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Postmarketing Surveillance
The following are requirements for surveillance programs:

  • Geographic specificity (at least at 3-digit ZIP code level) to guide further investigation and evaluate effects of simultaneous non-REMS interventions
  • Product and formulation specificity (immediate- vs extended-release, tamper deterrence, etc.)
  • Timely reporting of data to allow improvement of REMS as early as possible in the process
  • Multiple perspectives from different points over the course of the natural history of the drug use/dependence (e.g., treatment seeking, non-dependent community-dwelling, diversion, etc.)
  • Include a measure of drug availability in the community.  Studies have found repeatedly that much of the drug available for abuse and diversion arises directly or indirectly form a licensed prescriber of controlled substances
  • Appropriate quality control to assure that data are collected appropriately, managed clearly and reported accurately without sacrificing time.  A quality assurance program is needed to address quality issues and assure that the system improves itself
  • Representative national coverage