UPDATE: USP creates resource to help hospitals assess Pfizer drug shortages while company sets emergency order limits

by A.J. Plunkett (aplunkett@decisionhealth.com)

Pfizer is asking customers to exhaust other supply sources before ordering 12 sterile injectable drugs from the company as it continues to assess its ability to produce the drugs following a tornado that severely damaged one of its manufacturing plants in North Carolina.

A letter Pfizer sent to its customers was published online by the FDA on August 3 in which the company said 12 drugs would be available only through an “emergency ordering process” until further notice.

“Given the medical importance of these products, we kindly request customers exhaust all channels to obtain product or appropriate therapeutic alternatives prior to making an emergency request,” according to the letter which outlined the 12 drugs and the emergency ordering process.

Meanwhile, the U.S. Pharmacopeia (USP) is encouraging hospitals to prioritize those and several other products on the National Drug Codes (NDC) list for “stewardship and low waste protocols” as the FDA and other officials continue to assess the nation’s supply of sterile injectables.

The Pfizer manufacturing plant in North Carolina was hit by a tornado July 19. Both Pfizer and the FDA have said that they expect the immediate impact to the supply chain to be minimal.

“The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at Pfizer’s Rocky Mount, North Carolina, facility,” according to a July 21 FDA news release. The assessment is evaluating “what is in Pfizer’s other warehouses and what is stocked by wholesalers and distributors, if those companies are willing to share that information with the FDA.”

“Importantly, we do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system, but this is a dynamic situation and FDA staff are in frequent communication with Pfizer and other manufacturers,” said the FDA.

“Notably, while Pfizer has one third of the total sterile injectable drug market for hospitals in the U.S., and this facility only makes 25% of Pfizer’s total product for this market—not the entire market. This means 8% of U.S. consumption is supplied by this site.”

While minimizing the impact of the tornado damage, according to USP, Pfizer released a “subset of 65 Rocky Mount products that may experience continued or new supply disruptions” because of the tornado damage, which the nonprofit has used to create a table for resource reference.

The table lists a product name, Pfizer’s market share, potential alternate suppliers, whether the product is considered an essential medicine and a score calculated by USP as to the likelihood there could be a product shortage within 12 months.

For example, USP says that atropine sulfate injection, USP (adult) 1mg/10ml (0.1 mg/ml) ANSYRTM plastic syringe, faces a 98% chance of a product shortage within the next 12 months.

The resource is available for free download here. You will be asked for your name, title, and email address.

In addition, USP says it will continue to monitor FDA and American Association of Health-System Pharmacists (ASHP) drug shortage updates “to determine whether we can provide additional support including injectable compounded preparation monographs (CPMs), operational considerations documents, and/or general compounding quality recommendations.”

Continuing information from the FDA about drug shortages can be found here:  https://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information


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