United States

Prescription drug spending on generics has increased drastically in recent decades. Now, with over ninety percent of dispensed prescriptions in the United States being generic, there is a greater need to create strong legislation to prevent exorbitant financial burdens on patients. These burdens lead to decreased compliance with their needed prescription drugs and increased sacrifices of healthy lifestyle choices to accommodate for increased prices. Ultimately, the health risks compound, further affecting individuals’ physical and mental health and causing worse health outcomes. Prescription drug spending can be managed by addressing barriers to affordability, including shortages, price gouging, and abuse by brand-name drug manufacturers and pharmacy benefit managers. The Inflation Reduction Act, FAIR Drug Pricing Act, and Pharmacy Benefit Manager Reform Act are important bills that have been proposed but have yet to make significant headway toward passing into law. More federal support is needed for federally backed and trusted non-profit manufacturers to create generic products that compete with the private market. Such a solution will help increase competition and encourage the creation of a stable supply chain. Furthermore, amending current legislation to respond to the exploitations performed by brand-name drug manufacturers and pharmacy benefit managers by increasing transparency of pricing and practice will serve to improve access and affordability of generic prescription drugs. My policy recommendation is to tackle these challenges comprehensively and integrate these solutions for a more pronounced improvement in generic drug pricing. 


AMA Research Challenge 2023

Policy Proposal to Improve Access and Affordability of Generic Prescription Drugs

poster

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Background
Neonatal jaundice is a condition that develops in approximately 85% of live births and becomes severe when total serum bilirubin (TSB) levels surpass 85 µmol/L and physical signs appear including yellow skin, yellowish eye appearance, pale stools, and dark urine. If untreated, kernicterus, an irreversible brain injury, occurs. As diagnosis of severe neonatal jaundice (SNJ) remains a challenge globally, it is imperative to address existing gaps, which have prompted this literature. The goals of our project include: 1) To consolidate diagnostic practices for SNJ in ten 
countries, 2) To determine gaps in screening measures, and 3) To provide feedback on areas of improvement.

Methods
Our search was conducted using the PubMed database to include 13 papers published between 2013 to 2023. The search terms used were “neonatal jaundice screening challenges,” “screening challenges in neonatal hyperbilirubinemia,” “prevalence of neonatal jaundice,” and “neonatal screening in developing countries.” We reviewed diagnostic practices and screening gaps for SNJ in ten countries including Malawi, Nigeria, India, Egypt, Netherlands, Bangladesh, Sweden, South Africa, Indonesia, and Turkey.

Results
Within our review of screening issues, four specific areas of improvement in diagnostic approach were identified: 1) access to healthcare facilities with appropriate resources for transcutaneous 
bilirubin (TcB) or TSB testing, 2) timely pre-discharge testing, 3) diagnostic education of SNJ for parents and community healthcare workers, and 4) compliance to the diagnostic guidelines by healthcare providers. In Malawi, Nigeria, India, Egypt, Netherlands, and South Africa, families with newborns had difficulty with accessing TcB or TSB testing. In Sweden and Turkey, appropriate pre-discharge testing needed 48-72 hours post-birth did not occur. Within Malawi, Bangladesh, and Indonesia, parents of newborns and community health workers did not receive adequate education to identify symptoms of SNJ. Studies in Nigeria and the Netherlands 
highlighted overuse of visual assessments to diagnose SNJ without use of additional tests to confirm diagnosis.

Conclusion
The following three recommendations were developed using the weaknesses in diagnostic approach in ten countries: 1) to design future healthcare facilities that have TcB or TSB testing and are geographically accessible to rural populations, 2) to offer community forums for community health workers, parents, and healthcare providers to educate on key symptoms and diagnostic tests of SNJ, and 3) to monitor compliance with diagnostic guidelines by healthcare providers. Key limitations of this review were the rising number of births occurring outside of 
the hospitals and inadequate financial resources to implement these recommendations.

