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On September 24, 2008, a regulatory group instructed hospitals to adopt firm measures to prevent errors involving blood thinners including Heparin mistakes that have been made nearly 60,000 times and led to dozens of deaths in recent years.

The Joint Commission issued a safety alert saying hospitals need to adopt prevention measures that could include bar-coding technology for medicines or computerized drug orders. It advised hospitals to more closely monitor patients on these drugs and make sure that adult-strength Heparin is stored nowhere near children’s units.

The alert said 28 deaths are among 32 reports of drug errors involving blood thinners that it received between 1997 and last year.

“We know that there are many more (deaths) and that’s the reason for issuing this alert,” said Dr. Mark Chassin, president of the Oakbrook Terrace, Illinois based commission.

Recent errors include accidental life-threatening Heparin overdoses given to actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. In July, 14 babies received accidental Heparin overdoses at a hospital in Corpus Christi, Texas.

Commission investigators will make unannounced visits to make sure hospitals are adopting strict measures to prevent blood thinner errors, and those who fail to do so could see their accreditation revoked, Chassin said.

The commission is a private group that sets hospital standards and accredits most of the nation’s hospitals. Accreditation brings prestige and federal dollars.

A total of 59,316 medication errors involving blood thinners were reported between 2001 and 2006 to a database run by U.S. Pharmacopeia, a group that sets drug standards, the alert said. Nearly 3 percent, or roughly 1,700, resulted in patient harm or death, the commission said.

Blood thinners are particularly tricky to use because too much can cause hard-to-control bleeding internally and from everybody opening; too little can result in life-threatening blood clots, Chassin said.

Heparin is usually given intravenously. Warfarin, another blood thinner cited in the alert, is available in pills patients can take at home but can cause bad reactions when mixed with other medicines.

The recommendations “absolutely” will make a difference and hospitals will pay attention, said James Conway, senior vice president of the nonprofit Institute for Healthcare Improvement in Cambridge, Massachusetts.

On September 23, 2008, University of California, San Francisco researchers stated that more than half of all supporting clinical trials for U.S. FDA approved drugs remain unpublished five years after permission has been given to sell the drugs in the United States.

They combed the medical literature to determine the publication status of all 909 clinical trials that supported the 90 new drug applications approved by the FDA between 1998 and 2000.

They found that 76% of pivotal trials such as large Phase II and Phase III trials designed to determine the overall risks and benefits of a drug had been published in medical journals, usually within three years of FDA approval of the drug. However, only 43% of all supporting trials submitted to the FDA had been published.

The UCSF team also found evidence of selective reporting of the results from these trials. For example, a pivotal trial in which a new drug outperforms an old drug is more likely to be published than a trial showing a new drug is no better than an old one.

This type of publication bias may lead to an inaccurately favorable record in the medical literature of a drug’s performance compared to similar drugs. That can cause physicians to favor newer and more expensive drugs, the researchers explained.

They said their study findings, published in the journal PLoS Medicine, provide a baseline for monitoring the impact of the FDA Amendments Act 2007. It was introduced to improve the accuracy and completeness of drug trial reporting.

The act requires that all trials supporting FDA-approved drugs be registered when they start and that all outcomes must be posted within a year of drug approval on the U.S. National Institutes of Health’s clinical trials Web site.

New York Health Department officials announced on September 17, 2008, that a New York City dialysis center was shut down after one patient tested positive for hepatitis C.  As a result, an estimated 700 patients of the Life Care Dialysis Center in Manhattan are being urged to get tested for both hepatitis B and C strains, as well as HIV.

Claudia Hutton, a spokeswoman for the Health Department, said on September 16, 2008 that it inspected the clinic, the Life Care Dialysis Center, at 221 West 61st Street, for a week in mid-August and found that employees had failed to wash their hands properly, disinfect equipment or change gloves between patients. Inspectors also found blood on treatment chairs.

“It was repulsive,” Ms. Hutton said. “The treatment chairs that they gave people to relax in had someone else’s dried blood on them.”

Ms. Hutton said that the clinic was ordered to begin sending its patients to other clinics immediately while the Health Department began testing patients for signs of infection.

She said that when one patient was found to have been infected by hepatitis C, a liver disease, because of contaminated equipment, the clinic shut down voluntarily.

Richard F. Daines, the state’s health commissioner, sent letters on September 15, 2008 to 657 patients of the clinic going back to January 2004, the last time infection-control violations had been found, urging them to be tested for possible exposure to hepatitis C, hepatitis B and H.I.V. The clinic, which had 171 patients at the time of the inspection, agreed to pay for the testing, even if it is done by private doctors, officials said.

Ms. Hutton said there was no evidence that other patients had been infected.

Dr. Walter Wasser, the clinic’s operator and medical director, was fined $300,000 and surrendered his operating certificate, Ms. Hutton said. He could face the loss of his medical license after an investigation by the State Office of Professional Medical Conduct, Ms. Hutton said. She declined to say whether such an investigation had begun.

Dr. Wasser did not return a call for comment left with his answering service.

Ms. Hutton said that the Health Department visited the clinic in August to follow up on previous violations, not because of any specific new complaints from patients. She said the department tried to inspect clinics once a year, but was sometimes not able to do so that often because of manpower shortages and the volume of complaints.

She said the department was particularly concerned about dialysis clinics because their patients have compromised immune systems that make them vulnerable.

Hepatitis C is a chronic infectious disease of the liver that is most commonly transmitted by needle-sharing during intravenous drug use, according to the National Institutes of Health. Worldwide, an estimated 180 million people have chronic hepatitis C, with more than 4 million of these cases in the United States, the NIH said on its Web site.