Drug Topics - June 16, 2008 - (Page HSE5)

HSE 5 Clinical Practice < < < Beware of inflammatory masses from implantable infusion systems Jillene Magill-Lewis, R.Ph. T Implanting the systems he recent recall of requires surgery, which Medtronic’s implantable Most common has inherent risks and is intrathecal infusion sys- symptoms costly—the procedure tems due to the occurrence of associated with can cost $20,000 or more inflammatory masses has un- inflammatory per patient. There are also derscored the need for physi- masses issues with mechanical miscians, pharmacists, and patients • decreased therapeutic response/ inadequate pain relief haps and failures. The Medtronic to be aware of the problem and • pain intrathecal systems have been recalled monitor for it accordingly. • neurological deficit or dysfunction several times in the past for various meAlthough the incidence of • paralysis/paraplegia/paresis chanical issues. inflammatory masses associ- • weakness/muscle weakness The latest recall is based on reports ated with implanted intrathecal • numbness of inflammatory masses that may ocinfusion systems has increased, • incontinence cur at or near the distal tip of intrait is still relatively low at 0.49%. Marc Lapointe, Pharm.D., has worked with this thecal catheters. These masses have been reported population of patients for about 10 years. Out of with the intrathecal infusion of an estimated 50 or more patients in his practice, opioids, baclofen, pharmacyUse implantable Lapointe said he is aware of three patients who devel- compounded drugs, and other intrathecal admixtures, according to both oped inflammatory masses. systems safely Intrathecal therapy is used to treat patients with the Food & Drug Adminishen administering intrathecal chronic pain or severe spasticity. By the time patients tration and Medtronic. The opioids, the lowest effective turn to intrathecal therapy, they have already tried masses have been associated dose and concentration should be and failed oral medications, surgery, or other methods most often with relatively high administered. In patients treated with intrathecal of treatment. Implantable intrathecal pumps deliver doses of opioids. baclofen, physicians should closely Lapointe explained that comcontinuous infusions of medications to the intrathemonitor them in order to identify cal space. Studies have indicated that patients treated pounded medications are used the prodromal clinical signs and this way have significantly less pain than with prior because they are less expensive. symptoms of inflammatory mass, They can also be compounded especially if using pharmacy-comtreatments. Patients with severe spasticity have also responded in higher concentrations, al- pounded drugs or baclofen admixwell to intrathecal therapy. Spasticity can be caused lowing patients to have their tures that include opioids. In patients with new neurologiby cerebral palsy, multiple sclerosis, stroke, or damage pumps refilled less frequently. to the brain or spinal cord. Intrathecal baclofen (Lio- Medtronic is recommending cal signs or symptoms, consider resal Intrathecal, Novartis) is indicated for spasticity that only medications FDA ap- neurosurgical consultation and an imaging procedure to confirm or and is approved for use in implantable intrathecal proved and indicated for use rule out the diagnosis of an inflamsystems. Lapointe has worked with the Medtronic with the intrathecal systems be matory mass. intrathecal systems since they were in clinical trials used for this type of therapy. Infumorph (Baxter Healthcare Lapointe said it’s important Corp.), Prialt (Elan Pharmaceuticals), for spasticity therapy. He is also an associate professor with the colleges of medicine and pharmacy at the for pharmacists to be aware of and Lioresal Intrathecal are the only Medical University of South Carolina and director of the symptoms of inflamma- drug products approved and inditory masses in order to refer cated for use with the Medtronic the translational research unit for the university. Because intrathecal therapy delivers drugs directly to patients to their physicians for implantable intrathecal systems. Drug products injected into the spine the intrathecal sac, intrathecal doses are 100 to 1,000 evaluation. “This technology is should never contain preservatives. times lower than oral doses, LaPointe said. As a result, unique,” he said, “but you have Preservatives are not compatible patients usually experience fewer and milder adverse to be careful with it.” with neurological drug infusion pumps and are neurotoxic. effects. THE AUTHOR is a writer based in the But the intrathecal systems have some drawbacks. Seattle area. W

Table of Contents Feed for the Digital Edition of Drug Topics - June 16, 2008

Drug Topics - June 16, 2008 Contents Latebreakers Letters Latebreakers in Depth Pharmacists Lose in Final ESRD Rule New Drug Helps Palliative Patients on Opioids Take Care of Business Oral Treatment Reduces Multiple Sclerosis Flare-ups Beware of Inflammatory Masses From Implantable Infusion Systems Safer Therapeutic Options Emerging for Atrial Fibrillation Congressional Committee Chair Calls for Action Against Hospital Infections This Software System Helps Hospitals Manage Anticoagulation Therapy Rx Care Community Practice JP at Large Self-Care Cover Story Long-Term Care Chains and Business Technology Technology Update Continuing Education New Products Advertisers Index Classified Viewpoint

Drug Topics - June 16, 2008

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