Area hospitals dealing with drug shortage

Pharmacist Robert Glander says the Fort Smith area has not avoided a nationwide shortage of some critical drugs. In fact, he says it is the worst shortage he has seen in his 30 years in the business.

Glander, a doctor of pharmacy and director of pharmacy at St. Edward Mercy Medical Center in Fort Smith, said the shortage that began in 2010 has become more pronounced in 2011.

“Absolutely, we’ve been dealing with it on a continuing basis,” Glander said during a recent interview. “It’s as bad as we’ve seen it all year. We are actually moving today to substitute one product (stomach acid blocker) for another.”

Much has been reported about the growing number of drug shortages in the U.S. The Federal Drug Administration (FDA) has said it “is aware that in 2010 there was a record number of shortages and in 2011 FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs.” More than 200 drugs were on the shortage list in 2010.

A detailed report form the American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Society of Health-System Pharmacists and the Institute for Safe Medication Practices indicates that regulatory barriers, ambiguities and lack of FDA authority were “considered significant contributors to drug shortages.” Continuing, the report noted: “Examples include the absence of a requirement for manufacturers to notify FDA of anticipated market withdrawal and no statutory authority for enforcing notification requirements for medically necessary drugs.”

The report also said the “cost and complexity” of FDA rules “is a disincentive for entering or maintaining a market presence” among drug manufacturers.

“Shortages may be caused when companies are delayed in complying with these new requirements,” according to the report.

Glander said patients are not going without drugs, but may be inconvenienced by having to switch to a new drug, especially patients receiving outpatient chemotherapy treatment. He also said there were just a few delays in surgery related to a drug shortage.

St. Edward manages through the shortages by staying in more frequent contact with the Mercy System distribution center in Springfield, Mo. Also, the large Mercy System — more than 60 health care facilities in four states — is able to acquire direct “allocations” with drug manufacturers for medications with a history of shortage.

Rural hospitals, Glander admitted, will not have that advantage.

“I think they would really be struggling,” he said.

Glander also said the hospitals in the Mercy System network using “e-mail blasts” to ship limited supplies within the network.

Sparks Health System, owned by Naples, Fla.-based Health Management Associates, issued a statement when asked about the drug shortage problem: “We are tackling this issue on several fronts. We monitor all national drug shortage databases (i.e. FDA website, American Society of Health System Pharmacies website)  daily so we’re aware of any shortage alerts. We can then appropriately increase stock when necessary. Since Sparks is a large organization, we are able to keep a larger stock in place compared to other organizations. We have greater access to medications due to our ability to purchase from multiple manufacturers, strong purchasing group agreements, and agreements with our wholesaler. All of this strategic planning has allowed us to maintain a supply of critical medications.”

The drug summit report identified the following solutions to the drug shortage problem.
• Explore expanding FDA authority to require manufacturer notification of market withdrawals (e.g., notification required 9 to 12 months prior to planned market exit).

• Evaluate the current FDA definition of medically necessary, including the established criteria and responsible party for making this determination, to assess the need for increased FDA statutory authority in this area.

• Define and implement evidence-based and other criteria for identifying critical drug therapies that are vulnerable to drug shortages. Criteria might include factors such as availability of therapeutic alternatives, supply chain characteristics, and other elements that determine products’ vulnerability for shortages.

• Explore providing incentives (e.g., tax credits) to manufacturers that produce critical drug products or upgrade manufacturing plants to meet or exceed Good Manufacturing Practices (GMP) in exchange for guarantee of continued production of these therapies.