Stivarga Approved for Some Stromal Tumors After Use of First-Line Therapies

WAYNE, NJ – Tthe U.S. Food and Drug Administration (FDA) has approved Bayer’s Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate,… Read More

Ofirmev Injection Available on VA Formulary For Relief of Mild/Moderate Pain

SAN DIEGO – Cadence Pharmaceuticals, Inc. announced that Ofirmev (acetaminophen) injection has been made available on the VA National Formulary (VANF) and must be available for prescription at all VA facilities. .Ofirmev is the first non-narcotic, non-NSAID, intravenous analgesic available… Read More

Kadcyla Approved for Treatment of HER2-positive Metastatic Breast Cancers

SAN FRANCISCO – The FDA has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine… Read More

Air Force Pharmacy Uses Survey to Track Energy Drink Consumption

“People think that if something is available over the counter, [then] it’s safe. That’s not necessarily true. Any product with caffeine will increase respiration and heart rate, and its diuretic effects can cause dehydration.” — Lt. Col. Nicholas Milazzo, chief… Read More

DoD/FDA Program Seeks to Extend Lives of Expired Medications

By Annette M. Boyle A worker at FDA’s Detroit District Laboratory, which is one of three facilities supporting the DoD Shelf Life Extension Program. FORT DETRICK, MD – Far from expiring in the one to five years stated on their… Read More

Chicago IT Intergration Issues Help Create Future Roadmap for DoD/VA Collaboration

By Stephen Spotswood CHICAGO — A government report shows that delays in integrating VA and DoD IT systems at the James A. Lovell Federal Health Care Center (FHCC) in Chicago have proven costly for the jointly-run facility. VA officials responded,… Read More

Durham VA Seeks to Improve Labeling of Investigational Drugs to Improve Safety

DURHAM, NC — Research into investigational drugs focuses on clinical safety and effectiveness after use and must assume that the correct drug was administered in the correct dose. Inadequate or confusing labeling and packaging sometimes can make that difficult, however.… Read More

Designing a Better EMR to Combat Providers’ Medication Alert Fatigue

By Stephen Spotswood INDIANAPOLIS, IN — While the medication alerts, automated reminders and warnings that pop up in electronic medical records (EMRs) improve patient care in theory, reality can be quite different: Alerts may be viewed as unhelpful noise… Read More

More Opioid Prescriptions Adverse Effects for Vets With PTSD

By Stephen Spotswood WASHINGTON — Veterans with PTSD are more likely than others to be prescribed opioids for post-injury pain, and that can lead to an increase in adverse mental and physical effects, according to a recent VA study.  “Iraq… Read More

New Report – Expand Pharmacists’ Private Sector Scope of Practice

By Sandra Basu WASHINGTON — Scope of practice for pharmacists in the private sector needs to be expanded to improve the quality and costs of healthcare delivery, according to a new U.S. Public Health Service report. “There has never been… Read More

DC Pharmacy Chief Finds Creative Solutions to Manage Drug Shortages

By Stephen Spotswood WASHINGTON — As government agencies struggle with an ever-increasing number of drug shortages on a national level, pharmacists at VA hospitals deal with the problem — usually very successfully — on a day-to-day basis. Terrill Washington, PharmD… Read More

VA Patients with Certain Types of Cancer Survive Longer

The survival rate for older men receiving colon cancer care and some types of lung cancer in VA was better than similar fee-for-service (FFS) Medicare beneficiaries, according to a study out of Harvard Medical School. 1 Prior to this research,… Read More

FDA’s Role in Protecting US Pharmaceutical Jobs Debated in House Subcommittee

By Stephen Spotswood WASHINGTON — What should FDA’s role be in the continuing globalization of the prescription drug market, and should the agency be obligated to consider the health of the American pharmaceutical industry in any decisions it makes? Those… Read More

Multiple Factors Spur Big Increases in TRICARE Mail Order Pharmacy Usage

By Sandra Basu WASHINGTON — Last year, a “perfect storm” seemed to result in more prescriptions filled by TRICARE’s mail-order pharmacy, and Chief of Pharmaceutical Operations Rear Adm. Thomas McGinnis said he hopes the trend will continue in 2012. Rear… Read More

Legislation Introduced to Help FDA Prevent and Control Drug Shortages

By Stephen Spotswood WASHINGTON — Unless FDA knows of a potential drug shortage in advance, the agency is not very effective in preventing or controlling that shortage, according to a recent government report. The agency also has failed to keep… Read More

Increasing TRICARE Mail order Pharmacy Incentives Alarms Community Pharmacies

An Obama administration proposal that affects drug co-pays in TRICARE has raised concerns from trade groups representing community pharmacies, which, in 2010, filled 40% of TRICARE prescriptions. The National Association of Chain Drug Stores (NACDS) and National Community Pharmacists Association… Read More

National Drug Shortages Plague VA – Pharmacy Officials Detail Response at Public Hearing

SILVER SPRING, MD — VA is not immune to the effects of drug shortages, and even small problems in the drug pipeline can have serious effects on the department’s ability to get the right pharmaceutical to the right patient, VA… Read More

FDA Is More Bark than Bite on Foreign Drug Imports, Seeks More Authority

WASHINGTON — FDA needs the authority to keep foreign manufacturers who do not comply with regulatory requests from importing their products into the United States, agency officials are telling legislators. Currently, the agency can stop products from entering the country… Read More

Drug Shortages Tripled in Last Five Years; Critical Medications Unavailable

WASHINGTON — The number of drug shortages reported annually has nearly tripled over the last five years, with much-needed drugs such as chemotherapy, anesthetics and electrolytes disproportionately affected. FDA sometimes can mitigate or even prevent a shortage, but this… Read More

FDA Views Future Role as More Than Just Regulator

WASHINGTON — Since taking office, FDA Commissioner Margaret Hamburg, MD, has pushed for science to play a stronger role in the agency, both in the rationale for its decision-making and in meeting its basic purpose.  FDA, she has said,… Read More