Aeromedical Risk Assessment of Pharmaceuticals Using Evidence-Based Medicine.

Background: Using concepts from evidence-based medicine, systems theory, and risk assessment, a standardized model was developed to accept or reject medications for use in flight. The model calculates the risk scores of medications, which can then be compared to an organization's acceptable risk tolerance.

Methods: Risk scores for each medication were established by summing the products of incidence rates and severity scores for all published side effects. The incidence of each side effect was obtained in an evidence-based manner and each assigned a severity multiplier. Using statistical analysis of the calculated risk scores of approved medications, an acceptance control chart was generated.

Results: Range of calculated risk scores of historically approved medications was 10-9140. Six Sigma Acceptance Control Line was calculated at 1.5 SDs above the mean and was 9822. Risk score range of medications generally felt unsafe was 27,010-41,294. Risk score range of medications under consideration for approval was 986-6863.

Discussion: This novel approach to medication approval is the first in aerospace medicine to attempt to combine evidence-based medicine, risk analysis, and control charts to standardize and streamline the medication approval process within an organization. The model was validated by testing against medications generally accepted to be unsafe for use in flight. These medications fell several deviations above the control line. Other medications not yet authorized fall well below the acceptance line and could be considered for approval.