News for January, 2009

Czech ‘heparin murderer’ gets life in prison

Petr Zelenka liked the excitement around crisis situations and the constant activity of hospital staff, which is why he pursued a position at an anaesthesiological-resuscitation ward at Havlickuv Brod hospital in the Czech Republic. To further his excitement, he administered heparin to patients between May and September 2006, which resulted in serious health complications and even death in some patients.

Read the rest of this entry »

Lawmakers call for rule requiring drugs be made in U.S.

Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.”

Read the rest of this entry »

FDA opens offices in India to help oversee drug importation

In an ongoing effort to ensure the safety of foods and drugs imported to the United States, the is opening offices in foreign countries to oversee quality control of those products. The agency announced this week that it has opened two offices in India, according to Med Page Today.

Read the rest of this entry »

Torti named interim commissioner of FDA

chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News.

Read the rest of this entry »

Lawmaker opens investigation into ’software glitches’ at VA

Software “glitches” that lead to medical mishaps and prolonged infusions of drugs such as heparin administered to patients at Veterans Affairs hospitals throughout the U.S., which was reported by the Associated Press earlier this week, have raised concerns from the chairman of the House Veterans Affairs Committee, according to a new report by AP. Nearly one-third of the country’s 153 VA hospitals reported problems with the electronic medical records.

Read the rest of this entry »

CDC study provides details on OSCS-laced heparin

The New England Journal of Medicine reported that the Centers for Disease Control and Prevention (CDC) in a study titled “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” has confirmed the cause of serious adverse reactions in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, the CDC also determined that the contaminated heparin was linked to 152 adverse reactions in 113 patients from 13 states from Nov. 19, 2007 through Jan. 31, 2008.

Read the rest of this entry »

FDA launches pilot project to oversee foreign drug products

The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S.

Read the rest of this entry »

Pharmacy tech steals bagfuls of heparin and other drugs

Pharmacy technician Wanda Lopez told guards she had left her wallet in the pharmacy at Shaughnessy-Kaplan Rehabilitation Hospital in Salem, Mass. Guards led her back to the pharmacy, where she used her key code to re-enter the room with the guards. She searched for her wallet and as her search became fruitless, guards left her alone. Shortly afterward, the guards saw Lopez walking around the hospital with a plastic bag covered by her coat. It was the third trip the pharmacy technician made to her car with bags taken from the hospital, according to a hospital employee. That’s when security guards became suspicious, according to The Salem News.

Read the rest of this entry »

AP: ’software glitches’ led to prolonged infusions of heparin

Medical mishaps including prolonged infusions of drugs such as the heparin were given to patients at Veterans Affairs medical centers throughout the U.S., potentially putting their lives in danger, according to the Associated Press. The errors, which occurred between August 2008 and December 2008, were blamed on “software glitches” that interfered with patients’ electronic health records. Nearly one-third of the country’s 153 VA hospitals reported seeing problems with the electronic medical records.

Read the rest of this entry »

Quaid-Cedars-Siani lawsuit over heparin overdose finally closed

Actor Dennis Quaid and his wife Kimberly now have closure in their year-long heparin overdose lawsuit against Cedars-Siani Medical Center, according to OK! and Entertainment Tonight. The entertainment media reported that a Los Angeles judge has signed off on the $750,000 settlement the couple reached with Cedars-Siani last month. According to the settlement, the hospital did not admit wrongdoing in the potentially fatal overdose of heparin that was accidentally administered to the couple’s newborn children Zoe Grace and Thomas Boone Quaid. The settle also allows for the couple to pursue claims for their children in the future. The California Department of Public Heath fined Cedars-Siani $25,000 for the error.

Read the rest of this entry »