Chester County Medicine Fall 2023

YO U R CO M M U N I T Y R E S O U R C E F O R W H AT ’ S H A P P E N I N G I N H E A LT H C A R E

FALL 2023

P u b l i s h e d

b y

P e n n s y l v a n i a ’s

F i r s t

M e d i c a l

S o c i e t y

landon peacock Cardiovascular Disease in South Asians p 5

Chester County Suicide Prevention Task Force Addresses a Public Health Crisis p 9

p 18

The Transformative Power of Generative AI in Medicine p 11

Contents OFFICERS 2023 President David E. Bobman, MD President Elect Mahmoud K. Effat, MD Vice President Richard O. Oyelewu, MD Treasurer Winslow W. Murdoch, MD Secretary Christina J. VandePol, MD Editor & Immediate Past President Bruce A. Colley, DO Board Members Norman M. Callahan, III, DO Asare Christian, MD Heidar K. Jahromi, MD Mian A. Jan, MD John P. Maher, MD Manjula K. Naik, MD Sean V. Ryan, MD Francis X. Speidel, MD Lynne A. Stilley, MBA Executive Director Chester County Medical Society 1050 Airport Road PO Box 5344 West Chester, PA 19380-5344 Website – www.chestercms.org Email – OurCCMS@gmail.com Telephone – (610) 425-9190 Chester County Medicine is a publication of the Chester County Medical Society (CCMS). The Chester County Medical Society’s mission has evolved to represent and serve all physicians of Chester County and their patients in order to preserve the doctorpatient relationship, maintain safe and quality care, advance the practice of medicine and enhance the role of medicine and health care within the community, Chester County and Pennsylvania.

The opinions expressed in these pages are those of the individual authors and not necessarily those of the Chester County Medical Society. The ad material is for the information and consideration of the reader.

It does not necessarily represent an endorsement or recommendation by the Chester County Medical Society.

FALL 2023

In Every Issue 3 President’s Message 18 The Art of Chester County

Features 5

Cardiovascular Disease in South Asians

8

Out & About

9

Chester County Suicide Prevention Task Force Addresses a Public Health Crisis

11 The Transformative Power of Generative AI in Medicine: A Comprehensive Exploration for Physicians and Healthcare Stakeholders 14 Phoenixville Free Clinic Recognized for Community Health Impact 16 2023 Update on Xylazine, a not-so-new Drug of Abuse 22 Prostate Cancer – The Second Leading Cause of Death in Men in the US 24 Guest Column: Health Care Professionals: A Needed Treatment for Legislative Issues 26 The Corporate Practice of Medicine – Structuring Your Business 28 FDA Warns Consumers Not to Purchase or Use Certain Eye Drops From Several Major Brands Due to Risk of Eye Infection 30 An Evening Together Letters to the Editor: If you would like to respond to an item you read in Chester County Medicine, or suggest additional content, please submit a message to OurCCMS@gmail.com with “Letter to the Editor” as the subject. Your message will be read and considered by the editor, and may appear in a future issue of the magazine.

Cover: “Wren” by Landon Peacock

Read more in The Art of Chester County on page 18.

PUBLISHER: Hoffmann Publishing Group, Inc. 2669 Shillington Rd, Box #438, Reading, PA 19608

www.Hoffpubs.com

For Advertising Information & Opportunities Contact: Tracy Hoffmann 610.685.0914 x201 tracy@hoffpubs.com

www.CHESTERCMS.org

PR E S I DE NT’S M E SSAG E

Fall 2023

BY DAVID E. BOBMAN, MD PRESIDENT OF CHESTER COUNTY MEDICAL SOCIETY

T

he fall season is already upon us! This is always a wonderful time of year as we look forward to the Holiday season which will soon be here. It is also an exciting time as fall is a season of change. We may best be reminded of this by the current beautiful spectrum of colors on the trees that surround us. However, as the year comes to an end, this also leads me to look back on the accomplishments of the past year as well as what we are still striving to change.

Over the past year, we have worked with colleagues, hospital administrators, and our politicians to try to maintain and improve access to medical care. While still in a nascent stage, we have also begun work to address the malpractice venue issue. Working on these issues has been a learning process, one proving quite complex and therefore difficult to change. These are problems that will require patience, persistence, and creativity to change.

David E. Bobman, MD President, Chester County Medical Society

What’s on your mind?

Help us to learn more about emergent trends affecting your work!

Write to us at: OurCCMS@gmail.com

On a more positive note, the CCMS hosted an outing at Top Golf. This was well attended and was enjoyed by all, with many requesting that we have a similar outing in the future. The Physician’s Dinner, formerly known as the CCMS Clambake, was held at the Concord Country Club. Dr Arvind Venkat, the only physician in the Pennsylvania state legislature, was our keynote speaker and gave a compelling speech on the need for physician involvement and advocacy. This event was well attended and many people remarked on how much they enjoyed the event. More recently, the CCMS hosted a forum during which the four candidates running for County Commissioner in the upcoming election responded to our questions pertaining to health care issues in Chester County. This provided a great opportunity to bring up issues that are important to us and to find out their stances on these topics. (A recording of this is available to be viewed on our web site: ChesterCMS.org.)

Finally, several of our board members attended the Pennsylvania Medical Society House of Delegates meeting, helping to determine policy and priorities for the Pennsylvania Medical Society in the coming year. During these events, we have had the opportunity to meet and welcome a number of physician members new to our group.

As the new year rolls around, our goal will be to maintain our momentum. We intend to continue fighting for change in the venue ruling. Also, look forward to news of further CCMS events. As always, we welcome your involvement and input.

Fond Regards, David

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 3

WELCOME TO BETTER

BUSINESS

BANKING Your Practice Built for

We understand that starting, running, and expanding a practice is no small feat. Our team of Relationship Managers offers years of experience partnering with healthcare professionals to develop custom strategies that address your distinct needs and challenges.

Meet Our Healthcare Banking Expert Andre Jones, Senior Relationship Manager Healthcare Banking 484.947.6309 | CitadelBanking.com/Healthcare Citadel is recognized as a Forbes 2022 Best-in-State Credit Union.

Federally Insured by NCUA

Cardiovascular Disease in South Asians

BY MIAN A. JAN, M.D., F.A.C.C., F.S.C.A.I. AND ANKIT RAINA

Cardiovascular Disease in South Asians

The South Asian Diet

South Asians have a 40% increased chance of dying from heart attacks compared to the average population. This alarming statistic draws even more concern when acknowledging that the South Asian population accounts for 60% of the world’s heart disease patients, although comprising just a quarter of the global population. Further investigation of this vast proportional discrepancy in cardiovascular disease elucidated the manifold contributing factors, including: the decadent South Asian diet, a unique makeup of body fat, and the underwhelming medical data on those from the Indian subcontinent.

