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Archive for the ‘Tampering’ 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>, ...

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 ...

Update on Brazil’s Move toward Drug Serialization

Monday, September 20th, 2010

We thank Peter Schmitt, founder of Montesino Associates, for speaking in our Webcast, "UPDATE: Brazil Law 11.903 - An "Emerging" Regulation for Traceability & Serialization." Peter did a wonderful job of bringing attendees up to date on the law and the evolving proposals to meet it. You may have heard some ...

Hospital Decided to Divert Drugs

Wednesday, February 17th, 2010

I hope you read this news in today's  PMP News.com Daily Newsletter: "Hospital makes a profit trading NHS drugs in Europe."  Before you click to read it, though, I just want to share a few quick thoughts. This story shocked me. We've reported instances of tampering and theft by healthcare professionals ...

Can Tamper Evidence Reduce Risk?

Friday, December 11th, 2009

Recent cases of syringe tampering have made me wonder: Should prefilled syringes carry tamper evidence as part of a risk-mitigation strategy? Tamper-evident packaging is not required for prescription drugs. According to an FDA spokesperson, "the regulation that requires tamper-evident packaging (21 CFR 211.132) applies only to over-the-counter drugs, not prescription drugs." ...

First Glue, Now Tape?

Monday, December 7th, 2009

Demerol has been victimized again. The U.S. Department of Justice United States Attorney District of New Hampshire reported that Trinidad Smith, of Manchester, NH, pleaded guilty to an indictment charging her with violations involving consumer product tampering and obtaining a controlled substance by fraud or deception. Smith was a registered nurse ...

How Super Glue Fooled Hospital Staff

Wednesday, November 11th, 2009

A drug-addicted nurse who was convicted for stealing Demerol reportedly used super glue to cover up her tampering. The U.S. Attorney's Office in Washington state reported that Drea Lynne Gibson was sentenced to just over a year in prison for tampering with doses of Demerol at the surgical center where she ...