Special report: A better way to handle device and drug recalls
Providers are taking the lead in revamping system for handling questionable drugs and medical devices
The high-profile drug and device recalls of recent years have set the backdrop for healthcare organizations to establish more efficient, proactive systems that can better identify early signs of troubled products.
Drug and device recalls have been continually cited as causes for increased scrutiny of the Food and Drug Administration’s device approval process because of safety concerns, as well as for the drug shortages affecting hospitals and health systems.
The FDA noted in a letter to government officials that it has experienced “significant increases” in the number of recalls for the drugs, devices and diagnostics that are regulated by the federal agency.
“In recent years, the agency has experienced significant increases in the number of recalls of FDA-regulated products, some of which involve the largest and most complex recalls in FDA history,” the agency wrote.
Robert Pezzin, interim vice president of supply chain for Nexera, the supply-chain management and consulting firm owned by the Greater New York Hospital Association, says the financial burden of a recall, including developing the systems to manage a recall along with the costs when a product is recalled, often falls to hospitals, rather than manufacturers.
Pezzin works on-site at West Penn Allegheny Health System, based in Pittsburgh.
“What we see is every organization is burdened with developing its own process and sys- tem,” Pezzin says. “That takes considerable resources and finances. Right now, you don’t see that being funded by the manufacturers or by the FDA to assist hospitals in standardizing this practice.”
Along with the costs incurred for the labor and expense of pulling products from shelves and returning them to a manufacturer—some companies will refund the freight cost—finding alternative drugs or devices can carry additional costs.
“A substitute product could carry a premium over what you were using before,” Pezzin says.
Recalls have pushed hospitals and health systems to establish automated responses rather the manual systems that many facilities still have in place, says Kathy DeLacio, director of procurement and administration for corporate contracting at West Penn Allegheny. Depending on the product and the nature of the recall, it can take between a few days to a month to get a response to a recall from a vendor about a return authorization.
The FDA’s role is to oversee a manufacturer’s management of the recall, according to the GAO, but other stakeholders that take part in the recall efforts include manufacturers, distributors, hospitals and patients.
“There is the need to automate and compress the timeframe from which a hospital or a healthcare system is notified of a recall,” DeLacio says. “By the time you get it out to all your end users, especially when you have implantables involved, time is of the essence.”
Johnson & Johnson is one example of a pharmaceutical and device manufacturer that has reported numerous recalls over the past several years.
With J&J already dealing with a number of over-the-counter product recalls, DePuy Orthopaedics, a subsidiary of the New Brunswick, N.J.-based company, recalled its ASR hip system in August 2010. The company said the implant had a high early failure rate, which led to more revision surgeries. The recall prompted hundreds of lawsuits.
“DePuy has a comprehensive process in place for evaluating and acting on any concerning product performance data and rapidly alerting customers if necessary,” DePuy spokeswoman Mindy Tinsley said in a statement responding to an interview request. “We constantly evaluate our processes for improvement.”
The recalls, including the hip implant, were a key complaint in allegations of wrongdoing from J&J shareholders in a recent lawsuit. The recall for the implantable device affected 93,000 patients worldwide.
The ASR hip systems recall is expected to cost J&J $184 million in “reasonable and customary costs of testing and treatment associated with the recall” over the next five years, according to a company report.
Recent recalls have also put the FDA under examination. Following a Senate hearing in April that addressed the agency’s handing of recalls, the Government Accountability Office released a report two months later that recommends the federal agency take a more proactive stance in
“Several gaps in the medical device recall process limited firms’ and FDA’s abilities to ensure that the highest-risk recalls were implemented in a timely and effective manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.”