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Using risk analysis to guide changes to compounding formulae
Author(s) -
Rio Luis A.,
Trives Carmen
Publication year - 2017
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/jppr.1310
Subject(s) - compounding , medicine , frame (networking) , risk analysis (engineering) , product (mathematics) , statistics , econometrics , actuarial science , pharmacology , mathematics , business , engineering , mechanical engineering , geometry
“Frame formulations” are a framework for extemporaneously preparing pharmaceutical products. Alterations to the frameworks are allowed, e.g. by changing the quantity of active ingredients or by changing the percentage of excipients, as long as the variations do not affect the level of risk associated with the final product or their efficacy. Here we detail a method of analysing the risk of changes to frame formulations by assigning a risk priority number to the changes using Failure Modes Effects Analysis. The risk priority number estimates the severity and probability that changes to the formulation would have.