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Comprehensive Product Surveillance Program

"The non-medical use of prescription drugs has become an increasingly widespread and serious problem in this country; one that calls for immediate action. The Federal government is embarking on a comprehensive effort to ensure that potentially addictive medications are dispensed and used safely and effectively."
~ John Walters, Director, Office of National Drug Control Policy, March 1, 2004

Be Part of the Solution, Not the Problem
• Prescription drug abuse has risen at an alarming rate over the past decade.
• Emergency room visits resulting from the abuse of narcotic analgesics have
  increased 163 percent since 1995.
• Florida Medical Examiners Commission reported that more than half the 7,128
  drug-related deaths in 2004 resulted from abuse of prescription drugs.
• Prescription drugs now rank second, after marijuana, in frequency of abuse.
• Research shows that physicians avoid prescribing highly abusable drugs, even
  when properly indicated.
• Research also shows that patients often fear being prescribed abusable drugs.
• A PDRC comprehensive RiskMAP will help to meet federal and state regulatory
  standards while optimizing your product's market potential.

Food and Drug Administration: In March 2005, the FDA issued "Guidance for Industry: Development and Use of Risk Minimization Action Plans" (RiskMAPs) to encourage manufacturers of prescription drug products, including potentially abusable drugs, to establish active product surveillance programs to monitor and address safety-related issues. Specifically addressed in the FDA's guidance document was the "significant risk of overdose, abuse, and addiction" associated with certain drugs.

PDRC

Almost a year before the FDA's guidance on RiskMAPs was announced, PDRC was reviewing FDA proposals and advisory committee minutes and advising clients that product surveillance programs were on the horizon.

Product Surveillance

In accordance with FDA's guidance, your RiskMAP should include an active product surveillance plan that utilizes a variety of data sources to monitor abuse risks. PDRC pioneered the development of a unique Sentinel Network to survey active professionals in the fields of science, medicine, drug treatment, law enforcement, and drug regulatory work. Their information is integrated with retrospective data available from published and unpublished (obtained via the Freedom of Information Act) government sources to produce dependable and accurate assessments of abuse and diversion. In addition, PDRC tracks products by keywords in over 300 daily publications in the print and electronic media. PDRC monitors technical and scientific publications, including medical journals, for the latest information on product use and misuse. Product-specific events are quickly identified for appropriate follow up. Contact us for more information today.

Contact us in Fairfax, Virginia, for research on prescription drugs for the pharmaceutical industry. (703) 277.7734

 

 
 

Prescription Drug Research Center
4031 University Drive, Suite 200
Fairfax, VA 25203-3409

Phone: (703) 277.7734
Fax: (703) 277.7730
Email: