Heparin fix leads to new concerns

The Baltimore Sun

WASHINGTON -- Efforts to make the blood thinner heparin safer - and to replace supplies that were depleted by a major recall this year - have meant unintended and fresh safety concerns for hospitals, heart clinics and dialysis centers that use it.

The drug, a staple of medical care prescribed tens of millions of times a year, was recalled in February after contamination during production in China led to as many as 81 deaths in the United States. Its leading maker, Baxter International Inc., has suspended manufacture of most of its heparin products.

The resulting shortage of heparin - the least expensive and most commonly used drug of its type - means heparin from new suppliers is arriving in different quantities and strengths than medical staffs are accustomed to, and pharmacists and others worry that patients may be vulnerable to receiving improper doses.

Even before the drug's recall, proper administration was a major concern. Heparin is one of the five drugs most commonly associated with errors in hospitals, an issue publicly highlighted last year when the actor Dennis Quaid's newborn twins were mistakenly given 1,000 times the intended dosage.

Neither the Food and Drug Administration nor the private Institute for Safe Medication Practices has received reports of medication errors since the recall, but some medical centers are establishing extra precautions.

"I would be very concerned," said Michael Cohen, president of the Institute for Safe Medication Practices near Philadelphia, which is planning to warn about the higher risk of medication error in the next newsletter it sends to the country's 6,000 hospitals. "I wouldn't be surprised if it has already happened."

The problem, pharmacists and others say, is that doctors and nurses may be unfamiliar with new packaging for heparin and could easily give a patient a more potent dose than intended. Unlike the single-dose products typically distributed by Baxter, many of the vials now contain larger or more potent quantities.

"It can lead to dosing errors ... that could harm the patient," said John R. DiBona, director of pharmacy at LifeBridge Health, the parent company of Northwest and Sinai hospitals in the Baltimore area.

At Northwest and Sinai hospitals, DiBona said, pharmacists have taken several steps to prevent medication errors, such as reminding nurses to draw the drug from a vial instead of using a pre-filled syringe. The hospitals have removed the syringes so nurses won't make a mistake while switching between two different products.

Similarly, Children's Hospital in New Orleans, which has been forced to buy heparin products with half the potency it used to get, has given nurses extra training in administering the drug. The hospital also keeps the entire supply in its pharmacy so that nurses are automatically reminded to use a higher concentration when picking up the medication, said Helen M. Calmes, assistant director of pharmacy.

"You just don't want to put them out there for someone to grab," Calmes said.

Heparin supply was disrupted after hundreds of people suffered allergic-type reactions from contaminated heparin. Baxter was forced to recall most of its heparin products. In the company's absence, two smaller makers have significantly increased production, and federal health officials insist that supplies are sufficient.

But the American Society of Health-Systems Pharmacists, representing 30,000 pharmacists at hospitals and other medical facilities, lists heparin among the drugs in short supply. And pharmacists at several hospitals around the country said in interviews that their suppliers were rationing heparin products due to the shortages.

"They're scrambling to make do with whatever heparin products they can get their hands on," said Ronald A. Hartmann, vice president of the pharmacy division at MedAssets Supply Chain Systems in St. Louis, which negotiates drug purchases on behalf of 1,000 hospitals, dialysis centers, surgery clinics, nursing homes and doctor's offices.

Northwest and Sinai hospitals have been able to muster just a third of their normal supply because of rationing by their supplier, DiBona said. Their supplier, McKesson Corp., declined to comment.

To fill the gaps, some hospitals have stepped up use of alternative drugs, including a more purified form of heparin, that works just as well at preventing blood clots. But the alternatives are far more expensive, and hospitals have scrounged for whatever dose sizes and concentrations of heparin they can get their hands on.

For the University of Utah Hospitals and Clinics, that has meant buying heparin in 20-dose vials rather than in syringes filled with a single dose that a nurse could readily administer, said Erin R. Fox, a pharmacist at the Salt Lake City hospitals, which monitors drug shortages for the American Society of Health-System Pharmacists.

The hospitals, which were using 5,000 of these syringes a month before the recall, have been able to meet their needs by buying the larger vials, Fox said, but nurses must draw individual doses into syringes and sometimes refrigerate them before administering the drug.

"Smaller hospitals may not be equipped with the right sterile area to prepare batches of syringes. They may not have the manpower either," Fox said. Her hospitals and clinics are training nurses in drawing the right dose and posting reminders to prevent medication errors.

Pharmacists and industry officials proposed a variety of explanations for the heparin shortages, starting with hospitals' need to replace most of the existing supply from scratch. Also slowing the path to market, pharmacists and officials said, is a new requirement that heparin products must undergo sophisticated testing for the contaminant before being sold.

As supplies are replenished, industry officials see the high demand weakening. U.S. Pharmacopeia, a private group that sets the standards for drug production and quality in the United States, is helping heparin makers prepare to conduct in-house testing for the contaminant soon to speed up production, said Dr. Darrell Abernathy, chief science officer.

Johns Hopkins Hospital has already seen improvement, said Brian Pinto, a drug information specialist at the Baltimore hospital.

After the recall, Hopkins was getting less than half of its normal heparin supply, Pinto said. Within the past few weeks, its supply has returned to almost pre-recall levels, but the hospital is not getting the drug in the form it had normally used. "Those are in short supply," he said.


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