Regulatory Requirements for Pharmacy Involvement
Medicare Conditions of Participation:
The DNV has developed NIAHO® (national Integrated Accreditation for Healthcare Organizations) Standards and Guidelines. The DNVoutlines 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 DNV 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 pharmacy's Investigational Drug Service unless pharmacy grants an exemption for not fully utilizing University Hospital's Department of Pharmacy. It is highly recommended that medications be stored, handled and dispensed by the 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 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 DNV standards and hospital policy and government regulations.