VOL . 73 N O. 1 Wi nte r 2 0 2 2
“We want to make sure that California’s finest physicians are properly protected.”
A Team Approach to Medical Malpractice Coverage is a Winning Approach for Physicians More than 12,000 physicians rely on the Cooperative of American Physicians (CAP) to protect their practices every day.
Sarah E. Scher, JD Chief Executive Officer
Physician-founded and physician-governed, CAP provides superior medical malpractice coverage and solutions to help California physicians realize professional and personal success. CAP members also receive risk management services, claims support and a dedicated in-house defense firm, practice management resources, and so much more. Find out what makes CAP different.
CAPphysicians.com
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Medical professional liability coverage is provided to CAP members by the Mutual Protection Trust (MPT), an unincorporated interindemnity arrangement organized under Section 1280.7 of the California Insurance Code.
Redhill Biopharma is proud to announce...
Talicia is now on Medi-Cal 1 * with no restrictions ®
With Talicia on the Medi-Cal Rx Contract Drugs List, millions of low-income and disabled Californians now have access to this important medicine.1
Eradication Starts HereTM Learn more at Talicia.com REFERENCE: 1. California DHCS website. https://www.dhcs.ca.gov/Pages/AboutUs.aspx Accessed Jan 1, 2022. *Insurance plans and coverage may vary and are subject to change. This is for general information only and is not a guarantee of coverage. Formulary coverage and status do not imply efficacy or safety. Trademarks are owned by or licensed to RedHill Biopharma Inc. or its related companies. ©2022 RedHill Biopharma Ltd. All rights reserved. US-TAL-238 01/2022
816 21st Street • Sacramento, California 95811 • www.familydocs.org Phone (415) 345-8667 • Fax (415) 345-8668 • E-mail: cafp@familydocs.org
Officers and Board President Shannon Connolly, MD, FAAFP Immediate Past President David Bazzo, MD, FAAFP President-elect Lauren Simon, MD, MPH, FAAFP Speaker Raul Ayala, MD, MHCM Vice-Speaker Alex McDonald, MD, FAAFP Secretary/Treasurer Anthony "Fatch" Chong, MD Chief Executive Officer Lisa Folberg, MPP Foundation President Marianne McKennett, MD AAFP Delegates Jay Won Lee, MD, MPH, FAAFP Lee Ralph, MD AAFP Alternates Michelle Quiogue, MD Lisa Ward, MD, MPH, FAAFP CMA Delegates Kimberly Buss, MD Felix Nunez, MD Sumana Reddy, MD, FAAFP Kevin Rossi, MD, FAAFP CMA Alternate Delegates Raul Ayala, MD, MCMH Noemi Doohan, MD, PhD Adia Scrubb, MD, MPP David Tran, MD
Staff Lisa Folberg, MPP Chief Executive Officer lfolberg@familydocs.org Anita Charles Program Assistant acharles@familydocs.org Morgan Cleveland Manager of Operations & Governance mcleveland@familydocs.org Jerri Davis, CHCP Vice President, Professional Development, CME/CPD jdavis@familydocs.org Christine Lauryn Manager, Member Communications clauryn@familydocs.org Josh Lunsford Vice President, Membership & Communications jlunsford@familydocs.org Pamela Mann, MPH Executive Director, CAFP Foundation pmann@familydocs.org Catrina Reyes, Esq. Vice President, Policy and Advocacy creyes@familydocs.org Jonathan Rudolph Manager, Finance jrudolph@familydocs.org Tiyesha Watts Legislative & Policy Advocate trwatts@familydocs.org
Brent Sugimoto, MD, Editor Josh Lunsford, Managing Editor The California Family Physician is published quarterly by the California Academy of Family Physicians. Opinions
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EDITION 41 4
California Family Physician Winter 2022
UPCOMING EVENTS Wi nte r 2 0 2 2
March 12-13 All Member Advocacy Meeting (Sacramento) March 13-19 Family Medicine Week! March 15-17 Virtual Lobby Days! March 16 Webinar: Key Insights into a Trauma-Informed Approach to Care
April 22-24 2022 Family Medicine Clinical Forum (San Francisco) August 26-27 Summit: A Gathering of FM Residents and Medical Students (Los Angeles)
features CARING FOR PATIENTS THROUGH THEIR LIFE: FOCUS ON ADOLESCENTS 24 Re-Envisioning Family Medicine Education and Training 26 Supporting your transgender/non-binary adolescent patients 27 Recognizing LGBTQIA+ Youth in Your Practice 28 Trauma-Informed In All We Do
Jeremy Fish, MD Julie Celebi, MD, MS Scott Nass, MD, MPA, FAAFP, AAHIVS Erika Roshanravan, MD
29 Childhood Obesity – Among the 21st Century's Gravest Public Health Challenges
Shani Muhammad, MD, FAAFP
This Enduring Material activity, 2022 Winter California Family Physician Magazine, has been reviewed and is acceptable for up to 5 Prescribed credit(s) by the American Academy of Family Physicians. AAFP certification begins February 1, 2022. Term of approval is for one year from this date. Complete the CME quiz at www.familydocs.org/cfp to claim credit!
departments 6 Editorial
Applying a trauma-informed perspective… to ourselves
Brent Sugimoto, MD, MPH, FAAFP
8 President’s Message
Sometimes the Best Medicine is Furry
12 Political Pulse
And That’s a Wrap!
Carla Kakutani, MD
20 Legislative Update
Family Medicine Advocacy Fixes Unintended Consequences Caused by the PTL
Catrina Reyes, Esq.
33 CEO Message
Health Care System Transformation as an Eight-Track Player
Shannon Connolly, MD
Lisa Folberg, MPP
Your Online Resource for Continuing Medical Education. Visit education.familydocs.org!
Brent K. Sugimoto, MD, MPH, AAHIVS, FAAFP
editorial
Applying a Trauma-Informed Perspective… to Ourselves During medical school, I served on my institution’s admissions committee. If you cannot resist measuring your worth relative to the accomplishments of others, I don’t recommend it as a confidence boosting exercise. Global health NGO founders, Fulbright scholars, White House fellows, patent holders, and even an Olympian, made me wonder—aloud as I recall—what exception was made to allow me to study there. However, there was one application I remember vividly for helping me understand why medicine looks the way that it does, and in doing so, dimmed my view of academic medicine as merit-based, regardless of the challenges of my own personal journey. One applicant clearly stood out with objectively excellent grades and scores, including a stellar MCAT score (in the forties out of maximum that was then 45). Although she started off in community college, followed by a transfer to the California State University system (my school gave points for the “rigor” of the university), her references practically made her application package glow. Her community service experience was replete with work with the underserved: substantial and meaningful work that was clearly not a checkbox for her application. But this woman’s story is what caught the committee’s attention. She was a person of color raised as the oldest in a single parent household, with a mother who was abusive and depressed. She and her siblings often went hungry due to both poverty and neglect. At one point, her mother was eventually diagnosed with bipolar depression when she had an extended hospitalization for mania. Somehow this applicant was able to continue to care for her younger siblings during her mother’s absence while in high school, went to community college so she could continue to do so, and was able to excel at everything she put her hand to. And yet, there was doubt. There were questions. Her mother, now appropriately treated, was back at home and caring for the woman’s younger siblings. One committee member asked how this woman would handle the rigors of medical school if her mother decompensated? 6
California Family Physician Winter 2022
And that began a discussion about whether accepting this applicant was too risky when these medical school spots were so valuable. There were objections, but they never reached the volume they should have, and this woman, who always had found a way to overcome, was told by my school that she could not be more than her life’s circumstance. The last few years have been exciting for the broadened understanding of how pervasive patterns and systems of bias are, and how they perpetuate inequities, including within the house of medicine. I am proud that the CAFP will be prioritizing justice, equity, diversity and inclusion (JEDI) in our strategic plan. In this issue, Dr. Erika Roshanravan also explains the significance of the new objective in CAFP’s strategic plan that the Academy will “apply a trauma-informed lens to all our work,” and how JEDI and a trauma-informed perspective are complementary, especially as trauma disproportionately impacts the disadvantaged. Knowing now what I do about trauma, this applicant had experienced so many adverse childhood experiences (ACEs). She was exceptionally resilient in the face of trauma, and yet, this woman’s trauma still had the power to disadvantage her despite all her strengths. Just imagine how trauma prevents others without her resilience from fully participating in life and its opportunities. I am hopeful that today, a trauma-informed perspective can help dislodge some of these patterns of bias, and to help medicine develop the empathy and the strategies to bring missing voices to the table, especially those underrepresented in the medical profession who are integral in the effort to achieve health equity. This applicant took a risk in sharing her life story and was penalized for it. Although I do not know whether that risk was mortal for her medical career, I do hope another institution had the wisdom to see her worth as a future physician. Our patients, and really, our profession, need more doctors like her.
NEW FROM CDC
Make HIV Screening the Standard of Care in Your Practice With CDC’s Screen for HIV Toolkit. Early diagnosis of HIV is critical for reducing HIV incidence and improving health outcomes for people with HIV. Yet 1 in 8 people with HIV are unaware that they have the virus. The Centers for Disease Control and Prevention’s (CDC’s) new Screen for HIV Toolkit contains useful resources for your practice and your patients with: • The latest CDC guidance on HIV screening. • Practical tips for integrating routine HIV screening into your practice. • Information to empower your patients to get tested, understand their test HIV results, and connect with support services.
To download or order CDC’s Screen for HIV Toolkit today, visit: cdc.gov/ScreenForHIV.
p r e s i d e n t ’s m e s s a g e
Shannon Connolly, MD, CAFP President
Sometimes the Best Medicine is Furry interrupting maladaptive behaviors and redirecting them with a gentle wet nose. Sadie helped tremendously in school, as all the students loved her, and the dog provided opportunity to educate classmates about autism while also deflecting some attention away from my patient. I must confess that I was always thrilled to see that patient on my schedule, because seeing the young woman thrive with Sadie by her side made me incredibly happy too.
