Cause For Concern

The Hospitalist. 2011 July;2011(07):

July 1, 2011 | The Hospitalist

Patient Safety and Communication Errors

Lalit Verma, MD, director of the hospital medicine program at Durham Regional Medical Center in North Carolina and assistant professor of medicine at the Duke University School of Medicine, is unaware of any situations in which a shortage put patients in jeopardy at his hospital. He says the pharmacy at Durham Regional, which has seen recent shortages in morphine and heparin, among other drugs, keeps doctors up to date and has adjusted doses appropriately when replacements are used.

“It’s probably been more than I’ve experienced in my 10 years as a hospitalist,” Dr. Verma says. “We have a very good pharmacy program that updates us regularly on drug shortages and offers alternatives.”

Dr. Li also says no patient’s safety has been jeopardized by a shortage.

By the Numbers

Key results from a July-September 2010 survey of 1,800 healthcare practitioners by the Institute for Safe Medication Practices:

One in 3 respondents reported their facility had experienced a “near miss” during the past year due to drug shortages.
One in 4 reported actual errors being made in the past year due to drug shortages.
One in 5 reported adverse patient outcomes in the past year due to drug shortages.
More staff-level practitioners (21%) reported adverse patient outcomes than administrative staff or directors/managers (18%).
One in 3 physicians reported an adverse outcome caused by drug shortages in the past year, more than pharmacists (21%) and nurses (16%).
Many respondents commented that errors and adverse patient outcomes were not shared with them on a routine basis, were based on sporadic voluntary reporting, or were difficult to quantify.
Many respondents felt the frequency of errors and adverse outcomes due to drug shortages is much greater than reported.
Very few (6% to 15% depending on practitioner type) rely on the FDA website or an advanced notice from wholesaler, distributors, buying groups, or manufacturer to learn about drug shortages.
Half of physicians reported learning about shortages from pharmacists who call them after they have prescribed a drug in short supply, or from colleagues and the literature.
Some respondents reported that they think a full-time position will be needed to manage drug shortages if the situation does not improve.

Others say patient safety has been affected, according to 1,800 healthcare practitioners who participated in a survey last year conducted by the Institute for Safe Medication Practices (ISMP), a nonprofit group. Twenty percent of the respondents said drug-shortage-related errors were made, while 32% said they had “near misses” related to drug shortages. Nineteen percent said there had been adverse patient outcomes as a result of drug shortages.

The study noted two instances in which patients died when they were switched to dilaudid because morphine was in short supply; both patients were given morphine doses instead of adjusted doses for dilaudid.

“It’s about six- or sevenfold more potent than morphine,” says Michael Cohen, ISMP president. “And so when that drug is prescribed in a morphine dose, that would be a massive overdose for some patients.”

He adds that hospitals have tried to stay on top of the drug shortage problem, but that “it’s very difficult.”

“A lot of this happens last-minute,” Cohen says. “Physicians aren’t given a chance to even realize that a certain drug isn’t available, so it causes an interruption in the whole flow of things in the hospital.” Some hospitals have had to hire staffers who handle just the inevitable daily drug shortages, he adds.

A law has been proposed in the U.S. Senate that would require drug manufacturers to notify the FDA when circumstances arise that might reasonably lead to a drug shortage (see “Senate Bill Would Require Advance Notice of Potential Shortages,” p. 41).