Larry Clark, PharmD., director of pharmacy at St. Mary's Hospital in Grand Junction, Colo., summarizes the problem succinctly. "I have 170 drugs in short supply and have to check availability every day and try to buy them before anyone else in the country gets to their wholesaler." When drugs aren't to be found at wholesalers or other hospitals or pharmacies, providers may have to go to the "gray market," which comprises alternate suppliers that offer the medications at a considerable mark-up in price.
Missing information
Pharmacy directors are further hampered in obtaining drugs because 75 percent of shortages have no release date, Clark says. That means the manufacturers don't know or have not reported when more will be available. In the past year, federal officials have taken new steps to address the shortage issue, including an executive order that calls for reviews of new suppliers and manufacturing changes. The steps are modest and incomplete but demonstrate the issue is becoming top-of-mind for policymakers, Clark believes.
Information technology can help hospitals and group practices better deal with drug shortages. These tools, however, often are not used or inadequately integrated, experts say, hampering the ability of I.T. systems to analyze and report shortages.
For instance, medications in a hospital are in the pharmacy, cabinets and dispensing carts on nursing floors, crash carts, satellite facilities, the emergency and surgery departments and storage carousels in the pharmacy, notes Larry Pawola, PharmD, chair of the biomedical and health information sciences department at the University of Illinois at Chicago. With drugs and information systems spread out across the enterprise, hospital pharmacies often don't know where and what their real inventory is, he explains.
Why shortages exist
The largest class of drugs in short supply is sterile injectable drugs, particularly chemotherapy medications, and most often in generic form. Although the total percentage of drugs in shortage is tiny, it still represents a serious patient care problem since the drugs often are critical medications.
"If you are a cancer patient who relies on a certain drug, then it's an emergency for that patient," says Jeremy Lazarus, M.D., a psychiatrist in Denver and president-elect of the American Medical Association. "If we don't have the anesthetics to put a patient under for surgery or wake them up, it's an emergency."
Shortages occur for a variety of reasons. In the case of chemotherapy, "While several manufacturers are currently expanding capacity, most of the capacity will not become available for several years," according to an October 2011 issue brief from the HHS Office for Planning and Evaluation. Product disruptions also cause shortages. Sometimes, the problem is a shortage of raw materials. Oftentimes, disruption occurs because the FDA has shut down production at a plant because of safety issues, such as bacteria found in injectables.
Market forces also play a role. Generic drug manufacturers won't gear up capacity to produce a generic version of a name-brand drug until there is certainty that the patent is expiring and won't be extended, explains Pawola. Further, the movement to generic drugs has been more substantial than many manufacturers anticipated, so while the demand may be there, capacity isn't yet in place.
To better deal with shortages, Pawola suggests hospitals and large clinic pharmacies have a pharmacy informaticist who assesses the points in information systems and departments where medication lists are used, including computerized physician order entry and other ordering systems, nursing stations and outpatient departments, among other areas. Centralize drugs in short supply when possible, he advises, to ensure there's an accurate inventory.
Better use of clinical reporting modules also can provide intelligence to better manage shortages, Pawola says. For example, EHR reports can determine how many patients are currently using a drug in shortage, enabling clinicians to determine if there are viable alternatives. Then, alerts in ordering systems can let clinicians know when a drug in shortage has available alternatives. Conversely, it's important, to also have an alert when a shortage is alleviated, he adds.
Federal response
Unless specifically required by law, pharmaceutical firms report shortages to the FDA on a voluntary basis. Legislation in Congress would require six-month notification of discontinuances or interruptions in manufacturing a drug that could create a shortage, or give notice as soon as practical.
The bills, S. 296 in the Senate and H.R. 2245 in the House, were introduced in February and June 2011, respectively, but have seen no action. The White House didn't support the bills until Oct. 31 when President Obama issued an executive order directing the FDA to use all administrative tools permitted under law to require advance notification covering drugs critical to life or preventing debilitating disease.
Under the executive order, FDA also would expedite regulatory reviews of new suppliers, manufacturing sites and manufacturing changes. "In prioritizing and allocating its limited resources, the FDA should consider both the severity of the shortage and the importance of the affected drug to public health," according to the order.
The executive order further took steps to target the gray market. "The FDA shall communicate to the Department of Justice any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices." Federal and state agencies then could take action against entities engaging in such activities.
