The FDA has authorized imports of cisplatin from China, as this crucial medication remains in short supply in the United States due to a halt in cisplatin production by the Indian manufacturer Intas Pharmaceuticals following a 2022 FDA inspection that raised concerns about the company’s manufacturing process.

The agency may allow imports for carboplatin, another chemotherapy medication facing a shortage.

While welcoming the new stock, American Society of Health-System Pharmacists (ASHP) representatives encourage pharmacists to carefully inspect the packaging of imported cisplatin, which won’t necessarily come with the same labeling they are accustomed to recognizing.

“In the U.S. we often use tall man lettering, based on guidance from the Institute for Medication Best Practices [i.e., Institute for Safe Medication Practices], to distinguish products that look alike or sound alike,” said Michael Ganio, PharmD, BCPS, FASHP, the senior director for pharmacy practice and quality at ASHP. That won’t be the case with the Chinese products, Dr. Ganio noted; the word “cisplatin” will be in English on the label, but with the letters all at the same height, and everything else on the label will be written in Chinese characters.

Should carboplatin eventually be imported from another country as well, Dr. Ganio said, there would be no uppercase “CIS” or “CARBO” on the labels to easily distinguish the two chemotherapies on a crowded pharmacy shelf. And because other pertinent details, such as the product’s preparation and storage requirements, would be in Chinese, Dr. Ganio recommends that pharmacists print out the FDA’s “Dear Provider Letter” for every imported product to have ready access to this information.

Dosage is another concern with imported drugs, Dr. Ganio said. The Chinese formulation of cisplatin, manufactured by Qilu Pharmaceutical, will come in 50-mg vials; but other manufacturers produce cisplatin in 100-mg vials. Pharmacists may need to adjust the amount or concentration of drug they prescribe—sometimes more, sometimes less—when working with imported medications, Dr. Ganio noted.

The drug shortage problem goes well beyond cisplatin and carboplatin. According to ASHP and the University of Utah’s Drug Information Service, 301 drugs were in short supply in the United States during the first quarter of 2023, with 47 new shortages cropping up just this year. This is the highest recorded drug shortage total in 10 years.

“There are a number of chemotherapy drugs in short supply right now. Cisplatin is the first to be imported, but it wouldn’t surprise me if there are others,” Dr. Ganio said.

Whenever imports of drugs are used to address a shortage—whether for chemotherapy drugs or other medications—Dr. Ganio noted that foreign drug labels may not include barcodes that can be used for safety and quality checks. Imported drugs also do not include National Drug Codes, which makes billing problematic. It’s worth the up-front time to barcode any product that doesn’t already have it, Dr. Ganio said. It’s also important to update electronic health record systems to reflect usage of imported drugs, he added.

The roots of the spike in drug shortages are complex, Dr. Ganio said. “It could be inspection-related. It could be spikes in demand, like with the attention-deficit/hyperactivity disorder medication Adderall [dextroamphetamine saccharate-amphetamine aspartate-dextroamphetamine sulfate-amphetamine sulfate, Teva] or the diabetes medication Ozempic [semaglutide, Novo Nordisk],” he noted. “And it could be economic; maybe we’ve priced some drugs so low, especially our generics, that there’s no incentive for manufacturers to get in the game.”

—Marcus A. Banks

Dr. Ganio reported no relevant financial disclosures beyond his current employment.