Allegheny County MediCAl SoCiety Bulletin AuguSt 2022 A Plague Upon Both Your Houses Dietary Supplements: Widely Accessible For Better or For Worse-
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Bulletin AuguSt 2022 / Vol. 112 No. 8 Allegheny County MediCAl SoCiety ArticlesOpinion Departments Materia Medica .......................20 • Gemtesa® (vibegron) Habibur Rahman, PharmD Courtney Simpkins, PharmD Materia Medica .......................24 • Dietary Supplements: Widely Accessible For Better or For Worse Anna Packis, Kendall Benjamin, Rebecca R Schoen, PharmD, BCACP Legal Summary .....................31 • Post-Dobbs Fallout: Federal Guidance Abounds Beth Anne Jackson Grant Application ..................35 Editorial ....................................5 • A Plague Upon Both Your Houses Deval (Reshma) Paranjpe, MD, MBA, FACS Associate Editorial ..................8 • The Sweet Spot Andrea G. Witlin, DO, PhD Editorial ..................................10 • The Purge Richard H. Daffner, MD, FACR Perspective ............................13 • A Pediatrician Travels Back Home to Old San Juan Johanna Vidal-Phelan, MD, MBA, FAAP, CHIE Society News .........................17 • Pittsburgh Ophthalmology Society Announces 2022-2023 Monthly and Annual Meetings Dates Society News .........................18 • ACMS Announces New Social Media Marketing & Public Relations Partnership Society News .........................19 • Greater Pittsburgh Diabetes Club set to host Fall Program Reportable Diseases..............33 2022 ACMS Meeting and Activity Schedule......................7 On the cover lENHART Mark E. Thompson, MD Dr. Thompson specializes in Cardiology.
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company or its products. Annual subscriptions: $60 Advertising rates and information available by calling (412) 321-5030 or online at www.acms.org. ISSN: 0098-3772 Improving Healthcare through Education, Service, and Physician Well-Being. BulletinMedicalEditor Deval (Reshma) (reshma_paranjpe@hotmail.com)Paranjpe Associate Editors Douglas F. (dclough@acms.org)Clough Richard H. (rdaffner@acms.org)Daffner Kristen M. (kehrenberger@acms.org)EhrenbergerAnthonyL.Kovatch(mkovatch@comcast.net)JosephC.Paviglianiti(jcpmd@pedstrab.com)AndreaG.Witlin(agwmfm@gmail.com) www.acms.org Executive Director Sara (shussey@acms.org)Hussey Vice President - Member and Association Services Nadine M. (npopovich@acms.org)Popovich Manager - Member and Association Services Eileen (etaylor@acms.org)Taylor Administrative & Marketing Assistant Melanie mmayer@acms.orgMayer Director of Publications Cindy (cwarren@pamedsoc.org)Warren ADMINISTRATIVE STAFF
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Monkeypox Let’s start with monkeypox. Poxviruses can be spectacular in their presentation and infliction of suffering (hence Mercutio’s curse) and monkeypox lives up to the family name. The name monkeypox is somewhat of a misnomer as primates including humans are secondary hosts; the natural reservoir is thought to be squirrels and other rodents.
Famed wit Dorothy Parker was wont to answer the telephone with “What fresh hell is this?” This is not an uncommon thought for most of us while checking our smartphones for the latest news. Because variety is the spice of life, we have not one but several new plagues and poxes to face, possibilities to ponder and unmentioned implications to consider. Let us begin.
A Plague Upon Both Your Houses
Smallpox vaccine offers protection against monkeypox. However since 1980 when smallpox was declared to be eradicated smallpox vaccination has ceased, leaving humanity vulnerable to bothThediseases.UShas already missed the boat on containing monkeypox (as it did with COVID-19) in terms of quarantine and contact tracing. Initially reported as a disease exclusive to the gay community and spread only by close physical or sexual contact, monkeypox is now spreading widely among the population at large, often by mysterious modes of transmission. In more and more cases patients deny any sick contacts or physical contact of any kind: they have no idea how they came in contact with the virus. The lessons of COVID-19 have not been learned. The CDC and WHO currently maintain that monkeypox is transmitted through close contact with infected individuals (via direct or droplet transmission) or contaminated materials such as bedding (fomite transmission). What implications does this have for contaminated surfaces such as hotel comforters, inadequately cleaned hotel rooms, airplane and public transportation seating, and subways? What implications does this have for
Monkeypox, like its closely related cousin smallpox, is an Orthopoxvirus from the family Poxviridae. Like smallpox, it presents with fever, lymphadenopathy and characteristic rash; severe cases and death can occur. The case fatality rate for the unvaccinated is much better for monkeypox but still 3-6%, while it is a stunning 30% with the variola major form of smallpox.
Editorial
n Shakespeare’s day, when both plague and pox were all too prevalent, to wish a plague (or a pox!) on someone was a curse with teeth. “How quaint!”, we said of this curse as schoolchildren studying Romeo and Juliet. “How curious!” said we who had never seen a pox. Poor Mercutio, a casualty of the war between the Montagues and Capulets, utters this immortal line when he realizes he is mortally wounded so we could imagine the gravity of this curse. My medieval history class collectively dressed up in black as the Black Death for Halloween. But plagues are no longer quaint and curious or relegated to costume parties. Today, we have both plague in the form of ever-evolving variants of Covid, and pox in the form of monkeypox. And we have a nation bitterly divided between warring political parties which is a plague and a pox in itself. America might as well be Verona, but the days of a detente a la James Carville and Mary Matalin’s marriage seem long gone. How much medical and political carnage will we see before our nation develops unity and a strong, fast, agile, apolitical and organized public health response to new threats? Plays and novels will no doubt be written about these days we are living through. I Mercutio’s curse has teeth again.
5ACMS Bulletin / August 2022 Continued on Page 6
Everything old is new again. Lest you think poxviridae are having all the fun, our old nemesis poliovirus is coming back to play as well. We are lucky enough to live in the city where Jonas Salk developed his revolutionary polio vaccine (and refused to patent it) thereby saving countless lives around the world. Before vaccination, polio would paralyze 1 in 200 children who caught the disease, and 10% of those paralyzed children would die.
Parents were terrified. We have all but forgotten the iron lung negative pressure ventilator, but there are still a few polio survivors who are still trapped in them.
6 www.acms.org From Page 5
In addition, the first case of human to dog transmission of monkeypox has just been reported in the United States; be careful what you touch and wear a mask for Fido if you won’t do it for yourself. Polio
Editorial the traveling public and the recovering hospitality and transportation industries? Remember that in the early days of the pandemic the CDC and WHO were adamant that COVID-19 transmission was solely via droplet and fomite despite all the accumulating evidence of airborne transmission. Finally and quietly, these entities recognized that airborne transmission of COVID-19 was the primary route, and we all stopped washing our groceries. I suspect that we may see a similar CDC/WHO reversal regarding monkeypox. Why?
One of these patients is 76-year old Paul Alexander of Texas, who has been dependent on an iron lung machine since the age of 6 when polio paralyzed him below the neck. Hopefully we will not see routine paralysis in children again from polio, but polio is rising again. Wild type polio is endemic in Afghanistan and Pakistan; imported cases have been found in Mozambique and Malawi recently.
Don’t throw away your N95 masks just yet.
While wild-type polio is rare, vaccinederived polio has been detected in sewage/wastewater in London, New York and Jerusalem with one case of paralysis already reported in New York State according to Reuters.
Vaccine derived polio is thought to originate from the live oral polio vaccine which is given predominantly in underprivileged countries. Immunized children shed the live virus in their feces; the virus can mutate and go on to infect others via wastewater in undervaccinated communities. The COVID pandemic-induced disruption in routine immunizations is thought to have spurred the threefold increase in vaccine derived polio cases wordwide between 2020 (1081 reported cases) and the previous year. The UK is now recommending a booster dose of inactivated polio vaccine to all children between ages 1 and 9 to reduce further spread and protect against paralysis. We may soon be in a similar situation in the US between undervaccination due to anti-vaccine movements and global travel. The method of transmission is via contact with infected fecal matter, so swimming areas, hot tubs, and water parks are potential sources for concern, as are daycares and preschools.
The size of the viral particles of these poxvirus cousins is comparable. Both variola and monkeypox viral particles are 0.2-0.3 microns in size. (For reference, COVID-19 viral particles are 0.1 micron in size). Smallpox can be aerosolized and weaponized, and is a major source of concern for bioterrorism experts. Monkeypox can also be aerosolized in lethal doses as shown in primate experiments and can cause death via bronchopneumonia. A review of various transmission route studies for smallpox concludes that evidence for airborne transmission of smallpox is undeniable; another cites multiple sources from the 1960s (including a WHO bulletin) which conclude that airborne transmission of smallpox is the “usual natural route of transmission in humans.”Whythen would airborne transmission of monkeypox not only be considered but widely discussed? The economic implications would be considerable, as we learned from the COVID-19Considerpandemic.theimplications of this: all health care workers would need to be immunized against monkeypox. The airline industry could be greatly affected or at least require masks again; indeed any venue with recycled air including hospitals would need to redesign airflow systems.
Sources: Erez N et al. Diagnosis of Imported Monkeypox, Israel 2018. Emerg Infect Dis. 2019 May; 25(5): Zaucha,transmission/what-size-particle-is-important-to-https://www.aerosol.mech.ubc.ca/980-983.G.,Jahrling,P.,Geisbert, T. et al. The Pathology of Experimental Aerosolized Monkeypox Virus Infection in Cynomolgus Monkeys (Macaca fascicularis). Lab Invest 81, 1581–1600 (2001).
Editorial 2022 ACMS Meeting & Activity Schedule By Committee Finance Committee August 30 Keith T. Kanel, MD, Chair November 15 Board of Directors September 13 Patricia L. Bononi, MD, Chair December 6 House of Delegates October 21-22 MPHC (Management Professionals in November 16 Health Care) at the Westin Pittsburgh Full Day Conference Meetings begin at 6:00 pm. If you are interested in attending any of the meeting, please contact Melanie Mayer @ mmayer@acms.org. What else have we got to look forward to?
Microbiol.forofMiltonoffered-a-dose-of-polio-vaccineall-children-aged-1-to-9-in-london-to-be-https://www.gov.uk/government/news/it-2022-08-15/york-jerusalem-how-dangerous-is-has-polio-been-found-london-new-healthcare-pharmaceuticals/why-https://www.reuters.com/business/DK“Whatwastheprimarymodesmallpoxtransmission?Implicationsbiodefense.FrontCellInfect2012;2:150.7ACMS Bulletin / August 2022
Multidrug resistant (XDR) typhoid resistant to 5 classes of antibiotics emerged in 2016 in Pakistan where there is an ongoing outbreak. As of January 14, 2021, the CDC reported 71 cases in the US, of which 67 had a travel history and 58 had travelled to Pakistan in the last 30 days. The CDC reported 9 cases across 6 states; none had any travel history to Pakistan. Typhoid is spread through contaminated water and food and person to person contact (e.g. TyphoidChineseMary).scientists have reported an outbreak of a little known Langya henipavirus affecting farmers; the reservoir appears to be shrews. Crossspecies transmission is concerning, but there are no reports of human to human transmission--yet. Symptoms include fever, cough, fatigue, nausea, vomiting andCOVID-19headache.itself continues to evolve, with the latest variant BA2.75 demonstrating vaccine escape ability, high transmissibility and a large spike occurring in India right now which will be replicated in the US shortly. Together with the relaxing of restrictions by the CDC as schools reopen, this makes for a very interesting fall and winter. Flu lurks, as ever. And who knows what awaits us as the Siberian Permafrost melts. Stay alert, friends.
The Sweet Spot
Editorial
anDRea G. Witlin, DO, PhD s of this writing, I am a newly minted member of the “senior knee replacement club,” three months in and well on the road to complete recovery. I escaped any major perioperative complications despite all my numerous doctors’ trepidations. I likely set a record for the number of diverse, requisite pre-op clearances. It would be easy to blame my onerous journey on my complicated medical history. Unfortunately, my unscientific survey of other “club” members yielded similar narratives. My journey traversed 5 years and included 4 visits to 3 different knee replacement surgeons, an arthroscopy for a torn meniscus, 10 intraarticular steroid injections, 4 SYNVISC-type injections, and 4 PRP injections. I exhausted my yearly PT benefits, and paid cash for personal trainers, massage therapy, and weekly acupuncture therapy. Had I merited acceptance to the “club” yet? Knee replacements are considered “elective.” Thus, the excessive standard of care to clear a candidate for surgical risk. But should it be? I regarded PT as my most important life chore. Conceivably that conveyed the wrong impression to my docs that my quality of life was better than it appeared. But I only “came out to play” at limited, carefully chosen times. I hibernated for far too many hours when I was consumed by pain or physical exhaustion. My quality of life was likely misconstrued by others. In my heart of hearts, I felt like I was only delaying the inevitable. How much more suffering did I need to endure? I relentlessly calculated my presumed life expectancy versus my surgical risk versus my quality of life. I was afraid to share my deliberations with my husband. The possibility of yet another surgery stressed him immensely although he tacitly understood my suffering and intensifying limitations. Correspondingly, I recalled friends and family who procrastinated and never joined the “club”. I didn’t want to experience similar decline at the end of my life with increasingly substantial knee limitations as I observed with countless elderly relatives and friends. I continued my search for that sweet spot. The surgeons proclaimed that “I wasn’t ready yet,” that the procedure and rehab were too demanding, that I was too young, and/or I had too many co-morbidities. My tribulations were complicated by the emergence of Covid over two years ago. I was fearful of in-person care. I attempted to continue my rehab in our home gym. It became obvious that I backtracked as my time in isolation progressed. Eventually, I relented and returned for additional intraarticular injections and physical therapy. My mind was in overdrive. I was confused by the narrative regarding risk because most of the patients that I knew undergoing knee replacement weren’t young and healthy. Many were far older than I. They were in their 80s, usually overweight, likely hadn’t exercised since high school, and likely had other cardio-pulmonary riskI’dfactors.heard that knee replacement surgery and the associated rehab was daunting but everyone in my non-scientific sample was pleased with their decision. In contrast, those who eschewed surgery regretted their choice and were miserable at the end of their life.
By late last year, it was obvious (at least to me) that I had failed my last foray into conservative therapies and required surgery. I spent two months to query all my relevant providers on my surgical risk and lobby them for approval. I was finally at peace with my decision when my “lead” doc who had treated me through many difficult flares and therapy decisions uttered: “You need to find that sweet spot. You will make the right decision. You always do.” That was the “blessing” that I needed.
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Asroutine.forthe nitty gritty of ADLs postop…I was sent a bedside commode prior to surgery. It was a rude awakening (literally multiple times each night) for my husband when he had to assist me with its use followed by the requisite cleaning each morning. During the day, we modified the commode for use as a shower chair. Bathing was an ordeal for both of us – it’s hard to know who got sprayed with more water. Dressing was an exhausting ordeal, especially when one knee wouldn’t bend. Then came meal time with food preparation and clean up, washing clothes, taking out the dog…I was sent home with a walker and fortunately was fairly adept with its use from previous experience. But you can’t safely carry anything using a walker. I needed large pockets to carry “stuff” or alternatively as we joked, use our dog’s leash for my husband. Lastly, my husband was the drill sergeant admonishing me to do my exercises! My peri- and post-operative experience may have been a little rougher than average because of my numerous medical co-morbidities. My surgeon acknowledged that he needed to adjust his surgical technique as my knee pathology was worse than he anticipated. As time progressed, he was both amazed and pleased with my post operative recovery and progress. We first credited his skill and the responsiveness of his team. Additionally, we emphasized the seldom discussed importance of my husband as caretaker and surrogate. We successfully navigated the sweet spot.
The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.
The most important and least spoken about phase of surgery is the transition from hospital to home. As rough as the immediate post-op period in the hospital is…replete with the uncomfortable hospital room, lousy hospital food, the seemingly forever time for the nurse to answer your call button…It’s actually relatively easy compared to those first few days or weeks at Regrettably,home.the typical surgeon doesn’t have sufficient time during their brief preoperative consultation to explore these quality of life issues. Occasionally their nurses or advance practice practitioners will review post operative instructions as related to driving, showering (keeping surgical site clean), return to work, etc. PCPs occasionally pursue these discussions at pre-op consultation visits. However, I’ve found those venues fall short with regards to what home life and post operative home care really entails.
Editorial
It’s easy for the caretaker to get overwhelmed and exhausted with a new set of chores and responsibilities added to their daily home and/or work
9ACMS Bulletin / August 2022
It was still far from a done deal. I needed to share my decision with my husband and find a surgeon. My first surgical consultation was a relative disaster. That surgeon had no intention of ever operating on me solely based upon the information in my EPIC chart. My husband joined me for my next and final surgical consultation. I finally had a date for surgery. It was my first surgical consultation where we candidly reviewed quality of life issues, our previous experience with orthopedic surgical procedures, and the role of my husband as caretaker. I emphasized my husband’s ability to care for me in the present tense. Just as I would get older and amass additional comorbidities, so would my husband. Thus, his ability and stamina to provide post-op assistance would decline over time. That must have struck a chord that many other patients didn’tWediscuss.realized that an issue given short shrift during those pre-op consultations was an honest dialogue of the patient’s home environment and presence, health, and skill set of their respective caretaker. A standard pre-op question and requirement is that “someone” must be available to drive the patient home. I don’t ever recall asking or being asked about the availability or skill of a caretaker during the post operative home recovery period. Each orthopedic surgery is unique. All to some degree require assistance with meal prep and clean up, showering and personal hygiene related issues, maneuvering in one’s residence with regard to stairs, doorways, fall hazards.
RiChaRD h. DaFFneR, mD, FaCR uring my tour of duty in the Air Force, I saw an older Master Sergeant in the ED for symptoms of sinusitis. I noted that he was wearing Command Pilot wings on his uniform. I had always thought that military pilots were all officers. And so, after discharging my patient, I asked my top sergeant why an enlisted man had pilot’s wings. He told me, in a matter-of-fact way that my patient had been “RIFfed”—part of a ReductionIn-Force (RIF). RIF is a mechanism of terminating military personnel who have poor performance (efficiency) reports. In the case of my patient, he had been in the Air Force for 17 years and needed three more years of service to retire and be eligible to collect a pension. He was allowed to continue as an enlisted man (at a pay grade below that of his previous rank of Major). In academia, there is an adage that “you’ll move three times before you find a home.” Presumably, with each move you will advance one more academic rank. The positive side of that premise is that with each move the individuals will encounter different philosophies and methods of dealing with clinical situations and broaden their experiences. Still, today, a few people are fortunate enough to stay permanently in their first job. I’m frequently asked how I came to settle in Pittsburgh, interestingly, my third position post residency. I explained that several years ago in a previous editorial1. What started the events that led me here was a departmental purge, a harsher version of a RIF. The word “purge” often conjures up images of the removal of real or perceived political rivals by dictator Joseph Stalin in the former Soviet Union. More simply, a purge is defined as getting rid of someone or something unwanted. In Stalin’s regime a purge was fatal. Stalin was reputed to have said, “I have no problems. No man, no problem.”
Editorial
The roots of the purge that resulted in my relocation to Pittsburgh began in the early 1970s. The late Dr. William Anylan was Dean of the medical school as well as Chancellor for Health Affairs of Duke University. Bill was a man of vision who built the Duke Health system to the powerhouse it is today. In 1972, he gave an interview to The New Physician in which he was asked what he envisioned health care would look like at the turn of the century. Bill must have had the world’s largest crystal ball because he accurately predicted what the state of health care would be in 30 years: reduced reimbursements, the closing of smaller hospitals and/ or mergers with large facilities, community hospitals providing mostly primary care and referral of patients with complex medical or surgical issues to larger tertiary care academic centers, such as Duke. Today, we see how Dr. Anylan’s predictions have come true here in Pittsburgh with the ascendency of the UPMC, Allegheny Health Network, Heritage Valley, and Excela systems, and the demise of St. Francis, Southside, Suburban General and many other smaller hospitals. (UPMC is the largest employer in the Pittsburgh region today).
The Purge
Duke was one of the first academic medical facilities to offer their clinical faculty a private practice benefit through the founding of the Private Diagnostic Clinic (PDC) in 1931 as an independent, for-profit group practice affiliated with Duke Hospital and Duke University. The University created this arrangement, in part, to help recruit more faculty by permitting them to engage in private practice and subsequently supplement their incomes. The PDC was self-governed and not subject to university direction. Under their by-laws, a small percent of the earnings of each department was kept by the PDC for management (including billing) and the balance was paid to the clinicians in each department, as each chairperson www.acms.org
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11ACMS Bulletin / August 2022 Continued on Page 12
The new chairman of radiology decided the best way to accomplish Dr. Anylan’s goals was two-fold. First, he decided to “encourage” senior faculty, who had the highest salaries, to leave. While most organizations and academic departments have a pyramid-shaped hierarchy, his philosophy was to have an inverted “T”, with most of the faculty at the entry (Instructor and Assistant Professor) levels, and the upright arm of the inverted “T” occupied by a few of the chairman’s loyalists. John, my mentor and a tenured full Professor, was one of many faculty members pressured to depart. I, too, as an Associate Professor was on the chairman’s “hit list” and was aware that my Duke days were numbered. And thus, the purge began, with most of the senior faculty leaving. Their places were taken by younger hires fresh out of residencies or fellowships, who were told not to plan on making their time at Duke a permanent stop. They were told to work hard, publish some scientific papers, and move on to a promotion elsewhere. In this way, the lowest paying positions were rolled over, with the result that the chairman was able to contribute several million dollars of clinical money back to the institution.
The second method used was to reduce the number of faculty perks. Faculty travel and payment of society dues were restricted to attendance at two national society meetings. Coincidentally, these societies were ones in which the chairman was active. These actions alone convinced many senior faculty members to leave. Ironically, most opted for private practice, because of the bad taste left in their mouths from their academic experiences. I was young and naïve in those days and believed that I was doing all the right things to guarantee a long career at Duke. Academic promotions are based on three things: service, teaching, and research. I was doing a significant amount of clinical work, was recognized by the residents and medical students for my teaching, all the while building a solid CV through my publications and presentations at national and international society meetings. As a result, I thought I was secure. My epiphany came when the chairman informed me, at the conclusion of my sixth year that I was eligible for tenure. At that time, Duke had changed the tenure eligibility rules for clinical faculty from seven to eleven years of service. However, those individuals who had been working under the old system were “grandfathered” to be eligible at seven years. What I did not know was that under those old rules, if there were no negative incidents during the individual’s first seven years of employment, that tenure would be automatic. The chairman encouraged me to formally apply for tenure. Six weeks later he came and “apologized” for having misled me, telling me that tenure was being denied to most applicants, and if I did not want to be forced to leave after my seventh year, I would have to withdraw my tenure application. I agreed, and he told me to write him a letter stating my intentions. And with that, he cheated me out of
In addition, his office was occupied by three transcriptionists and his new office was in a converted janitor’s closet. He took the hint and left shortly thereafter.)
