More than half of Americans may receive inappropriate opioid treatments

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Previous research shows that widespread opioid overprescribing contributed to the opioid epidemic.

In a new study, researchers found that this dangerous trend has apparently been coupled with another: inappropriate use of high-potency opioids.

The study showed that more than half of Americans starting the most highly regulated opioids might be receiving inappropriate treatment.

The research was led by 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.

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 medications examined in the study included high-dose, extended-release oxycodone; all doses of extended-release hydromorphone; fentanyl patches; and all varieties of transmucosal ― oral or nasal delivery ― fentanyl.

To determine whether these medications were inappropriately used across the U.S., the team used pharmacy and medical claims data, and linked electronic health records from the OptumLabs Data Warehouse.

OptumLabs is a collaborative center for research and innovation co-founded by Optum Inc. and Mayo Clinic and focused on improving patient care and patient value.

Examining pharmacy and medical claims data from 2007 to 2016, the team identified 153,385 instances of new outpatient prescriptions of opioid medications occurred among 131,756 people from across the U.S.

Less than 48% of these showed evidence of prior opioid tolerance.

The findings are concerning because it appears that many people starting to use these drugs may be at risk for some quite serious outcomes.

The team says 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.

Furthermore, regulations for one of the drug classes that the team studied — transmucosal immediate-release fentanyl, or TIRFS — require physicians who prescribe, and pharmacists who dispense, the drugs to complete a certification process and enroll each patient.

One author of the study is W. Michael Hooten, M.D., a Mayo Clinic anesthesiologist, and pain medicine specialist.

The study is published in JAMA Network Open.

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