PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2018 Oct;142(Suppl 2):S72-S81. 2018-0333I.

Patients 52

Patients Complication Management Consulting 52

FDA Law Blog

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. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Day 90 FDA sends final MDUFA Decision on 510(k).

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

JUNE 8, 2023

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. If in your own work, your clinical work, is this something that you see people struggle with you, you see yourself struggle with? Goldilocks zone). Eric: Let me ask you a question.

Diabetes 74

Diabetes Management Patient-Centered Family 74

FDA Law Blog

MAY 17, 2022

FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. and more likely 15-20. A provision has already been included in H.R.

IT 40

IT Patients Provider Individual 40

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

Physician's Weekly

JUNE 19, 2025

Independent Association The study involved analysis of data from 43,842 adults in the National Health and Nutrition Examination Survey (NHANES, 1999-2018). Clinical Implications “Higher DII is independently associated with an increased risk of CHD, potentially through pathways involving metabolism, lipid levels, and kidney function.

Hypertension 52

Hypertension Individual Diabetes Diagnose 52

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. 2 Opioids contribute a large share of this overdose crisis.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

Community 115

Community Transportation IT PCP 115

FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

JULY 21, 2022

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. That’s where it really gets to this individual risks and balances, individual situation.

IT 102

IT Family Families Diagnosis 102

GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? J Am Geriatr Soc.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

FEBRUARY 6, 2025

So let’s just say you have a healthy 55 year old or 65 year old in your clinic. So whether it’s 50, 52, 55, 65, we should ask every person who comes into clinic at least once a year, how do you feel like your thinking is? So I’m in a specialty clinic, so I’m in this interdisciplinary memory assessment clinic.

Primary Care 96

Primary Care Diagnosis Screening IT 96

The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series.

Community 52

Community Patient-Centered Family Families 52

GeriPal

AUGUST 17, 2023

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”. I’m a prescriber.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Alex joined in 2018.

IT 64

IT Hospital Screening Patients 64

GeriPal

JUNE 22, 2023

Michele: Yeah, so in May of 2018, there was an article by Suleika Jaouad in the New York Times Magazine, and they spent about two weeks in our hospice with us learning about the work that’s done. Michele: The article was 2018, but I think Bonnie read the article more recently. Eric: How long ago was this? Alex: A few years back.

Family 132

Family Families IT Community 132

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences. Alex: What did it changed to after 2018? We can work it out! AlexSmithMD. Transcript.

Illness 73

Illness IT Healthcare Patient-Centered 73

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. Eric 06:58 It could be CPR in an individual with metastatic cancer in the icu. It’s just that he was foregoing things that we think would have provided him more benefit.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

GeriPal

MARCH 3, 2022

I want to say like 2017, 2018, something like that. I think there’s so much more, that’s known now about Alzheimer’s and out in the general public, hopefully providers are having these conversations, but we can’t really take too much comfort in it because of those findings that you just mentioned by John Tino.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

Family Medicine Initiative

APRIL 10, 2024

Having Your Own Long-Term GP Can Save Your Life Patients who choose a GP rather than a specialist as their primary care provider have a 19% 8 lower mortality and produce 22% 9 -33% 8 lower healthcare spending. million people in 2018), shows that the longer you know your GP, the better off you are. million Canadian patients).

Family Physician 130

Family Physician Family Families GP 130

GeriPal

OCTOBER 3, 2024

How the act of drawing can help us sloooow down, pay attention to the people and world around us, and ultimately let go… The possibility of incorporating drawings in research and even clinical care. I cracked myself in my head of these individuals. Frank, welcome to the GeriPal podcast. Frank 08:43 Well, briefly.

IT 122

IT Patient-Centered Patients Relationship 122

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Eric 08:37 And that’s because you randomized clinics, you didn’t randomize patients interventions. We did it by the clinic level. And so everyone who’s in that clinic was.

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

PEMBlog

DECEMBER 4, 2024

We will review the clinical presentation, diagnostic strategies, management protocols, infection control practices, and vaccination updates. This episode also covers what healthcare providers need to know about post-exposure prophylaxis, respiratory precautions, and managing occupational exposures. link] UpToDate Yeh S et al.

IT 52

IT Vaccination Diagnosis Complication 52

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Drug Price Negotiation to Benefit Medicare and Commercial Plans.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98