No doubt you’ve heard it said before, but drug shortages really have become the new normal. Shortages have grown more persistent and long-lasting over the years. Some have even been active for more than eight years! The intensity of shortages also remains high – as does the public health impact. At a November 2018 U.S. Food and Drug Administration (FDA) drug shortage summit, FDA task force members provided a succinct summary with some key themes of the current situation facing hospitals today:
The FDA task force conducted key stakeholder listening sessions as part of its research that uncovered four key shortage themes:
- Broad impact – The impacts of drug shortages affect every level of the healthcare system. Drug shortages compromise care and increase costs.
- Contributing factors – Multiple market factors, including consolidation, low margins and contracting practices contribute to shortages.
- Transparency – The healthcare community lacks adequate transparency across the supply chain. The FDA says the right level of transparency, which factors in both the security concerns of manufacturers and the needs of hospitals and pharmacies, is not yet clear.
- Inconsistency – Hospitals and others in the industry must navigate different authorities within multiple federal agencies for reporting shortages and plans to manage them. Suggestions for resolving the discrepancies between agencies may unintentionally exacerbate the problem.
Lack of clear guidance
U.S. hospitals struggle with inconsistent standards of how to manage drug shortages and how to prioritize available supply. This struggle stands in marked contrast to other countries around the world. Drug shortages occur worldwide. Yet, unlike other countries, the U.S. has not adopted the UN World Health Organization’s (WHO) essential medicines list that identifies the most efficacious, safe and cost effective medicines that must be available at all times in a functioning health system. Additionally, the list prioritizes patient conditions for using available drug supply which gives health systems clear guidance in a shortage situation.
In the absence of guidance from a central authority, U.S. hospitals are left to set clinical guidelines, restrictions and standards themselves. Unfortunately, not all health systems are providing clear guidelines, either. In a survey of medical oncologists published in the New England Journal of Medicine, nearly 70 percent said their hospital or practice lacked formal guidance to help them decide which patients should get chemotherapy drugs in short supply. Creating such guidelines and restrictions can be time-consuming and requires clinical expertise that may not always be available within every health system.
In his opinion piece recently published in STAT, Yoram Unguru, MD, a pediatric hematologist and oncologist at The Herman & Walter Samuelson Children's Hospital at Sinai in Baltimore, said, “Most experts agree that the primary driver for drug shortages is economic.” He quoted Martin VanTrieste, a pharmaceutical executive and president and CEO of Civica Rx, saying “all drug shortages are the result of economics, financial and management decisions.”
Unguru goes on to state, “We cannot continue to overlook the economic drivers that lead to shortages of older drugs costing just dollars per dose that offer cures for cancer, while newer chemotherapy agents costing hundreds of thousands of dollars that may prolong life by just a few months are rarely, if ever, in short supply.”
In making his point, Unguru offers several examples of the impact of drug shortages on pediatric oncology patients. One example he points to is acute lymphoblastic leukemia, the most common form of childhood cancer. Using drugs that have been available for more than 50 years, the survival rate for patients with that condition is nearly 90 percent. Unfortunately, eight of the 10 drugs most commonly used to treat this type of leukemia experienced significant shortages during the last decade. Patients are suffering needlessly as a result.
The role of governments and economic drivers are, of course, macro issues that no single stakeholder can resolve. As those issues are debated and addressed, drug shortages persist – and hospital systems need a better way to manage them.
To help mitigate the impact of shortages and manage them more efficiently when they can’t be avoided, hospitals across the country are turning to The Drug Shortage App from LogicStream Health™. This management tool helps hospitals better manage drug shortages and minimize disruptions to patient care. The Drug Shortage App provides hospital pharmacy teams visibility into ordering, prescribing and dispensing practices so they can take control of medications in short supply.
Learn more about what this solution can do to help your organization by downloading a free overview of The Drug Shortage App at www.thedrugshortageapp.com.
Brita Hansen, M.D., is Chief Medical Officer of LogicStream Health. She began her career as an internal medicine hospitalist physician after receiving her undergraduate degree at NYU and her Doctorate of Medicine from the University of Minnesota School of Medicine. She served as Chief Health Information Officer for the Hennepin County Medical Center before joining LogicStream Health.