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32 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2024 PharmTech.com Compounding • Calculations objective. Identifying the calcula- tions objective forces prospective thinking about future dosage form calculations (Stage 1). • Incomplete or unverified information. Infor- mation (patient, medication order, dr ug/dos- age form) required for compounding must be correct; suspect information must be verified (Stage 1). • Calculation estimation. Values to be calculated should be estimated before actual calculations (Stage 1). • Copying previous calculations. Each calcula- tion must be a new effort. Do not copy from pre- vious approved calculations (Stages 1, 2) • Units of measure. Units of measure must be clearly written on all terms in equations. (Stages 1, 2). • Evaluation of calculations. After calculations are completed, calculated values must be evalu- ated using critical thinking and common sense (Stages 2, 3). • Incomplete or substandard documentation. Calculations documentation must be thorough, complete, legible, and understandable (Stages 1, 2, 3). • Omitted, delayed, or incomplete independent verification. Verification by an independent per- son must not be omitted or delayed (Stage 3). • Human characteristics. Be watchful of human failings such as dyslexia, dyscalculia, and other disorders (Stage 3). • Personnel accountability. Personnel must per- form procedures as required and feel personal responsibility for their actions; signature/date affirms personal responsibility (Stages 1, 2, 3). Summary This discussion describes an ordered pharmaceuti- cal calculations process to be applied in the work- place environment. The process includes a defined sequence of activities to accomplish numeric oper- ations while minimizing the potential for deficien- cies and errors. Stage 1 forces proactive planning and thinking in advance of actual numeric operations— these are fundamental activities requiring critical thinking and good judgment. Stage 2 includes actual calculations and evaluation of results; common sense is vital when evaluating results. Stage 3 confirms prior work including documentation review by an independent person. Process stages, activities, and potential calculations failings are summarized in Table I. Management has a significant responsibility for compounding calculations in the organization. Cal- culations will be successf ul if management devel- ops a workplace quality culture with emphasis on personnel suppor t; management commitment to qualit y in both daily activities and suppor tive or- TABLE I. Pharmaceutical calculations process. Stage Activity Potential failings Equation design Identify calculations objective Incorrect calculations objective Compile/verify information • patient • medication order • drug/dosage form Erroneous information • Patient information • LASA, High-alert, confusing drugs • Drug abbreviations • Problematic symbols • Technical error Calculation estimate Estimates omitted Design equation Units of measure omitted Copy previous approved equation Initiate calculation record Incomplete documentation Accountability – signature/date Misunderstanding accountability Numeric operations Execute designed equations Units of measure omitted Copy previous approved calculation Evaluate calculations Calculation error not detected Common sense failure Calculated value different from estimate Accountability – signature/date Misunderstanding accountability Independent verification Evaluation and verification Stage 1 deficiencies Stage 2 deficiencies Number transpositions Verification delayed or omitted Accountability – signature/date Misunderstanding accountability