Several U.S. hospitals have reported short supplies of two chemotherapy drugs, vincristine and etoposide. The former is used to treat leukemia and the latter is an ingredient in several regimens to treat common cancers. According to a report from the Financial Times, the shortages are caused by manufacturing issues at drugmakers Pfizer and Hikma Pharmaceuticals.
Pfizer is the sole supplier of vincristine. The manufacturer reported that 2 mL vials of vincristine were in “limited supply,” meaning that demand is outpacing supply, but there were no shortages as of early May. Etoposide is made by Hikma and other smaller pharmaceutical companies; the company did not respond to requests for comment by the Financial Times.
If supplies fall too low, this would be the latest in a line of recent drug shortages in the U.S. – again raising questions about how well manufacturers are maintaining supplies of critical medicines. Earlier this year, pharmaceutical companies struggled to keep up with demands for saline during the flu season and hospitals also are facing limited supplies of morphine and other painkillers used during surgery.
While U.S. hospitals have not yet reported chemotherapy shortages leading to drug-switching for cancer patients, they note that these recent issues highlight vulnerabilities in the drug-manufacturing process. For instance, when prices of older, off-patent drugs decline, manufacturers may leave the market, leaving a limited number of suppliers for certain medicines. Other manufacturers may be forced to buy the active pharmaceutical ingredients (API) from a single source.
These issues have prompted hospital pharmacists, like Michael Ganio, PharmD, director of pharmacy practice and quality at the American Society of Health-System Pharmacists, to call for greater transparency in drug-supply chains. “We need to approach the problem from an emergency preparedness position and ensure there is some sort of catastrophe plan in place,” he said. He offered one possible solution: The U.S. Food and Drug Administration could force pharmaceutical manufacturers to disclose their API sources and provide a public timeline for expected recoveries from shortages or supply issues.
Source: Financial Times, May 9, 2018.