Drug Shortages in Generic Injectables: Solving the Quality Issue
Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent paper, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur. In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
In a market that does not “reward” quality, which as in all industries, tends to come at a higher price, drug manufacturing companies may choose to minimize quality-related investments that can make a difference in the overall efficacy of their drug product. Areas such as maintenance of production facilities and equipment, quality control testing and preventive actions on early indications of quality problems may not receive the investment needed to help ensure high quality.
In addition, many customers assume that quality has been “regulated” into the drug product, and base purchase decisions on price alone.
But as the old saying goes, you get what you pay for.
West provides a variety of options to help ensure that quality requirements are met. Product selection should be made based on the needs of the end-user and the needs of the drug product itself. Westar® Ready-to-Use (RU) component processing provides an excellent option for drug product manufacturers seeking to place the regulatory burden further upstream. Doing so will shift risk to the component manufacturer.
Additional options, such as West’s EnvisionTM 100-percent vision verification process, also may help to increase quality by reducing end-of-line rejections. For biologics and sensitive drug products, West offers high-quality NovaPure® components, which provide consistent, reliable, high quality through a product development process that incorporates Quality by Design principles.