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ASHP Driving National Effort to Manage Drug Shortages Crisis

Sep 23, 2011

DURING HIS LONG CAREER AS A PHARMACIST, RICHARD CARVOTTA, R.PH., M.B.A., has never experienced anything quite like the prescription drug shortages currently plaguing hospitals and health systems across the U.S. “I’ve been a director for 27 years, and the past year has been the worst I’ve ever experienced,” said Carvotta, director of pharmacy for St. John’s Hospitals in Oxnard and Camarillo, Calif. “The challenges presented to hospitals are immense.”

The results of two national surveys released at an ASHP Capitol Hill press briefing in July—one from ASHP and the University of Michigan Health System and one from the American Hospital Association (AHA)—attach some hard numbers to the scarcity:

• In 2010, there were 211 drug shortages, the highest number recorded in a single year. By comparison, 224 shortages were reported over the six-and-a-half-year period from January 1996 to June 2002.

Eighty-two percent of hospitals delayed patient treatment as a result of a drug shortage.

• Annual labor costs associated with managing shortages total an estimated $216 million nationally.

• Shortages of three drugs affected over 80 percent of health systems (dextrose, epinephrine, and succinylcholine injections).

• 99.5 percent of hospitals reported at least one shortage in the past six months, and 78 percent implemented rationing or restrictions for drugs in short supplyi.

The most obvious fallout from drug shortages are postponed treatment and less-than-ideal patient care, which results from either lack of good alternative therapies or, when alternatives are available, use of drugs that may have more side effects or be less effective.

Drug shortages also contribute to medication errors, because clinicians suddenly find themselves working with unfamiliar substitutes, or with strengths or dosage forms they ordinarily do not use. In a 2010 survey of more than 1,800 health care practitioners conducted by the Institute for Safe Medication Practices, 35 percent of respondents said that their facility experienced near-miss errors caused by a drug shortage in the previous year; about one in four reported actual errorsii.

A Public Health Crisis

Erin R. Fox, Pharm.D.

“The current situation is nothing short of a health care crisis,” said Erin R. Fox, Pharm.D., manager of the Drug Information Service at the University of Utah Hospitals & Clinics, Salt Lake City. “What makes the current batch of shortages even more difficult is that these are chemotherapy products and, in many cases, there are no alternatives. Patients are having their treatments delayed and may have their chance for a best outcome destroyed because of these shortages.”

Among the assorted reasons given for the shortages are industry consolidation; production stoppages related to noncompliance with good manufacturing practices; voluntary recalls or holds placed on production due to quality problems; interruptions in raw material acquisitions; limited manufacturing capacity in the face of increased demand; and manufacturers’ decisions to halt production of low-profit drugs.

Chemotherapy agents (for which there are few therapeutic alternatives), antimicrobials, and analgesics have been particularly hard hit.

Helping ASHP members manage drug shortages has become a top priority for ASHP. At the heart of the organization’s multifaceted strategy to help hospitals cope with the problem is its Drug Shortages Resource Center (the most frequently visited section of ASHP’s website). The center, created in 2001, disseminates detailed information on the status of current and resolved drug shortages, including expected resupply dates. This information is also shared with the Food and Drug Administration (FDA).

“Awareness of this issue is so great across the country that we don’t miss much,” said Cynthia Reilly, B.S.Pharm., ASHP’s director of practice development, whose team manages the ASHP resource center. “ASHP members play a critical role because their reports are often the first indication that a shortage is occurring.”

 A Legislative Solution?

ASHP is pressing for legislation that would give the FDA greater authority to manage shortages. A bill introduced in the House of Representatives in June requires all manufacturers of prescription drugs, including biologic agents, to notify the FDA of any discontinuance, interruption, or adjustment in the manufacture of a drug that may result in a shortage. Penalties for noncompliance run up to $10,000 per day, with a $1.8 million cap.

The bill requires the FDA to publish information related to manufacturing problems and shortages on its website.

Currently, FDA regulations require only that sole-source drug manufacturers send a six-month notice of an anticipated supply disruption. A similar bill introduced in the Senate in February does not yet include monetary penalties.

Joseph Hill

According to Joseph Hill, ASHP director of federal legislative affairs, ASHP is working closely with the sponsors of the bills in both chambers (Reps. Diana DeGette and Tom Rooney, and Sens. Amy Klobuchar and Robert Casey) and will continue to encourage bipartisan support.

“The intent of both bills is to create an early warning system so that the FDA can plan ahead when a shortage is looming,” said Hill. The added time would give the FDA an opportunity to work with other manufacturers to ramp up production of drugs about to go into short supply. (The agency does not, however, have authority to compel a manufacturer to increase production of a medically necessary product.)

In 2011, the FDA claimed to have averted 38 shortages the previous year when it was alerted in advance.

Given the highly contentious mood in Congress these days, it’s hard to say when either bill will move forward, but Hill is guardedly optimistic. The Senate recently formed a bipartisan working group to explore solutions to drug shortages. “Congress is not doing much bipartisan work these days, so I think this is significant,” said Hill. He anticipates some movement in the House of Representatives this fall.Missing Health Care Tools

Legislation is only one step toward a comprehensive solution to a complex and multifactor problem, said Bona Benjamin, B.S.Pharm., ASHP’s director of medication-use quality improvement. “There’s a large landscape of moving parts involved, and we need feasible solutions that won’t have unintended consequences, such as creating inequities in the marketplace,” she said. “We have to ensure that manufacturers of critically needed drugs continue to produce them.”

Benjamin works closely with the FDA and the University of Utah Drug Information Service to find innovative solutions to shortages, such as cobbling together comparable therapies from more plentiful drugs, and ensuring that clinicians receive all the necessary information they need to administer alternatives safely. “Health care workers are in the profession to help people get and stay well,” she added, “and drugs are an essential tool to achieve that goal. Right now we’re missing many of our fundamental tools.”

Carvotta, the pharmacy director, makes it clear just how high the stakes are: “Drug shortages have created a new world for hospital pharmacy, and we need to be creative and resourceful in coming up with alternatives,” he said. “But the time it takes to do this is absorbed by existing staff, and the productivity gurus have no idea about the work effort that is involved.”

Fox said that she loses a lot of sleep over the issue of shortages. “I talk to so many patients who can’t get their treatments,” she said. “I also talk to so many pharmacists who are worried about medication errors due to the high rate of shortages. It is an absolute nightmare for both patients and pharmacists.”

 i “Impact of Drug Shortages on U.S. Health Systems,” R. Kaakeh, B. Sweet, C. Reilly, C. Bush, S. DeLoach, B. Higgins, A. Clark, and J. Stevenson; AJHP, October 2011; www.ajhp.org/site/DrugShortages.pdf?fm_preview=1

 ii www.ismp.org/Newsletters/acutecare/articles/20100923.asp

 Editor’s Note: For more information about drug shortages, read the accompanying interview with Erin R. Fox, Pharm.D., manager of the Drug Information Service at the University of Utah Hospitals & Clinics, Salt Lake City.  

 

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