The National Clozapine Coordinating Center (NCCC) has responsibility for enterprise wide tracking of Clozapine prescriptions, the collection and reporting of data required by the Food and Drug Administration (FDA)-mandated Clozapine National Registries, monitoring of compliance with FDA requirements (Lab test: White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) at specific intervals), and authorizing approval of patients to be placed on Clozapine therapy. However, much of the work NCCC is responsible for is not automated, leading to delays in prescriptions being approved and posing potential risks or errors when manual review is required. More specifically, the Veterans Health Information Systems and Technology Architecture (VistA) Outpatient Pharmacy application currently performs WBC count and ANC safety checks, but the same safety checks are not performed in the Inpatient Medications application, requiring pharmacists to check an inpatient’s lab test results using Outpatient Pharmacy before finishing the order in Inpatient Medications.

Enhancements are needed to automate required safety checks in Inpatient Medications. In addition, the weekly Clozapine data rollup contains inaccuracies, requiring NCCC staff to use National VistA Web to manually search for the correct data in each facility’s VistA database. This is a time consuming manual effort, which could be alleviated by automating a transmission of “real time” data to the Clozapine database stored at Hines Office of Information & Technology (OI&T) Field Office. The enhancement could improve data accuracy and timeliness, and support a more seamless approach for NCCC to download the formatted data for FDA reporting requirements. In addition, both software and business process improvements are needed to provide tracking and dispensing of Clozapine during off hours or weekends, or in anticipation of a natural disaster when a patient may need to extend their Clozapine prescription.

The issues summarized above are major challenges, and pose a significant barrier to appropriate treatment for patients with Serious Mental Illness (SMI).  Mental health staff members are prescribing Clozapine at an increasing rate to meet the requirements of the Uniform Services for Mental Health (USMH) Handbook (1160.01) requirement1, but continued reliance on manual tracking methods and other workarounds are inadequate to allow appropriate prescribing and management of Clozapine. Thus, there is a pressing need to add new automation, and to build new functionality to address these issues; therefore, this requirements specification document provides detailed analysis for the following enhancements:

* Automation of ordering clozapine and reporting data for inpatients including all patient safety features currently provided to   outpatients
* Reducing transaction times, increasing data security, and eliminating manual paper (fax) handling, recording and storing of patient   information.
* Supplementing computer logic to prevent unnecessary lockouts which prevent dispensing of Clozapine and/or adding mechanisms to allow the NCCC to diagnose and repair   problems remotely.
* Increasing the reliability and accuracy of data reported to the NCCC via immediate “real time” transmission of Clozapine prescription data upon activating the order   or dispensing the prescription, thus reducing the amount of time     currently required to manually retrieve missing information and correct erroneous information   before transmission to the FDA.
* Creating the mechanisms to safely dispense a limited supply of clozapine under emergency conditions or when FDA and supporting agencies are not available during off   business hours and weekends.