The world-renowned flavors of South Asia are owed to hallmark dishes composed of a base of grains – like white rice, roti, or naan – commonly paired with a curry or side dish abundant in butter and ghee. The grains heavily contribute carbohydrates to the diet while the curry provides rich saturated fats. This combination not only makes a robust flavor profile, but also creates a robust – and devastating – impact on the average South Asian’s cardiovascular health, namely through insulin resistance. Despite being home to a large vegetarian population, the Indian subcontinent boasts one of the highest sugar consumption rates in the world. This observed glucose intolerance is further exacerbated by the dietary confluence of the aforementioned South Asian cuisine and Western food: fried fast food, and sugary dairy and beverage products.

Figure 1: South Asians have a 4 times greater risk of heart disease compared to other ethnic groups

Figure 2: Population map of South Asian countries continued on next page > FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 5

www.CHESTERCMS.org

Cardiovascular Disease in South Asians continued from page 5

South Asians also suffer from attacks at a young age, with 25% of heart attacks occurring under the age of 40 and 50% occurring under the age of 50.

Insulin resistance severely heightens the risk for atherosclerosis and cardiovascular related events – ultimately impacting 20% of all South Asians. The MASALA study (Mediators of Atherosclerosis in South Asians Living in America) indicated a 23% higher prevalence of Type 2 Diabetes Mellitus in South Asians compared to 18% in Blacks, 15% in Latinos, 13% in Chinese Americans and 6% in Caucasians. The study highlighted a paradox: although South Asians present with lower body mass indices compared to other ethnic groups, they have increased central adipose content – specifically visceral fat surrounding the abdomen, liver and heart. Moreover, the MASALA study identified South Asian patients as having smaller blood vessel diameters as well as higher mortality rates in both coronary artery bypass grafting and percutaneous coronary intervention procedures compared to Caucasians. South Asians also suffer from attacks at a young age, with 25% of heart attacks occurring under the age of 40 and 50% occurring under the age of 50.

6 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

Figure 3: Risk Factors (smoking, dyslipidemia, hypertension, diabetes, poor diet, lack of exercise, and obesity) account for the 86% increased risk of heart disease in South Asians compared to other countries

www.CHESTERCMS.org

PentaHealth is an independent, physician-led group of dedicated providers located throughout Southeastern Pennsylvania who proactively deliver seamless, high quality, and accessible care to all, one person at a time.

New patients always welcome

Appointments available 7 days a week Our family caring for your family Call us first, we are always available

610-423-8181

www.pentahealth.com

This constellation of anatomical differences owes to the critical inflammatory process adversely affecting the cardiovascular system of South Asians, especially paired with resistance to insulin.

A Distinctive Body Fat Composition Higher incidences of atherosclerosis and coronary heart disease in South Asians implicate an unforeseen genetic culprit: a unique lipid profile. Similar levels of LDL-cholesterol [LDL-C], “bad cholesterol,” were found in South Asians and Caucasians.

Despite this, South Asians suffer more frequently from coronary heart disease compared to their ethnic counterparts. How can this be?

Delving deeper, the INTERHEART study (a global casecontrol study comparing acute myocardial infarction between South Asians and various ethnic groups) identified the LDL-C particles n South Asians to be denser and therefore more capable of promoting atherosclerosis. Lipoprotein(a) [Lp(a)], a subset of LDL-C, also demonstrates these disease-enhancing qualities.

Lp(a) causes premature atherosclerosis in the vessels of the heart and brain, leading to devastating myocardial infarction and even stroke. South Asians exhibit elevated quantities of Lp(a) compared to Caucasians.

Further research uncovered the dysfunctional nature of HDL-cholesterol [HDL-C], “good cholesterol,” in the South Asian population. Normally exhibiting cardioprotective qualities, HDL-C shuttles peripheral cholesterol back to the liver for metabolic processing and breakdown – ridding the body’s vessels and extremities of potential harmful cholesterol deposits.

The HDL-C in South Asians is not only scarcer in quantity compared to other groups, but the size of the HDL-C particles are smaller as well. These quantitative and qualitative deficiencies ultimately owe to the dampened cardioprotective abilities of HDL-C.

Scarce Data Incurs Higher Cardiovascular Risk The outcomes of the MASALA and INTERHEART studies indicate an undisputed truth: the distinct anatomic and genetic makeup of South Asians owe to the high rates of cardiovascular disease seen in these patients. Despite this, medical research and data in the United States fail to stratify the Asian-American demographic by ancestry – erroneously grouping South Asians with East Asian groups: Koreans, Chinese, and Japanese. This impairs research aimed at preventing heart attack and stroke in South Asians. In fact, current heart disease “calculators” (algorithms doctors use to anticipate and detect heart disease) continued on next page > FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 7

www.CHESTERCMS.org

Out &About

Cardiovascular Disease in South Asians continued from page 7

with Mian A. Jan, MD

President Joseph Biden and Mian A. Jan, MD

Govenor Josh Shapiro and Mian A. Jan, MD

do not accurately portray the heightened risk of adverse cardiovascular events in South Asian Americans. South Asians account for only 1% of patients studied in the formulation of these heart disease calculators – a grievous underrepresentation, given the group’s proclivity for heart disease. These errors in detection and measurement veil existing cardiovascular disease in South Asians, derailing timely illness identification and proper medical intervention.

Figure 4: Cardiovascular diseases account for 31% of death in South Asians As more attention is drawn to this matter, medical organizations such as the American Heart Association newly qualify South Asian ancestry as a risk enhancer for cardiovascular disease – an important step forward in illness awareness and prevention. It is necessary to have more reporting and data on South Asians to combat the current medical disparities this group faces. Establishing specific cholesterol management and treatment goals catered to this population will solidify a good starting point, with the ultimate objective of reducing cardiovascular disease in South Asians overall.

This article was written in collaboration between Mian A. Jan, MD, Chairman Department of Medicine, Penn Medicine Chester County Hospital, and Ankit Raina, a medical student at Philadelphia College of Medicine.

Ankit Raina and Mian A. Jan, MD 8 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

www.CHESTERCMS.org

Chester County

Suicide Prevention Task Force

Addresses a Public Health Crisis

I

t’s a word that no one wants to say, let alone discuss. Suicide, still able to evoke fear and shame in those it touches, has become the public health concern no one talks about.

For decades suicide rates have been on the rise, and in 2022, the CDC (Centers for Disease Control and Prevention) reported the highest rates on record. After a slight decline in 2019 and 2020, almost 50,000 American lives were lost to suicide last year. Despite being rated one of the healthiest counties in the Commonwealth, Chester County is not immune to the tragedy of suicide.

“Right before the pandemic hit, we saw a small decline in rates nation-wide,” said Kate Siolek, the Executive Director of the Chester County Suicide Prevention Task Force.

“Unfortunately, that trend changed, but our county’s Suicide Prevention Task Force has continued to work tirelessly to raise awareness and provide prevention education.”

A mostly volunteer-driven organization, Chester County’s Suicide Prevention Task Force has been working to prevent suicide for almost 20 years. Last year the group received funding through the American Rescue Plan Act to hire a full-time Executive Director, broaden the scope of programming, develop more community partnerships, and boost the organization’s impact. Over the past six months, Siolek, who has been a member of the Task Force for seven years, has connected with local non-profits and businesses across the county to offer hope, provide education, and address stigma.

“Last year, in partnership with the Chester County Intermediate Unit, we trained almost 3,500 individuals in Question, Persuade and Refer (QPR), a suicide prevention program,” Siolek noted. “Through a partnership with the Chester County Department of Mental Health and Intellectual Disabilities, in addition to QPR, we offer Mental Health First Aid (MHFA) classes to the community, at no cost to participants.”

Question, Persuade, Refer (QPR) is a one and a half to two-hour class compared to CPR or the Heimlich Maneuver, in that it teaches everyday people basic skills to recognize and respond to warning signs that someone may be thinking about suicide. Mental Health First Aid (MHFA) is a longer, more comprehensive class that teaches how to recognize, understand, and respond to signs of mental health or substance use challenges. Both QPR and MHFA are national programs that have been researched and considered evidence based.

Looking ahead to 2024, Siolek says the Task Force will continue to expand QPR and MHFA in the community, and spread awareness to address stigma, but also the Task Force is planning to implement new programs and resources. One of which is peer-led support groups for survivors of loss to suicide. Supporting survivors, Siolek said, is a critical part of continued on next page >

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 9

www.CHESTERCMS.org

Chester County Suicide Prevention Task Force Addresses a Public Health Crisis continued from page 9

prevention because of the devastating and complex grief survivors experience.

“Grief after a loss to suicide is a different kind of grief. It is profound and can be layered with guilt, confusion, shame, and anger. And unfortunately, people who have experienced this loss can be at higher risk for an attempt,” Siolek said. “That is why we feel this type of support for loss survivors is central to our mission.”

The Task Force recognizes that addressing the public health crisis of suicide cannot be done alone; it takes a multifaceted approach in which all sectors of the community are working together. If you have interest in joining the Task Force, or getting trained in QPR or MHFA, please reach out on the Task Force website, ChesterCountySuicidePrevention.com.

If you or someone you know is experiencing a mental health or suicide crisis, help is available. Call or text 9-8-8, the Suicide and Crisis Lifeline which is available 24/7.

In Chester County, teens between the ages of 12-18 in need of mental health support can call or text the Teen Talk Line between the hours of 3:00pm – 7:00pm. The call line is 855-852-TEEN (8336) and the text line is 484-3629515.

The guidance and expertise you expect.

The personal attention you deserve.

Wealth Management | Private Banking Lending and Deposit Solutions | Mortgages

Cheryl M. Vaughan Senior Relationship Manager WSFS Wealth Center 3801 Kennett Pike, Suite C200 | Greenville, DE 19807 M: 302.379.9647 | O: 302.571.7210

Member FDIC | NMLS #417673 | wsfsbank.com/pb

1 0 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

www.CHESTERCMS.org

The Transformative Power of Generative AI in Medicine: A Comprehensive Exploration for Physicians and Healthcare Stakeholders

BY DONNA MURDOCH, ED.D. FACULTY, COLUMBIA UNIVERSITY TEACHERS COLLEGE

Introduction The healthcare landscape has been undergoing a seismic shift, thanks in large part to the integration of Artificial Intelligence (AI).

From its nascent stages focusing on diagnostic algorithms to the cutting-edge applications in robotic surgeries and telemedicine, AI has been a game-changer. Most providers have been using AI, whether they are aware or not, for many years. However, the advent of Generative AI – which started when Google’s Deep Mind group published a paper in 2017 called Attention is All You Need that focused on the use of transformers which were able to connect words (introduced first by ChatGPT in 2022) – that the world took notice. In similar ways in which we were able to connect images and other data, we were able to use words to talk to the software and get responses.

Now it appears to be an epoch changing moment, offering a multitude of benefits that span across society, and for physicians, patients, administrative staff, and the entire healthcare ecosystem, it can be a game-changer.

This article aims to provide a high-level understanding of Generative AI’s unique capabilities and its far-reaching implications for the practice of medicine. Generative AI, also known as LLMs (large language or foundational models) or ChatGPT (which is like using Kleenex as the word for Tissues), was brought to us by Open AI, a company and foundation heavily funded by for-profit companies like Microsoft.

Part I: The Evolutionary Journey of AI in Medicine The Early Years: Rule-Based Systems The 1970s marked the debut of AI in medicine with rule-based expert systems. These systems were designed to mimic human decision-making in specific medical domains, such as diagnostics and treatment planning.

The Machine Learning Era By the early 2000s, machine learning algorithms became the cornerstone of medical AI. Specializing in parent recognition, these algorithms found applications in diagnostic imaging, predictive analytics, and even drug discovery. However, these were instances of “narrow AI,” highly specialized for specific tasks but lacking the ability to generalize their learning to broader applications.

continued on next page >

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 1 1

www.CHESTERCMS.org

The Transformative Power of Generative AI in Medicine continued from page 11

Section II: The Generative AI Paradigm What Sets It Apart?

Generative AI, exemplified by models like GPT-4, is a paradigm shift. ChatGPT3 is the free version, and less robust but available. There are other products such as Claude2 and Anthropic, brought to market by Google and also much more specific tools. If you have Doximity, you have ChatGPT4 built in, and it speaks to clinicians. Unlike traditional AI models that are designed to analyze and interpret data, Generative AI can create new data that closely mimics its training data. This generative capability is not just analytical but also creative, enabling the AI to propose novel solutions, generate new ideas, and simulate complex medical scenarios.

The Creative Edge The creative aspect of Generative AI sets it apart from its predecessors. It can generate medical reports, simulate patient responses, and even suggest innovative treatment pathways, thereby acting as a creative partner in medical practice.

2. Advanced Diagnostic Support: Generative AI goes beyond pattern recognition to provide a detailed rationale for its diagnostic suggestions, making it a more interactive and reliable diagnostic partner.

3. Treatment Personalization: Generative AI can analyze a myriad of factors, including genetic makeup and lifestyle choices, to assist in crafting highly personalized treatment plans.

4. Research Acceleration: Generative AI can simulate complex biological systems, accelerating the pace of medical research and drug discovery.

For Patients 1. Tailored Care Plans: Generative AI can analyze a patient’s comprehensive medical history and current condition to suggest personalized treatment and preventive measures.

