Dallas campus researchers present study findings to FDA
Traditionally, compounded pharmaceuticals are quality checked through a “double-check” system where a second pharmacist does a paper check to ensure that compounded pharmaceuticals are prepared accurately. Unfortunately, the literature is replete with reports of compounding errors related to the use of the double-check method of quality control. With that in mind, a team of researchers from the Texas Tech University Health Sciences Center (TTUHSC) School of Pharmacy, Cook Children’s Health Care System in Fort Worth and Children’s Medical Center in Dallas have been working to improve this practice that is so common to compounding and reduce the number of compounding errors.
The researchers proposed a novel approach to assuring the quality of compounded pharmaceuticals through the use of hand-held Raman spectrometers. The results of their project, titled “Raman Spectroscopy: A Sensitive and Specific Technique for Determining the Accuracy of Compounded Pharmaceutical Formulations,” was recently published in the Journal of Pediatric Pharmacology and Therapeutics (21:413-8, 2016).
Because the study findings drew the attention of the U.S. Food and Drug Administration (FDA), School of Pharmacy researchers Claudia Meek, Ph.D., Trey Putnam, Ph.D., and Richard Leff, Pharm.D., were invited to speak about the study and its findings Dec. 15 at the FDA headquarters in Silver Springs, Maryland. More than 50 FDA officials — including several FDA directors — were invited to attend the presentation, which was part of FDA’s Critical Path Innovation Meetings.
Putnam said these preliminary studies demonstrated that the novel technique provided “robust quantitative information on the identity and the concentration of the formulation’s components.” In conclusion, he added, the investigators found that utilizing hand-held Raman spectrometers as a quality control measure is accurate, quantitative, rapid and cost-effective.
“The dialogue during the meeting was robust,” Putnam said. “FDA is interested in watching the future directions of our research.”
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