ASHP Urges Congress to Hold Hearings on Drug Shortage Crisis

ASHP is demanding that legislators take immediate action to address the ongoing shortages of critical medications in hospitals and health systems. The extent to which shortages of injectable opioids, small-volume parenteral (SVP) solutions, and other critical medications is dangerously interfering with patient care and straining daily operations in hospitals nationwide was revealed in a survey by ASHP.

Paul W. Abramowitz, PharmD, CEO of ASHP, said in a press release: “The ongoing shortages of these vital lifesaving medications are overwhelming the resources of our nation’s hospitals, placing our healthcare system on the brink of a public health emergency. Congress must act now to implement remedies that will address the underlying causes of drug shortages and ensure that patients have access to the medications they need.”

“While the number of new shortages has decreased over the previous few years, the shortages we are experiencing are having a substantial impact on patient care. As hurricane season returns, the medical community is bracing for the potential for more shortages and the strain they place on limited healthcare resources,” says Michael Ganio, PharmD, BCPS, FASHP, director of Pharmacy Practice and Quality for ASHP.

ASHP surveyed its members in April to assess the recovery from the small-volume parenteral solution shortage and to assess the impact of the acute shortage of injectable opioids (including morphine, hydromorphone, and fentanyl). The survey was informal and nonscientific, and was not designed for statistical analysis. It contained 16 questions and garnered 343 responses. Some key findings:

• 98.4% of respondents say their facility experienced severe or moderate shortages of morphine, hydromorphone, and fentanyl.
• Most respondents indicated their hospital is managing the shortage by switching to oral opioid medications, restricting the use of injectable opioids, prioritizing patients based on clinical need, and converting to nonopioid medications.
• Among strategies used to mitigate the impact of the injectable opioid shortage, respondents say that procurement of products through a 503B outsourcing facility to be more costly than using alternative therapy or repackaging available products.
• 86.4% of respondents indicated they are still affected by the small-volume parenteral (SVP) shortage, but this is down from 99.1% seen in a November 2017 survey.

Injectable Opioids

98.4% of respondents indicated that their hospital has been affected by the injectable opioid (morphine, hydromorphone, and fentanyl) shortage:

• 96.2% of respondents indicated that the shortage has been severe (67.8%) or moderate (28.4%). Severe was defined as “has impacted daily operations and patient care.” Moderate was defined “has been a problem but not yet impacted patient care.”

Concerning the impact on patient care:

• 74.4% switched patients to oral opioid medications.
• 55.7% implemented restriction protocols on injectable opioids.

Participants

The respondents represented hospitals of various sizes:

• Small hospitals (< 200 beds): 40.8%
• Medium hospitals (201-500 beds): 36.2%
• Large hospitals (> 500 beds): 19.2%.

ASHP supports amending the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to require additional information - including the cause, duration, and expected timeline for resolution - when manufacturers report a drug shortage to the FDA. The association has asked Congress to require manufacturers to develop production contingency plans when there are fewer than three manufacturers producing a medication.