Hospira ($HSP) recalled more than 60 lots of the pain reliever ketorolac tromethamine injection in January because of the potential for crystals in the 18 million vials that had been shipped in the U.S. and Singapore. The Lake Forest, IL, injectables specialist has fixed the production issue and is again shipping it, but some doses of the surgery drug remain hard to get. German drugmaker Fresenius Kabi also makes ketorolac, but a surge in orders with the Hospira recall left it unable to meet demand. It will release more product this month and next.
Despite the best efforts by both drugmakers and the FDA to prevent or quickly resolve shortages, there are still dozens and dozens of drugs the supplies of which are limited. The University of Utah's Drug Information Service, which tracks drug shortages differently than the FDA, says about 265 drugs were in short supply at the end of the last quarter. That is an improvement from about 300 shortages at the end of last year but still a very large number.
The shortages of ketorolac and other drugs force doctors to sometimes turn to alternatives they would prefer not to use because of their side effects or because they just are not as effective, according to The Wall Street Journal.
"The shortage of ketorolac deeply affects patient care, as we don't have great substitutes," Sean Adams, an anesthesiologist in Naperville, IL, told the newspaper.
Hospira is the largest maker of sterile injectables in the world, so its recalls can often have a big impact on supplies. Pfizer ($PFE) in January announced it would buy Hospira for about $15 billion, raising hopes that the pharma giant could help Hospira do a better job. But it is not as if Big Pharma companies like Pfizer are immune to manufacturing problems that lead to drug shortages.
Pfizer ran into problems at a plant in Italy that required repairs, affecting production of its antibiotic Zosyn, a combo of piperacillin and tazobactam. The interruption led to a shortage of the widely used drug. Pfizer told the WSJ it is expects to resume shipping in September, but there is currently nowhere for doctors to turn. Seven other companies that produce Zosyn generics, including Hospira, say their supplies are on back order.
Some shortages leave patients and their doctors with very difficult choices. When mold problems caused Big Pharma player Sanofi ($SNY) to halt production of the bladder cancer drug ImmuCyst/TheraCys in 2012, some patients faced having their bladders removed, and so living with urostomy bags. Merck ($MRK) stepped up production of its BCG drug to help meet demand but ran into some manufacturing issues itself that temporarily interrupted production.
Sanofi resumed production in March for some countries after Health Canada gave the plant an approval. It was still awaiting an inspection from the FDA, which had issued a warning letter for the plant in 2012 because of the contamination issues. Product is expected to begin shipping in the second half of the year, but meanwhile, some patients are left wondering what to do.
"I feel like I am too young to go through that kind of life change," one patient said in a FiercePharmaManufacturing comment about the possibility of having her bladder removed. "I have always been a fighter, but lately I feel like I am giving up the fight."
- here's the WSJ story (sub. req.)