A new initiative to identify preoperative patients who may be predisposed to developing dependence on opioid analgesics could facilitate treatment plans that reduce their exposure to opioids and mitigate that risk.
The joint endeavor by specialty pharmaceutical manufacturer Pacira Pharmaceuticals and therapeutic management firm GeneAlign has incorporated behavioral histories and pharmacogenetic and pharmacogenomic testing into the preoperative risk assessments for selected procedures at pilot institutions.
While Pacira products include a localized, long-acting anesthetic that can be a component of the multimodal analgesic strategies that are increasingly recommended to reduce postoperative opioid requirements (bupivacaine, Exparel), CEO Dave Stack explained in an interview that he is supporting the program for reasons that go beyond the product.
“Although guidelines and recommendations continue to advocate for multimodal therapy, opioids continue to be a significant mainstay for postsurgical pain management, and available nonopioid treatment options are significantly underutilized,” Mr. Stack said. “We expect our partnership with GeneAlign to allow us to take that next step in identifying patients who would gain the most from receiving significantly reduced opioids or even an opioid-free postsurgical multimodal strategy.”
The joint announcement of the initiative late last year cited a recent study in JAMA Internal Medicine that associated several surgical procedures on opioid-naive patients with chronic opioid use after surgery (2016;176:1286-1293).
Particular surgeries associated with an increased rate of chronic opioid use included total knee arthroplasty, open and laparoscopic cholecystectomy, total hip arthroplasty, simple mastectomy, functional endoscopic sinus surgery, and open and laparoscopic appendectomy. The study also determined that men and elderly patients could be particularly vulnerable, and that preoperative use of benzodiazepines or antidepressants also was a risk factor.
Testing Genetic Vulnerability To Opioid Dependence
Jim Silliman, MD, CEO of GeneAlign, explained how the company’s capacity to conduct and interpret genetic tests, and consideration of these along with the medication and behavioral histories in routine preoperative assessments, could improve identifying people at increased risk for chronic drug use and dependence. He anticipates informing both the patient and the surgeon of a possible vulnerability to opioid dependence after surgery, with greater detail on the context and interpretation of the results provided to the surgeon.
The pharmacogenetic testing will focus on the individual’s capacity to metabolize analgesics for activation and elimination. The pharmacogenomic panel will incorporate factors that are now, and in the future, linked to heightened response to opioid reward mechanisms, and possibly to behavioral traits linked to substance disorders such as impulsivity.
“Specific guidance on opioid selection will be given with regard to metabolic phenotype CYP (hepatic cytochrome P450) 2D6 and others, as well as regarding response gene phenotypes OPRM1 (mu-opioid receptor). In addition, we will also take into consideration all major and minor pathways that impact each drug, and will give drug-centric recommendations that take into account all metabolic genetic findings and all relevant response genetic findings,” Dr. Silliman said in an intereview.
Expanding Pilot Program
Dr. Silliman related in the joint announcement that provision of genetic data at the point of care is necessary to integrate personalized medicine into clinical practice. “We are proud … to help advance clinicians’ therapeutic decision-making processes and, ultimately, to optimize patient outcomes and reduce the overall opioid burden,” he said.
The pilot phase of the program is meeting objectives and progressing along the anticipated timeline, according to Mr. Stack.
“We are actively working with our pilot hospital institutions to collect and analyze data generated through this comprehensive opioid risk assessment program. By midyear 2017, we expect to have compelling information about the prevalence of opioid addiction risk in presurgical patients, and the cost and quality impact achieved when implementing an opioid-minimizing pain strategy with these patients,” Mr. Stack said.
Expansion of the program beyond the pilot institutions will be subject to its cost-effectiveness, Mr. Stack explained. He expects that the program will be an acceptable component of the Diagnosis-Related Group reimbursement, as part of preoperative risk assessment.
“Although these tools will require an additional cost to the hospital as part of the prospective payment system, we expect them to contribute significantly to institutional cost savings,” Mr. Stack said.
In addition to reducing risk for chronic opioid use after surgery, Mr. Stack anticipates the program will improve time to patient mobilization, enhance the opportunity for physical therapy and shorten hospital length of stay.