How A Nationwide Opioid Shortage Has Put Hospitals In A Tough Position

By Paul Gaita 03/22/18

Hospitals are struggling to provide adequate treatment to pain patients in the midst of a Big Pharma manufacturing issue.

pharmacist counting pills

A feature on PBS NewsHour illustrates a growing concern among the medical community in the United States: hospitals across the country are forced to find ways to properly treat patients' pain with an ever-decreasing number of opioid medications.

The story examines the problem from the perspective of the staff at Brigham and Women's Hospital (BWH) in Boston, where daily meetings are held to determine the number of opioids available each day, and how to properly distribute that amount to patients, including emergency care and surgery cases.

PBS attributes the shortage to the pharmaceutical company Pfizer, which has halted production on some of its injectable opioid drugs due to a manufacturing problem, and will not be able to fully resume production until 2019, although restrictions on the supply of injectable opioids imposed by the Drug Enforcement Administration (DEA) also play a factor in the issue, as does the national opioid epidemic.

At Brigham and Women's Hospital, a team of doctors, pharmacists and nurses must meet each morning to determine the volume of their supply of opioids, and how they will be administered to maintain patients' pain levels.

"Any shortage of these medicines has the potential to impact the ability to provide adequate pain management to patients admitted with painful conditions or patients undergoing surgeries," said Dr. Charles Morris, associate chief medical officer at the hospital. "We stood up this incident command response to make sure that this impact is not realized."

But their best efforts are sorely tested by the extent of the shortage in opioid products, which became clear to health providers after Pfizer notified customers that it had halted production on certain medicines.

Pfizer—which had already announced a nationwide shortage of fentanyl citrate, an injectable drug used to treat breakthrough cancer pain, in late 2017—said that orders will not fully resume until the first quarter of 2019, a situation that will place significant burdens on hospices in Florida, Maryland and Hawaii, which have reported a complete depletion of certain opioid products.

The cause for the shortage, according to Pfizer, is a manufacturing issue involving a third-party company that produces a component of its Carpuject and iSecure pre-filled syringes containing opioid formulations.

As PBS noted, hospitals are not yet considering rationing medication, but some, like BWH, have attempted to counter the shortage by prescribing oral opioid medications or using IV Tylenol—though at $37 per vial, the latter medication costs nearly 20 times more than IV morphine, which is priced at $2 a vial. 

Although the shortage is not directly impacted by the opioid crisis, the supply of opioids to medical facilities has been impacted by the DEA's response.

As NewsHour stated, the DEA has attempted to control the supply of opioids by imposing quotas on smaller manufacturers; the downside to this approach is that it has also placed further limits on the volume available to health care providers. Though manufacturers and hospitals have both lobbied the DEA to increase the supply, the agency has yet to do so, though a spokesperson was quoted as saying that it is "considering all possible solutions."

Should that happen, there is the additional problem faced by manufacturers and hospitals alike in meeting the increased need in production and administration with more workers and expanded facilities.

"After this last round of shortages, I think it's become pretty apparent that there is still some work that needs to be done," said Jillanne Schulte, director of regulatory affairs for the American Society of Health-System Pharmacists. "If you don't have enough manufacturing capacity going, and something goes offline, you may be in a very uncomfortable position very quickly."

In all cases, the situation facing hospitals and pharmaceutical companies is a complex one, without immediate solutions. "It's bad for our industry, it's bad for patients and it's bad for the hospitals that now have to scramble," said Dan Motto, executive vice president for U.S. injectables at West-Ward Pharmaceutical Corp., the second-largest supplier of such opioids. "We have every incentive to try to meet the needs of the customers."

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, and The Los Angeles Beat, among many other publications and websites.