), p = 0.002
HR 1.3 (0.71-2.38), p = 0.397
HR 1.08 (0.72-1.62), p = 0.715
Clopidogrel: Non-LOF N/A HR 1.67 (1.27 - 2.19), p < 0.001
Non-LOF: CYP2C19 loss-of-function allele non -carrier Data reported as hazard ratio (HR) (95% confidence interval)
Since clopidogrel is a prodrug requiring CYP2C19-mediated conversion to its active metabolite, patients with polymorphisms in the CYP2C19 alleles can have a reduced response to clopidogrel. This reduction in clopidogrel activity is associated with a black box warning due to increased ischemic risk. More than 30% of U.S. individuals carry a CYP2C19 loss-of-function allele, and those of East Asian descent have a higher prevalence.16 Genotype-guided therapy has been considered in select patients. The 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines recommend prasugrel or ticagrelor for patients who are intermediate or poor metabolizers without contraindications.16 ACC and AHA guidelines provide little to no guidance on utilizing CYP2C19 genotype-guided therapy.
The POPular Genetics trial evaluated a genotype-guided de-escala-
tion strategy (Table 3).17 Patients in the intervention group were started on DAPT with ticagrelor or prasugrel unless they were identified as intermediate or poor CYP2C19 metabolizers. Results from POPular Genetics concluded that, compared to standard therapy (DAPT with prasugrel or ticagrelor), a genotype-guided de-escalation strategy significantly reduced bleeding without increasing MACE.
PHARMCLO and TAILOR-PCI compared genotype-guided therapy to standard therapy, which was defined as DAPT with clopidogrel, ticagrelor, or prasugrel in PHARMCLO and DAPT with clopidogrel in TAILOR-PCI (Table 3).18,19 PHARMCLO showed a significant reduction in MACE with genotype-guided therapy, suggesting that standard therapy with clopidogrel, ticagrelor, or prasugrel could be linked with higher ischemic risk. This finding was consistent when only evaluating patients on clopidogrel from both groups. In TAILOR-PCI, genotype-guided therapy significantly reduced MACE at 90 days but not at 12 months, and there was no difference in bleeding between the two groups.
Beitelshees et al conducted a retrospective, real-world study and demonstrated similar benefits with the use of genotype-guided therapy (Table 3).20 Among patients with a loss-of-function allele who underwent PCI, alternative antiplatelet therapy (prasugrel, ticagrelor, or high-dose clopidogrel 150 mg/day) was associated with significantly reduced MACE without increased bleeding when compared to clopi-
dogrel. On the other hand, for patients without a loss-of-function allele, there were no statistically significant differences in MACE or bleeding between alternative antiplatelet therapy and clopidogrel. Notably, this study found that among patients on clopidogrel, those with a loss-of-function allele had a significantly higher rate of MACE than those without a CYP2C19 loss-of-function allele.
Key Takeaways – CYP2C19 Genetic Polymorphisms
Overall, existing evidence shows that genotype-guided therapy reduces the risk of MACE without significantly increasing major bleeding when compared to standard therapy (varying definitions). While genetic testing is not routinely recommended to guide P2Y12 inhibitor choice, it can be considered in certain highrisk patients, including those with ACS. Ticagrelor or prasugrel is the recommended P2Y12 inhibitor agent for patients with CYP2C19 loss-of-function alleles.
Conclusion
Certain patient populations, particularly those with high bleeding risk or CYP2C19 genetic polymorphisms, warrant a more in-depth evaluation of DAPT use. Pharmacists understand the importance of considering the many factors that can influence DAPT management, including pharmacokinetic properties and patient characteristics. This knowledge allows for a thorough assessment of a patient’s DAPT regimen and the ability to intervene if safety issues are identified. By staying up to date on new literature, pharma-
cists can provide evidence-based recommendations on optimizing DAPT regimens after PCI. In summary, P2Y12 inhibitor selection and DAPT duration after PCI should be tailored to patient-specific factors and concomitant medical conditions.
