Drug Shortages: A Focused Review
Tuesday afternoon also saw an education session on drug shortages, led by Diane L. Hustead, Associate Director, Regulatory Affairs, Merck & Co. Inc. She introduced the two speakers and explained that each presentation would be followed by a Q&A session.
Education is key and that is largely the role of the ISPE Drug Shortages Initiative steering committee, which created the Report on the ISPE Drug Shortages Survey (2013), ISPE Drug Shortages Prevention Plan (2014), ISPE Drug Shortage Assessment and Prevention Tool (2015), ISPE Drug Shortages Initiatives Webinar (2016), and Drug Shortages, a collaborative report from ISPE and the Pew Charitable Trusts (2017). These all help members understand and mitigate drug shortages.
Pew Charitable Trusts/ISPE drug shortages report
The first speaker, François Sallans, Vice President and Chief Quality Officer, Johnson & Johnson, stepped in for scheduled presenter Frances Zipp, President of Lachman Consultant Services, Inc. He presented "Major outcomes of the Pew Charitable Trusts/ISPE drug shortages report (01.2017)." The 2017 Member of the Year award recipient has led the ISPE drug shortages initiative since its launch in 2012.
Sallans began by stating "It's always an honor and a privilege to speak about drug shortages because the problem is still ongoing, and it is quite complex." He spoke at length about the issue, yet focused his attention on the Pew/ISPE report.
This report, he explained, focused on the sterile injectables market in the United States because it accounts for almost three-quarters of the shortages that are listed by the US Food and Drug Administration (FDA). "By surveying 51 decision-makers at 10 companies," said Sallans, "we discovered that quality problems were the main driver: They play a role in 45% of shortages."
The other big factor the report revealed was limited flexibility to ramp up production to meet demand. "In today’s world, supply chains are extremely complex," he said. APIs and bulk products are manufactured in different places and packaged in other places across the globe. Although supply chain risk management is applied across our industry and backup plans are defined for the most critical products, not all products have an active or at least an approved backup supply for every step in the network. "If anything goes wrong anywhere along this complex network, including at a contract manufacturer, an alternate site might not be able to increase production within the requisite timeframe and drug shortages may occur."
But quality and flexibility aren’t the only factors. Market withdrawals, limited market insights into future demand, and a lack of clear expectations from regulators were also cited as a cause of shortages. "Limited market insights about future demand is an interesting factor," said Sallans. While it’s a small percentage, it can have a longer-lasting effect on shortages. A company may have a good idea of what the current competition landscape looks like, but it’s difficult to have a clear view of the future.
The key, he said, is to establish appropriate and meaningful supply chain risk management plans.
In the Q&A session that followed, Sallans answered several questions from participants on broader questions around drug shortages, including the recent situation in hurricane-torn Puerto Rico.
FDA Update on Drug Shortages
The second speaker, Jeannie David, Senior Program Management Officer, FDA/CDER/OCD/DSS, presented an "FDA update on drug shortages."
She thanked Sallans, and ISPE, on its continued commitment to working on drug shortages "You are working on a part of drug shortages that we can’t," said David.
"We don’t have enough visibility and we don’t know your products and your manufacturing partnerships. All that behind the scenes works, anticipating potential problems, that is all work that we appreciate greatly from ISPE."
She went on to explain how the role the FDA has, because it can't get at the root causes, and because it can't know what all the issues are and how to address them, is primarily a secondary response to industry. The agency gets involved as soon as it hears from hospitals, patients, and industry, that there are issues. "Shortages due to manufacturing and quality problems seem to cause the most severe shortages for patients and the most difficult to recover from."
She then described some of the best practices that have come across her desk, when the FDA is involved in shortage notifications. "What helps," she shared, "is an across-the-board commitment to ensuring ongoing supply of life-saving medicines." Companies who make that commitment will initiate notification to the FDA early. "They understand this information is confidential and that the FDA treats it as such." The FDA can then use this information to mitigate risk, including working with companies to prioritize drugs that meet a critical medical need during a manufacturing shutdown or slowdown.
"You may not know the entire market, or all the different patient populations that rely on your market," explained David. "If we are in a shortage situation, we need to communicate that to the public, like hospitals, so they can do their work."
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