Editorial saw fit. In addition, each department chairperson was obligated to make an annual contribution to the medical school (“Dean’s Tax”). The Department of Diagnostic Radiology, during my residency was very profitable, and the chairman, a true mensch (a person of integrity and honor) was generous in distributing benefits to his staff. He was under pressure, however, from Dr. Anlyan to increase his department’s contributions to the medical school, and he told the dean that he would do so only when the chairmen of Surgery and Medicine increased their contributions. And for that, he was “urged” to retire in 1976. Under Dr. Anylan’s guidance, Duke began a program of retrenchment –cutting of expenses – in the late 1970’s to prepare the medical center for the changes he foresaw coming in health care. All department chairs were told to reduce costs and streamline their operations. Chairpersons in academia wield tremendous power without ,in most cases, fear of legal interference. Faculty who are unhappy with the chair’s decisions know that their only real alternative is to leave for what they hope will be greener pastures. Tenure, a system whereby the institution and the individual faculty member make a lifetime commitment to each other, is not a safeguard from removal. Tenured faculty may be dismissed for “cause,” such as failure to perform their assigned duties or some act of moral turpitude. Without “cause,” tenured faculty can be “encouraged” to leave. (As an example, one tenured full professor, whom my chairman wanted to leave, returned from vacation to find his reserved parking space was gone.
And that was my second epiphany. Those at the top, (no matter the discipline) play on a different field, with different rules, and different priorities than those of us below them. Hard work and following all the rules are no guarantee of a successful career if the chairperson wants you out. I, however, was fortunate to be able to make lemonade when I was given a big lemon.
The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.
Reference 1. Daffner RH. Taking the tide. ACMS Bulletin 2019 (Oct) 324-325.
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Dr.Daffner is a retired radiologist, who practiced at Allegheny General Hospital for over 30 years. He is Emeritus Clinical Professor of Radiology at Temple University School of Medicine
From Page 11
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Editorial tenure. It was then that I realized my days at Duke were numbered and that I would become one of the victims of the purge. Most chairpersons are honest and forthright. They do not hesitate to communicate their wishes to their faculty. I would have appreciated if the chairman, who always told people that they could speak frankly, had told me (and the others) that I had no future at Duke and should be looking to move on. I would not have been happy, but I would have respected the man for his honesty. Instead, not wanting to be thought of negatively, his modus operandi was to put the individuals whom he wanted to leave in no-win situations. For example, he told me he wanted me to work with the ENT surgeons and the oral surgeons to utilize head and neck CT scanning for their patients and then to write several papers on the subject. He then told the CT people not to notify me when they had a head and/or neck case. Thus, I would not be able to comply with his request, grounds for dismissal. Fortunately, as I have previously written1, I was recruited to come to Pittsburgh and, like the line in the Godfather movies, I was made an “offer I couldn’t refuse.” I have been happy ever since, in a 31-year career that married the very best features of academia and private practice. As a final footnote, on my exit interview, I asked the chairman why he pushed me out. For once he was honest with me. He said, “Don’t you realize I can hire three people for the same money I’m paying you?” “Will they do the job as well?” I replied.“That’s not the point,” he said.
Since I was a young child growing up in Puerto Rico, I always wanted to be a pediatrician. At the age of seventeen, my dreams of becoming a doctor led me to move and pursue higher education in the mainland U.S., while my family remained on the island. During both my undergraduate and medical school years, I would travel back to the island frequently. After I met and married my husband, when our family grew by two (sons), and with my work responsibilities ever increasing, traveling to Puerto Rico is no longer a simple undertaking. The last time I went to Puerto Rico was in 2018, when our family took part in a missionary trip focused on the reconstruction of homes impacted by Hurricane Maria. Although we had planned another trip in 2020, the COVID-19 pandemic complicated things greatly and prevented us from returning to Old San Juan for another two years. Four years is the longest time that I have ever been away from my beloved island. So, you can imagine just how excited I was to travel back to Puerto Rico with my family this past June Returning2022.toPuerto Rico is more than just a visit or a vacation for me. Traveling to the island restores my soul! When arriving to San Juan, the airplane passes above the islet where you can easily spot Old San Juan jOhanna viDal-Phelan, mD, mBa, FaaP, Chie and Castillo San Felipe del Morro.
Although Christopher Columbus first arrived at the island of Puerto Rico in 1493, naming it “San Juan Bautista,” it was Juan Ponce de León who established a settlement on the island and became its first Governor. As you walk the busy streets of Old San Juan, it is easy to imagine Puerto Rico’s early Spanish colonial days. From the 16th and 17th century artefacts at Casa Blanca Museum, to the adoquines (cobblestones) streets, walking through Old San Juan is a living-breathing history lesson.
During our travels, we visit many parts of the island, from the rainforest named “El Yunque,” to the beautiful turquoise water beaches of “Luquillo.”
Figure 1. streets of Old San Juan, do not miss the beautiful blue adoquines. These cobblestones are over 500 years old and were made from iron smelting waste.
13ACMS Bulletin / August 2022 Continued on Page 14
A Pediatrician Travels Back Home to Old San Juan
Perspective
Upon landing at the airport, don’t be surprised when people start clapping and cheering! It is a true celebration to return to the island of “Borinquen,” or “La Isla del Encanto,” as it is often called. I invite you to join in the commotion, as people from all over the world are often eager to experience everything Puerto Rico has to offer. As a commonwealth of the U.S., neither a passport nor currency exchange are needed to travel to Puerto Rico.
But one place that we never miss when we go to Puerto Rico is the incredible city of Old San Juan. Sharing the colors, sounds, flavors, and warmth of Old San Juan with my family is an extraordinary experience. When visiting, I cherish sharing with my sons the most intricate aspects of the culture, history, architecture, gastronomy, art, and music that make the island of Puerto Rico such an amazingVisitingdestination.ViejoSan Juan (Old San Juan) is like traveling back in time, 500 hundred years to be exact. Due to its geographic location, Puerto Rico became a very important port where early European travelers crossing the Atlantic Ocean could obtain fresh water, food, and supplies. Founded by the Spaniards in 1519, Old San Juan is the second oldest city in the Western Hemisphere.
You will not miss the piragϋeros’ bright colorful pushcarts! When enjoying our favorite flavored piraguas this most recent visit, our family could not stop thinking of Lin-Manual Miranda’s “Piragua” song from the musical In the Heights. We even sang it out as we enjoyed our special treats, making our friendly piragϋero smile.
Pay close attention to the architectural beauty of the buildings along Calle del Cristo (Cristo Street), stopping along the way to visit the Catedral de San Juan Bautista (San Juan Cathedral, the second oldest church in the Western Hemisphere). Be sure to ask a local about the legend of the Capilla del Santo Cristo de la Salud (Chapel of Christ the Savior) while smiling at the children playing and feeding the pigeons next to the chapel at the Parque de las Palomas (Pigeon Park). This is the same park I visited as a child with my grandmother, and it’s a little hidden gem overlooking the San Juan Bay. Figure 2. Entrance to Castillo San Felipe del Morro. This impressive fortification guarded the entrance to the San Juan Bay during Spanish rule and took 250 years to build. Another highly anticipated stop for our family is always the San Juan National Historic Site, which includes Castillo San Felipe del Morro (or simply “El Morro” if you’re a local), Castillo San Cristobal, and the old city walls. On the weekends, many local families come to large open grounds at the entrance to El Morro to fly chiringas (kites), and to enjoy the treats brought by the colorful street merchants. When visiting the Castillos, be sure to find at least one garita (sentry box) and take a picture. San Juan’s garitas are commonly portrayed in the works of local artisans as a symbol of Puerto Rico. For those who have traveled by sea, the garitas and El Morro of Old San Juan are the first and last sights of theWeisland.greatly enjoy walking at El Paseo de la Princesa (Princess Promenade) and talking to the local merchants. Artisans from all over the island come to visit El Paseo to bring their latest creations. From musical instruments to delicious local candies, El Paseo is always a fun experience. At El Paseo, my eldest son learned directly from an artisan how he handcrafts a gϋiro using a hollow gourd. The artisan gladly demonstrated how the gϋiro, a percussion instrument frequently heard in Puerto Rican music, comes to life when rubbing tines along the carved notches. Our son’s new guiro even has the artisan’s signature!
14 www.acms.org From Page 13
A visit to Old San Juan would not be complete without a stop at the Puerta de San Juan (the San Juan Gate). The Puerta de San Juan is essentially a gate in the old city walls that opens to a pier where the Spanish galleons would moor after their transatlantic voyages. When the weary travelers would make landfall in Puerto Rico, the first thing they saw through the gate was the San Juan Cathedral, just up the hilled street from the Puerta. According to my high school history teacher, many travelers showed their gratitude for arriving safely to the island by making the Cathedral their first stop after their long voyages. Honoring this tradition, our family makes visiting the San Juan cathedral an essential stop when returning to the island.
Perspective
Figure 3. Many families enjoy a Sunday’s afternoon stroll around the beautiful plazas in Old San Juan. As a family, our favorite time to visit Old San Juan is on Sunday afternoons, when you can see many locals taking a walk (un paseo) through the city wearing their Sunday best. From newborns to abuelos (grandparents), entire families join in the local tradition of visiting the many open plazas in Old San Juan, sitting on benches, and enjoying local refreshing treats together. My favorite treat is called a piragua, or Puerto Rican shaved ice. Walking around Old San Juan, you will notice local vendors called piragϋeros. To make a piragua, piragϋeros shave a large block of ice, by hand, and shape the ice like a cone into a paper cup, covering it with local fruit-flavored syrups like tamarindo (tamarind), frambuesa (raspberry), parcha (passion fruit), or guayaba (guava).
Perspective
Figure 5. Do not be frightened of vejigantes. You may see a vejigante dancing to Puerto Rican bomba and plena music during festival season. If you love chocolate as much as I do, then you may also enjoy a visit to the Chocobar Cortés on Calle San Francisco. When I was growing up in the island, my grandmother enjoyed making and drinking Chocolate Cortés hot chocolate. Paired with Maria Cookies, I would sit on my grandmother’s front porch to sip the scrumptious beverage with her. And yes, you read correctly, we drink hot chocolate, even in the Caribbean heat! Chocolate Cortes has been a stable of Puerto Rican and Dominican families since 1929, and when the Chocobar opened in Old San Juan in 2013, I couldn’t be more excited. The Chocolate Cortes family’s vision is to “inspire the world with the taste of our chocolate, the richness of our culture, and the warmth of the Caribbean.”
ACMS Bulletin / August 2022 Continued on Page 16
Figure 4. A visit to Old San Juan is not complete without a piragua! Old San Juan is also filled with colorful businesses and wonderful restaurants showcasing local gastronomical favorites. I greatly enjoy visiting the local artisan shops at Calle Fortaleza where you will find vejigante masks (made of papier-maché or coconuts), lithographs of the island’s landmarks, and other hand-made items. One of our favorite places to eat and recharge is Calle Fortaleza’s Barrachina Restaurant. While enjoying a mofongo (a local Puerto Rican dish made with plantains) in the restaurant’s courtyard, I encourage you to relish the architecture of the beautiful colonial building. As part of your visit to Barrachina, you can also savor a deliciously sweet homemade piña colada. Although disputed by the nearby Caribe Hilton hotel, the Barrachina Restaurant claims to be the location where, in 1963, the Piña Colada was created by Don Ramon Portas Mingot. Regardless of who created it first, a freshly made virgin piña colada was a treat our family could not pass up in the tropical heat.
Finishing your day in Old San Juan should include a visit to the San Juan City Hall and the Plaza de Armas, a main square built in the 16th century. Inside the City Hall, find a white marble plaque engraved with the words “En mi Viejo San Juan” (“In my Old San Juan”). After a day visiting Old San Juan’s historic landmarks, learning about its history, traditions and people, the words of Noel Estrada’s nostalgic song will have a new meaning. Written in 1943, “En mi Viejo San Juan” is considered by many as a Puerto Rican anthem that acknowledges the painful sacrifice many Puerto Ricans have made when leaving the island to15
Figure 6. You will not regret enjoying a chocolate treat as part of your Old San Juan experience at Chocobar Cortés.
Besides all the delicious candies, and chocolate and coffee beverages at the Chocobar, you can also treat yourself to delicious treats like the Rio Chocolate Cake, quesito Cortes (cheese pastry), or churros.
Dr. Daffner, associate editor of the ACMS Bulletin, is a retired radiologist who practiced at Allegheny General Hospital for more than 30 years. He is emeritus clinical professor of Radiology at Temple University School of Medicine and is the author of nine textbooks. He can be reached at bulletin@acms.org.
the group asked us to bill using their billing system. Besides the benefit of keeping their EHR, the group is now experiencing greater efficiency and stability in their office by eliminating problems caused by biller turnover, vacations, diversion, and other time off. Contact Ruby Marcocelli,
References 1. Shem S. The House of God. Richard Marek Publishers 1978. 2. Freud S, (Strachey J, Trans.). Jokes and their relation to the unconscious New York: W. W. Norton, 1960 (Original work published 1905). so Vice President at
Perspective seek better opportunities and a new future. “One afternoon I left, towards a foreign nation, as fate would have it, but my heart remained facing the sea in my Old San Juan”. Although the man in the song leaves, his hope is to return one day to the “land of my love”. Unfortunately, “time passes by, and destiny mocked my terrible nostalgia, and I couldn’t return to the San Juan that I loved, little piece of my land.” When standing in front of “En mi Viejo San Juan” and reading the lyrics, line by line, I always remember that although I left Puerto Rico many years ago to become a pediatrician, a “little piece of my heart” will always be found among the streets and walls of my precious Old San Juan. Figure 7. The author during her recent visit to Old San Juan.
The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.
229ACMS Bulletin / August 2021 adjacent lumbar vertebra, explaining her pain. My resident, from Georgia, upon seeing the findings said, in his deep southern drawl, “Fellahs, there’s a lesson here. Crocks daah (die), too.” Unfortunately for the patient, CT scanning and ultrasound exams had not been developed. The important lesson is that for most patients with a diagnosis of psychosomatic illness, the symptoms are real, and in fact a small number of these patients indeed have real abnormalities accounting for their symptoms.Sigmund Freud’s view of humor was that it was a conscious expression of thoughts that society usually suppressed or was forbidden. As long as the humor, in this case namecalling, is meant in a benign fashion, it is considered harmless. However, in today’s politically divisive atmosphere, it is best to use humor only when you truly know your audience. As a good example, I remember the not so “good old days,” when it was expected that a speaker at a conference or a refresher course would tell jokes. Many of the “old timers” were very colorful characters. Today, fortunately, speakers are business-like and jokes are tacitly forbidden, since they are bound to offend someone. Finally, we should always remember that no matter how unpleasant some of our patients are to us, they are still our fellow human beings.
• Physician Billing Services for All Specialties We would use OUR billing system or YOUR billing system based on YOUR preference. • Credentialing Services for All Specialties • Accounts Receivable Follow-Up for Practice Support We would work your accounts on your system to maximize cash flow. NEW Billing Client Example: A new client (a 6-physician family medicine group) liked their EHR,
Editorial
412-788-8007 or rmarcocelli@fennercorp.com OUR SYSTEM or YOUR SYSTEM? Three Penn Center West Pittsburgh, PA It’sfennercorp.com15276uptoyou. For more info on Puerto Rico visit https://www.discoverpuertorico.com/ 16 www.acms.org From Page 15
17ACMS Bulletin / August 2022
2022-2023
The ballroom, located on the 2nd level is a non-smoking facility and provides ample social distancing space.
*The November 3 program will be the only meeting held at the Babb Insurance Building (850 Ridge Ave, Pgh, PA 15212). More details will be provided on the November meeting notice and registration site. Registration begins at 4:00 pm with the first lecture to commence at 4:30 pm. The Agenda includes a Resident Case Presentation. This year’s secondyear Resident presenters from the University of Pittsburgh Eye Center include: Sonny Caplash, MD; Timothy
Members will receive registration information, including the link to register, 1-month prior from the date of each meeting. Registration is required (no walk-ins, please) and will be handled on-line only. At the time of print, guest faculty for all meetings are in the process of being confirmed. Please visit the POS website www.pghoph.org periodically for updates on guest faculty and presentation details, as well as registration information. for more information how participate.
Pittsburgh Ophthalmology Society Announces Monthly and Annual Meetings Dates
Society News
2022 ACMS Bulletin Photo Contest See back page
Marshall Stafford, MD, President of the Pittsburgh Ophthalmology Society (POS), is pleased to announce the 2022-2023 POS Monthly Meeting Series and Annual Meeting dates.
A total of six meetings are scheduled, beginning September, and concluding with the Annual meeting in MarchThe2023.POS will host the monthly meetings as in person meetings in the Ohio Room at the Rivers Casino (777 Casino Dr, Pgh, PA 15212)*. The venue is centrally located on the North Side and offers free parking. Valet parking is also available for a small fee.
Chen, MD; Jonathan Peterson, MD; Matthew Sommers, MD; and Bushra Usmani, MD.
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The Allegheny County Medical Society is excited to have partnered with The Corcoran Collective for our social media marketing and public relations activities. The Corcoran Collective is a creative, forward-thinking marketing and public relations agency based in Pittsburgh, PA. The team at The Corcoran Collective have a passion for representing individuals, small businesses, corporations and anyone in between that has a belief in doing better and in doing good.
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ACMS Announces New Social Media Marketing & Public Relations Partnership
By: Sara Hussey, ACMS Executive Director
You may have already noticed a refresh on our social media pages including LinkedIn, Instagram, Twitter and Facebook. We’ve got some great things coming your way in September, including impactful content around Physician Suicide Awareness Day on September 17. Throughout the entire month of September, we will be highlighting stress relief techniques, tips for managing a busy schedule, and local businesses that support medical professionals through free programming, discounts, and more. We’ll also be doing some fun giveaways throughout the month of September to our social media followers. Make sure you give our social media accounts a follow so that our important info can reach as many people as possible. In addition to social media, we’re also looking to elevate the profile of ACMS members through intentional public relations work. We want to get our ACMS members in the news and present them as the experts both locally and nationally. Please join our ACMS Media Contact list to be listed as a key contact for any news requests that come our way. We’d also love to hear your story pitches. You are the boots on the ground in the hospitals and working alongside patients, and you will know firsthand if there is a newsworthy story. You can sign up to become a media contact AND submit a story pitch at: www.acms.org/acmspress. www.acms.org
Society News
We begin the series on September 8th and welcome guest speaker Sandra. F. Sieminski, MD, Vice Chair of Clinical DirectorAssociateAffairs;Professor,of Glaucoma Ira G. Ross Eye Institute, Department of Ophthalmology Jacobs School of Medicine & Biomedical SciencesUniversity at Buffalo/State University of New York (SUNY). Thank you to Ian Conner, MD, PhD for inviting Dr. Sieminski. Dr. Sieminski joined the Ross Eye Institute in 2010, and received the Resident Teaching Award in 2012. She has spoken at several meetings nationally and internationally, and was an invited speaker in 2020 for Glaucoma Subspecialty day at the American Academy of Ophthalmology. She has co-authored numerous peer-reviewed publications and has a special interest in laser therapy in glaucoma. Dr. Sieminski also serves as the Ophthalmology Clerkship Director for the University at Buffalo Jacobs School of Medicine and is the Chief of Service for Ophthalmology at the Erie County Medical Center. In October, the POS will not meet due to the AAO Annual Meeting, scheduled for September 30th through October 3, 2022. Contact Nadine Popovich, administrator to confirm the status of your membership, registration, or to inquire about an upcoming program. She can be reached by email: npopovich@acms.org or by phone: 412.321.5030
Society News
416 Cedar Run Rd - Hartwood Acres $980,000 PENDINGSALE1Trimont 960D - Mt $1,200,000Washington 1092 Fox Chapel Rd - Fox Chapel $1,700,000 1315 Inverness - Squirrel Hill $1,850,000 19ACMS Bulletin / August 2022
Greater Pittsburgh Diabetes Club set to host Fall Program
The Greater Pittsburgh Diabetes Club (GPDC) will host their annual fall program, Tuesday, October 25th.
Joseph Aloi, MD
The GPDC is pleased to welcome guest speaker Joseph Aloi, MD, Section Chief for Endocrinology and Metabolism, Wake Forest Baptist Health, Winston Salem, NC. He will present Integrating Diabetes Technology with Inpatient Care. Thank you to the following who provided support for the program: AstraZeneca, Bayer, Boehringer-Ingelheim, Corcept Therapeutics, Dexcom, Novo Nordisk, Dr. Aloi is the current Chair of the American Diabetes Technology Interest Group at the American Diabetes Association. He is very involved with trials examining the continuous glucose monitors, inpatient glucose management software and is well published in this field. Dr. Aloi is an active investigator and is focused on bringing technology to help improve the care of persons with diabetes. He is a moderator for many national and international diabetes meetings and serves on the Carolinas Society of Endocrinology Board of Directors. For more information and to register for the program, please visit www. pghdiabetesclub.org. Registration begins September 1 with a fee of $15 for members and a guest fee of $40.00 (which includes 1 year of membership in the GPDC). Questions can be directed to Nadine Popovich, administrator by email to: npopovich@
The in-person event will be held in the Babb Insurance Bldg., 850 Ridge Ave, Pittsburgh, PA, beginning at 6:00 pm with the popular Vendor Showcase. Following a brief welcome, the dinner and program will begin at 7:05 pm. The meeting is open to members of the Club and non-members (guest fee will apply).
Materia Medica
haBiBuR Rahman, PhaRmD COuRtney simPkins, PhaRmD Intro Gemtesa® (vibegron) is a novel β3-adrenergic receptor (β3-AR) agonist that is FDA approved for treatment of overactive bladder (OAB) with symptoms of urge incontinence, urgency, and urinary frequency.1 It is the first selective β3-AR agonist to achieve FDA approval since introduction of mirabegron in 2012, the only other β3-AR agonist on the market. Gemtesa® is highly selective, with a greater than 9000-fold selectivity for the β3-AR compared to β1 or β2 receptors. The selectivity of this agent is a point of emphasis as broad β receptor agonism can lead to greater adverse drug reactions. Other OAB medications target muscarinic receptors and have significant anticholinergic effects.2 Safety In a 2018 phase 3 trial conducted in patients of Japanese descent with OAB, the incidence of drug-related adverse events associated with Gemtesa® was similar to placebo and less than the comparator anticholinergic, imidafenacin.3 In this four-arm, parallel-group, 12-week active treatment, placebo-controlled trial, patients with OAB symptoms for greater than or equal to 6 months were randomized to receive Gemtesa® 50mg daily (n=370), Gemtesa® 100mg daily (n=369), placebo (n=369), or imidafenacin 0.1mg twice daily (n=117) in a 3.3:3.3:3.3:1 ratio respectively. Safety was assessed based on rates of adverse events, clinical testing, postvoid residuals, vitals, and 12-lead electrocardiogram (ECG). Clinical tests included hematological markers, biochemical markers, and urinalysis.
