August, 2023

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How will AI and ChatGPT impact concierge medicine?

SignatureMD

One of the latest breakthroughs affecting the well-being of society may not have originated in a lab, but it could affect the health and practice of medicine as we know it. It’s an artificial intelligence (AI) chatbot known as ChatGPT. This is more than a trendy app; ChatGPT is a form of generative AI that […] The post How will AI and ChatGPT impact concierge medicine?

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Introduction to Diagnostic Stewardship with Ryan Doster and Audry Hawkins

Louisville Lectures

In this presentation, Dr. Ryan Doster gives an introduction to diagnostic stewardship after last week's discussion on antimicrobial stewardship. After, Audry Hawkins, PharmD, BCIDP, returns to give an overview on blood culture. Click here for a lecture on Antimicrobial Stewardship. Watch on YouTube Listen as a Podcast Watch more lectures about Internal Medicine Audry Hawkins, PharmD, BCIDP Ryan Doster, M.D., Ph.d.

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Understanding Heat Stroke: Symptoms and Essential Solutions

Doctor On Demand

As the summer sun blazes on, it’s imperative to grasp the potential risks linked with soaring temperatures. Among the grave heat-related conditions, heat stroke stands out as a medical emergency demanding swift attention. Familiarizing yourself with heat stroke symptoms and exploring various solutions, including the option of consulting an online doctor , can prove pivotal in averting severe consequences.

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Adult Attention-Deficit/Hyperactivity Disorder (ADHD): Current Treatment and Follow-up Recommendations 

University of Utah Family Medicine Residency

by Leila Noghrehchi, MD Currently many psychiatrists are struggling with the ability to take patients with newly or undiagnosed ADHD into their practices due to schedule congestion with maintenance and follow-up appointments. Many primary care providers (PCP) continue to be wary of prescribing stimulants due to concerns of misuse and cardiovascular risk.

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Episode 297: WDx #24 – Clinical Unknown Discussion with Dr. Casey Albin

The Clinical Problem Solvers

[link] In this episode of WDx, Dr Casey Albin joins Kiara, Jane, & Sharmin to discuss a clinical unknown. Presented by Kiara, the case starts with the chief concern of difficulty recognizing family members. Casey Albin , MD is an Assistant Professor at Emory University School of Medicine where she is a member of the department of Neurocritical Care.

Clinic 52
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How Does Amazon Clinic Compare with Direct Primary Care?

The Direct Doctors Difference

​Just when we thought Amazon had already conquered all the industry spaces, they have recently come out with a new health offering. According to their site’s tagline, they can “quickly treat common conditions with 24/7 video visits and messaging with a clinician. Upfront pricing. No appointments, and no insurance needed.” Sounds a lot like Direct Primary Care, doesn’t it?

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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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Should We Be Prescribing Cookware? A Potential Intervention for Iron Deficiency Anemia - Clinical Correlations

Clinical Correlations

By Marie T. Mazzeo Peer Reviewed Anemia poses a significant threat to public health and affects approximately 2 billion people, nearly one-quarter of the world’s population.1,2 Iron deficiency is the most common cause of anemia worldwide and is the most common nutrient deficiency. 1,2.

Clinic 59
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Best Mistake I’ve Ever Made

University of Utah Family Medicine Residency

by Siri Loken, MD Intern year is notorious for its steep learning curve.

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Episode 299 – Neurology VMR – Clumsiness

The Clinical Problem Solvers

[link] Episode 299: Neurology VMR – Clumsiness Episode description : We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, María presents a case of clumsiness to Andrea and Sridhara. Neurology DDx Schema Andrea Mendez Colmenares @andreamendez92 Andrea is a Venezuelan medical doctor and cognitive neuroscientist specializing in advanced white matter imaging.

