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Recent developments toward the safer use of opioids in the USA, with a focus on hydrocodone

Research in Social and Administrative Pharmacy, In Press, Corrected Proof, Available online 13 February 2015, January 1970


Opioids have become a mainstay of treatment for pain in the United States, with over 250 million prescription issued in 2012 alone. The increased prescribing of these medications has also contributed to the unintended consequence of a widening prevalence of abuse and misuse, and therefore safety has become a top agenda item for both government and health care providers alike. The move toward new abuse-deterrent formulation technologies, enhanced regulatory requirements from the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), and developments in national/state policies have worked together to target a goal of promoting safer clinician prescribing, pharmacy dispensing and patient use of opioids. Hydrocodone in particular, as the most widely prescribed opioid product, has recently been subject to a myriad of changes, both through the federal rescheduling of hydrocodone-combination products (HCPs) to Schedule II, as well as the introduction of two new extended-release formulations to the USA market. These efforts represent a first step toward tackling the opioid harms epidemic, although continuing follow-up through research and policy implementation is needed to see any measureable impact on safety in the future.

Keywords: Drug Enforcement Administration, Food and Drug Administration, Controlled substance scheduling.


Division of Clinical, Social and Administrative Sciences, Duquesne University Mylan School of Pharmacy, 600 Forbes Ave., Pittsburgh, PA 15282, USA

Corresponding author. Tel.: +1 412 396 2636.

Conflicts of interest: None.

Funding: None.