2. Health Literacy: Generative AI can produce easy-to-understand medical literature, empowering patients to make informed decisions about their health.

3. Virtual Health Assistants: AI-driven chatbots can provide realtime answers to patients’ queries, offering a more interactive and informative healthcare experience.

Section III: The Multifaceted Benefits of Generative AI

4. Remote Monitoring: Generative AI can analyze data from wearable devices to provide real-time health updates and alerts, facilitating better remote care.

For Physicians

For Office and Support Staff

1. Automated Documentation: Generative AI can autocomplete medical forms, patient histories, and even draft preliminary diagnoses, freeing physicians to focus more on patient care. If you are using medical dictation software, such as Dragonspeak/Nuance (the writer has no interest), there is a functionality known as Ambient AI, which listens to conversations and can put them in a format that is easy to review and change if mistakes are recognized, which can streamline EMR documentation.

1. Operational Efficiency: Generative AI can automate a range of administrative tasks, from appointment scheduling to inventory management, thereby streamlining operations.

1 2 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

2. Enhanced Customer Service: AI-powered chatbots can handle routine patient queries, allowing human staff to focus on more complex and sensitive issues.

3. Training and Onboarding: Generative AI can create simulated scenarios for training new staff, reducing the learning curve and enhancing skill acquisition.

www.CHESTERCMS.org

f

IT’S YOUR #1 DEFENSE AGAINST ONE OF THE MOST LETHAL CANCERS. It’s fast. It’s painless. Most insurance will cover it for patients 45 or older. And it could save their lives.

Colon cancer can be deadly when it’s not caught early. But it can be completely eradicated through early detection by colonoscopy. Now, thanks to a GI Genius™-enabled colonoscopy, technology aided by artificial intelligence, doctors at Main Line Gastroenterology Associates can diagnose colon cancer with unprecedented accuracy.

COLONOSCOPY CANCER

It could be the choice of your patient’s life.

DON’T PUT IT OFF. REFER YOUR PATIENTS FOR A COLONOSCOPY TODAY.

Main Line Gastroenterology Associates Main Line Gastroenterology Associates

Call USDH at 610-644-6755 or schedule online at usdigestivehealth.com.

For Administration 1. Data-Driven Governance: Generative AI can synthesize vast datasets into actionable insights, aiding in strategic planning, policy formulation, and resource allocation.

2. Regulatory Compliance: Generative AI can automatically update and cross-verify records to ensure compliance with healthcare regulations, thereby mitigating legal risks.

3. Cost Optimization: By automating various processes, Generative AI can significantly reduce operational costs, providing financial benefits to healthcare institutions.

Section IV: Addressing the Risks While the promise of Generative AI is immense, it is not without its challenges. Data privacy, algorithmic bias, and the potential for generating incorrect or misleading medical information are significant concerns. Rigorous validation, ethical considerations, and robust cybersecurity measures are imperative for the safe and effective implementation of this technology.

Remember, Generative AI is an “auto complete” on steroids.

That means you are getting the most likely suggestion based on input from others, just as images or pools of data have been used as a collective for radiology, labs, and discovery; however, critical thinking is crucial before documentation or suggestions must be used.

It is not doing work FOR you; it is there to streamline some of the work you would normally do with oversight and input by you.

Conclusion Generative AI stands on the cusp of revolutionizing healthcare, offering benefits that extend to all stakeholders involved. While challenges and risks exist, they can be addressed with careful planning, ethical governance, and stringent validation processes. The future of healthcare is not just automated; it’s generative, perhaps bringing a new era of efficiency, personalization, and ethical care for all.

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 1 3

www.CHESTERCMS.org

Phoenixville Free Clinic Recognized for Community Health Impact

BY SHELLEY MEENAN, ADVANCEMENT DIRECTOR, PHOENIXVILLE FREE CLINIC

D

espite known physical and mental health issues, Bradley hadn’t seen a doctor in seven years. He didn’t have health insurance, and there just wasn’t enough money left over at the end of the month to support the cost of medical care. Then his wife learned about Phoenixville Free Clinic, which provides comprehensive medical services to uninsured and underserved members of the community.

Phoenixville Free Clinic began a little over 20 years ago as the dream of two women, Dr. Lorna Stuart and The Reverend Marie Swayze, after they witnessed countless individuals in the Phoenixville community foregoing medical care because of their inability to pay. With a lot of grit, determination, and fundraising, the two rehabbed the former rectory of St. Peter’s Episcopal Church, which has served as the home for PFC ever since. To date, PFC has provided over 175,000 patient visits to at-risk individuals, offering primary and specialty care, lab testing, medications, advanced diagnostic testing, and behavioral health services.

1 4 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

As a result of their work improving lives and the health of the community, PFC was recently awarded a Highmark Foundation Bright Blue Futures $100,000 matching grant through its collaborative partnership with the Phoenixville Community Health Foundation. This match award recognizes a philanthropic organization whose leadership advances innovative solutions and demonstrates meaningful progress toward community health issues. As the foremost organization advancing the strategic goals of the Phoenixville Community Health Foundation, PFC was the obvious choice to receive the matching funds from this prestigious award.

Tamela Luce, President and CEO of the Phoenixville Community Health Foundation, recognized not only the vital work of Phoenixville Free Clinic but also the warm and welcoming environment in which patients receive care.

“Phoenixville Free Clinic is more than a medical center – it’s a place where people can get the medical diagnoses and treatments

www.CHESTERCMS.org

Phoenixville Community Health Foundation (PCHF) Program Director, Viviann Schorle, Phoenixville Free Clinic Executive Director, Christi Seidel, and Highmark Foundation President, Yvonne Cook, at the award ceremony in Pittsburgh on September 25, 2023.

they need from people who truly care about them. Phoenixville Free Clinic’s compassionate and caring staff and volunteers strengthen the healthcare safety net in the Greater Phoenixville region.”

“We were honored to be recognized in this way by both Highmark and our community partner PCHF,” says Christi Seidel, Executive Director of Phoenixville Free Clinic. “This funding will go a long way in supporting the health needs of uninsured individuals and families who would otherwise go without medical care. Since we don’t receive government funding for our operations, the majority of our services are funded through grants and generous donations from individuals in our community. We’re also sustained by a truly dedicated team of volunteer physicians, nurses, and administrative support.”

Thanks to PFC, Bradley is now well on his way to improved physical and mental health. Under the care of Dr. Sissy John,

PFC’s Medical Director, he was diagnosed with ADHD and started on prescription treatment. With PFC’s guidance, he became more active, started managing his weight, and addressed physical issues that he had begun to accept as “normal.” He also started regularly seeing an LCSW as part of the PFC Behavioral Health Program. “I am at a good place right now with the help of PFC,” says Bradley.