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You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

PEMBlog

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. The Choosing Wisely Pediatric Emergency Medicine Recommendations The Choosing Wisely Campaign Toolkit Expert Contributors Michele Nypaver, MD University of Michig

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GMP Update: CDER Official Explains, Advises, and Predicts

FDA Law Blog

By Douglas B. Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. He talked about regulatory discretion being exercised for drug manufacturing facilities with serious compliance problems, about how firms should respond to FDA inspectional observations, and about an upcoming guidance that will be of

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Skin Tag Removal at Plum Health DPC

Plum Health

View this post on Instagram A post shared by Paul Thomas MD (@plumhealthdpc) Skin tag on the bra line - ouch! And irritating 😠 Many women have skin tags along the bra line and many men have skin tags on the belt line that get irritated 😤 when taking off and putting on clothing Sometimes they can bleed 🩸 and sometimes they can be painful. Overall, it’s just a nuisance.

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The Rise and Fall of “MONA BASH” - Clinical Correlations

Clinical Correlations

By Galen Hu Peer Reviewed It seemed like everyone I spoke to about heart attacks during my clinical year of medical school had a different opinion on the famous mnemonic “MONA BASH”: Morphine Oxygen Nitrates Aspirin/Anti-platelet Beta-blocker Angiotensin-converting enzyme inhibitor/Angiotensin receptor blocker Statin Heparin Having.

Clinic 52
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Amyloid Antibodies and the Role of the Geriatrician: Nate Chin, Sharon Brangman, and Jason Karlawish

GeriPal

Summary Transcript Summary It’s been over two years since one of the worst product launches of all time – Aduhelm (aducanumab). Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”.

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Episode 298: Spaced Learning Series – Nausea, Vomiting, & Abdominal Pain

The Clinical Problem Solvers

[link] Episode description: The spaced learning series team discusses a case of nausea, vomiting and right upper quadrant pain in a pregnant patient.

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Announcing a new 5 part comprehensive education series featuring the Pediatric Emergency Medicine Choosing Wisely recommendations

PEMBlog

Staring this week, and continuing for the next five, we will be releasing new content supporting the key Pediatric Emergency Medicine recommendations of Choosing Wisely. I have partnered with world experts on the subject matter, and we’ve been developing this series over the past several months. There will be episodes of PEM Currents: The Pediatric Emergency Medicine Podcast, blog posts here on PEMBlog, articles from Don’t Forget the Bubbles , videos, and more!

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FDA Sets a Recommended Framework for Predicting the Mutagenic and Carcinogenic Potential of Nitrosamine Drug Substance-Related Impurities

FDA Law Blog

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs that may be nitrosamines, even having a deviation in pH of an Active Pha

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How a Family Care Physician Can Save Your Life

Hitchcock Family Medicine

According to Healthcare IT News, just 67% of millennials have a primary care physician. Yet, it is an invaluable service. In fact, there are several ways that a family care physician can save your life. From treating personal injuries to helping prevent disease, your physician can do more things than you realize. There are several ways in which they can save your life.

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The Vital Role of Sports Physicals for Young Athletes

East Cary Family Physicians

Participation in sports and physical activities offers numerous benefits, from improved cardiovascular health to enhanced mental well-being. To ensure a safe and healthy experience, it’s crucial to prioritize sports physicals for athletes of all ages. As your trusted family physicians, we understand the significance of ensuring your child’s health and safety before they dive into the world of school sports and physical activities.

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Normalcy, Introspection, & the Experience of Serious Illness: Bill Gardner, Juliet Jacobsen, and Brad Stuart

GeriPal

Summary Transcript Summary How do people react when they hear they have a serious illness? Shock, “like a car is rushing straight at me” (says Bill Gardner on our podcast). After the shock? Many people strive, struggle, crawl even back toward a “ normal ” life. And some people, in addition or instead, engage in deep introspection on how to make meaning or live with or understand this experience of serious illness.

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Episode 300: Schema Episode – Cytopenias

The Clinical Problem Solvers

[link] Jack, AMK , and Maddy discuss their approaches to cytopenias and DVTs as they talk through a case presented by Sharmin. Frameworks: Pancytopenia Thrombocytopenia Download CPSolvers App here RLRCPSOLVERS Click here to view the weekly episode recap email!

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A podcast about Henoch–Schönlein Purpura (HSP)

PEMBlog

Henoch–Schönlein Purpura (HSP) is a common vasculitis seen in younger children. The classic skin finding is palpable purpura in gravity dependent areas of the body (buttocks and legs). Children can also have arthralgias, abdominal pain and intussusception, and even nephritis. Learn about the diagnosis and management of Henoch–Schönlein Purpura (HSP) in this brief podcast episode.

