FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(d) Draft Guidance III.B.2(f) 2(f) at 9-10.

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

FDA Law

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. The PR goes on to state that the FD&C Act definition of a device does not turn on where or by whom a test system is “manufactured.”

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

GeriPal

OCTOBER 13, 2022

When I’m on service these days there is inevitably a moment when a resident says “Patient so-and-so is on X” – and I have absolutely no idea what X is. It’s Lona Mody who is a translational infectious disease researcher at the University of Michigan and VA Ann Arbor Healthcare System. Summary Transcript Summary.

Complication 97

Complication Patient-Centered IT Patients 97

GeriPal

DECEMBER 2, 2022

She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. You wrote about how when it comes to talking about patients with dementia, they’re rarely portrayed as resilient. And the person with dementia, the patient, said yes. How do we move on?

Community 101

Community IT Individual Patient-Centered 101

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And nurses and other healthcare practitioners knew nothing about it. Over-the-counter hearing aids: What will it mean for older Americans?

IT 102

IT Screening Hospital Clinic 102

GeriPal

JULY 27, 2023

Cathy: Actually, many years ago, I did some research on delirium and then I was doing some research on nursing home residents and we were doing work looking at, I was interested in how sleep problems and nighttime events might lead to delirium, and then I just became very, very interested in sleep. And often they’re coexisting.

Illness 85

Illness IT Medical Clinic 85

The Clinical Problem Solvers

DECEMBER 20, 2021

difficulty of sending patient messages through the electronic medical record in languages other than English), limited healthcare literacy, and English-only signage on healthcare campuses are just a few of the structurally racist barriers faced by many Asian folks seeking healthcare. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

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. 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.

Community 114

Community Transportation IT PCP 114

GeriPal

MAY 22, 2025

Jenny Chen is a palliative care fellow at Yale who regularly sings for her seriously ill patients. Jenny reached out to us because she plays music regularly for her patients, and she said, you should do a podcast about music. And I performed for many palliative patients, and that’s when I started to understand.

IT 96

IT Patient-Centered Patients Board-Certified 96

FDA Law

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. establish and maintain adverse event files.” [9] establish and maintain adverse event files.” [9]

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

FEBRUARY 20, 2025

Kate and Ashwin talked about their research on the prevalence of lifetime trauma and its association with physical and psychosocial health among adults at the end of life. So there’s an event or a series of events. So there’s an event or a series of events. I guess that’s an event.

Patient-Centered 66

Patient-Centered IT Screening Patients 66

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

JULY 11, 2024

It’s a jampacked 50 minutes, filled with pearls on taking care of patients with liver disease. Kirsten 04:16 So, in emergency medicine, obviously, we are interacting and caring for these both exciting and interesting, but also very complex and humbling patients to care for in the ED setting. AMA PRA Category 1 credit(s) ™.

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

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.

IT 137

IT Families Family Physicals 137

GeriPal

OCTOBER 17, 2024

We talk about what is heart failure, particularly HFpEF, how we treat it (including the use of sodium–glucose cotransporter-2 inhibitors (SGLT2’s), and how we should apply guidelines to individual patients, especially those with multimorbidity who are taking a lot of other medications. When I see a patient? Matthew, I get the lyrics.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? It’s Lona Mody who is a translational infectious disease researcher at the University of Michigan and VA Ann Arbor Healthcare System. difficile that patients are exposed to and antibiotic resistance.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. The patient case. So in some ways, it was an iatrogenic event. Alex 03:33 Yeah.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

SEPTEMBER 12, 2024

On today’s podcast, we talk with Jane Thomas , Naomi Saks , and Ishwaria Subbiah about the concepts of wellness, well-being, resilience, and burnout, as well as what can be done to truly improve the lives of healthcare providers and bring, I dare say it, joy into our work. I mean, in other work, hard work environments as well.

IT 110

IT Healthcare Healthcare Professional Patient-Centered 110

GeriPal

JUNE 13, 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.

