5. SERIOUS ADVERSE EVENT REPORTING MUST BE HANDLED WITH DILIGENCE
Toyota example: At the time of this writing, 39 deaths have been attributed to runaway Toyotas.5
Lesson for Pharma: The FDA has specific regulations to handle serious adverse drug experiences on marketed products. In the case of pharmaceutical
or biological products, the recipient of a serious and unexpected adverse drug experience has 15 calendar days to report it
to the FDA.6 The industry faces its greatest challenge to meet the reporting deadline because international adverse event reporting sometimes
is delayed by time and holiday differences. Strict adherence to allotted review times and adequate global adverse event handling
systems are essential.
6. CONDUCT A THOROUGH SITUATION ANALYSIS BEFORE MAKING PUBLIC STATEMENTS
Toyota example: During its handling of the recalls, Toyota's managers made inconsistent and sometimes contradictory statements, suggesting
that they had not analyzed the situation carefully before they began speaking about it.
Lesson for Pharma: When a major problem begins to surface, a situation analysis should be prepared to pull together all of the information and
analyses for management review and action. The company's conclusions must be supported with a well-thought-out rationale that
will avoid inconsistent statements. Don't get caught like a deer in the headlights, unable to respond effectively and demonstrate
as clear an understanding of the problem as available data permits.
7. PERSIST UNTIL YOU IDENTIFY THE ROOT CAUSE OF THE PROBLEM
Toyota example: Toyota defined the problem (unexpected acceleration, faulty braking) and then investigated, but may not have gotten to the
root cause. Problems were blamed on faulty floor mats and sticky gas pedals; however, there have been reports that the problem
continued after the "fix," which suggests that the root cause may not have been identified.7
Lesson for Pharma: Promptly define the problem, investigate, and get to root cause by performing a root cause analysis (RCA). If you do not
get to the root cause, there cannot be an effective corrective or preventive action (CAPA).
8. WHEN ADDRESSING A PROBLEM, INCLUDE ALL AFFECTED PRODUCTS
Toyota example: Toyota knew about those problems years ago and made some fixes on models sold in Japan, but delayed addressing the problems
on other cars.8
Lesson for Pharma: Effective CAPA includes addressing all other products that may be affected. For example, if one drug or one model of medical
device is judged to have a deficiency, all of the drugs in that class or all medical devices in the same family must be examined
as part of the investigation.