Patients and Safety - Pharma Rep Focus

Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial

MedCity News

APRIL 14, 2025

Pfizer said a patient dosed with danuglipron developed potential drug-induced liver injury. Pfizer is stopping further work on this program, a move that comes nearly two years after it discontinued development of a different obesity drug due to liver safety signals in a clinical trial.

Safety

Safety Patients Biopharma Pharma

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

MedCity News

OCTOBER 1, 2024

CMS recently finalized the Patient Safety Structural Measure, which sets forth a broad roadmap for the implementation of a culture of safety, learning, transparency and accountability within hospitals and health systems nationwide — enabling and encouraging significant progress towards safer care and improved support for healthcare workers.

Safety

Safety Patients Healthcare Healthcare

4 Steps Needed to Improve Patient Safety On a National Level, Per PCAST

MedCity News

SEPTEMBER 7, 2023

The President’s Council of Advisors on Science and Technology (PCAST) issued a report that laid out four recommendations to improve patient safety across the nation. Some of these included creating federal leadership positions focused on advancing patient safety and hastening research on systems of safe care.

Safety

Safety Patients Healthcare Healthcare

Staff Safety is Key to Sustaining Home Health Growth

MedCity News

OCTOBER 1, 2024

Innovative approaches to home care will only be successful if organizations can ensure the safety of the professionals who enter patient homes. The post Staff Safety is Key to Sustaining Home Health Growth appeared first on MedCity News.

Safety

Safety Patients Healthcare Healthcare

How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

NOVEMBER 1, 2024

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | said in an interview with Fierce Pharma.

FDA

FDA Safety Pharma Patients

The Value-based Care Throughline to Healthcare Quality and Safety

MedCity News

MAY 27, 2024

By prioritizing continuous patient engagement and strategic communication across the entire care journey, healthcare organizations can drive real progress toward value-based care. The post The Value-based Care Throughline to Healthcare Quality and Safety appeared first on MedCity News.

Safety

Safety Healthcare Healthcare Patients

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

MedCity News

NOVEMBER 12, 2024

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

Safety

Safety Patients Biopharma

Medication Management Technology Puts Patient Safety at the Center of Care

MedCity News

FEBRUARY 21, 2024

In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

Safety

Safety Management Medical Patients

Pediatric Mental Health Crisis Tops ECRI’s List of 2023 Patient Safety Concerns

MedCity News

MARCH 13, 2023

Each year, nonprofit ECRI creates a list of the industry’s top ten patient safety concerns. This year, the pediatric mental health crisis topped the list, above other important issues like violence against healthcare staff and clinicians being expected to work outside their scope of practice.

Safety

Safety Patients Healthcare Healthcare

Why Sentara Health Invested $11M Into iPhones for Nurses

MedCity News

JANUARY 24, 2025

Sentara Health invested $11 million into smartphones for its nurses, equipping them with HIPAA-compliant devices to streamline communication, increase time at the bedside and improve patient outcomes. The post Why Sentara Health Invested $11M Into iPhones for Nurses appeared first on MedCity News.

Safety

Safety Patients Healthcare Healthcare

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

MedCity News

JUNE 14, 2024

The post From Recalls to Reliability: Tools to Ensure Software Safety in MedTech appeared first on MedCity News. Cutting-edge technology empowers developers to proactively detect and mitigate issues before they cause problems, reducing recalls and fostering trust in the industry.

Safety

Safety Patients Medical

Why We Need a New Category for Safety Devices

MedCity News

FEBRUARY 26, 2023

Creating a category for technologies like the safety release valve would confer benefits, including improved patient safety, reduced costs for the healthcare system overall, and lowered liability risk.

Safety

Safety Healthcare Healthcare Patients

Sometimes Striking Is the Only Way Nurses Can Protect Patient Safety, Expert Says

MedCity News

JANUARY 13, 2023

Nurses only strike when it’s the only option left to protect patients and deliver quality care, she declared. There’s been a recent wave of nurse strikes, but Theresa Brown — a nurse and New York Times bestselling author — said she’s never met a nurse that happily embraces striking.

