The Hospice Clinician Blog

We’ve all noticed—and many of us have been directly affected by—the drastic increase in drug shortages over the past few years. The number of drug shortages has quadrupled since 2005, with the American Society of Health-Systems Pharmacists (ASHP) website currently listing 216 drugs that are in short supply. Injectable medications make up the majority of the list (examples include injectable diazepam, fentanyl, haloperidol, and midazolam), but other routes of administration are affected as well (such as ciprofloxacin tablets, diclofenac gel, nystatin oral suspention and scopolamine transdermal patches). Many of the medications on the list are ones commonly used in hospice and palliative care.

On January 31^st, U.S. Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced the bipartisan “Drug Shortage Prevention Act”, which is the latest action plan to address the increasing problem of drug shortages. According to its sponsors, the bill “brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients.”

The Drug Shortage Prevention Act would:

• Require the FDA to identify drugs that are vulnerable to shortages through the creation of a “Critical Drug List” and “Critical Drug Shortage List.” The agency would determine the standards of what constitutes a “critical drug” and “critical drug shortage.”
• Require the FDA to expedite review of: applications seeking approval of a “critical drug”, requests to approve changes to manufacturing processes or facilities of drugs in shortage, and applications for an alternative active pharmaceutical ingredient supplier.
• Attempt to cut down on the “gray market” by requiring the FDA to notify distributors of an imminent critical drug shortage, while also allowing the agency to withhold notification to a distributor determined by the Attorney General to be stockpiling, price gouging or engaging in other unlawful activities related to distribution of a drug in shortage.
• Require the FDA to develop a system to notify members of the public—including providers and patients—when a drug is added to the drug shortage list.
• Mandate closer and more expedient internal communications between FDA's regulatory staff and its drug shortage team.
• Allow the Attorney General to determine whether it is appropriate to increase one or more DEA quotas to address a drug shortage, and mandate that DEA, in consultation with FDA, increase the quota for controlled substances on the shortage list to address a shortage.
• Require the Secretary of Health and Human Services to conduct a feasibility study to determine the efficacy and logistics associated with creating a national contingency plan in the event of a critical drug shortage, including the creation of a national stockpile for these drugs.

The topic of drug shortages is expected to be raised next week at a House Energy and Commerce Committee hearing.