Medical practice perspective: identification and mitigation of risk factors for mortality associated with intrathecal opioids for non-cancer pain.
OBJECTIVE
The authors recently determined that early and longer term mortality after initiation or reinitiation of intrathecal opioid therapy is higher than previously appreciated: 0.088% within 3 days, 0.39% at 1 month, and 3.89% at 1 year. These rates were 7.5 (confidence interval, 5.7-9.8), 3.4 (confidence interval, 2.9-3.8), and 2.7 (confidence interval, 2.6-2.8) times higher, respectively, at each interval than expected based on the age- and gender-matched general U.S. population. A substantial portion of this excess mortality is probably therapy related and cannot be entirely accounted for by underlying demographic or patient-related factors, or by device malfunctions. We also analyzed multiple complementary internal, governmental, and insurance databases to quantify mortality and to identify medical practice patterns that appear to be associated with patient mortality risks, and to suggest measures for physicians and health care facilities to consider in order to reduce those risks. Both of those objectives involve judgments, which may be controversial and are subject to practical limitations.


RESULTS
Multiple clinical and patient- or therapy-related factors appear to increase the risk for early post-implant mortality. Specific risk mitigation measures associated with each factor include: close attention to the starting intrathecal opioid dose (or restarting dose after therapy interruption); avoidance of outpatient implant or other device procedures that involve less than 24-hour monitoring for respiratory depression; supervision of concomitant opioid, respiratory depressant, or other central nervous system active drug intake early post-implant and chronically in the outpatient setting; and careful programming or dosage calculations and decisions in order to avoid the unintentional administration of high intrathecal opioid drug doses.


CONCLUSIONS
Mortality after initiation of or device interventions in intrathecal drug delivery patients appears to occur as a result of multiple factors that present possible mitigation opportunities for physicians and health care facilities.
Coffey
Robert J
RJ
Medtronic Inc., Minneapolis, Minnesota 55432, USA. robert.coffey@medtronic.com
Owens
Mary L
ML
Broste
Steven K
SK
Dubois
Michel Y
MY
Ferrante
F Michael
FM
Schultz
David M
DM
Stearns
Lisa J
LJ
Turner
Michael S
MS
D000701:Analgesics, Opioid / Q000506:poisoning / Q000627:therapeutic use; D016208:Databases, Factual; D062787:Drug Overdose; D006801:Humans; D015918:Infusion Pumps, Implantable / Q000009:adverse effects; D007278:Injections, Spinal / Q000009:adverse effects / Q000401:mortality; D010146:Pain / Q000188:drug therapy*; D012307:Risk Factors
D000701:Analgesics, Opioid