Safety

Safety Patients

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

Safety

Safety FDA Patients Biopharma

Payers Are Putting Profit Over Patients with Denials and Prior Auth Policies, Hospitals Say

MedCity News

OCTOBER 6, 2024

Hospitals are facing increasingly burdensome policies from commercial insurers, leading to problems with cash flow and patient safety. The post Payers Are Putting Profit Over Patients with Denials and Prior Auth Policies, Hospitals Say appeared first on MedCity News.

Patients

Patients Insurance Safety Leads

Nursing & Patient Safety – Using Malpractice Claims to Identify Risk Trends [Sponsored]

MedCity News

JULY 26, 2022

Nurses face challenges that put themselves and their patients at risk. Using closed claim data, Coverys identified nursing risk trends. A full report, including recommendations, will be released this year.

Safety

Safety Patients Management Healthcare

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security

MedCity News

JUNE 22, 2022

The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning of medical device remanufacturing and empower the FDA to educate company technicians so they know if they’ve crossed the line into a regulated activity. .

Safety

Safety Medical Education FDA

Aggregate Data to Improve Patient Safety: How Data Can Inform Risk Management [Sponsored]

MedCity News

APRIL 3, 2023

Data can help healthcare facilities improve patient safety, but first, healthcare leaders need to bring data from multiple sources together using a common taxonomy.

Safety

Safety Management Patients Healthcare

Stronger Cybersecurity in Healthcare Starts with Smart Policy

MedCity News

DECEMBER 6, 2024

Leaders across healthcare, technology, and policy circles agree that cybersecurity isn’t just a technical necessity it’s foundational to patient safety The post Stronger Cybersecurity in Healthcare Starts with Smart Policy appeared first on MedCity News.

Healthcare

Healthcare Healthcare Safety Patients

How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development

MedCity News

APRIL 11, 2023

Risk-based quality management, or RBQM, is the process by which pharmaceutical organizations monitor and manage quality throughout clinical trials.

Management

Management Safety Patients Pharmaceutical

Correcting Provider Biases About Transgender and Gender Non-Conforming Patients Can Protect Their Health and Safety

MedCity News

SEPTEMBER 22, 2023

Providers, administrators, health insurers and other healthcare-access gatekeepers can learn, train, change policies and remove barriers facing vulnerable groups so they can receive the long-overdue opportunity to pursue their best health and well-being.

Safety

Safety Insurance Training Healthcare

The Rise of Plant-Based Self-Medication and What Healthcare Must Do Next

MedCity News

APRIL 17, 2025

On the other, it raises alarms about safety, oversight, and the risk of delayed care. The self-medicating plant movement sits at the intersection of empowerment and misinformation. On one hand, it signals a growing desire for agency in personal health.

Medical

Medical Healthcare Healthcare Safety

Private Equity Ownership Leads to Worse Patient Outcomes at Hospitals, Study Shows

MedCity News

JANUARY 2, 2024

Yet another study has been published showing that patients receiving care at PE-owned hospitals experienced a higher rate of hospital-acquired adverse events, like infections and falls, than patients receiving care at hospitals that are not PE-owned.

Patients

Patients Leads Healthcare Healthcare

Microsoft’s Healthcare AI Efforts Holds Huge Promise for Patients

MedCity News

OCTOBER 16, 2023

Called Microsoft Fabric, which was rolled out broadly in May, the announcement on October 10 marks the availability of Fabric’s capabilities specifically for the healthcare vertical – to clinicians, administrators but perhaps, most importantly, to patients. Lungs hyperinflated to clear. No pneumothorax or pleural eltusion.

Healthcare

Healthcare Healthcare Patients Doctors

Beyond Engineering: Integrating UX for Safer and More Efficient Medical Products

MedCity News

AUGUST 2, 2024

While the approach to patient and treatment safety is crucial, there is a notable shift towards processes centered around patients and healthcare professionals. Many medtech products, very often too technical and scientific, emphasize features at the expense of processes and their interactions.

