Drug recalls are more widespread than previously thought

Thousands of drugs are recalled each year after reaching pharmacy shelves and ultimately the homes of unsuspecting people across the country, according to the findings of a recent Kaiser Health News (KHN) investigation. The ever-expanding recalls of medications containing losartan and valsartan have garnered significant attention in the media. However, these recalls may be just one example of a problem that is more widespread than previously thought.

From January 2013 to October 2018, approximately 8,000 medications were recalled by pharmaceutical companies across the United States and abroad, the KHN report indicates. Causes ranged from adulteration—the strength of an active ingredient was lower/higher than standards allow, or bacteria/mold or glass/rubber particles were present—to mislabeling and sterility concerns.

“We all want to be able to trust that what we are dispensing is safe and effective, so these kinds of situations are really disturbing,” said Ashley Trask, PharmD, pharmacy supervisor at Medication Policy & Safety at UC Davis Health System, who was not involved in the KHN investigation. “The bottom line: As care providers, we are horrified by these types of situations.”

The KHN report also found that more than 2,500 facilities remained uninspected over a 5-year timespan, and more than 1,600 facilities, including 400 located outside the U.S., had not been inspected in 10 years.

“Nobody is looking over the shoulder of these drug manufacturers overseas,” said David Gortler, PharmD, PhD, former senior FDA medical officer. “No one’s making sure that these so-called sweatshop countries are doing a reliable job.”

Gortler, a consultant with Former FDA.com, said that U.S. drug facilities are subjected to rigorous inspection—“everything from engineering to pharmacologists”—once every 24 months. In contrast, overseas inspections occur every 6 to 7 years, he said. Considering travel requirements, including notifying departments of state, “there may be a leak” of the visit that compromises FDA’s ability to perform thorough impromptu inspections.

“FDA does everything possible … to address any potential risks in a sustainable way that will help ensure continued patient access to vital, safe, and effective drugs,” said FDA spokesperson Kristofer Baumgartner.

For the full article, please visit www.pharmacytoday.org for the March 2019 issue of Pharmacy Today.