Morphine pumps dangerous glitch

Article a week old---- probably no longer avail free; post from healthleaders review. Just getting chance to post today extensively as busy with real life--"youngest" graduated from Eighth grade last night. Karen


Morphine pumps dangerous glitch
Sabin Russell, Chronicle Medical Writer
Sunday, June 9, 2002
©2002 San Francisco Chronicle.

URL: http://sfgate.com/cgi-bin/article.cg...9/MN227684.DTL


For thousands of chronic pain sufferers, the Medtronic implantable morphine pump has been a godsend.

The size of a hockey puck, the high-tech gadget is tucked surgically under the skin of the abdomen -- primarily in injury and cancer patients -- and drips morphine and other painkillers from a reservoir directly into the spine.

But a dangerous complication, once thought extremely rare, has now turned up in scores of patients. An inflamed mass of tissue develops at the tip of the tube where the drug enters the spine. These "granulomas" can grow to the size of a golf ball, compressing the spinal cord and causing paralysis -- either suddenly or slowly, and often irreversibly.

Dr. Eugene Mironer, who has seen the complication crop up in four of the roughly 150 patients at his South Carolina pain management clinic, dubbed it "the curse of the pumps."

With mounting urgency, surgeons are attempting to pinpoint why this is happening. One possible culprit: the use of unapproved drugs to refill the half-ounce reservoirs during monthly visits to the pain clinic.

It has become a common practice in pain management to refill the pump's built-in tank with medicines made from scratch by community druggists known as "compounding pharmacists."

Instead of prescribing the FDA-approved morphine, known as Infumorph, doctors can order higher concentrations of compounded morphine, or mix it with other medications such as clonidine that enhance the painkiller's effect.

Compounders -- druggists who make up all kinds of medicine from bulk powders -- also make the painkillers dilaudid and fentanyl for use in the pumps.


MAKING MONEY FROM MIXING
Mixing morphine for use in pumps is a lucrative business for both compounders and the doctors who buy it. Less than $5 worth of powdered morphine is needed to refill the pump for a month. Reimbursements to physicians who refill the pumps can be as high as $1,000 a month, although Medicare will pay about $250 for eligible California patients.

Regular visits to pain clinics for pump refills are routine for grateful patients like Peggy Wooldridge, who had the device implanted in 1997 after nearly 10 years of debilitating back pain.

"From the moment it was put in, it has been relief beyond my wildest dreams, " said Wooldridge, 60, a former emergency room nurse who now gardens at her home near Placerville.

Like most patients with pumps, she has not experienced any problems with it.

Direct application of morphine to her injury requires much less of the drug than she would have to take orally, and it has fewer side effects. She needs a refill only once every three months.

But the number of reports of granuloma cases -- most of which have been found in the past two years -- has sent pain doctors and Minneapolis pump- maker Medtronic scrambling.

"The fact of the matter is we do not know with medical certainty what causes these granulomas," said Scott Ward, president of Medtronic's neurological and diabetes division.


PROBLEMS IN TENNESSEE
That mystery deepened when eight of 13 patients at a Memphis, Tenn., pain clinic suffered severe neurological problems two years ago after a pharmacist apparently made faulty batches of morphine from bulk ingredients to refill their pumps.

Three of the eight required surgery and are now partially paralyzed.

"My client spent 60 days in the hospital, and has motor skills and speech problems ever since," said Memphis attorney Chris Wagner.

Although the Food and Drug Administration and the Centers for Disease Control and Prevention were notified, the incident has been unpublicized outside medical circles. The sole account of the case appears in the January issue of the American Journal of Medicine.

An investigation by the Tennessee Board of Pharmacy found two jars of compounded solution labeled morphine at the drugstore. But both contained a mixture of morphine and methadone -- a heroin substitute used in drug treatment programs. Investigators also found ethanol and methanol, contaminants sometimes found in poor quality morphine powder.

The pharmacist voluntarily agreed to stop making painkillers for use in the pumps. Tennessee has taken no disciplinary action, but the case remains active,

according to the state board.

Doctors reported both similarities and differences in the Tennessee cluster to previous cases of granulomas, but did not conclude they were related.


NUMBERS APPEAR TO GROW
The first pump granuloma case was reported in 1991. Most recently, 41 were identified in the journal Neurosurgery by Dr. Kim Burchiel of Oregon Health & Science University and Dr. Robert Coffey of Medtronic.

Burchiel confirmed that since the article was submitted a year ago, the number of cases has grown to at least 74. "We don't know what the true incidence is," he said.

Medtronic's Coffey, who estimates that 30,000 patients in the United States are wearing portable infusion pumps, discounts compounded drugs as the cause of the problem.

Granulomas have occurred in patients who used FDA-approved morphine as well,

he said. The inflammation may be a chemical irritation ''related to the properties of morphine itself."


PHARMACIST SEES RISKS
Pharmacist Sarah Sellers, a consultant to an FDA advisory committee on pharmacy compounding, has been a longtime critic of using compounded drugs to fill implantable pumps.

Because compounders make the refills from bulk, unsterile powders, Sellers said, there is a risk of contamination not only from processing chemicals, but also from organic debris that can slip through filters designed to strain out bacteria.

"It's extremely dangerous," she said. ". . . You might as well stamp a question mark on the box the drug came in."

Nevertheless, pain doctors contacted by The Chronicle are skeptical that the use of compounded drugs is related to the growing number of pump-related paralyses.

Elliot Krames, a Bay Area pain specialist and Wooldridge's doctor, has seen only two such cases among the 400 pumps he has implanted in his patients. "One had compounded drug, the other didn't," he said.

Fully 80 percent of Krames' patients rely on compounding pharmacists for their pump refills, and he said barring compounded drugs would be disastrous for his patients.

"I still believe this is an extremely rare problem," he said. "I wouldn't blame compounding pharmacists for it."

Sellers said that compounded drugs simply shouldn't be used in morphine pumps tied directly to the spine.

"There's nothing in the scientific literature to support these drug mixtures," she said. "They are experimenting with patients, and billing a lot of money for it."

E-mail Sabin Russell at srussell@sfchronicle.com.

©2002 San Francisco Chronicle. Page A - 1