Oklahoma ranked 5th nationally in rates of opioid prescribing in 2016, with 97.9 opioid prescriptions per 100 people. Opioids account for the majority of prescription drug-related overdose deaths. Despite recent declines, deaths from opioids remain common.
Importance Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain.
Objective To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.
Design, Setting, and Participants Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized.
Interventions Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response.
Main Outcomes and Measures The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19).
Results Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, −0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).
Conclusions and Relevance Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.
Trial Registration clinicaltrials.gov Identifier: NCT01583985
The US Food and Drug Administration (FDA) approved DSUVIA, the synthetic opioid sufentanil in tiny blue tablet form, on Nov. 2, 2018 for single doses ingested under the tongue. Sufentanil is chemically similar to fentanyl (the lethal narcotic showing up as fake oxycodone pills and as a cutting agent in heroin) but estimated to be five to 10 times stronger. The opioid has been administered in solution form via IV and epidural injection since 1984, and typically employed as an anesthesia during major surgery (high dose) and in low-dosages as part of pain-relieving regimen for general surgery. (ROCIC Drug Publication)
Most patients taking opioids for chronic pain are managed by primary care providers and their staff. Many practices are looking for help in managing their patients using chronic opioid therapy. To meet this need, AHRQ funded the Six Building Blocks project through grant number R18HS0237850. Additional funding was provided by Washington State Department of Health subcontract (HED23124) of Cooperative U17CE002734, funded by the Centers for Disease Control and Prevention.
Objectives
Discuss the good, the bad, and the ugly of the following:
This Patient-provider agreement records the discussion about the patient’s rights and consent to treatment for chronic pain, particularly when the treatment involves using a controlled substance or any opioid drug.
The ongoing opioid crisis lies at the intersection of two substantial public health challenges—reducing the burden of suffering from pain and containing the rising toll of the harms that can result from the use of opioid medications. In March 2016, the U.S. Food and Drug Administration (FDA) asked the National Academies of Sciences, Engineering, and Medicine (the National Academies) to convene an ad hoc committee to
• update the state of the science on pain research, care, and education since publication of the 2011 Institute of Medicine (IOM) report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, including the evolving role of opioids in pain management;
• characterize the epidemiology of the opioid epidemic and the evidence on strategies for addressing it;
• identify actions the FDA and other organizations can take to respond to the epidemic, with a particular focus on the FDA’s development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring; and
• identify research questions that need to be addressed to assist the FDA in implementing this framework.
