FALLS CHURCH, Va.—Almost immediately after the Food and Drug Administration alerted hospitals back in December about an impending shortage of IV opioid drugs, Inova Health System began to experience early signs that supply was dwindling.
"Suppliers were not able to provide their routine amounts of medication that were being ordered," said James Landzinski, a pharmacy clinical manager at the hospital located just outside Washington, D.C. "That affected everyone in the region. Supplies would come in at only a small portion of what you would typically get on your allocations."
Later, when he'd go into the online ordering system to schedule a shipment from distributors—part of a daily order that gets placed based on current inventories and historical usage data—he began to find the amount he could even request drastically cut.
That began a monthslong retooling between pharmacy staff and physicians, as well as vendors for Inova, an exercise taking place at hospitals across the U.S. as they scrambled to deal with an opioid crisis based on shortages, rather than overuse and abuse. Hospitals across the country, such as St. Joseph's University Medical Center in Paterson, New Jersey, have sought creative alternatives to pain management including laughing gas and trigger point injections, NPR reported.
"It's still an uphill battle here," said Roslyne Schulman, the American Hospital Association's director of policy, about the shortages. "It's not expected to fully resolve, depending on the product you're looking at, until mid- or second-quarter next year. It's a very serious issue."
The shortage began in 2017 as a result of manufacturing problems at one of the facilities run by pharmaceutical giant Pfizer, which controls at least 60% of the market of injectable opioids, Kaiser Health News previously reported.
Some production has since resumed—particularly after the Drug Enforcement Agency allowed Pfizer to give some of its production quota of the controlled substances to other companies in the marketplace—but it is not even close to full capacity, Schulman said. She pointed specifically to players like West-Ward Pharmaceuticals, Fresenius Kabi and Akorn Pharmaceuticals.
"Even they are on backorder. If you go look on the FDA website for these products, you can see everyone is on backorder because Pfizer controlled such a huge share of that market," she said.
Hospitals are waiting on an announcement that the FDA and the DEA have finalized approval of importation of Pfizer products from other countries, Schulman said. It would follow the model of the importation of saline products following the closure of manufacturing facilities in Puerto Rico because of Hurricane Maria.
"It's a little more complicated because these are controlled substances and the DEA has to approve them as well. It requires coordination between FDA, DEA and the company that agrees to import the product," Schulman said.
The FDA also gave Pfizer approval to release some of the quarantine products with warnings that pharmacists ensure glass vials of drugs they use are not cracked or appear to have been contaminated. FDA also issued approval to Fresenius Kabi to expand production from syringes to vials of certain opioids and they'll be releasing more of that supply in August, Schulman said.
"Ensuring access to the drugs patients need means finding creative responses to shortages while also addressing the root causes of the shortage issue," said Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research in a statement late last month. "The FDA’s role is focused on working with manufacturers, using all of our authorities to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition."
Of course, shortages are nothing new. The American Society of Health System Pharmacists has been monitoring shortages since 2000 and routinely reports that between 130 and 140 drugs are in short supply. The group published recommendations about the best ways to minimize the impact of shortages on patient care earlier this year.
The shortage of IV opioids like hydromorphone, morphine and fentanyl—which are used for the treatment of cancer patients or during surgical procedures as well as for the care of other critically ill patients—presented its own unique challenges.
"It made us, as a system, reevaluate what we were doing with our opioids," Landzinski said. They looked to alternatives including oral opiates or to nonopioid drugs like Tylenol or anti-inflammatories like Ibuprofen that are often forgotten but can be just as effective for pain control, he said.
They also began to use more nerve relaxing agents like Neurontin and nerve blocks that can be administered by pain specialists, he said.