Protamine Shortage?

ANAHEIM, CALIF.—Drug shortages are a fact of life for every major hospital, and for many reasons, including manufacturing problems, regulatory issues, recalls, and mergers and acquisitions in the pharmaceutical industry, these shortages will continue to challenge clinicians and pharmacy directors.

One of the most obvious ways of dealing with a drug shortage on the clinical side of the problem is to substitute an equivalent drug. But what if there is no substitute available? Quick and creative thinking can turn a potential disaster into success.

Agatha Nolen, MS, DPh, FASHP, director of regulatory compliance support at the Hospital Corporation of America (HCA), Nashville, Tenn., addressed the problem during the 2006 Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP). She used a case study from her own experience as director of pharmacy at Centennial Medical Center, also in Nashville, during a protamine shortage last year. This was a serious problem for Centennial, which performs 1,000 open heart procedures per year.

Because the manufacturer could supply only 25% of the protamine that the hospital needed, it looked as if Centennial would have to close its Emergency Department to cardiac patients and cancel its open heart surgeries. Dr. Nolen responded by assembling a team to develop a plan to keep the cardiovascular surgeons operating throughout the shortage.

The first key to solving the problem was understanding the allocation process. By asking careful questions of her buyer and the manufacturer, Dr. Nolen learned that protamine was allocated per wholesaler account. So she used the hospital’s two additional wholesaler accounts, in dietary and materials management, to order the drug. “Every morning the dietician brought me three vials of protamine. It worked. I called two of our sister hospitals that do not have open heart programs and asked them to order it for me as well,” she said.

Another successful workaround was looking for alternative storage sites for the drug. Supplies of protamine were located in some areas that had not been inventoried, including carts already set up in the operating room and disaster stockpiles. “Our philosophy is that if the hospital is out, that qualifies as a disaster. We would feel comfortable using that supply on a patient who really needs it.”

Dr. Nolen emphasized that communication is important throughout the process. Due to improper communication, the chief of the hospital’s Cardiac Surgery Department preemptively decided to notify hospital administration that the department wanted to cancel all elective open heart surgeries, causing a great deal of confusion and distress. Dr. Nolen resolved the situation by opening appropriate lines of communication between the pharmacy, physicians and operating room staff.

Erin Fox, PharmD, drug information specialist atÊUniversity Health CareÊHospitals and Clinics in Salt Lake City, also stressed the importance of communication during such episodes. “Drug shortages are scary for doctors and patients. If you can give people a reason behind the shortage and let them know how long it might last, it helps soften the blow,” said Dr. Fox, who provides the content forÊthe Drug Shortages page at the ASHP Web site. The page provides extensive information on current drug shortages as well as the reasons behind them and their expected duration.

Dr. Fox described a difficult shortage of betamethasoneÊthat occurred from 2000 to 2006. Because the shortage could not be resolved in the short term, doctorsÊhad to make difficult decisions, placing priority on using the drug for mothers about to deliver premature babies, rather than patients with back pain or other problems. Clear communication helped doctors know when it was time to make these hard choices.

When a critical drug is no longer available, the situation may seem hopeless. However, taking a very thorough inventory, asking a lot of questions and understanding the rules that govern the availability of the drug can offer unexpected solutions.