Group seeking changes in drug labels

EpiPens are pre-loaded epinephrine syringes carried by some adults and children with known allergies to bee stings and other environmental allergens.  BANGOR DAILY NEWS PHOTO BY GABOR DEGRE
BDN
EpiPens are pre-loaded epinephrine syringes carried by some adults and children with known allergies to bee stings and other environmental allergens. BANGOR DAILY NEWS PHOTO BY GABOR DEGRE
Posted June 18, 2010, at 10:15 p.m.

DOVER-FOXCROFT, Maine — The head of an independent safety organization that monitors pharmaceutical drugs was concerned when he read a Bangor Daily News account of an Atkinson man’s death earlier this month from a massive overdose of epinephrine administered at Mayo Regional Hospital.

The death of Timothy Harvey, 51, who arrived at the Dover-Foxcroft hospital with symptoms of anaphylaxis — an acute allergic reaction that included facial swelling and thickening of the tongue — was not the first in the nation involving an error in the clinical dosing of an epinephrine injection.

There have been many serious and fatal errors over many years connected with the drug’s dosing, according to Michael R. Cohen, a registered pharmacist and president of the nonprofit Institute for Safe Medication Practices in Pennsylvania.

“I just wanted people to know that this little 25-bed hospital is certainly not alone in some of these horrible medication errors in this particular drug,” Cohen said Friday.

He said the errors occur for many different reasons, but one issue has been the concentration of epinephrine expressed on drug vials by a ratio such as 1:1,000 (one part epinephrine to 1,000 parts of saline solution), 1:10,000, and 1:100,000.

“It gets confusing,” he said. “People sometimes don’t see the zeros properly or they don’t put a comma in or they make a math error.”

Because of the errors, Cohen said, the institute petitioned the standard-setting United States Pharmacopeia in 2004 asking for changes in the drug’s labeling, but had no success. Since epinephrine, a synthetic hormone, was introduced before the Food, Drug and Cosmetic Act was adopted in 1938, it is governed by United States Pharmacopeia, or USP, a nongovernmental organization that determines the standards for prescription drugs and over-the-counter medicines made or sold in the United States.

Cohen said he was “very taken aback” that the petition for the change had taken so long to go through official channels. About a year ago, Cohen said, he was invited to speak at a USP gathering and he presented the case about the need for changes to avoid confusion over epinephrine injections.

“ISMP has tried to move this thing along and unfortunately we haven’t been successful,” he said, referring to the Institute for Safe Medication Practices.

The standard-setting process at United States Pharmacopoeia involves the deliberation by volunteer scientists, and these experts evaluate all of the available evidence when a change is requested to a standard, such as in ISMP’s request, Laura Provan, USP’s director of media relations, said Friday.

“The expert committee apparently decided that there wasn’t sufficient evidence at the time to prompt an expedited change,” Provan said. Many experts believe the problem with epinephrine isn’t a labeling issue but an education and systems issue, she said. In other words, it is not unreasonable to expect doctors and nurses to read the labels and be able to convert ratios when necessary, she said.

Despite that, Provan said, an advisory committee has been established to look at the labeling further. “It is USP’s responsibility to assess the full range of expert opinion on this matter, of which ISMP is one,” she said.

Mayo’s hospitalist Dr. Tom Murray said Friday he was familiar with ISMP, which issues a newsletter every two weeks, and its effort to make changes in the labeling. While ISMP’s issue is related to the confusion over the ratio method used in dispensing the epinephrine, Murray said, Mayo’s incident involved a decimal point error in meting out the dose. A provider wrote 3 milligrams rather than a proper dose of 0.3 milligrams, he said.

For Cohen, one mix-up is too many. “The time has come, enough already, I can’t see people risking lives,” he said.

Ironically, Cohen said, there is a shortage of the 1 milligram/10 milliliter epinephrine pre-filled syringes. ISMP and the American Society of Health-System Pharmacists jointly sent out an alert to medical facilities across the country this week about the shortage.

Jill McDonald, a spokeswoman for Eastern Maine Medical Center in Bangor, said her hospital does not have a shortage of epinephrine pre-filled syringes.

“We’re all set,” she said Friday.

Nor does Mayo Regional Hospital currently have any shortage, according to Murray. Depending upon how long the shortage lasts, he said it could have an effect on the hospital.

Cohen said there had been two U.S. companies manufacturing epinephrine, but one of them stopped producing the product. Today, only Hospira manufactures the drug and it is behind in production, he explained.

He said the shortage could make it difficult for emergency medical technicians, doctors and emergency room employees who, without the pre-filled syringes, will have to make up their own doses of epinephrine when it’s used systemically for a cardiac arrest or for any other severe medical condition. The shortage, he believes, will create more mix-ups.

“We need the FDA to step in and get this labeled properly,” Cohen said, referring to the U.S. Food and Drug Administration. “We need the companies to do it and we have to prevent shortages with such a critical drug,”

Without the changes, there likely will be more serious errors and deaths, he predicted.

SEE COMMENTS →

ADVERTISEMENT | Grow your business
ADVERTISEMENT | Grow your business

Similar Articles

More in State