Illness 133

Illness Patient-Centered Patients IT 133

GeriPal

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. Eric: And what a research agenda that you’ve done, including one of the most seminal papers that we have in palliative care in lung cancer patients.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

OCTOBER 12, 2023

Summary Transcript Summary For surgeons and patients, deciding if and when to operate can be challenging. Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. We hope you enjoy this episode. I did it before and this guy, he was 85, but he was climbing Mount Everest.”

IT 128

IT Families Family Patient-Centered 128

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. GeriPal podcast with Linda Fried on frailty.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

GeriPal

JUNE 22, 2023

We start off part one by interviewing Michele DiTomas, who has been the longstanding Medical Director of the Hospice unit and currently is also the Chief Medical Executive for the Palliative care Initiative with the California Correctional Healthcare Services. Did I get that close? Michele: That was perfect. Alex: That was perfect.

Families 132

Families Family IT Community 132

GeriPal

MARCH 13, 2025

Yes, it means to cloak, but theres more Whole-person-care Total pain Healing as a process distinct from the deterioration of the body Sympomatologists The patient and family as the unit of care Our guests referenced many articles on this podcast, linked above and below. You’re talking about a paradigm shift in healthcare.

IT 104

IT Patient-Centered Families Family 104

GeriPal

APRIL 3, 2025

So if you haven’t been to this event, there is a literature review where we. That was actually Ken, you remember that article, Nancy Schoenberg’s article on screening and what to say and what not to say to patients on how to talk. How to talk to patients about screening colonoscopies. Ken 09:56 We did a role play.

IT 64

IT Hospital Screening Patients 64

GeriPal

MARCH 6, 2025

-Alex End Well Talk [link] Resources on the PEACH Program Program Review Paper A recent publication in Longwoods Healthcare Quarterly reviewing the PEACH model. I always knew that I wanted to get into healthcare, to use healthcare as a springboard for social change in our communities. Have you thought about that?

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

OCTOBER 5, 2023

I love this article as it specifically discusses what’s wrong with “ need ” statements and how we can shift our communication and thinking to create space for deliberation about patients’ priorities and the best course of action. Now doctors are unwilling to understand patients’ values and make recommendations, taking the science to it.

Illness 136

Illness IT Patient-Centered Families 136

GeriPal

OCTOBER 27, 2022

As Alex Lee says on our podcast today, all prognostic models will be wrong (in some circumstances and for some patients); our job is to make prognostic models that are clinically useful. I think this is a really difficult topic to talk about with patients. She has a point. Prognosis is inherently uncertain.

IT 95

IT Clinic Screening Patients 95

FDA Law

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies.

Clinic 59

Clinic Provider Individual IT 59

GeriPal

JUNE 26, 2025

Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Today we talk about disruptive events, or health and wealth shocks. Wait, so one key message is that social health is linked to physical and cognitive health?!? What’s a disruptive event?

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. So the things that Karl mentioned, but also access to healthcare during a disaster or even heat. Ruth: Yeah. Ruth: Yeah.

Healthcare 129

Healthcare IT Education Community 129

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. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Turns out, it’s maybe not.

Healthcare Professional 102

Healthcare Professional Healthcare IT Relationship 102

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. It is appropriate for all patient populations, and it is developed specifically for the palliative care and hospice populations. Why do this?

Families 106

Families Family Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. It was in the mid-nineties, and about half of the patients that we cared for in the inpatient service were homeless.

Mental Health 123

Mental Health IT Community Individual 123

Pamela Wible MD

JUNE 19, 2025

Read transcript and/or download & listen to MP3 below:  Physician burnout—symptom of a broken system “Burnout” has become one of the most talked-about issues in healthcare—but behind the buzzword lies a deeper crisis. In order to heal her patients she first had to heal her ailing profession. Think about it.

Clinic 246

Clinic Nurse Practitioner IT Medical 246

GeriPal

JULY 16, 2024

We talk about positive aspects of aging, cognitive screening, the line between legitimate concerns and ageism, ableism, advice for a geriatrician asked to comment on TV, frailty and physical disability, images in the press , historical situations including , and an upper age limit for the Presidency, among other issues. But I agree with Ken.

Diagnosis 141

Diagnosis Diagnose IT Physicals 141