Global Analysis of Challenges in Diagnosing Severe Neonatal Jaundice: Identifying Areas of Improvement

Background
Gestational diabetes mellitus (GDM) is a condition that affects 14.7% of women globally and occurs when a mother develops diabetes during the course of pregnancy. Increased insulin resistance in pregnant mothers can lead to further complications, such as a larger baby, increased risk of the baby developing Type II diabetes, having low blood sugar, and even premature birth, which can cause respiratory issues. The lack of policies in place to address GDM in various countries worldwide highlights the need for this literature.
The goals of this project are to compile health policies pertaining to GDM implemented in several countries across the world, analyze core differences and similarities amongst Gestational Diabetes protocols, and pinpoint disparities in existing health policies in order to determine areas of policy improvement.

Methods
We focused on specific countries which included India, Canada, South Africa, United Kingdom, and China. Several global policies that we focused on were from the American College of Obstetricians and Gynecology, International Association of Diabetes and Pregnancy Study Group, American Diabetes Association, WHO 2013, and Carpenter-Coustan criteria. With the use of the databases including PubMed and Scopus, ten policies were examined that described the gestational diabetes diagnosis/protocol.

Results
After scoping through the data and analyzing the policies based on intended audience, main recommendations of the policy, and fulfillment of culturally relevant recommendations, data was combined from the articles. Identifiable gaps that were perceived as significant included lack of perceived risk of type 2 diabetes, challenges in establishing homogenous GDM screening and diagnosis practices, issues with cost-effectiveness, and obstacles in addressing low resourced regions and population diversity including pregnant women lacking social support and knowledge of GDM.

Conclusion
There are clear identifiable gaps amongst the different health policies. There are many populations that are predisposed to gestational diabetes due to genetics, past pregnancies, area of residency, socioeconomic status, etc. In reviewing the country specific and global policies, many of the policies reported broad criteria for diagnosing GDM as they did not include specific risk factors for consideration. Many gaps need to be addressed to reduce the increasing prevalence of GDM through early diagnosis, development of risk factor screening, and providing support to pregnant women at high risk of developing GDM. There were several limitations to this study such as the inability to research specific policies due to the lack of reporting policies, inaccurate reporting, and outdated criteria for GDM.

A Global Comparison of Health Policies Focused on Gestational Diabetes: Recognizing Pertinent Gaps

This study analyzes the voting behaviors of medical college students at a large public medical school, focusing on their likelihood of voting in primary elections. The study utilized the Georgia voters database to analyze a student population of 518 individuals from two consecutive class years. The primary variable studied was registration address, specifically whether students who changed their registration address to the campus location were more likely to vote than those who remained registered in their hometown or another location separate from their medical school campus. 

Statistical analysis was conducted for each class separately, with results showing a significant association between voting behavior and whether a student's registration city was the same as their campus city.

The study builds upon previous research on physician voting trends, which have shown lower overall voter turnout compared to the general population, but increasing turnout during election years. The study also identified common barriers to voting among physicians and residents, including long work hours and barriers to the use of absentee ballots. Similar barriers were found in the medical student population, including limited time to learn about candidates and difficulty utilizing the absentee balloting system.

Overall, this study emphasizes the importance of registering to vote where one currently lives to improve voter engagement among medical students. As government leadership plays a critical role in shaping health policy, it is essential that medical students exercise their right to vote. Nonprofit programs geared towards civic engagement in the medical community are working to improve access to voter registration and education for physicians, and similar initiatives should be implemented for medical students. By increasing voter engagement among these groups, we can ensure that the voices of healthcare professionals are heard in the political process and that policies are developed with their input and expertise.


