Drug shortages impede care, threaten lives

The American Society of Health-System Pharmacists (ASHP) views drug shortages as a public health crisis that is putting our most vulnerable patients at risk for delays or disruptions that may have life-threatening consequences. The number of drug shortages have quadrupled over the last 4 years, which is the greatest increase since ASHP began tracking shortages over a decade ago. In previous years, shortages went largely unnoticed because pharmacists could usually find the medications that their patients needed, but that is no longer the case.

Today, patients are increasingly aware of the problem. Treatment disruptions and delays have been particularly troublesome for cancer patients and patients whose medications are critical to their survival.

Pharmacists must go to great lengths to find products that are in short supply. They start each day by discussing the drugs that are in shortage, and how they are going to try to get these medications or effectively treat their patients with alternative therapy. They develop spreadsheets that list products in short supply, the wholesaler that typically supplies the product, the dosage, the amount of product that the hospital has left, and potential alternatives. Pharmacists then use this list to proactively inform physicians, nurses, and others where the challenges lie.

Constant communication with wholesalers and other hospitals has helped pharmacists identify who may have product. It is not uncommon for hospitals and health systems to work with one another to ensure patient care is not interrupted because the medication is not available. All of this time spent tracking down product or developing alternative treatment plans is time not spent by pharmacists in the direct care of patients.

Legislation is critical

In early 2011, senators Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) introduced the "Preserving Access to Life Saving Medications Act" (S. 296), which would require manufacturers to notify FDA when they discontinue a product or experience a production interruption. And just weeks ago, representatives John Carney (D-Del.) and Larry Buchon (R-Ind.) introduced legislation that expands the early warning system to include the cause, duration, and severity of shortages. In the House, representatives Diana DeGette (D-Co.) and Thomas Rooney (R-Fla.) introduced H.R. 2245, legislation similar to S. 296.

ASHP and other organizations like the American Hospital Association, American Society of Anesthesiology, and the American Society of Clinical Oncology recognize that there is no simple solution to this crisis, but all agree that passing this legislation is essential because it establishes an early-warning system – the 1 element that makes a difference. FDA was able to prevent almost 200 shortages in 2011 when it was notified ahead of time of a discontinuation or production interruption.

While the early warning system and continuity-of-supply plans outlined in this legislation are critical elements of this crisis that should be addressed immediately, they are not the entire answer to the problem. Economic factors such as Medicare Part B reimbursement have also been raised as a potential contributing factor. More research, however, will be necessary to assess its potential impact.

Time is of the essence

Drug shortages seem to be caused by a complex interplay of factors. Therefore, fixing the problem is likely going to take more than 1 solution. But we must not wait to act. And we must not guess about answers. It's vital that we take the steps now that we know can make a real impact.

The legislation before Congress clearly addresses things that we can do right now to help prevent future drug shortages. ASHP will continue to make solving the problem of shortages a top priority, and will do everything possible to help our members with their daily struggles to address this patient-care crisis.

Paul W. Abramowitz is the CEO of the American Society of Health-System Pharmacists.