National drug shortages reach Hawaii

Mililani resident Deborah McDonald receives chemotherapy treatments every three weeks to keep at bay the cancer that doctors predict could end her life in two to five years.

Unbeknownst to McDonald, 48, the dose of a specialized chemotherapy drug she uses was cut by 75 percent due to a nationwide shortage of critical cancer drugs.

The shortage — which includes antibiotics for severe infections, anesthetics for surgery, and pain medications — is affecting Hawaii patients and in some cases has become life-threatening when drug regimens are changed or delayed. The situation also has driven up the cost of drugs in short supply because of price gouging by gray-market wholesalers.

"The last thing I need to worry about is shortages," said McDonald, a former Waikiki mail carrier who was diagnosed with stage 4 colon cancer in 2009. She testified last week at a legislative hearing at the state Capitol before the Senate Health Committee. "It upsets you, and for cancer patients you don’t want to be stressed out. It’s discouraging. It’s just always in the back of your mind."

The Hawaii resident of 27 years is moving to the mainland today in part because of concerns over future shortages and "to do the best I can to hopefully live 10 years."

Just how many Hawaii patients have been affected by the drug shortage is unclear. Sen. Josh Green, a Hawaii County emergency room physician and chairman of the Senate Committee on Health, said at least 13 patients in Hawaii were affected by a shortage of the chemotherapy drug Doxil, which is made by Johnson & Johnson. Green chaired the hearing at which McDonald spoke.

President Barack Obama issued an executive order Oct. 31 directing the U.S. Food and Drug Administration to "broaden reporting of potential shortages, speed up regulatory reviews that can help prevent or respond to shortages," as well as "examine whether potential shortages have led to illegal price gouging or stockpiling."

"Shortages of pharmaceutical drugs pose a serious and growing threat to public health," Obama said in the order. "The number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent."

Reasons for the shortages include a scarcity of raw materials, voluntary recalls based on product purity, industry consolidations and business decisions based on low profit margins for some drugs, said William Loui, chief of oncology at the Queen’s Medical Center, testifying at the legislative hearing.

"These are lives at stake. Youhave patients who might not get the best care they can and might suffer because we don’t have pain medication or might die because of ineffective therapy for cancer," Loui said. "It’s been a very frustrating, trying time for many doctors. We’re scrambling."

Green, the Hawaii island senator, said he called the fact-finding legislative hearing last week to connect pharmaceutical manufacturers to health care providers, insurers and patients to find a solution.

The maker of Doxil, in a statement submitted for the hearing, said the main reason for the short supply of the drug is equipment failures.

"Such equipment failures require investigation and repair, sometimes resulting in the shutdown of entire production lines, which is the case of Doxil," said Janssen Products LP, a subsidiary of Johnson & Johnson.

Green is proposing that the state put pressure on pharmaceutical companies through the purchasing of drugs for about 500,000 Hawaii government workers, retirees, dependants and Medicaid recipients to ensure they make the medicines available. Green said that could be accomplished through administrative rules or legislation.

"I want guarantees (pharmaceutical companies) will get us the medications that are promised, otherwise they don’t get our business," he said. "I’m personally gravely concerned that a shortage developed that prevented people from getting the chemotherapy that they needed. Some constituents contacted me that they were in the middle of a chemo course and had to change drugs."

On the federal level, Green said he has begun to contact Hawaii’s congressional delegation to recommend possible legislation that would require some redundancy in the production of drugs to guarantee no single manufacturer causes a national shortage.

The "innumerable shortages" are getting worse, said pharmacist Stuart McElhaney, owner of The Pillbox Pharmacy in Kaimuki.

"It’s just nonstop — more than we’ve ever seen," McElhaney said. The shortages "result in increased prices, and unfortunately the payers who pay us don’t increase reimbursement to the same degree as the prices go up. So the providers (hospitals and pharmacies) end up losing money."

McElhaney said the across-the-board shortages affect every class of drugs, including topical agents.

"Some drugs just go up a couple bucks; then you get things that have gone up tenfold," he said. "The last six months just have been horrific."

"The worst part about these shortages is not the economics, but the fact that the care is suffering," McElhaney added. "People don’t get the products that they’ve been stabilized on and that have worked for them. In certain cases, if they have to switch drugs, it makes the problem worse."

Green said the problem came to a head this year with the shortage of Doxil, which affected about 7,000 individuals nationwide, including 2,500 who were placed on a waiting list.

"A waiting list is not where you want to be when a doctor tells you that you have cancer and need medicine," Green said.