Insights from SupplySide West

Adverse event reporting can provide valuable data to companies, expert says

By Hank Schultz contact

- Last updated on GMT

Reporting adverse events is something all dietary supplement companies must prepared to do to be in compliance with the law.  But beyond that basic requirement, companies that fully embrace an AER system can use it to provide valuable market data, an expert says.

Ignorance of what having a functional AER system really means is unfortunately still widespread in the industry, said Rick Kingston, PharmD, president of regulatory and scientific affairs at the consultancy Safety Call International.  Kingston, who is also a professor at the University of Minnesota’s College of Pharmacy, spoke with NutraIngredients-USA recently at the SupplySide West trade show in Las Vegas, NV.

“The compliance has been increasing over the years. But there are still a number of companies that don’t understand the regulation and don’t have a system in place to meet their reporting requirements,” ​Kingston said.

But beyond that basic level, Kingston said a functional AER system can actually provide companies valuable market intelligence.

“I think it is absolutely vital for companies to understaind their consumers and how they are using their products,” ​Kingston said.

Kingston said properly collecting data on AER reports and mining that data can yield a wealth of information. It can show what other products consumers might typically be using in conjunction with the product in question, products that might more to blame for the reported stomach ache, for example.  Kingston said companies could use that information to better educate their consumers on the successful use of their products.  A sophisticated system can help companies sort through the ‘background noise’ that is to be expected in reports submitted by consumers (unlike in the drug arena, where most of the data is gathered an submitted by a professional such as a physician or a a pharmacist).  Being able to eliminate that noise to find what could be an emerging signal of a safety or manufacturing issue can put a company in a much better position when explaining to FDA what a set of adverse event reports might mean, Kingston said.

Related topics: Regulation, GMPs, QA & QC, Manufacturers

Related news

Show more

Follow us

Products

View more

Webinars