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Manufacturing Snags Contribute to Pfizer Drug Shortages

Manufacturing snags at Hospira, a unit of Pfizer, are helping create shortages of a wide range of injectable drugs, some of which have been voluntarily recalled by the company, the US Food and Drug Administration (FDA) announced yesterday.

Hospira products in short supply include vials and syringes of both sodium bicarbonate and dextrose 50% injection as well as emergency syringes of epinephrine, calcium chloride, and atropine sulfate.

Production problems at Hospira have been making headlines lately. In February, the FDA sent a warning letter to Pfizer saying that Hospira's process for manufacturing sterile injectable solutions at its McPherson, Kansas, plant was "out of control." The agency said foreign particulates had contaminated several products, and that pieces of cardboard had compromised injectable antibiotic vancomycin.

The FDA said it had found similar violations at other Hospira facilities over the years. "These repeated failures at multiple sites demonstrate that your company's oversight and control over the manufacture of drugs is inadequate," the agency said.

And today, the FDA announced that Hospira is voluntarily recalling a large quantity of injectable solutions made at its plant in Rocky Mount, North Carolina, after a routine simulation of the manufacturing process revealed microbial growth in the products. Hospira stated in a news release posted on the FDA website that it was voluntarily recalling the injectables because it could not guarantee that they were sterile.

Pfizer has attributed the shortage of Hospira products to not only manufacturing issues but also distribution and third-party delays, according to a news release issued by the FDA yesterday.

Pfizer spokeswoman Rachel Hooper told Medscape Medical News that the company has "prioritized the manufacture of medically necessary products, and given the complexity of the injectable production process we will continue to work diligently to alleviate shortages while ensuring the highest quality and safety standards for all of our products."

"We understand and regret the challenges these shortages pose to clinicians and patients," Hooper said.

The FDA said it was working with Pfizer to address the underlying causes of the shortages. In the meantime, it is looking for alternative manufacturers of the products in short supply and exploring other options to relieve the shortages. These include expedited review of drug applications and other submissions, and temporary regulatory flexibility for other drug sources, which in the past has sometimes meant foreign sources.

The FDA also is coping with the shortage by allowing Pfizer to extend the expiration dates of certain lots of emergency syringes after having reviewed stability data provided by the company. The drugs in question are:

  • Atropine sulfate injection, 0.1-mg/mL, 5-mL, Abboject syringe

  • Atropine sulfate injection, 0.1-mg/mL, 10-mL, Abboject syringe

  • Dextrose 50% injection, 50-mL, Abboject syringe

  • Epinephrine injection, 0.1-mg/mL, 10-mL, Abboject syringe

Lot numbers for the above products with extended expiration dates are listed on the FDA website.

SOURCES:

Manufacturing Snags Contribute to Pfizer Drug Shortages. Medscape. June 19, 2017.


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