Pediatric Informatics: Computer Applications in Child Health (Health ...

392 D.C. Stockwell and A.D. Slonim
It allows subscribing facilities to learn valuable lessons from the experiences of
other users. 26
Federal agencies have developed systems for broad oversight of medication
errors. The Food & Drug Administration has developed and is improving a system
of voluntary reporting of adverse events associated with the use of Agencyapproved
products. The Agency’s MedWatch program receives about 25,000
adverse event and medical product problem reports annually, mostly from health
care professionals and consumers. The MedWatch data are entered into Food
& Drug Administration’s Adverse Events Reporting System, which also receive
270,000 manufacturers’ reports. The manufacturers’ reports, which must be filed
periodically, are based on information provided by physicians and other health care
providers. 27
Another important Food & Drug Administration program is the Vaccine Adverse
Events Reporting System. It received more than 14,000 reports of adverse reactions
in FY 2002, most of which were volunteered by health care providers, patients and
their parents. 28
To ensure the safety of the blood supply, the Food & Drug Administration’s
Center for Biologics Evaluation and Research requires all blood banks to promptly
report fatalities connected with blood transfusions and donations. The Center for
Biologics Evaluation and Research regulates the collection of blood and blood
components used for transfusion or for the manufacture of pharmaceuticals derived
from blood and blood components, such as clotting factors. It also establishes
standards for the products themselves. In addition, the Center operates a web-based
voluntary reporting system for rapid identification of supply shortages affecting
blood, blood components and reagents. 29
Also in blood administration, collaboration with University of Texas Southwestern
and Columbia University by way of a National Institutes of Health funded project
called the Medical Event Reporting System for Transfusion Medicine (MERS-TM).
The MERS-TM tracks transfusion errors through a no-fault, standardized reporting
system. 30
30.5.2 Administrative Coding
Administrative data such as diagnosis and procedure codes have been utilized to
screen for complications that occur during the course of hospitalization. 31 The coding
data represents one of the few sources of clinically relevant data. 11 The codes
provide direct and indirect evidence of the clinical state of the patient, comorbid
conditions and the progress of the patient during the hospitalization or clinic visit.
However, since these administrative codes are typically generated for reimbursement
and legal documentation their accuracy and appropriateness for clinical
studies may be unreliable. There are errors within the coding itself, it is not in realtime
and therefore cannot be addressed during a hospitalization or clinic visit. And
unfortunately adverse event codes are rarely used in practice. 32