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So far lennis@wi.rr.com has created 12 blog entries.

New e-Tool Helps Maintain Supply Chain Integrity

"As the Drug Supply Chain Security Act (DSCSA) deadline approached, Gary Merchant, RPh, MBA, an administrative director of the New England Pharmacy Collaborative, in Lebanon, N.H., knew his members would need some help meeting the new requirements. “It seems like the only profession more regulated than we are is the nuclear industry,” said Mr. Merchant, who also serves on the New Hampshire Board of Pharmacy. “The next challenge before us is how to be compliant with the DSCSA. Trying to do it manually..." Read the full story at pharmacypracticenews.com

May 29th, 2016|

Major Health Care Systems Choose ConsortiEX™ Service to Track and Trace Prescription Drugs

Leading health care institutions act to comply with new FDA laws governing $400 billion U.S. prescription drug market   MILWAUKEE -- April 28 -- ConsortiEX, a Milwaukee-based hospital pharmacy IT software and services company, today announced that three major U.S. health care systems have implemented ConsortiEX's Pedigree Management Service, that tracks and traces prescription medicines, to meet recently mandated federal regulations. Froedtert & the Medical College of Wisconsin regional health network and Memorial Hermann Health System, the largest non-profit health system in southeast Texas, have implemented ConsortiEX's Pedigree Management Service, a software-as-a-service that sets new standards for drug quality assurance and traceability. A third major health care system, based in New England, also has contracted to use ConsortiEX's software service. Effective March 1, 2016, the U.S. Food and Drug Administration (FDA) began enforcing Title II of the Drug Quality Security Act (DQSA) contained in the Drug Supply Chain Security Act (DSCSA). DSCSA requires organizations that dispense prescription medicines to [...]

May 27th, 2016|

FDA Track-and-Trace Reprieve Gives Pharmacies Breathing Room (1 Jul 2015)

“BETHESDA, MD 01 Jul 2015—Pharmacies have until November 1 to comply with certain elements of the Drug Supply Chain Security Act (DSCSA) that were scheduled to go into effect July 1, according to an FDA guidance document (PDF) released June 30.” Read full story at ASHP

May 26th, 2016|

ConsortiEX raises $1 million, plans new financing round

ConsortiEX, a start-up company in Milwaukee that is developing software for hospital compounding pharmacies, said it has raised $1 million from investors. The investment will enable the company to receive a $250,000 loan and $250,000 in investor tax credits from the Wisconsin Economic Development Corp. The loan and tax credits were contingent on the company raising $1 million from investors. ConsortiEX is developing software that would help hospital pharmacies sell compounded drugs to other hospitals, including those that are too small to have “clean rooms” to prepare the drugs and instead buy from pharmacies that specialize in compounding… Read the full story at Journal Sentinel 

May 25th, 2016|

Post-MassChallenge, Healthtech Startup ConsortiEX Growing in WI (20 Oct 2014)

“Consolidation is the name of the game these days in the healthcare industry, as hospitals, clinics, and private physician groups across the country are increasingly teaming up. While healthcare officials and critics of such mergers and acquisitions might disagree over the real motives behind them, there’s no question that healthcare providers are taking a hard look at how they run their operations…” Read the full story at Xconomy.com

May 25th, 2016|

Safety, sanitary problems prompt scores of drug recalls (7 Oct 2014)

“The infection came out of nowhere, 36 hours after Eloise Soler’s heart surgery last summer at the Corpus Christi Medical Center in South Texas. As her fever spiked to 103, other patients developed similar symptoms. Doctors raced to pinpoint the cause. Tests showed that all of the patients had been sickened by the same bacteria, Rhodococcus equi, which typically infects horses and other grazing animals, and they all fell ill after infusions of the same drug, calcium gluconate. The drug was made 200 miles away by Specialty Compounding, which sits in a category of pharmacies that mix unique or hard-to-find drugs not only for individual patients, but also in batches for doctors and hospitals. By the time the company recalled the medication days later, investigators believed it had sickened at least 15 people; two had died…” Read full story at USAToday.com

May 25th, 2016|

Insourcing IV Sterile Compounding (23 Jun 2014)

“Determined to cement access to reliable and safe sources for crucial IV drug admixtures, a growing number of hospitals are bringing production of compounded sterile products (CSPs) in-house and turning their backs on external compounding pharmacies. Such far-reaching decisions reflect the lingering distrust of outsourced CSPs, according to several administrators from hospitals that have made this move…” Read more at Pharmacy Practice News

May 25th, 2016|

FDA Compounding Quality Act (Mar 2014)

Summary: On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. Title I of this new law, the Compounding Quality Act, removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) that were found to be unconstitutional by the U.S. Supreme Court in 2002. Section 503A describes the conditions under which certain compounded human drug products are entitled to exemptions from three sections of the FDCA requiring… Read full story at FDA.gov

May 25th, 2016|

Healthtech Startup ConsortiEX Closes $1M Round Led By Open Prairie(27 Jul 2015)

“ConsortiEX, a healthcare IT startup with roots in both Wisconsin and Massachusetts, has closed a $1 million funding round led by Open Prairie Ventures, the company announced today. “ConsortiEX developed an ordering and tracking software system for the production and distribution of sterile injectable compounds, such as antibiotics, analgesics, and neuromuscular blockers. Its target customers are hospitals, who are trying to reduce costs and efficiently manage their supplies of such products—crucial drugs that have been in short supply in recent years. ConsortiEX says its software can help achieve those goals, while also potentially improving safety by helping to prevent patients from receiving recalled medications and catching problems with product quality…” Read the full story at Xconomy.com

July 27th, 2015|

The New Track and Trace Law Places Hospitals on High Alert (Jun 2015)

http://www.pharmacypracticenews.com/Policy/Article/06-15/The-New-Track-and-Trace-Law-Places-Hospitals-on-High-Alert/32701    

June 25th, 2015|
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