Local hospital pharmacy departments are working to keep a growing, nationwide issue of drug shortages from affecting patient care.
“We spend an extraordinary amount of time problem-solving and coming up with ways to mitigate any drug shortages the hospital is experiencing,” said Christopher Martin, the pharmacy manager at UCHealth Memorial Hospital Central. “Any hospital that tells you they aren’t experiencing [drug] shortages isn’t being honest with you.”
The scarcity of certain products is forcing hospital pharmacists, including those at Memorial and Penrose-St. Francis Health Services, to come up with alternative solutions for patient care.
Nine out of 10 emergency physicians surveyed in May by the American College of Emergency Physicians said they don’t have access to critical medicines, with four in 10 stating it’s negatively affected patient care.
“It’s all over the map with the types of drugs that are running low, and it changes often,” Martin said. “There are shortages in antibiotics, blood pressure medications and some pain relievers, but if we [the pharmacy department] do our job well, it doesn’t affect our patient care.”
Both at Memorial and Penrose-St. Francis the pharmacy departments conduct regular meetings to evaluate possible drug deficiencies.
“We meet about our options for any drug shortages the hospital has to see if we can make it in our clean room or if we need to find something different to recommend our providers use in its place,” Martin said. “We always engage physician leaders in each of the departments that are going to be affected by a possible drug shortage and try to make decisions together on how we are going to mitigate any impact to patient care.”
Alison Schlang, the director of pharmacy at Penrose-St. Francis, said her department gathers twice weekly in addition to issuing at least one drug shortage bulletin a week to providers and nurses.
Last week, the hospital was monitoring 20 different drugs on its shortage list, according to Carter Birkel, the assistant director of pharmacy at Penrose-St. Francis.
“We break them down into how much we do have left of the current product, so we can prioritize and plan from there,” he said.
The department will explore what other dosage forms are available for any drugs facing shortages, in addition to alternative solutions if the none of the product in question is on hand.
“The shortages increase [the pharmacy department’s] workload, and they are concerning and add risk when we are having to compound things we can normally buy,” Schlang said.
Martin believes three things cause drug shortages hospitals have been battling for years: market forces, increased government oversight and manufacturing disruptions.
“When you look at the pharmaceuticals that we hospitals buy, there are two different types of products,” he said. “There is the innovative [market] with new patent protection — meaning only one company can manufacture the product — and then the second market or the generic market.”
Once drugs move into the generic market, the price typically drops.
“That has held true over time for oral products, but over the last 10 years, the injectable generic market has changed dramatically,” Martin said. “The [injectable] products can be expensive to make, and there is a lot of [Federal Drug Administration] regulation to produce them.”
As a result, the market has seen a lot of consolidation, where smaller manufacturers are acquired by larger companies such as New York-based Pfizer.
“We used to be able to buy certain drugs from multiples suppliers but now there is only one company manufacturing it,” Martin said.
For example, a blood pressure medication called nitroprusside used to be sold for about $40 but after being bought by Valeant Pharmaceuticals International Inc., the price jumped to roughly $800.
“Consolidation really can lead to higher prices and drug shortages when only one manufacturer is left making something in the market,” Martin said. “And if that company has manufacturing difficulties, there will be increased regulations and oversight for them.”
That’s what has happened to the country’s main morphine supplier, Pfizer, after it acquired Illinois-based Hospira, which had known quality control issues.
“The FDA increased inspections and started requiring more mitigation efforts at those [Hospira] facilities,” Martin said.
Earlier this month, Pfizer “voluntarily paused” production at its manufacturing facility in India, which was part of its acquisition of Hospira in February 2015 in a $17-billion deal.
The halt in production came after the FDA conducted an inspection last spring and then issued a report that detailed a host of quality control issues at the facility.
Schlang said Pfizer is only one of the manufacturers from which the hospital has struggled to procure drugs due to increased oversight by the FDA.
“We’ve been struggling with a lot of manufacturers,” she said. “I think Pfizer being referenced in recent articles comes from them buying Hospira, and we also had supply issues from Hospira before they bought them because of plants being shut down.”
Birkel said 503B compounding pharmacies also have been increasingly scrutinized by the FDA after the New England Compounding Center meningitis outbreak in 2012 that and caused 76 deaths.
“Coincidently, on the heels of that comes the drug shortages, which also increased the need for those compounding pharmacies,” he said. “I think our department has definitely tried to take the brunt of that [extra work] to not distract from those bedside nurses and providers.”
Another government agency regulating and “manipulating the opioid drug market” is the Drug Enforcement Agency, both Martin and Schlang said.
“[The DEA] shrinking the supply exacerbates the drug shortages — at least where opioids are concerned,” Martin said. “In my opinion, the DEA is artificially manipulating the opioid drug market.”
There is some debate about whether the DEA should be restricting the availability of raw product as a way to reduce opioids on the market.
“Also, if the [DEA] should be allowing more IV pain meds to be made — that’s definitely affected that supply,” Schlang said. “One thing that I have seen in articles about the DEA regulating opioid production is that they are being asked by hospital systems and pharmacy organizations to allow more production of IV opioids. Hopefully, we will see that in the future.”
While hospitals have been dealing with drug shortages for years, Hurricane Maria exacerbated the problem last year when it disrupted Puerto Rico’s pharmaceutical manufacturing industry.
“[The drug shortages] got a lot worse after that hurricane,” Schlang said, adding the biggest shortage was for IV bags with saline that are used to dilute and administer medication.
All in all, Martin says there has to be a strategy to combat shortages.
“Our strategy, which is working for us so far, is to stay ahead of it,” he said. “Smaller facilities struggle more because they can’t produce certain drugs when there is a shortage and they aren’t able to share across the board with other providers like we are.”
Schlang also noted the benefits of being part of a large hospital system.
“We talk at a system level about shortages and try to move product around when we can,” she said. “We also have a central distribution center in Denver for our organization, so we can buy up some products to store and then share within the system.”
It’s a “team effort” making sure drug shortages don’t affect patient care, Birkel added.
“I think a key to our ability to adapt and be sustainable with drug shortages is our communication and partnerships with nurses and providers,” he said. “That way we can make a decision [about drug shortages] and get that information out in a very urgent manner, since in some situations the shortages change daily.”