Rhea Sanborn learned in November that her ovarian cancer had returned for the third time. After the Eliot woman’s oncologist at Maine Medical Center informed her of the devastating diagnosis, he dropped another bombshell.
Supplies of the medication that offered Sanborn the best shot at beating the disease had run out.
“He said the preferred treatment for you at this point in time would be Doxil” combined with another drug, she said. “But the Doxil isn’t available.”
Sanborn was shocked.
“When you find out your options are compromised, you’re surprised,” she said.
About a week ago, Sanborn, a mother to two grown sons, underwent her first chemotherapy treatment for this third round of cancer. She was injected with an alternative drug that’s more toxic, carries additional side effects and must be administered more frequently than Doxil.
“Hopefully that will buy me more time,” she said.
The backup drug also lacks a distinct advantage of Doxil, according to Sanborn’s physician, Dr. Christopher Darus, a gynecologic oncologist at Maine Medical Center.
“There’s no hair loss with Doxil,” he said.
He’s had to inform many of his other patients that his preferred drug for them isn’t available.
“It’s hard to tell patients that,” Darus said. “I tell them the truth. I tell them this is the drug I’d like to give you and I can’t.”
Doxil is among about 18 drugs vanishing from pharmacy and hospital shelves this year, following shortages of 267 medications in 2011, the worst year on record, according to Joseph M. Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists.
“It’s a crisis, and so far we’ve been able to avoid any massive loss of life or suffering, but it’s really only a matter of time until we’re just not able to get product and that has consequences,” he said.
Medications used for anesthesia, pain relief, infections and intravenous feeding are being used faster than drug makers can replace them. This week, news broke that hospitals were on the brink of running out of a critical drug for treating childhood leukemia, called methotrexate.
The principal supplier in Ohio — also the sole worldwide maker of Doxil — shut down after failing a federal inspection.
Federal regulators stepped in to work with manufacturers to boost production of methotrexate, and are considering licensing a foreign company to supply Doxil.
Care rationed, procedures delayed
Many of the drugs in short supply are widely used in hospitals. Almost all of the Maine Hospital Association’s members expressed significant concern about drug shortages in a December poll conducted at the request of U.S. Sen. Olympia Snowe.
“We heard from almost every hospital in the state, and what became abundantly clear is that managing drug shortages wastes a phenomenal amount of time and money, and it detracts from patient care,” Snowe said in a statement.
A survey by a national counterpart revealed similar problems. Nearly every hospital surveyed by the American Hospital Association in June reported dealing with a drug shortage in the previous six months. More than 80 percent delayed treatment as a result.
Often, scarce medications are manufactured by just a few companies, magnifying the impact when a plant runs into production problems, can’t obtain raw ingredients or fails an inspection. The majority of drugs in short supply are injected medications, which require complex manufacturing processes, Hill said. Unexpectedly high demand for a drug can also lead to shortages.
Shortages also result from foreseeable disruptions, such as when drug makers decide to stop manufacturing medicines with poor profit margins. Rather than make costly updates to aging plants, drug makers sometimes phase out older medications without notice.
The scarcity has led providers to ration care, delay treatments and send patients to other facilities, according to Hill.
From 2006 to 2010, the number of drug shortages in the U.S. grew by more than 200 percent, according to a November report by the Government Accountability Office. Over the last decade, most cases represented drugs that ran out more than once, and more than 280 medications were in short supply for an average of nearly two years. The majority of shortages lasted a year or less.
As a result, health care facilities sometimes stockpile supplies, and secondary drug distributors step in to sell the medications at much higher prices. It’s illegal for hospitals to buy drugs from outside the country, though in rare cases drug makers work with the FDA to import medications from foreign manufacturers, Hill said.
While substitute drugs are sometimes available, they can be more expensive. Doctors are also resorting to older drugs that can come with more side effects and troublesome interactions with other drugs, Hill said. Younger clinicians may not be as familiar with those medications, increasing the risk of errors.
“Even in the case where you’ve got something else to turn to, it’s not always ideal,” he said.
Doctors may not learn of a drug shortage until a pharmacist calls up after the patient tries to fill a prescription.
“Generally, most pharmacies will find out about a shortage when they can’t get it,” said John Curran, pharmacy manager for Martin’s Point Health Care.
Drug makers tend to reformulate medications without planning ahead to ensure demand is met, he said.
“A company will wind down their production of the stock but they’re not necessarily forward-thinking enough to ramp up production of the new one so it’s a seamless transition,” Curran said.
Many drug wholesalers have adopted the business practice of “just in time delivery,” he said, which seeks to cut costs by reducing inventory to the bare minimum. That leaves scant flexibility when a drug shortage occurs.
A remedy for shortages
Health providers and pharmacies should know about shortages ahead of time, especially since a notification protocol is already in place for drug recalls, Curran said.
“It needs to be a stronger system, without a doubt,” he said. “You don’t want to make that decision about switching to another medication at the last minute.”
The U.S. Food and Drug Administration requires that drug companies notify the agency of shortages for drugs that are considered “medically necessary,” according to Hill.
“The problem is, there’s no enforcement mechanism if a company fails to report,” he said.
Hill’s organization supports a bill co-sponsored by U.S. Sen. Susan Collins that would mandate prescription drug companies to notify the FDA well ahead of drug shortages. Notification is required now only in cases where just one manufacturer makes a particular drug.
The legislation, introduced this week as an amendment to a federal transportation bill, also directs the FDA to provide timely notification to the public of shortages and steps the agency is taking to address them.
Under a House companion bill, drug makers would be subject to a fine of up to $10,000 for each day they violate the notification requirements, with a cap of $1.8 million.
The FDA prevented nearly 200 drug shortages in 2011 thanks to voluntary early notifications from drug makers, according to Collins’ office. That’s up from 38 in 2010.
“The shortages of these vital drugs are causing serious problems around the country, including forcing some medical centers to ration drugs, postpone elective surgeries, or even modify chemotherapy regimens midcourse,” Collins said in a statement. “Our legislation aims to give the FDA the tools and information they need to prevent drug shortages, and ensure that our hospitals and health professionals are able to provide the best care medical science allows- giving patients the medications they need when they need them.”
Snowe said she also supports legislation for early warnings as a first step, as well as tackling drug hoarding, price gouging and incentives for companies developing new drug production technologies.
A list of current drug shortages is available at fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm