OR WAIT null SECS
Kelly Stanton, director of quality at Qualio, talks about the impact on patients of prescription drug recalls.
U.S. consumers are taking drug recalls and quality issues seriously, according to a new survey of more than 2,000 people conducted by Qualio, a provider of quality management systems. In fact, more than half (51%) of adults are unlikely to use a prescription drug that has experienced a recall, regardless of whether that issue was fixed.
Additionally, 80% of consumers are at least somewhat unlikely to use a specific healthcare product if they learn the FDA has issued a warning letter related to product quality issues, and 52% overall indicated they would be very unlikely to use — or would never use — that product again.
“At the end of the day, quality matters,” Kelly Stanton, director of quality, Qualio, said in an interview with Formulary Watch. “Quality contributes to supply chain interruptions. And that cascades into people not being able to get their medications.”
Consumers, she said, are asking their healthcare providers to care about quality as well. Since the pandemic, consumers are now more focused on medical care. “Three years ago, nobody knew or cared how vaccines got approved. And now, we all know, and we all really care about how these things work,” Stanton said.
Qualio’s survey also found that consumers want regulators to measure quality for prescription drugs and other products. According to the survey, 84% believe the FDA should gather and publicly report quality management data about an entire manufacturer — and not just about a single product or practice area.
Stanton believes that once the FDA implements the Quality Metrics Reporting Program, this will create a more standard approach to assessing drug manufacturing quality. Currently, quality processes are generally manual
In March 2022, the FDA released a draft of the program for comment. The agency is proposing that regulators would identify practice areas that are critical to ensure sustainable product quality and availability and would permit manufacturers to select metrics from each practice area to enable them to identify continual improvement opportunities.
FDA officials hope the upcoming guidance will lead to safer products, but also would better address supply chain challenges. They would also help the FDA with inspections, improve prediction of drug shortages and enhance the agency’s surveillance of compliance.
Additionally, the quality management system would provide consumers with confidence about their medication, the agency said in a white paper released in April 2022.
Stanton said the reporting system will also provide payers a central source for drug and manufacturer quality information.
“We need visibility into the entire supply chain,” she said. “The agency is going to be focused, first and foremost, on those companies that are selling to consumers or to doctors and not necessarily the supply chain that supports drug manufacturing. But I think the companies that make the vials and stoppers, for example, will comply as well with the FDA quality metrics. It’s good business.”
Other findings of the Qualio survey include:
• Consumers tend to hold an entire brand accountable, not just a product, when they learn about a quality issue.
• High-profile product recalls can have long-term impact on healthcare companies and products.
• U.S. healthcare consumers, especially younger generations, are more attuned to news about healthcare products.