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Wearables, Sensors, and Apps Part 2 – Development and Qualification of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. Earlier this year, FDA hosted a public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review , intended to bring together key stakeholders, such as patie

Clinic 59
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August Back to School Month

Family Physicians of Greeley

As the summer winds down and we get ready to go back to school, it is important to remember to schedule your child’s back-to-school wellness visit. And if your child is going to participate in school sports, they will need a sports physical. All our providers are available to deliver these important services for you, your infants, children, and adolescents!

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Saving lives?

Blood, Sweat, and Tears

Sometimes I feel like I am living my life in slow motion, in reverse procession. I could be doing a random act and thoughts from 5 years ago surface. I brush it off as a random memory but quickly feel depth in it. It means something. I guess you can’t process your life if you’re constantly in survival mode. Your goal is to survive, everything else is a distraction.

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Dignity at the End of Life: A Podcast with Harvey Chochinov

GeriPal

Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. You’d imagine that as a seasoned palliative care doc, I’d have a pretty good definition by now of what “maintaining dignity” or “loss of dignity” means, but you’d be sadly wrong. Well that all changes today as we’ve invited the world’s foremost expert in dignity at the end of life, Dr.

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Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

FDA Law Blog

By Karla L. Palmer — On Friday, August 25, 2023, FDA released a much-anticipated Final Guidance titled, “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act,” addressing FDA’s implementation of certain electronic interoperability provisions of the Drug Supply Chain Security Act (DSCSA), which were due to become effective on November 27, 2023.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — As part of FDA’s Prescription Drug User Fee Act (PDUFA) VII goals published in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027 (PDUFA Goal Letter), which we blogged about here , FDA included a goal for enhancing use of digital health technologies (DHT) to support drug development and review.

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Pharmacies Selling PSE: Remember to Train Employees and Self-Certify

FDA Law Blog

By Larry K. Houck — Last week the U.S. Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). Austin Pharmacy to Pay $200,000 in Civil Penalties for Alleged Violations of the Controlled Substances Act, Aug. 16, 2023 ( DOJ Press Release ).

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OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

FDA Law Blog

By Dara Katcher Levy — Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again! OPDP is back in the game, letting all the people know that they are back to run the show. In what may be the surprise “ Warning Letter of the Year ” (can you tell this blogger was pretty shocked?

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Enforcement Trends: CDER Presentation Confirms Fewer Warning Letters Are Issued by FDA for OAI Inspections

FDA Law Blog

By Douglas B. Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. Jennifer Maguire, the Director of the Office of Quality Surveillance within the Office of Pharmaceutical Quality at CDER, told attendees that there were 163 FDA inspections from the beginning of October 2022 to the end of March 2023 conducted at drug manufacturing f

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FDA Issues Draft Guidance on Registration and Listing for Cosmetics Required under MOCRA

FDA Law Blog

By Riëtte van Laack — On August 7, 2023, a little less than five months before the registration and listing of cosmetic product facilities and products becomes mandatory, FDA announced the availability of a draft guidance regarding the new facility registration and product listing requirements under the Modernization of Cosmetic Regulations Act of 2022 (MOCRA).

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Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests

FDA Law Blog

By McKenzie E. Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. For each of these facilities, FDA did not conduct an on-site inspection of the facility prior to issuing the warning letter. Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA).

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Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

FDA Law Blog

By Larry K. Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do not allow the patient such an option.

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Fast Facts: Management of sleep apnea in children

PEMBlog

There are many infants and children that have sleep apnea – categorized as obstructive, central, and a mix of both. The cumulative risk of untreated sleep apnea is an increase in neurobehavioral deficits and cardiovascular morbidity. Management is based on data assessed via the apnea-hypopnea index (AHI) which is the combined average number of apneas and hypopneas that occur per hour of sleep during a polysomnography (sleep study).

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DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law Additions

FDA Law Blog

By Larry K. Houck — Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlled substances with currently accepted medical uses in the U.S. Other anabolic steroids are approved only for use in veterinary medicine. Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 20