To make a donation to PFC’s life-changing work or to become a volunteer, please reach out to Shelley at smeenan@ phoenixvillefreeclinic.org.

Healthcare For The Uninsured | Phoenixville Free Clinic (formerly The Clinic) | United States Our mission at the Phoenixville Free Clinic is to provide quality health care to the uninsured in an atmosphere which fosters dignity and respect for our patients. It is our privilege to do so. www.phoenixvillefreeclinic.org.

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 1 5

www.CHESTERCMS.org

2023 UPDATE ON XYLAZINE, a not-so-new drug of abuse

BY CHRISTINA VANDEPOL, MD

T

he Chester County Coroner’s office recently hosted a xylazine training for law enforcement, first responders, emergency medical providers, and medicolegal death investigators. DEA and FBI agents, Penn Medicine and Cooper University Hospital experts, forensic toxicologist Dr. Sherry Kacinko from NMS Labs, and deputies from Chester County Drug and Alcohol Services and the Coroner’s Office gave presentations. This post summarizes what medical professionals should know about this not-so-new drug.

What is xylazine?

soon—its use in most states is not illegal. Some states, including Pennsylvania (PA), have passed their own laws to make its illicit use a criminal offense. On June 3, 2023, the PA Department of Health added xylazine to the list of Schedule III drugs under the state’s Controlled Substance, Drug, Device, and Cosmetic Act. The listing is effective for one year after which it can be renewed.

House Bill 1661, a bill criminalizing illicit use of xylazine, is currently with the PA Senate.

Street names for the drug include Tranq, Tranq-Dope, HorseTranq, Juice, and Sleep Dope. The media like to refer to it as a “skin-rotting zombie drug.” Spanish speakers may refer to it as Anestecia de Caballo.

Xylazine is a legally available veterinary drug that vets use to sedate or anesthetize large animals like horses or cattle. The veterinary product is a liquid that drug dealers often convert to a powder by drying it out. When a medicolegal drug death investigation finds xylazine on the toxicology test, illicit fentanyl is almost always present as well. One reason for adding it seems to be its ability to prolong the effects of fentanyl, a short-acting opioid.

In the past few years, xylazine has become notorious for its association with severe, potentially fatal, skin ulcerations. For example, the CCCO presented a case in which the soft tissue in a person’s arm died, leaving the humerus bone completely exposed.

Although now considered a human health threat, xylazine was once studied as a potential antihypertensive agent because it is an a-2-agonist in the same drug class as clonidine, lofexidine, and dexmedetomidine (1). Human studies were discontinued because of adverse effects.

Xylazine can show up in any illicit fentanyl supply, but can also be mixed with other drugs (cocaine, methamphetamine, benzodiazepines). Very rarely is it found alone.

Because xylazine is currently unscheduled by the Food and Drug Administration (FDA)—although that may change

1 6 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

Where is xylazine?

Xylazine showed up in Puerto Rico about 20 years ago, then moved to New York City and Philadelphia with migrants to those cities. Xylazine was reported in Philadelphia in 2006

www.CHESTERCMS.org

and in Maryland from 2006-2018. Xylazine was first identified in Chester County in February 2019 when Coroner Christina VandePol issued a press release linking two deaths to the drug.

In 2022, it was the fourth most common drug found in Chester County overdose deaths, detected in 29% of the county’s 111 drug deaths (2). The Philadelphia and South Jersey areas are hotspots for xylazine, but it’s now spread across the country.

Table 1: Number of xylazine-associated overdose deaths

Withdrawal from xylazine causes severe symptoms and requires inpatient medical management that takes simultaneous opioid withdrawal into account. Kacinko et al (NMS Laboratories) provide an extensive pharmacologic review of xylazine alone and in combination with other drugs in a 2022 article (3).

Xylazine skin ulcers and necrosis can cause bone infections and sepsis. Medical care includes advanced wound care but severe cases can result in amputation. Malayala et al provide a detailed case description of severe xylazine-related skin ulceration in a 37-year-old Philadelphia-area resident in a 2022 article in Cureus (4). Treatment included intravenous antibiotics, debridement, and topical care.

The prevalence of illicit xylazine in the Chester County area requires physicians and other health care providers to remain vigilant, especially in emergency room encounters. Routine urine screens will not detect xylazine which should be assumed to be present if a patient tests positive for fentanyl or opioids. An FDA alert issued in November 2022 provides further information on management of xylazine toxicity (5).

Preventing and treating xylazine overdose, withdrawal, and complications Xylazine test strips became available this year. They cost about $2.00 per strip and it’s not clear how individuals can get them or whether they might be considered “drug paraphernalia.” The PA Department of Health has a Xylazine Fact Sheet that recommends people “check with your local harm reduction organization.” In Chester County, the best resource would probably be the county’s Drug and Alcohol Services office.

Conference presenters emphasized that first responders should always try naloxone in suspected drug overdose cases. Naloxone does not reverse xylazine, but it can mitigate the effects of the fentanyl that is almost always on board with xylazine. Critical care pharmacist Lauren Igneri, PharmD, described several drugs (yohimbine, tolazoline, atipamezole) that can reverse the effects of xylazine, but they are not approved for human use at this time.

That means only supportive measures are currently available for acute overdoses.

Gupta, R. Perspective: Xylazine — Medical and Public Health Imperatives, N Engl J Med 2023; 388:2209-2212, DOI: 10.1056/NEJMp2303120.

Accessed 10/24/2023.

(1)

Overdose Death Data, Chester County, 2022, overdosefreepa.org. Accessed 10/24/2023.

(2)

Kacinko SL, Mohr ALA, Logan BK, Barbieri EJ. Xylazine: pharmacology review and prevalence and drug combinations in forensic toxicology casework.

J Anal Toxicol 2022; 46:911-917.

(3)

Malayala SV, Papudesi B, Bobb R, et al. (August 19, 2022) XylazineInduced Skin Ulcers in a Person Who Injects Drugs in Philadelphia, Pennsylvania, USA. Cureus 14(8): e28160. DOI 10.7759/cureus.28160 (4)

FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs. November 8, 2022. Fda.gov/drugs/.

(5)

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 1 7

www.CHESTERCMS.org

landon peacock

BY BRUCE A. COLLEY, DO

I

t is my pleasure to introduce you to Landon Peacock, our featured artist for our autumn issue. David Katz, a previously featured artist (Autumn 2017; all previous issues can be viewed on our website), suggested Landon to me, describing him as an extremely dynamic artist with a compelling approach to his art with respect to style and themes. After spending time interviewing Landon and viewing his art, David’s comments are understatements. I am sure you will agree.

“ENLIGHTMENT”

Landon comes to Chester County from Michigan. It was growing up in the rural west central area of Michigan where he incubated his appreciation for nature and the environment. As you will note, his artistic themes are tied tightly to the outdoors and reflect his commitment to conservation and our environment. Moreover, Landon has an uncanny ability to capture the emotions and personalities of his subjects. It is uncommon in my observations that artists are accomplished in rendering both “nature” themes and portraits with equal proficiency.

Landon is a rare example. I told him he should pursue portraiture a bit more, but I am sure he needs no suggestions from the peanut gallery.

I have been lucky to meet and interview about 2 dozen artists to feature in our journal for the past ten years. It has been interesting that most “find” their interest and talent at an early age. A few, however, find their calling, interest, and talent quite later in life. (See Robert Jackson Winter 2021.) Landon counts himself among them. He was in college at the University of Wisconsin on a track and cross-country scholarship and a poly-sci major when continued on page 20 >

1 8 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

www.CHESTERCMS.org

“FISHERMAN”

“KESTREL”

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 1 9

www.CHESTERCMS.org

The Art of Chester County continued from page 18 he found his artistic proclivities. Landon had been running since junior high, and it was and is his passion as he ran at world class levels – a two-time All-Americana and Big Ten conference champion. He discovered Political Science was not so much a calling for him, and curious about other disciplines Landon signed up for some art courses as electives. A “light went on” so to speak and art joined with his running to become his second passion.

Now a professional artist, Landon considers his uncle, Rob Vander Zee, to be his model. (It is worthwhile visiting his uncle’s website as well as Landon’s.) Since moving to Chester County four years ago Landon also finds inspiration from many artists in our Chester County art community.

Landon’s media is mostly oil and acrylic and his works reflect his integration of the several styles he is drawn to including abstraction, impressionism, and Chester County realism. Take a moment to review Landon’s works of art. I know you will enjoy them.

“FLORA”

“WREN”

2 0 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

www.CHESTERCMS.org

LANDON PEACOCK Artist Statement Healing has been a recent theme in my art work. The conveniences of modern society come at the expense of the natural world and the damage that occurs takes an emotional toll. As sustainability efforts emerge and awareness of environmental issues broaden, many are faced with the stark reality that their way of life has severe consequences. We are at a moment in history where many people are being reflective and willing to rethink what they value. Much of my work reflects this emerging mindset and comes from a place of hope for the future.

The process of layering with a combination of thick painterly applications and thin glazes has helped me to use my artistry as a way to express my deep appreciation for the environment and advocate for its health.

“BUTTERFLY GARDEN”

“ORDOVICIAN”

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 2 1

www.CHESTERCMS.org

PROSTATE CANCER

THE SECOND LEADING CAUSE OF DEATH IN MEN IN THE US

BY PANKAJ KALRA, MD, CHIEF OF ROBOTIC SURGERY AT PHOENIXVILLE

P

rostate cancer continues to be the second leading cause of death in men in the United States. In the past decade, there have been mixed messages regarding screening, which in turn has led to confusion about PSA testing, and less screening as a result. Although the diagnosis of prostate cancers initially decreased, recent studies have shown more cancers are now being diagnosed at an advanced stage.

In the past few years, there have been significant refinements in how we diagnose and treat prostate cancer. There is an awareness that this disease has diverse types of tumor biology and tailoring treatment towards tumor aggressiveness incorporates individual patient factors. In some patients, it is appropriate to perform active surveillance, where the cancer is simply followed without any active treatment. In others, the disease can be quite aggressive, and sometimes is already in an advanced stage on presentation. Every situation is different. Urologists typically use more sophisticated tests, such as a multi parametric MRI, which can better help in visualizing lesions that may be suspicious for high-risk disease. In addition, when there is a diagnosis of cancer, there are now genomic assays, which can

2 2 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

detect the molecular signature of the tumors. These assays also help better predict biology to aid in the prognosis and to guide treatment decisions. Genetic testing can also identify individuals and family members who would benefit from risk-reducing strategies and targeted medications.

The mainstay of treatment remains robotic prostatectomy. Since the advent of robotic surgery, this procedure has become the standard of care. However, having a robotic system does not necessarily ensure better outcomes. We know surgeon training and experience, as well as patient factors, all play a role. Locally, Phoenixville Hospital has received a designation as a Center of Excellence after a rigorous process by the Surgical Review Corporation, a nonprofit patient safety organization. The reviewers meticulously evaluate outcomes on surgical quality and patient outcomes before awarding this recognition.

This designation is not static, and requires continued data collection, which is ongoing at every Center of Excellence. Our community should be comfortable knowing they are getting the highest level of quality prostate cancer care in Chester County.

Living to the Power of You SageLife communities are designed to meet aging seniors wherever they are in their journey — giving them the power to be their best, most vibrant self. Our mission is to encourage, empower and celebrate successful aging.

Each of our communities reflect priorities that matter most: dynamic lifestyle, adaptable care, and sophisticated amenities.

We go where our residents lead us — allowing them to find their purpose and live their best life on their own terms.

That’s the SageLife difference.

AMBLER, PA

215-461-4880

MALVERN, PA

484-568-4777

The501.com

LivingAtEchoLake.com

INDEPENDENT LIVING ASSISTED LIVING MEMORY CARE

INDEPENDENT LIVING ASSISTED LIVING MEMORY CARE

WALLINGFORD, PA

610-690-1630

PAOLI, PA

610-640-4000

PlushMills.com

DaylesfordCrossing.com

INDEPENDENT LIVING PERSONAL CARE

PERSONAL CARE MEMORY CARE

Living to the power of you.

SageLife.com

www.CHESTERCMS.org

P olitics & Medicin e G U EST COLU M N:

HEALTH CARE PROFESSIONALS:

A Needed Treatment for Legislative Issues A

BY STATE REP. ARVIND VENKAT, MD D-Allegheny http://www.pahouse.com/Venkat

“Health care and having a healthful community have therefore become increasingly political.”

2 4 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

s an emergency physician, I have the privilege of caring for everyone in my community, no questions asked. But I also see the gaps in our health care system and society as a whole. For all of us as physicians and health professionals, the COVID-19 pandemic exemplified the challenges we face in delivering care to our patients and revealed that so much of health is determined by what happens outside of the four walls of the clinic, hospital, emergency department, lab, or operating room.

For example, whether our patients have access to housing, food security, quality schools, safe communities, and a clean environment all determine their health along with what we do as physicians. As concerning, with the U.S. Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization that access to abortion is not a constitutional right, health professionals have faced the prospect of criminal liability for providing reproductive health care, and attacks on access to abortion continue.

