FDA Law Blog

AUGUST 16, 2023

Breztri was approved just over 3 years ago in July 2020 for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The promotional piece at issue is a 12-page brochure intended for healthcare professionals, with the offending presentations appearing on pages 6 and 7.

Healthcare Professional 52

Healthcare Professional Healthcare Asthma IT 52

GeriPal

AUGUST 4, 2022

My take home from this is that while the most preferred explanation for deprescribing statins and sedative-hypnotics is one focused on the risk of side effects, we also need to individualize it to the patient and the medication that they are taking. But how to talk to patients about the risk and benefits when starting. Eric: Yeah.

Specialization 104

Specialization Medical Patient-Centered Provider 104

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

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. And we invited Tamryn Gray from the Dana Farber joins us to ask insightful questions, including: What blood sugar range should we target for patients in the nursing home or hospice?

Diabetes 73

Diabetes Management Patient-Centered Families 73

GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. I was coaching someone this morning, who really wanted to know, what does your clinic template look like, and how do you respond to patient messages?

Board-Certified 110

Board-Certified IT Primary Care Referral 110

GeriPal

JANUARY 30, 2025

In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. What do different patient populations need? But watch out! Alex 01:06 Yeah, go in person.

Telehealth 105

Telehealth Patient-Centered IT Patients 105

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

BMJ

FEBRUARY 8, 2021

It is imperative for policy makers, school administrators, healthcare professionals, and parents to become aware of these emerging dangers and take appropriate steps, like what has been done for the opioid epidemic. doi: 10.1136/fmch-2020-000374. Accessed 02/05/2020. References Agaku I, Odani S, Nelson J.

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.

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Patient-Centered IT Healthcare Medical 96

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. My Life, My Story: VA’s healthcare improvements through deliberate storytelling – YouTube. Storytelling Helps Hospital Staff Discover The Person Within The Patient.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

OCTOBER 19, 2023

Caveat as well that RCTs should not be placed on pedestal as the only answer- often patients enrolled in RCTs do not represent real world patients – observational studies do. For a trial to have value, it should not exclude patients over age 80, or those with dementia, or patients residing in nursing homes.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

GeriPal

SEPTEMBER 12, 2024

Eric 04:44 Could just make you a little bit more resilient, you can increase your Rvus so you can see more patients. Naomi 04:59 So we know that we in healthcare, and all of our colleagues are some of the most resilient people that ever existed. If you were just. If you could make it, if we. Eric 05:27 80 2080 20.

IT 110

IT Healthcare Healthcare Professional Patient-Centered 110

GeriPal

MARCH 30, 2023

Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma. Today we’re going to be talking about narrative writing specifically for healthcare professionals.

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IT Patient-Centered Patients Healthcare 95

GeriPal

FEBRUARY 8, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Families Family Physicals 137

BMJ

MAY 10, 2022

METHOD The cross-sectional study was conducted on family physicians and family health staff working in primary care family health centers in Üsküdar district of Istanbul with a population of 520,771 between 25-29 December 2020 [4]. Two hundred seventy-six of the healthcare professionals were reached (response rate: 85.4%).

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Vaccination Healthcare Professional Healthcare Primary Care 40

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

NOVEMBER 2, 2023

Ryan: For those of you that aren’t familiar, GERI-A-FLOAT stands for Geriatrics Fellows Learning Online and Together it was created amongst the COVID pandemic in 2020 when all of the fellowship rotations were shutting down. And he asked me questions like, “Why is this patient in bed? Eric: Can I just add it?

Board-Certified 91

Board-Certified IT Community Medical Student 91

GeriPal

DECEMBER 5, 2024

We talked with Thor Ringler, who helped found the My Life My Story Project at the VA and beyond, and Heather Coats about the evidence base for capturing patient stories. Because we all interface with it at the end of the day as patients. That was January 2020. We had, you know, it was a Monday night in June of 2020.

IT 107

IT Community Patients Families 107

GeriPal

FEBRUARY 20, 2025

If you want a deeper dive, check out the following resources: Our Nature of Suffering podcast with BJ Miller and Naomi Saks Dani Chammas Annals paper on countertransference and why we shouldnt say that the patient was difficult rather than that I felt frustrated. Eric 04:55 Does it need an experience directly? I guess that’s an event.

IT 66

IT Patient-Centered Individual Screening 66

GeriPal

MAY 26, 2022

Govind: So even if there’s some reason to worry about considering vaccination status, on the one hand, maybe disadvantage some unvaccinated COVID patients who might disproportionately suffer certain kinds of disadvantage, in scarcity you have to think, well, what’s the alternative? Govind: Same.

