Physicians are opening medicine cabinets, only to find certain drugs missing.
Increase in demand. Manufacturer shortages. Market withdrawal. Inadequate products. Unavailable raw material.
The Food and Drug Administration cites these reasons for some of the worst shortages in memory of pharmaceutical companies' ability to bring to market prescription drugs that treat life-threatening ailments ranging from cancer to serious blood disorders. As 2012 approaches, it appears the situation will get worse, despite efforts to boost supplies.
According to the White House, while a small number of drugs experience a shortage in any given year, the number of prescription drug shortages in the U.S. has nearly tripled between 2005 and 2010, with the shortages becoming more severe and frequent.
Lawrence A. Solberg Jr., MD, PhD, professor of medicine in the Department of Hematology/Oncology at the Mayo Clinic in Jacksonville, FL, says the drug shortages have been life-threatening to patients with blood-related diseases, particularly those with cancers such as leukemia, lymphoma, and myeloma.
As a result, physicians have had to choose alternative, less effective, and sometimes more toxic therapies for patients when first-line treatments were not available, says Solberg, who is chairman of the American Society of Hematology Committee on Practice. The society represents 16,000 clinicians, practitioners, and scientists who evaluate blood and blood related diseases.
"Imagine sitting there, as a patient with cancer, and your physician says, 'Sorry, We just don't have the drug right now to start your treatment.' It's a huge shock, a horrible anxiety," Solberg told HealthLeadersMedia. "And from a physician's point of view, say you are planning a treatment and have six cycles and go over six months. You may have one of the drugs right now, but how do we know three months down the road if there might be a shortage? You are partway down the treatment course and it affects that treatment course. You may be forced to use a different regimen, and perhaps the outcome in terms of cure is the same, but the toxicity profile differs."
As of August 31, 2011, there were 200 national drug shortages reported, compared to the overall total of 211 in all of 2010, according to Solberg. Some of the drug shortages have lasted for months. He says a six-month shortage of cytarabine, part of a standard therapy for certain leukemias and lymphoma, has been particularly detrimental.
He told the FDA about the case of a 50-year-old man with primary refractory diffuse large B-cell lymphoma who was receiving chemotherapy to prepare him for a bone marrow transplant. The patient received the first part of the chemotherapy and was responding well, Solberg says.
The treatment schedule called for cytarabine to be included in the second dose of chemotherapy, but because it was not available, the "physician was forced to choose an alternative therapy that was more toxic," Solberg said. "The patient was not able to receive the transplant and died from complications."
"This story is one example of several cases that have recently been described to ASH about physicians having to give patients less effective or more toxic alternatives," he told the FDA. "The increasing number of drug shortages has significantly affected the practice of hematology because the standard therapies frequently used include older, sterile injectable products that are particularly vulnerable to production, marketing, and business factors."
Another impact has been on as many as 200 clinical trials that have been interrupted by the shortages, Solberg says.