Health care and having a healthful community have therefore become increasingly political. We as physicians have little choice but to engage in the political process and have the expertise to treat the legislative issues within our government, almost all of which relate to health care.

www.CHESTERCMS.org

In 2019, more than 69% of Americans thought that the federal government should prioritize reducing the cost of health care. Since then, the cost of health care continues to increase with spending expected to rise by 5.1% from $4.2 trillion in 2022.

Moreover, 38% of Americans delayed treatment due to the cost of health care and medical debt.

As health care professionals, we have a duty to our patients, just as lawmakers have a duty to their constituents. Together, we have a duty to advocate on their behalf in health care, but also in policymaking about health care.

When I first began my career as an emergency physician, I didn’t think that I would one day serve as a legislator in the Pennsylvania House of Representatives. Now, I am the state representative for the 30th Legislative District and the first physician to serve in the House in almost 60 years since former Rep. John Cavender. Spurred by attacks against health care professionals during the COVID-19 pandemic and the potential criminalization of health professionals for doing their job, I am committed to addressing issues relating to health care and beyond within the Pennsylvania General Assembly.

Since taking office in January, I have served on the Health, Insurance, and Professional Licensure Committees. As of October, I now also serve on the Aging & Older Adult Services

and Human Services Committees. I therefore bring my expertise to all areas of policymaking about health care in Pennsylvania. I have focused on bipartisan solutions to our pressing health care challenges, including medical debt relief, evaluating our response to the COVID-19 pandemic, regulating the use of artificial intelligence by health insurers, and publicizing the dangers of fentanyl in non-clinical settings and how bystanders can respond to overdoses.

Whether serving as a policy maker or advocating to legislators on behalf of patients, physicians and health care professionals can and must influence legislation and public policy. By engaging in the political process, we ensure that legislators consider our expertise as they craft legislation, which benefits our patients and the public as a whole. The best ways to do so are to belong to your county and state medical societies and specialty organization, build a relationship with your local legislators, and make sure that our political leaders know what you see every day in providing care to your patients.

Physicians and health care professionals treat patients, and we should continue to advocate on behalf of our patients and health care professionals in all levels of government. By doing so, we can treat legislative issues in government to make health care more accessible for our community and improve the health of all.

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 2 5

www.CHESTERCMS.org

The Corporate Practice of Medicine –

Structuring Your Business

BY VASILIOS (BILL) J. KALOGREDIS, ESQ., AND SONAL PAREKH, ESQ.

Background Medical practices are subjected to various state and federal laws and regulations, whether related to business formation, licensure, general compliance or otherwise. While most healthcare practitioners are generally aware of more well-known legal requirements, such as HIPAA compliance, many remain blissfully unaware of other requirements or regulations hidden in the weeds. Depending on the circumstances, these lesser-known laws and regulations may come to haunt a healthcare practitioner and others after-the-fact.

One such that all healthcare practitioners (physicians, dentists, podiatrists, and the like) should be aware of is the Corporate Practice of Medicine Doctrine (the “CPOM”).

The CPOM is very state specific. Some states have no such restrictions while others have stringent proscriptions.

Pennsylvania and New Jersey are two examples of the latter. In Pennsylvania, the CPOM is rooted in Neill v. Gimbel Brothers, Inc., 199 A.178 (1938). In 1938, the Pennsylvania Supreme Court in Neill ruled that a corporation (here, a department store) is prohibited from engaging in the practice of optometry and may not employ optometrists for the rendering of such services to the customers of the corporation where the contractual relationship of the client or customer is not with the optometrist but with the latter’s unlicensed employer. The Court reasoned that a corporation’s employees, though professionally trained and duly licensed to practice, owe their primary allegiance and obedience to their employer rather than to the clients or patients of their employer. The Court emphasized the necessity of an immediate and unbroken relationship between a professional man and those who engage his services.

The CPOM can come into play when structuring a medical, dental, or other healthcare-related entity or transaction. As business opportunities for both licensed practitioners and non-licensed entrepreneurs and investors proliferate with regard to the ownership and operation of medical and dental

practices, med spas, and other healthcare facilities, licensed practitioners and businesspersons must be mindful to structure their businesses in accordance with the CPOM rules of the jurisdiction in question.

In essence, the CPOM prohibits or otherwise restricts the ownership of medical or medical-adjacent practices or businesses by non-licensed professionals. In other words, the CPOM can prohibit a licensed practitioner from providing healthcare services as an employee of a general business corporation or other type of business entity in which the owners are not licensed practitioners. The CPOM is rooted in public policy concerns that the corporate employment or control of a licensed professional: (1) commercializes and dilutes licensed professions; (2) interferes with the physician (or practitioner)-patient relationship and the practitioner’s exercise of independent medical judgment; and (3) allows unlicensed corporate entities to practice medicine and healthcare without being subject to the various professional standards and regulations. Suitably, the CPOM is aimed at protecting healthcare practitioners from external influence or control, particularly from non-physicianowned corporate entities which might abridge or diminish patient care and treatment decisions to maximize profits and reduce costs. While the CPOM is generally associated with a physician’s provision of medical services, depending on the jurisdiction, such as in Pennsylvania, the CPOM prohibitions also extend to other licensed health care professionals, such as dentists, optometrists, psychologists, podiatrists, etc.1

Permissible Business Structure Given the rise in private equity investment and other nonlicensed entrepreneurial interest in the ownership of businesses providing professional healthcare services, various investment, contractual, and entity structures have been implemented in an attempt to accomplish these goals.

15 Pa.C.S.A. §§ 2923 and 8105.

1

2 6 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

www.CHESTERCMS.org

One of the most typical business structures to attempt to comply with the CPOM is a Captive PC Structure. Here, a professional corporation (“PC”) owned by a licensed professional in that state would engage with a management services organization (“MSO”) to run the practice. Under the Captive PC Structure, the PC would employ physicians or other healthcare practitioners through which healthcare services are furnished. The MSO, pursuant to a management services agreement (“MSA”) with the PC, would handle “back-office functions” by furnishing all non-healthcare services to the PC including space, equipment, staffing, billing and collection, financial management, administrative duties, and in some cases, marketing. This Captive PC approach is structured such that the licensed professional remains in ownership of the entity practicing medicine and provides services pursuant to his or her license, while the MSO provides administrative services to assist in the efficient operation of providing healthcare to patients.

Common Pitfalls and Considerations When setting up a Captive PC Structure, licensed professionals should be mindful to carefully structure each agreement (MSA, business associate agreement, stock transfer restriction agreement, among others) to adhere to the CPOM rules of the state in question. The focus in any regulatory investigation likely will be on the level of control the MSO exercises over the operation of the practice and the professional judgment of licensed health care professionals from a professional services perspective. When the MSO exerts a high degree of control, the arrangement may be found to be a sham intended to disguise the unauthorized practice of medicine by an unlicensed entity. A few considerations to keep in mind include the following.

