ASH Clinical News October 2017 | Page 57

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FEATURE

The Pains of Opioid Prescribing

The United States is in a state of emergency : The Centers for Disease Control and Prevention ( CDC ) estimates that 91 Americans die each day from an opioid overdose . 1 Over the past two decades , the amount of prescription opioids sold in the U . S . has quadrupled , contributing to the current epidemic of opioid misuse and abuse .

In response , federal agencies , medical organizations , and health-care professionals are working together to more closely monitor and regulate opioid prescriptions to prevent abuse . For patients with cancer or hematologic conditions who rely on opioids to manage their disease-related pain , though , the actions may have the unintended effect of limiting access to necessary drugs .
“ Patients [ who ] suffer from pain require treatment – that sounds simple , but the truth is that our patients suffer significantly from pain related to their hematologic conditions , and this pain affects their ability to function ,” Amanda M . Brandow , DO , MS , associate professor of pediatrics in the section of hematology / oncology at Medical College of Wisconsin , told ASH Clinical News . “ They have a medical indication for pain treatment , and opioids are the backbone of therapy to relieve their suffering .”
Medical societies and research organizations are creating new guidelines to inform pain management in patients with hematologic conditions . For example , the American Society of Hematology ( ASH ), with input from physicians and patients , is currently developing clinical practice guidelines for the management of acute and chronic complications of sickle cell disease – including the care and management of pain .
As new guidelines are introduced , hematologists and oncologists must ensure that their patients are not left without access to opioids for pain management . ASH Clinical News spoke with Dr . Brandow and other health-care professionals about the factors that led to the opioid crisis and the struggle to balance the risks and benefits of prescribing opioids .
How Did We Get Here ?
Many factors over the past several decades came together to create the “ perfect storm ” that led to the current opioid crisis , according to Daniel Clauw , MD , director of the Chronic Pain and Fatigue Research Center at the University of Michigan . When the U . S . Food and Drug Administration ( FDA ) gained much of its regulatory authority in the 1960s , scientific panels were convened to assess which drugs were effective for which conditions , and determined that opioids were effective for treating both acute and chronic pain , Dr . Clauw explained .
“ Since the 1960s , opioid labels have stated that these medications could be used to treat either type of pain but , in practice , clinicians were not using them for that purpose – except in patients with cancerrelated pain or SCD-related pain ,” he said . “ Every time a manufacturer came out with a new version of an older opioid , the FDA would look to the past evidence and come to the conclusion that , because oxycodone works for acute and chronic pain , the new drug could also be marketed for any acute or chronic pain condition .”
In 1980 , the New England Journal of Medicine published a short letter to the editor written by two doctors from the Boston Collaborative Drug Surveillance Program of Boston University Medical Center . 2 The now-infamous letter downplayed the rate of addiction in patients treated with narcotics in hospitals , stating that , in a group of nearly 12,000 hospitalized patients , there were only four cases of “ reasonably well documented addiction in patients who had no history of addiction .” The authors concluded that , “ despite widespread use of narcotic drugs in hospitals , the development of addiction is rare in medical patients with no history of addiction .”
In the 1990s , pain experts started a campaign to make patient pain “ more visible ,” inadvertently opening the door for potential overprescribing of painmanagement medications . Organizations like the Veterans Health Administration implemented a new National Pain Management Strategy to prevent patient suffering and lobbied for pain to be considered “ the fifth vital sign .”
Pharmaceutical companies were there to answer the call for increased management of patient pain . In 1995 , Purdue Pharma gained regulatory approval for OxyContin tablets , a controlled-release oral formulation of oxycodone hydrochloride , “ for the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days .” 3 The product label stated that the controlled-release formulation had a lower potential for abuse and warned that crushing the tablets would disrupt the drug ’ s controlled-release properties .
According to Dr . Clauw , Purdue Pharma was one of the first drug companies to promote opioids for chronic , non-malignant pain , even starting a marketing blitz .
Soon after , The Joint Commission ( formerly the Joint Commission on the Accreditation of Healthcare Organizations , or JCAHO ) introduced standards to help organizations better care for patients with pain , calling on hospitals to educate practitioners about assessing and managing pain . 4
“ Practitioners believed that if you had to ask about it and put it in a chart , then there was some imperative that you should be treating it ,” Dr . Clauw said . “ Combined with some accomplices in academia who said opioids were good for chronic pain and not addictive , that led to a dramatic increase in prescribing opioids for chronic pain .”
Nearly 40 years later , in 2017 , the New England Journal of Medicine published a response to the 1980 letter , claiming that the original was “ heavily and uncritically cited ” as evidence that addiction was rare . According to the 2017 response , citation of the original letter in other research “ contributed to the North American opioid crisis by helping to shape a narrative that allayed prescribers ’ concerns about the risk of addiction associated with longterm opioid therapy .” 5
“ There was a general lessening of the concerns about using opioids ,” Dr . Clauw said . “ This led to skyrocketing numbers of opioid prescriptions for both acute and chronic pain .”
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