THE BAD NEWS: Chronic drug shortages continue unabated across the country, delaying medical procedures, potentially contributing to medication errors, leading to price-gauging by third-party suppliers, and frustrating hospital personnel who must scramble to substitute therapeutic equivalents. The good news? Pharmacists are successfully stepping into that gap, creating systems and processes for coping with the shortages.
An Escalating Problem
Hospitals are increasingly experiencing shortages of drugs that are critical for patient care, including morphine, succinylcholine, and amikacin. “From a direct patient care viewpoint, it has been very difficult,” said Bernadette S. Belgado, Pharm.D., clinical assistant professor and manager of therapeutic policy at Shands Jacksonville, an affiliate of the University of Florida Health Science Center Jacksonville.
According to Bona E. Benjamin, B.S. Pharm., director of medication-use quality improvement at ASHP, the number of shortage reports has steadily grown since 2006. “If you were to chart shortages, the line would be straight up,” she said.
To minimize the impact of shortages, hospitals and health systems across the country are proactively developing new processes and strategies.
At Shands Jacksonville, the purchasing, inpatient operations, and therapeutic policy managers meet weekly to review an electronic report that includes a spreadsheet of inventory and utilization and a plan to manage the process. If a nonformulary item is involved, a process is in place to fast-track the formulary addition or therapeutic substitution through the pharmacy and therapeutics (P&T) committee.
From there, communication fans outward, said Joel Parnes, Pharm.D., MHA, manager of central operations in the department of pharmacy. “The shortage may prompt a direct bulletin to physicians and different departments as well as phone calls,” he said. “We make sure it gets down to nurses and those providing care at bedside.”
Contingency plans for shortages at WakeMed Health & Hospitals in Raleigh, N.C., include a step-by-step description of the procedures required to make a substitution.
“We use a checklist of all the pieces that have to be put in place when you make a change,” said Lynn Eschenbacher, Pharm.D., MBA, the pharmacy’s clinical manager. “We look at the data, determine how much drug we need, how much we have on hand, what the therapeutic alternatives are, and what our options are.”
The process is driven by a committee that includes WakeMed’s product buyer, business manager, operations manager, pharmacy director, medication safety officer, and Eschenbacher. “We meet to decide when to take a shortage to our P&T committee to get approval for a formulary change,” she said.
The plan also accounts for technical changes that must be put in place, such as adding new products to the pharmacy order system or rotating items from automated dispensing cabinets on the patient care units back into the pharmacy, Eschenbacher added.
The Problem With Third Parties
Coping with shortages is a time-consuming, labor-intensive task, according to Eschenbacher. “On any given day, I can spend two to four hours working on a shortage,” she said. “You have to figure out what the restrictions are for therapeutic substitution and decide if and when to go to a third party, such as a compounding pharmacy.”
Buying from third parties is an expensive option. For example, during a shortage of prefilled syringes of epinephrine, WakeMed chose to contract with compounding pharmacies even though the system would not be reimbursed for the markup.
“We felt that safety outweighed the cost,” Eschenbacher said. “The alternative would be mixing and pulling up a syringe in a crisis. In a code situation, that takes extra time you may not have.”
The cost of going to third parties rankles Belgado, who noted how the recent amikacin shortage affected Shands Jacksonville. “Working with third parties is part of the cost of business, but when the pricing is 400 or 500 percent more than what we normally pay, it is astounding that that is legal,” she said.
Belgado is equally frustrated by thegray market, which provides alternate sources of drug products outside the normal supply chain.
“We were desperate, calling all over to get amikacin,” Belgado said. “We were even looking at veterinary options. But when you look at the gray market companies and find that they have plenty of product, that can be really hard for us to digest. Why is it that those of us who care directly for patients cannot get it?”
According to Parnes, one reason shortages are so tough to handle is that they often occur with little to no warning. “Often we find out about evolving shortages from product managers or from ASHP,” he said. “We want to be proactive, but a lot of what we do is reactive, which makes it difficult.”
Need for the FDA to Step In?
Parnes feels there is room for the Food and Drug Administration (FDA) to get involved. “When companies pull out of the market, the FDA needs to assess what impact that will have,” he said.That is where it gets tricky, according to ASHP’s Benjamin. “The FDA has fairly limited authority to do much about drug shortages,” she said. “They can’t require manufacturers to tell them of an evolving shortage, and they can’t prevent a manufacturer from discontinuing a product that many people use. They cannot interfere with trade.”
However, change at the federal regulatory level with respect to information management would be immensely helpful, she said. “Information that would allow people to predict a shortage, how long it might last, and its impact on care should be available more transparently so that people can at least plan for the shortage,” she said.
In the meantime, pharmacists can help one another by reporting shortages to ASHP. “We talk almost daily with the FDA,” said Benjamin. “As soon as I hear of a shortage report from a member, I call my contact at the FDA and let her know we need to look into this. Sometimes, that’s the only way the FDA learns of the problem.”