1. The MSO’s services must not interfere with the licensed professional’s medical, dental, or clinical judgment or patient relationships, whether in regard to types of diagnostic tests needed, referrals, patient schedules, or otherwise.

2. MSO services should be carefully structured so that the PC and its licensed professionals retain control and have ultimate responsibility over the practice of medicine, dentistry, or other healthcare specialty in accordance with CPOM principles of that state.

3. The MSO’s services should be in exchange for a fair market value or commercially reasonable fee.

4. The MSO’s fee arrangements must strictly adhere to state and federal law to avoid implicating state feesplitting, Anti-Kickback statutes, Stark, and other laws.

The CPOM presents a significant concern to healthcarerelated business ventures as failure to comply may result in: (1) professional licensure action or revocation; (2) civil liability for non-professional partners or entities engaging in the practice of medicine (or other specialty) without a license; (3) repayment of all revenue for billed services to patients,

insurance companies, and the government as a result of an improperly structured arrangement; (4) fines and penalties; and/or potential criminal liability.

Advantages Given the complexity in nature of the CPOM, why bother setting up any business structure other than a professional corporation or entity owned by licensed professionals? A licensed owner of a healthcare practice may choose to engage with a non-professional corporation or entity for a variety of reasons, including the following.

1. The business structure may allow healthcare practitioners to focus mainly on the practice of healthcare and patient relationships, leaving the business management and “back office” functions to be streamlined and handled by the MSO. This relationship might provide a high quality of patient care while maintaining the necessary efficiency to run the practice from a business standpoint.

2. Healthcare practitioners may have access to more capital than would have been the case without this outside investment to develop a platform for better delivery of healthcare services.

3. Oftentimes, in transition planning, such a structure expands the pool of potential buyers or partners with deeper pockets, which may result in a bigger sale price.

Conclusion There are several advantages for licensed professionals to use a Captive PC Structure for their healthcare practice. However, given the complexity and heightened scrutiny of the CPOM and other laws surrounding the practice of regulated professions, licensed professionals and businesspersons should be mindful to strictly adhere to all applicable laws and regulations. Accordingly, licensed professionals and businesspersons should consult with an experienced healthcare attorney before structuring a business arrangement for the provision of healthcare services.

This article is for educational purposes only and is not intended to provide legal advice. Should you require legal advice on this topic, feel free to reach out to Vasilios J. Kalogredis, Esq., and/or Sonal Parekh, Esq. Vasilios J. (Bill) Kalogredis, Esq., has been advising physicians, dentists, and other healthcare professionals and their businesses as to contractual, regulatory and transactional matters for over 45 years.

He is Chairman of Lamb McErlane PC’s Health Law Department.

Bill can be reached by email at bkalogredis@lambmcerlane.com or by phone at 610-701-4402.

Sonal Parekh, Esq., is an associate at Lamb McErlane PC who focuses on healthcare transactional matters and a broad range of healthcare regulatory-related issues on behalf of healthcare systems, physicians, dentists, and other healthcare providers. Sonal can be reached by email at sparekh@lambmcerlane.com or by phone at 610701-4416.

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 2 7

www.CHESTERCMS.org

FDA Warns Consumers Not to Purchase or Use Certain Eye Drops From Several Major Brands Due to Risk of Eye Infection

BY FOOD AND DRUG ADMINISTRATION

[11/15/2023] The manufacturer, Kilitch Healthcare India Limited, has issued a voluntary recall for these products. FDA recommends confirming the products on the list the agency provided.

[11/3/2023] Cardinal Health Inc. has initiated a voluntarily recall for all lots of six Leader brand ophthalmic products.

The list FDA provided on October 27 included five products branded as Leader. The list has been updated to include the sixth product.

Walmart in stores and online. Walmart is removing the product from their store shelves and website.

[10/27/2023] FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately. These products are marketed under the following brands:

Additionally, Harvard Drug Group LLC also initiated a voluntary nationwide recall for all lots of two Rugby Laboratories brand eye drops.

CVS Health

The agency has updated the list of products to include the national drug codes (NDCs) that have been confirmed. FDA will provide additional information as it becomes available.

Rite Aid

Leader (Cardinal Health) Rugby (Cardinal Health) Target Up & Up Velocity Pharma

[10/30/2023] FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by

2 8 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.

www.CHESTERCMS.org

FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found unsanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products.

CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.

Eye Drop Retailers and Product Information visit https://www.fda.gov/drugs/drug-safetyand-availability/fda-warns-consumers-notpurchase-or-use-certain-eye-drops-severalmajor-brands-due-risk-eye#eyedrops

FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program: Complete and submit the report online at Medwatch; or Download and complete the form, then submit it via fax at 1-800-FDA-0178.

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 2 9

www.CHESTERCMS.org

An Evening Together

3 0 C H E S T E R C O U N T Y M e d i c i n e | FA L L 2 0 2 3

www.CHESTERCMS.org

Reach Your Audience...

Advertise in

Reach 35,000+ Engaged Consumers

Plus,

YOUR

COMM

3,500+ Physicians, Dentists & Practice Managers Throughout Chester County Reach out to us today!

Tracy Hoffmann 610-685-0914 x201

UNIT

Y RES O

URCE

FOR

WHAT

’S HA PP

ENIN

G IN HEAL

TH C ARE

SUMMER 2023 P u b l i

s h e d

b y

P e n n s

y l v a n

i a ’s

F i r s t

M e d i c

a l

S o c i e

t y

Kristi Gilfil lan p 18

Brain Inju Opioid Use ry & Information Disorder: & Support For Profess ionals p 4

Ticks…

What You Nee d to Know p 6

Burnout Defined p 8

www.Hoffpubs.com

FA L L 2 0 2 3 | C H E S T E R C O U N T Y M e d i c i n e 3 1

When it comes to MRI providers, there is a difference.

MRI Group has a long tradition of excellence: Accurate image reading. Collaborative, highly trained physicians. Exceptional patient experience. Affordable rates.

• Images read by local radiologists • Radiologists available 24 hours a day, year round, to read images and provide consultation

MRI scans performed at our Parkesburg location • Abdomen • Magnetic Resonance • Brain Angiography • Chest (MRA) • Extremity • Pelvis • Joint • Spine

• All MRI Group locations are ACR accredited • All radiologists are board certified by American Board of Radiology • Experts in various radiology specialties including cardiovascular, interventional, neuroradiology, vascular, musculoskeletal, and pediatric imaging • Evening appointments available

Phone: 717-291-1016 Fax: 717-509-8642

MRIGroup.com Several locations in Lancaster County and Chester County

CHESTER COUNTY LOCATION: 950 S. Octorara Trail, Parkesburg (Intersection of Routes 30 and 10) We are located at the Penn Medicine Lancaster General Health Parkesburg outpatient facility.