Joel M. Prince, MD; William B. Seiden, MD, FACP
After falls, the leading cause of accidental death in 2013 among all Wisconsin residents was drug overdoses. That year, prescription opioids such as oxycodone, hydrocodone, and methadone were involved in 45% of these overdoses.1 Nationally, overdoses are the number one cause of unintentional injury deaths among 25 to 65 year olds.2
Prescription opioids were developed to treat the pain associated with terminal conditions like cancer, end-of-life pain, and severe acute pain following surgery. In the 1990s, the concept of pain as the “fifth vital sign” was developed by the Veterans Affair Hospital System with the thought that pain was undertreated. The American Pain Society quickly adopted and propagated this view, resulting in professional and consumer groups advocating for increased use of opioids for management of chronic, nonterminal pain. Coincidently, in 1996, Purdue Pharmaceuticals released OxyContin, an extended release form of oxycodone, that was touted in an aggressive marketing campaign as having less abuse potential than short-acting opioids. In 2000, the Joint Commission for Accreditation of Hospital Organizations’ Ambulatory Care Division launched a campaign in partnership with Purdue Pharmaceuticals advocating patients’ right to effective pain assessment, thus perpetuating the treatment of pain as a vital sign. The addiction and abuse potential soon became clear as this original OxyContin could be chewed, crushed, snorted, or injected, producing a high similar to heroin. This is of concern because 1 in 4 patients prescribed prescription painkillers will transition to long-term use.3 In the United States, the number of prescriptions written for opioids increased by 300% between 1991 and 2009.4 In 2007, Purdue Pharmaceuticals pleaded guilty to misleading marketing regarding the abuse and addiction potential of OxyContin, resulting in a $634.5 million fine.5
Evidence supporting the efficacy of long-term opioid use over nonopioid therapy for chronic pain treatment is poor outside of the setting of end-of-life care and must be weighed carefully against the substantial risks.6 Studies suggest that opioids for chronic pain actually may increase pain and decrease functional status by potentiating pain perception.7 Chronic opioid therapy is associated with an increased risk of myocardial infarction; heart failure; respiratory depression; opioid-associated androgen deficiency; osteoporosis; fractures secondary to increased falls; immunosuppression; opiate-induced hyperalgesia, addiction, and misuse; fatal and nonfatal overdose; and all-cause mortality.8 Risk for overdose clearly increases in a dose-response manner with markedly greater risk at doses of 90 or more morphine milligram equivalents (MME) per day.6
Prior to initiating opioids, other pharmacologic options should be considered. Nonopioid pharmacologic options include acetaminophen, NSAIDs, Cox-2 inhibitors, duloxetine (particularly for chronic pain related to fibromyalgia or coincident with depression), gabapentin (particularly for neuropathic pain), other antidepressants, eg, tricyclics and topical analgesics.9 Nonpharmacologic modalities include physical therapy, massage, manipulation, physical activity and weight loss, cognitive behavioral therapy, and treatment of comorbid mental illness.9
The 2016 Centers for Disease Control and Prevention (CDC) Guideline6 is consistent with contemporary review papers along with platforms from the American Medical Association (AMA), American College of Physicians (ACP), and the Wisconsin Medical Society. We strongly support the CDC guideline: providing direction for clinicians, recommendations for health systems and legislatures, and awareness of the issues nationally. The guideline provides practicing clinicians a structure for safe prescribing of opioids and guidance with patient discussions. (See Box 1 in full text pdf.) We also strongly support and advocate for the dissemination of the 2016 Wisconsin Medical Examining Board (MEB) Opioid Prescribing Guideline.10 This guideline closely follows the CDC guideline for evidence-based best practices and adds specific recommendations to indications, dosing, follow-up, discontinuing opioids with specific tapering regimens, and assessing risk and mitigating harms of opioid use. (See Box 2 in full text pdf.)
Additionally, we applaud the Food and Drug Administration (FDA) for its proactive response to prescription opioid abuse.11 The FDA supports development of abuse-deterrent formulations of opioids, expanding availability of lifesaving reversal agents like naloxone and prioritizing approval of nonopioids for pain. Manufacturers of long-acting opioids are now required to have stricter labeling, post-market safety and outcomes research, and funding of voluntary continuing medical education for prescribers referred to as Risk Evaluation and Mitigation Strategy (REMS).
To help limit the substantial risks of addiction, overdose, and death from chronic opioid therapy, we advocate for the following measures and also make special note of measures already addressed in Wisconsin. (Download full text pdf to read more.)