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Archive for the ‘Diversion’ Category

USP Workshop To Focus On Common Approach For Supply Security

Friday, May 4th, 2012

The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of  stakeholders for a workshop this month on the complexities of protecting the supply chain. The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other ...

US Pharmacopeia Takes Up Supply Chain Security

Monday, December 19th, 2011

The United States Pharmacopeia is placing supply chain security at the forefront with a new general chapter on best practices for ensuring supply chain integrity and protecting consumers from poor quality and counterfeit medicines. USP General Chapter <1083>, Good Distribution Practices-Supply Chain Integrity, with the recently published USP General Chapter <1079>, ...

December’s New To-Do List: E-Pedigree and Track and Trace

Wednesday, November 30th, 2011

If pharmaceutical electronic pedigrees and track and trace are on your radar, December will be a busy month for you. California's State Board of Pharmacy (CA BoP) has announced that it will discuss implementation of the state's electronic pedigree requirements during its board meeting on December 6. In addition, GS1 ...

Solving Shortages through Serialization

Thursday, September 29th, 2011

The Institute for Safe Medication Practices (ISMP) has surveyed pharmacists and purchasing agents on drug shortages and the "gray" market again, and the bad news is that we could have just reposted our blog on last year's survey and been just as timely. Hospitals continue to struggle with drug shortages, ...

GS1 Standards Pick Up Support

Wednesday, September 14th, 2011

GS1 Healthcare standards are gaining traction. As the latest country to support GS1, India has called for serialized codes following GS1 data formats for exported pharmaceuticals. Most of the top pharmaceutical and medical device companies, wholesalers, and many hospital systems in the US have embraced GS1 Healthcare’s system for product ...

FDA: Reduce the Opportunity for Crime

Tuesday, July 12th, 2011

During a policy forum held today in Washington, DC, the Pew Health Group introduced its report, "After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs." Referring to the heparin-contamination case as a "wake-up call" to supply-chain risks, Allan Coukell, Pew's director of medical programs, said that while ...

Grappling with a “Bizarre, Multijurisdictional” Supply Chain

Friday, July 8th, 2011

This week we saw some U.S. congressional activity regarding pharmaceutical supply-chain safety. Legislators recognize that FDA or other federal agencies need more authority to crack down on substandard or counterfeit drugs. Could we be nearing legislation? For instance, yesterday the Committee on Homeland Security's Subcommittee on Oversight, Investigations, and Management held ...

Call Attention to Threats

Wednesday, June 29th, 2011

While reading about Canada's seizure of counterfeit Cialis in Toronto, I came across an interesting site: www.buycialissafely.com. While it sounds like the subject line of spam e-mail, I do encourage you to check it out. There you will learn that "this website is now owned by Eli Lilly ...

The Package Says Sterile but . . .

Thursday, May 5th, 2011

Yikes! Here is a risk to stolen and diverted medical devices that I had barely considered. How about you? Nonsterile products! Today in our daily newsletter we reported on a story from the Star Tribune in Minneapolis that Boston Scientific Corp. has warned hospitals to look for endoscopic and urological medical devices ...

Will Standards and Audits Provide Enough Supply-Chain Visibility?

Tuesday, November 16th, 2010

Axendia has released the findings of its study on the global supply chain, and I wasn't at all surprised to see that what life science executives say they need is guidance from industry consortia (59%) and regulatory mandates (51%). "Our research shows that industry executives are relying less on internal ...