“Safe and Effective When Used As Directed”: The Case of Chronic Use of Opioid Analgesics

Abstract

Opioid analgesics have been used increasingly over the past 20 years for the management of chronic noncancer pain in the USA under the assumption that they were safe and effective when used as directed. The accuracy of that assumption has not been tested against accumulated evidence. The safety of opioids used on a long-term basis has not been tested in clinical trials. Epidemiologic evidence from examinations of such use in the general population indicates that the risk of overdose increases in a doseresponse manner. Such evidence also suggests increased risk of fractures and acute myocardial infarctions among elderly users of opioids for chronic pain. Experimental evidence supports short-term use of opioids, but trials of long-term use for chronic pain have not been conducted. Epidemiologic evidence suggests that long-term use does not result in improvement in function or quality of life while being associated with significant dropout rates and a high prevalence of adverse drug effects. Substantial fractions of patients are not using opioid analgesics as directed, while millions of US residents are using them without a prescription for nonmedical reasons. A prudent treatment approach consistent with the available evidence would be to reserve chronic opioid therapy for serious pain-related problems for which the effectiveness of opioids has been demonstrated and for patients whose use as directed is assured through close monitoring and for whom an explicit, informed calculation has been made that the benefits of opioids outweigh the risks.

Opioid receptor agonists may favorably affect bone mechanical properties in rats with estrogen deficiency-induced osteoporosis

“…More and more patients, including the elderly, in whom bone mass physiologically decreases, undergo prolonged exposure to opioid analgesics (agonists, partial agonists and agonist-antagonists of opioid receptors) (Ballantyne 2012). This applies particularly to postmenopausal women who are at increased risk of developing osteoporosis due to estrogen deficiency (Braden et al 2012).…”

Sleep-disordered breathing decreases after opioid withdrawal

“…3,4,8,21,26,36 The reasons for these unintentional opioidassociated deaths are not sufficiently understood. 43 Furthermore, the mechanism is unknown, which could explain the reported increased rate of cardiovascular events in elderly patients with arthritis treated with opioids 36 or the increased incidence of stroke in patients with prostate cancer 21 also treated with opioids.…”

Eight-Year Trends in the Use of Opioids, Other Analgesics, and Psychotropic Medications Among Institutionalized Older People in Finland

“…11,14,15 Observational studies suggest there is considerable interpatient variability in tolerability and opioid-related adverse drug events (ADEs) vary according to the specific agent. 12,16,17 When used among older people, opioids have been associated with abuse, overdose, falls and fractures, 18e21 hospitalizations, 20 cognitive decline, 22,23 and delirium. 24 The use of opioids at the population level has increased substantially over the past decade 25e27 ; however, less is known about the change in opioid prevalence among institutionalized older people.…”