2 leaders in hospital pharmacy on the causes and solutions to drug shortages
Shortages of essential medicines are a challenge that hospitals have always faced, but the American Society of Health-System Pharmacists has predicted that trade restrictions, pandemics and climate change will only increase the potential for further shortages.
With continued uncertainty about the stability and quality of the pharmaceutical supply chain, the pharmacist in hospitals and in the healthcare system must be prepared for “significant disruptions to the normal delivery of healthcare, including a disruption of health care. drug supply, ”Erin Fox, PharmD, Senior Director of Drug Information and Support. health departments at the University of Utah Health in Salt Lake City, wrote, with Aaron Kesselheim, MD, a doctor of internal medicine at Brigham and Women’s Hospital in Boston, in a report published in February in the American Journal of Health-System Pharmacy.
Dr Fox, who is part of the team that provides all content for the company’s drug shortage tracking, as well as Jennifer Tryon, PharmD, chief pharmacist at Wake Forest Baptist Health in Winston-Salem, North Carolina , recently spoke with Becker Hospital Examination on the causes of drug shortages, changes to the pharmaceutical supply chain to reduce shortages and provided advice to hospital pharmacy executives to manage shortages.
What causes drug shortages?
There is a combination of factors at play that causes a shortage, including quality issues in drug factories. More than 50 percent of drug shortages are caused by a manufacturing problem, Dr. Fox said.
Eli Lilly’s manufacturing facility in Branchburg, NJ, where it makes its COVID-19 drug bamlanivimab and its bestselling diabetes drug Trulicity recently made headlines with quality concerns. The plant was subpoenaed by the US Department of Justice in May after being flagged for quality control issues following two separate inspections by the FDA. The company has also faced allegations from factory workers that a high-quality official altered documents to minimize these issues.
Emergent BioSolutions, previously a largely unknown Maryland-based biopharmaceutical company, also made headlines after its manufacturing facility mixed ingredients from 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 issues 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 manufacturing generic drugs and high government regulations make the pharmaceutical market difficult, she said.
The most common drugs in short supply, Dr. Fox said, are the inexpensive injectable generic drugs that have long been used in hospitals, such as lidocaine or saline. Brand name drugs are so expensive that companies have an incentive to build the resilience of their supply chains, she said. They have a back-up plan so they never run out of brand name drugs.
What would make it easier to predict when a drug will be in short supply?
Greater transparency in the pharmaceutical supply chain would make it easier to forecast shortages, Dr Fox said. Many elements of drug manufacturing are completely opaque and are considered proprietary secrets, such as the source of raw materials and the list of pharmaceuticals made in 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 be in short supply.
Drugmakers are required to disclose more information to the FDA than is made public, and the agency works to avoid certain shortages when it detects drugs vulnerable to a shortage, according to Dr. Fox. The FDA can take actions such as approving another drug manufacturer to manufacture a certain drug or authorizing imported products.
Hospital pharmacy executives with more visibility into the pharmaceutical supply chain and more information about drug makers who have better quality drugs would do a lot to tackle drug shortages, Dr Fox said. Many drugmakers are unlikely to invest in quality because there is so little transparency in the manufacture of prescription drugs, she said.
“If we had that transparency, people might care a little bit more about it,” Dr. Fox said. “We know a lot more about where our food comes from than where our medicine comes from. Drugs are one of the only things we buy where we have very little information about who made them, where they were made, and the reputation of those who made them. this.”
What can hospital pharmacy managers do to address drug shortages?
Addressing 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 are downstream of most solutions because you have your manufacturer, your [group purchasing organization], your wholesaler. So we are at the mercy of many players in this space, ”said Dr Tryon. “I think it would be best if we worked to ensure a constant supply of raw materials, make sure we have more visibility into the supply chain and make sure there is no purchase of panic. Much of the change has to come from the top down. “
One thing pharmacy executives 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 their inventory so they know where their drugs are in the system at all times, Dr Tryon said. A dashboard is specific to shortages to help the team monitor them.
The healthcare system also has a committee made up of pharmacy leaders from across the organization that meets weekly to review the management of emerging drug shortages.
“At any given time, we are actively managing over 100 drug shortages. It’s pretty typical, ”Dr Tryon said.
Dr. Fox added that she believes every hospital should at least have a framework in place for how they would allocate shortage drugs so that the pharmacy team doesn’t have to make this decision alone. Just as providers had to make decisions during the height of the COVID-19 pandemic about who to choose for care, hospitals should have protocols in place to determine who is treated with a drug in case of illness. shortage.
“If you have 10 doses of something left and you need 30 people, who gets it?” Dr. Fox asked.
Many of the changes that should be made to prevent drug shortages are the responsibility of manufacturers and regulators, but hospital pharmacy executives can take a proactive approach to detect shortages early and have plans in place to allocate drugs when they are needed. they are in short supply, Dr Fox and Dr Tryon agreed.