Archive for the ‘Safety’ 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 »
Friday, April 13th, 2012
The Pharmaceutical Distribution Security Alliance (PDSA) has succeeded in bringing together several manufacturers, wholesalers, and pharmacy chains in support of a federal law automating pharmaceutical tracking. Its proposed RxTEC Act would replace the "pedigree" requirements of the Prescription Drug Marketing Act as well as any state laws with ...
Posted in Counterfeiting, FDA, security, supply chain | No Comments »
Wednesday, February 1st, 2012
Pfizer took to the Internet today to address its voluntary recall of approximately one million packs of birth control pills. Recalled are 28 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States.
Pfizer's Chief Medical Officer Freda Lewis-Hall explained ...
Posted in Blisters, FDA, Inspection, Recalls, Safety | No Comments »
Tuesday, January 24th, 2012
In our daily newsletter today, we shared a report of a substantial payout in a court case involving contaminated propofol vials. A jury had ordered Teva Pharmaceuticals and Baxter Healthcare Corp. to pay $104 million to a 71-year-old patient and his wife after he contracted hepatitis C reportedly after being ...
Posted in Design, Drug Delivery, Hospital, Medical Errors, Safety, vials | 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 »
Friday, December 16th, 2011
I was intrigued to see packaging mentioned in the new child safety program promoted by the Centers for Disease Control and Prevention (CDC) and other partners, Up and Away. The program is part of the PROTECT Initiative, with drug manufacturers, packaging suppliers, and ...
Posted in Baby Boomers, Blisters, Bottles, clinical trials, Design, Labeling, Safety | No Comments »
Wednesday, November 30th, 2011
As the end of 2011 nears, we'll all be looking back to ensure we've wrapped up any unfinished business and making resolutions for 2012.
Is preventive maintenance on your list?
Or has your schedule slipped? If so, how do you know whether your machinery is still operating to your specifications? Could product ...
Posted in FDA, machinery, Recalls, Safety | No Comments »
Wednesday, October 26th, 2011
A first concern of nurses is avoiding contaminating the inside of sterile packaging when devices are flipped to a sterile field or handed off to the scrub nurse.
At the Healthcare Packaging Immersion Experience organized by Michigan State University and Oliver-Tolas Healthcare Packaging, Tony Trier, a masters degree candidate at the ...
Posted in Compliance Packaging, Counterfeiting, Design, End-Users, Handling, Hospital, Medical Devices, Medical Errors, Pouches, Quality, Safety, security, standards | No Comments »
Wednesday, October 26th, 2011
Doctors and nurses are often tripped up by product packaging and labeling, putting patients and themselves at risk, warns Dr. John Gosbee, Human Factors Engineering & Healthcare Specialist at Red Forest Consulting and University of Michigan Health System.
Gosbee spoke at the Healthcare Packaging Immersion Experience, organized by Michigan State University’s ...
Posted in Design, End-Users, Handling, Hospital, Labeling, Medical Devices, Medical Errors, Package Inserts, Printing and Coding, Safety | No Comments »
Friday, September 23rd, 2011
The role of a paramedic is to stabilize a patient in an emergency situation. Seconds count---so ask yourselves this question: Does your package ease emergency care, or get in its way?
In just a couple weeks (October 5-6), Michigan State University (MSU) and Oliver-Tolas Healthcare Packaging will offer the chance to ...
Posted in Drug Delivery, End-Users, Handling, Hospital, Medical Devices, Medical Errors, Safety | No Comments »