It was, by any reasonable assessment, an awful day. I wrapped up an overwhelmingly busy clinic—late, of course, called the family of my patient who had just died to express my condolences, and drove home. Once safely in sweatpants and curled up on my couch, I allowed myself to feel the sadness that had accumulated over the day, grieving the loss of my uncle to COVID that morning and my longtime patient to an overdose. I would have continued my pity party on the couch indefinitely, but my kitten, Love, hopped up beside me and placed a delicate little paw softly on my leg, asking permission to cuddle. She then carefully arranged herself on my lap, curled her floofy tail around herself, looked up at me with big liquid eyes, and began to purr as loudly as she possibly could. It was just what I needed. I gathered her up in my arms, buried my face in her soft fur, and had a good cry. A few minutes later, I was done, and felt much better. Love jumped down, stretched her back, yawned, slow-blinked, and then trotted off to do cat stuff while I reflected on how animals—both service animals and household pets, can be incredibly therapeutic for their humans. How did Love, my feral house tornado of a kitten, know to curl up calmly on my lap and let me have a good cry? How many of us have been the recipient of a generously proffered sock or tennis ball from a canine seeking to brighten a bad day? How many of us would skip some physical activity if it weren’t for the dog demanding “walkies”? As we’ve gathered pictures of the “CAFP Pets,” for this issue, I’ve marveled at how many of my colleagues in medicine 8
California Family Physician Winter 2022
also benefit from their furry—or scaly, or finned, or feathered companions. I suspect many doctors find that their pets help to ease their stress, adding humor and unconditional love to their lives. Maybe someone should study the impact that companion animals have on the wellbeing of doctors! I’m also amazed at how animals have helped some of my patients, at all stages in life. Years ago, I had a patient, a thirteenyear-old with autism who had been having a lot of trouble in school. For this young woman, school was confusing and overstimulating and she frequently got overwhelmed and shut down. Fortunately, the summer before high school, she got a service dog, an affable yellow lab named Sadie. The dog was a sweet soul with floppy velvety ears and a tail that wagged gently all the time. My patient and the dog had an immediate connection, and I could see the confidence that Sadie gave her,
I can recall another woman, a lady that established care with me after being “fired” from two other medical practices. She was a person who had experienced a lot of traumas in her life, and used anger and defiance liberally in her interactions with others. We had reached an impasse. I was unable to address her pain in a way that was satisfying to her, and she was frustrated that I would not escalate her opioid prescription. Somewhere in my assessment of functional impairment, she mentioned that it was difficult to take care of Voldemort. “Who,” I asked, “is Voldemort?” As it turns out, Voldemort was her pet bearded dragon, a large lizard native to Australia. We then took quite the detour away from pain management to discuss bearded dragon care, how she came to acquire Voldemort, Voldemort’s propensity for escaping enclosures, and how lizards are in fact quite trainable and intelligent. Her eyes lit up as she talked about her pet and as we rounded out our visit, we agreed that we would use her ability to take care of Voldemort and his three continued on page 10
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continued from page 8
reptile enclosures as a good measure of her functional status. It was a start to our therapeutic journey and a very rewarding physician-patient relationship. I am quite grateful that Voldemort was able to facilitate some good communication between us. We will not mention the time that patient snuck Voldemort into clinic so I could meet him. With stories like these, it’s no wonder that there is now a large body of literature
Zeke Steven Harrison, MD
10
demonstrating that animals have positive health effects on the people they live with. A PubMed search with the keyword “pets” produces 830 results, on topics ranging from the mental health benefits of pets for people experiencing homelessness to the positive effect on self-esteem that pet ownership has on adolescents to the beneficial impact of pets on the lives of older adults during the COVID-19 pandemic.
Ellie Jay W. Lee, MD, MPH, FAAFP
California Family Physician Winter 2022
Frida Dulce Maria S. Oandasan, MD, FAAFP
As doctors, we can learn a lot from animals on how to care for our patients and ourselves. Animals are patient, loving, and consistent. They do not judge, they form strong relationships, and they are endlessly optimistic—just ask my friend’s dog anytime anyone walks near the refrigerator. As I look through all the CAFP pet pictures, I am thrilled to see your furry family members. Tell them all I say "hello" and give them treats for me.
Strawberry Robin Linscheid Janzen, MD, FAAFP
Polkadot Robin Linscheid Janzen, MD, FAAFP
political pulse
Carla Kakutani, MD Chair, CAFP Legislative Affairs Committee
And That’s a Wrap October 10th was the last day Governor Newsom had to sign into law or veto bills passed by the Legislature. The Governor signed into law twelve CAFP-supported bills that would increase access to health care services, protect reproductive health care patients and providers, support physician practices and residents, close the existing racial gaps in maternal and infant mortality, and protect patients and providers at vaccination sites.
Governor Signs Twelve CAFP-Supported Bills AB 342 (Gipson) Colorectal cancer: screening and testing This bill would require health plans to provide coverage without any cost sharing for a colorectal cancer screening test assigned either a grade of A or B by the United States Preventive Services Task Force (USPSTF), including when a colonoscopy is required after a positive result on a test or procedure that is a colorectal cancer screening examination or laboratory test assigned either a grade of A or B by the USPSTF.
AB 457 (Santiago) Protection of Patient Choice in Telehealth Provider Act This bill requires a health care service plan and a health insurer to comply with specified notice and consent requirements if the plan or insurer offers a service via telehealth to an enrollee or an insured through a third-party corporate telehealth provider, as defined. For an enrollee or insured that receives specialty telehealth services for a mental or behavioral health condition, the bill would require that the enrollee or insured be given the option of continuing to receive that service with the contracting individual health professional, a contracting clinic, or a contracting health facility. The bill would exempt specified health care service plan contracts and Medi-Cal managed care plan contracts from these provisions. The bill would require the State Department of Health Care Services to consider the appropriateness of applying these requirements to the Medi-Cal program, as specified.
AB 615 (Rodriguez) – Higher Education EmployerEmployee Relations Act: procedures relating to employee termination or discipline This bill would require a higher education employer to provide a procedure for all medical and dental interns 12
California Family Physician Winter 2022
and residents, persons in accredited resident physician subspecialty programs, and other postgraduate medical and dental trainees in unaccredited programs to challenge a termination of employment or a disciplinary action, as defined, by the employer, after the employee has exhausted available administrative or academic grievance processes, as provided. The bill would prohibit applying that procedure to a termination of employment or disciplinary action based on certain academic or clinical matters.
AB 1356 (Bauer-Kahan) Reproductive health care services This bill would prohibit a person, business, or association from knowingly publicly posting, displaying, disclosing, or distributing the personal information, as defined, or image, of a reproductive health services patient, provider, or assistant, as defined, without that person’s consent and with specified intent. This bill would also make it a crime, within 100 feet of the entrance to or within a reproductive health services facility, to intentionally videotape, film, photograph, or record by electronic means a reproductive health services patient, provider, or assistant, as defined, with the specific intent to intimidate a person from becoming or remaining a reproductive health services patient, provider, or assistant. It would also be a crime to intentionally disclose or distribute material obtained in this manner with the specific intent to intimidate a person from becoming or remaining a reproductive health services patient, provider, or assistant. The bill would exempt specified persons, including news reporters, from these provisions, as specified. Further, the bill would require local law enforcement agencies to report, in a manner prescribed by the Attorney General, the number of anti-reproductive-rights crime-related calls for assistance, the total number of arrests for anti-reproductive-rights crimes, and the total number of cases in which the district attorney charged an individual, as specified. Finally, the bill would require the development of an interactive training course on antireproductive-rights crimes and, subject to an appropriation in the annual Budget Act or other statute, update the course every 7 years, or on a more frequent basis as specified. The bill would also require all law enforcement agencies to develop, adopt, and implement written policies and standards for responding to anti-reproductive rights calls by January 1, 2023.
SB 48 (Limon) Dementia and Alzheimer’s disease As originally drafted, this bill would have required all general internists and family physicians to take at least four hours of mandatory continuing medical education (CME) on the special care needs of patients with dementia. CAFP successfully negotiated with the author and sponsors to delete that requirement. The bill was amended to create Medi-Cal payment for an annual “cognitive health assessment,” however providers can only bill for this if they complete a cognitive health assessment training as approved by DHCS and use a validated tool recommended by the department (a similar model to ACEs screening and payment). CAFP successfully garnered amendments that will require DHCS to consult with representatives of primary care physician specialties, including family medicine, prior to approving the cognitive health assessment training and prior to recommending the validated tool, and to require DHCS to select multiple validated tools.
SB 65 (Skinner) Maternal care and services SB 65, the California Momnibus Act, is designed to improve maternal and infant outcomes – particularly for families of color. The bill will improve research and data collection on
racial and socio-economic factors that contribute to higher rates of maternal and infant mortality in communities of color. Specifically, SB 65 codifies and strengthens the work of the Pregnancy-Associated Mortality Review Committee, which will investigate pregnancy-related deaths and make recommendations on best practices to avoid these preventable tragedies; improves data collection in the Fetal and Infant Mortality Review process; creates a fund to support the midwifery workforce, upon appropriation from the Legislature; establishes a stakeholder workgroup to support implementation of the new Medi-Cal doula benefit; and reduces CalWORKs paperwork requirements for pregnant women.
SB 242 (Newman) Health care provider reimbursements This bill requires health care service plans and insurers to reimburse health care providers for business expenses to prevent the spread of respiratory-transmitted infectious diseases causing public health emergencies.
SB 280 (Limon) Health insurance: large group health insurance This bill would require large group market products under the regulation of the California Department of Insurance (CDI) to
continued on page 14
We Too Believe... Healthcare is a Fundamental Human Right! Join our team! Visit our Careers page at srhealth.org
phone: 707.303.3600 ext. 2587 California Family Physician Winter 2022
13
continued from page 13
cover medically necessary basic health care services and codify the federal Affordable Care Act’s prohibition on discriminatory large group health insurance benefit designs and marketing practices in the Insurance Code. The basic health care services required in the bill include physician services, hospitalization, outpatient services, diagnostics, and preventive health services. Currently, CDIregulated large group policies routinely limit or exclude coverage for essential medical care such as women’s reproductive services, obesity care, organ transplants, and life-threatening complications caused by excluded services such as cosmetic surgery. SB 306 (Pan) Sexually transmitted disease: testing SB 306 will expand access to STI testing remotely at home and in the community, increase access to STI treatment for patients and their partners, and update state law to boost congenital syphilis screening. SB 306 will expand access to STI testing and treatment by requiring health plans to cover at-home test kits for HIV and STIs; increasing the number of providers that can provide STI testing in the community; supporting the delivery of expedited partner therapy, which allows patients to obtain STI treatment for their partners; and requiring syphilis screening during both the first and third trimester of pregnancy. SB 428 (Hurtado) Health care coverage: ACEs screenings This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after January 1, 2022, that provides coverage for pediatric services and preventive care to additionally include coverage for adverse childhood experiences screenings.
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California Family Physician Winter 2022
SB 510 (Pan) Health care coverage: COVID-19 cost sharing This bill would require a health care service plan contract or a disability insurance policy that provides coverage for hospital, medical, or surgical benefits, excluding a specialized health care service plan contract or health insurance policy, to cover the costs for COVID-19 diagnostic and screening testing and health care services related to the testing for COVID-19, or a future disease when declared a public health emergency by the Governor of the State of California, and would prohibit that contract or policy from imposing cost sharing or prior authorization requirements for that coverage. The bill would also require a contract or policy to cover without cost sharing or prior authorization an item, service, or immunization intended to prevent or mitigate COVID-19, or a future disease when declared a public health emergency by the Governor of the State of California, that is recommended by the United States Preventive Services Task Force or the federal Centers for Disease Control and Prevention, as specified. The bill would only extend the prohibition on cost sharing for COVID-19 diagnostic and screening testing, or an item, service, or immunization intended to prevent or mitigate COVID-19, with respect to an out-of-network provider for the duration of the federal public health emergency. The bill would also apply these provisions retroactively beginning from the Governor’s declared State of Emergency related to COVID-19 on March 4, 2020.
Total Funding Existing
$ 20,750,000
Total FM Funding $15,500,000
SB 742 (Pan) Vaccination sites: unlawful activities: obstructing, intimidating, or harassing This bill would make it unlawful for a person to knowingly approach a person or an occupied vehicle at a vaccination site, as specified, for the purpose of obstructing, injuring, harassing, intimidating, or interfering with, as defined, that person or vehicle occupant. The bill would define “vaccination site” as the physical location where vaccination services are provided, including, but not limited to, a hospital, physician’s office, clinic, or any retail space or pop-up location made available for large-scale vaccination services. The bill would impose a fine not exceeding $1,000, imprisonment in a county jail not exceeding 6 months, or by both that fine and imprisonment for a violation. FMRPs Once Again Perform Exceptionally Well in Song-Brown The Song-Brown Primary Care Physician Training program awards grants to primary care (FPs, Peds, IM, OB-GYN) residency programs located in underserved areas, that serve underserved populations, and that graduate ethnically diverse physicians who remain in primary care. These grants support existing programs, provide startup funds for new programs, help programs increase their class sizes through new slots, and support Teaching Health Center (THC) residency programs. Once again, family medicine residency programs performed exceptionally well compared to other eligible specialties, receiving 75 percent of the total funds for existing programs and
Total Grants 69
Total FM Grants 46
FM Proportion of Funds 75%
FM Proportion of Grants 67%
THC
$5,875,000
$4,625,000
10
8
79%
80%
New Slots
$5,400,000
$2,400,000
8
4
44%
50%
New Programs
$3,200,000
$ 1,600,000
4
2
50%
50%
TOTAL
$35,225,000
$24,125,000
91
60
68%
66%
DERMATOLOG Y
79 percent for THCs. Half of the total grants for new slots and for new programs went to family medicine residency programs. In total, family medicine received over $24 million of the approximately $35 million available this year. CAFP Awarded Leadership in State Government Advocacy Award CAFP is honored to be awarded the AAFP 2021 Leadership in State Government Advocacy Award, for outstanding chapter contributions to further family medicine through state legislative accomplishments, particularly to advance alternative payment models to support primary care. Thank you to the AAFP Center for State Policy for recognition at this year’s State Legislative Conference. If you would like to be involved in CAFP’s advocacy efforts, please visit the Advocacy/ Policy section of CAFP’s website: https://www. familydocs.org/advocacy/get-involved/
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California Family Physician Winter 2022
15
For the treatment of Helicobacter pylori infection in adults
Eradication Starts Here
TM
High rates of H. pylori eradication**2 • 84% eradication overall • 90% eradication in confirmed adherent patients
All medications combined into identical all-in-one capsules Simple dosing: 4 capsules q8h with food for 14 days3 Favorable safety and tolerability3 The most common adverse reactions (≥5%) observed in the pivotal trial were diarrhea (10.1%), and headache (7.5%). Chromaturia (13.0%) was observed in the supportive placebo-controlled trial.† Treatment discontinuation due to an adverse event occurred in only 1% of patients receiving Talicia in clinical trials. Please see Brief Summary of Prescribing Information on adjacent pages.
IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycins. Talicia is contraindicated in patients receiving delavirdine, voriconazole or rilpivirinecontaining products. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Severe cutaneous adverse reactions (SCAR) (e.g. Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm and is not recommended for use in pregnancy. It may also reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Now covered on Medi-Cal*1
Eradication Starts HereTM
Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus and systemic lupus erythematosus have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
*Insurance plans and coverage may vary and subject to change. This is for general information only and is not a guarantee of coverage. Formulary coverage and status do not imply efficacy or safety. **Findings from the Talicia phase 3 pivotal study in 455 treatment-naïve subjects with confirmed H. pylori infection. Eradication rates were 84% for Talicia in the intent-to-treat population. Eradication rates were 90% for Talicia in the confirmed adherent population, which was a prespecified, protocol-defined population with confirmed blood levels of study drug at day 13 of the 14-day regimen. † Riboflavin administration in the pivotal trial may have contributed to under-reporting of chromaturia. REFERENCES: 1. California DHCS website. https://www.dhcs.ca.gov/Pages/AboutUs.aspx Accessed Jan 1, 2022. 2. Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. Ann Intern Med. 2020;172(12):795-802. 3. Talicia prescribing information. Trademarks are owned by or licensed to RedHill Biopharma Inc. or its related companies. ©2022 RedHill Biopharma Ltd. All rights reserved. US-TAL-235 01/2022
BRIEF SUMMARY OF PRESCRIBING INFORMATION TALICIA® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules, for oral use 1 INDICATIONS AND USAGE 1.1 Helicobacter pylori Infection TALICIA is indicated for the treatment of Helicobacter pylori infection in adults. 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 2 DOSAGE AND ADMINISTRATION Administer four (4) TALICIA capsules every 8 hours for 14 days with food. Instruct patients to swallow the TALICIA capsules whole, with a full glass of water (8 ounces). Each dose (4 capsules) of TALICIA includes rifabutin 50 mg, amoxicillin 1,000 mg and omeprazole 40 mg. Do not crush or chew TALICIA capsules. Do not take TALICIA with alcohol. If a dose is missed, patients should continue the normal dosing schedule until the medication is completed. Do not take two doses at one time to make up for a missed dose. 4 CONTRAINDICATIONS 4.1 Hypersensitivity Reactions TALICIA is contraindicated in patients with known hypersensitivity to the components of TALICIA: amoxicillin [or other ß-lactam antibacterial drugs (e.g., penicillins and cephalosporins)], omeprazole [or other benzimidazoles (e.g., proton pump inhibitors (PPIs) and anthelmintics)], rifabutin (or any other rifamycins), or to any other component of TALICIA. Hypersensitivity reactions may include anaphylaxis or Stevens Johnson Syndrome, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, rash and urticaria [see Warnings and Precautions (5.1, 5.2, 5.5, 5.7), Adverse Reactions (6.1)]. 4.2 Rilpivirine-containing Products Proton pump inhibitors (PPIs), including omeprazole (a component of TALICIA), are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7.1)]. 4.3 Delavirdine The use of rifabutin (a component of TALICIA), is contraindicated in patients receiving delavirdine [see Drug Interactions (7.1)]. 4.4 Voriconazole The use of rifabutin (a component of TALICIA), is contraindicated in patients receiving voriconazole [see Drug Interactions (7.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Serious and fatal hypersensitivity reactions, (e.g., anaphylaxis, angioedema, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, acute tubulointerstitial nephritis, and serum sickness) have been reported with the components of TALICIA: omeprazole, amoxicillin and rifabutin. Signs and symptoms of these reactions may include hypotension, urticaria, angioedema, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia or flu-like syndrome (weakness, fatigue, muscle pain, nausea, vomiting, headache, fever, chills, aches, rash, itching, sweats, dizziness, shortness of breath, chest pain, cough, syncope, palpitations). There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with TALICIA, inquire about history of hypersensitivity reactions to penicillins, cephalosporins, rifamycins, or PPIs. Discontinue TALICIA and institute immediate therapy, if hypersensitivity reactions occur. 5.2 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported with the components of TALICIA: rifabutin, amoxicillin, and omeprazole [see Warnings and Precautions (5.1) and Adverse Reactions (6.3)]. In addition, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin, a component of TALICIA. Monitor closely and discontinue TALICIA at the first signs of SCAR. 5.3 Clostridioides difficile-Associated Diarrhea Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of omeprazole, a component of TALICIA and nearly all antibacterial agents, including amoxicillin and rifabutin, which are components of TALICIA and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhea following proton pump inhibitor and or antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is confirmed, TALICIA should be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. 5.4 Reduced Efficacy of Hormonal Contraceptives TALICIA may reduce the efficacy of hormonal contraceptives. Therefore, an additional non-hormonal highly effective method of contraception should be used while taking TALICIA [see Drug Interactions (7.1)]. 5.5 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs including omeprazole, a component of TALICIA. TIN may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions, to nonspecific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). TIN has also been observed in patients taking penicillins, such as amoxicillin, a component of TALICIA. Discontinue TALICIA and evaluate patients with suspected acute TIN [see Contraindications (4)]. 5.6 Risk of Adverse Reactions or Loss of Efficacy Due to Drug Interactions Components of TALICIA have the potential for clinically important drug interactions [see Contraindications (4) and Drug Interactions (7)]. Avoid concomitant use of TALICIA with other CYP2C19 or CYP3A4 inducers (e.g., St. John’s Wort, rifampin) as they can substantially decrease omeprazole concentrations. Avoid concomitant use of TALICIA with CYP2C19 and/or CYP3A4 inhibitors (e.g., fluconazole, itraconazole) as it may significantly increase the plasma concentration of component(s) of TALICIA. Depending on the protease inhibitor, the concomitant use of TALICIA should be avoided (e.g., amprenavir, indinavir) or dose adjustments for a concomitantly administered protease inhibitor(s) may be required. Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. Avoid TALICIA in patients on high-dose methotrexate. Concomitant use of clopidogrel and omeprazole reduces the pharmacological activity of clopidogrel. Avoid TALICIA in patients on clopidogrel. When using TALICIA, consider alternative anti-platelet therapy [see Drug Interactions (7)]. 5.7 Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE. If signs or symptoms consistent with CLE or SLE develop in patients receiving TALICIA, discontinue the drug and evaluate as appropriate. 5.8 Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Avoid TALICIA in patients with mononucleosis. 5.9 Uveitis Due to the possible occurrence of uveitis, patients should be carefully monitored when rifabutin, a component of TALICIA, is given in combination with clarithromycin (or other macrolides) and/or fluconazole and related compounds. If uveitis is suspected, refer for an ophthalmologic evaluation and, if considered necessary, suspend treatment with rifabutin [see Adverse Reactions (6.2)]. 5.10 Interactions with Diagnostic Investigations for Neuroendocrine Tumors Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Assess CgA levels at least 14 days after TALICIA treatment and consider repeating the test if initial CgA levels are high [see Drug Interactions (7)].
5.11 Development of Drug-Resistant Bacteria Prescribing TALICIA either in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] • Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.3)] • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.5)] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7)] • Rash in Patients with Mononucleosis [see Warnings and Precautions (5.8)] • Uveitis [see Warnings and Precautions (5.9)] 6.1 Clinical Trials Experience with TALICIA Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TALICIA was assessed in adult patients who were screened and found to be positive for H. pylori infection in one active-controlled (Study 1) and one placebo-controlled (Study 2) clinical trial. Patients received TALICIA, amoxicillin and omeprazole, or placebo every eight hours for 14 consecutive days taken with food. A total of 305 patients received TALICIA in Studies 1 and 2, 227 patients received amoxicillin and omeprazole (as omeprazole magnesium) in Study 1, and 41 patients received placebo in Study 2. These patients had a mean age of 46.4 years (range 18 to 70 years); 62.3% were female, 80.3% were white with 64.2% Hispanic or Latino. Adverse Reactions Leading to Discontinuation Treatment discontinuation due to an adverse reaction occurred in 1% (4/305) of patients receiving TALICIA, <1% (1/227) of patients receiving amoxicillin and omeprazole, and 2% (1/41) of patients receiving placebo. Adverse reactions leading to discontinuation of TALICIA were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, in one patient each. Most Common Adverse Reactions Selected adverse reactions occurring in ≥1% of patients receiving TALICIA in Study 1 and 2 are described in Table 1. Table 1: Selected Adverse Reactions Occurring in 1% or Greater of Patients Receiving TALICIA in Studies 1 and 2 Study 1 Study 2 Amoxicillin and TALICIA Placebo Adverse Reaction Omeprazole (N=77) (N=41) (N=227) n (%) n (%) n (%) Diarrhea 23 (10.1) 18 (7.9) 11 (14.3) 4 (9.8) 17 (7.5) 16 (7.0) 12 (15.6) 4 (9.8) Headachea Nausea 11 (4.8) 12 (5.3) 3 (3.9) 1 (2.4) Abdominal painb 8 (3.5) 11 (4.8) 3 (3.9) 2 (4.9) 0 0 10 (13.0) 1 (2.4) Chromaturiac Rashd 6 (2.6) 2 (0.9) 4 (5.2) 0 5 (2.2) 3 (1.3) 1 (1.3) 0 Dyspepsiae Vomiting 5 (2.2) 5 (2.2) 1 (1.3) 2 (4.9) Oropharyngeal pain 2 (0.9) 2 (0.9) 3 (3.9) 0 Vulvovaginal candidiasisf 5 (2.2) 5 (2.2) 0 0 a Headache includes: headache and migraine. b Abdominal pain includes: abdominal pain, abdominal pain upper, and abdominal pain lower. c Riboflavin was administered in Study 1 to prevent unintentional unblinding and may have contributed to under-reporting of chromaturia. d Rash includes: rash, rash maculo-papular, rash morbilliform, and urticaria. e Dyspepsia includes: dyspepsia and epigastric discomfort. f Vulvovaginal candidiasis includes: vulvovaginal candidiasis, vulvovaginal mycotic infection, fungal infection, and vaginal discharge + vulvovaginal burning sensation + vulvovaginal pruritus. 6.2 Other Important Adverse Reactions from the Labeling of the Individual Components of TALICIA Additional adverse reactions that occurred in 1% or greater of patients treated with omeprazole or rifabutin alone in clinical trials were as follows: Omeprazole Flatulence, acid regurgitation, upper respiratory infection, constipation, dizziness, asthenia, back pain, and cough. Rifabutin Flatulence, asthenia, chest pain, fever, pain, leucopenia, anemia, anorexia, eructation, myalgia, insomnia, and taste perversion. The following selected adverse reactions occurred in less than 1% of patients treated with rifabutin alone: flu-like syndrome, hepatitis, hemolysis, arthralgia, myositis, dyspnea, skin discoloration, thrombocytopenia, pancytopenia, and jaundice. 6.3 Post-Marketing Experience with Components of TALICIA Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure. Omeprazole Cardiovascular: angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema Endocrine: gynecomastia Gastrointestinal: pancreatitis including fatal pancreatitis, anorexia, irritable colon, fecal discoloration, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis, fundic gland polyps, gastroduodenal carcinoids in patients with Zollinger-Ellison syndrome on long-term treatment as a manifestation of the underlying condition associated with such tumors Hepatic: fatal hepatic failure or necrosis, hepatic encephalopathy, hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice Metabolism and Nutritional disorders: hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain Musculoskeletal: muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture. Nervous System/Psychiatric: depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, dream abnormalities, tremors, paresthesia, vertigo Respiratory: epistaxis Skin and subcutaneous tissue disorders: Severe cutaneous adverse reactions (SCAR) such as SJS, TEN, and AGEP, photosensitivity, urticaria, pruritus, petechiae, purpura, alopecia, dry skin, hyperhidrosis Special Senses: tinnitus, taste perversion Ocular: optic atrophy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision Urogenital: hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain Hematologic: Agranulocytosis, hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leukocytosis TALICIA (N=228) n (%)
Amoxicillin Gastrointestinal: black hairy tongue Liver: hepatic dysfunction, cholestatic jaundice, cholestasis, acute cytolytic hepatitis Renal: crystalluria Hemic and Lymphatic Systems: anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis Central Nervous System: hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness Skin and subcutaneous tissue disorders: SCAR, such as SJS, TEN, and AGEP. Rifabutin Blood and lymphatic system disorders: agranulocytosis, lymphopenia Skin and subcutaneous tissue disorders: SCAR, such as SJS, TEN, DRESS, and AGEP. 7 DRUG INTERACTIONS 7.1 Interactions with Other Drugs and Diagnostics Drug interaction studies with TALICIA have not been conducted. The drug interaction information described here is based on the prescribing information of individual TALICIA components: omeprazole, amoxicillin, and rifabutin. Rifabutin is a substrate and inducer of cytochrome P450 (CYP) 3A enzymes. Omeprazole is a substrate and an inhibitor of CYP2C19, and a substrate of CYP3A4. Co-administration of TALICIA and other drugs that are substrates, inhibitors, or inducers of these enzymes may alter concentrations of rifabutin/omeprazole or other co-administered drugs [See Table 2 below]. Omeprazole magnesium is a PPI. Refer to the prescribing information of the drugs used concomitantly with TALICIA for further information on their interactions with PPIs. Table 2: Interactions with TALICIA When Co-Administered with Other Drugs and Diagnostics CYP2C19 or CYP3A4 Inducers Clinical Impact Decreased exposure of omeprazole when used concomitantly with strong inducers. St. John’s Wort, rifampin: Avoid concomitant use with TALICIA [see Warnings and Prevention or Precautions (5.6)]. Management Ritonavir-containing products: See prescribing information for specific drugs. CYP2C19 or CYP3A4 Inhibitors Clinical Impact Increased blood levels of omeprazole and rifabutin. Voriconazole: Concomitant use with TALICIA is contraindicated [see Contraindications (4)]. Prevention or Fluconazole, posaconazole, and itraconazole: Avoid concomitant use with TALICIA. If Management coadministration cannot be avoided, monitor patients for rifabutin associated adverse events, and lack of anti-fungal efficacy. CYP2C19 Substrates (e.g., Clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Increased plasma concentrations of CYP2C19 substrate drugs or decreased/increased plasma Clinical Impact concentrations of its active metabolite(s). Prevention or Clopidogrel: Consider use of alternative anti-platelet therapy [see Warnings and Precautions (5.6)]. Management Avoid concomitant use with TALICIA. Antiretrovirals/Protease Inhibitors Antiretrovirals/protease inhibitors may increase rifabutin blood levels. The effect of PPIs (such as omeprazole in TALICIA) on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the Clinical Impact development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity. There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Delavirdine: Combination treatment with TALICIA and delavirdine is contraindicated [see Contraindications (4)]. Rilpivirine-containing products: Concomitant use with TALICIA is contraindicated [see Prevention or Contraindications (4)]. Management Avoid concomitant use of TALICIA with amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, or nelfinavir [see Warnings and Precautions (5.6)]. Other antiretrovirals: See prescribing information for specific antiretroviral drugs. Probenecid Clinical Impact Increased and prolonged blood levels of amoxicillin. Allopurinol Increase in the incidence of rashes is reported in patients receiving both allopurinol and amoxicillin together compared to patients receiving amoxicillin alone. It is not known whether Clinical Impact this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Prevention or Discontinue allopurinol at the first appearance of skin rash. Assess benefit-risk of continuing Management TALICIA treatment. Warfarin, and Other Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants and in patients receiving Clinical Impact PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Prevention or Monitor INR and prothrombin time and adjust the dose of warfarin or other oral anticoagulants to Management maintain the desired level of anticoagulation. Methotrexate Concomitant use of omeprazole with methotrexate (primarily at high doses) may elevate and Clinical Impact prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities [see Warnings and Precautions (5.6)]. Prevention or Avoid concomitant use of TALICIA in patients receiving high-dose methotrexate. Management Digoxin Clinical Impact Potential for increased digoxin blood levels. Prevention or Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug Management concentrations. See digoxin prescribing information.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Omeprazole can alter the absorption of other drugs due to its effect of reducing intragastric Clinical Impact acidity thereby increasing gastric pH. Prevention or Mycophenolate mofetil (MMF): Use TALICIA with caution in transplant patients receiving MMF. See Management the prescribing information of other drugs dependent on gastric pH for absorption. Tacrolimus Potential for increased tacrolimus blood levels, especially in patients who are intermediate or poor Clinical Impact metabolizers of CYP2C19. Prevention or Monitor tacrolimus whole blood levels and adjust dose as per the prescribing information for Management tacrolimus. Drugs Metabolized via the CYP450 Enzymes (e.g., cyclosporine, disulfiram) Clinical Impact Interactions are reported with omeprazole and other drugs metabolized via the CYP450 enzymes. Prevention or Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when Management taken concomitantly with TALICIA. Oral Contraceptives Concomitant use of amoxicillin and rifabutin with hormonal contraceptives may lead to loss of Clinical Impact its efficacy due to lower estrogen reabsorption and decreased ethinylestradiol and norethindrone concentrations, respectively [see Warnings and Precautions (5.4)]. Prevention or Patients should be advised to use additional or alternative non-hormonal methods of Management contraception. Diagnostic Investigations for Neuroendocrine Tumors PPI-induced decrease in gastric acidity may lead to increased serum chromogranin A (CgA) levels, Clinical Impact which may cause false positive results in diagnostics for neuroendocrine tumors [see Warnings and Precautions (5.10)]. Assess CgA levels at least 14 days after stopping TALICIA treatment and consider repeating the Prevention or test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same Management commercial laboratory should be used for testing, as reference ranges between tests may vary. Urine Glucose Test High urine concentrations of ampicillin or amoxicillin may result in false-positive reactions when Clinical Impact using glucose tests based on the Benedict’s copper reduction reaction that determines the amount of reducing substances like glucose in the urine. Prevention or Glucose tests based on enzymatic glucose oxidase reactions should be used. Management Interaction with Secretin Stimulation Test Hyper-response in gastrin secretion in response to secretin stimulation test may falsely suggest Clinical Impact gastrinoma. Prevention or Test should be performed at least 14 days after stopping TALICIA treatment to allow gastrin levels Management to return to baseline. False Positive Urine Tests for Tetrahydrocannabinol (THC) Clinical Impact There have been reports of false positive urine screening tests for THC in patients receiving PPIs. Prevention or An alternative confirmatory method should be considered to verify positive results. Management Other Laboratory Tests Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease Clinical Impact in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on animal reproduction studies, TALICIA may cause fetal harm when administered to pregnant women. There are no adequate and well controlled studies of amoxicillin, omeprazole, or rifabutin (used separately or together) in pregnant women. Use of TALICIA is generally not recommended for use in pregnancy. If TALICIA is used during pregnancy, advise pregnant women of the potential risk to a fetus. 8.2 Lactation Risk Summary Data from a published clinical lactation study reports that amoxicillin is present in human milk. Published adverse effects with amoxicillin exposure in the breast-fed infant include diarrhea. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TALICIA and any potential adverse effects on the breast-fed child from TALICIA or from the underlying condition. 8.3 Females and Males of Reproductive Potential Contraception Both rifabutin and amoxicillin components of TALICIA interact with hormonal contraceptives resulting in lower levels of these contraceptives. Therefore, female patients taking hormonal contraceptives should use an additional non-hormonal highly effective method of contraception while taking TALICIA. 8.5 Geriatric Use Clinical studies of TALICIA did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. 8.6 Renal Impairment It is recommended to avoid the use of TALICIA in patients with severe renal impairment (GFR < 30 mL/min). Amoxicillin is primarily eliminated by the kidney. 8.7 Hepatic Impairment It is recommended to avoid the use of TALICIA in patients with hepatic impairment. In patients with hepatic impairment (Child-Pugh Class A, B, or C) exposure to omeprazole substantially increased compared to healthy subjects. 10 OVERDOSAGE No information is available on accidental overdosage of TALICIA in humans. In case of an overdose, patients should contact a physician, poison control center, or emergency room. TALICIA is distributed by RedHill Biopharma Inc. Raleigh, NC TALICIA is manufactured in Sweden for RedHill Biopharma Ltd. Tel Aviv, Israel TALICIA is a trademark registered with the U.S. Patent and Trademark Office and used under license by RedHill Biopharma Inc. ©2020 RedHill Biopharma Ltd. All rights reserved. US-TAL-241 12/2021
legislative update
Catrina Reyes, Esq.
