Shortages of paclitaxel—a drug used intravenously to treat ovarian, breast and lung cancers—have been reported by hospitals and researchers since May, but there’s still no firm end to these in sight. We tend to expect that when an effective drug has been found, hospitals in the U.S. will have no problem obtaining it for patients in need. But a spate of recent drug shortages—of everything from antibiotics to electrolytes needed for nutrient solutions to blood pressure medications—have proved otherwise, showing just how unreliable the pharmaceutical supply chain in this country can be.
Paclitaxel, sold under the trademarked names Taxol and Abraxane, is a chemotherapy agent used primarily in treating ovarian, breast and lung cancer, and off-label to treat quite a few other cancers, including bladder, endometrial, cervical, esophageal and leukemia. There are alternatives, but no single drug can be substituted for paclitaxel, and the specific ‘alternative regimen’ must be decided on a case-by-case, per-patient basis. Treatment regimens that use paclitaxel often lack equally effective substitutes, Cynthia Reilly, director of the American Society of Health-System Pharmacists’ practice development decision, told ABC news.”That’s what makes not just this, but all of the chemotherapy shortages significant. There’s cancer patients who will die because of this. This could change their survival.” Paclitaxel joined the American Society of Health-System Pharmacists’ shortage list in May. NPR reported last week that hospital giant Mass General has less than a month’s supply left.
Paclitaxel injection is indeed still in short supply, according to ASHP. Bedford Laboratories, one of the bigger producers of paclitaxel, attributed its shortages to manufacturing delays, as did another maker, Teva. Two other makers said their shortages were due to increased demand for the drug, one blamed a raw material shortage and one didn’t provide a reason. Some couldn’t estimate a release date; one said between mid-October 2011 and December, one said late-November, one said early 2012. Pharmaceutical giant Pfizer will be launching paclitaxel production later this year.
Drug shortages in general have involved a lot of generics. Generic drugs are less profitable for pharmaceutical companies, leading some to blame the shortages on corporate greed. But the FDA says only 11% of shortages stem from a company deciding to stop making an unprofitable drug; it’s more common for something to go wrong in the manufacturing of a medication that halts production. Producing sterile injectable medicines is more complicated and expensive than stamping out pills. And because there are fewer pharmaceutical companies making these drugs (only a half-dozen companies make the majority of injected generics), one botched supply can seriously put a crimp in the overall amount available.
When demand for a medication outpaces supply, doctors and hospitals are forced to make difficult choices. In some cases, doctors and hospitals are forced to ration, deciding which patients need the drug most critically. Patient care suffers. The Associated Press reported that 15 patients have died in the past 15 months as a result of drug shortages.
Some hospitals have turned to ‘gray-market’ suppliers, the Associated Press reported last month—secondary vendors who buy scarce drugs from small, regional wholesalers and them market them to hospitals, usually at marked-up prices. The average price markup on drugs sold by these secondary distributors was 650%, according to an August report by the Premier Healthcare Alliance. Over a 2-week period of 2011, the group recorded 1,745 examples of gray market offers made to 42 hospitals; all of the top 10 drugs offered were in short-supply and manufacturer back-ordered or unavailable. The marketing offers, via fliers and email, contained language such as “We have only 20 of this drug left and quantities are going fast.”
The House Committee on Oversight and Government Reform is taking action against at least one grey-market supplier of paclitaxel.
The FDA says 2010 saw a record number of drug shortages, and it’s continued to see an increase so far in 2011. In 2010, there were 211 drug shortages, the highest number recorded in a single year.