The opioid crisis in the United States was largely driven by widespread overprescribing. This trend has now merged with a dangerous pattern of prescribing opioids with an unnecessarily high potency, according to a new study led by the Mayo Clinic.
The researchers found that more than half of Americans starting out on highly-regulated opioids may be receiving inappropriate treatment. Study co-author Dr. W. Michael Hooten is an anesthesiologist and pain medicine specialist at the Mayo Clinic.
“In pain management, there is a need to use a variety of treatment options, including – when appropriate – extended-release opioids and very strong immediate-acting opioids like fentanyl,” said Dr. Hooten. “However, these particular medications can cause a number of serious adverse effects, so extra safeguards are needed when these medications are prescribed.”
“One of the key factors in determining whether these drugs can be used safely is the presence of opioid tolerance in the patient who was prescribed one of these medications.”
“In other words, tolerance to some of the most dangerous adverse effects of opioids, including suppressing breathing and excessive sedation, develops only after a patient takes daily doses of opioids over time. Patients who are not opioid-tolerant should not be receiving high-potency fentanyl or extended-release opioid products because they are susceptible to these life-threatening adverse effects.”
The investigation was focused on medications such as high-dose oxycodone, extended-release hydromorphone, and fentanyl patches.
To investigate the inappropriate use of these medications across the country, the researchers used pharmacy and medical claims data and linked electronic health records from the OptumLabs Data Warehouse. Between 2007 and 2016, the team identified nearly 300,000 prescriptions for medications that should be strictly reserved for people with opioid tolerance.
After removing records with inadequate information or for patients who had recently been hospitalized, the remaining 153,385 cases of new outpatient prescriptions for the reserved medications involved 131,756 people across the United States. Among these individuals, less than 48 percent had evidence of prior opioid tolerance in their records.
“Our findings are concerning because it appears that many people starting to use these drugs may be at risk for some quite serious outcomes,” said study lead author Dr. Molly Jeffery. “In general, physicians are allowed to prescribe drugs off-label – that is, without adhering to the indications or warnings included in the drug label. But these particular drugs are considered risky enough that the FDA (Food and Drug Administration) requires manufacturers to provide additional oversight and education to physicians to make sure they understand the risks associated with the drugs.”
“We used natural language processing – a type of artificial intelligence – to look through physician notes in the patients’ health records, and also looked at information about prescriptions written. We did not find substantial additional evidence that patients were opioid-tolerant when they started these drugs.”
Dr. Jeffery said that, with no evidence of opioid tolerance in more than half of the patients examined in the study, the team looked into the clinical notes for reasons why the physicians would have prescribed these particular drugs.
The analysis did not offer any insight into the physicians’ reasons for prescribing to patients who were not opioid-tolerant. However, the researchers had ideas about why certain prescriptions may have been chosen.
“My colleagues and I discussed the possibility that, in particular, fentanyl patches might have been prescribed for patients who have serious medical or surgical problems that limit the ability to swallow oral medications,” said Dr. Hooten. “Also, fentanyl patches contain a three-day supply of the drug, so patches could be a possible solution for patients who may not be able to take oral medications on a scheduled basis.”
Dr. Hooten hopes that fellow clinicians will pay attention to the findings of this research.
“I often treat people mired in addiction. As physicians, our first charge is to do no harm, and with opioids – especially this group of medications – the risk of harm is very real,” said Dr. Hooten. “It concerns me that I might have patients coming to me whose substance abuse disorder was exacerbated by inappropriate prescribing practices.”
The study is published in the journal JAMA Network Open.
By Chrissy Sexton, Earth.com Staff Writer