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Hospitals Search for IV Opioids

Has the DEA Been Fast and Flexible Enough?
Stephen Barlas

A severe shortage of injectable opioids caused primarily by manufacturing problems flagged by the Food and Drug Administration (FDA) at a Pfizer plant has led the Drug Enforcement Administration (DEA) to allow three companies to boost their sales of morphine, hydromorphone, and fentanyl. Intravenous (IV) opioids are used in a variety of practice settings within hospitals and ambulatory surgical centers for the treatment of acute or chronic pain that cannot be managed because the patient has a contraindication for oral opioids.

Groups such as the American Hospital Association, American Society of Health-System Pharmacists, and American Society of Clinical Oncology have been pressing the DEA since mid-2017 to adjust IV opioid production quotas that limit manufacturer sales volume. On April 10, 2018, the DEA responded to the pressure, saying it is working closely with the FDA, drug manufacturers, wholesale distributors, and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. It mentioned the manufacturing troubles of one manufacturer, though the DEA statement did not mention Pfizer, and went on to allude to “an increase in DEA procurement quotas to various manufacturers” not naming them either, nor stating to what extent they would provide products no longer being manufactured by Pfizer. The statement did say the DEA “cannot alone prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products.”1

Asked for details of what exactly the DEA has done, Wade Sparks, an agency spokesman, said the names of the companies whose production quotas have been adjusted upwards are not publicly available. Moreover, Sparks noted, “It is important to remember DEA sets quotas for raw ingredients, not specific medications, presentations, or dosage units. Those are all business decisions made by each company. This is an important part of understanding DEA’s role in the quota process. If a company decides it does not want to make a certain presentation of a drug, the DEA is not involved in that decision.”

The shortages are having a negative effect of varying magnitudes on hospitals all over the country. The Charleston, South Carolina, Post and Courier in March quoted Roper St. Francis’ Medication Safety Officer Kim Gaillard, saying the system gets 60% of its IV opioid drugs from Pfizer.2 The Philadelphia Inquirer ran a story in February quoting Nishaminy Kasbekar, Director of Pharmacy at Penn Presbyterian Medical Center, who estimated that her hospital spent an extra $30,000 over the past three months buying more expensive alternatives to the unavailable Pfizer drugs. At that point, the hospital could get between 40% and 50% of the drugs it needed.3

Steven Danehy, a spokesman for Pfizer, says, “We have restarted production of our Carpuject prefilled syringes. The first shipments are expected to reach wholesalers in July 2018, and we will work to expedite the process where possible. We recognize the importance of these medications to patients and physicians and are committed to resolving these shortages as quickly as possible. We continue to work toward full recovery across the opioids product line in 1Q–2Q 2019.”

Though the DEA did not name the other companies allowed to amp up their production, two are West-Ward Pharmaceuticals and Fresenius Kabi. The latter manufactures ready-to-administer prefilled syringes under the Simplist brand. “We have increased production and communicated that plan to customers,” states spokesman Matthew Kuhn. Even with a significant increase in production, we are unable to satisfy the needs of the entire market.” The company currently does not offer opioids in vial presentation but plans to introduce one this year.

Keri Butler, spokeswoman for West-Ward, says her company manufactures vials of opioids, not prefilled syringes. Although the DEA lifted its production quota, which is still limited and below the company’s ability to manufacture product, “We continue to take steps to meet the increased customer demand, including investing in additional headcount, overtime, and adjusted production schedules,” she adds.

The FDA issued a warning letter to Pfizer for the McPherson (Kansas) plant in February 2017 and found a number of issues. The warning letter said: “The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm to patients.”

The DEA was made aware of Pfizer’s manufacturing issue in early 2017, according to spokesman Sparks. It is true that DEA does not control the quantity or the speed by which manufacturers produce IV opioids. However, it is fair to ask whether the DEA needed to wait one year before increasing production volume caps for some alternative producers and whether those caps could have been raised higher, as West-Ward’s Butler suggests.

Author bio: 
Mr. Barlas is a freelance writer in Washington, D.C., who covers issues inside the Beltway. Send ideas for topics and your comments to sbarlas@verizon.net.

References

  1. Drug Enforcement Administration. DEA working to avoid U.S. drug shortages April 10, 2018; Available at: www.dea.gov/divisions/hq/2018/hq040918.shtml. Accessed May 25, 2018
  2. Wildeman MK. South Carolina hospitals dealing with “critical shortage” of opioids. The Post and Courier March 21, 2018; Available at: https://www.postandcourier.com/health/south-carolina-hospitals-dealing-with-critical-shortage-of-opioids/article_33c49db6-2c7a-11e8-b468-eb78b128b456.html. Accessed May 25, 2018
  3. Burling S. There’s a shortage of opioids where they’re needed most—in hospitals. Philadelphia Inquirer February 28, 2018; Available at: http://www.philly.com/philly/health/opioid-shortage-hospitals-painkillers-morphine-hydromorphine-dilaudid-fentanyl-20180228.html. Accessed May 25, 2018