Description

The VA National Clozapine Registry tracks the health and demographics of patients who have been prescribed clozapine by the VA. Clozapine, or the brand name Clozaril, is a drug used to treat the most serious cases of schizophrenia. Unfortunately, clozapine may also affect portions of the blood, lowering the body's resistance to infection and sometimes creating life-threatening circumstances. Realizing the severity of the problem, the Food and Drug Administration (FDA) established guidelines for analysis of White Blood Cells and Neutrophils and set strict minimum limits. The FDA also mandated that any manufacturer of clozapine must maintain a Clozapine Registry. These registries are to track the location and the health of clozapine patients and to ensure 'weekly White Blood Cell testing prior to delivery of the next week's supply of medication'. To date, the clozapine manufacturer registries have been unable to develop sufficient controls to meet these requirements, especially the ability to prevent dispensing clozapine when blood results are abnormal. However, because of the unique structure of Veterans Health Information Systems and Technology Architecture, the Veterans Health Administration obtained permission from the FDA and clozapine manufacturers to use its in-place computer network to gather and evaluate weekly patient information, then export this data to manufacturer clozapine registries. The VA assigned functional administration of this effort to the National Clozapine Coordinating Center (NCCC) located in Dallas, Texas. Weekly data on each VA clozapine patient is processed at two locations. Facility Level --When a clozapine prescription is written, a computer program in each facility's internal computer system retrieves white blood cell count, neutrophil count, and clozapine dose and evaluates the information according to FDA guidelines. If an adverse blood condition is found, the computer may warn to trigger a physician reevaluation, or lock out entirely to prevent dispensing, depending on the severity. Weekly, this information, along with certain patient demographic information, is gathered locally and transmitted to Hines Office of Information & Technology Field Office for centralized storage. This data can only be accessed by the NCCC. Raw data is downloaded from the Hines OI Field Office database on a weekly basis. An ancillary computer program reformats the data and evaluates the information for inconsistencies and data gathering errors. The computer-corrected data is manually compared with hand-written facsimile information sent to the NCCC by each site. This manually corrected data is again reformatted for data storage in MS Access format at the NCCC. The corrected data is also reformatted into American Standard Code for Information Interchange fixed-length fields and transmitted via modem to the manufacturers' Clozapine Registry and, in turn, to the FDA.

General Information

• This data is described at

  http://catalog.data.gov/dataset/va-national-clozapine-registry Do you think this data is incorrect? Let us know

• This data is published by

  Department of Veterans Affairs Do you think this data is incorrect? Let us know

Legal Information

• The rights statement is at

  http://catalog.data.gov/dataset/va-national-clozapine-registry Do you think this data is incorrect? Let us know

• Outside the US, this data is available under

  Creative Commons CCZero Do you think this data is incorrect? Let us know

• There are

  yes, and the rights are all held by the same person or organisation Do you think this data is incorrect? Let us know

• The content is available under

  Creative Commons CCZero Do you think this data is incorrect? Let us know

• The rights statement includes data about

  its data licence Do you think this data is incorrect? Let us know

• This data contains

  no data about individuals Do you think this data is incorrect? Let us know

Practical Information

• The data appears in this collection

  http://catalog.data.gov/organization/va-gov Do you think this data is incorrect? Let us know

• The accuracy or relevance of this data will

  go out of date but it is timestamped Do you think this data is incorrect? Let us know

• The data is

  backed up offsite Do you think this data is incorrect? Let us know

Social Information

• The documentation includes machine-readable data for

  title Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  description Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  identifier Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  landing page Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  publisher Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  keyword(s) or tag(s) Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  release date Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  modification date Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  temporal coverage Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  language Do you think this data is incorrect? Let us know

• Find out how to contact someone about this data at

  http://catalog.data.gov/dataset/va-national-clozapine-registry Do you think this data is incorrect? Let us know

• Find out how to suggest improvements to publication at

  http://www.data.gov/issue/?media_url=http://catalog.data.gov/dataset/va-national-clozapine-registry Do you think this data is incorrect? Let us know