“Physicians need to have some advance warning that shortages are coming to give us enough time to look at alternative medications.”
• A lack of information about the dura- tion of the shortage;
• No advance warning and suggested alternatives;
• No information about the cause of the shortage;
• Substantial resources expended to de- velop a plan of action to respond to the shortage;
• Difficulty obtaining a suitable alterna- tive drug; and
• A significant financial impact on hos- pitals.
Thirty-five percent of respondents to the 2010 ISMP survey indicated that a drug shortage caused their facilities to make errors that could have harmed pa- tients in the past year. About 25 percent reported errors that reached patients, and one in five reported adverse patient outcomes.
“Right now, we don’t have drugs that allow us to make IV nutrition optimal. Because of the shortage, babies, particu- larly the smaller, more vulnerable ones, are at increased risk of fractures,” said Michael Speer, MD, a faculty member in the Neonatology Section of Baylor Col- lege of Medicine and Texas Medical As- sociation president-elect.
Besides calcium gluconate, neostig-
mine, propofol, epinephrine, furosemide, and a host of sterile injectables, as well as antibiotics and other medications, are among the drugs on an expansive list of shortages tracked by the U.S. Food and Drug Administration (FDA). A record 246 drugs were in short supply as of June, according to FDA. That figure has many Texas physicians worried about potential risks to patient safety and qual- ity of care.
Brad Butler, MD, a Longview anes-
thesiologist and chair of the TMA Com- mittee on Professional Liability, says that while alternative medications often can replace preferred drugs during a short- age, the change in protocol it necessi- tates isn’t ideal.
“Some of the alternative drugs aren’t as effective and can have worse side ef- fects for the patients,” he said. “You can also increase the risk of adverse out- comes or errors when you have to switch to a substitute.” Indeed, last year’s shortage of 211
drugs caused some patients to develop complications and even die from receiv- ing a less effective alternative medica- tion or the wrong dosage of the substi- tute drug or from having to go without the drug altogether. According to the Drug Information
Service of the University of Utah, re- cent shortages are up drastically from 74 drugs in 2005. To view a list of cur- rent drug shortages, visit
www.fda.gov/ Drugs/DrugSafety/DrugShortages/
ucm050792.htm. (See “Drug Shortage Resources,” opposite page.)
Brad Butler, MD Russell Kridel, MD 24 TEXAS MEDICINE October 2011
A national Institute for Safe Medica- tion Practices (ISMP) survey conducted from July through September 2010 re- veals health professionals encountered many difficulties from drug shortages. The most common problems included:
Among the more than 1,000 errors and adverse patient outcomes described in the survey are:
• Two patients died from being admin- istered intravenous hydromorphone prescribed at the intended dose for morphine.
• A patient with a pseudomonas infec- tion sensitive only to the antibiotic amikacin died when the drug could not be provided.
• A paralyzed, ventilated patient was not sedated because propofol was not available and an alternative drug was never prescribed.
• A patient with renal failure received the neuromuscular blocking agent pancuronium, causing excessive and prolonged paralysis and tachycardia.
• Substituting the chemotherapy drug Xeloda (capecitabine) for leucovorin caused serious gastrointestinal toxic- ity in many patients.
Dr. Butler says he learns of drug shortages from pharmacies and hospitals every month. He describes drug short- age notification as somewhat inadequate and sometimes delayed. Dr. Speer wants FDA to expand its au-
thority related to drug shortages. “It would be helpful if FDA could give physicians, pharmacists, and health
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68