Archive for the ‘Tampering’ Category
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 ...
Posted in Bar Coding, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Fraud, Medical Devices, Recalls, Reimportation, Safety, security, serialization, standards, supply chain, Tampering, Theft | No Comments »
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>, ...
Posted in Bar Coding, Cold Chain, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Handling, Hospital, Imports, Inspection, Internet, Outsourcing, Reimportation, RFID, Safety, security, serialization, standards, supply chain, Tampering, Theft, Transporation | No Comments »
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 ...
Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Hospital, Imports, Inspection, Medical Devices, Medical Errors, Safety, security, serialization, standards, supply chain, Tampering, Theft | 1 Comment »
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 ...
Posted in Bar Coding, Counterfeiting, Labeling, Printing and Coding, security, Tampering | No Comments »
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 ...
Posted in Diversion, serialization, Tampering, Theft | 3 Comments »
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." ...
Posted in Bar Coding, FDA, Hospital, Labeling, Medical Devices, REMS, Safety, security, Tampering, Theft | No Comments »
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 ...
Posted in Safety, Tampering | 2 Comments »
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 ...
Posted in Compliance Packaging, Healthcare Reform, Safety, Tampering, Theft, Uncategorized | 3 Comments »
