Washington, DC—How much effect did moving hydrocodone analgesic products from schedule III of the Controlled Substances Act to the more restrictive schedule II have on rates of opioid prescriptions?

Apparently a lot, according to a research letter published recently in JAMA Internal Medicine.

Researchers from the FDA and the U.S. Department of Health and Human Services note that the opioid analgesic hydrocodone bitartrate, traditionally available in combination with nonopioid analgesics, is one of the most commonly abused opioids. In fact, in 2011, hydrocodone combination analgesic products were involved in almost 100,000 abuse-related emergency department visits in the United States, more than double the number in 2004, according to background information in the report.

To determine whether placing the compounds in a more restrictive schedule in late 2014 was an effective deterrent, the research team looked at prescription data from the IMS Health National Prescription Audit, which captures almost 80% of all dispensed retail prescriptions.

Researchers then calculated the quarterly number of dispensed prescriptions and tablets (for solid oral dosage forms) for hydrocodone combination product and nonhydrocodone combination product opioid analgesics for the 36 months before and the first 12 months after rescheduling.

Healthcare professional specialty data from the American Medical Association was then used to compare dispensed hydrocodone combination product prescriptions and tablets by specialty for the 12 months before and after the products were rescheduled.

Results indicate that, during the 36 months before rescheduling, the number of dispensed hydrocodone combination product prescriptions declined by 8.4% and the number of dispensed tablets declined by 6.0%. At the same time, dispensed prescriptions and tablets for nonhydrocodone combination product opioid analgesics declined by 0.2% and 0.5%, respectively.

After rescheduling, however, the number of dispensed hydrocodone combination product prescriptions and tablets declined rapidly. Compared with the 12 months before rescheduling, dispensed hydrocodone combination product prescriptions plummeted 22.0% in the year following rescheduling, while dispensed hydrocodone combination product tablets dropped by 16.0%.

Refills accounted for 73.7% of the decline and were essentially eliminated by March 2015, study authors write.

During that time period, dispensed prescriptions for nonhydrocodone combination product opioid analgesics modestly increased by 4.9% and dispensed tablets increased by 1.2%.

Analysis suggests that reductions in dispensed hydrocodone combination product prescriptions and tablets were substantially greater than would have been predicted in the absence of rescheduling; researchers calculate that an overall reduction of 14,360,378 opioid prescriptions and 750,095,774 opioid tablets dispensed occurred in the 12 months after rescheduling.

Primary care physicians and surgeons accounted for the largest absolute reductions in dispensed hydrocodone combination product prescriptions and tablets, while pain medicine physicians had modest increases in both dispensed hydrocodone combination product prescriptions and tablets, according to the report.

”Most of this decline was due to the elimination of hydrocodone combination product prescription refills, consistent with the prohibition on prescription refills for schedule II medications,” study authors conclude. “The modest increases for non-hydrocodone combination product opioid analgesics after rescheduling did not substantially offset the large hydrocodone combination product reductions.”

Researchers note that the federal health officials have attempted several other measures—some moderately successful—to reduce hydrocodone combination prescribing, “However, the abrupt change in dispensing of hydrocodone combination analgesic products immediately after rescheduling suggests a primary role for this intervention in the observed change.”

Study authors call for future researcher on whether these changes are sustained, have had an effect on access for patients, and are associated with the desired goals of reduced abuse, addiction, and overdose.

« Click here to return to Weekly News Update.