Effect of US Drug Enforcement Administration’s Rescheduling of Hydrocodone Combination Analgesic Products on Opioid Analgesic Prescribing

Prescription opioid abuse is a major public health problem in the United States.¹ The opioid analgesic hydrocodone bitartrate, traditionally available in combination with nonopioid analgesics, is one of the most commonly abused opioids.² 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 2004.³

On October 6, 2014, the US Drug Enforcement Administration⁴ moved these products from schedule III of the Controlled Substances Act to the more restrictive schedule II. This change entailed tighter controls on prescribing hydrocodone combination products, including the prohibition of prescription refills. We examined national prescribing patterns to identify trends before and after rescheduling.

Prescription data are from the IMS Health National Prescription Audit,⁵ which estimates the number of prescriptions dispensed from US pharmacies based on a proprietary sample that captures almost 80% of all dispensed retail prescriptions. We 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 hydrocodone combination products. Linear regression analysis was used to compare predicted dispensed prescriptions and tablets in the absence of hydrocodone combination product rescheduling with actual dispensed prescriptions and tablets after rescheduling. We used health care professional specialty data from the American Medical Association to compare dispensed hydrocodone combination product prescriptions and tablets by specialty for the 12 months before and after rescheduling.⁵

During the 36 months before rescheduling, the number of dispensed hydrocodone combination product prescriptions declined by 8.4% (Figure, A), and the number of dispensed tablets declined by 6.0% (Figure, B). During the same period, dispensed prescriptions and tablets for nonhydrocodone combination product opioid analgesics declined by 0.2% and 0.5%, respectively. After rescheduling, there was a rapid decline in the number of dispensed hydrocodone combination product prescriptions and tablets. Compared with the 12 months before rescheduling, dispensed hydrocodone combination product prescriptions declined by 22.0% in the 12 months after rescheduling, and dispensed hydrocodone combination product tablets declined by 16.0%. Refills accounted for 73.7% of the decline and were essentially eliminated by March 2015. In contrast, dispensed prescriptions for non–hydrocodone combination product opioid analgesics increased by 4.9% in the 12 months after hydrocodone combination product rescheduling, and dispensed tablets increased by 1.2%.

Linear regression analysis indicates that the reductions in dispensed hydrocodone combination product prescriptions and tablets were substantially greater than would have been predicted in the absence of rescheduling. Compared with predicted values for hydrocodone combination product and nonhydrocodone combination product opioid analgesics, there was an overall reduction of 14 360 378 (95% CI, 14 037 780-14 682 876) opioid prescriptions and 750 095 774 (95% CI, 733 245 286-766 946 262) opioid tablets dispensed in the 12 months after rescheduling.

Reduced prescribing of hydrocodone combination products was seen for most health care professional specialties after rescheduling (Table). Primary care physicians and surgeons accounted for the largest absolute reductions in dispensed hydrocodone combination product prescriptions and tablets. Pain medicine physicians had modest increases in both dispensed hydrocodone combination product prescriptions and tablets.

Dispensed hydrocodone combination product prescriptions decreased substantially after rescheduling by the US Drug Enforcement Administration, with 26.3 million fewer hydrocodone combination product prescriptions and 1.1 billion fewer hydrocodone combination product tablets dispensed in the year after rescheduling. 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. The modest increases for nonhydrocodone combination product opioid analgesics after rescheduling did not substantially offset the large hydrocodone combination product reductions. The decreases in dispensed hydrocodone combination products were seen among most health care professional specialties and were especially pronounced among primary care physicians and surgeons.

Numerous actions to address the opioid epidemic have been taken in the past several years,¹ with some resulting in reduced hydrocodone combination product prescribing.^6,7 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. Future research should examine 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.

Corresponding Author: Christopher M. Jones, PharmD, MPH, Office of the Assistant Secretary for Planning and Evaluation, US Department of Health and Human Services, 200 Independence Ave SW, Washington, DC 20201 (christopher.jones@hhs.gov).

Published Online: January 25, 2016. doi:10.1001/jamainternmed.2015.7799.

Author Contributions: Dr Jones had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Jones, Lurie.

Acquisition, analysis, or interpretation of data: Jones.

Drafting of the manuscript: All authors.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Jones.

Administrative, technical, or material support: Jones.

Conflict of Interest Disclosures: None reported.

Funding/Support: This work was funded by the US Food and Drug Administration.

Role of the Funder/Sponsor: The sponsor supported the authors, who were responsible for the preparation, review, and approval of the manuscript and the decision to submit the manuscript for publication. The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation and review of the manuscript; or decision to submit the manuscript for publication. The sponsor reviewed and approved the manuscript.

Disclaimer: The findings and conclusions of this study are those of the authors and do not necessarily reflect the views of the US Food and Drug Administration or the US Department of Health and Human Services.