Authors: Jahnavi Yetukuri, PharmD, BCPS; Internal Medicine Clinical Assistant Professor, Rutgers University Ernest Mario School of Pharmacy, Piscataway, NJ; Morristown Medical Center, Morristown, NJ; ( jyetukuri@ gmail.com) Manali Patel, PharmD, MBA, BCPS; Internal Medicine Clinical Pharmacy Specialist; Andrew Darkow, PharmD, MBA, BCPS; Clinical Assistant Professor and Internal Medicine Clinical Pharmacy Specialist; Payal Desai, PharmD, BCCCP; Cardiac Surgery Clinical Pharmacy Specialist; Morristown Medical Center, Morristown, NJ
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2. Cuisset T, Deharo P, Quilici J, et al. Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study. Eur Heart J 2017;38(41):3070-3078.
3. Kim CJ, Park MW, Kim MC, et al. Unguided de-escalation from ticagrelor to clopidogrel in stabilized patients with acute myocardial infarction undergoing
percutaneous coronary intervention (TALOS-AMI). Lancet. 2021;398:1305-16.
4. Hahn JY, Song YB, Oh JH, et al. Effect of P2Y12 inhibitor monotherapy vs dual antiplatelet therapy on cardiovascular events in patients undergoing percutaneous coronary intervention. JAMA 2019;321(24):2428-2437.
5. Mehran R, Baber U, Sharma SK, et al. Ticagrelor with or without aspirin in high-risk patients after PCI. N Engl J Med 2019;381:2032-2042.
6. Kim BK, Hong SJ, Cho YH, et al. Effect of Ticagrelor monotherapy vs ticagrelor with aspirin on major bleeding and cardiovascular events in patients with acute coronary syndrome. JAMA 2020;323(23):2407-2416.
7. Watanabe H, Morimoto T, Natsuaki M, et al. Comparison of clopidogrel monotherapy after 1 to 2 months of dual antiplatelet therapy with 12 months of dual antiplatelet therapy in patients with acute coronary syndrome (STOPDAPT-2 ACS). JAMA Cardiol. 2022;7(4):407-417.
8. Hong SJ, Lee SJ, Suh Y, et al. Stopping aspirin within 1 month after stenting for ticagrelor monotherapy in acute coronary syndrome (T-PASS). Circulation 2024;149:562-573.
9. Ge Z, Kan J, Gao X, et al. Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT). Lancet. 2024;Epub ahead of print.
10. Kumbhani DJ, Cannon CP, Beavers CJ, et al. 2020 ACC Expert Consensus Decision Pathway for anticoagulant and antiplatelet therapy in patients with atrial fibrillation or venous thromboembolism undergoing percutaneous coronary intervention or with atherosclerotic cardiovas-
cular disease. J Am Coll Cardiol. 2021;77(5):629-658.
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12. Gibson CM, Mehran R, Bode C, et al. Prevention of bleeding in patients with atrial fibrillation undergoing PCI. N Engl J Med 2016;375:2423-2434.
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The PGY-2 Conundrum
By: Dr. Mackenzie Wagner
I made many important decisions before becoming a pharmacy resident in the postgraduate year one (PGY-1). As a senior in high school, I decided to pursue a Doctor of Pharmacy. I chose the college I wanted to attend, and at the end of pharmacy school, I decided I wanted to work in a hospital as a clinical pharmacist. This led me to pursue a PGY-1 pharmacy residency. I made these decisions without much thought because each next step was required to reach my end goal of becoming a clinical pharmacist. In residency, my next step was no longer predetermined and required. I hoped I would have an epiphany at some point where the rest of my career path would become clear, but that failed to happen. Instead, I carried the weight of the unknown on my shoulders for what felt like an eternity.
Many pharmacy residency programs offer their PGY-1 pharmacy residents the opportunity to early commit to a postgraduate year 2 (PGY-2) pharmacy residen-
cy program at the same hospital. This happens within a few short months after starting a PGY-1 pharmacy residency. While a PGY1 pharmacy residency provides a general overview of hospital pharmacy practice, a PGY-2 pharmacy residency provides a deeper dive into a specialty area. When the early commitment process started, I was interested in many areas within pharmacy and could not steer myself in one direction over another. As a result, I decided to forgo the early commitment process and delay my decision about a PGY2 residency a little longer.
