Dangerous Flaws in Drug Recall System
By Gerri Elder
In California, nearly 100 pharmacists and the hospitals that they work for are now facing fines for failing to take action after a federal drug recall.
Last winter, the blood thinner Heparin was recalled and should have been pulled from the shelves of all hospitals. However, Heparin was still found on plenty of pharmacy shelves during inspections after the recall.
According to the California State Board of Pharmacy, at least 16 hospitals still administered the drug to patients after the recall. During pharmacy inspections, Heparin was found 94 times during the inspections of the 533 hospitals in California.
The hospitals will be required to pay fines ranging from $2,500 to $5,000. This is a slap on the wrist for the hospitals. However, for families who have been impacted by injuries and illness due to improper use of this drug, it is a slap in the face. Who is being punished here?
The Associated Press reported that Virginia Herold, head of the state's pharmacy board, said that these findings are an alert that the drug recall system does not work. And honestly, what other conclusion could be drawn from these findings?
The full list of hospitals where the drug was found after the recall has not been released by the regulators. However, the Daily Journal obtained documents that show that Heparin was allegedly administered to newborns at the University of California San Francisco Medical Center and Children's Hospital of Central California in Madera. These hospitals are appealing the charges.
The Dangers of Heparin
The problem with Heparin seems to be not so much in the drug itself, but with its labeling. Heparin is often given to premature babies to prevent blood clots, but has made headlines recently because of dangerous drug overdoses. Most notably, actor Dennis Quaid's newborn twins, who were born at a Los Angeles hospital last November, were given accidental overdoses of the drug.
Fourteen other babies were given accidental overdoses of Heparin in July at a Corpus Christi, Texas hospital.
The Quaid twins survived the drug overdose, but this case in particular brought Heparin, and its labeling, under scrutiny and led to the recall.
In February, the Federal Drug Administration (FDA) issued a drug recall because of a "higher than usual number" of patients who reported adverse effects to the drug. These adverse side effects included headaches, chest pain and dizziness.
In California, the state's Department of Public Health also launched an investigation to determine whether recalled Heparin, Digitex and Procrit had caused harm to any patients. The investigation found no link, but the department says it will still try to make sure that drugs recalled by the FDA are removed from the hospitals.
Drug Tracking Necessary to Prevent Patient Injuries
Apparently someone needs to check and double check that recalled drugs are removed. There is an obvious procedural breakdown when recalled drugs still sit on pharmacy shelves and are still administered to patients. It would seem that no system is readily in place to remove recalled drugs, therefore they can (and often do) remain in hospitals and pose the potential risk of injury to patients.
Perhaps a better system is in the works. In March, the State Board of Pharmacy in California unanimously voted to give drug makers, wholesalers and pharmacies until January 1, 2011 to start electronically tracking drugs as they make their way from the factory to the patient.
This tracking system is not a new idea though. It actually has been proposed and delayed a number of times since 2004. It was the recall of 175,000 fake bottles of the cholesterol drug Lipitor in 2004 that led California state regulators to talk about requiring drug tracking.
As is evident by the Heparin checks, an accurate drug tracking program to prevent patient injury is well overdue.