The supply of fentanyl, epinephrine injection, and heparin, however, have been impacted by the July 19 tornado at Pfizer's North Carolina facility.
Although the extensive damage to Pfizer’s Rocky Mount, N.C., manufacturing facility on July 19 affects the supply of several medications supplied to hospitals — including fentanyl, epinephrine injection, and heparin — it does not impact supply of Bicillin L-A (penicillin G benzathine).
The North Carolina facility is one of the largest sterile injectable facilities in the world, Pfizer said in a letter, with more than 1.4 million square feet of manufacturing space on 250 acres of land. The site is responsible for manufacturing nearly 25% of all Pfizer’s sterile injectables — including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers. This represents nearly 8% of all the sterile injectables used in U.S. hospitals, Pfizer said in a news release.
Most of the tornado damage was caused to the warehouse facility, which stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance. “Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies,” the manufacturer said. Pfizer is also “exploring alternative manufacturing locations for production across our significant manufacturing presence in the United States and internationally and across the company’s partner network.”
The site is closed while the damage is assessed, the letter noted. “Crews are working around-the-clock to restore power, assess the structural integrity of the buildings and move finished medicines to nearby sites for storage and to identify sources to replace damaged raw materials and supplies.”
Although Pfizer is working to restart production, it cannot provide an estimated date that will happen. “We will continue to keep customers apprised as we learn more,” Pfizer said.
After an initial assessment, there does not appear to be any major damage to the medicine production areas. However, the damage will temporarily delay shipments of certain medications manufactured there, including fentanyl, epinephrine injection, dextrose injection, lidocaine hydrochloride and epinephrine injection, Quelicin and vitamin K1.
But Pfizer does not produce Bicillin L-A, the COVID-19 vaccine Comirnaty or Paxlovid (nirmatrelvir tablets and ritonavir tablets), an oral antiviral COVID-19 treatment, at the site. It also does not produce sterile injectable oncology products Solu-Cortef (hydrocortisone sodium succinate for injection), and Solu-Medrol (methylprednisolone sodium succinate for injection) there.
In June, Pfizer notified the FDA and its customers that it will soon have limited supply on certain Bicillin formulations. Select formulations of Bicillin L-A (penicillin G benzathine) and Bicillin C-R (penicillin G benzathine and penicillin G procaine) prefilled syringes are expected to be in limited supply and out-of-stock, Pfizer said. The supply interruption is the result of “a complex combination of factors, including significant increases in demand, an increase in syphilis infection rates, as well as competitive shortages,” Pfizer said in the letter.
The Pfizer plant damage underscores the need for reform in drug manufacturing to prevent future drug shortages, according to the American Society of Health-System Pharmacists. The organization recently called on Congress to remedy this long-standing problem, offering short- and long-term recommendations.
In the short term, ASHP recommends better transparency about manufacturer quality and reliability issues and better enforcement of existing requirements for manufacturers. In the longer term, the organization wants to see the federal government encourage multi-year, guaranteed volume contracts and use its purchasing power to ensure a minimum number of manufacturers remain in the market, a spokesperson told Formulary Watch.