Despite not participating in the early commitment process at my residency program, there was still the opportunity to pursue a PGY-2 pharmacy residency at a different hospital. If I was going to pursue a PGY-2 residency, I knew that I would want to participate in the Personnel Placement Services (PPS) at the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in December. This service allows
potential residents to network with residency programs. In the months leading up to December, I was busy with rotations, longitudinal projects, and staffing requirements, and this decision weighed heavily on my mind.
In order to come to a decision about whether to pursue a PGY2 residency, I thought to myself, what do I want my career to look like? How do I get that position? What is most important to me? Can I afford to make my decision?
1. What do I want my career to look like?
A PGY-2 pharmacy residency provides focused training in a specialty area. This could be critical care, cardiology, or internal medicine, to name a few. My sights were set on critical care and cardiology after completing an advanced pharmacy practice experience (APPE) in a cardiothoracic surgery intensive care unit as a pharmacy student. I continued down the path of cardiology as a resident and completed a 4-week rotation in a cardiology ambulatory care clinic. With continued interest in cardiology, I worked with my residency program director to change my schedule to allow another cardiology rotation before deciding about a PGY2. After spending 4 weeks in the cardiovascular intensive care unit, the disease states became repetitive, secondary to the area’s highly specialized nature. I started to find it redundant and realized I preferred to be a jack of all trades instead. As a result, I opted to forgo my pursuit of a PGY-2 pharmacy residency focused on critical care or cardiology.
2. How do I get the position I want?
I knew I wanted to be in a position that encountered a variety of disease states, so I started to consider career options within the field of internal medicine. There are multiple paths one can take to obtain a certain job position. Therefore, I reached out to my mentor, an internal medicine clinical pharmacist, to learn more. She offered insight on the opportunities available for pharmacists after a PGY-1 pharmacy residency alone. In addition, I connected with a pharmacist who completed a PGY-2 pharmacy residency in internal medicine. With these two perspectives, I realized I would be a qualified candidate for a role in internal medicine without a PGY2 pharmacy residency. However, a PGY-2 pharmacy residency in internal medicine would be beneficial if I wanted to pursue a career in academia. It is helpful to reach out to pharmacists working in the role you desire as they can offer you a better understanding of the educational requirements that may or may not be necessary to reach your goals.
3. What is most important to me?
Pharmacy school is a long endeavor. As I grew in my personal and professional life, my priorities shifted, and I found it helpful to reflect on my priorities to make my decision. I asked myself if I would move anywhere to complete a PGY-2 pharmacy residency and then again to obtain a position in a specialty of interest. By doing so, I realized the location was a priority, as I aimed to stay in
the area where I was completing a PGY-1 pharmacy residency. Similarly, I took some time to compare the hours associated with different positions. During my cardiology ambulatory care rotation, I learned that my preceptor, who was an ambulatory care pharmacist, did not work weekends or holidays as the clinic was closed. This led me to consider pursuing a PGY-2 pharmacy residency in ambulatory care. However, this thought was short-lived as I quickly realized I was not ready to leave inpatient pharmacy practice.
4. Can I afford to do a PGY-2 pharmacy residency?
Priorities may change, and that is okay. I realized pharmacy was no longer my top priority at this point in life. Other things, such as finances, started to factor into the equation more. The application and interviewing process for a PGY-2 pharmacy residency comes with several direct costs, like PPS registration, PhORCAS applications, and travel expenses for interviews. In addition, there are opportunity costs as pharmacy residents earn a significantly lower wage than their pharmacist colleagues. While working to achieve my career goals over the past eight years, I have delayed other life goals, such as paying off my student loans, owning a house, investing in retirement accounts, and starting a family. A higher salary would allow me to start working towards the goals I have neglected sooner rather than later. That said, many hospitals do offer a higher starting salary for pharmacists who have completed a PGY-2 pharmacy residency. So,
there may be some compensation for the additional time spent training during a PGY-2 pharmacy residency.