Treatment-emergent adverse events (TEAE) were all adverse events recorded after the start of each treatment that may or may not be attributed to each treatment arm. From a safety standpoint, the most common TEAE was nasopharyngitis (8.6%, 9.5%, 7.3%, 3.4%), cystitis (2.4%, 2.2%, 0.8%, 0.9%), and blood alkaline phosphatase increases (0%, 0.3%, 0.3%, 2.6%) for the 50mg, 100mg, placebo, and imidafenacin treatment arms respectively. Drug-related TEAE were adverse events that occurring during treatment that investigators attributed to each treatment arm. The most common drug related TEAE were blood alkaline phosphatase increase (0%, 0.3%, 0.3%, 1.7%) and hypertension (0%, 0%, 0%, 1.7%).
Serious TEAE included back pain, pyelonephritis, colon cancer, acute myeloid leukemia, dizziness, and breast cancer. These occurred in 1 patient in each active drug treatment arm and in 3 patients in the placebo arm, none of which were thought to be related to the intervention. TEAEs that led to discontinuation were in 3 patients in the 50mg Gemtesa® group (edema, eczema, and neutrophil count decrease), and 3 patients in the 100mg Gemtesa® group (supraventricular tachycardia, blood creatinine increase, and abdominal pain). There were no other notable changes in clinical laboratory values and vital signs than the ones mentioned. There were similar rates of ECG changes among all groups as well as no substantial changes in postvoid residuals. This study demonstrated the relative safety of Gemtesa® with low incidences of key safety parameters. In a phase 3 trial, patients with OAB were treated with Gemtesa® 50mg (n=116) or 100mg (n=51), and the long-term safety profile of the medication was evaluated.4 In patients that did not respond appropriately within 8 weeks to 50mg, they were increased to 100mg and continued this treatment for 44 weeks. The primary safety outcome was evaluated in overall percentages of TEAE which were 55.1% and 16.2% for 50mg and 100mg respectively. Three cases of cystitis and 5 cases of postvoid residual increase were discovered, all in the 50mg group and none in the 100mg group. Severe TEAE, which were angina pectoris (n=1), falls (n=1), 20 www.acms.org
Gemtesa® (vibegron)
Continued on Page 22 21ACMS Bulletin / August 2022
Efficacy There are 2 randomized, doubleblind, phase 3 trials with both short and long-term data that show the efficacy of Gemtesa® in treatment of OAB symptoms.3 Yoshida et al had a primary outcome of change in the number of micturitions a day at 12 weeks from baseline. Their secondary outcomes included changes in baseline OAB symptom variables. They found the estimated difference in mean micturitions a day between Gemtesa® groups and placebo was -0.86 (-1.12, -0.60) for Gemtesa® 50 mg (p < 0.001) and -0.81 (-1.07, -0.55) for Gemtesa® 100mg (p < 0.001). For secondary outcomes of daily urgency episodes, urgency incontinence episodes, incontinence episodes, and nocturia episodes, both doses had significantly lower rates compared to placebo. A phase 3 trial by Yoshida et al evaluated the efficacy after 1 year of treatment in Japanese patients treated for OAB. If investigators determined patients needed further symptom management after 8 weeks of 50mg, doses were increased to 100mg. This long-term study confirmed the statistically significant OAB symptom improvements were maintained through 52 weeks and patients that initially did not have improvements with 50mg had an improved condition with doseTheescalation.international EMPOWUR trial showed that Gemtesa® 75mg dose significantly reduced micturitions per day by a mean of 1.8 compared to 1.3 in placebo, a least-square (LS) mean difference of -0.5 (95% CI -0.8, -0.2) p <0.001.6 Tolterodine had a LS mean change of 1.6, a LS mean difference of -0.3 from placebo (95% CI -0.6,
Materia Medica and cerebral infarction (n=1), occurred only in the 50mg group. Besides cerebral infarction, all other severe TEAEs were not considered to be caused by Gemtesa® because there was no correlation between adverse event onset and dose administration. A third of all TEAE were reported within the first 12 weeks of treatment and decreased in a time dependent manner. No clinically significant changes were found in clinical labs, vitals, or ECG changes after 1 year of treatment.Thereislittle concern for toxicities related to drug metabolism and clearance with Gemtesa®. The drug has not shown to be a significant inhibitor or inducer of major cytochrome P450 enzymes.5 With concomitant administration of ketoconazole, diltiazem, rifampin, or tolterodine, no significant differences were observed in Gemtesa® pharmacokinetics.1
The coadministration with digoxin increased digoxin area under the curve by 21%. Renal dose adjustments are not required for mild to severe renal impairment. Patients with an eGFR less than 15mL/min/1.73 m2 with or without hemodialysis, use is not recommended as it has not been studied in this patient population. No hepatic dose adjustments are required in patients with a Child-Pugh score of A or B but in patients with a score of C, use is not recommended as it has also not been studied. Tolerability Gemtesa® has been shown to be well-tolerated by patients in clinical trials. The most common drug-related TEAE were constipation (1.6%, 0.3%, 0.8%, 0.9%) and dry mouth (1.4%, 0.3%, 0.5%, 4.3%) for Gemtesa® 50mg daily (n=370), Gemtesa® 100mg daily (n=369), placebo (n=369), or imidafenacin 0.1mg twice daily (n=117) respectively.3 Data from long-term follow-up in Japanese patients also showed constipation (1.7%, 3.9%) and dry-mouth (2.6%, 3.9%) to be the most frequent adverse events for 50mg and 100mg respectivly.4 The EMPOWUR trial compared 75mg Gemtesa®, placebo, and extended release 4mg tolterodine for 12 weeks of treatment in patients with OAB.6 Similar to the short-term trial in Japanese patients, this 2020 trial found low rates of discontinuation due to adverse events with 1.7% in Gemtesa® (n=545), 1.1% in placebo (n=540), and 3.3% in tolterodine (n=430) patients. The most common adverse events were headache (4%, 2.4%, 2.6%), nasopharyngitis (2.8%, 1.7%, 2.6%), diarrhea (2.2%, 1.1%, 2.1%), nausea (2.2%, 1.1%, 1.2%) and constipation (1.7%, 1.3%, 1.4%) for the Gemtesa®, placebo, and tolterodine groups respectively. In the EMPOWUR extension trial, patients were continued on therapy for 40 weeks.7 Patients that received placebo were randomized 1:1 to get either tolterodine or Gemtesa® Between the groups, there were no meaningful differences between the incidence and severity of adverse events. The most common adverse event reported were hypertension (8.8, 8.6%), headache (5.5%,3.9%), diarrhea (4.8%, 1.7%), constipation (3.7%, 2.6%) and nausea (3.7%, 3%) in the Gemtesa® and tolterodine groups respectively.
Gemtesa® has demonstrated significant improvements in urinary symptoms in patients which is maintained at 52 weeks. Since the half-life of Gemtesa® is long, it allows for once daily 75mg dosing, making administration easy. The major drawback of Gemtesa® therapy is the cost of the medication. Although clinically it is effective and well tolerated, cost significantly limits access for patients. If cost is not a significant burden, Gemtesa® may be considered as a first-line treatment option.
Bottom Line Gemtesa® (Vibegron) is a highly selective β3-AR agonist that can be used to treat urinary symptoms of OAB. Trials have found little evidence of significant safety concerns and only mild side effects with treatment.
2. Scarneciu I, Lupu S, Bratu OG, et al. Overactive bladder: A review and update. Exp Ther Med. 2021;22(6):1444. doi:10.3892/ ETM.2021.10879
4. Yoshida M, Kakizaki H, Takahashi S, Nagai S, Kurose T. Long-term safety and efficacy of the novel β(3) -adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study. Int J Urol Off J Japanese Urol Assoc. doi:10.1111/iju.135962018;25(7):668-675. www.acms.org
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Dr. Habibur Rahman is a PGY1 Pharmacy resident at UPMC St. Margaret and can be reached at rahmanh@upmc.edu. Dr. Courtney Simpkins is a PGY2 Ambulatory Care Pharmacy resident at UPMC St. Margaret and can be reached at simpkinsca@upmc.edu. Dr. Heather Sakely, PharmD, BCPS, BCGP, the Director of Geriatric Pharmacotherapy and Director of the PGY2 Geriatric Pharmacy Residency served as editor and mentor for this work and can be reached at sakelyh@upmc.edu.
Although Gemtesa® is a CYP3a4 and P-gp substrate, little pharmacokinetic changes were observed with concomitant administration of strong inhibitors and inducers. This simplifies therapy as drug interaction are not of significant concern.
3. Yoshida M, Takeda M, Gotoh M, Nagai S, Kurose T. Vibegron, a Nov el Potent and Selective β(3)-Adreno receptor Agonist, for the Treatment of Patients with Overactive Bladder: A Randomized, Double-blind, Placebo-controlled Phase 3 Study. Eur Urol. doi:10.1016/j.eururo.2017.12.0222018;73(5):783-790.
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Materia Medica 0.1).The study drug also reduced urge incontinence episodes by a mean of 2 episodes a day compared to 1.4 in placebo and 1.8 for tolterodine, an LS mean difference from placebo of -0.6 (95% CI -0.9, -0.3) and -0.4 (95% CI -0.7, -0.1) for Gemtesa® and tolterodine respectively. For the secondary outcomes of number of urgency episodes, volume per micturition, and proportion of incontinent patients with a 75% or greater reduction in urge incontinence episodes, Gemtesa® was statistically superior to placebo. This symptom improvement was maintained through 52 weeks as demonstrated in the EMPOWUR extension trial.7 Price Currently the only FDA approved dose of Gemtesa® is 75mg daily, based on data from the EMPOWUR trial. The average wholesale price for a 75mg tablet is $18.34, making a month supply of Gemtesa® equal $550.20.8 A manufacturer Simple Savings Card is available if patients have a qualifying commercial insurance plan and need cost assistance.9 In comparison, the average wholesale price for a 30 day supply of mirabegron is estimated to be $500.70.10 Simplicity Gemtesa® once daily 75mg dose is optimal for patients that have trouble with pill burden or may forget to take a dose. The long half-life of 30.8 hours makes consequences of late dosing less severe.1 Furthermore, for patient that have trouble swallowing, tablets may be crushed and administered with applesauce. With consideration to dietary requirements, no clinically relevant pharmacokinetic differences were observed with administration of high fat meals.1 Since Gemtesa® has no renal or hepatic adjustments, no changes to therapy need to be made for patients that have a decline in renal or hepatic function, outside of eGFR less than 15 and severe hepatic impairment. In those patients, therapy would not be initiated.
References 1. Gemtesa (Vibegron) [package insert].Irvine, CA: Urovant Sciences, Inc.; 2020.
6. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PNJ. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. J Urol. 2020;204(2):316-324. JU.0000000000000807doi:10.1097/
5. Edmondson SD, Zhu C, Kar NF, et al. Discovery of Vibegron: A Potent and Selective β3 Adrenergic Receptor Agonist for the Treatment of Overactive Bladder. J Med Chem. 2016;59(2):609-623. acs.jmedchem.5b01372doi:10.1021/
source=panel_search_result&seformation?search=vibegron&com/contents/vibegron-drug-inhttps://www.uptodate.-lectedTitle=1~5&usage_type=panel&kp_tab=drug_general&display_rank=1#F55364947
10.com/savings-programhttps://gemtesa.Lexicomp.Mirabegron:Druginformation.https://www.uptodate.com/contents/mirabegron-drug-in-formation?search=mirabegron&source=panel_search_result&selectedTitle=1~14&usage_type=pan-el&kp_tab=drug_general&display_rank=1#F14965672
The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society. Thank you for PleaseinmembershipyourtheAlleghenyCountyMedicalSocietyTheACMSMembershipCommitteeappreciatesyoursupport.Yourmembershipstrengthensthesocietyandhelpsprotectourpatients.makeyourmedicalsocietystrongerbyencouragingyourcolleaguestobecomemembersoftheACMS.Forinformation,callthemembershipdepartmentat(412)321-5030,ext.109,oremailacms@acms.org 23ACMS Bulletin / August 2022
7. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PNJ. Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy from a Dou ble-Blind Extension Study of the In ternational Phase 3 Trial (EMPOWUR). J Urol. doi:10.1097/JU.00000000000015742021;205(5):1421-1429.
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8. Lexicomp. Vibegron: Drug information. Accessed October 16, 2021.
9. Gemtesa (vibegron). Accessed October 16, 2021.
Accessible For Better or For Worse
anna PaCkis, kenDall Benjamin, ReBeCCa R sChOen, PhaRmD, BCaCP
As access to online information grows, many people are seeking a more active role in their health. Patients are increasingly looking to the dietary supplement aisle at their local pharmacy for an easy, affordable way to improve their health.1 Many supplements are well-tolerated and when used properly, could address nutritional deficiencies and other concerns. However, they are not necessarily benign. The marketing of these products often focuses on “natural” remedies, and many patients assume that they are inherently safe to use under any conditions.2 Unfortunately, with many supplements, this viewpoint is not necessarily accurate in all patients. Further, many patients omit supplements from their medication lists despite relevant side effects and interactions.1 This article will discuss potential concerns and considerations for physicians to be aware of when guiding our patients on the safe, efficacious use of these products.
The FDA defines dietary supplements as products intended to supplement the diet with one or more of the following dietary ingredients:2 Vitamins 2. Minerals 3. Herbs and other botanicals 4. Amino acids 5. A dietary substance for use by man to supplement the diet by increasing total dietary intake
6. A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above These products are often sold in the over-the-counter aisle of the pharmacy, store or online and are therefore widely accessible to the public. This can be both useful and potentially harmful depending on the safety and efficacy of the ingredients, the individual patient considerations, and the quality of the product purchased.
Importantly, under DHSEA, responsibility for safety and appropriate labeling falls on the manufacturer. Manufacturers are not required to conduct studies, do not need to submit documentation to the FDA, and can begin producing and selling dietary supplements without notifying the FDA unless the product is considered a new ingredient, a requirement that has been difficult for the FDA to enforce.1,2
Materia Medica
Regulation Concerns
The regulations around dietary supplements differ from regulations surrounding medications. For a prescription drug to be made available to patients, manufacturers must show proof of safety and efficacy through extensive clinical trials.2
Dietary Supplements: Widely
What are Dietary Supplements?
1.
After a medication is released to the public, the FDA may require additional post-marketing surveillance studies to ensure that nothing was missed during the original trials.3 Regulations are less stringent for dietary supplements and are largely informed by the Dietary Supplement Health and Education Act of 1994 (DSHEA).4
DSHEA condemned adulteration and misbranding of supplements, meaning manufacturers are responsible for producing contamination-free products that contain the advertised ingredients. It also barred manufacturers from claiming that their products could diagnose, treat, or prevent any diseases or conditions, as those claims require clinical trials.
The burden to demonstrate concern for patient harm is on the FDA, who can intervene only after a product 24 www.acms.org
In practice, this labeling is often small, ambiguous, and can be overlooked with larger text claiming that the ingredient supports certain organ systems or well-being, which risks consumers being misled about the intended purposes.1 These concerns highlight the importance of researching information from other reputable sources beyond the manufacturer regarding the effectiveness of these ingredients when taken as a DSHEAsupplement.requires supplements to be manufactured using Common Good Manufacturing Practices (CGMP).2,4 CGMP refers to an extensive set of standards used during manufacturing to prevent adulteration and maintain product integrity.2 Products that have not been manufactured using these practices can be removed from the market by the FDA.4 While these practices are required by law, there is limited government oversight for dietary supplements.1,2 The manufacturers self-report the quality of their manufacturing processes, which at time has led to dubious business practices.1 In order to guide consumers towards high-quality products, the United States Pharmacopeia (USP) externally reviews dietary supplements for adulteration, misbranding, and CGMP. Products that pass this review are physically stamped with the “USP verified mark.”
Green Tea Extract 8 Hepatotoxicity Vitamin A7 Headaches, Hepatotoxicity, Birth defects *Please note this is not an
Materia Medica has already reached the market.4 In order to be removed from the market, there needs to be evidence presented to the FDA showing that a product or ingredient is a risk to the public. Without clinical trials, the FDA relies on consumer and manufacturer reports to show that a dietary supplement ingredient may be unsafe. Patients can report any adverse effects directly to the manufacturer or through the FDA safety reporting portal.2 Historically, there are instances where these products have been taken off of the market. For example, in 2021, cesium salts, which were marketed as an alternative treatment for cancer, were recalled by the FDA for causing cardiovascular death.5 While there is a process to remove these products, typically significant patient harm occurs first to prompt a product’s removal. DSHEA does not require that a dietary supplement be efficacious, as long as the labeling is consistent with regulations.4 Discerning this distinction and label information can be confusing for patients, particularly when they are sold next to other regulated drugs like over-the-counter medications.1 Manufacturers are required to differentiate dietary supplement claims from drugs on their labeling. Specifically, claims regarding the structure or function of the marketed dietary ingredient must be labeled with the phrase from DSHEA: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Patients may underestimate the potential for harm from dietary supplements. As shown in Table 1, common supplements can have harmful effects. The chance for harm from a dietary supplement can be increased by the regulatory concerns previously discussed. There are no laws or regulations regarding a labeled “serving” and this decision is left to the discretion of the manufacturer, not the FDA.2 Also, many ingredients in dietary supplements and different vitamin formulations can be duplicative. A patient taking multiple supplements may not realize that they are taking multiple forms of the same ingredients, which can cause them to intake a larger amount of the supplement than intended and put them at an increased risk of harm.
Adverse Effects from Dietary Supplements
Adverse
effects of Continuedsupplements.onPage26 25ACMS Bulletin / August 2022
Iron7 Nausea, Vomiting,
list
6 When recommending these products to patients, it may be prudent to select products that are USP verified in order to confirm the quality of the products and accuracy of their labeling.
Table 1: Examples of Adverse Reactions due to DietarySupplementSupplements* Reaction Hepatotoxicity extensive of all the potential adverse
Patients may not realize that some supplements can interact with prescription or over the counter medications and cause potentially life-threatening adverse effects.2
Studies have found that many products may contain additional ingredients in place of or in addition to the labeled ingredient. According to a study by Newmaster, et al., only 48% of the 44 products sampled in the study contained the labeled herb ingredient.9 Further, 59% of the products studied contained plant species that were not on the label and 33% had unlisted contaminants and fillers. Even if the patient receives the intended dietary ingredient, concentrations of the ingredient can be inconsistent between products, causing the risk for adverse reactions to be potentially higher than the labeling suggests.1
Iron is a common supplement used for anemia that is also known for causing gastrointestinal adverse effects including nausea, vomiting, and diarrhea.If there is a higher than labeled amount of the iron in the products, the risk for gastrointestinal effects may increase, as well as potential hepatotoxicity due to an excessive buildup of iron.7 Drug Interactions with Prescription Medications
St. John’s Wort 14 Extensive list, including but not limited Selectiveto: serotonin note that Table 2 contains examples of drug supplementdrug interactions that highlight different types of risks, rather than an extensive list of all interactions. Changes in active drug levels subtherapeuticsupratherapeuticcausingorlevels and corresponding effects, serotonin syndrome with other serotonergic agents 26 www.acms.org
Vitamin K Increased clotting risk
Some interactions may seem straightforward but can be obscured when integrated into combination products. Patients and clinicians may be aware of the impact of vitamin K on warfarin use. However, vitamin K intake may be contained in other supplement preparations such as a daily multivitamin.17 If a patient on warfarin were to start taking a multivitamin with Vitamin K, it can decrease the international normalized ratio (INR) and increase clotting risk.13 If taken consistently, the risk can be mitigated with INR monitoring, but changes in adherence or which manufacturer of the multivitamin is purchased can increase the risk for INR fluctuations.
Additional safety risks may not be immediately apparent from the label.
Table 2: Example Supplement-Drug Interactions* Supplement Interacting Potential Adverse EffectMedication
reuptake medicationsTricyclicTacrolimusIfosfamidecontraceptivesCombinedinhibitorsoralantidepressantsDigoxinCertainHIV Curcumin Anticoagulant and Bleeding Risk(Turmeric)15 Antiplatelet medications Ginkgo Biloba16 Anticoagulant and Bleeding RiskAntiplatelet medications *Please
From Page 25 Materia Medica
Table 2 provides examples of commonly used dietary supplements, several medications that they can interact with, and the potential consequences.
These concerns could occur with dietary supplements that are routinely recommended to patients. For example, the Bone Health and Osteoporosis Foundation and the Endocrine Society discuss the use of calcium to support the growth of and prevent the loss of bone, particularly in postmenopausal women.10,11 Calcium supplements are known to cause gastrointestinal side effects such as bloating and constipation when used at normal doses and at consistently higher doses, they can cause more serious adverse effects such as kidney stones.12 If the patient takes calcium from a calcium supplement, a multivitamin that contains calcium, and potentially an over-the-counter antacid with calcium, they could be getting calcium from three different products beyond their dietary intake.
13 Warfarin
Lack of Reliable Information
One of the main sources that can be used is the National Center for Complementary and Integrative Health (NCCIH). This website will provide information on various supplements as well as any alerts or advisories.23
Medline Plus is a government-run website with information about a wide variety of supplements written at the consumer level so providers may be able to utilize this information or direct their patients to it.25 Some health institutions also have databases such as Memorial Sloan Kettering which maintains an “About Herbs” database that includes a patient directed section, a detailed list of potential adverse effects, and drug interactions available at no cost on the internet or through a mobile app.26
Health care practitioners should encourage patients to discuss their intentions before starting any new dietary supplement and specifically ask patients about their supplement use.
The internet and social media can facilitate the spread of false or misleading information about dietary supplements to a wide audience.1 Advertisements online often have misleading disease claims and lack required disclaimers so patients may start taking these easily accessible products without realizing the true benefits or potential harms. Some patients may try to research the product before starting it but previous studies have raised concerns about the quality of online information and a patient’s ability to discern the quality of that information.22 Some patients may ask their health care team about these products, but health care professionals may also find insufficient information to help their patients because the lack of regulation around dietary supplements means high quality safety and efficacy information may simply not exist for a However,product.many of the most common products do have some available data to assist patients and providers and there are some key resources that can be used.
