| The objective of this study was to derive a quantitative occupational health hazard assessment level (HAL) model for developmental stage active pharmaceutical ingredients (APIs). The undesirable health effects of these new developmental stage APIs can include chronic organ system toxicity, infertility, adverse fetal effects, or cancer. The researcher examined the extent to which the proposed quantitative HAL model could supplement or replace the current decision-making approach, the occupational health committee-based qualitative health hazard, which is based on a 16-criteria decision matrix. This qualitative approach has produced a 39% rate of undesirable and inconsistent occupational health hazard determinations that have either overprotected or underprotected worker health.; Pharmaceutical data from 102 APIs were evaluated using stepwise logistic regression analysis. The researcher used 10 preselected criteria from the original 16 criteria in a unique criteria-weighting scheme to statistically derive a 7-criteria successful best-fit HAL model. The derived quantitative HAL model produced an improved agreement rate of 84.3%, compared to the committee-based decision-making consistency rate of 61%, thus providing greater consistency and accuracy in determining health hazard levels. Therefore, by applying the quantitative HAL model to new developmental stage APIs, the pharmaceutical industry can better meet its ethical and legal obligations of protecting the health of pharmaceutical workers and health care professionals. |
