Every week, it seems, a new report detailing the persistence of prescription drug shortages — and their impact on hospitals, patients and other health care providers — is released. The problems raised by drug shortages range from patient safety concerns — when life-saving drugs simply aren't available when needed — to the indirect creation of gray markets for drugs where the markups can reach as high as 650 percent, according to Premier.
Back in August, my colleague Matthew Weinstock took a look at some of the issuessurrounding the shortages. And earlier this year, the print edition of H&HN documented the extent of the problem as it relates to hospitals, particularly in light of the potential threats to patient safety.
"A lot of people say this is the worst shortage in 30 years," Michael Alkire, president of Premier Purchasing Partners, told H&HN at the time. "I believe we are at a trigger point where something must be done."
Frustratingly little had been done, though, until Monday, when President Obama issued an executive order directing the Food and Drug Administration to take steps to "prevent and reduce "current and future disruptions in the supply of lifesaving medicines." The steps include requiring drug manufacturers to provide advance notice of potential supply disruptions for drugs deemed "life supporting or life sustaining," expediting regulatory reviews of drug suppliers and assessing whether suppliers are stockpiling or selling drugs "at exorbitant prices."
With regards to the last practice, "the DOJ shall then determine whether these activities are consistent with applicable law."
The American Hospital Association hailed the announcement, adding that additional steps, including the passage of the bipartisan Preserving Access to Life Saving Medications Act, which would require manufacturers to notify the FDA of any incident that could result in a drug shortage, are also needed. The AHA and others are also calling for more steps to expedite the FDA approval process for prescription drugs where shortages exist.
"The executive order is a solid step in the right direction but there is more to do to address this issue," Rick Pollack, the AHA's executive vice president, said in a statement. "The AHA has long supported bipartisan legislation in Congress that requires drug firms to notify FDA as soon as possible of interruptions in product supply or discontinuations. In addition, we believe that obstacles must be removed so that FDA is able to streamline approval of drugs in shortage."
Premier, one of the biggest health care industry voices on the subject in recent years, also weighed in with support.
"The Premier healthcare alliance commends President Obama and his administration for taking action to help further reduce and prevent drug shortages and subsequent price gouging that is challenging our nation's providers to effectively care for patients and control costs," Alkire said in a statement.
The same day the executive order was released, the New England Journal of Medicine published a report by Bruce Chabner, M.D. on the impact of drug shortages on oncology.
"These shortages, which primarily affect injectable generic drugs, have forced physicians to prioritize patients, improvise standard regimens … and at times, choose unproven treatment options for patients with curable disease," Chabner wrote. "The list of generic drugs in short supply across all medical specialties is astounding and includes antibiotics, anesthetic agents, antihypertensive medications, and common electrolyte solutions and vitamins."
Chabner also hailed the executive order, though he noted that the specifics of the FDA's action plan are still unclear, and don't address all aspects of the problem.
"The executive order does not improve reimbursement for generic drugs or address the need for redundant production facilities or incentives such as rewarding past performance in the approval of new generics applications," Chabner wrote.
Only time will tell if the executive order will have a sizeable impact on its own — or if additional steps are needed to alleviate what many observers see as an issue with major ramifications for patient safety.
I'd like to hear from you, though. What impact will President Obama's executive order have on the drug shortage crisis, and what other actions are needed? Email your thoughts to firstname.lastname@example.org.