Morphine pumps dangerous glitch – SFGate – San Francisco Chronicle
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. 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.”
As we know from the New England case where hundreds of patients were poisoned by non-sterile compounded drugs injected into their spines, this industry is not tightly regulated.
Doctors can order all kinds of exotic mixes to be compounded for injection into the spine through epidural injections or implanted pain pumps. Such creative compounding is NOT regulated like oral drugs, so it’s the “wild west” of pain management.
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.
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
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
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.
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.
Sellers said that compounded drugs simply shouldn’t be used in morphine pumps tied directly to the spine.
When we take a drug orally it is exposed to and broken down by our caustic digestive juices, which can mitigate sterility and pollution problems.
But when a drug is injected directly into the major highway of our whole nervous system, our body cannot defend itself against any impurities.
“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.”