Engineering

Engineering Medical Safety Healthcare

Overcoming the Challenges of Integrating AI in Care Management

MedCity News

AUGUST 30, 2024

Providers should carefully evaluate how different AI models can be strategically integrated to optimize the care management lifecycle and address the complex needs of their patients and populations, while at the same time prioritizing patient safety and ethical considerations.

Management

Management Ethics Safety Patients

Patients Everywhere Deserve Safer Care – Here’s How We Get There

MedCity News

AUGUST 29, 2024

Healthcare organizations tend to view issues in pockets – how they are impacting their specific organization and region – but patient safety is a collective mission. No matter what hospital or health system they are in, or which care model they belong to, patients everywhere deserve safer care.

Patients

Patients Safety Healthcare Healthcare

The future of healthcare: Digitally streamlined workflows

MedCity News

AUGUST 11, 2022

The shift to digitally streamlined workflows is long overdue, and organizations that fall behind risk higher costs, lower patient satisfaction, and higher staff member burnout and put the facility at risk for a patient safety event.

Healthcare

Healthcare Healthcare Safety Patients

Lack of Autonomy Is a Major Reason Clinicians Are Exiting the Field

MedCity News

OCTOBER 22, 2023

Patient safety and lack of autonomy are two of the biggest factors driving so many clinicians away from the medical field, according to a new EY report.

Safety

Safety Medical Patients

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

DECEMBER 9, 2023

BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous side effects. | A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions.

Side effects

Side effects FDA Safety Doctors

‘The Stakes Couldn’t Be Higher’: How DEA’s Proposal Will Affect Telehealth Controlled Substance Prescribing

MedCity News

MARCH 21, 2023

The DEA recently released proposed rules that would require an in-person visit before a patient can receive a telehealth prescription for a controlled substance.

Prescription

Prescription Safety Patients Electronics

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Fierce Pharma

JANUARY 25, 2024

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more (..)

Safety

Safety FDA Medicine Patients

Do patients care about accelerated approval drugs?

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

Patients

Patients FDA Doctors Physicians

How UNC Health Saved Over $5M On Annual Nurse Turnover Costs

MedCity News

OCTOBER 2, 2023

The startup’s technology automates administrative tasks for frontline nurse managers — such as patient rounding, schedule making, and quality and safety checks. UNC Health published a study showing that Laudio’s automation software saved the health system $4.5 million in annual nurse turnover costs.

Safety

Safety Management Patients

How One Startup Is Working to Reduce Surgical Variability & Bring Transparency to the OR

MedCity News

FEBRUARY 5, 2023

The startup recently uncovered a key reason why patient suffer complications after hysterectomies, and it stems from the fact that surgeons lack a standardized set of safety practices to which they must adhere.

Safety

Safety Patients

Gene therapy is saving lives; There are still key challenges to realize its full potential

MedCity News

OCTOBER 20, 2022

Gene therapy can offer hope to patients with previously untreatable diseases, but there’s more work to be done to improve both the safety and efficacy of this therapeutic modality.

Safety

Safety Patients Biopharma

Crucial Factors Healthcare Providers Should Consider When Migrating CRM Platforms

MedCity News

FEBRUARY 28, 2023

Maintaining patient safety and ensuring HIPAA-compliance are also pressing factors. Within the healthcare sector, the migration of CRMs faces even bigger challenges due to the sheer amount and dispersion of data. Nonetheless, the results of a CRM migration are definitely worth it.

CRM

CRM Healthcare Provider Healthcare Healthcare

Why the AMA President Thinks Scope of Practice Expansions Are a ‘Terrible Idea’

MedCity News

OCTOBER 11, 2023

He argued that throwing other professionals into physicians’ roles will have poor ramifications of patient safety. American Medical Association President Dr. Jesse Ehrenfeld said this is a “terrible idea.” In his view, the industry should focus on uplifting strong interprofessional care teams.

