FDA Law

JULY 7, 2021

Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. The use of GEDs by JRC is subject to extensive regulation by Massachusetts, including the need for a judge to authorize the treatment for any patient.

Medical 52

Medical Patient-Centered Patients IT 52

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. Discuss options like oral medications, intranasal routes, or the presence of trusted caregivers during procedures.

Families 77

Families Family Patient-Centered Physicals 77

FDA Law

DECEMBER 13, 2023

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. However, the challenges faced by these stakeholders are not isolated to products overseen by DRDMG alone.

Patient-Centered 59

Patient-Centered Medical Patients IT 59

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. Goldilocks zone).

Diabetes 73

Diabetes Management Patient-Centered Families 73

FDA Law

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

IT 69

IT Medical Patient-Centered Provider 69

PEMBlog

APRIL 20, 2023

Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

Patients 52

Patients Patient-Centered Clinic IT 52

The Clinical Problem Solvers

AUGUST 25, 2020

Trainees may use this foundation to question how this might impact their medical education and think about this educational legacy may be reformed through curricular and structural changes at their institutions. Trainees We encourage trainees to reflect on the ways they have been socialized to learn and think about racism in our country.

Community 52

Community Patient-Centered Relationship Education 52

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

PEMBlog

MAY 11, 2023

Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). Is there evidence for the J-Tip?

Patient-Centered 52

Patient-Centered IT Provider Patients 52

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients?

Medical 98

Medical IT Patient-Centered Healthcare 98

BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. misuse of prescription medications). 3 To respond to this crisis, the U.S.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

SEPTEMBER 7, 2023

Does it improve outcomes that patients, caregivers, and clinicians care about? hint: 80% can be done in advance by patients or caregivers) Why is it that some oncologists are resistant to conducting a geriatric assessment, yet have no problem ordering tests that cost thousands of dollars? But does the geriatric assessment do anything?

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

GeriPal

OCTOBER 10, 2024

Alex 01:23 And we’re delighted to welcome DorAnne Donesky, who is a palliative care nurse practitioner at Queen of the Valley Medical center in Napa and professor emeritus at the UCSF School of Nursing. Show me your scars.” Scars, really? I’ve been there. You probably have too. Michelle 01:22 Thanks for having us today.

Screening 119

Screening IT Families Family 119

GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. They were stunned by the number of calls for lift assistance for older adults who had fallen. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. Alex: That is true.

Community 114

Community Transportation IT PCP 114

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. This discussion is hosted by Ashley Cooper, Sudarshan Krishnamurthy, and new team member Gillette Pierce.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. 2018 Systematic Review of Systematic Reviews on ACP. Alex: We are delighted to welcome to the GeriPal podcast, Susan Hickman, who is professor at the Indiana University schools of nursing and medicine, and is director of the IU Center for Aging Research at the Regenstrief Institute.

Illness 72

Illness IT Healthcare Patient-Centered 72

GeriPal

FEBRUARY 6, 2025

We have two new FDA-approved medications that reduce that amyloid buildup and modestly slow down the progression of the disease. He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. To start things off, Nate’s a returning guest. Great to be back.

Primary Care 95

Primary Care Diagnosis Screening IT 95

GeriPal

AUGUST 17, 2023

However, as noted in our editorial published with the donanemab trial , the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer. However, they are none of these. Welcome back to the GeriPal podcast, Jason.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. If its potentially unsafe, but has robust evidence, well thats most of the treatments we offer seriously ill patients! Think chemotherapy to imminently dying patients, or CPR.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

FDA Law

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). A registered nurse also admitted she replaced fentanyl and hydromorphone with saline solution for administration to patients. The tech’s husband distributed the drugs in the community.

Hospital 59

Hospital Patient-Centered Medical Provider 59

GeriPal

MAY 12, 2022

Raj: It was indeed very, very gradual, and the seeds were sown when I was a medical student. Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Prognosis communication and the subtle ways we may communicate it without intention. Social pain and loneliness. AlexSmithMD .

Community 115

Community IT Relationship Healthcare 115

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. I want to say like 2017, 2018, something like that.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

PEMBlog

JUNE 5, 2024

Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Cervical Spine Injuries are fortunately rare in children.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

OCTOBER 3, 2024

Alex 00:08 UCSF’s Division of Palliative Medicine are looking to build on their research and clinical programs and are interviewing candidates for the associate chief of research position and for full time physician faculty to join them in the in-patient and out-patient settings. Sit down and draw each other for only one minute.

IT 122

IT Patient-Centered Patients Relationship 122

Tiny Physician

MARCH 30, 2022

Archana Sharma committed suicide because of the harassment by the bystanders of the patient who died at her hospital. However, she found herself in trouble when one of her patients, whom she treated at her hospital, died due to postpartum hemorrhage (bleeding from the birth canal after delivery). Is this a case of medical negligence?

Hospital 52

Hospital Government Patient-Centered Medical 52

GeriPal

JULY 13, 2023

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. Is 4% meaningful? Welcome, Bob. Bob: Thank you.

Patient-Centered 83

Patient-Centered IT Patients Hospital 83

GeriPal

APRIL 21, 2022

Poetry holds us in that liminal space so many of our patients are in. We talk not only about reading poetry, but also writing poetry, and using poetry in medical education as a healing modality. Alex: We also have Mike Rabow, who is director of palliative care at the Cancer Center at UCSF. To let it go. . Redwing: Thank you.

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

MARCH 27, 2025

Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). Was there really a causal connection between the intervention, new advance directives, and higher rates of potentially burdensome interventions? Jasmine, is it you?

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

GeriPal

FEBRUARY 24, 2022

Since then there has been a lot of back and forth, with even a couple of podcasts from us, several JAMA viewpoints, and most recently a series of published replies from leaders in the field on why ACP is still valuable (see below for references). . Despite all of these publications, I’m still left at a loss of what to think about it all.

Illness 98

Illness Patient-Centered IT Patients 98

Common Sense Family Doctor

MARCH 23, 2025

This post first appeared on March 6, 2018, during the first Trump administration's failed attempt to eliminate the Agency for Healthcare Research and Quality (AHRQ). Nonetheless, its work has often been politically unpopular and unheralded outside of a small community of health services researchers and patient advocates.

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52

Pamela Wible MD

JUNE 19, 2025

Published 2/5/19, updated 6/19/25) Rowdiest audience ever (at a medical conference at least). It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. In order to heal her patients she first had to heal her ailing profession.

Clinic 246

Clinic Nurse Practitioner IT Medical 246

Physician's Weekly

JUNE 25, 2025

Dozens of insurance companies, including Cigna, Aetna, Humana, and UnitedHealthcare, agreed to several measures, which include making fewer medical procedures subject to prior authorization and speeding up the review process. “This is an opportunity for the industry to show itself.” Prior authorization isn’t going anywhere.

Insurance 52

Insurance Patient-Centered Patients Government 52

Physician's Weekly

JUNE 17, 2025

Until recently, the only treatment was growth hormone therapy to help patients stay leaner and grow taller, but it didn’t address appetite. This breakthrough for these patients comes as other drugs are revolutionizing how doctors treat obesity, which affects more than 40% of American adults. “All of a sudden, they flip.”

Patient-Centered 52

Patient-Centered Emergency Room Insurance Patients 52