July, 2023

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The Positive Impact of Direct Primary Care on Employer Healthcare Spending

Plum Health

In the ever-evolving landscape of healthcare, Direct Primary Care and Subscription-based Primary Care are emerging as promising models that could significantly benefit both employers and employees. Studies conducted by the Society of Actuaries (SOA) and Milliman provide valuable insights into these new models of healthcare delivery and financing. DPC and Subscription-based Primary Care are healthcare delivery models where a provider offers unlimited specified routine healthcare services for a mo

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Proactive Wellness: The Lifesaving Benefits of Regular Check-ups 

East Cary Family Physicians

In the hustle and bustle of daily life, it’s easy to put our health on the backburner. However, the adage “prevention is better than cure” couldn’t be truer when it comes to our well-being. Regular health check-ups are a cornerstone of preventive healthcare, allowing us to catch potential health issues early and maintain a better quality of life.

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Introduction to Antimicrobial Stewardship with Audry Hawkins and Sarah Moore

Louisville Lectures

In this introduction to antimicrobial stewardship, Audry Hawkins first lists untoward effects of antibiotic use. She then describes antibiotic stewardship principles, goals, and strategies. After, she recognizes changes in the regulatory roadmap and national landscape of antimicrobial stewardship over the past few years, including requirements for accreditation for stewardship programs.

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Nutritional Supplements for Robust Immunity

Altitude Family & Internal Medicine

Altitude Family & Internal Medicine (303) 730-2167 Nutritional Supplements for Robust Immunity Nutritional Supplements for Robust Immunity Thanks for watching one of our most popular webinars. Today Dr. Hansen discussed the specific nutritional supplements that he uses to keep his immune system. This post Nutritional Supplements for Robust Immunity first appeared on Altitude Family & Internal Medicine (303) 730-2167 and is written by Doug Hansen.

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Episode 295: Rafael Medina Subspecialty Series – fatigue in patient living with HIV

The Clinical Problem Solvers

[link] In this Infectious Disease Rafael Medina Subspecialty episode, Dr. Jorge Salazar presents a case to Dr. Monica Gandhi of a transgender woman with a recent diagnosis of HIV presenting with fatigue and weight loss. Session facilitator: Maddy Conte The goal of this series is to expand access to subspecialty, primary care, and internal medicine-adjacent specialty education to learners around the world.

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Maine CDC Health Advisory - Locally Acquired Malaria in US

Maine Academy of Family Physicians

In Maine, Anopheles mosquito vectors are present. While the risk in Maine remains low, it is possible for local mosquitoes to acquire Plasmodium spp. parasites from an infected person and transmit the parasite to a susceptible, non-infected person. Providers should encourage confirmed and suspected patients with malaria to avoid activities that would put them in contact with local mosquitoes.

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Burn Out or Run Out? Considering the role of AI in Healthcare

University of Utah Family Medicine Residency

by Misha Fotoohi, MD Burnout is a growing concern among healthcare professionals, particularly those in primary care. Factors such as heavy workloads, excessive administrative tasks, and the emotional toll that accompanies caring for our patients can contribute to this issue. With the advancement of artificial intelligence (AI), there is a rising interest—as well as some … More Burn Out or Run Out?

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Fracture Fridays: Keeping up with the Joneses

PEMBlog

The case A self-proclaimed dance team superstar presents after injuring her foot at a regional competition. She tried to finish the routine after landing awkwardly. But was having difficulty bearing weight. She applied ice overnight and despite ibuprofen is still in pain, and presents to the ED the next day.On her exam the neruovascular exam is normal, and she has pain along the proximal edge of the 5th metatarsal.

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Sleep problems and Insomnia in Serious Illness: A Podcast wtih Cathy Alessi and Brienne Miner

GeriPal

Summary Transcript Summary Insomnia. We’ve all had it. Lying in bed at 2 am staring at the ceiling, getting anxious every hour that you’re not falling asleep as you have a busy day coming up. Insomnia sucks. Chronic insomnia sucks even more. For those with serious illness, sleep problems and insomnia are all too common. Instead of reflexively jumping to melatonin or ambien, on today’s podcast we talk with two sleep experts, Cathy Alessi and Brienne Miner, about a better approach to sleep

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Episode 294: Schema Episode – Mediastinal Mass

The Clinical Problem Solvers

[link] Maddy presents a case to Jack, Sharmin , and Ann Marie of a patient who is found to have a mediastinal mass on imaging.

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Don’t take it personally

Blood, Sweat, and Tears

Calls are like public toilets. You either open the lid and see a squeaky clean bowl or a sh*t show. There’s often nothing in between. I didn’t realise it when I had this thought, but it’s true. I was in a situation where I witnessed 2 colleagues having a heated discussion. The argument was born out of which speciality a patient belonged to, at 3am.

