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Nearly 308 million Americans see a clinician each year primarily because of pain. Of these, 100 million are living with chronic pain, or pain lasting longer than 3 months.1 An opioid prescription is given to 20% of patients who have nonmalignant acute or chronic pain. In 2012, clinicians wrote 259 million prescriptions for opioid analgesics, equal to the number of adults in the United States. From 2007 to 2012, the number of opioid prescriptions written increased 7.3% per capita. Rates of prescribing increased more in primary care practices than in specialty practices.2,3 More than 50% of patients who have received uninterrupted opioid therapy for 3 months are still receiving it after 4 years.3 After the implementation of strategies to reduce opioid prescribing, the number of prescriptions written decreased to 207 million in 2013.4
The increased use of opioid prescriptions to treat chronic pain has resulted in the rise of opioid use disorder, addiction, and abuse. In 2013, 1.9 million people in the United States met the criteria for opioid analgesic abuse or dependence, according to the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition.5 Patients at increased risk for opioid misuse and/or opioid use disorder include those with a history of behaviors such as seeking early refills and “doctor shopping,” a personal and family history of substance abuse, a history of sexual abuse during preadolescence, or comorbid psychiatric disorders.3 The nonmedical use of opioid analgesics and the reduction strategies instituted to eliminate the overprescribing of these agents has led to an increase in heroin abuse. Most current heroin users were introduced to opioids as prescribed medications. Also, a major change has occurred in the demographic profile of persons with heroin addiction, who now comprise a populace that is older, more rural, and more gender equal, with fewer members of racial and social minorities.5
Paralleling the increase in the availability of opioid analgesics, opioid use disorder, and heroin use has been a rise in the number of deaths from prescription opioid overdose. Unintentional opioid analgesic overdose is a leading cause of accidental death in the United States.6 More than 16,000 deaths in the United States yearly are ascribed to prescription opioids.7 This is more than twice the number related to heroin use in 2013.8 As early as 2006, opioid drug poisoning deaths had surpassed the number of deaths related to heroin, cocaine, and psychostimulants collectively.4 Known contributing factors to opioid overdose include overprescribing by clinicians for the management of chronic pain, solicitation by patients from multiple providers or from profit-driven, high-volume pain management clinics (“pill mills”), and the nonmedical use of opioids by patients (ie, selling, sharing, and/or recreational use).9 As the dose of opioids increases, so does the death rate.5
A public health crisis
Opioid overdose has become a major public health crisis in the United States. It has also contributed to a substantial financial burden. The annual medical costs of opioid poisoning total $72 billion.9,10 Patients at increased risk for overdose are those with medical comorbidities that have the potential to cause respiratory depression or failure (eg, sleep apnea, lung disease, heart failure); those receiving benzodiazepines or sedative-hypnotics; those with psychiatric comorbidities (eg, depression, anxiety); and those with problematic alcohol use.3 Opioid morbidity and mortality may be prevented through the early administration of an antidote.7 The administration of naloxone, an opioid antidote, by laypersons or nonmedical witnesses of an opioid emergency provides a quick, lifesaving intervention to someone who may die before emergency services arrive, especially in rural locations or in situations in which witnesses are afraid to call emergency services.9
The management of chronic pain is necessary and unavoidable in primary care, especially in rural or remote areas of the country where the number of pain specialists to whom patients can be referred is limited. Chronic pain is often managed in primary care. Thus, it is necessary for primary care providers to meet the needs of patients at high risk for opioid overdose by co-prescribing naloxone.
Naloxone is a 40-year-old drug that the US Food and Drug Administration (FDA) approved in 2015 for the rapid reversal of respiratory depression induced by heroin or prescription opioid overdose.11 Naloxone is a high-affinity, short-acting opioid mu-receptor antagonist. It produces a discernible pharmacologic action only if opioid agonists are present. In the United States, a prescription is required to distribute a sterile solution of naloxone for parenteral (injected or intranasal) administration.4,12 The recommended dose of naloxone is 0.4 mg, which may be repeated in 2 to 3 minutes if arousal is unsatisfactory after first administration.2,13