The ICI Approach: Possible Adverse Reaction Information System

Abstract

The Product Safety Group at ICI receives 5,000 to 6,000 adverse reaction reports each year. To handle these, we have developed a computer-based storage, assessment, and tracking system known as PARIS (Possible Adverse Reaction Information System).

Adverse reaction events are entered into the system on the day of receipt and checked by the computer for duplication with existing reports. A data associate enters a “summary-time” score that depends on the outcome of the adverse reaction and the effects (where known) of dechallenge and rechallenge. This enables the program to fill in the appropriate boxes on the Council for International Organisations of Medical Sciences (CIOMS) form and provides an initial ranking — more serious combinations have higher scores. The program also contains a decisionmaking algorithm that suggests whether or not an event should be reported. The algorithm relies on the computer recognizing key phrases and drug names, as well as knowing about recognized adverse reactions.

To enable the program to recognize phrases, the computer holds a dictionary where equivalent terms are stored under a single code. When the program recognizes a term it allocates the relevant code. If an unrecognized term is used then the computer highlights this fact.

At this stage the report passes to a technical evaluator. The report is checked for the possible involvement of diseases or other drugs and is then classified according to the amount of information available and whether or not it should be reported. For reportable reactions, the computer “starts the clock” and generates a daily list of the status of all nonarchived reports ranked according to urgency. The evaluators also determine whether the event is recognized as being an adverse reaction of one of the coprescribed drugs or a sequel of the patient's known diseases. The computer accumulates this information.