The nation’s healthcare delivery system faces an unprecedented shortage of some pharmaceuticals, particularly sterile injectables, and Middle Tennessee isn’t immune to the problem. In fact, the shortages are frustrating providers and patients and eating up valuable resources in hospital pharmacies.
“The problem has been more pronounced over the last two years, and this year has been harder to manage than last year,” acknowledged Jeff Binkley, PharmD,
director of pharmacy at Maury Regional Medical Center in Columbia. “In every area of the hospital, patient populations have been impacted, from anesthesia to oncology to critical care. It’s some of those specialty areas that are probably the most concerning because the alternatives in those areas may be more limited.”
In October, the U.S. Food and Drug Administration reported that 2011 would see a record number of drug shortages, well more than 200. The 2010 number was 178. The FDA cited multiple reasons for shortages, from manufacturers halting production of an unprofitable drug to contamination issues.
“If you look at the shortages over the last couple of years, the majority of the shortages are sterile injectables, which affect the hospital because that’s usually the setting in which most of those products are used,” explained Keri Davenport, PharmD, clinical pharmacist at Summit Medical Center in Hermitage. She said shortages are occurring in a variety of areas, including oncology, surgery and emergency medicine. Some low-cost antibiotics and electrolytes are in short supply, too. “We never know what’s going to fall on the list next,” she said. “For us, it has no rhyme or reason.”
That’s one of the predominant complaints of providers and pharmacists, that there isn’t adequate notice of a shortage. Thus, they are left scrambling to find supplies or to change or delay patient treatment. “It’s required quite a bit of additional resources … both human resources as well as extra expenditures to try to mitigate the problem,” Binkley said.
For Dana DeMoss, a nurse practitioner at Tennessee Oncology, shortages prompt several emotions: frustration, awkwardness and concern. “What’s so frustrating to me is having to tell somebody, ‘I’m sorry. We don’t have your drug anymore.’ Patients have an amount of trust in us and our decision-making. Maybe I’m taking it a little too personally, and of course, it’s not our fault …,” said DeMoss, trailing off. She said it’s particularly difficult for nurses administering the chemotherapy to patients who, for example, know that the replacement drug will make them more nauseated than their previous treatment regimen.
DeMoss works in gynecologic oncology, and the drug shortage most affecting that practice is Doxil, used to treat ovarian cancer. Generally, Doxil therapy is six cycles, one every four weeks. DeMoss said one of her patients had completed five cycles and never received the sixth. Another patient, having completed two cycles, was forced to begin the cycles again with a different drug. To keep another patient on schedule, she said that she was “begging people” for one Doxil dose. She scrounged one dose from a local hospital with a promise to pay it back. What’s more, the Doxil shortage is affecting clinical trials, including trials in which Tennessee Oncology is participating with Nashville’s Sarah Cannon Research Institute.
“I’ve been on the phone with these pharmaceutical companies,” DeMoss said. “I was just on the phone this morning with Janssen (Doxil’s manufacturer), and they couldn’t tell me when I might get it.”
Binkley and Davenport agreed that the uncertainty is indeed exasperating. “We spend a lot of pharmacy labor time directed toward making sure that we have adequate supply of those agents,” Davenport said. “Sometimes we get advanced warning, but many times we don’t.”
Binkley said he believes the responsibility for communication about shortages should lie with the drug manufacturers, yet many times they’re silent. “I think the way to achieve that is through legislation to give the FDA more control over what is pulled from the market voluntarily by the drug manufacturers,” he said. “There are legislative opportunities to give the FDA that authority and maybe put a little more teeth into making sure drugs are available.”
Binkley said that communication should include regular notice of status to prescribers. “There can be a wide variety of information out there as to when availability is anticipated,” he said. “Sometimes that’s accurate, and sometimes it’s not so much.”