Cause For Concern

The Hospitalist. 2011 July;2011(07):

July 1, 2011 | The Hospitalist

Cohen says another concern is that some hospitals, faced with shortages in electrolytes, such as potassium phosphate and sodium acetate, have been turning to less-regulated sterile compounding pharmacies for the products.

Listen to more of our interview with Dr. Verma

Dr. Verma, of Durham Regional, says perhaps the biggest challenge is staying on top of changing doses. “I think there was a learning curve for physicians in using dilaudid [rather than morphine] because the dosing is quite different, so that can cause challenges for patient care when you’re switching in and out of drug classes,” he says. “It’s not a perfect science. It doesn’t cripple us, but it does make it more challenging to fine-tune patient care.”

Ginsburg, of the ASHP, urges hospitalists to stay in close contact with the pharmacists at their hospitals and to be diligent about reporting shortages to the ASHP.

“Please work closely with the pharmacists, because we’re the ones that can really help,” she says. “We’re in it together with them, in terms of trying to provide care for their patients.” TH

Thomas R. Collins a freelance medical writer based in Florida.

Senate Bill Would Require Advance Notice of Potential Shortages

If hospitalists and pharmacists were to get early warning that a drug might soon be in short supply, they might be able to adapt, perhaps beginning to use an alternative sooner rather than later, or pursue other sources of the medication earlier.

Advance notice, though, is often more of a wish than a reality.

But a bill (S. 296) proposed in the U.S. Senate by Sens. Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) would require that drug manufacturers notify the U.S. Food and Drug Administration (FDA) of factors that might lead to a drug shortage.

Advocate groups are pushing for a notification at least six months ahead of time.

The law would give the FDA the ability to impose penalties for not reporting such circumstances, although what those penalties would be has not yet been determined.

“Often, the first time pharmacists even learn about something not being available is when they order it and they get a notice back from the drug wholesaler or the company that it’s back-ordered,” says Michael Cohen, president of the nonprofit Institute for Safe Medication Practices (ISMP).

The FDA’s ability to avoid drug shortages is limited because there is no such advance-warning requirement. The FDA also does not have the ability to force a drug manufacturer to make a drug, although it can intervene in cases in which a drug considered medically necessary is facing a shortage. In those cases, the FDA can work with manufacturers to boost production, expedite the approval process, or help with finding alternative sources of raw materials.

The bill is being supported by the American Hospital Association, American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists (ASHP), and ISMP.

Without saying outright that the agency supports the legislation, FDA spokeswoman Yolanda Fultz-Morris said in an email, “Early notification helps us in many cases to avoid shortages and we continue to encourage manufacturers to notify us when they experience any issue which could lead to a change in supply.”

Diane Ginsburg, ASHP president and clinical professor and assistant dean for student affairs at the University of Texas’ College of Pharmacy in Austin, says the law would help the FDA handle the rising problem of drug shortages.

“This in essence would help the FDA and empower the FDA more so that we can better try to manage this before it occurs,” she says. “Right now, it’s a scramble.”—TC