In the months leading up to December, I carried the weight of the unknown on my shoulders. This was amplified by the pressure to decide whether to pursue a PGY-2 pharmacy residency in just a few months after starting as a PGY-1 pharmacy resident. While these emotions weighed me down, I asked myself several questions. What do I want my career to look like? How do I get that position? What is most important to me? Can I afford to make my decision? After taking the time to reflect on my answers, I felt the weight of the unknown lift from my shoulders. For the first time since starting residency, I had a next step. Ultimately, I decided to forgo a PGY-2 pharmacy residency, but you must ask yourself the fifth and final question: what is best for you?
Author: Mackenzie Wagner, PharmD, MBA; PGY-1 Pharmacy Resident; Novant Health New Hanover Regional Medical Center; Wilmington, North Carolina; mackenziewagner1@gmail.com
Sunday Evening Webinars
The Sunday Evening Webinar Series happens on the third Sunday of most months. The webinars are ACPE accredited for 1 hour of live CE for pharmacists and most webinars are also accredited for pharmacy technicians. Visit our webinar webpage to learn more and register for the webinars that interest you. Our next webinar will be Sunday, January 19, 2025 (details coming soon).
Leadership Buzz – Developmental Opportunity for New Practitioner & Student Members
The NCAP New Practitioner Forum (NPF) is hosting their annual book club, Leadership Buzz, for new practitioners who have graduated in the past 7 years (2018 - 2024)! Student members of NCAP are invited to take part as well. Virtual sessions will be facilitated by pharmacy leaders from across the state. To learn more and register to take part in this leadership developmental opportunity, visit our webpage. The next book discussion will be January 21, 2025!
NC MPJE and NAPLEX Review Resources
Are you looking for preparation resources and materials to help you study for the NC MPJE and NAPLEX? Visit our resource page to find two options to help you prepare for the NC MPJE. Scroll down the same resource page for a link to a NAPLEX preparation source and tell them NCAP sent you! The next NAPLEX preparation course will be in Spring of 2025. (MPJE books and the online MPJE study course are updated twice a year on April 1st and October 1st.)
SC Pharmacy Association’s Annual Leadership Conference
Each year, NCAP partners with the SC Pharmacy Association for their Annual Leadership weekend in Asheville, NC. This year’s conference is January 10 – 12, 2025. Because of this partnership, NCAP members are allowed to register at the member rate. Follow the link for full conference details. To confirm your NCAP membership and receive the promo code to register at the SCPhA member rate, contact Angie, angie@ncpharmacists.org.
Let’s
Huddle Up!
What’s a huddle? If you’ve ever watched football, you’ve seen one. It’s a quick meeting on the field for the players to decide their next plan of attack based on what’s happening around
them at that particular moment. Are you a health-systems/ hospital, or ambulatory care pharmacist or pharmacy technician? What’s going on around you? Do you sometimes wish you had a team to work with on solutions to current matters? Then check out the NCAP-hosted huddle for your practice academy below. Questions regarding NCAP huddles can be sent to Grant, grant@ncpharmacists.org.
Health-Systems and Hospital Practitioners Huddle
This NCAP-hosted “Huddle” is a virtual meeting held on the third Friday of every month. The meetings support open dialogue on topics important for health-system and hospital pharmacists and technicians serving in leadership and management roles. The meetings facilitate the sharing of ideas and solutions for common institution- and population- based operational, clinical, and financial challenges. Each meeting the agenda will be determined from the topics submitted by our “Huddle” attendees.
Join us when we meet next on January 17, 2025.
Ambulatory Care Practitioners Huddle
This NCAP-hosted “Huddle” is a virtual meeting held on the fourth Friday of every month. The meetings support open dialogue on topics important to ambulatory care pharmacy. The meetings will facilitate the sharing of ideas and solutions for common ambulatory care matters. Each meeting will be opened with a Pearls session or clinical case. The remainder of the agenda will be determined by the topics submitted by “Huddle” attendees.
