As of April 2023, there are 301 drugs in shortage
Drug shortages hit a 10-year high in the first quarter of 2023 due to a combination of new and ongoing unresolved shortages, according to the latest information from ASHP.
As of April 2023, there are 301 drugs in shortage—100 more than in the same time five years ago, and up from 295 at the end of 2022. Within the first quarter of 2023, 47 new drugs went on shortage.
Chemotherapy drugs, many of which do not have alternatives, have returned to the list of the top five drug classes affected by shortages, with 23 drugs currently in short supply. The other top drug classes on shortage include central nervous system (CNS) drugs (52), antimicrobials (35), fluids and electrolytes (30), and hormones (27).
“Shortages of local anesthetics and basic hospital drugs, albuterol solution, common oral and ophthalmic products, and ADHD [attention-deficit hyperactivity disorder] treatments are affecting large numbers of organizations and patients,” said Erin Fox, PharmD, the associate chief pharmacy officer for shared services at University of Utah Health. The University’s Drug Information Service provides content for the ASHP Drug Shortages Resource Center.
For more than half of the shortages (56%) investigated by the University of Utah Drug Information Service, the underlying reason was unknown or the manufacturer would not provide it. The most common identified reason for shortages was supply-and-demand issues (19%), followed by manufacturing issues (18%) and business decisions (5%).
“It always seems to come back to quality,” said Michael Ganio, PharmD, ASHP’s senior director of pharmacy practice and quality, in an interview with Pharmacy Practice News. He cited, as an example, a Form 483 warning letter issued by the FDA to Intas Pharmaceuticals after a December 2022 inspection found an array of problems at the company’s plant in Gujarat, India. Problems included issues related to microbial contamination risk and environmental monitoring, poor record keeping, and poorly defined procedures and controls.
“As the FDA was on site, the inspectors saw staff destroying documents,” Dr. Ganio said. “Intas is a contract manufacturer for Accord Pharmaceuticals, which has a large number of medications backordered. We don’t know for sure there’s a link, but when you see smoke, there’s probably fire.”
The chemotherapy shortages are particularly concerning. “These are treatments for patients where one of the primary determinants of their outcome is getting the full dose on the right schedule. And many of these drugs, such as cisplatin, are used in multiple regimens, so it’s not like the problem is limited to one specific type of cancer,” Dr. Ganio said. “This situation really leaves clinicians struggling to determine which patient population should receive the limited supplies of drugs they have available. After dealing with these shortages for more than 20 years now, we need to find a solution.”
The high number of CNS drug shortages relates in large part to chronic issues with fentanyl, morphine and hydromorphone, Dr. Ganio said. “These are older generic injectable medications that are more complex for manufacturing than oral dosage forms because of sterility and endotoxin testing.”
In the wake of a March 2022 Congressional hearing on drug shortages, there has been continuing interest in the issue. “There are a couple of proposals being floated, including one around improving notice to the FDA in the event of demand-driven shortages,” Dr. Ganio said. Other ideas under discussion involve increasing flexibility for outsourcing facilities and pharmacies regarding compounding in the event of a shortage and onshoring (bringing more pharmaceutical manufacturing back to the United States). “While that can’t hurt, we’ve had plenty of issues with U.S.-based manufacturing, like the Akorn shutdown and Teva’s recent closure of its plant in Irvine, California, so domestic manufacturing alone is not the solution,” Dr. Ganio continued. “By bringing more manufacturing into the U.S., the FDA will have easier access for its inspectors, which can help with quality oversight, but it’s not a panacea.”
Dr. Ganio noted that drug shortages are typically managed internally by the clinical team without much involvement of the patient, except in certain situations such as with chemotherapy. “If we have a hospitalized pediatric patient who can’t get amoxicillin, we typically just prescribe a different medication and the caregiver would probably have no idea there’s a shortage,” he said. “It’s time to get patients more involved. Don’t hesitate to have conversations like this: ‘We can’t give you the drug we want to give you because it’s in short supply. This is not uncommon; it happens frequently. Please consider reaching out to your legislator and letting them know your experience.’”
Tags: Drug Shortages FDA New Trends
