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Drug Shortages Abound, Threaten Patient Safety
By Emily Mullin
July 27, 2011

Increasing drug shortages around the country are causing delays in medical treatments for patients and making it more difficult for health professionals to provide quality care.
 
A July study by the American Society of Health-System Pharmacists found that drug shortages are a growing problem at U.S. health facilities and are increasing costs to the nation’s health system.
 
The study, conducted in partnership with the University of Michigan Health System, surveyed 353 pharmacy directors in hospitals across the country, and found that labor costs associated with managing shortages translates to an estimated annual impact of $216 million nationally. Out of the surveyed health systems, 32 percent said that they had to reallocate staff – including from patient care duties – to allow time for individuals to focus on managing shortages.
 
One of the most troubling effects of drug shortages is how they impact patient care. When drugs are scarce or unavailable, pharmacists are often pulled away from their clinical duties to manage shortages. This means patients don’t have access to medication expertise that pharmacists provide.
 
When a drug shortage occurs, health systems are forced to buy those drugs elsewhere or find a substitute drug, says Dr. Burgunda Sweet, director of drug information and medication use policy at the University of Michigan Health System.
 
"There are occasions when perhaps a manufacturer of a product doesn’t have it so you would need to substitute it for another,” says Sweet, one of the main authors of ASHP study. "Where it becomes problematic is if the drug entity is not available and you have to substitute the drug therapy.”
 
For some medications, however, such as Doxil, a chemotherapy drug used to treat cancer, there are no comparable alternative drugs. If a certain kind of drug is not available, patients could experience a delay in care. Three specific drugs – dextrose syringes, epinephrine injection and succinylcholine injection – were reported to be in short supply at more 80 percent of the health systems surveyed in the study.
 
In some cases, if a drug is not available through a hospital’s contracted wholesaler, it can be purchased through another source, such as a compounding facility, but it will often be at a higher price.
 
Cynthia Reilly, director of practice development at the American Society of Health-System Pharmacists, said one of the biggest ways drug shortages can affect patients and care coordination is when health professionals are transferring patients from one type of care setting to another.
 
"As patients are moving from one setting of care to another, it’s possible that they may experience a drug shortage that they didn’t experience in the setting they were previously at,” she says.
 
Reilly says that’s because different health facilities are experiencing drug shortages at different times depending on their patient caseload and which wholesaler they have a contract with. For healthcare providers, managing a patient’s drug therapy can be challenging if the hospital is facing a scarcity of certain drugs.
 
The root of the problem
 
Recent drug shortages have been spurred by a culmination of factors, which are often complex, Reilly says.
 
First, the recession and economic slowdown have caused more drug companies to leave the market – either because they shut their doors completely or they consolidated or were bought out by other companies. Consolidation has meant fewer companies making drugs across the board.
 
Strict regulations set by the Food and Drug Administration have also triggered hiccups in the manufacturing process. Reilly says many drug companies have been self-policing their own production lines, which means they have to halt producing certain drugs temporarily to make sure they are in compliance with FDA policies.
 
A growing crisis
 
The release of ASHP’s study relates to another report released earlier this month. The report, conducted by the American Hospital Association, surveyed 820 hospitals and revealed that 82 percent had reported having to delay treatment because of drug shortages. More than half of the hospitals included in the study said they were not always able to provide the patient with the recommended treatment and 69 percent of hospitals said patients were given a less effective drug.
 
"The number of drugs in short supply is increasing at an alarming rate and hospitals are working diligently to reduce the impact to the patients they care for," AHA CEO Rich Umbdenstock said in a statement.
 
The ASHP survey reported similar findings and noted that 47 percent of large hospitals experienced 30 or more shortages in the last six months. More than 90 percent of respondents of the ASHP study agreed that drug shortages were associated with an increased burden and increased costs today compared to two years ago.
 
On top of that, most hospitals rarely or never receive advance notification of drug shortages or are informed about the cause of the shortage, making it difficult to plan for a shortage. Seventy percent of respondents in the ASHP study felt the information and resources available to manage drug shortages are less than good.
 
"Clinicians need more notice about drug shortages so they have time to act to ensure that patient care is not disrupted,"Umbdenstock said.
 
A coalition of healthcare groups, including the ASHP and AHA, are working to change that.
 
The two groups, along with its partners – the Institute for Safe Medication Practices, the American Society of Clinical Oncology and the American Society of Anesthesiologists – are pushing for legislative and regulatory changes that would help address the crisis.
 
The coalition is throwing its weight behind the "Support for Preserving Access to Life-Saving Medications Act,” which would establish an early warning system to help avert or mitigate drugs shortages. The legislation would also remove obstacles so that the Food and Drug Administration is able to streamline approval of drugs in shortage.
 
The two groups also want to explore incentives to encourage drug manufacturers to stay in, re-enter or initially enter the market. 

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