Pfizer, the largest U.S. producer of injected narcotics, said Wednesday it has resumed production of some of the prefilled syringes that have been in short supply and expects to have the first shipments to wholesalers in July.
But Pfizer will have a smaller allotment to send after the DEA recently gave some of its narcotics quota to competitors because of ongoing problems that have left hospitals scrambling and Pfizer unable to meet demand.
Over the last year, a series of manufacturing issues at Pfizer have exacerbated a shortage of hospital-administered painkillers. With pressure building from healthcare providers, the DEA—which controls narcotics quotas—took steps to fix the situation.
Last month, the agency asked Pfizer to surrender some of its narcotics allocation, then turned around and gave the valuable supply allotments to three other drugmakers that could actually produce the essential drugs.
Without naming Pfizer, the DEA said in an announcement explaining its action that the largest U.S. manufacturer of the injectables had to slow production of the drugs while it made “required upgrades” to its McPherson, Kansas, plant where the drugs are made and filled. It said the company voluntarily surrendered a portion of its allotment, which the DEA reallocated to three other drug companies.
Pfizer acknowledged Wednesday it was the subject of the action, saying that after it was notified by the DEA, it reassessed how much product it was likely to produce this year and “responded quickly to relinquish some of our DEA API allocation.”
One of the companies to get the extra allotment is West-Ward, which in an email confirmed it had gotten some but not nearly enough.
"In the U.S., there is currently a shortage of injectable opioids used in hospitals for the management of pain, due to the dominant supplier in the market temporarily ceasing manufacturing," West-Ward said in a statement. "We, and the manufacturers who remain in the marketplace, are trying to make up for a nearly 60% drop in supply that is currently affecting patient care."
"While the DEA recently granted some additional quota for us to purchase the active pharmaceutical ingredient (API), we continue to submit requests for further quota to meet our customer needs," the company said.
The shortage of these hospital-administered pain medications, including morphine and fentanyl, started a year ago when Pfizer reduced output of prefilled syringes as part of an upgrade at its troubled sterile drug manufacturing site in McPherson, Kansas. Last fall, Pfizer told customers that because upgrades were taking longer than expected, "full recovery dates of prioritized prefilled syringes” had moved to Q1 2019 and deprioritized syringes to Q2 2019.
Then earlier this year, the problem worsened when the contractor that makes a key component of the Carpuject and iSecure injectors Pfizer uses with those drugs ran into its own production issue. To ensure safety, Pfizer said it had to put a quality hold on the injectors, again interrupting production.
The company said that it has been working closely with its supplier to fix the “root cause” of the injector problem and get a handle on the impact on its existing inventory and product supply moving forward. Additionally, Pfizer said it is “exploring the feasibility of increasing capacity within the global Pfizer manufacturing network and potential third party suppliers.”
Wednesday Pfizer spokesman Steven Danehy said in an email that the company has resumed production of its Carpuject prefilled syringes and that 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.”