Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database (MSDD)

    Basic Details
    Date Posted
    Monday, November 20, 2017
    Status
    Complete
    Medical Product
    buprenorphine
    Butrans
    extended-release (ER) oxycodone
    extended-release and long-acting (ER/LA) opioid analgesic
    fentanyl
    fentanyl transdermal system
    hydrocodone bitartrate
    hydromorphone HCL
    methadone HCL
    morphine sulfate
    morphine sulfate/naltrexone
    oxycodone HCL
    oxymorphone HCL
    tapentadol HCL
    Description

    Opioids Drug Screen Metrics

    The Workgroup created a metric to examine opioid prescribing patterns in the Mini-Sentinel Distributed Database (MSDD): a drug screens metric that characterized the proportion of new users of extended-release and long-acting (ER/LA) opioids who receive a drug screen assay before and/or after the opioid dispensing. The drug screen metric utilized an existing tool developed by the MSOC.

    The Opioid Analgesics Prescribing Trends Workgroup has requested execution of the Cohort Identification and Descriptive Analysis (CIDA) tool, version 2.0.7, to find estimates of the percentage of extended-release and long-acting (ER/LA) opioid analgesics users who have a drug screen in the month prior to opioid use or in the six months after opioid use. The query was run against the MSDD for the time period of January 1, 2009 to December 31, 2013. The request was distributed to 15 Data Partners on July 29, 2015. Report 1 contains results for ER/LA opioid analgesics and Report 2 contains results for ER oxycodone.

    This request was designed to identify exposures with and without drug screens in the month prior or within six months after opioid initiation. The number of exposure episodes in the MSDD was calculated overall and was stratified by age group, sex, and year.

    Extended-Release and Long-Acting (ER/LA) Opioid Use

    The Workgroup created a metric to examine opioid prescribing patterns in the Mini-Sentinel Distributed Database (MSDD): an opioid tolerance metric that characterized the proportion of patients who get an ER/LA opioid analgesic dispensed after meeting criteria for becoming opioid tolerant.  The opioid tolerance metric utilized de novo programming.

    FDA has requested execution of the Cohort Identification and Descriptive Analysis (CIDA) tool, version 2.0.8, to investigate the estimated numbers of ER (extended-release) and LA (long-acting) opioid analgesics users.

    This request was designed to calculate background rates.  The number of qualifying users with the exposure, number of eligible members, and member days were calculated overall and were stratified by age group, sex, and year.

    Information
    Time Period
    January 1, 2009 – December 31, 2013
    Population / Cohort
    All individuals 0-64 years of age
    Data Source(s)
    Mini-Sentinel Distributed Database (MSDD)