Ambulatory care practitioners join us for our inaugural huddle on January 31, 2025 then save the date for the next meeting on February 28, 2025.
NCAP’s Emerging Leaders Program 2025
This program is designed to help student pharmacists and new practitioners across the state of North Carolina develop their leadership skills, build meaningful professional connections, and prepare for leadership roles in pharmacy. Through five interactive, discussion-based sessions, participants will explore key leadership topics, gain practical insights, and network with pharmacy leaders and peers. We have completed our first two discussions in 2024, and we look forward to you joining our remaining 3 sessions in 2025! Learn more here.
In memory of F. Michael “Mike” James. Mike was a well-known figure among many pharmacists in North Carolina and was a long-time member of the North Carolina Association of Pharmacists (NCAP). He served for many years as the North Carolina Delegation Chairperson at the National Community Pharmacists Association’s Annual Convention.
Mike was a remarkable leader and advocate for independent pharmacists, having served as Vice President and Director of Government Affairs for the Association of Community Pharmacies Congressional Network. His dedication to his profession was evident in his role as the owner of Person Street Pharmacy and later PSP Pharmacy. He tirelessly championed the rights and needs of pharmacists, often walking
the halls of both the North Carolina General Assembly and Congress to ensure their voices were heard.
Beyond his professional achievements, Mike was a pillar of his community. As a long-time member and former Chairman of the North Carolina Retail Merchants Association, he embodied the spirit of service. He mentored countless aspiring pharmacy students and young pharmacists, guiding them with kindness and wisdom. His unwavering support and encouragement had a lasting impact on many, shaping the future of pharmacy in our state.
Mike’s contributions to both the community and the profession earned him various awards and accolades throughout his life, including National Independent Pharmacist of the Year, North Carolina Ambulatory Pharmacist of the Year, the Order of the Long Leaf Pine award, the Bowl of Hygeia award, and the M. Keith Fearing Award from Campbell University, which recognized his significant contributions to community pharmacy practice. He played an instrumental role in developing a new pharmacy course focused on healthcare legislation, creating opportunities for students to intern in the offices of U.S. Congressmen, and
bridging the gap between education and real-world advocacy.
His influence extended beyond the pharmacy community. Mike served on various boards and committees, including the North Carolina Health Coordinating Council and the State Medicaid Committee, showcasing his commitment to improving healthcare for all. He was also a Fellow of the American College of Apothecaries.
Mike’s integrity, warmth, and dedication to service were unmatched. He approached everyone with respect and kindness, never uttering a harsh word, even towards those with differing opinions. His legacy is one of compassion and commitment both to his profession and to his community.
Mike served five years in the United States Air Force and had a great love for sports, especially the UNC Tarheels and the New York Yankees.
We will miss Mike’s warm smile, tenacity, professionalism, and camaraderie. If you would like to share your condolences with his family, please mail cards to Barbara James at 314 Yadkin Drive, Raleigh, NC 27609.
• Flags (American, Christian, State, College Logo, etc.)
• Clocks (Battery Operated with Logos, etc )
• Crosses with US Flag Motif Made from Recycled Wooden Shipping Pallets See Photos at TarHeel Flags on Facebook/Market Place Contact Jim Knowles, PharmD (Retired) TarHeelFlags@PinevilleDSL.net 704-835-1042 – Please Leave Message
Complete SynMed XF System including Calibrated Containers, Dell OptiPlex 7040 with monitor, Wireless Honeywell bar code scanner, Lexmark laser printer model MA810, Zebra thermal printer model TLP2824 Plus, 4 positioning tray for two sets of blister cards, complete set of calibrated covers for containers, SynMed Image Module, SynMed Assist with includes Touch screen 23" Dell Computer
This unit was bought new when starting up a pharmacy in 2020 It was never used! The unit and all are in pristine condition This would be like buying a new unit for tens of thousands less Total Cost new was over $300,000 For Sale for $190,000 Purchase price does not include shipping charges, any tax and site preparation Contact Tom D’Andrea tdandrea@cstpharmacy.com 919-629-4900
