For the past 18 to 20 months, Joseph Morrissey has dealt with critical medications being in short supply.
"From day to day, you don't know what you're going to be faced with, and that's the piece that makes it difficult," said Morrissey, director of Pharmacy Services at Frederick Memorial Hospital.
"It keeps me up at night."
Morrissey is in the same predicament as other pharmacy directors, physicians and health care providers across the country. Most of the problems are with the sterile injectables -- IV medications -- and include anesthesia, chemotherapies and, over the past six to seven months, some antibiotics used to treat severe infections, Morrissey said.
FMH has taken steps to alert the pharmacy as well as medical and administrative staff members about potential shortages on a weekly basis, he said.
Coming up short
During the first quarter of this year, 89 drugs -- most of which are needed for patients in a critical or fragile condition -- were in short supply or unavailable in the United States, according to Coleen Cherici, director of Pharmacy Consulting for Premier health care alliance. By the end of this year, Cherici said, the shortages could be nearly double that of last year. Premier, a group of more than 2,500 U.S. hospitals and thousands of other health care sites, helps Frederick Memorial Hospital negotiate price contracts for drugs.
In a report released in March, Premier found shortages for more than 211 drugs in 2010 -- a tripling from 2005. More than 400 generic equivalents had been back-ordered for more than five days. Many of these were still in short supply this year, Cherici said.
About 77 percent of the 2010 shortages were for sterile injectable medications -- including cancer drugs, electrolytes used to treat heart disorders and neonatal care, and antibiotics, Cherici, FMH officials and physicians said.
Cherici said shortages for solid, oral drugs, especially those used to treat attention deficit disorder, are also on the rise.
"The shortages have reached critical levels, jeopardizing care and causing pharmacists nationwide to scramble for supplies," Cherici said.
"It's not business as usual."
A panoply of causes
Cherici, local physicians and Morrissey cited a variety of possible reasons behind the shortages, including substandard quality of active pharmaceutical ingredients, product discontinuation, stringent Food and Drug Administration enforcement and leaner inventories by pharmaceutical companies trying to improve financial margins.
In 2010, about 42 percent of sterile injectable drug shortages were due to product quality issues such as the presence of particulates, microbial contamination or other impurities, the Premier report states.
Nine percent were due to problems with the raw materials used to make the drugs, the report states. Most of these are sourced in foreign markets such as China, where investment in active pharmaceutical ingredients were cut in half in 2010 -- to $16 billion -- due in part to quality problems like that seen in 2008 for the injectable anticoagulant heparin.
Drug manufacturers are also delaying or stopping production of some drugs as their profits drop because of patent expiration, health care reform and investments related to regulatory compliance for older products, the report states. At least 18 percent of sterile injectable shortages in 2010 were due to product discontinuations.
Unless manufacturers are the sole producers of some critical drugs, the manufacturers are not required to report plans for product discontinuation to the FDA, Cherici said.
Dealing with shortages
Dr. A. Zakaria Hegazi of Frederick's Cancer Care Center said generic drugs are the ones he most often finds in short supply.
Treatment for certain types of cancers requires an exacting regimen of specific drugs over an orderly time frame, Hegazi said.
When some of those are found to be in short supply or unavailable, Hegazi said he and others must scramble to find alternatives.
"It is medically acceptable, but it is not exactly the way it is supposed to be," he said.
Shortages can lead some practices to hoard medications and enter a cycle of tightening supply that is difficult to exit. It also adds psychological pressures to patients already trying to cope with serious diseases, Hegazi said.
So far, the shortages have affected a small portion of Hegazi's patients and rarely, if ever, caused delays in treatment, he said.
"I wish I didn't have to deal with this," he said, noting his focus should remain on practicing medicine.
Dr. P. Gregory Rausch, director of FMH's Regional Cancer Therapy Center, said shortages have contributed to increased costs for patients and the potential danger they may not be able to get the necessary drugs.