title: Protocol: changes in rates of opioid overdose and poisoning events in an integrated health system following the introduction of a formulation of OxyContin® with abuse-deterrent properties.
abstract: Addiction, overdoses and deaths resulting from prescription opioids have increased dramatically over the last decade. In response, several manufacturers have developed formulations of opioids with abuse-deterrent properties. For many of these products, the Food and Drug Administration (FDA) recognized the formulation with labeling claims and mandated post-marketing studies to assess the abuse-deterrent effects. In response, we assess differences in rates of opioid-related overdoses and poisonings prior to and following the introduction of a formulation of OxyContin® with abuse-deterrent properties.
  
  
  
  To assess effects of this formulation, electronic medical record (EMR) data from Kaiser Permanente Northwest (KPNW) and Kaiser Permanente Northern California (KPNC) are linked to state death data and compared to chart audits. Overdose and poisoning events will be categorized by intentionality and number of agents involved, including illicit drugs and alcohol. Using 6-month intervals over a 10-year period, trends will be compared in rates of opioid-related overdoses and poisoning events associated with OxyContin® to rates of events associated with other oxycodone and opioid formulations. Qualitative interviews with patients and relatives of deceased patients will be conducted to capture circumstances surrounding events.
  
  
  
  This study assesses and tracks changes in opioid-related overdoses and poisoning events prior to and following the introduction of OxyContin® with abuse-deterrent properties. Public health significance is high because these medications are designed to reduce abuse-related behaviors that lead to important adverse outcomes, including overdoses and deaths.
authors.affiliation: Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. Shannon.L.Janoff@kpchr.org.
authors.forename: Shannon L
authors.initials: SL
authors.lastname: Janoff
authors.affiliation: Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Perrin
authors.affiliation: Purdue Pharma, L.P., One Stamford Forum, Stamford, CT 06901, USA.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Coplan
authors.affiliation: Indivior Inc., 10710 Midlothian Turnpike, Suite 302, Richmond, VA 23235, USA.
authors.forename: Howard D
authors.initials: HD
authors.lastname: Chilcoat
authors.affiliation: Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612, USA.
authors.forename: Cynthia I
authors.initials: CI
authors.lastname: Campbell
authors.affiliation: Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.
authors.forename: Carla A
authors.initials: CA
authors.lastname: Green
mesh_terms: D000701:Analgesics, Opioid / Q000506:poisoning*; D019033:Delivery of Health Care, Integrated / Q000379:methods / Q000639:trends*; D004339:Drug Compounding / Q000639:trends*; D062787:Drug Overdose / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control; D057286:Electronic Health Records / Q000639:trends; D006801:Humans; D009293:Opioid-Related Disorders / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control; D010098:Oxycodone / Q000737:chemistry / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000639:trends*
chemical_list: D000701:Analgesics, Opioid; D010098:Oxycodone
keywords: Opioids; Overdose; OxyContin®; Poisoning; Prescription drug monitoring