Pfizer notified customers Jan. 31 it is having difficulty making certain prefilled syringes of opioid painkillers — marking the third time in six months the company has encountered manufacturing issues, reports STAT.
Here are six things to know.
1. Pfizer attributes the latest manufacturing snag for Pfizer's Carpuject and iSecure syringes to an issue with a component made by a third-party supplier, according to a letter sent to customers obtained by STAT. As a result of the component problem, all Carpuject and iSecure product releases have been suspended, meaning no additional syringes will be shipped to customers.
2. The supply disruptions for the opioid-filled syringes began in 2017, when the drugmaker moved to fix FDA-cited violations at its McPherson, Kan.-based manufacturing plant. The Kansas plant makes Pfizer products and manufactures medicines for other companies.
3. As a result of the remediation at its plant in Kansas, the drugmaker initially anticipated a shortage of the syringes for several months but expected to meet demand once again by March 2018, according to a letter Pfizer sent to customers in July 2017.
4. However, because the renovations at its manufacturing plant are taking longer than expected, in November 2017 Pfizer pushed the full recovery timeline into 2019 and warned customers to anticipate backorders and product shortages.
5. A Pfizer spokesman told STAT the company is working closely with the third-party supplier to solve the issue with the component. And for now, Pfizer does not anticipate the component problem will affect its plan to resume shipments by 2019.
6. The opioid-filled syringes are used in hospitals nationwide in surgeries and to treat pain. Hospital pharmacy leaders told STAT the dwindling supplies are "a huge problem" and will require hospitals to "get creative."