July 16, 2018

Inside FDA's new drug shortage task force

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    Read Advisory Board's take on this story.

    FDA on Thursday announced plans to create a new task force to better address drug shortages.

    Background

    FDA Commissioner Scott Gottlieb said the United States "continue[s] to see ongoing shortages of medically necessary products." He noted, "When shortages occur, practitioners are forced to ration supplies or substitute alternate drugs that in some cases compromise patient care."

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    FDA launches task force focused on drug shortages

    To better address those concerns, Gottlieb said FDA is launching a new Drug Shortages Task Force. The task will "delve more deeply into the reasons why some shortages remain a persistent challenge" and "look for holistic solutions to addressing the underlying causes for these shortages," Gottlieb said.

    For instance, Gottlieb said the task force will look into ways to "encourage companies to invest in more capacity to make" drugs that are vulnerable to shortages "and to produce them with robust manufacturing processes that ensure consistently available quality products."

    Gottlieb also said the task force will create "several dedicated workgroups" to examine "various aspects" of issues contributing to drug shortages, including FDA's current regulatory authorities and "reimbursement policies from CMS and other payors that could be making it difficult for companies to manufacture certain drugs profitably." The task force also could consider whether the federal government should create "a critical drugs list, or a list of essential drugs," for which the federal government might "want to consider more significant interventions than [it] currently employ[s] to avert shortages," Gottlieb said.

    Keagan Lenihan, FDA's associate commissioner for strategic initiatives, will lead the task force, which will include senior FDA officials, as well as officials from CMS and Veterans Affairs. The task force also will get input from Congress, drugmakers, federal agencies, health care providers, and patient advocates. Gottlieb said the task force will "hold a meeting with stakeholders in the next several months to provide an opportunity for everyone with a stake in addressing drug shortages to come to the table."

    A step in the right direction

    Paul Kivela, president of the American College of Emergency Physicians, called the task force's creation "a major step toward solving the complex and severe, and persistent drug shortage issue in the United States."

    Girish Malhotra, a drug manufacturing expert and president of the consulting firm EPCOT International, also said FDA's announcement marks a step in the right direction, but expressed uncertainty that the task force will be able to solve issues that cause drug shortages. For instance, he said FDA lacks the experts needed to improve manufacturing technologies. "How quickly will patients see results? That's anybody's guess," he said (AP/Modern Healthcare, 7/12; Nedelman, CNN, 7/12; Court, MarketWatch, 7/13; FDA release, 7/12).

    Advisory Board's take

    Rebecca Tyrrell, Senior Consultant, Pharmacy Executive Forum

    By one estimate, drug shortages cost U.S. hospitals $446M annually—$230M generated by the need to purchase more expensive therapeutic substitutes, and $216M by increased labor costs. Additionally, shortages can have a profound and widespread effect on patient safety and outcomes, as well as staff burnout.

    What's troubling about the current state of affairs is that there are so many active shortages all at once. While there were only 105 new shortages in 2017, there were a total of 175 ongoing shortages requiring active management by health systems.

    The formation of a drug shortage task force should help defend against shortages of basic supplies such as saline and parenteral nutrition products. It should also hopefully minimize the intense burden individual hospitals face in responding to shortages.

    While a range of individuals within the hospital are affected, pharmacists bear the brunt of managing shortages and minimizing their impact. The time needed to complete tasks such as communicating with manufacturers and wholesalers, compounding and repackaging preparations, modifying policies and clinical protocols, and updating medication administration systems has more than tripled since 2004.

    There are several strategies progressive health systems are employing to bolster their defenses:

    • Adding dedicated pharmacy FTEs (at least 0.5 to 1) to manage shortage-related response efforts
    • Centralizing inventory to ensure cross-site visibility
    • Budgeting for shortages to account for increased acquisition and personnel costs
    • Getting 503B certified to enable the preparation of drugs and IV fluids in-house
    • Educating legislators on shortages and advocating for mitigation strategies

    To learn more about drug shortages and what your hospital can do to address the issue, view the briefing on drug shortages in the executive's guide to pharmacy issues.

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