Vice President of Advocacy and Policy
Family Medicine Advocacy Fixes Unintended Consequences Caused by the PTL After over a year of advocacy, the unintended consequences of the postgraduate training license (PTL) have been resolved through Senate Bill 806 (2021, Roth), which was signed into law by the Governor. In 2017, California revised how residents were licensed by creating the PTL, which went into effect on January 1, 2020. With the creation of the PTL, in order to be eligible for a physician and surgeon license, medical school graduates, regardless of whether the medical school attended was domestic or international, were required to successfully complete 36 months of postgraduate training in an accredited program, which includes 24 months of continuous training in the same program. During the 36 months of postgraduate training, residents would have a PTL rather than a physician and surgeon license. Prior to the PTL, residents were able to obtain an unrestricted physician and surgeon license upon successful completion of 12 months of approved postgraduate training for domestic medical school graduates and 24 months for international medical school graduates. The change in the law caused a number of unintended consequences, including the inability of residents to: bill Medi-Cal and other payers when moonlighting; obtain SAMHSA Drug Enforcement Agency X-waivers; sign
20
California Family Physician Winter 2022
birth certificates, death certificates, and disability forms; and take family or medical leave without having to extend their training program. These unintended consequences prompted CAFP to act and family physicians and residents to rally together. CAFP formed a coalition with the California Primary Care Association, California Medical Association, SEIU, California Chapter of the American College of Emergency Physicians, and Psychiatric Physicians Alliance of California. CAFP also submitted letters to and had numerous meetings with the Medical Board of California (MBC) and the Legislature. CAFP members, including program directors and residents, called their legislators, sent over 50 letters to the MBC and the Legislature, and engaged in a social media campaign. These efforts successfully led to the Legislature addressing the unintended consequences of the PTL through SB 806. Though SB 806 maintains the PTL, it allows residents to obtain a physician’s and surgeon’s license after receiving credit for at least 12 months of postgraduate training for graduates of medical schools in the United States and Canada or 24 months for graduates of foreign medical schools, pursuant to the attestation of the program director,
designated institutional official, or other delegated authority. This was the licensing timeline that was in place prior to the implementation of the PTL. This change in the statute will now allow residents to bill for services when moonlighting, sign state forms, and obtain a DEA X-Waiver. SB 806 adds that at the time of initial license renewal, residents must show that they received credit for at least 36 months of postgraduate training which includes successful progression through 24 months in the same program, pursuant to the attestation of the program director, designated institutional official, or delegated authority. Senator Roth and the MBC have made clear that any program-approved leave time counts towards the “received credit.” Moreover, as a contingency for unforeseen circumstances, SB 806 provides that upon review of supporting documentation, the MBC, in its discretion, may renew a license to a resident who has demonstrated substantial compliance. The advocacy efforts that went into fixing the PTL is a prime example of how the collective voice of family medicine can make a difference in Sacramento. If you would like to be involved in CAFP’s advocacy efforts, please visit the Advocacy/Policy section of CAFP’s website: https://www. familydocs.org/advocacy/get-involved/
Leading the future of health care EXTRAORDINARY BENEFITS: • Competitive compensation and benefits package, including medical and dental • Moving allowance and home loan assistance - up to $200,000 (approval required)
Adult & Family Medicine Physician Opportunities Northern & Central California The Permanente Medical Group, Inc. (TPMG - Kaiser Permanente Northern California) is one of the largest medical groups in the nation with over 9,000 physicians, 22 medical centers, numerous clinics throughout Northern and Central California, and a 75-year tradition of providing quality medical care. We currently have openings for BC/BE Family Medicine or Internal Medicine Physicians to join us throughout Northern & Central California. When you join Kaiser Permanente in Northern or Central California, you'll enjoy the best of both big city and small town amenities. Our locations offer family-oriented communities, spacious parks, tree-lined streets, excellent schools, great shopping, outstanding restaurants, and a multitude of cultural activities. You’ll also enjoy nearby destinations such as the Napa Valley wine country, San Francisco, Lake Tahoe, and the stunning shoreline of the Pacific Coast.
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• Malpractice and tail insurance • Paid holidays, sick leave, education leave • Shareholder track • Three retirement plans, including pension
FORGIVABLE LOAN PROGRAM $125,000 - $275,000 (based on location and experience)
Available exclusively to Internal Medicine and Family Medicine Physicians, the Forgivable Loan Program is just one of many incentives we offer in exchange for our Primary care Physician’s dedication and expertise. To learn more and to apply, please visit: https://tpmg.permanente.org. FAMILY MEDICINE: Contact Bianca Canales at: Bianca.Canales@kp.org or 510-421-2183 INTERNAL MEDICINE: Contact Harjit Singh at: Harjit.X.Singh@kp.org or 510-295-7857
CONNECT WITH US:
CAFP foundation
By Pamela Mann, MPH
CAFP Foundation:
Enhancing Student-Resident Programs Through the Shelly B. Rodrigues Education Fund The CAFP Foundation Board of Trustees (BoT) gathered virtually in October for their annual meeting. While hopes were high that this one would be in-person, we were once again video — calling from our living rooms and home offices — well, some from more enviable locations like the Balloon Festival in Albuquerque, and the beaches of Hawaii and Southern California. Nevertheless, it was nice to get a virtual glimpse into each other’s worlds and still feel the warmth and connectedness that radiates within the CAFP community — a gift, I’m convinced, specially belongs to our members. At the 2020 annual meeting, the BoT agreed to extend their terms for another year based on uncertainties brought by the pandemic, including transitions taking place at the Foundation. With several board terms soon ending and significant turnover approaching in January 2022, this meeting felt extra important for not only discussing critical opportunities, but also for having to say our goodbyes. We covered the usual regulatory procedures/updates and left room for one last strategic activity: enhancing student-resident programs through the Shelly B. Rodrigues Education Fund (SBR Fund). In 2020, Shelly Rodrigues, CAFP Foundation Executive Director and CAFP Deputy Executive Vice President announced her retirement from the California Academy of Family Physicians. For nearly three decades, Shelly led the organization to become an anchor philanthropy for education and leadership development. Shelly was deeply committed to finding innovative and collaborative ways to support medical students, family medicine residents, and family physicians in their training, practices, and networks. In recognition of Shelly's service, the CAFP Foundation established an Education Fund as an enduring tribute to her legacy. One thing became quite clear during this brainstorming exercise: who better to guide efforts for the SBR Fund than those who have worked alongside Shelly for years? The BoT drew inspiration from Shelly’s can-do attitude,
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creativity, warm smile, and tireless dedication to our members. They recommended several activities ranging from medical student and resident support to mentorship and new physician support. The group agreed that the best longitudinal use of these funds was to enhance work the Foundation was already doing, rather than take on new projects at this time. Subsequently, these ideas were further distilled into three actionable initiatives. Establishment of the Shelly Rodrigues Chief Resident Leadership Workshop When the pandemic hit in 2020, the opportunity for the national AAFP Chief Resident Leadership Development Program was put on hold, and the CAFP Chief Residents Workshop (CRW) was established in response to this temporary cancellation. The Foundation collaborated with California's family medicine residency programs to design a skills-based virtual workshop for residents transitioning into their new roles as clinical leaders. The first CRW was a great success and was recognized by the AAFP Foundation as the Program of the Year in 2021. To honor Shelly’s legacy of education, the BoT identified the CRW as a flagship activity for this fund. In 2022, the CAFP Foundation will re-introduce the newly branded Shelly Rodrigues Chief Resident Leadership Workshop and expand on existing curriculum to include a virtual half-day session in June, with a follow-up in-person session at the 2022 Summit. Leadership Development Workshop for Family Medicine Interests Groups California has a sizable network of Family Medicine Interest Groups (FMIGs) at 16 medical campuses across the state. Traditionally, the Foundation has supported FMIGs through funding and technical assistance for activities that promote student interest in family medicine. To further develop FMIG leadership skills, build connections among peers and promote service learning, the SBR Education Fund will support an FMIG Leadership Workshop at the 2022 Summit. The workshop will be designed to share best practices and help newer or less active chapters leave with suggestions to re-energize their activities.
Advanced Track for Residents at the Southern California Procedure Workshop For nearly eight years, the Procedures Workshop has brought together medical students, resident physicians, and family medicine faculty in the same learning community to introduce/practice officebased procedures. This hands-on event has evolved into a signature forum for developing professional skills and lasting connections between trainees and family physicians. To build on this very successful initiative, the SBR Fund will support an Advanced Resident Track at the workshop, which will provide in-depth learning and collaboration between experienced residents and FM faculty on procedures Elizabeth Sophy, MD demonstrates suturing knots for medical students at the Southern California Procedures Workshop.
CAFP Foundation President, Dr. Marianne McKennett, closed the meeting with words of gratitude, celebration, and reflection. “What an inspiration to share in each other’s creativity, expertise and passions! With the world being a bit on hold, it feels exciting to go beyond ideas and into some action. It’s been energizing to talk about our programs and to collectively promote opportunities for future generations of family physicians. Before we part — in the spirit of wellness, let’s close with a reflection on what has brought joy in service and in practice? After all, it is part of our mission.”
• Physician • Allied Health Provider (FNP, PA, etc.) • RN
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Faculty teach residents Point of Care Ultrasound at the Southern California Procedures Workshop.
such as mock codes, joint injections, POCUS, splinting, colposcopy and more.
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Jeremy Fish, MD Program Director John Muir Health Family Medicine
Re-Envisioning Family Medicine Education and Training.
From the Who, What and Where to the How and Why of Family Medicine. The ACGME is making major revisions to the structure and purpose of Family Medicine Residency training to go into effect in July 2022. The Society of Teachers of Family Medicine (STFM) recently published a truly remarkable collection of recommendations for the new purpose & more flexible structure to inform decisions by the ACGME. Our specialty began to move away from being a “piecemeal collection of other-specialist’s training” into a more positive and intentional framework around the core purpose and meaning of our specialty to care for all populations of people in a more team-based context. However, much of the current structure of FM Residency training retains the piecemeal nature of focusing on What we do (take care of patients), Where we do it (in the Hospital, in the Clinic), and Who we take care of (hospitalized people, people with Coronary Disease, people of a certain age or a certain health condition). Like all piecemeal approaches focused on what, where and who…the identity and core purpose of our specialty can get lost in the effort to include as many people, places, and conditions as we can. What if we began to shift the focus away from who, what and where and instead concentrated our efforts on Why and How we care for people? Simon Sinek has taught us all that organizations and companies that first speak through why and how they exist often inspire people to engage in what they do no matter where they are or who they are. In fact, that is the basis for the success of most of the largest companies in the world such as Apple, Google, and Amazon, all of whom are quickly entering into healthcare as we speak. We often struggle to understand why we are not drawing adequate new generations of students to join our ranks? Perhaps it’s because we focus on how much we do for so little — using sacrifice and servitude to explain
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ourselves, rather than focusing on why we do what we do and how we can do it better in the future to inspire them to join us? Why does Family Medicine exist in the United States? We reduce suffering and improve the health of people and communities in a more affordable way. Dr. BarbaraStarfield proved that to us and the world in 2005 with her landmark article on the value of primary care (2005). That is vital, yet not sufficient to inspire, so inspiration must come from other core components of our purpose. Dr. Andrew Bazemore of the American Board of Family Medicine brought these to the surface in his remarkable STFM article “Sailing the 7 C’s” in which he and his co-author, Timothy Grunert introduce 3 new C’s: • Community Engagement • Patient-Centeredness • Complexity Putting the 4 Starfield C’s (Continuity, First Contact, Comprehensiveness, Coordinated) together with their three additional C’s we find none of them describe what, where or who we are caring for — thus emphasizing the Why and How we care. Despite being resource starved, we save lives, use resources more wisely than others, and reduce unnecessary and expensive care that probably doesn't even help people. Just as we demand the ACGME codify the need for adequate leadership, faculty and staff time to lead our residency programs — we must demand the ACGME begins to codify the very real resources we will need to hire inter-professional teams and lay experts to manifest this vital teamwork especially within our Residency Practices. Let’s take a simple example of how profoundly this can begin to change how we see ourselves in the context of
care we provide….Geriatrics Everyone knows a “grey / silver tsunami” is emerging in the United States — yet “Geriatrics”(focused on Who as an age group) does not inspire most of us to pursue being as ready as we could be to care for this and other sub-populations facing complex healthcare challenges. Reframing “Geriatrics” to “Team-based Complex Care” or “Coordinated Complex Care” or “Collaborative Complex Care” suddenly shifts us over to HOW we care for people, no longer limited to an arbitrary age, sex, site of care or health condition. It also emphasizes our mastery in leading teams, collaboration, and navigating complexity — vital new skills with a growing body of evidence demonstrating improvements in the health of individuals, communities and populations. I have had 2 year olds who require team-based complex care and I've had 90 year olds who are the simplest people to take care of. Is a teen struggling with obesity or an eating disorder less worthy of team-based complex care because of his/her age?
Suddenly, caring for a specific age-group of people all by ourselves — something quite overwhelming to most of us — becomes engaging in team-based care to provide complex care services to people suffering from many conditions (including social determinants of health) regardless of age, sex, site of care, and health conditions. We go from fear of burn-out to exploring how best to engage our team in assuring the best outcomes for those we serve. Our journey begins with us. With the upcoming ACGME 10-year major revisions in Family Medicine training requirements, we have a remarkable opportunity for new directions, a reframing of our identity from the lone generalist caring for an entire community all the time by ourselves toward our new identity as masters of complexity, leadership, and teamwork who reduce suffering and increase the health & well-being of individuals, communities and populations regardless of age, sex, site of care or health condition.
PRIMARY CARE PHYSICIANS San Francisco Bay Area
Contra Costa Health Services is seeking full-time BC/BE FM, Peds or IM Primary Care Physicians. Our health centers across Contra Costa County are integrated with specialty care services and the public hospital. We are looking for providers from diverse backgrounds and lived experiences who share our vision of providing equitable and quality health care to all members of our Contra Costa community. Desired applicants would work with a motivated practitioner group to provide innovative community medicine that empowers patients by fostering an environment of belonging and well-being.
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We offer: • Modern facilities serving the needs of ethnically and culturally diverse populations • Opportunity to be involved in resident teaching with our nationally recognized Family Medicine Residency Program
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For more information, visit Recruitment Contact: Tanisha Washington (twashing@uci.edu) Recruitment Contact: Melissa Aguirre (m.aguirre@uci.edu) The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.
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Julie Çelebi, MD, MS
Supporting Your Transgender/ Non-Binary Adolescent Patients Adolescence can already be such a vulnerable time, but for our gender nonconforming teens, it can be especially challenging. We all want to be open and affirming in the care of our patients, especially those who may be more vulnerable to poor health outcomes due to prejudice and structural discrimination, which can inevitably breed health inequities. So how can we best support our gender-diverse teens? There has been a lot of controversy about the asking of pronouns. While it may seem that you are being inclusive by asking
Seeking: Physicians for Our Vista/Oceanside, North San Diego County Clinics
Full-Time, Part-Time and Per Diem Positions Available Requirements: California License, DEA License, Board Certified
someone about their gender identity, some can feel targeted or otherized in the process. Furthermore, for gender nonconforming patients, sometimes it can feel that their gender identity can become center stage in all of their health concerns. Overly focusing on gender issues in an acute clinic visit for a respiratory infection, for example, can miss the mark and disrupt therapeutic rapport with your patient. A more gentle approach is to simply create a space where patients feel they can share their sexual orientation and gender identity without fear of judgment. There are a lot of ways to provide a safe space for your gender-diverse patients— from wearing pronoun badges (I wear a bi pride “she/ her” button) to simply having LGBTQ+ friendly literature in your waiting areas and exam rooms. Using inclusive language in forms and providing an optional space for patients to share sexual orientation and gender identity if they wish, is a nonthreatening way to gather this important information that can inform their healthcare. For visits that are more centered on gender-affirming care, here are a few tips: • While transitioning can be incredibly hard for youth, it can also be very liberating. It’s okay to be enthusiastically supportive of their gender journey. When someone is able to embrace their true gender
•
•
•
•
and express that to their comfort level, it’s a wonderful thing! Ask what their goals are for their transition and how you can support them in the process — don’t assume hormones or surgery are part of the plan. Check in on support systems — are family and friends supportive? Are there safety concerns at school? Are they in a relationship and do they feel safe? Are they involved in any affinity groups to be in community with other LGBTQ+ youth? While it is important not to make assumptions, gender non-conforming individuals are unfortunately at higher risk for depression, anxiety, and substance use disorders, so routinely screening for these conditions is paramount. Always strive to provide traumainformed care for your patients — for more info, you can complete a workshop through CAFP: https:// www.familydocs.org/aces/
You aren’t expected to have all the answers, but an attitude of openness and humility is an investment in your therapeutic relationship with your patient. These approaches can optimize outcomes for your gender-diverse youth, and they’ll never forget how you made them feel.
References: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2775924 https://www.aafp.org/afp/2018/1201/p645.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034836/
Visit our website at www.vcc.org Forward resume to hr@vcc.org 26
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https://publications.aap.org/pediatrics/article/142/4/e20182162/37381/Ensuring-ComprehensiveCare-and-Support-for https://www.aafp.org/about/policies/all/trauma-informed-care.html
Scott Nass, MD MPA FAAFP AAHIVS Regional Medical Director, MedZed Chief Medical Officer, Transgender Health and Wellness Center
Recognizing LGBTQIA+ Youth in Your Practice As more and more youth have begun to identify along various dimensions of the LGBTQIA+ spectrum, family physicians increasingly are finding themselves encountering these youth in their practices, often accompanied by family members with many questions. According to data analysis by the Williams Institute at UCLA of federal survey responses, 9.5% of the US population aged 13-17 identifies as LGBT; importantly, additional youth may choose not to self-disclose for personal, family, or safety reasons, while others may not recognize yet that they are part of this community. Additionally, federal survey instruments do not include the full breadth of sexual and gender minorities, so youth who are non-binary, queer, pansexual, or asexual — or those who eschew labels — may be less likely to be counted by these surveys. Intersex children and young adults traditionally also have been excluded from national research, despite an estimated 2% of all live births having an intersex trait. Because intersex individuals often are unaware of cosmetic surgeries they had as infants to “normalize” their genitals, puberty can be particularly challenging as some begin to face resultant physical and sexual dysfunction, frequently learning in parallel of their surgical history. In findings from the first
national study of intersex adults, published in 2020, respondents reported a high prevalence of mental and physical health conditions when compared to non-intersex adults. Growing into, and coming to terms with, one’s sexual and gender identity can be challenging, predominantly because of societal pressures, which lead LGBTQ youth to attempt suicide at more than four times the rate of their non-LGBTQ peers. Intersex
youth who identify as LGBTQ have even higher rates of suicidal ideation and attempt than LGBTQ youth who are not intersex. As family physicians, we can incorporate questions of sexual orientation and gender identity easily into our routine HEADSSS assessment (where one “S” stands for “sex, sexual orientation, and gender identity”) and begin to support our young patients for who they truly are.
Conron, K.J. LGBT Youth Population in the United States. (September 2020). The Williams Institute, UCLA, Los Angeles, CA. Fausto-Sterling A. The Five Sexes, Revisited. The Sciences. July/August 2000. Rosenwohl-Mack A, Tamar-Mattis S, Baratz AB, Dalke KB, Ittelson A, Zieselman K, Flatt JD. A national study on the physical and mental health of intersex adults in the U.S. PLoS One. 2020 Oct 9;15(10):e0240088. The Trevor Project. (2021). 2021 National Survey on LGBTQ Youth Mental Health. West Hollywood, California: The Trevor Project. Price, M.N., Green, A.E, DeChants, J.P, & Davis, C.K. (2021).The mental health and well-being of LGBTQ youth who are intersex. New York, New York: The Trevor Project.
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Erika Roshanravan, MD
Trauma-Informed in All We Do “We will apply a trauma-informed lens to all our work.” When the sun settled over the bay at San Diego’s Paradise Point Resort on the second day of the strategic planning retreat of the CAFP’s Board of Directors, this sentence had made its way into the final triennial strategic plan. A momentous occasion, so it seemed to us—what many hold up as a core tenant of modern-day family medicine received the recognition and commitment it deserves amongst the few other guiding principles in our academy’s strategic plan. CAFP, a trendsetting organization in primary care, has pledged to uphold principles of trauma-informed care and walk the talk in all their work. But why do we care about applying a traumainformed lens to our work? What is that really, and why does it matter? The Substance Abuse and Mental Health Services Administration (SAMHSA) defines “trauma-informed” as “an approach [to care] that promotes a culture of safety and empowerment to foster recovery and healing through safe and collaborative relationships.” Trauma-informed approaches have markedly shaped behavioral health approaches, disability communities, school discipline and other aspects of our communities for years. A trauma-informed perspective has not been universally adopted in healthcare, at least not as a concerted, conscious effort. Yet, relationships and collaboration are at the core of the work done in both family medicine and trauma-informed 28
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care. Family physicians are thus uniquely positioned to lead the way to make healthcare a trauma-informed, resilienceoriented and healing place for both patients and for those who care for them. What we know from decades of research is that trauma is highly prevalent, and it is as common in health care staff— including physicians—as it is in our patients. Furthermore, the sequelae of trauma can strongly affect the physical and mental health of all individuals, including health care providers. Perhaps most profoundly, trauma can affect every aspect of an individual’s experience of life, and how they enjoy life and opportunity. As trauma disproportionately impacts disadvantaged communities, it is one of the root causes of inequity. Because of this, the CAFP Board of Directors has made the application of a trauma-informed lens an objective under its strategic goal of “Prioritizing Justice, Equity, Diversity and Inclusion (JEDI).” The CAFP has recognized that family doctors can successfully address JEDI only through a trauma-informed lens. What is structural racism, inequity, and injustice, but forms of trauma to individuals and communities? We family physicians want to dismantle the factors that make our patients unwell, but we must simultaneously be healers who can see through a traumainformed lens what is hurting them. We would argue that ultimately, the trauma-informed lens is an umbrella overarching all of CAFP’s strategic plans. Take another one of the newest CAFP strategic goals into consideration:
“Alleviate Burnout and Support Member Wellness.” For any organization, including the CAFP, being trauma-informed means to consider the wellness of those within the organization just as much as the wellness of those we serve, making this strategic goal truly a core tenant of trauma-informed care. We must care for each other, as much as we care for our patients. That is precisely what CAFP’s trauma informed lens allows us to do. That means being trauma-informed in the way we recruit, employ, and treat our employees and volunteers, in the ways we engage our members, and in the materials we present. It includes presenting members with knowledge and tools so each of us can in turn spread universal education about trauma and trauma-informed approaches in our own lives, our organizations and with our patients. It also means utilizing a trauma-informed lens in all materials we present on any topic, as we have pledged to do with JEDI. Whatever aspect of the CAFP’s work we look at, we will need to reflect on the above questions: Does it promote safety and trustworthiness? Is it transparent and collaborative? Is it empowering and promoting voice, choice, and self-agency? Does it employ cultural, historical and gender humility? Is it centering resilience and strengths to promote healing? As is always the case with new directions and new lenses, the true work is only about to start, but it is truly exciting work.
Shani Muhammad, MD, FAAFP
Childhood Obesity – Among the 21st Century's Gravest Public Health Challenges In September of 2021, the CDC issued a report detailing the effect the COVID-19 pandemic has had on the nation’s rate of pediatric obesity. Compounded by school closures, changes in physical activity, more time in front of a screen and less opportunity for regular physical activity and proper nutrition, and increased food insecurity, the rate of BMI (body mass index) increase among children and adolescents aged 2-19 doubled compared to pre-pandemic rates. This change was seen most prominently in children already overweight or obese pre-pandemic. The factors that contribute to excess weight gain include psychological, social, nutritional, hormonal, medical, genetic, activity, and neurological/sleep issues. These factors must be identified and addressed by Family Physicians to understand pediatric obesity and how to treat it. Initial treatment goals are to reduce risk, improve body composition and self-image, and minimize stigmatization, as well as understand when referral may be indicated and what secondary and tertiary treatments are available. Fast Facts About Childhood Obesity: •
•
•
During the pandemic, the national rate of obesity among kids ages 2 to 19 increased to 22.4% in 2020, up from 19.3% in 2019. In the U.S. childhood obesity alone is estimated to cost $14 billion annually in direct health expenses. The rate of children aged 6-11 living in food insecure homes increased from 11.1% (12/2018) to 23% (5/20)
First Steps After the initial diagnosis of obesity in a pediatric patient in the primary care office, first steps include family-based counseling on dietary changes such as the consumption of 5 or more fruits and vegetables/day, elimination of sugar sweetened beverages, and activity behaviors including less than 2 hours screen time and 1 hour of play or exercise daily. It is important to note that not all children have a safe place to play outdoors regularly and not all schools offer regular access to physical education. Additionally, with the very real threat of school closures and virtual learning secondary to the Covid-19 pandemic, it is important that family physicians remember to be creative with options for activity that can be done indoors and counsel appropriately. Overall Management Goals of Pediatric Patients with Obesity Obesity has different immediate risks in children and teens than adults and as such, should have appropriate management foci. Family Physicians should work with parents and children on developing healthy lifestyle habits and patterns that they can continue through adulthood. Quality of life is often impacted in children with obesity and may be affected by limitations in physical activity, weight stigmatization, experiencing bullying, and by health consequences such as sleep disturbance or metabolic conditions. Children and teens with obesity are more likely to suffer from depression, anxiety, and low self-esteem. Physicians can help to
improve health and quality of life beginning with screening for mood and social problems and by addressing family/friend support for healthy eating. Improving body composition is an obvious goal of overall management which can come both from limiting further weight gain or promoting actual weight loss. It is also important to prevent future health consequences with appropriate screening based on age and risk factors and implementing treatment when indicated. A key part of an evaluation for children with obesity includes screening for conditions such as hypertension, diabetes and pre-diabetes, sleep disorders and where indicated, lipid disorders. Secondary and Tertiary Interventions Behavioral health and nutrition referrals should be initiated or offered in the primary care office if time and experience allow. Family physicians should be equipped to offer behavioral counseling and it is well within their scope to do this. Behavior therapy should use patient centered empathetic behavior change approaches such as motivational interviewing. The approach should be collaborative with the parents and patients to achieve their goals and to address barriers to change. These discussions should also allow for personal family choices and consideration and respect for cultural norms and beliefs about foods, significance of family meals, and body size feelings/norms. When a child is not successfully maintaining their weight as they grow or is failing to lose weight when it is indicated, staged secondary continued on page 30
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continued from page 29
and tertiary interventions may include referral to a pediatric weight management clinic, if one is available locally. In certain patients there may also be an indication for weight loss medications or bariatric surgery as adjunctives to care.
their challenge is not a lack of food quantity but rather, having dependable access to high quality food. It is therefore important to include food insecurity and social determinants of health in obesity treatment.
Finally, while outside the scope of this article, it is important for Family Physicians to recognize that there are genetic disorders and other rare genetic variants that can cause obesity in children and referral for genetic testing should be provided for any child that seems to have unusually high adipose tissue composition.
A fast and effective way to address this in the office is by asking two simple questions:
Hunger and Obesity Can and Do Co-exist It is important to remember that obesity does not exclude food insecurity or poverty. The social determinants of health including socioeconomic status, food insecurity, and more are correlated with obesity and need to be considered in the treatment plan of any child with obesity. The picture of food insecurity is increasingly becoming that of a child with obesity consuming a poor-quality diet. The highest rates of obesity are found in people with the lowest income and
1. Within the past 12 months, we worried whether our food would run out before we got money to buy more. (Yes or No) 2. Within the past 12 months, the food we bought just didn’t last and we didn’t have money to get more. (Yes or No) A “yes” response to either question is a positive screen and should prompt referral to community resources that address food insecurity such as WIC, SNAP, summer meals, food pantries etc. Additional resources can be searched by zip code or city at the AAFP’s Everyone Project’s Neighborhood Navigator. Obesity is a relapsing and chronic disease that continues to rise in the pediatric population. As Family Physicians it is important that we understand the
multifactorial nature of obesity, including the social determinants that play a role. Having a plan for initial and secondary management of a child with obesity will aid in successful management of this chronic disease. References 1.
Schanzenbach, D., Pitts, A., How Much Has Food Insecurity Risen? Evidence from the Census Household Pulse Survey, NW Institute for Policy Research Rapid Research Report, June 10, 2020. https://www.ipr.northwestern. edu/documents/reports/ipr-rapid-researchreports-pulse-hh-data-10-june-2020.pdf
2. Lange S, Kompaniyets L, Freedman D, Kraus E, Porter R, Blanck H, Goodman A. Longitudinal trends in body mass index before and during the COVID-19 pandemic among persons aged 2-19 Years, United States, 2018–2020. Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, 9/17/2021. https:// www.cdc.gov/mmwr/index.html. 3. Cuda S, Censani M, Joseph M, Browne N, O’Hara V. Pediatric Obesity Algorithm, presented by the Obesity Medicine Association. www.obesitymedicine.org/childhood- obesity. 2018-2020. www.obesitymedicine.org/ childhood-obesity. 4. From Crisis to Opportunity: Reforming Our Nation’s Policies to Help All Children Grow Up Healthy, Robert Wood Johnson Foundation, October 13, 2021. https:// stateofchildhoodobesity.org/
Resources AAFP Obesity Resources: https://www.aafp.org/afp/topicModules/viewTopicModule.htm?topicModuleId=19 AAFP EveryOne Project: Address Your Patients' Social Determinants of Health: https://www.aafp.org/family-physician/patient-care/the-everyone-project/toolkit/ assessment.html AAFP’s Neighborhood Navigator: https://www.aafp.org/family-physician/patient-care/the-everyone-project/neighborhood-navigator.html World Obesity Federation: Healthy Voices Infographics: https://www.worldobesity.org/downloads/healthy_voices_downloads/Childhood_Obesity_1.pdf https://www.worldobesity.org/downloads/healthy_voices_downloads/Childhood_Obesity_2.pdf CDC: Childhood Obesity Healthcare - https://www.cdc.gov/obesity/strategies/healthcare/index.html https://www.cdc.gov/vitalsigns/pdf/2013-08-vitalsigns.pdf UpToDate: https://www.uptodate.com/contents/prevention-and-management-of-childhood-obesity-in-the-primary-care-setting Change Talk: ChangeTalk: Changing the conversation about childhood obesity. Available free of charge at: https://go.kognito.com/changetalk Obesity Medicine Pediatric Obesity Resources: https://obesitymedicine.org/clinician-resources/pediatric-obesity-resources/ CDC Report: Longitudinal Trends in Body Mass Index Before and During the COVID-19 Pandemic Among Persons Aged 2–19 Years — United States, 2018–2020 https://www.cdc.gov/mmwr/volumes/70/wr/mm7037a3.htm?s_cid=mm7037a3_w 30
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TARGETED ADVERTSING
MD/DO Medical Director Needed for a Rural FQHC
MEDICAL PROFESSIONAL FOR THE
(Federally Qualified Health Center)
Join us to provide health care services in a Federally Qualified Health Center (FQHC) located in California’s beautiful western sierras. Shingletown is a small town located along California State Route 44 in the mountains just below Mount Lassen. We are also known as “The Gateway to Lassen”. Work as an integral part of our provider staff by participating in our medical/behavioral health team, QA/QI and additional staff teams. Will also perform supervision of PA/NP staff.
Benefits:
• Regionally competitive salary, health benefits and voluntary
retirement plan we’ ve got the • Employment bonus and moving allowance
RIGHT STUFF
• Proposed schedule will consist of three 10-hour days (8:30am -7:00pm with half hour lunch) • Paid bereavement and jury duty leave, holidays, sick/vacation time • CME reimbursement • Company provided malpractice insurance for all providers Contact • No after hour call required
Advertise HERE Michelle Gilbert at 501-725-3561 If you are interested in additional information or are
Advertise HERE Contact Michelle Gilbert at 501-725-3561
mgilbert@pcipublishing.com
mgilbert@pcipublishing.com the right candidate for this position please contact
Advertise HERE Michelle Gilbert dhighfill@shingletownmedcenter.orgContact or at 530-474-3390 501-725-3561 Denise Highfill, Chief Operations Officer at:
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TULARE COUNTY HEALTH & HUMAN SERVICES AGENCY
MEANING. SATISFACTION. IMPACT.
If you’re searching for a profession with meaning, that gives you job satisfaction and where you can make an impact on others’ lives, consider Tulare County Health and Human Services Agency(HHSA). We are actively recruiting for multiple vacancies for Physicians, Nurse Practitioners, and Physician Assistants to work in our Health Care Centers and adult Mental Health Clinics. These offer a progressive and innovative working environment and provide comprehensive health care in the community. Our employees are driven by the desire to help people, and they take pride in providing assistance to others to cope with the challenges of life and finding a solution.
