When a patient’s cardiac arrest triggers a Code Blue, clinicians respond with rapid precision, until they need to take a brief break. Instead of a pre-filled syringe or a 1 mL premixed vial of epinephrine in the code trolley there is a bottle of concentrate epinephrinea solution of sodium chloride to dilute, a syringe and instructions for use.
Shortages of epinephrine syringes have become so common that this extra step usually takes less than a minute – extra seconds when every second counts, but smooth action. The ease of this readjustment shows how routine drug shortages in the country have become. Health system pharmacists and critical care clinicians are challenging the new normal of drug shortages – and gaining traction in a pandemic-fueled environment focused on global supply chain vulnerabilities.
“It’s like a chronic disease now rather than a catastrophic failure of the system,” said Kevin W. Hatton, MD, PhD, senior medical director of critical care at UK Healthcare in Lexington, Kentucky, and member of the drug system at two hospitals. shortage working group. “That doesn’t mean it’s healthy. We just have a chronic condition that bothers us periodically. Sometimes more, sometimes less, but never completely gone.”
As new shortages fell to their lowest level in 14 years, global shortages remain about as high as they were amid disruptions after Hurricane Maria in 2017, when manufacturing facilities suffered damage, according to data from the University of Medicines Drug Information Service. Utah. Current (and long-standing) shortages affect some of the most basic and commonly used products, including saline bags and electrolytes. “Short products are needed for just about every hospital patient,” said Erin Fox, PharmD, senior director of pharmacy at Utah Health University in Salt Lake City.
The pandemic has caused an increase in demand for certain drugs, such as central nervous system agents used in patients on ventilators, as well as labor and supply chain issues that affect many industries. Although COVID-19 has not fundamentally changed the number of drug shortages, protecting the medical supply chain has become an important national priority.
In March 2022, the National Academies of Science, Engineering, and Medicine published a report on Strengthen the resilience of the country’s medical supply chains, advocating greater transparency on the source of pharmaceutical raw materials, the volume and location of manufacture, and the quality of products. On May 24, the US Food and Drug Administration is organize a workshop examine how to assess the quality of facilities that manufacture drugs and raw pharmaceutical ingredients.
“COVID has really brought the supply chain to the fore. That’s why I’m optimistic that we could see real change,” said Fox, who served on the National Academies committee and attends the workshop.
Look for transparency
The lack of transparency is causing headaches for front-line healthcare professionals. Hospitals typically don’t receive notice if a manufacturer halts production or closes a plant due to maintenance or quality issues. Pharmacists also don’t know the specific manufacturing locations of the drugs they order, so they can’t anticipate a shortage due to a natural disaster or other disruptive event, said Collin Lee, PharmD, director. assistant of the clinical and educational services of the Department. pharmacy at Emory Healthcare in Atlanta, Georgia.
Lee manages drug shortages for a system of 11 hospitals. “These shortages often occur without prior warning and force our team to scramble to find and implement clinical alternatives while maintaining patient care and safety,” she said during a briefing. drug shortage session last week virtual conference of the Society of Critical Care Medicine (SCCM).
Buyers also lack information on product quality. While consumers are used to searching online for reviews and ratings of the most mundane household items, hospitals negotiate only on price, said Michael Ganio, PharmD, senior director of practice and quality at Pharmacy. the American Society of Health-System Pharmacists (ASHP) in Bethesda, Maryland. With very low margins on some products, manufacturers have little incentive to upgrade to improve quality and even continue to manufacture the items, he said. “If there was a way to reward manufacturers who invest in quality programs, it would be a way to improve reliability and quality,” he said.
While hospitals and health systems save money when prices drop, these savings are offset by the additional costs of managing shortages. In a 2019 report, Vizient Group’s central purchasing office estimated that US hospitals spend $359 million a year additional labor costs due to drug shortages. For example, at UK Healthcare, a Medicines Shortages Task Force of pharmacists and doctors meets weekly to monitor and manage shortages.
The impact of shortages on patients is more difficult to determine. “There is a perception that in some cases the results are altered. I think there needs to be data to better understand whether this is a reality or not,” said Sandra L. Kane-Gill, PharmD, MSc, President of the Society of Critical Care Medicine.
A retrospective study published in 2017 in the Journal of the American Medical Association showed that mortality in patients septic shock was higher in a year 2011 norepinephrine shortage than during periods without a shortage between 2008 and 2013. The study was not designed to show causation – and it would clearly not be ethical to randomize patients in a “shortage” situation. But better earnings data could shed light on the scale of the problem, Kane-Gill said. “Other variables can be difficult to control, but I still think we could do our best with observational data to get an indication. [of the impact],” she says.
In March 2022, ASHP surveyed 345 pharmacists and chiefs of pharmacy or clinical coordinators, almost all in hospitals, on the impact of shortages of sterile injectable drugs. More than half of respondents reported a severe impact from shortages of: 50% pre-filled dextrose syringes, vials of sterile water for injection, syringes or vials of 0.9% saline solution, local anesthesia vials (with or without epinephrine), pre-filled epinephrine syringes and concentrated electrolyte injections. Seven percent reported at least one drug safety event due to a drug shortage that caused at least temporary harm to the patient.
The CARES Act of 2020, passed during the initial response to the pandemic, requires manufacturers to provide more information about shortages and manufacturing disruptions, although manufacturers have asked for more time gradually introduce reports on the volume of production of drugs.
In an effort to boost supply, the Drug Shortage Shelf Life Extension Act, pending in Congress, would direct the FDA to extend the expiration dates of certain drugs to address shortages. Non-profit US-based generic drug makers, such as Plow and Civic Rxemerged in response to shortages of basic medicines.
But for now, coping with shortages requires adaptability. At SCCM 2022 Critical Care Congress, Gretchen Sacha, PharmD, a clinical critical care pharmacist at the Cleveland Clinic in Ohio, outlined the steps, beginning with an inventory of available supplies and an assessment of “true usage history,” to determine the quantity needed to get through a period of shortage. “These elements are necessary to determine how the institution will navigate through this early phase of the shortage where you will start using your own supply and then start developing a plan to mitigate it,” she said.
The plan takes patient needs into account. For example, if a shortage affects an IV drug, some patients may be able to switch to an oral alternative, conserving the IV supply for others, she said.
Communication is key to helping clinicians adapt to change, Sacha advised. “Several methods of communication are always better than one,” she advised. “Don’t just send an email that might go unread and get lost in an inbox of hundreds of emails.” Instead, also provide alerts in the electronic medical record, place information in facility newsletters and provide updates at unit rallies or department meetings, she suggested.
The end goal of mitigation efforts, Hatton said, is “to ensure that patients always get the best drugs to treat problems at the right time.”
Erin Fox is an unpaid advisory board member for Civica Rx. No other relevant financial relationships were disclosed.
Society for Critical Care Medicine (SCCM) Critical Care Congress 2022: What do you mean we’re out? Mitigation and prevention of drug shortages. Presented April 18, 2022.
Michele Cohen Marill is a freelance journalist based in Atlanta, Georgia. She has written for Wired, STAT, Health Affairs and other publications. She can be reached at [email protected]