Response to AHCPR on CERTs:

Steven Teutsch, Merck & Co., Inc.
December 4, 1998

I have some suggestions:

• Encourage collaboration with and funding from providers and industry: with providers to facilitate access to patients and clinical data which may be important for studies and to demonstrate methods, and with industry since we have legitimate interests in the appropriate use of pharmaceutical agents and have expertise. Centers should consider how large existing databases can be used—this would require identifying the necessary data elements and data sets which contain them.
• Add research component on adherence/compliance by patients and providers. This would include research to increase adherence to guidelines and development of theory and practice of enhancing compliance. This should be directly linked to demonstrations of effectiveness in real-world situations. The focus as written is on traditional Food and Drug Administration (FDA) interests of safety and efficacy, including misuse of pharmaceuticals, interactions, etc. While appropriate, estimates of underutilization are equally important.
• Add research component on guideline development for pharmaceutical agents, implementation and evaluation of programs to increase appropriate use of pharmaceutical agents.
• Add research component on alternative medications. These are in wide-spread and increasing use and information is desperately needed about efficacy, effectiveness, safety and interactions with other medications. FDA has little jurisdiction over these products, yet their consequences are poorly understood. Among the issues: are these products used in addition to pharmaceuticals, do they substitute for them, does their use lead to delay in seeking effective medication, does their use avoid unnecessary visits and use of pharmaceuticals?
• Models of organization of the Centers: The Centers for Disease Control (CDC) has models which may be appropriate, e.g., injury centers, prevention centers, urban research centers.

Steven Teutsch
Outcomes Research and Management
PO Box 4, WP39-169
Merck & Co., Inc.
West Point, PA 19486-0004
Telephone: (215) 652-2788
Fax: (215) 652-0860
E-mail: steven_teutsch@merck.com

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