Taking a Closer Look at Medical Student Voter Engagement – an analysis of voter turnout in the medical student community


The increasing rise of national public concerns for the opioid epidemic within the United States regarding substance abuse and addictions has led to the development of opioid response networks. This study aimed to examine barriers to access to Medication for Opioid Use Disorder (MOUD) for opioid addiction in West Virginia. It focused on the availability of clinics, weekly out-of-pocket cost for treatment, acceptance of Medicaid and earliest available appointment. The study analyzed data from 100 randomly selected MOUD clinics obtained from The Opiate Addiction & Treatment Resource (OATR) website through survey phone-calls. Results showed that only 23% of the clinics responded, 35% of the phone numbers provided were no longer in service and 42% went to voicemail. The average wait time for an initial appointment was within 1 week but could range up to months. The weekly cost of treatment varied greatly, with an average of $122 per week. However, 70% of the clinics reported accepting Medicaid. The study highlights barriers to access to care and lack of reliable information on MOUD clinics in West Virginia, making it difficult for patients to access much-needed treatment in a timely manner.

Dialing For MOUD: Barriers to Finding Help

This study analyzed medical debt lawsuits against minority patients in New Jersey from 2017-2021. Among 2,354 lawsuits identified, 42.3% targeted minority patients, mainly in low-income areas. These patients were likelier to face civil lawsuits, particularly in high poverty quartile regions. Church-affiliated hospitals were less likely to sue minority patients, while non-profit hospital status had no impact. There is a negative impact of predatory billing on health equity, suggesting a review of legislation on hospital lawsuits and better adherence to charity care policies.

Characteristics associated with Hospital Medical Debt Lawsuits against Minority Patients

Background
The Coronaviridae family, including SARS-CoV-2 responsible for COVID-19, leads to a severe inflammatory respiratory infection with varying clinical outcomes. With an ever-changing virus epidemiology and COVID-19 vaccines playing a crucial role in prevention, trust issues and vaccine hesitancy persist. This systematic review and meta-analysis aim to examine the link between clinical outcomes and vaccination status in COVID-19-infected individuals to address knowledge gaps. By evaluating the impact of vaccination on disease course, this study seeks to provide clear insights into the preventive potential and effectiveness of COVID-19 vaccines, contributing to better public health policies and strategies in combatting this infectious disease.

Methods
We conducted a meta-analysis to assess COVID-19 vaccination effectiveness in North America. PRISMA guidelines were followed for English studies published between March 17, 2020, and July 10, 2022. Studies comparing vaccinated and unvaccinated groups in terms of COVID-19 outcomes were considered. Primary outcomes were incidence, hospitalization, ICU admission rates, mortality rate and mechanical ventilation need. Data were extracted and pooled using a random-effects model. Bias assessed with Joanna Briggs Institute criteria. A snowball search complemented PubMed, Cochrane, and Google Scholar searches. Pooled proportion estimates and risk ratios were calculated with 95% confidence intervals. 

Results
The meta-analysis included 14 articles with a total of 24,164,227 COVID-19 patients. The results showed that unvaccinated patients with COVID-19 infection were 2.36 times more likely to contract COVID-19 compared to vaccinated patients (p = 0.02). Additionally, unvaccinated patients were six times more likely to be admitted to the ICU (p < 0.0001), 3.37 times more likely to be hospitalized (p < 0.0001), and 6.44 times more likely to require mechanical ventilation (p < 0.0001) compared to vaccinated patients. Lastly, the OR for COVID-19 mortality was 2.46 (95% CI: 1.71 to 3.53; p < 0.0001), indicating unvaccinated patients were 2.46 times more likely to die from COVID-19.


Conclusion
In conclusion, this meta-analysis provides robust evidence that COVID-19 vaccination significantly reduces the incidence of infection, hospitalization rates, ICU admissions, mechanical ventilation requirements, and mortality among COVID-19-infected individuals in North America. The findings highlight the importance of widespread vaccination campaigns to enhance public health and control the spread of COVID-19. Efforts to address vaccine hesitancy and promote vaccination acceptance are crucial for maximizing the benefits of vaccination and minimizing the impact of the pandemic. Further research on the effectiveness of different vaccine types and their protection against emerging variants is warranted to guide vaccination strategies effectively.

Unlocking the Power of COVID-19 Vaccines: A Meta-Analysis Reveals Impact on Patient Outcomes in North America

Background
Mpox is an infectious disease characterized by a painful rash. It is caused by the monkeypox virus, which spreads through direct contact with skin or bodily fluids. The United States has been experiencing an outbreak of mpox since May 17th, 2022, which has disproportionately affected men who have sex with men (MSM).
When the outbreak began, there were two mpox vaccines already approved for use, and the federal government already had 36,000 doses of one such vaccine (Jynneos) in stockpile. However, by June 28th, 2022, only 9,000 doses of Jynneos had been released, which was widely critiqued as inadequate.
Little has been previously published about the sentiments of MSM during this time period. This research project thus sought to better understand the perspectives and experiences of MSM seeking a mpox vaccine in June–July 2022 as told in their own words.
Methods
41 conversations were conducted with gay or bisexual men via phone or instant messaging between July 12th and July 15th, 2022. Participants were recruited from Instagram, the author’s personal social circle, or from friends of friends. Individuals were nearly all in their 20s and 30s, and nearly all came from urban areas, including New York City, Los Angeles, San Francisco, Chicago, Boston, Austin, Houston, Seattle, Minneapolis and Atlanta.
Results
At time of interview, 12 of 41 (29%) respondents had been able to access a first dose of the mpox vaccine. Those able to get vaccinated attributed their success to luck or word of mouth, having free time to wait in lines, and getting vaccinated in Canada.
Of the 29 respondents not yet vaccinated, 28 (97%) said they had been trying without success. Twelve of these respondents were then asked about their overall feeling towards the situation; the most common response was “frustrated” (4 respondents), followed by “afraid”, “annoyed as fuck”, “awful”, “hilarious”, “hopeless”, “messy”, “panicked”, and “pathetic” (1 respondent each). The most common hurdles experienced included a lack of appointments, restrictive eligibility criteria, clinics running out of doses or closing early without advance warning, websites crashing, and no information available from public health authorities.
Conclusion
The early mpox rollout in the United States was slow and beset with widespread logistical failures, leaving the MSM community frustrated and anxious. Future public health vaccination campaigns should emphasize the rapid acquisition and distribution of vaccines, as well as improved communication from health authorities.

Delays, disarray and disparities in early United States mpox vaccine rollout, June–July 2022

Our study addressed COVID-19 vaccine knowledge and attitudes among medical students at the University of New England College of Osteopathic Medicine (UNECOM). Medical students recruited to complete an anonymous online survey assessed backgrounds, experiences, knowledge, and attitudes toward the COVID-19 vaccine. The correlation analysis utilized gender, physical health rating, close connection to someone with COVID-19, and work in the medical field during March 2020 as potential factors affecting students' attitudes. Respondents included 139 medical students aged 20-39 years old, with 99.3% having received at least one dose of the COVID-19 vaccine under institutional mandate. Every student obtained vaccine information from any combination of medical professionals, scientific journals, or review articles. Almost all correctly identified the components of the vaccine, its benefits, and its potential side effects. We found that 85% of medical students expressed little hesitancy toward receiving the vaccine; about 90% of participants supported a vaccine mandate for students. The marked enthusiasm expressed by UNECOM medical students to receive the vaccine contrasts surveys conducted before any vaccine mandate, although students' accurate knowledge of the vaccine and its potential benefits may have influenced acceptance. Overall, consideration of societal and individual implications is paramount. Access to scientifically validated information is essential when implementing public health policy at both institutional and federal levels.




Medical Students' Attitudes and Knowledge on the COVID-19 Vaccine and Mandate

Background
The reimbursement landscape for infectious diseases is constantly evolving. In recent years, there have been significant changes in Medicare reimbursement for infectious disease procedures. These changes have had a major impact on infectious disease specialists, who may be disproportionately affected by changes in reimbursement in certain regions, which could have implications for access to care. Previous research has not examined these fluctuations especially in different geographic regions. Thus, our study analyzed Medicare reimbursement changes from 2013 to 2023 for all U.S. states and territories. We also explored the relationship between these changes and select social determinants of health (SDOH).
Methods
Medicare Administrative Contractor codes for the top 50 infectious disease procedures were used to identify states using the Centers for Medicare and Medicaid Services’ Physician Fee Schedule. Each price was adjusted for inflation using the consumer price index and weighted using an index of codes. A total percent change was generated for each state or territory. State-based data for various SDOH were used to calculate a correlation coefficient with geographic changes in
reimbursement (statistical significance factored with α of 0.05).
Results
From 2013 to 2023, the inflation-adjusted Medicare reimbursement for the top-grossing infectious disease procedures for U.S. states and territories decreased by a mean and median of 24.8% and 25.0%, respectively. The greatest total decrease was experienced by Illinois (-29.0%), Wyoming (-26.8%), Kansas (-26.8%), and Wisconsin (-26.6%). Massachusetts (-22.5%), New York (-22.3%), Washington (-19.8%), and Puerto Rico (-14.2%) were states that had the lowest change over the ten-year period. Some of the top grossing procedures (Current Procedural Terminology code) and their yearly percent change included critical care for the first 30-74 minutes of instance(99291, -197.2%), debridement of subcutaneous tissue for the first 20 cm2 or less(11042, -197.0%), transitional care management with high medical decision complexity(99496, -197.0%), and removal of central venous catheter without subcutaneous port or pump (36589, -197.0%).
Conclusion
Our findings suggest that over the past ten years, Medicare reimbursement for infectious disease procedures has decreased in many regions of the United States. These findings have important implications for access to care. Decreased reimbursement may make it more difficult for infectious disease specialists to provide care in certain regions, which could lead to longer wait times and decreased
access to care for patients. Policymakers should consider and develop strategies to address these geographic disparities. This could include providing financial assistance to infectious disease practices or expanding access to telehealth services.

The Impact of Geography on Medicare Reimbursement for Infectious Diseases: A 10-Year Analysis

Background: America is in the midst of an epidemic of sexually transmitted infections (STI). Between 2020-2021, the CDC reported a 32% increase in the incidence of primary/secondary (early) syphilis with underserved and marginalized communities predominantly affected. Treponemal central nervous system (CNS) invasion is estimated to occur in approximately 25-60% of cases, however, the current standard of care for early syphilis does not achieve CNS clearance. This raises concern for a preventable burden of neurologic morbidity secondary to treponemal CNS persistence and subsequent neurosyphilis. Our central hypothesis is that individuals with history of syphilis infection will experience greater odds of neurologic morbidity relative to their uninfected counterparts. 

Methods: An FQHC-based, preliminary 10-year retrospective analysis (01/2013-12/31/2022) of deidentified electronic medical records (EMR) was undertaken in summer of 2023. The exposure of interest consisted of grouped ICD-10 codes representative of early syphilis infection with neurologic outcomes defined as ICD-10 diagnoses reflective of the principle clinical manifestations of neurosyphilis. Unadjusted, bivariate analysis was performed for preliminary assessment of exposure-outcome association.

Results: 3,711,053 EMR from an academic health system were included in final analysis. 5,981 patients were found to have a diagnosis of syphilis. Patients with syphilis exposure had significantly higher odds for stroke (OR = 5.14; 95%CI = 4.71-5.61), dementia (OR = 20.68 ; 95%CI = 19.27–22.19 ), sensorineural hearing loss (OR= 5.75; 95% CI= 5.07-6.2), and blindness (OR= 15.74 ; 95%CI = 14.31-16.54) relative to unexposed patients. 

Conclusion: Syphilis infection was associated with significantly increased odds of neurologic morbidity across all representative outcome measures queried. These data are concerning as they suggest a clinically significant limitation to the current standard of care for early syphilis. We plan to more rigorously evaluate our hypothesis in a follow-up study that will utilize regression analysis to determine the independent effect of syphilis exposure adjusting for multiple confounders.


Next from AMA Research Challenge 2023

Global Analysis of Challenges in Diagnosing Severe Neonatal Jaundice: Identifying Areas of Improvement

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