Blumenthal targets drug shortages, "gray market" hoarding
Blumenthal targets drug shortages, "gray market" hoarding
Wednesday, January 4, 2012
Treatment for Susan Block's ovarian cancer required doctors, drugs and, critically, the intervention of a U.S. senator.
The West Hartford woman was two days away from her fourth course of chemotherapy this summer when she learned that the drug was not available, causing her to miss the treatment.
The drug Block needed, known as doxil, is among the potentially lifesaving drugs that have become frequently unavailable, the result of drug shortages that are vexing doctors, patients and policymakers.
"The very thing that was buying me time was taken away," said Block, 72, a healthy, avid cyclist, gardener and yoga instructor before her diagnosis. "The very thing that was giving me hope was withdrawn."
Block tried on her own to find doxil, even planning a trip to England to get the drug there. She was finally able to continue the treatment after calling Sen. Richard Blumenthal's office, which got in touch with the drug maker and ensured that Block could get her doses. Blumenthal said his office has taken similar action for a handful of other constituents.
On Wednesday, Block -- now healthy and back to her active life -- and Blumenthal spoke of the need for a broader solution to drug shortages.
"It may well be that the government has to stockpile or build reserves of these medications, much as it does for petroleum, where we have a strategic petroleum reserve," Blumenthal said during a news conference at Hartford Hospital. He noted that many of the shortages involve generic drugs with lower profit margins and sterile injectable drugs that can be more complicated to manufacture.
The first-term Democratic senator also called for a Department of Justice investigation into potential price gouging and price fixing, and said he thinks there's evidence that some distributors hoard the drugs, keeping them off the market before selling them at inflated prices.
Nationally, the number of drug shortages in the country has increased substantially since 2006, with a record 196 shortages reported in 2010 and 146 in the first 6½ months of 2011, according to the Government Accountability Office. The average shortage over the past decade lasted more than nine months, and many involved anesthesia, chemotherapy and anti-infective drugs.
The GAO reviewed 15 cases and attributed many of them to manufacturing problems, such as a manufacturer shutting a facility to make improvements that took longer than expected, and disruptions in the supply of ingredients. Often, other problems exacerbated the primary causes of the shortages, the review found.
Connecticut hospitals have also experienced increases in drug shortages in recent years, according to the findings of a survey Blumenthal presented. Those that are commonly in short supply include doxil, the generic anesthetic propofol, acetaminophen injections used in pain management, the chemotherapy drug cytarabine and epinephrine syringes that are often used for asthma attacks, cardiac arrest and allergic reactions.
Dr. Amy K. Brown, director of gynecologic oncology at Hartford Hospital, said there have been shortages in the past year of the top three drugs used for ovarian cancer, which are also used to treat endometrial and cervical cancers. Often, she said, the shortages are unpredictable and come with little warning, requiring patients to delay treatment or get a less-than-ideal alternative. It's often not clear if the drug will be available soon enough that the patient could wait rather than take another drug, she said.
"As a physician, it is disheartening to have to tell a patient we know what your best chance (is), but we can't give it to you, we have to give you an older drug, we have to give you a second choice, or we have to give you a newer drug but we don't really know if it's going to work as well," Brown said.
The shortages lead physicians to have to prioritize among patients to determine who are too sick and need to get the best drug and who are healthy enough to tolerate the potential side-effects of an alternative drug, she said.
Just as bacteria can develop resistance to antibiotics if patients don't take their full dose, Brown said cancer cells can become resistant to chemotherapy drugs if a patient doesn't receive a full course, making the need to switch drugs in the middle of treatment especially problematic.
"It's not safe and it's not the best care for these patients," she said.
Shortages have become so routine that Brown said she now learns about them from a regular "drug shortage update" from the Hospital of Central Connecticut, which is part of Hartford Hospital's network.
Michael Rubino, Hartford Hospital's pharmacy director, said shortages have been intense for the past two years. In addition to manufacturing and raw material issues, he said, some likely stems from increased compliance audits by the Food and Drug Administration, which have led to more manufacturers being shut down in recent years. Generic injectable drugs in particular can have low profit margins that make some companies less interested in making them, reducing the number of suppliers if one company has a shortage.
Most of the drugs affected are those that hospital pharmacies buy, rather than drugs consumers get from their local pharmacies, Rubino said.
At the hospital, Rubino said, pharmacists try to find out as soon as possible what drugs are facing shortages, and buy ahead of time those that they suspect will become scarce. They can try to borrow drugs from other hospitals that have more, or try to find other manufacturers or wholesalers. But when they get down to just over a week's supply, the pharmacists meet with the medical staff to discuss alternatives.
Many of the shortages Hartford Hospital has faced were for anesthesia drugs, and they nearly caused the hospital to stop performing elective surgeries. "We never got to that, but it got very close," Rubino said.
Drug shortages can pose a risk to patient safety. Even if doctors are familiar with an alternative drug they're using, they could be more likely to make errors with the dose, Rubino said. And switching to alternative drugs often costs more, raising health care costs.
In a statement Wednesday, John J. Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the factors behind drug shortages are "complex and multidimensional," and that pharmaceutical companies and the organization are working to find ways to avoid and address the problem.
"In the instance a shortage is anticipated, an innovator or generic manufacturer is encouraged to notify the FDA in order to address, avert and mitigate drug shortages," he said.
"In the event there is a discontinuation of sole source, medically necessary drugs, companies are required to inform FDA six months in advance. Manufacturers have stepped up the voluntary reporting of anticipated events that might lead to drug shortages, and according to the FDA, in 2011, this early notification helped prevent 99 shortages."
Like Blumenthal, Castellani pointed to a "gray market" for drugs, citing secondary wholesalers that price gouge. He said drug providers who get drugs through the "gray market" can't be assured that the products have been handled properly, raising concerns about patient safety.