Visit our website at http://tularecounty.ca.gov/hrd to obtain more information regarding the various career opportunities Tulare County HHSA has to offer! California Family Physician Winter 2022
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VA Sierra Pacific Network
Serving Veterans in Central and Northern California, Nevada, Hawaii the Philippines and US Territories in the Pacific Basin.
Whether your a new graduate or an experienced professional, physicians are always needed at the VA. Our Northern and Central California locations have a lot to offer those seeking good weather and an abundance of outdoor activities such as hiking, snow skiing, boating, hunting and fishing. Enjoy the area’s beautiful rural settings with access to many national parks, rivers, and lakes at your fingertips. Whether you’re interested in work/life balance, research or academics you will find that working for the VA offers many benefits not to mention the great honor we have in serving our nation's heroes. Opportunities in our system of clinics in/around: San Francisco (4 locations), Palo Alto, Susanville, Sacramento, *Yuba City and *Redding
You could be part of an important initiative to provide quality medical care for our nations Veterans! The Department of Veterans Affairs (VA) needs primary care professionals who possess the energy, compassion, and commitment to serve those who served our Country. Whether you serve as a Staff Physician or *Supervisory Physician, every position in VA will give you a chance to make a meaningful and personal contribution to the lives of truly special and deserving people - our Veterans. America's Veterans need you! Candidates must: 1) be a US citizen or PRA (Non-citizens may be appointed when it is not possible to recruit qualified citizens in accordance with [38 U.S.C. § 7407(a)]; 2) possess a current, full, unrestricted medical license in any state; 3) board prepared/certified in Family or Internal Medicine; and 4) Participate in the seasonal influenza and Coronavirus Disease 2019 (COVID-19) Vaccination programs as required for all Department of Veterans Affairs Health Care Personnel (HCP) Benefits: Paid vacation; Paid sick leave; 11 paid Federal holidays/Competitive Salary/Malpractice protection with tail coverage/Annual Physician Performance Pay/Paid authorized absence to attend CME if BC/No Physician Employment Contract or significant restriction on moonlighting To apply, make an inquiry and/or receive information on benefits, please forward a current CV to:
V21HealthcareRecruiters@va.gov
Education Debt Reduction Program (up to $200,000/tax-free over 5-years) and/or Recruitment Incentive may be available for highly qualified candidates.
ceo message
Lisa Folberg, MPP
Health Care System Transformation as an Eight-Track Player As we have said goodbye to 2021 and welcome 2022, I am feeling hopeful. More aptly put, I have concocted a mental stew of hope, with the natural bitterness of skepticism balanced by a sprinkle of faith. As I write this, the Omicron variant has made its debut in the U.S., right here in California, but I am still hopeful that the worst of COVID is behind us. I am also optimistic that we can take some of the forced change that came from the pandemic and turn it into a lesson about how to do better. I hope that rather than having to spend our time defending against misinformation and new viruses, we will build on lessons learned during the pandemic, including the importance of centering our health care system around a value-based, primary care-centric structure. There has been some important movement to that end. Earlier this year the National Academies of Sciences, Engineering and Medicine (NASEM) released a report, Implementing High Quality Primary Care: Rebuilding the Foundation of Health Care. This report is emphatic that a strong primary care-focused system is foundational to a well-functioning health care system. It characterizes primary care as a public good that must receive public and governmental funding and support. Specifically, the report recommends an implementation plan for high-quality primary care including; paying for team-based care based on outcomes not volume, expanding access to high-quality primary care and ensuring primary care providers are trained in the environments in which they practice. The report emphasizes the importance of primary care and stresses how under-resourcing is resulting in a dysfunctional health care system. The report notes that, “people in countries and health systems with high quality primary care enjoy better health outcomes and more health equity.” One problem that has eroded access to high-quality primary care in the United States is certainly lack of resources. Primary care accounts for 35 percent of health care visits while making up just five percent of health care expenditures. However, as the NASEM report documents, fixing our system to put more emphasis on primary care isn’t only about how much we pay, but how we pay, as well as how health care providers are trained. The report was being drafted as the COVID 19 pandemic hit. Sadly, the pandemic served to highlight problems with a system that is based on paying for volume
of services. These problems including health inequities, and a financially shaky primary care foundation. There is often a misunderstanding, particularly in a highly capitated state like California, that we have largely moved away from a volumebased system. Often the intent of the contracted model has been manipulated such that providers are still paid based on what is essentially a fee-for-service basis. Your AAFP and CAFP have been advocating for changes that move us toward a value-based primary care-centric system for decades. Others have joined the band. CAFP has been working with Covered California, Blue Shield and others to move away from a specialty-driven fee-for-service model. Last year CAFP sponsored legislation, SB 402 (Hurtado) to bring together health care payers and purchasers, primary care providers, and health care consumer representatives to collaborate on the establishment of multi-payer payment reform pilots in areas hardest hit by COVID-19, particularly in regions wherein the impact has been greatest among minority and marginalized communities. The pilots would use uniform value-based payment methods, a common set of quality measures, and a standardized means of reporting. The legislation worked its way through the legislative process unopposed, ultimately getting hung up on cost in the Appropriations committee. Family physicians have often been at the forefront of embracing system change by being willing to adopt new quality improvement measures, technology and payment models. However, new payment structures and quality improvement programs have bred some understandable skepticism. You have been promised new programs that will change the health care system before. As I think about the history of health care payment and quality improvement programs, I am reminded of the history of music listening devices. I remember driving with my parents as they shoved a Beach Boys eight-track cassette in the car stereo. Eight tracks were the thing that were going to change the way we listened to music forever. Eight-tracks were quickly replaced by cassettes and then CDs. Music listeners were told CDs were the answer to everything… portable, light, and scratch resistant. I believed it until I put my Digital Underground CD in my new continued on page 34
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bright yellow CD-Walkman and went for a jog, which quickly slowed to a careful walk to keep it from skipping. I treaded cautiously through MP3 and iPods, knowing these too would likely be just another stop to music listening nirvana. As applied to health care systems, it is easy to wonder if new programs and efforts may go the way of the eight-track player. Policy makers know we need to make it better, but they don’t quite get it right.
Help Your Patients Make Better Informed Decisions About Their Care The California Prostate Cancer Coalition, founded in 1997 as a 501(c)(3) not-for-profit organization, is dedicated to savings men’s lives www.prostatecalif.org https://naspcc.org/docs/informed-decision-9-11-17.pdf www.naspcc.org
Of course, healthcare is not music listening. Health care spending continues to gobble up GDP and families’ incomes, and access remains intractably unequal. Primary care is the way to achieve the multiple aims of lowering system cost, improving quality, expanding access, preventing provider burnout, and improving health equity. As the NASEM report notes, “primary care is the only health care component where an increased supply is associated with better population health and more equitable outcomes.” While we have seen efforts at reform come and go, I am hopeful we are in a unique moment of opportunity for system transformation. Your CAFP will continue to lead the effort for a value-based, primary arc centric system in 2022. I remain hopeful that soon we will be standing on the precipice of change looking back on the way things were and forward to a future system that costs less, has better patient outcomes and experience, provides better and more equal access, and helps keep the joy in medicine.
The Ventura County Medical Center Addiction Medicine Fellowship has 1 remaining opening for a fellow to start 8/22. We are a full spectrum ADM training program that covers SUD management in the NICU, L+D, clinic, residential treatment, and hospital consult service. Come train in sunny Southern California! Please contact Paula Areias for more information: Paula.Areias@Ventura.org https://www.venturafamilymed.org/addiction-medicinefellowship 34
California Family Physician Winter 2022
Family Medicine Physician Job Opening Position Summary:
UCI Family Medicine, a Department of the University of California-Irvine School of Medicine, is committed to upholding the highest professional and institutional standards. We thrive by promoting optimal health for patients, staff, trainees, and faculty. UCI Family Medicine provides clinical services for patients of all ages in a variety of settings as follows: Family Health Centers (federally qualified health centers or FQHC’s) in Santa Ana and Anaheim; Gottschalk Plaza; Senior Health Center; skilled nursing facilities; inpatient services and obstetric deliveries at the UCI Douglas Hospital in Orange. UCI Family Medicine provides education across a variety of programs including undergraduates; medical students; family medicine residents; fellows in geriatrics and sports medicine; and outreach to the community. We are seeking a qualified individual who is an excellent clinician with a strong commitment to clinical leadership, quality improvement and teambased patient care. The incumbent in collaboration with the Executive Medical Director (EMD) of the Federally Qualified Health Center (FQHC), will direct, coordinate, and implement the QI Program for the Federally Qualified Health Center and function as the Anaheim Site Medical Director. The incumbent will collect, manage, and analyze FQHC quality data and prepare quality reports for review. Incumbent will have practical knowledge and skills in Continuous Quality Improvement, including analysis and interpretation of data using computer based disease registries or similar data collection systems is essential. The incumbent reports directly to the EMD and to the Department Chair.
Essential Job Functions:
• Provides clinical expertise and leadership while assisting in the development, monitoring, and presentation of internal quality measures and initiatives. Disseminates QI performance to clinical staff team on a regular basis. Adheres to all UCI FQHC Policies and Procedures. • Leads and participates in Quality, and ad hoc meetings as directed by the EMD. Assists with coordination of monthly QI Meetings. Communicates FQHC initiatives to department members to ensure adequate understanding. Assists department medical directors to prepare QI reports and statistics. • Provides leadership by focusing teams and organization units on visions and distinctive strategies that result in excellent short and long-term performance. This includes coordinating, tracking, and reporting of clinical outcomes. Assist with annual UDS and HRSA reports and ensures timely completion of corrective action plans related to quality. • Reviews incident reports from the Safety and Quality Information System (SQIS) as well as patient grievances and conducts follow up investigations as warranted. • Collaborates with the FQHC Executive Medical Director in the investigation of clinical events including sentinel events, sentinel event near misses, and significant adverse events; leads and/or participates in the development of root cause analyses. • Oversee all aspects of patient care services at FHC Anaheim with the site Practice Manager to assure that the medical care provided is of highest quality and standards and consistent with all accreditation and licensure requirements. • Provide leadership, oversight, and supervision of all physicians and allied health care providers working at the site. • Serve as the medical liaison with outside referring physicians to facilitate inter-institutional transfers.
Requirements:
• Family physician; board-certified, full-scope ambulatory health care services including care of children, adults and the elderly. • Experienced in providing and/or oversight of pre-natal care. • Demonstrated experience in quality improvement to improve patient outcomes • Leadership skills; ability to motivate, inspire, communicate with faculty, residents, staff, and peers to maintain a professional, team-based approach in the care of patients. • Proficiency in Spanish
Compensation Range:
Commensurate with Experience
Link to Apply:
https://careersucirvine.ttcportals.com/jobs/7529484-staff-physician Note: Applicant may be eligible to apply for loan repayment.
CALIFORNIA ACADEMY OF FAMILY PHYSICIANS 1520 PACIFIC AVE SAN FRANCISCO, CA 94109 -2627
Presorted Standard U.S. POSTAGE PAID
Fayetteville, AR Permit No. 986
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