Paul M Coplan1,2, M Soledad Cepeda1, Kenneth R Petronis3, Angela DeVeaugh-Geiss4, Alexandra I Barsdorf5, David M Kern1, Richard Fanelli6. 1. Epidemiology, Johnson and Johnson, Titusville, NJ, USA. 2. Adjunct, Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 3. Epidemiology, Pfizer Inc., New York, NY, USA. 4. Risk Management & Epidemiology, Purdue Pharma L.P., Stamford, CT, USA. 5. Patient & Health Impact, Pfizer Inc., New York, NY, USA. 6. Regulatory Affairs, Purdue Pharma L.P., Stamford, CT, USA.
Abstract
Background: Among patients with chronic pain using long-term opioid therapy, the incidence of opioid abuse, addiction, overdose, and associated death are not well quantified. The range of estimates for these adverse outcomes varies drastically and may depend on how they are measured (i.e. study definitions of outcomes) and on patient characteristics and opioid-use factors (e.g. regimen, daily dose). Methods: Based on a review of the literature, the US Food and Drug Administration (FDA) required companies that manufacture and sell extended-release/long-acting (ER/LA) opioids conduct as a postmarketing requirement (PMR) a series of observational studies to estimate the rates of treatment-emergent misuse, abuse, addiction, overdose, and death using validated measures. The companies formed a consortium, the Opioid PMR Consortium (OPC), to conduct the studies. Results: The FDA initially requested four observational studies (a cohort study, a questionnaire validation study, a code validation study, and a doctor-shopping validation study), but in order to achieve the FDA's goals of the 4 studies, OPC and FDA agreed to 10 observational studies (a prospective cohort study, a retrospective database cohort study, three questionnaire validation studies, two code validation studies, and three doctor-shopping validation studies). The studies are continuing through 2020.Conclusions: A series of 10 observational studies was or are being conducted in response to the FDA's postmarketing requirement. All studies have been feasible to conduct, although a validated algorithm for measuring abuse and addiction in databases was not successful.
Background: Among patients with chronic pain using long-term opioid therapy, the incidence of opioid abuse, addiction, overdose, and associated death are not well quantified. The range of estimates for these adverse outcomes varies drastically and may depend on how they are measured (i.e. study definitions of outcomes) and on patient characteristics and opioid-use factors (e.g. regimen, daily dose). Methods: Based on a review of the literature, the US Food and Drug Administration (FDA) required companies that manufacture and sell extended-release/long-acting (ER/LA) opioids conduct as a postmarketing requirement (PMR) a series of observational studies to estimate the rates of treatment-emergent misuse, abuse, addiction, overdose, and death using validated measures. The companies formed a consortium, the Opioid PMR Consortium (OPC), to conduct the studies. Results: The FDA initially requested four observational studies (a cohort study, a questionnaire validation study, a code validation study, and a doctor-shopping validation study), but in order to achieve the FDA's goals of the 4 studies, OPC and FDA agreed to 10 observational studies (a prospective cohort study, a retrospective database cohort study, three questionnaire validation studies, two code validation studies, and three doctor-shopping validation studies). The studies are continuing through 2020.Conclusions: A series of 10 observational studies was or are being conducted in response to the FDA's postmarketing requirement. All studies have been feasible to conduct, although a validated algorithm for measuring abuse and addiction in databases was not successful.
Authors: Jennifer S Gewandter; Shannon M Smith; Robert H Dworkin; Dennis C Turk; Tong J Gan; Ian Gilron; Sharon Hertz; Nathaniel P Katz; John D Markman; Srinivasa N Raja; Michael C Rowbotham; Brett R Stacey; Eric C Strain; Denham S Ward; John T Farrar; Kurt Kroenke; James P Rathmell; Richard Rauck; Colville Brown; Penney Cowan; Robert R Edwards; James C Eisenach; McKenzie Ferguson; Roy Freeman; Roy Gray; Kathryn Giblin; Hanna Grol-Prokopczyk; Jennifer Haythornthwaite; Robert N Jamison; Marc Martel; Ewan McNicol; Michael L Oshinsky; Friedhelm Sandbrink; Joachim Scholz; Richard Scranton; Lee S Simon; Deborah Steiner; Kenneth Verburg; Ajay D Wasan; Kerry Wentworth Journal: Pain Date: 2021-11-01 Impact factor: 7.926
Authors: David S Carrell; Ladia Albertson-Junkans; Arvind Ramaprasan; Grant Scull; Matt Mackwood; Eric Johnson; David J Cronkite; Andrew Baer; Kris Hansen; Carla A Green; Brian L Hazlehurst; Shannon L Janoff; Paul M Coplan; Angela DeVeaugh-Geiss; Carlos G Grijalva; Caihua Liang; Cheryl L Enger; Jane Lange; Susan M Shortreed; Michael Von Korff Journal: J Drug Assess Date: 2020-04-28