2017 ISPE/FDA/PRQI Quality Manufacturing Conference

Interactive Discussion on Drug Shortages Prevention

François Sallans, Vice President, Quality and Compliance, Chief Quality Officer, Johnson & Johnson, and Chair of the ISPE Drug Shortages Initiative, led the featured session “Interactive Discussion on Drug Shortages Prevention” on Tuesday, 6 June 2017.

He opened the gathering by noting that ISPE’s research and publications have “done a hell of a job in preventing and remediating drug shortages.” The Gap Analysis Tool in particular, he said, “helps you assess the situation and status at your company. It’s not about yes or no and good or bad. Download the PDF,” he encouraged the audience.

ISPE also published a 2017 research report on sterile injectable shortages with the Pew Charitable Trusts. The report looked not only at manufacturing and quality issues, but at the other dimensions that trigger shortages as well. “Companies often make decisions in isolation,” he said. “They shut down and stop production. Then there’s not enough capacity to serve patients who desperately need those drugs. We have to act, prevent, and remediate those problems,” he said.

“As Chair of the Drug Shortages Task Force I am so proud of these publications,” he added. “But their value is zero unless you read them.”

The US Government Accountability Office Report of July 2016 showed a “slight improvement” in drug shortages, said Sallans, “but it’s fragile.” While there have been fewer new shortages, there are an alarming number that have been open for a long time. “There are no solutions for those patients,” he said. “The world is not changing for them.”

To start the group discussion, Sallans asked the audience a series of thought-provoking questions: “What is your experience with drug shortages? What changes have you made to prevent shortages in your company? What do you need from ISPE to be more effective at preventing drug shortages? Even if you haven’t experienced drug shortages, what are your ideas and suggestions?”

Captain Valerie Jensen, Associate Director of the Drug Shortage Program, FDA, added that the agency is “100% dependent on industry. We need to hear about shortages early on. We will work with you and can also bring in our team to help. Our goal is to work to prevent and address shortages.” She expressed appreciation for all the work ISPE has done, and encouraged listeners to contact the FDA with ideas for solutions.

A substantive discussion between attendees and regulators followed. Topics included the role of older drugs in shortages, the consequences of import alerts, and the social responsibility of manufacturers.

Considerable conversation revolved around one observation: Many drug shortages are associated with aged facilities. “If you analyzed it,” said one participant, “you’d have a 0.9 correlation of old facilities to problems. How do we move forward to address this?”

Another posited “Maybe that gets to what ISPE can do. ISPE is better than any organization at quantifying process capability and demonstrating the loss created by incapable equipment.”

Well-trained operators are also important, added someone else. “That’s the other dimension you always have to think about. They’re worth their weight in gold. Knowledge transfer is very important. We need that across the board.”

One regulator in attendance, who acknowledged that he’d “done a few sterile drug inspections,” was asked to identify “the two or three things at the top of your list to prevent shortages. What actions can keep a plant in a good state?”

The answer: Be proactive so you have some assessment of your operation.

Sallans closed the session by asking, “What do you need from us? If you think there’s anything missing that we can work on, we’d be delighted to consider it.”

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