Progress seen In addressing US drug shortages, but challenges remain
While new shortages are down from a few years ago, several significant products remain difficult to find, and hospitals, still shaken by the critical shortages of the recent past, remain concerned that key drugs could once again become scarce.
“Trending for this year so far looks fairly similar to the last couple of years, where we’re seeing lower numbers of new shortages, which seems to indicate we’re coming out of this crisis,” said Valerie Jensen, Director of Drug Shortages Staff, US Food and Drug Administration (FDA), in a telephone interview.
“But we continue to see new shortages, like saline, where demand has really increased and firms haven’t been able to keep up with demand over time.”
New US drug shortages reached an all-time high in 2011, with 251 new shortages occurring that year, the FDA said. That fell to 117 new shortages in 2012, 44 in 2013 and 44 again in 2014. Though the number of new shortages has stabilised, they include some very important drugs, including IV saline and peritoneal dialysis solution, both of which fell short last year.
New drug shortages in 2015 include epinephrine emergency syringes as well as several injectable antibiotics, including ceftazidime, cefepime and imipenem/cilastatin.
In late June, the FDA sent out a Dear Healthcare Professional letter to warn of a critical shortage of Lipiodol injection due to manufacturing issues, and allowed temporary importation of foreign-manufactured product. The US manufacturer, Guerbet, is working with the FDA to increase availability of the product, which is used by injection as a radio-opaque contrast agent to image tumors.
Communications and remediation
New shortages aside, Jensen believes recent improvements reflect better communications between the industry and the FDA, as well as remediation efforts by companies that dealt with quality issues.
“What we’re seeing now – and why things are better – is that companies…are better communicators,” Jensen said. “They’re calling to give us a heads up about developing situations, and letting us work with others to ramp up if they’ll be out of the market. Companies realize they can come to us and we’ll work with them.”
Early notification by companies began to improve as far back as 2011, when President Barack Obama issued an executive order requiring manufacturers to notify about possible shortages. The FDA Safety and Innovation Act (FDSIA) was signed into law the following year, improving the Agency’s abilities to help prevent drug shortages.
Just last month, the FDA issued a final rule requiring all manufacturers of certain medically important drug and biologic products to give FDA early notification of potential drug shortages and to report reasons for the potential shortage.
“I agree things are definitely improving, which is really good news,” said Erin Fox, Director, Drug Information Service, University of Utah Health Care. “It’s still a problem, but the trend is one of improvement. We’re finally reaping the benefits of the FDA getting advanced notice from suppliers when they have problems.”
Additionally, Fox said, remediation at plants that had quality problems is finally having an impact on supply.
But at her hospital, physicians still feel concerned.
“Doctors are still worried – very much so,” Fox said in a phone interview. “Even though the nitroglycerin shortage is solved, our cardiologists still worry because it was devastating.”
Fox said certain products such as diagnostic dyes remain hard to find, and she worries because many drugs are single-source products. Import bans on Indian companies also raise concerns. So does industry consolidation. Despite all this, Fox said she’s “hopeful” that improvements will continue.
David Gaugh, senior vice president, Science and Regulatory Affairs, at the Generic Pharmaceutical Association (GPhA), noted that “some progress is being made with fewer new products going on the shortage list.”
“The only way to mitigate current shortages and prevent future shortages from occurring is a collaborative effort,” Gaugh said in a statement. “This means continued communications between regulators and manufacturers, enhancing the Abbreviated New Drug Application (ANDA) review and approval process and making sure that generic manufacturers continue to be part of the solution to this complex issue.”