Prescriptions for hydrocodone plummet after US tightens prescribing rules

BMJ 2016; 352 doi: (Published 27 January 2016) Cite this as: BMJ 2016;352:i549
  1. Michael McCarthy
  1. 1Seattle

Prescriptions for combination analgesics containing the opiate hydrocodone have fallen by 22% since the US government imposed tougher prescribing rules in 2014, a study has found.1 Hydrocodone bitartrate, which is often formulated with a non-opioid analgesic such as paracetamol, is one of the most commonly misused prescription opioids in the United States.

In October 2014, in response to a growing opioid use epidemic, the US Drug Enforcement Administration tightened prescribing requirements for hydrocodone combination products by moving them from schedule III of the Controlled Substances Act to the more restrictive designation of schedule II.

Under schedule III the hydrocodone combination drugs were deemed to pose a moderate risk of dependence, and physicians were allowed to prescribe them with several refills at a time. After the products were moved to schedule II, physicians had to comply with stricter documentation and reporting requirements, and patients had to return to the physician for a refill.

In the new study, published in JAMA Internal Medicine, researchers looked at a national sample of dispensed retail prescriptions to compare prescribing trends before and after the drug’s rescheduling. The study was funded by the US Food and Drug Administration. The lead author was Christopher M Jones, of the Office of the Assistant Secretary for Planning and Evaluation at the US Department of Health and Human Services.

The researchers found that, although the number of dispensed hydrocodone combination product prescriptions had already been declining (falling by 8.4% in the 36 months leading up to the scheduling change), the number of prescriptions plummeted by 22% in the subsequent 12 months. And the actual number of tablets dispensed, which had also been falling (dropping by 6% in the 36 months before the schedule change), fell by 16% after the change in designation. A decline in refills accounted for 73.7% of this decline, the researchers wrote.

Although prescriptions of combination products that contained non-hydrocodone opioids rose by 4.9% after the schedule change, the increase did not significantly affect the total number of opioid analgesics dispensed, the researchers added.

Acknowledging that prescriptions of hydrocodone combination products had already been declining the researchers estimated an overall reduction, in the 12 months after rescheduling, of 14 360 378 opioid prescriptions (95% confidence interval 14 037 780 to 14 682 876) and 750 095 774 opioid tablets (733 245 286 to 766 946 262) dispensed in the US.

Most medical specialists reduced their prescribing of hydrocodone combination products, and primary care physicians and surgeons accounted for the largest reductions both in prescriptions and the tablets dispensed. Among pain medicine physicians, however, a modest increase of 7.2% was seen in prescriptions and the tablets dispensed.

The researchers concluded, “Numerous actions to address the opioid epidemic have been taken in the past several years, with some resulting in reduced hydrocodone combination product 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.”


Cite this as: BMJ 2016;352:i549


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