Shortages of essential drugs is a challenge hospitals have always faced, but the American Society of Health-System Pharmacists has forecast that trade restrictions, pandemics and climate change will only increase the potential for more shortages.
With continuing uncertainty about the stability and quality of the pharmaceutical supply chain, hospital and health system pharmacist must be prepared for "significant disruptions to normal healthcare delivery, including disruption of medication procurement," Erin Fox, PharmD, senior director of drug information and support services at the University of Utah Health in Salt Lake City, wrote, along with Aaron Kesselheim, MD, an internal medicine physician at Brigham and Women's Hospital in Boston, in a report published February in the American Journal of Health-System Pharmacy.
Dr. Fox, who works on the team that provides all the content for the society's drug shortage tracker, along with Jennifer Tryon, PharmD, chief pharmacy officer of Wake Forest Baptist Health in Winston-Salem, N.C., recently spoke with Becker's Hospital Review about what's causing drug shortages, what changes need to be made to the pharmaceutical supply chain to reduce shortages and gave advice for hospital pharmacy leaders to manage shortages.
What's causing drug shortages?
There's a combination of factors at play that cause a shortage, most notably quality issues at drug manufacturing plants. More than 50 percent of drug shortages are caused by a manufacturing issue, Dr. Fox said.
Eli Lilly's manufacturing plant in Branchburg, N.J., where it makes its COVID-19 drug bamlanivimab and its blockbuster diabetes drug Trulicity has made headlines recently with quality issues. The plant was subpoenaed by the U.S. Justice Department in May after being flagged for quality control problems following two separate FDA inspections. The company also faced allegations from plant employees that a top quality official altered documents to play down those problems.
Emergent BioSolutions, previously a largely unknown biopharmaceutical company based in Maryland, has also made headlines after its manufacturing plant mixed up ingredients of AstraZeneca's COVID-19 vaccine with ingredients for Johnson & Johnson's vaccine, ruining 15 million doses. After an inspection, the FDA cited a number of quality concerns with the plant.
Dr. Tryon said consolidation among drugmakers is also a major disruptor causing shortages. There are simply fewer companies making drugs. The low profitability of making generic drugs and high government regulation make for a tough pharmaceutical market, she said.
The most common drugs that go into shortage are cheap, generic, injectable ones that have been used at hospitals for a long time, such as lidocaine or saline, according to Dr. Fox. Brand-name drugs are so expensive, companies have the incentive to build resiliency into their supply chains, she said. They have a backup plan so they never run out of the brand-name drugs.
What would make it easier to predict when a drug will go into shortage?
More transparency into the pharmaceutical supply chain would make predicting shortages easier, Dr. Fox said. A lot of elements of drug manufacturing are completely opaque and are considered proprietary secrets, such as the source of raw materials and the list of drug products made at a specific factory, according to Dr. Fox.
Because there are so many secrets, it's impossible to have the metrics needed to do predictive modeling to know when a drug will go into shortage.
Drugmakers are required to disclose more information to the FDA than is made public, and the agency works to prevent some shortages when it sees drugs that are vulnerable for a shortage, according to Dr. Fox. The FDA can take steps such as approving another drugmaker to make a certain drug, or allowing imported products.
Hospital pharmacy leaders having more visibility into the pharmaceutical supply chain and more information about which drugmakers have higher quality drugs would do a lot to combat drug shortages, Dr. Fox said. Many drugmakers likely don't invest in quality because there's so little transparency into the manufacturing of prescription drugs, she said.
"If we had that transparency, people might care a little bit more," Dr. Fox said. "We know a lot more about where our food comes from than where our medicine comes from. Medicines are one of the only things we buy where we have very little information about who made it, where it was made and the reputation about who was making it."
What can hospital pharmacy leaders do to combat drug shortages?
Fixing the root causes of drug shortages is complex, as there are many players in the pharmaceutical supply chain.
"Part of our challenge is that we're downstream of many of the solutions, because you have your manufacturer, your [group purchasing organization], your wholesaler. So, we're at the mercy of many of the players in this space," Dr. Tryon said. "I think it would be best if we worked to ensure a steady supply of raw materials, make sure we have more visibility into the supply chain and make sure there's no panic buying. A lot of the change has to come from the top down."
One thing pharmacy leaders can focus on is developing a method to detect drug shortages as early as possible. At Wake Forest Baptist Health, the pharmacy team has developed dashboards to manage its inventory so it knows where its drugs are across the system at any given time, Dr. Tryon said. One dashboard is specific to shortages to help the team monitor them.
The health system also has a committee made up of pharmacy leaders across the organization that meets weekly to look at managing new drug shortages.
"At any one time, we're actively managing more than 100 drug shortages. That's pretty typical," Dr. Tryon said.
Dr. Fox added that she believes every hospital should have at least a framework in place for how it would allocate drugs in short supply so the pharmacy team doesn't have to make that decision on its own. Similar to how providers had to make decisions during the height of the COVID-19 pandemic on who should be prioritized for care, hospitals should have protocols in place to determine who gets treated with a drug when it goes into shortage.
"If you have 10 doses of something left and you need it for 30 people, who gets it?" Dr. Fox asked.
Many changes that would need to be made to prevent drug shortages fall on manufacturers and regulators, but hospital pharmacy leaders can take a proactive approach to detect shortages early and have plans in place for allocating drugs when they do go into shortage, Dr. Fox and Dr. Tryon agreed.