Leaders from eight top healthcare institutions author paper using Valisure and Govzilla data for the creation of actionable drug quality scores that can guide drug purchasing decisions.
NEW HAVEN, CT – MAY 27, 2020 – Authors from NYU Langone Health, Columbia University, the Defense Health Agency, the University of Utah, the People’s Pharmacy, the Cleveland Clinic, Yale School of Medicine, and the University of Connecticut posted a study today that proposed a detailed system for the creation and use of drug quality scores. The study was posted to medRxiv.org, the preprint server for health sciences.
The quality scores proposed in the paper can be as simple as red/yellow/green and health systems can use them as guidance for drug purchasing or reimbursement decisions. Essentially, providers could strive to acquire drug products with a “green” rating most of the time, occasionally “yellow” with further review, and attempt to entirely avoid “red.”
Valisure and Govzilla data and analytics comprised the computational aspects of the paper and the paper illustrates a first look at the utility of the collaboration that the two companies announced earlier in the year. Valisure and Govzilla stated they are working together to build a platform that will use AI to generate quality scores based on a combination of regulatory data and Valisure’s chemical batch-analysis of on-market drug products.
The paper shows an analysis of current suppliers of the angiotensin receptor blocker medication valsartan, which has suffered a multitude of recalls due to contamination with probable human carcinogens. Drug quality scores, using evidence-based criteria, are derived and compared to real pricing data which reveals no correlation between quality and price. This implies that by simply adding transparency into drug quality, buyers and payers can select quality drug products and avoid medications with potential issues without paying more for them.
“The current pharmaceutical industry is critically lacking transparency in general, and especially in regard to quality,” stated Valisure’s Founder and CEO, David Light. “Consumers demand quality and transparency in every product they put in their bodies, but this has unfortunately been entirely absent for medications, not just for patients but even for healthcare systems. As this paper shows, independently generated drug quality scores can finally give health systems critical transparency that does not need to add cost. Beyond the paramount intent of improving patient care, it is likely that such a platform could save health systems a significant amount of time and money by potentially avoiding problematic drug products.”
The FDA has previously proposed a rating system for manufacturers according to “quality management maturity” on multiple occasions. This underscores the general consensus that transparency is critically needed and that not all manufacturers produce quality products. However, the previously proposed systems were intended to be voluntary and primarily based on self-reported data from manufacturers.
In order to be broadly applicable, a ratings system must rely on objective, science-based data that is not voluntarily provided by manufacturers but generated by independent, private sector parties. The American College of Cardiology underscored the need for “independent testing and verification of the chemical content of batches of pharmaceuticals” in a 2019 resolution to the American Medical Association. Such scores could provide a rational approach for not just industry but also regulators to use for more efficient management of oversight resources depending on manufacturer rankings.
“It is our hope,” says David Light, “that this paper will provide a springboard for healthcare systems to adopt the use of drug quality scores and that this much needed transparency will be a strong driver to incentivize the production of quality drug products.”
Valisure is an online pharmacy attached to an analytical laboratory and is the first and only pharmacy in America that chemically batch-validates every medication it sells. Valisure’s mission is to help ensure safety, quality, and transparency in the medications it delivers to consumers. In response to rising concerns about counterfeit medications, generics, and overseas manufacturing, Valisure’s team of Harvard- and Yale-trained scientists developed proprietary analytical technologies to screen out poor-quality batches. Every medication or supplement Valisure ships comes with a certificate of analysis listing important chemical properties of the samples analyzed at Valisure’s lab. Valisure has ISO 17025 accreditation and is DEA and FDA registered. For more information, please visit www.valisure.com and or follow @Valisure on Twitter
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