Shortages of chemotherapy drugs have increased over the past 2 years. At St. Jude, where 85% of the cancer patients are enrolled in clinical trials, enrollment in acute myeloid leukemia protocols were suspended because of a shortage of cytarabine and lymphoma protocols were modified because of the shortage of mechlorethamine (nitrogen mustard). He pointed out that with 10 drugs, about 90% of patients with childhood acute lymphoblastic leukemia, the most common childhood cancer, can be cured, but over the last decade, 8 of these 10 drugs have been temporarily unavailable.
Substitute drugs can often be more expensive and involve additional labor costs, adding up to an estimated $415 million annually, according to Bryant Mangum, vice president of pharmacy services at Premier Healthcare Alliance, a network of over 2,500 hospitals in the United States. An analysis of 636 unsolicited sales offers from gray-market vendors conducted by Premier found that the average markup of a drug price was 650%. Almost half the drugs were marked up by at least 1,000%, more than 25% were marked up by at least 2,000% – and a drug used to treat hypertension that usually costs $25.90 was being offered at $1,200, "a staggering increase," he said at the meeting.
The greatest markups were for drugs used to treat patients in the areas of critical care sedation and surgery, chemotherapy, emergency care, and anti-infective drugs, he said.
How the FDA Handles Shortages
Currently, the FDA’s approach to drug shortages involves encouraging companies that make a product that is in short supply to ramp up manufacturing. The FDA also works with firms to address problems behind the shortage, such as manufacturing or quality issues. In rare cases, the FDA allows a product from an unapproved source to be imported into the U.S. temporarily, which was the case in 2010 for propofol and in 2011 for foscarnet, norepinephrine, leucovorin, and capecitabine.
Manufacturers have been giving the agency earlier notification about the potential for supply issues, a strategy that the FDA claims has successfully head off some shortages. Such reports have helped prevent 99 shortages so far this year, an increase from 38 in 2010, Dr. Cox said at the meeting. Most of the prevented shortages (84) were derailed by expediting FDA review of new manufacturing sites, suppliers and other issues that affect the drug production.
Other recommendations for resolving, preventing, and alleviating drug shortages now and in the future include creating stockpiles of certain drugs, similar to vaccine stockpiles; developing guidelines on treatment alternatives when there is a shortage of a drug, such as an antibiotic; and improving communications about drug shortages between FDA and stakeholders.
Clinicians need to be notified faster about shortages so they can be better prepared, according to several practicing physicians who spoke at the meeting. Of the hospitals surveyed by the AHA, 70% responded that the available information on how to manage drug shortages was not adequate. Sources for such information include the American Society of Health-System Pharmacists, the FDA drug shortage website, and direct communication with manufacturers.
Dr. Blum, Dr. Cox, and Mr. Mangum had no disclosures. Dr. Lichtenfeld disclosed that he owns Johnson & Johnson stock and that the ACS receives grants from pharmaceutical companies and the foundations they oversee. Disclosure statements for Mr. Hoffman and Dr. Porter were not available.
To report drug shortages, call 888-463-6332, e-mail drug shortages, or go to the FDA drug shortage website. To report shortages of biologic products (such as blood, vaccines, or allergenics), call 301-827-4239 or e-mail CBER shortages.