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MPS-2.2 Data Details

MPS-2.2 Reduce the number of non-FDA-approved pain medications

About the Data

Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

National Data Source
FDA Drug Registration and Listing Database; Food and Drug Administration (FDA)
Electronic database of prescription sales in the US; Intercontinental Marketing Services (IMS)
Changed Since the Healthy People 2020 Launch
No
Measure
number 
Baseline (Year)
575 (2007)
Target
518
Target-Setting Method
10 percent improvement
Numerator
Number of non-FDA-approved pain medications (opioids, NSAIDs, and acetaminophen used to treat pain) that are on the market in one year
Comparable Healthy People 2010 Objective
Not applicable
Methodology Notes

Pain medications are defined as opioids, NSAIDS, and acetaminophen.

Each new drug application that goes through the FDA Approval Process is given a unique identifier and, once approved by the FDA, is required to list the product with the FDA in the database. The data for this objective will select Drug Listings for a given year that are determined to be “Unapproved” in the Drug Registration and Listing Database. The goal of this objective is to decrease the overall number of “Unapproved” drugs that are marketed and, subsequently listed with the FDA. This is not to imply that “Unapproved” drugs should not be listed with the FDA, but that the number of “Unapproved” marketed drugs should be minimized.

The estimates are reflective of the drugs that have multiple ingredients, potency levels in a drug, and different routes of administration.

Caveats and Limitations
For the purposes of this measure, pain medications are defined as opioids, NSAIDS, and acetaminophen.

References

Additional resources about the objective.

  1. Approvals of FDA-Regulated Products. US Food and Drug Administration. Available from: http://www.fda.gov/opacom/7approvl.html. Accessed October 6, 2008.
  2. FDA Enforcement Report Index
    http://www.fda.gov/opacom/Enforce.html
  3. Is It Really FDA Approved? US Food and Drug Administration, September 30, 2008. Available from: http://www.fda.gov/consumer/updates/approvals093008.html. Accessed October 6, 2008
  4. Marketed Unapproved Drugs: Compliance Policy Guide Center for Drug Evaluation and Research. US Food and Drug Administration, June 2006. Available from: http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm.
  5. National Drug Code Directory
    http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm
  6. US Sales and Prescription Information