Patient Safety

How Quality Assurance Shapes US Drug Manufacturing

by Alivia Kaylor

The world of pharmaceuticals stands as a cornerstone of modern medicine. Behind every pill, every capsule, and every syringe lies an intricate process of creation, where precision and excellence are non-negotiable. Drug manufacturing is a...

National Blood Supply Dropped 25%, Causing Critical Shortage

by Veronica Salib

Last week, the American Red Cross announced a national blood shortage across the United States. In addition to a dire need for blood due to natural disasters and climate crises, the organization...

FDA Issues Warning Letters for Marketing Unapproved Ophthalmic Drugs

by Veronica Salib

On September 12, 2023, the United States Food and Drug Administration (FDA) issued warning letters to eight companies, including Boiron Inc, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc,...

Red Cross Adopts FDA’s Blood Donation Policies to Expand Eligibility

by Veronica Salib

On August 7, 2023, the American National Red Cross announced that it would adopt the United States Food and Drug Administration’s new blood donation protocols. This shift will widen donor...

FDA Launches Programs to Reduce Risk of Cancer Biomarker Testing

by Veronica Salib

Last week, on June 20, 2023, the United States Food and Drug Administration (FDA) launched a pilot program to reduce the risk of laboratory-developed tests to identify cancer biomarkers. The program...

FDA Proposes Amendment to Human Prescriptions Drug Labeling Guidelines

by Veronica Salib

On May 30, 2023, the United States Food and Drug Administration (FDA) proposed an additional Patient Medication Information (PMI) section on human prescription drug labels, amending current...

DEA Issues Public Safety Alert for Fentanyl Mixed with Xylazine

by Veronica Salib

On Wednesday, April 12, 2023, the United States Drug Enforcement Administration (DEA) issued a public safety alert on fentanyl mixed with xylazine. Linked to a press release by the Biden...

A New Era in Medicine: The Therapeutic Promise of HMO-Based Medications

by Alivia Kaylor

Human breast milk has long been recognized as the optimal source of infant nutrition, providing essential nutrients and antibodies that promote growth and protect against infection. However, research has revealed that breast milk contains...

FDA Requires Mail-Back Envelops with Opioid Analgesics Dispensation

by Veronica Salib

As a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS), the FDA will now require mail-back envelops with opioid analgesic dispensation in outpatient settings to...

Pfizer Recalls Migraine Medication Under Advisement From CPSC

by Veronica Salib

On March 16, 2023, just days after the FDA approved another new nasal migraine medication, Pfizer recalled its Nurtec ODT medication. Under advisement from the United States Consumer Product Safety...

Alternatives to Animal Testing Models in Clinical and Biomedical Research

by Alivia Kaylor

Before the FDA Modernization Act 2.0 was passed in December 2022, the US government required that all investigational drugs be tested on animals before they could advance to human trials. Although this act does not ban animal testing, it...

Understanding Pharmaceutical Recalls, Key Players, and Their Roles

by Veronica Salib

Like any industry, recalls in the pharmaceutical industry are complex and expensive. However, as an added concern, pharmaceutical recalls have the potential to alter short and long-term health outcomes. Understanding the recall process for...

FDA Grants Approval for HIV Treatment to Fight Drug Resistance

by Hayden Schmidt

Last week, the FDA approved Gilead Science’s Sunlenca (lenacapavir), the first and only capsid inhibitor-based HIV treatment. The treatment is intended for adult patients whose HIV cannot be...

FDA Investigates Prolia’s Association with Severe Hypocalcemia

by Veronica Salib

In a Drug Safety Communication issued on November 22, 2022, the FDA announced that it is investigating Prolia and its associations with severe hypocalcemia — low blood calcium levels — in...

Exploring Psychedelics to Treat Mental Health Issues

by Veronica Salib

In recent years, psychedelics have been explored for pain management and treatment-resistant depression. While receiving criticism from the general public, clinicians and researchers are working tirelessly to prove the safety and efficacy...

Clinical Pharmacists Are a Major Contributor to Quality Patient Care

by Veronica Salib

In recent years — especially considering the COVID-19 pandemic — the public has become increasingly aware of pharmacists’ role in healthcare. Despite the current prevalence of clinical pharmacists and their position on...

Merck & Co Manufacturing Mishap Leads to Carcinogen in Diabetes Medication

by Hayden Schmidt

Last week, Merck & Co made the FDA aware of the presence of nitrosamine in its type 2 diabetes drug, Januvia. Merck’s analysis of the drug found nitrosamine levels higher than allowed by the...

$4.25 Billion Opioid Settlement by Teva Pharmaceuticals

by Veronica Salib

The opioid epidemic has run rampant since the 1900s. While healthcare professionals play some role in the spread of opioid use, pharmaceutical companies are the main culprit. Recently, Teva...

FDA Releases Drug Safety Communication regarding Cancer Drug, Copiktra

by Veronica Salib

On June 30, the FDA released a drug safety communication that warned against the risks associated with Copiktra. Copiktra, also called duvelisib, is a cancer drug used to treat relapsed or...

Nephron Pharmaceuticals Recalls 2.1 Million Doses of Medicine, Medical Equipment

by Alivia Kaylor

According to the FDA’s enforcement report, Nephron Sterile Compounding Center, in Columbia, South Carolina, is recalling 2,158,351 medical products including syringes and bags because of a lack...