The current opioid crisis calls on health care providers to embrace a cautious new approach to opioid prescribing that emphasizes safety. The following recommendations address key safety concerns that are relevant to all pain phases.
Empirical research examining the effect of PMPs on opioid prescribing behavior is growing; however to date the evidence remains mixed. Among states that have implemented mandatory registration and use laws among providers, reductions in opioid prescribing is demonstrated (Bao, 2015; Wen, 2017). However, evidence from states where use is voluntary suggests a more limited impact of PMPs on prescribing behavior (Finley, 2017). Based both on the growing body of evidence that supports the effectiveness of PMPs in states where use is mandatory and on expert consensus, the PMP is an effective patient safety tool for providers and should be used whenever opioid therapy is considered.
Concomitant use of benzodiazepines and opioid analgesics creates significant risk for opioid-related harm and overdose deaths. Three studies of fatal overdose deaths found evidence of concurrent benzodiazepine use in 31 to 61 percent of decedents (Gomes, 2011; Dasgupta, 2015; Nuckols, 2014). In addition, emergency visits and substance abuse treatment admissions involving the combined use of these two drug classes are also increasing (Jones, 2015).
Nearly all recent opioid prescribing guidelines recommend against the concomitant use or prescribing of opioids and benzodiazepines, yet concomitancy remains common. A recent study of concomitant use found that the proportion of opioid users who were co-prescribed benzodiazepines nearly doubled from 9 percent in 2001 to 17 percent in 2013 (Sun, 2017). Clinicians should be extremely cautious about concomitant prescribing and use among their patients. Check with the PMP for current benzodiazepine use frequently and inquire about intermittent use when prescribing opioid analgesic therapy.
There are a number of conditions associated with significant opioid use for which the evidence strongly discourages opioid therapy. These conditions include: fibromyalgia; headache, including migraine; self-limited illness, e.g. sore throat; and uncomplicated, acute neck, back and musculoskeletal pain. Two longitudinal studies found that outcomes in fibromyalgia in opioid-treated participants were worse than those treated with non-opioid drugs (Fitzcharles, 2013; Peng, 2015). There is no evidence from randomized controlled trials to support the use of opioids for fibromyalgia. Systematic reviews of opioid efficacy for low back pain demonstrate modest improvements in pain, but little improvement in function and no evidence that pain relief will be sustained (Chou, 2007; Chaparro, 2014). Evidence from a population-based, prospective study of a low back pain cohort in Washington State’s workers compensation program supports non-opioid therapy for acute pain. The study found that even minimal use of opioids in the first six weeks following an acute low back injury was associated with doubling the risk of disability one year later (Franklin, 2008). The American Academy of Neurology recommends against the use of opioids for conditions such as headache, fibromyalgia and chronic low back pain, given that the risk of death, overdose, opioid use disorder or serious side effects outweighs any benefit (Franklin, 2014).
Certain medical conditions significantly increase the risk of opioid related harm for patients on long-term opioid therapy. Two large observational studies of patients with a history of chronic obstructive pulmonary disease (COPD) and sleep apnea who were prescribed opioids showed a weak, but positive association with opioid-related toxicity/overdose and overdose-related death (Zedler, 2015; Bohnert, 2011). Zedler et al, found that sleep apnea and chronic pulmonary disease as well as renal disease, moderate or severe liver disease and age > 55 years were associated with increased risk for life-threatening respiratory central nervous system depression or overdose. Reduced renal and/or hepatic function results in decreased ability to process and excrete drugs, which can result in greater peak effect and longer duration of action. Although the evidence primarily examines the effect of long-term opioid use, clinicians should consider these comorbidities in the risk-benefit analysis anytime opioids are considered for pain management.
Address the following at each visit:
Shared decision-making about opioid therapy for pain management should begin with the first opioid prescription. Carefully describe the risks and benefits of opioid use to every patient, regardless of their perceived risk profile or the intended duration of opioid therapy. Explain the harms associated with opioids in an objective, non-judgmental manner and repeat patient education often. Clinics and health systems should have a variety of patient education materials—written materials, references to online content, suggested videos on platforms such as YouTube—available to patients beginning with the first opioid prescription.
Address the following safety considerations with the patient at every visit when opioid therapy is initiated or continued (SAMHSA, 2016):
Co-prescribing naloxone with opioid analgesia and providing the necessary information about naloxone administration are important risk mitigation strategies to prevent opioid overdose-related death. A systematic review of 22 observational studies provided moderate-quality evidence that take home naloxone programs are effective in improving overdose survival and decreasing mortality, with a low rate of adverse events (McDonald, 2016). Prescription of naloxone kits and accompanying education have also been found to reduce opioid-related emergency department visits (Coffin, 2016).
Clinicians should ask their patients whether they have received a previous prescription for naloxone and whether it was filled. Educate patients that naloxone is not a self-administered drug. Review the following with the patient and a family member, friend or caregiver prior to prescribing naloxone: 1) how to identify an overdose; 2) how to properly use naloxone; and 3) safe storage. Educational resources are available on the Minnesota Department of Health’s Expanding Access to Naloxone and Preventing Opioid Overdose web site.
Consider prescribing naloxone to the following populations at high-risk of opioid overdose:
Other patient populations who are at elevated risk of opioid-related harm, especially when prescribed long-term opioid therapy, include:
