[BLOG]: Use and abuse of opioids: FDA responds

Calabrese

It is estimated that over 2.1 million people in the United States suffer from substance abuse related to prescription opioid pain relievers, and the number of unintentional overdose deaths from prescription pain relievers has more than quadrupled in the US since 1999.¹ Among drug overdose deaths, approximately 37% are reported to involve prescription opioids.² In an effort to further control the growing epidemic of opioid abuse and risks of drug overdose, the Drug Enforcement Administration (DEA) mandated significant changes in the classification of specific prescription pain medications in 2014. These changes included the redesignation of tramadol ER (August 2014) from an uncontrolled agent to a schedule IV controlled drug requiring greater oversight and hydrocodone (October 2014) from a schedule III substance to a schedule II substance requiring prescribers to write a new prescription every 30 days and blocking authorization of automated refills.³

Related:FDA: Final guidance on evaluation, labeling of abuse-deterrent opioids

Marks

In 2014, prescription pain medications accounted for about $0.03 of every dollar of pharmacy spent based on Catamaran statistics. Although the costs within the opioid category are fairly well managed through active promotion of generic options, Catamaran’s clinical team remained concerned regarding misuse and abuse of narcotic agents. The team examined trend data reflective of August through December 2014 as well as data on market share shifts from the first quarter of 2015. With the DEA’s mandated changes, the organization was interested in determining whether these changes would in fact curb the use of prescription narcotic medications, specifically the newly designated schedule II drug, hydrocodone-containing products. Additionally, we wanted to determine whether such changes might simply drive a shift in utilization to other short- or long-acting narcotic pain medications.

Related: PCORI awards prision system $2M to study naltrexone benefit in opioid abuse

 

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