title: The effect of FDA approval of a generic competitor to OxyContin (oxycodone HCl controlled-release) tablets on the abuse of oxycodone.
abstract: Controversy exists concerning whether abuse of oxycodone will increase after the introduction of generic controlled-release (CR) oxycodone. We evaluated the effect of FDA approval of generic CR oxycodone on the misuse/abuse of oxycodone, hydrocodone, methadone and morphine utilizing data from eight poison control centers (PCC). PCC intentional exposure (IE) reason codes were used as measures of abuse. Opioid-specific quarterly IE rates (per 100,000 population and per 10,000 patients) were calculated for 1 year before and after approval (March 24, 2004). Changes in regression slopes (1 year before to 1 year after) and in IE rates (1 quarter before to 1 quarter after) were analyzed using Poisson regression. The regression slopes for oxycodone, methadone and morphine did not change after approval but decreased significantly for hydrocodone. None of the prescription opioids' IE rates significantly increased after approval. When changes in oxycodone's IE rates were compared to the other opioids, no statistically significant differences were found, indicating a lack of time-opioid interaction. These results did not vary when population rates or patient rates were used. PCC data indicate that approval of generic CR oxycodone was not followed by an immediate unfavorable effect on the misuse/abuse of oxycodone.
authors.affiliation: Rocky Mountain Poison and Drug Center, Denver Health, CO, USA. J.Elise.Bailey@RMPDC.org
authors.forename: J Elise
authors.initials: JE
authors.lastname: Bailey
authors.forename: Phoebe Lindsey
authors.initials: PL
authors.lastname: Barton
authors.forename: Dennis
authors.initials: D
authors.lastname: Lezotte
authors.forename: Steven R
authors.initials: SR
authors.lastname: Lowenstein
authors.forename: Richard C
authors.initials: RC
authors.lastname: Dart
mesh_terms: D000701:Analgesics, Opioid; D002391:Catchment Area, Health; D003692:Delayed-Action Preparations; D017277:Drug Approval / Q000706:statistics & numerical data*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D016568:Drugs, Generic; D006801:Humans; D006853:Hydrocodone; D008691:Methadone; D009020:Morphine; D010098:Oxycodone; D011039:Poison Control Centers; D011159:Population Surveillance; D015995:Prevalence; D019966:Substance-Related Disorders / Q000453:epidemiology* / Q000517:prevention & control*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D006853:Hydrocodone; D009020:Morphine; D010098:Oxycodone; D008691:Methadone