Materia Medica
Some supplements can change the pharmacokinetics of a medication. St. John’s Wort is a supplement patients may take for conditions like depression and menopause symptoms. However, St. John’s Wort is a CYP3A4 inducer, which can interact with many commonly used medications causing drug toxicity or subtherapeutic levels.14 For example, St. John’s Wort induces the metabolism of combined oral contraceptives resulting in a subtherapeutic response and potential contraceptive failure.14,18 Alternatively, St. John’s Wort’s inducing effects can increase the rate of prodrugs conversion to active metabolites, which increases the risk of drug toxicity.20 This effect can be seen in the case of the chemotherapeutic agent ifosfamide, which can increase the risk of neurotoxicity or nephrotoxicity.19,20Supplementscan cause pharmacodynamic interactions with other medications that can have clinically significant consequences and even impact surgical cases. For example, patients may choose to take turmeric or ginkgo. Curcumin, the primary bioactive compound in turmeric, appears to inhibit platelet aggregation and prolong bleeding time.15 While many patients can take curcumin without issue, combining this herb with anticoagulants and antiplatelets may present bleeding additional risks. Similarly, Gingko can interact with platelet activation factors and collagen which increases bleeding due to decreased platelet aggregation.16 Therefore, patients should consider stopping this dietary supplement at least two weeks prior to surgery.21 If this supplement is used in combination with anticoagulants such as apixaban (Eliquis®) or rivaroxaban (Xarelto®), it can potentially put the patient at an even higher risk of bleeding.
The Dietary Supplement Database contains the label information for each product which can be helpful when researching a supplement.24
Searching PubMed may be helpful in some cases and PubMed incorporates information that is found on the NCCIH website. When searching on PubMed including “nccih[gr]” in the search box with the topic can reveal studies about a given supplement.27 Including NCCIH with the grant search tag indicates that the NCCIH funded the study which indicates the study may be more likely to have reliable information.
Conclusion Common dietary supplements can often be used without harm in many patients, and drug-supplement interactions can be mitigated with dose adjustments and monitoring. Some patients should consider avoiding certain supplements when considering individualized risks with their medical history or potential drug interactions. Regardless of the determined treatment plan, it is not possible to proactively address these concerns without a complete medication list.
Continued on Page 28 27ACMS Bulletin / August 2022
16. Bent S, Goldberg H, Padula A, Avins AL. Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature: a case report and systematic review of the literature. J Gen Intern Med. 2005; 20(7):657-61. doi: 19.18.17.1497.2005.0121.x.10.1111/j.1525-Vitamins&minerals:WhatisvitaminK?UnitedStates.Availableat:https://www.centrum.com/learn/vitamins-minerals/vitamin-k/.AccessedApr212022.ZhangN,ShonJ,KimMJ,etal.RoleofCYP3AinOralContraceptivesClearance.ClinTranslSci.2018;11(3):251-260.doi:10.1111/cts.12499FasinuPS,RappGK.HerbalInteractionWithChemotherapeuticDrugs-AFocusonClinically Findings. Front Oncol. 2019;9:1356. Published 2019 Dec 3. doi:10.3389/fonc.2019.01356 IFEX [Package insert] Deerfield, IL; Baxter Corporation;Healthcare2012 www.acms.org
3. Clinical Trials: What Patients Need to Know. Food and Drug Administration. Available at: Accessedwhat-patients-need-know.www.fda.gov/patients/clinical-trials-https://Jul112022.
7. Office of dietary supplements. NIH Office of Dietary Supplements. Available Accessedhttps://ods.od.nih.gov/factsheets.at:April27,2022.
20.
From Page 27
8. Patel SS, Beer S, Kearney DL, Phillips G, Carter BA. Green tea extract: a potential cause of acute liver failure. World J doi:10.3748/wjg.v19.i31.51742013;19(31):5174-5177.Gastroenterol.
Significant
9. Newmaster SG, Grguric M, Shanmughanandhan D, et al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013; 12.11.10.doi:10.1186/1741-7015-11-222.11(222).CosmanF,deBeurSJ,LeBoffMS,etal.Clinician’sGuidetoPreventionandTreatmentofOsteoporosis[publishedcorrectionappearsinOsteoporosInt.2015Jul;26(7):2045-7].OsteoporosInt.2014;25(10):2359-2381.doi:10.1007/s00198-014-2794-2ShobackD,RosenCJ,BlackDM,etal.PharmacologicalManagementofOsteoporosisinPostmenopausalWomen:AnEndocrineSocietyGuidelineUpdate,TheJournalofClinicalEndocrinology&Metabolism.2020;105(3):587–594.https://doi.org/10.1210/clinem/dgaa048CalciumCarbonate.Lexi-Drugs.Lexi-compOnline.Hudson,OH,Lexi-Comp;2022.AccessedJul12022.
14. St. John’s wort. Mayo Clinic. Available at: AccessedPublishedst-johns-wort/art-20362212mayoclinic.org/drugs-supplements-https://www..February13,2021.Apr212022.
4. Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress. (1994) National Institute of Health
1. Starr RR. Too Little, Too Late:Inef fective Regulation of Dietary Supplements in the United States. Am J of Pub Health. 2015; 105:478485. AJPH.2014.302348https://doi.org/10.2105/
References
Questions such as “What supplements, vitamins, minerals, and herbs are you taking?” will often elucidate other products the patient is using compared to only asking about “overthe-counter” or “medications” more generally. Use of a non-judgmental tone when discussing supplements may ensure patients feel comfortable asking questions about a product they are using or considering. By inviting this open dialogue, we can help guide patients on these products as a part of their complete treatment plan.
13. Coumadin [package insert] Princton, NJ; Bristol Meyer Squibb; 2017.
2. Food and Drug Administration. Available at: Julfood/dietary-supplements.https://www.fda.gov/Accessed112022.
Materia Medica
15. Turmeric. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed Jul 27 2022. micromedexsolutions.com.http://www.
28
6. USP Verification Services. United States Pharmacopeial Convention. Available at: https://www.usp.org/ services/verification-services. Accessed Jul 11 2022.
5. Dietary Supplement Ingredient Advisory List. Food and Drug Administration. Available advisory-list.dietary-supplement-ingredient-supplement-products-ingredients/https://www.fda.gov/food/dietary-at:AccessedJul112022.
24. Dietary Supplement Label Database. National Institute of Health Office of Dietary Supplements. Available at: aspx.Supplement_Label_Database.ods.od.nih.gov/Research/Dietary_https://AccessedJul272022.
27. How to find information about complementary health on pubmed. National Center for Complementary and Integrative Health. Available at: https://www.nccih.nih.gov/health/ how-to-find-information-abouton-pubmed.complementary-health-approaches-AccessedJun12022.
21. Ginkgo. Mayo Clinic. Available AccessedPublishedsupplements-ginkgo/art-20362032.https://www.mayoclinic.org/drugs-at:November18,2020.Apr252022.
25. \About Herbs, Botanical, and Other Products. Memorial Sloan Kettering Cancer Center. Available at:
Materia Medica
22. Daraz L, Morrow AAW, Ponce OJ, et al. Can Patients Trust Online Health Information? A Meta-narrative systematic Review addressing the Quality of Health information on the Internet. J Gen Intern Med. 2019; 34(9): 18841891. Doi: 10.1007/21160601905109-0.
23. Alerts and advisories. National Center for Complementary and Integrative Health. Accessednccih.nih.gov/news/alertshttps://www..Apr252022.
Accessedmedicine/herbs/search?letter=T.symptom-management/integrative-cancer-care/diagnosis-treatment/https://www.mskcc.org/Jul272022.
Join MediatheList here!
Join ListMediatheContacthere We are fortunate to have over 2,000 local physicians, residents, and students as part of the ACMS membership. We are grateful for the range of expertise that exists within our thethatwantcommunitymembershipandwetohelpyoushareexpertisewithcommunity!
26. Herbs and Supplements. Medline Plus. Available at: html.medlineplus.gov/druginfo/herb_All.https://AccessedJul272022.
At the time of this writing in June 2022, Ms. Packis and Ms. Benjamin are Doctor of Pharmacy candidates at Duquesne University School of Pharmacy with an anticipated completion of study in May of 2023. Dr. Schoen is an Assistant Professor in the Pharmacy Practice Division at Duquesne University School of Pharmacy. She serves as a clinical pharmacy specialist focused in primary care with the Allegheny Health Network. She can be reached at schoenr@duq.edu.
29ACMS Bulletin / August 2022
Christopher Pfanstiel, CFP Building a Financial Plan Mindful of Student Loans Understanding Student Loans – All Strategies Student Loans in Private Practices Mortgages for Physicians Credit Score / Credit Management Tax Efficient Investing Risk Management Navigating your Career in Medicine Series Dates & Topics: *Topics and Dates are Subject to Change* November 9, 2022 Physician Wellness January 25, 2023 Leadership Skills April 19, 2023 Contract Negotiation Seminar REGISTRATION IS FREE FOR ContactGuest*RegistrationMEMBERSACMSRequired*Registration$20.00Questions?EileenTayloretaylor@acms.org 6:00 p.m. | Check-in and Social Hour Drinks and Appetizer Stations 6:45 p.m. | Welcome Sara Hussey, MBA, CAE, ACMS Executive Director 7:00 p.m. | Understanding Unique Financial Planning Decisions for Physicians Christopher J. Pfanstiel, AIF, CLU, ChFC, RICP®, CFP Axias Wealth Advisors – Wealth Manager Advisor/Founder 8:00 p.m. | Conclusion Please feel free to stay and mingle with our speakers and your colleagues October 12, 2022 6:00 p.m. – 8:00 p.m. The Foundry Table & Tap 381 N Shore Dr | Pittsburgh, PA | 15212REGISTERAllegheny County Medical Society Presents: “Navigating Your Career in Medicine” A Professional Series for Early Career Physicians
The release of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization dated June 23, 2002, was followed swiftly by actions by the U.S. Department of Health and Human Services (“HHS”) and an executive order. HHS had launched the HHS Reproductive Access Task Force (the “Task Force”) to plan for the previously leaked Dobbs decision. So, it is not surprising that HHS issued guidance regarding two federal statutes within weeks of Dobbs: EMTALA and HIPAA. The Emergency Medical Transfer and Active Labor Act (“EMTALA”) requires that hospitals with emergency rooms provide all patients with an appropriate medical screening examination, stabilizing treatment for any emergency medical conditions, and transfer to another facility, if necessary. Prompted by President Biden’s July 8, 2022, executive order titled Protecting Access to Reproductive Healthcare Services, which required Secretary of HHS Xavier Becerra to submit a report to the President “identifying steps to ensure that all patients – including pregnant women and those experiencing pregnancy loss, such as miscarriages and ectopic pregnancies – receive the full protections for emergency medical care afforded under the law,” HHS released guidance on EMTALA. This came in the form of a letter from Secretary Becerra, as well as a CMS memorandum to State Survey Agency Directors, both of which were published on July 11, 2022 (the “EMTALA Guidance”). The EMTALA Guidance states that EMTALA and the duties imposed on hospitals and medical personnel thereunder, “preempts any directly conflicting state law or mandate that might otherwise prohibit such treatment.”
While, of course, the treatment necessary to stabilize these emergency medical conditions is determined by the treating physician or other qualified medical personnel, the EMTALA Guidance states that such treatment could include “medical and/or surgical interventions (e.g., abortion, removal of one or both fallopian tubes, antihypertensive therapy, methotrexate therapy, etc.) irrespective of any state laws or mandates that apply to specific procedures.” (Emphasis added)
The EMTALA Guidance proceeds to advise physicians that their obligation under EMTALA, specifically to provide an “abortion” when necessary to stabilize the pregnant patient’s emergency, is both mandatory and protected under federal law when state law does not include an exception for the life and health of the pregnant patient. The EMTALA Guidance reminds physicians that not only are they potentially subject to civil monetary penalties that may be imposed against a physician for failing to provide necessary stabilizing treatment or appropriate transfer, but also suggests that they can use EMTALA as a defense against state enforcement action or to assert a retaliation claim if disciplined for refusing to transfer a patient who had not received the recommended stabilizing care. The EMTALA Guidance from CMS goes into further detail regarding hospitals’ obligations under EMTALA, particularly with respect to transfers of pregnant patients: transfers may only occur based on the patient’s request after informed consent or a physician’s determination that the benefits of transfer to the woman and/or the unborn child outweigh its risks. State law cannot be cited as the basis for the transfer. Although EMTALA does not apply once a patient is admitted, the EMTALA Guidance also cites the
Post-Dobbs Fallout: Federal Guidance Abounds
Beth anne jaCksOn 31ACMS Bulletin / August 2022 Continued on Page 32
In accordance with the executive order, the EMTALA Guidance specifically addresses emergency medical conditions including, but not limited to, ectopic pregnancy, complications of pregnancy loss, and preeclampsia with severe features.
Legal Summary
From Page 31 32
Within days of issuance of the EMTALA Guidance, the State of Texas sued Secretary Becerra in federal court to challenge the validity of the Guidance as exceeding statutory authority and violating Texas’s “sovereign right to enforce its criminal laws,” as well as the federal Administrative Procedure Act by imposing an “Abortion Mandate” on Texas hospitals and physicians. That litigation is pending in the U.S. District Court in Lubbock, Texas.
Even if the official had a court order, the Privacy Rule would permit but not require the clinic to disclose the PHI, but only the specific PHI identified in the court order. (Note, however, that a court of competent jurisdiction can compel the clinic to disclose such information and, if the information is not disclosed, hold the clinic in contempt of court.)
Similarly, the Privacy Guidance clarifies that a health care provider in a state that bans abortion cannot use the “disclosure to avert a serious threat to health or safety” exception to report to law enforcement a pregnant patient’s intent to get a legal abortion. HHS asserts two bases for this conclusion. First, a statement regarding the “individual’s intent to get a legal abortion [presumably in another state] or any other care tied to pregnancy loss, ectopic pregnancy or other complications related to or involving a pregnancy does not qualify as a ‘serious and imminent threat to the health or safety of a person or the public.’” Further, such a disclosure would be inconsistent with professional ethical standards because it compromises the physicianpatient relationship and may actually increase the risk of harm to the patient. Accordingly, such a disclosure would constitute a breach of PHI under HIPAA.
Legal Summary
With respect to disclosures “required by law,” the first example describes an individual who goes to the hospital emergency department during a miscarriage in the tenth week of pregnancy when applicable state law prohibits abortion after six weeks.
HHS issued guidance on HIPAA, titled “HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care” (the “Privacy Guidance”), on June 29, 2022. The Privacy Guidance discusses potential provider disclosures of the PHI of pregnant patients under three exceptions under the Privacy Rule: disclosures “required by law;” disclosures for law enforcement purposes; and disclosures to avert a serious threat to health or safety, all in the context of state laws on abortion.
Disclosures for law enforcement purposes are similarly limited. For example, if a law enforcement official asked a reproductive health care clinic for records of abortions performed there, the clinic could not disclose any such records in the absence of a court order.
Medicare Conditions of Participation (“CoPs”) requirements to provide appropriate care to inpatients, including: medical staff accountability; quality assessment and performance improvement programs; and discharge planning. Failure to follow these CoPs, and thereby protect patient health and safety, “could result in a finding of noncompliance at the condition level for the hospital and lead to termination of the hospital’s Medicare provider agreement.”
In such a case, the Privacy Guidance states that if a hospital workforce member suspects the individual of having taken medication to cause the miscarriage, the Privacy Rule would not permit a disclosure to law enforcement unless the state statute expressly requires such reporting. Reporting when not required by law constitutes a breach of protected health information (“PHI”).
DISCLAIMER: This article is for information purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem.
Any physician who interacts with patients who may be or become pregnant and who practices in a state that limits or prohibits abortion (or may do so in the future) should be aware of this guidance. Hospital-based physicians might look to the facilities in which they work for assistance in navigating EMTALA and HIPAA privacy issues, while office-based physicians will need to develop and enforce appropriate policies to ensure that they and their staff understand limits on disclosure that are set forth in the Privacy Guidance. It should be noted, however, that the EMTALA Guidance and the Privacy Guidance are subregulatory guidance that reflect the Biden administration’s interpretation of existing law and rules: they do not have the force and effect of law. Nevertheless, they can be used to prioritize enforcement actions by HHS.
Ms. Jackson is a shareholder in the Health Care Practice Group of Brown & Fortunato, P.C., which is headquartered in Amarillo, Texas, and serves healthcare providers nationally. She is licensed in both Pennsylvania and Texas and maintains an office in the greater Pittsburgh area. She may be reached locally at (724) 413-5414 or bjackson@ bf-law.com. Her firm’s website is www.bf-law.com. www.acms.org
REPORTABLE DISEASES 2022: Q1-Q2 Allegheny County Health Department Selected Reportable Diseases/Conditions Selected Reportable Disease/Condition* January to June** 2020 2021 2022 AMEBIASIS 3 0 3 ANAPLASMOSIS 3 5 12 BABESIOSIS 0 0 0 BOTULISM INFANT 0 1 0 CAMPYLOBACTERIOSIS 55 47 48 CANDIDA AURIS 0 0 1 CARBAPENEMASE-PRODUCING CARBAPENEM-RESISTANT ENTEROBACTERALES 5 8 10 COVID-19 3,808 46,689 111,512 CRYPTOSPORIDIOSIS 8 8 11 DENGUE FEVER 0 1 0 GIARDIASIS 25 27 28 GUILLAIN-BARRE SYNDROME 0 2 0 HAEMOPHILUS INFLUENZAE 12 3 7 HEPATITIS A 2 0 1 HEPATITIS B ACUTE 2 0 1 HEPATITIS B CHRONIC 9 33 16 HEPATITIS C ACUTE 0 3 6 HEPATITIS C CHRONIC 534 489 529 LEGIONELLOSIS 20 20 16 LISTERIOSIS 1 1 0 MALARIA 0 2 3 MEASLES 0 0 0 MONKEYPOX 0 0 3 MUMPS 1 0 1 NEISSERIA MENINGITIDIS 0 0 1 PERTUSSIS 23 3 1 SALMONELLOSIS 30 47 43 SHIGELLOSIS 10 2 12 SHIGATOXIN-PRODUCING E COLI 9 13 5 STREPTOCOCCAL DISEASE INVASIVE, GROUP A 16 10 22 STREPTOCOCCUS PNEUMONIAE INVASIVE 18 6 21 TOXOPLASMOSIS 0 1 0 TUBERCULOSIS 7 7 4 TYPHOID FEVER 0 1 0 VARICELLA 5 4 6 WEST NILE VIRUS 0 0 0 ZIKA VIRUS 0 0 0 * Case classifications reflect definitions utilized by CDC Morbidity and Mortality Weekly Report. ** These counts do not reflect official case counts, as current year numbers are not yet finalized. Inaccuracies in working case counts may be due to reporting/investigation lag. NOTE: Disease reports may be filed electronically via PA-NEDSS. To register for PA-NEDSS, go to https://www.nedss.state.pa.us/NEDSS To report outbreaks or diseases reportable within 24 hours, please call the Health Department’s 24-hour telephone line at 412-687-2243. For more complete surveillance information, see the following webpages: • Influenza Influenza (Flu) Information | Health Department | Allegheny County • Monkeypox Monkeypox | Health Department | Allegheny Home (alleghenycounty.us) • COVID-19 COVID-19 Dashboards (alleghenycounty.us)
Register NOVEMBERnow! 16 KEYNOTE SPEAKER 34 www.acms.org
MPHC 2022, a premier educational event for medical practice administrators and their office personnel, provides a robust engagement opportunity to discuss the challenges facing medicine and to leave with innovative strategies to improve practices! Highlights include: Conference Kickoff and Closing Keynote: by Jordan Corcoran, CEO & Creator: ListenLucy.org Don’t miss this timely presentation on mental health in the workplace. Jordan candidly discusses her battle with mental illness in a relatable, honest, and informal way. Attendees will come away with self care and coping techniques to share with staff.
Legislative and Regulatory Update: presented by a Pennsylvania Medical Society Advocacy team staff member, you’ll receive exclusive insight following the 2022 mid term elections. Idea Exchange! Connect with your colleagues to share professional experiences and solutions to your most challenging professional issues. Coding Session: *AAPC CEUs available: 1.0 CEU available for session. This session will help you to understand the high level changes for EM code sets in 2023, split/shared visits with mid-levels documentation rules for 2023, and current landscape of telehealth. Payor Help Support Desk: an exclusive opportunity to meet with insurance payors to discuss your practice's pain points. Time slots must be reserved and open only to MPHC 2022 attendees. Presented by:
Conference
The following is a list of criteria that will be considered in the review process:
• Project addresses a pressing need or timely issue OR presents a unique approach to addressing an “every day,” ongoing challenge.
Proposals Due: September
• Project has potential for broader impact or replication.
The Allegheny County Medical Society Foundation 2022 Grant Application window is now open.
• Project will respond to the ACMS Foundation Mission: Advancing Wellness by confronting Social Determinants & Health Disparities. How to Apply To apply for a grant, complete the application form in its entirety. Should you wish to include a formal RFP in addition to the form, you may submit that directly to shussey@acms.org. Grant applications will not be considered complete without a fully completed form. Proposals must be completed and submitted with all required responses and attachments in order to be considered for funding in this grant cycle.
Funds Dispersed:
The ACMS Foundation will support organization al-based activities that engage individuals and families in the planning, development, evaluation, and implementation of programs at the community level that assist individuals in creating supportive and healthy home environments.
The Foundation believes that all people have the inherent capacity to effect change in their lives and in their communities. The Foundation will support programs that respect and value individuals and their collaborative work to improve healthcare in our community. July 1, 2022 30, 2022 25, 2022 November 30, 2022
• Project will create an impact on communities in Allegheny County, PA.
Funding Decisions: October
If you have questions regarding the application, please contact Sara Hussey, Executive Director at shussey@acms.org
.
Download Full List of RFP Criteria 35ACMS Bulletin / August 2022
Application Details Proposal Review and Timetable: RFP Release Date:
Applications will be accepted from: July 1, 2022 - September 30, 2022 As the 501(c)3 philanthropic arm of the Allegheny County Medical Society, the Foundation awards grants to support home and community environments that nurture and develop healthy children and families for a healthy Allegheny County.
2022 ACMS Bulletin Photo Contest Please note instructions below for participating in the 2022 ACMS Bulletin Photo Contest: 1 Email your VERTICAL jpg photos with a resolution of 300 dpi or higher to ACMSBulletin@acms.org. Photos should be 8”W x 10”H. No more than three photos may be submitted. 2 You must be an ACMS member physician to submit photos. 3 Include the name of the photo (please keep file names short) as well as your name, specialty, address and phone number in the email. 4 You will receive verification that your photo has been received and is eligible to be entered in the contest. a) Horizontal photos will not be considered. b) Photos with low resolution will not be considered. c) Panoramic shots or photos featuring specifically identifiable individuals, relatives, will not be considered. d) Be aware top third of image will be obstructed by Masthead. 5 5 The deadline for submission is Monday, October 3rd, 2022. After this date, a group of individuals selected by the ACMS Board of Directors and ACMS Editorial Board will vote on the top 12 photos. 6 Winners will be announced on the ACMS website, in the Bulletin and via email. The 1st-place winner’s photo will appear on the January 2023 cover; the remaining winning photos will appear on Bulletin covers throughout the year. 7 Please continue to check the ACMS website and future issues of the Bulletin for further updates and reminders. 8 If you have any questions, please contact Contact Cindy Warren at ACMSBulletin@acms.org.
