The war on drug shortages

The “War on Drugs” focused on ridding illegal narcotics like crack, cocaine, and heroine from the streets in the 1980's. Now, there is a new type of drug war, one that involves fighting to get the drugs people need.

Medical professionals are at the front-lines of the fight against drug shortages in the U.S.

Deputy Director of the Office of New Drugs at the F.D.A, Sandra Kweder, MD, says “I think the public has a right to be dismayed and outraged.” She says that quality control in manufacturing plans has caused nationwide recalls, and led to massive drug shortages.

According to the American Society of Healthcare System Pharmacists, the number of drug shortages has almost quadrupled over the past few years. In 2005 there were 74 shortages. That number spiked to 267 in 2011.

The problem is not isolated to one particular class of drug, but the majority of shortages are generic sterile injectables. These kinds of medicines are used in everything from nutrition for babies, to surgical anesthesia and cancer treatments.

A government report found that while the injectables make up only a small percentage of the overall prescription drug market in 2011, they still accounted for 74-percent of drug shortages.

Duke University Hospital pharmacist Gene Rhea says some of his colleagues compare the shortages to working in a Third World country.

"On a daily basis, we probably only get in about 60 to 70 percent of the products that we order. It's kind of the new norm," Rhea says for many patients, including ovarian cancer patients on the drug Doxil, the shortages have led to rationing.

“Patients were put on waiting lists and it was a very difficult situation." But Rhea notes that getting Doxil and other crucial drugs back on track will take time, “it’s not going away. It’s really kind of reached a steady state.”

The “steady state” of shortage has baffled many in the medical profession. Reports attribute 15 deaths to the drug shortages, including one man who died because the only antibiotic he responded to was not available to him when he needed it.

Kwedar says it is hard to figure out exactly how many have been affected by the shortages. She estimates the number to be in the hundreds of thousands, if not millions.

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RESEARCH SUMMARY

TOPIC: DRUG SHORTAGE DILEMMA: THE PROBLEM
REPORT: MB # 3531

BACKGROUND: Drug shortages have been an ongoing problem that has spiraled in the last few years with number of drug shortages increasing almost 300% since 2005. 80% of the drugs currently in short supply are generic injectable medications and many patients have been unable to receive their usual drugs. This has been especially hard for those people with cancer because some of the drugs affected were chemotherapy treatments such as Doxil and others used to treat cancer. Both patients and health care providers are in a difficult situation of having to find alternatives for drugs that just are not available at the moment.
MAIN PROBLEMS: The main problems to be affecting the drug shortage seem to be on the manufacturing side which can be difficult because of regulations on how drugs are made, especially for injectable medications. Some manufacturing plants have even been shut down because of multiple problems in the manufacturing process discovered by the FDA. In the case of Ben Venue Laboratories, inspectors found various problems from metal shards in some of the drugs produced on site to a 10-gallon can filled with urine in the storage room. Due to these issues the lab was shut down in November 2011, and Ben Venue was one of the largest drug manufacturing companies in the United States. However, that is an extreme case and many times the difficulties in the manufacturing process are due to how stringent the requirements for making these drugs are.
WHO'S TO BLAME?: Some have put the blame on the Food and Drug Administration (FDA) for the drug shortages because some believe FDA regulations on manufacturing companies in the United States have made it harder and a longer process for the companies to produce the drugs. When discussing the drug shortage, the House Oversight Committee also said that the FDA is partly to blame for the current situation as their regulatory activities have shut down 30% of total manufacturing power at four of the U.S.'s largest producers of generic injectables. However, others claim the FDA is part of the solution, not the problem and that the responsibility for the drug shortages cannot be placed on any one person or organization.
Drug shortages occur, manufacturers report (according to the Food and Drug Administration's website), because of unanticipated increase in demand or due to shortages of raw materials. Also, some companies have experienced quality control and other manufacturing problems that take time to correct. Others have made business decisions to stop making older, less profitable drugs. An article in the New England Journal of Medicine laid much of the blame for cancer drug shortages on the way oncologists in private practice operate. (Source: www.cnn.com, The Huff Post)
ASPE ISSUE BRIEF-Economic Analysis of the Causes of Drug Shortages:
http://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml
Bottom of Form
FOR MORE INFORMATION, PLEASE CONTACT:

Sarah Clark-Lynn
FDA Office of Public Affairs
Drug Shortages Notification and Updates:
drugshortages@fda.hhs.gov

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Andrew McIntosh at amcintosh@ivanhoe.com.


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