IDEA Details

OVERVIEW OF CAPABILITIES

Pharmacy

  • Agent Ordering: Permits the ordering of investigational agents to be aligned with the patient and protocol using a variety of scalable order forms, email, and online ordering.
  • Receive Agent: Updates agents on order.  Identifies those back-ordered, re-ordered, and abandoned.  Updates Drug Accountability Records (DARs) and notifies the requesting individual of agent arrival.
  • Dispense Agent: Provides comprehensive capability related to the dispensing of agents including patients receiving treatment, agent availability, and projection of future ordering needs.
  • Transfer Agent: Allows for the transfer of an agent among protocols and locations (as permitted by the sponsoring organization) and then evaluates the ramifications of a transfer on current inventories.
  • Waste Agent: Provides the ability to document drug waste and update the DAR inventory per patient or protocol.
  • Agent Return Request: Tracks agents on hold awaiting return authorization from the supplying agency.
  • Return Confirmation: Notifies the supplying agency of the agent being returned and method of transit.

Protocols

  • Base Data: Captures the national identifier, sponsor, disease site, protocol title, and local coordinator.
  • Schema Definitions: Establishes a segment of treatment time (weeks/days, months/years) capable of unlimited duration; supports multiple overlay segments for each protocol arm.
  • Treatment Agents: Allows for the selection of the agent by generic or commercial name. Determines the ability of the agent to be “date adjusted (cascaded)” on patient schedules. Assigns the agent as provided or not provided, patient specific or not patient specific.
  • Establish Treatment Cycles: Simplifies establishment of treatment cycles through check off mechanism. For example, a treatment cycle for an agent to be given on day 1, every 35 days x 5 cycles only requires the user to place 5 checks in boxes on displayed page.
  • Agent Return Request: Tracks agents on hold awaiting return authorization from the supplying agency
  • Return Confirmation: Notifies the supplying agency of the agent being returned and method of transit.

Patients

  • Demographics: User enters a patient name and zip code. IDEA© selects the city, state and telephone area code. Provides capability to load in a digital photograph of the patient. All standard demographics are allowed including a notepad area.
  • Protocol Assignment: User selects a protocol and arm for a patient and enters the date treatment begins. IDEA© creates the entire schedule from the master protocol schema.
  • Schedule Tracking: As treatments occur, the event is automatically logged in the patient schedule. If treatment delay is required, the user simply selects the starting point of the delay and reassigns the new treatment date. IDEA© automatically “cascades” the patient schedule to accommodate the delay.

Reports

The comprehensive Reports module allows ultimate flexibility and vast options for generating reports for every conceivable need related to patients, protocols, pharmacy inventory management, and staff involvement.

Alignment with National Cancer Institute Clinical Trials Requirements 

In 1997 DDOTS began working on the development of pharmacy management software for institutions participating in National Cancer Institute trials. Collaboration with members of the NCI’s Pharmacy Management Branch at that time enhanced DDOTS’ understanding of the NCI’s issues and future directions required of investigational drug management systems.

IDEA© incorporates numerous elements to manage the entire process of drug ordering and dispensing, drug tracking, and NCI reporting:

The Drug Order Module permits the logging of a drug to be aligned with the patient and protocol.

The Receive Drug/Agent Module updates drugs on order, identifies those back ordered, and updates the Drug Accountability Records (DARs) in NCI format.

The Transfer Module allows the potential to transfer drugs among protocols and locations and then evaluates the ramifications of a transfer on inventory. This capability was of particular interest to the NCI in order to streamline or eliminate the process of shipping, returning, and re-shipping investigational drugs.

The Returns Module tracks drug returned to the NCI with email availability for notification of returns, including NCI return authorization numbers.

A comprehensive Reports Module includes an accountability report through which the NCI and/or research bases can perform random audits of research site drug usage and inventories.