Evidence-Based Quality Scores for Rating Drug Products and Their Utility in Health Systems

Abstract

The quality of drug products in the United States, which are largely produced overseas, has been a matter of growing concern. Buyers and payers of pharmaceuticals, whether they are health-systems, insurers, PBMs, pharmacies, physicians, or patients, have little to no visibility into any quality metrics for the manufacturers of drug products or the products themselves. A system of quality scores is proposed to enable health-systems and other purchasers and payers of medication to differentiate among drug products according to evidence-based metrics. Metrics influencing the quality scores described herein include both broadly applicable regulatory information and more drug-specific, third-party chemical analysis information. The aggregation of these metrics through a proposed set of rules results in numerical values on a 0-100 scale that may be further simplified into a red/yellow/green designation. The simplicity of such scores enables seamless integration into existing healthcare systems and an integration scheme is proposed. Using real-world data from currently on-market valsartan drug products, this proposed system generated a variety of quality scores for six major manufacturers. These scores were further evaluated according to their current market price showing no significant correlation between quality score and price. The implementation of drug quality scores at healthcare institutions in the United States and their potential utilization by regulators, could create a much-needed, market-driven incentive for pharmaceutical manufacturers to produce quality medications that would reduce drug shortages and improve public health.

Countries Manufacturing Pharmaceuticals for the US Market: A 10-Year Analysis of Public Data

“…22 One proposed tool is a quality score for each manufacturing facility, promoted by the FDA and others. 28,29 However, whether buyers (eg, wholesalers, pharmacy chains, mail-order pharmacies, and hospital systems) will pay for products with higher quality is unknown. Pursuing the lowest price is linked to decreasing generic quality and is proposed as a root cause for shortages.…”

Site-Specific and Country-of-Origin Labeling for Pharmaceutical Manufacturing

“…Quality scores provide a direct link between the manufacturing site and the product. The FDA’s SIS is a crude example of a quality score, independent groups have proposed criteria for different quality scores, 19 and commercial versions of quality scores already exist (e.g., QRx by Pharm3r). 5 Group purchasing organizations, wholesalers, hospitals, mail-order pharmacies, and chain pharmacies might be willing to pay more for higher-quality products made at a reputable facility.…”