Best Practices for Intrathecal Drug Delivery for Pain

Fentanyl Overdose Caused by Malfunction of SynchroMed II Intrathecal Pump

“…6,7 In contrast, in our patients presented previously, intrathecal pump failure very likely led to an overinfusion. An earlier published case reported an intrathecal overinfusion of baclofen due to pump failure, 8 and a retrospective study assessing the efficacy of intrathecal morphine infusion, reported 1 complication of overinfusion of morphine.…”

“…Apart from pump malfunction, other causes can lead to an overdose in patients with IDDS, such as inadvertent injection of the drug into the patient's subcutaneous tissue during refill (called a pocket fill), inappropriate flow-rate setting due to a programming error, or a backflow of the medication by a leaking silicone septum. 6,10 Overdose symptoms after a pocket fill typically occur immediately. 6 As our first patient complained of sleepiness during the whole period of the last weeks before the refill and in our second patient the overdose symptoms started 5 hours after the pump refill, a pocket fill in both patients was unlikely.…”

“…6,10 Overdose symptoms after a pocket fill typically occur immediately. 6 As our first patient complained of sleepiness during the whole period of the last weeks before the refill and in our second patient the overdose symptoms started 5 hours after the pump refill, a pocket fill in both patients was unlikely. Furthermore, in both of our patients, pump analysis confirmed the possibility of an overinfusion.…”

The Enduring Vitality of Implausible Claims for Neurostimulation and Psychosurgical Therapies

“…When we analyzed how implantable device-based pain therapies had zero efficacy, disagreements over the quality of evidence were of limited consequence in public health terms [23,24] . However, as data have emerged that undermine the notion that spinal cord stimulation and intrathecal opioid drug delivery are safe [ 26,27 , http://www.wsj.com/articles/SB10001424052702 304512504579493843647492538] a subset of implanting physicians have collaborated with industry to generate publications that misrepresent efficacy and underestimate (or deflect attention from) relative risks [28,29] . Readers may not be aware that with the exception of ziconotide (Prialt, Jazz Pharmaceuticals, Dublin, Ireland), and despite pre-1976 legacy status and other historical factors, no FDA-approved neurostimulation or intrathecal drug therapy for noncancer pain has successfully undergone formal clinical trial programs to establish safety and efficacy.…”

“…Salient examples of trials with straw-man control groups for spinal cord stimulation include the EVIDENCE and PROMISE trials [ 30 , https:// clinicaltrials.gov/ct2/show/NCT01697358?term=NCT01697358 &rank=1]. Industry-sponsored activities to defend and promote arguably hazardous and ineffective intrathecal drug delivery practices include a decade-long series of polyanalgesic consensus documents [28][29][30][31][32][33][34] . Despite manufacturers and FDA having information to the contrary, physician-industry collaborative publications that relied upon incomplete or selective data have provided unrealistic assurances of safety and substantially underestimated risk -specifically, in discussions of paralysis related to implantation of surgical (paddle) spinal cord stimulation leads and death during maintenance of intraspinal opioid therapy, respectively [31][32][33][34][35][36][37] .…”