Regulatory Requirements for Pharmacy Involvement

The JCAHO 2009 Hospital Accreditation Standards require the following:

Standard MM.01.01.03: The hospital safely manages high-alert and hazardous medications.

The JCAHO outlines that the institution is required to manage all medications that are classified as "high-risk". Investigational medications and medications NOT approved by the FDA are classified as high-risk. As representatives for the institution, the department of pharmacy is responsible for the management of these medications.

To comply with this JCAHO standard and to follow this standard's elements of performance, it is a University Hospital policy that all clinical research involving pharmaceutical agents given to human subjects be handled through the hospital pharmacy's Investigational Drug Service. It is highly recommended that medications be stored, handled and dispensed by the hospital pharmacy, however it is not a requirement. Medications may be stored in a department or a clinic when it is determined to be logistically necessary. In this situation, the hospital pharmacy Investigational Drug Service will perform a Compliance and Oversight service (which shall include audits) to ensure that study materials are being handled in a manner consistent with JCAHO standards and hospital policy and government regulations.