Vaccination 87

Vaccination Individual IT Healthcare 87

FDA Law Blog

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, in other words, directed, and continues to direct, pregnant women to a learned intermediary.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

FEBRUARY 13, 2025

How to be sensitive to the risks of stereotyping based on recommendations from the few members of the board to the many heterogeneous patients served? And so it was really the patients, you know, the caregivers, the family members were the ones who were sort of the closest in observing. Who would/should be on that board?

Consulting 63

Consulting Community Patient-Centered Families 63

GeriPal

JANUARY 20, 2023

You were on a National Academy of Sciences committee started in 2020? I know you’ve been a strong advocate for nursing home patients particularly in California. Eric: All right, let’s jump into this topic. Improving nursing home quality. Jasmine, I’m going to start with you. Jasmine: Yes. Is that right?

Finance 95

Finance Board-Certified IT Provider 95

GeriPal

SEPTEMBER 21, 2023

I think that’s something we’ve seen even with the most recent issues that came out, not new issues, but came to the surface with the racial reckoning that we saw in 2020 related to murders and deaths and killings and that sort of stuff that helps to reshape how we refer to different groups of individuals in our community.

Community 128

Community Families Family IT 128

GeriPal

NOVEMBER 3, 2022

You’d imagine though that our professional expertise and experiences in helping patients and families cope with loss and grief would be helpful in managing our own personal losses. These debriefings create a safe outlet for health care professionals to talk about the feelings resulting from their work. Turns out, it’s maybe not.

Healthcare Professional 102

Healthcare Professional Healthcare IT Relationship 102

GeriPal

DECEMBER 7, 2023

Big heat waves in England in 2020, 2,224 excess deaths in the obits over the age of 65. Eric: So as we start talking about things that we can do about it, maybe we can just start off with this thing of including it in the curriculum for healthcare professionals. So how are your patients going to deal with extreme heat and cold?

Healthcare 129

Healthcare IT Education Community 129

GeriPal

DECEMBER 29, 2022

Journal of Patient Experience. December 2020. I mean, it’s something that frustrates me on a daily basis, the number of times that I’ve had to argue with patients and even my own grandparents. Training Hospitalists in Negotiations to Address Conflicts with Older Adults around Their Social Needs. Geriatrics.

Families 96

Families Family IT Patient-Centered 96

BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2021-001143 The COVID-19 pandemic has resulted in profound changes in patient and prescriber behaviour. In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions.

Primary Care 40

Primary Care Supply Chain General Practitioner Vaccination 40

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. Isn’t that what we always work with, with patients, with our colleagues, with ourselves? Can I ask, Redwing, do you ever ask patients or people you care for to write poetry? Alex: Mm-hmm (affirmative).

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

JULY 6, 2023

And just going back to that patient, I’ll tell you, before I started this role, I would have probably looked at the handout box in our clinic and been like, oh, okay. We just kind of start to amass these handouts and I would give them to the patient. Is it the patient? Eric: Wait, county 911? Lindsey: Our county 211.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Everything.

Patient-Centered 125

Patient-Centered IT Families Family 125

GeriPal

JULY 14, 2022

Two-thirds of the patients in the home now have COVID-19. Seventeen of your patients are dead. The other physicians who previously saw patients in the nursing home are no longer coming to your facility because you have COVID positive patients. You’re short on gowns and facemasks.

Nurse Practitioner 136

Nurse Practitioner Patient-Centered Vaccination Emergency Room 136

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. 2020 Hospital at Home-Plus: A Platform of Facility-Based Care. But we ended up doing, basically, a case series of… I think it was 18 or 20 patients or so.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

OCTOBER 31, 2024

Summary Transcript CME Summary In March 2020, we launched our first podcast on COVID-19. And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath. Especially in these nursing facilities where you get to know patients over time. All good ones.

Vaccination 127

Vaccination IT Patient-Centered Patients 127

GeriPal

JUNE 2, 2022

it was April, 2020. We’re actually lower of COVID deaths in this country than we’ve ever been since March of 2020. So you plan on your geriatrician, older patients, getting it every year. Monica: And the patient said, “I don’t like my doctor wearing masks.” Monica: Yeah. So where are we?

Vaccination 100

Vaccination IT Hospital Management 100

GeriPal

JULY 16, 2024

So you have to kind of walk a fine line in saying, I am unable to make a diagnosis without seeing a patient. But to actually make a diagnosis without the patient in front of you. And that’s why we have a comprehensive evaluation of patients. Eric 30:42 Trump did a MoCA in 2020, I remember that he did the OmoC ever.

Diagnosis 141

Diagnosis Diagnose IT Physicals 141