Archive for the ‘Hospital’ Category
Wednesday, September 1st, 2010
While working on our next issue of Tracking & Tracing Pharmaceutical Products, we checked in with Huda Midani, business development manager, Schreiner ProSecure, Schreiner MediPharm L.P. about making a switch to a security label. I hear from many of you that changing packaging or labeling can often be challenging ...
Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Hospital, Labeling, Medical Devices, Safety, security, supply chain | No Comments »
Thursday, May 13th, 2010
Today is the final day for comments on California's new prescription drug labeling requirements aimed to boost patient safety. Don't worry--they appear to target pharmacy-generated labels, not manufacturer-generated labeling--but I wonder how they ultimately could influence your labeling.
The new rule drives a number of changes that would result in what ...
Posted in Baby Boomers, Bar Coding, Bottles, Compliance Packaging, Counterfeiting, FDA, Healthcare Reform, Hospital, Labeling, Medical Devices, Medical Errors, Pharmacies, Safety | 2 Comments »
Tuesday, April 13th, 2010
The U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality (AHRQ) published its 2009 National Healthcare Quality Report and National Healthcare Disparities Report today, and results are mixed. Most media reports today--including the AHRQ's own press release--focused on the lack of progress ...
Posted in Hospital | No Comments »
Monday, April 5th, 2010
Heparin is in the news again, although it is not exactly clear what role it played in the death of a 23-month-old girl at the Nebraska Medical Center. According to a story from CNN, "Nebraska Medical Center believes that the child received an overdose of heparin, and that it contributed ...
Posted in Hospital, Medical Errors | 1 Comment »
Thursday, March 11th, 2010
If you are wondering what FDA is thinking these days when it comes to drug safety, you should read yesterday's statement from Joshua M. Sharfstein, M.D., FDA's principal deputy commissioner, before the Committee on Energy and Commerce, Subcommittee on Health, U.S. House of Representatives. You may not have all your ...
Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Hospital, Imports, Third Parties, security, serialization | No Comments »
Tuesday, February 16th, 2010
I have always heard that historically, FDA has pretty much just regulated the manufacture and marketing of the products it oversees (i.e., pharmaceuticals and medical devices, among others) but not the practice of medicine itself. Currently, though, FDA can mandate certain activities under a risk evaluation and mitigation strategy (REMS). ...
Posted in FDA, Hospital, Labeling, Medication Guides, REMS, Safety | No Comments »
Monday, January 25th, 2010
Packaging is being called upon to help consumers identify counterfeit Alli. Could you call upon your own packaging to help in the event of a counterfeit attack on your brands?
FDA updated its public health alert about a counterfeit version of Alli 60 mg capsules (120 count refill pack) being sold ...
Posted in Bar Coding, Counterfeiting, FDA, Hospital | 2 Comments »
Wednesday, January 20th, 2010
After Republican Scott Brown's win in Massachusetts, political pundits are already predicting the failure of President Obama's healthcare reform efforts. But even if the bill currently tied up in Congress fails to pass, healthcare reform does not have to end. In fact, if the bill does fail, maybe healthcare reformers ...
Posted in Bar Coding, Compliance Packaging, Counterfeiting, Healthcare Reform, Hospital, Inspection, Labeling, Medical Devices, Medical Errors, Safety, security | 1 Comment »
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, Tampering, Theft, security | No Comments »
Monday, November 9th, 2009
Healthcare reform efforts are still in the making. But so far, bills in the Senate and House of Representatives have clauses for medication therapy management (MTM) services, reports Anne Burns, vice president of professional affairs for the American Pharmacists Association (APhA). "We are excited that medication therapy management (MTM) services, ...
Posted in CMS, Compliance Packaging, Counterfeiting, Healthcare Reform, Hospital, Medication Therapy Management, Safety, Senior Friendly Packaging | 1 Comment »
