Tuesday, December 13, 2011

Drug Scarcity’s Dire Cost, and Some Ways to Cope

When Jenny Morrill, who has been battling ovarian cancer since 2007, went to the hospital for her scheduled chemotherapy treatment in June, the nurse greeted her with both good news and bad.
Ellen Weinstein
“She said, ‘The good news is that you’re doing really well on this drug Doxil. The bad news is that we have no Doxil to give you,’ ” said Ms. Morrill, 55. “My jaw dropped.”
Ms. Morrill, a mother and a former arts administrator who lives near Kingston, N.Y., is one of thousands of patients with ovarian cancer, multiple myelomaAIDS-related Kaposi’s sarcoma or other cancerwho were left in the lurch last summer when supplies of Doxil, a chemotherapy drug less toxic than many comparable agents, ran out because of production problems at the only plant that made it.
In recent years, about 7,000 patients in the United States were using the drug at any given time. But by November, the factory had shut down completely.
The shortage has disrupted treatment plans and has upset patients.
“A lot of things can go wrong when you’re in cancer treatment — your white count can go down, you can become too frail to get treatment, the chemo can stop working. One of the things you never consider is that treatment might just not be available,” said Ms. Morrill, who has suffered from severe nausea since being switched to another chemotherapy drug.
“It’s like you’re out in the ocean and the guy on the lifeboat says, ‘Sorry, they ran out of life rings.’ ”
Doxil is hardly the only drug disappearing from pharmacy and hospital shelves. More than 251 drugs have been in short supply this year, including about 20 chemotherapy agents, according to the American Society of Health-System Pharmacists, which has been tracking the problem.
The vast majority are generic injectable medications widely used in hospitals, including drugs used to relieve pain, fight cancer or infections, anesthetize surgical patients, treat cardiovascular disease and manage psychiatric conditions. Critical intravenous nutritional supplements and oral drugs for controlling diabeteshigh blood pressure and attention-deficit hyperactivity disorder are difficult to find, said Cynthia Reilly, the director of practice development at the pharmacists’ organization.
Roslyne Schulman, a director of policy at the American Hospital Association, said: “This is very serious. This is a public health crisis. The shortage cuts across all treatment categories. It affects bread-and-butter drugs that hospitals have depended on for many years.”
Nearly all hospitals in an A.H.A. survey in June reported that they had struggled with one or more drug shortages in the previous six months, and nearly half had experienced shortages of more than 20 drugs. Three out of four hospitals reported rationing or restricting drugs that were in short supply.
The scarcity drives up health care costs as hospitals turn to more expensive substitutes and must spend time and money teaching staff how to use unfamiliar drugs. The risk of medical errors and complications also increases, experts say; many procedures have been delayed or canceled.
A number of complex factors have contributed to the shortages, according to Ms. Reilly, who called the situation a “perfect storm.”
Recent consolidation in the pharmaceutical industry has reduced the number of factories; most of the drugs in short supply are made by just one or two companies. That means greater repercussions when any single plant experiences production problems, cannot obtain ingredients or fails an inspection, as happened with Doxil.
Shortages often beget more shortages as health facilities stockpile supplies. Prices often spike when unethical distributors take advantage of the panic.
Indeed, some observers have blamed manufacturers of generic drugs, suggesting that they are trying drive up prices. But industry representatives say their business is to sell in large quantities.
“It’s to our advantage not to have shortages and to keep the products flowing,” said Ralph G. Neas, the president and chief executive of the Generic Pharmaceutical Association. “We sell affordable medications at a very good prices. We have to do more of that, not less.”
Most of the missing drugs are generic simply because the vast majority of drugs in use are generic, he said.
The shortages will not be solved easily, most experts believe. “There is no silver bullet,” said Maya J. Bermingham, assistant general counsel at the Pharmaceutical Research and Manufacturers of America, a trade group.
The consequences for patients can be varied and unexpected.
While alternative drugs are usually available, they may pose hazards. Physicians who turn to a second- or third-line drug may be less familiar with dosing and side effects. They are often unaware of the shortages and may be caught by surprise, increasing the risk of a medical error.
The substitute drugs also may be more toxic for frail, elderly or very young patients or — for pain medication, in particular —take longer to work.
Second-choice anesthesia drugs can lead to longer hospital stays because patients may not wake up as quickly, said Dr. Jane C. Fitch, the vice president of the American Society of Anesthesiologists.
“For procedures that can be put off and don’t have to be done right then and there, some patients have made the decision to wait and defer the surgery,” Dr. Fitch said.
Substituting a brand-name drug for a generic is also likely to drive up the patient’s out-of-pocket costs.

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