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Free Content Aeromedical Risk Assessment of Pharmaceuticals Using Evidence-Based Medicine

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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.

Prudhomme MB, Ropp LG, Sauer SW, LaVan JT. Aeromedical risk assessment of pharmaceuticals using evidence-based medicine. Aerosp Med Hum Perform. 2015; 86(9):824–829.
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Keywords: control charts; evidence-based medicine; medication approval; risk analysis; systems theory

Document Type: Research Article

Affiliations: Naval Aerospace Medicine Institute, Pensacola, FL, USA

Publication date: September 1, 2015

More about this publication?
  • This journal (formerly Aviation, Space, and Environmental Medicine), representing the members of the Aerospace Medical Association, is published monthly for those interested in aerospace medicine and human performance. It is devoted to serving and supporting all who explore, travel, work, or live in hazardous environments ranging from beneath the sea to the outermost reaches of space. The original scientific articles in this journal provide the latest available information on investigations into such areas as changes in ambient pressure, motion sickness, increased or decreased gravitational forces, thermal stresses, vision, fatigue, circadian rhythms, psychological stress, artificial environments, predictors of success, health maintenance, human factors engineering, clinical care, and others. This journal also publishes notes on scientific news and technical items of interest to the general reader, and provides teaching material and reviews for health care professionals.

    To access volumes 74 through 85, please click here.
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