Physicians

Physicians Safety Medical Healthcare

What Seniors Should Know About Home Health

MedCity News

NOVEMBER 10, 2023

In addition to safety and convenience, it is usually less expensive and just as effective as the care provided in a hospital or skilled nursing facility. Home health clinicians are specially trained to educate patients and their caregivers on a personalized nutrition plan. There are many advantages to receiving care in the home.

Safety

Safety Food Patients Insurance

Avoiding a ‘bad trip’ in psychedelic clinical trials

PharmaVoice

NOVEMBER 28, 2022

Psychedelic drug trials pose a number of challenges, but researchers can take these steps to boost patient safety.

Safety

Safety Patients

How Should Providers Begin to Regulate Their Staff’s Use of ChatGPT?

MedCity News

JUNE 4, 2023

The use of LLMs in healthcare is still incredibly nascent, so many experts are calling for a safety framework to make this uncharted territory feel safer.

Safety

Safety Healthcare Healthcare Patients

Woman of the Week: Ironwood Pharmaceuticals’ Diane Stroehmann

PharmaVoice

OCTOBER 26, 2022

The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.

Pharmaceutical

Pharmaceutical Safety Patients

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

FDA

FDA Leads Safety Patients

Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

Trending Sources

4 Steps Needed to Improve Patient Safety On a National Level, Per PCAST

Staff Safety is Key to Sustaining Home Health Growth

How Machine Learning Drives Clinical Trial Efficiency

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

The Value-based Care Throughline to Healthcare Quality and Safety

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

Medication Management Technology Puts Patient Safety at the Center of Care

Pediatric Mental Health Crisis Tops ECRI’s List of 2023 Patient Safety Concerns

Why Sentara Health Invested $11M Into iPhones for Nurses

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

Why We Need a New Category for Safety Devices

Sometimes Striking Is the Only Way Nurses Can Protect Patient Safety, Expert Says

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Payers Are Putting Profit Over Patients with Denials and Prior Auth Policies, Hospitals Say

Nursing & Patient Safety – Using Malpractice Claims to Identify Risk Trends [Sponsored]

Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security

Aggregate Data to Improve Patient Safety: How Data Can Inform Risk Management [Sponsored]

Stronger Cybersecurity in Healthcare Starts with Smart Policy

How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development

Correcting Provider Biases About Transgender and Gender Non-Conforming Patients Can Protect Their Health and Safety

The Rise of Plant-Based Self-Medication and What Healthcare Must Do Next

Private Equity Ownership Leads to Worse Patient Outcomes at Hospitals, Study Shows

Microsoft’s Healthcare AI Efforts Holds Huge Promise for Patients

Beyond Engineering: Integrating UX for Safer and More Efficient Medical Products

Overcoming the Challenges of Integrating AI in Care Management

Patients Everywhere Deserve Safer Care – Here’s How We Get There

The future of healthcare: Digitally streamlined workflows

Lack of Autonomy Is a Major Reason Clinicians Are Exiting the Field

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

‘The Stakes Couldn’t Be Higher’: How DEA’s Proposal Will Affect Telehealth Controlled Substance Prescribing

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Do patients care about accelerated approval drugs?

How UNC Health Saved Over $5M On Annual Nurse Turnover Costs

How One Startup Is Working to Reduce Surgical Variability & Bring Transparency to the OR

Gene therapy is saving lives; There are still key challenges to realize its full potential

Crucial Factors Healthcare Providers Should Consider When Migrating CRM Platforms

Why the AMA President Thinks Scope of Practice Expansions Are a ‘Terrible Idea’

What Seniors Should Know About Home Health

Avoiding a ‘bad trip’ in psychedelic clinical trials

How Should Providers Begin to Regulate Their Staff’s Use of ChatGPT?

Woman of the Week: Ironwood Pharmaceuticals’ Diane Stroehmann

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

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