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Benefits of a Single-Payer System

University of Utah Family Medicine Residency

by Caitlin Henry, MD As family doctors, we work hard to make sure their patients are well cared for. A single-payer healthcare system, which provides equally accessible care for everyone, could be a huge boost to this mission.

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The Active Ingredient Stands Alone

FDA Law Blog

By Sara W. Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme. While it is exceedingly obvious that some products, like eyeshadow for example, are cosmetics, or a pacemaker is a device, it can get thorny where the disti

IT 95
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NSAID or *NSYNC? Music as an Analgesic - Clinical Correlations

Clinical Correlations

By Mikaela Belsky Peer Reviewed As I walked out of Bellevue, I plugged in my headphones and clicked shuffle. Minutes later, I passed a friend who was confused.

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How to replace a gastrostomy tube

PEMBlog

The original post was authored by Ashley Endres in 2018. this is an updated version for July 2023 Replace a G-tube Gastrostomy tube dislodgment and malfunction are top causes for G-tube related ED visits in pediatric patients so it is important to understand how to replace a G-tube. Gastrostomy tubes can be placed surgically or endoscopically. It is important to determine how the G-tube was placed and how long ago.

IT 52
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IMG VMR Navigating the US Match – July 14, 2023

The Clinical Problem Solvers

[link] speaker: Dr.

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How State and Local Agencies on Aging Help Older Adults: Susan DeMarois, Greg Olsen, and Lindsey Yourman

GeriPal

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Is your brain hurting yet with all these questions?

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Pep Talks for My Former Self

University of Utah Family Medicine Residency

by Katie Myrick, MD Family medicine residency is hard. Turns out, learning how to be a good doctor for all types of patients and disease processes doesn’t come easy. Here are some notes on how to navigate some of the challenges I encountered in the process.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% t

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FDA Considers Changing Its Nitrosamine Targets as Global Focus Continues

FDA Law Blog

By John W.M. Claud & Sara W. Koblitz — We need to talk about nitrosamines. Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What are nitrosamines? Nitrosamines are chemicals that can form during drug manufacturing, known by their scientific names as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminob

IT 52
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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

By Sara W. Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA. This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority

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ACI’s 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA – October 10-26, 2023 (Virtual)

FDA Law Blog

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials AND a critical competency for legal and business professionals in the biopharmaceutical arena AT THE American Conference Institute’s (ACI’s) 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA ! Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series from October 10-26, a virtual three-week program designed to provide new lawyers and executives for the life sciences industry with a solid foundation

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OPQ’s 2022 Report Shows the Global Task of Ensuring Quality

FDA Law Blog

By John W.M. Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. Among its top priorities, OPQ’s Director Mike Kopcha has recently said that OPQ is focused on quality problems that contribute to drug shortages.

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Finalizing the Quality Management System Regulation – A High Priority for End of 2023

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ).

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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog

By Kalie E. Richardson & Karla L. Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 5

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3 in 1 Guidance Issued by FDA Covering Formal Dispute Resolution, Administrative Hearings and Consolidated Proceedings for OTC Monograph Drugs

FDA Law Blog

By Deborah L. Livornese — On June 23, 2023, FDA issued a draft guidance for industry – Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act (the Monograph FDR Guidance) – to fulfill another commitment agreed to in support of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act)(see our blog posts here , here and here about the CARES Act and OTC monograph reform).

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To All the Things that Got Me Through

University of Utah Family Medicine Residency

by Katie Myrick, MD A compilation of ‘thank yous’ for a few of the things that got me through the last 3 years. To my husband, Wood: Thank you for everything you have done in and around our home.

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Management Reasoning VMR – July 15, 2023

The Clinical Problem Solvers

[link] presenters & discussants: Noah & YoussefCase details & teaching points: Here

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Episode 296 – RLR – A curious case of cough

The Clinical Problem Solvers

[link] Episode description RR discuss a grounding case of chest pain Student discount [link] IMG discount Use coupon code RLRIMG at check out [link]

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Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

GeriPal

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Today we discuss a new paper in JAMA that tests a stripped down version of the clinician only facing intervention in a pragmatic randomized trial for older adults with serious illness and those 80+.

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Telemedicine in a Post-Pandemic World: Joe Rotella, Brooke Calton, Carly Zapata

GeriPal

Summary Transcript Summary There’s a saying, “never let a crisis go to waste.” The pandemic was horrific in many ways. One positive change that came about was the lifting of restrictions around the use of telemedicine. Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic.