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By Casey Christie / The Californian
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By Casey Christie / The Californian
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By Casey Christie / The Californian
BY KELLIE SCHMITT Californian staff writer firstname.lastname@example.org
Hall Ambulance had run out of an important drug to treat seizures, and John Surface wasn't taking any chances on the next best substitute.
"I called the supplier and said, 'How much Versed do you have left?" said Surface, manager of the ambulance division. "I said, 'Send it all.'"
He bought the supplier's last 55 boxes about three weeks ago, which may be enough to stock local ambulances until April. But Surface is still juggling dwindling supplies of other prescription drugs, and bracing for more shortages to come.
"From a paramedic's standpoint, the day is going to come when we won't be able to move stuff around," Surface said. "And that's going to affect patient outcomes."
The nationwide prescription drug shortfall is not only impacting ambulance supplies but also stressing Bakersfield hospital pharmacists, who must monitor drug lists daily and search for possible substitutes.
Local health experts say the worst effect may be on cancer patients who aren't able to receive promising drugs treatments at critical moments.
"It's a big issue and it's continuing to get worse," said Dr. Ravi Patel, founder of Bakersfield's Comprehensive Blood & Cancer Center. "In certain situations, it does compromise patient care."
A GROWING PROBLEM
In the past couple of years, the nation's drug shortage problem has escalated dramatically, with more than 230 different medications affected last year compared to just 61 in 2005, according to U.S. Rep. John Carney, D-Delaware.
Earlier this month, Carney and Rep. Larry Bucshon, R-Indiana, introduced legislation that would require the Food and Drug Administration (FDA) to expedite the review process for the most vulnerable drugs; give the FDA more flexibility in addressing manufacturing problems; and develop an earlier notification system when shortages arise.
The legislation follows an October executive order from President Barack Obama that directed the FDA to take action in response to the shortages. That order also asks the FDA to work with the Department of Justice to examine whether the shortages have led to illegal price gouging or stockpiling.
A simple reason for the growing shortage is hard to pinpoint. A 2011 FDA report cited problems at drug manufacturing facilities, delays in manufacturing or shipping and ingredient shortfalls as key causes.
Some industry experts point to overregulation, while others emphasize pharmaceutical consolidation. Others fault speculators who may hoard medications to drive up prices.
A piece in the New England Journal of Medicine blamed the simple economics of pricier brand-name drugs vs. their cheaper generic alternatives: "If manufacturers don't make enough profit, they won't make generic drugs."
The shortages are already impacting patient care, in part because using unfamiliar alternatives can increase the probability of errors, according to a recent report from The Institute for Safe Medication Practices. A quarter of clinicians surveyed reported that an error occurred at their site because of drug shortages.
But perhaps the most alarming impact is on patients who are no longer able to receive what could be life-saving drug treatments.
One of those patients is Bakersfield resident Jim Smith, 65, who was diagnosed last year with multiple myeloma, an incurable cancer of the blood cells. Smith, an avid gardener, golfer and wine aficionado, suddenly found himself housebound, fatigued and without a sense of taste.
For Smith, remission could mean driving again, going to the store and working part-time from home. But the best hope for remission may be a drug that's currently not available: Doxil.
Around the time Smith was diagnosed last year, Doxil joined the list of unavailable drugs. Even though it could return as soon as later this year, Smith is missing treatment during an early stage of his cancer, a time during which remission could be more likely, said his wife, Lana Smith, a nurse.
When her husband of more than 40 years was diagnosed, Lana stayed up until the early morning hours, researching every aspect of his cancer -- and the elusive drug that could treat it.
"The doctors caution people that there is a market in the third world, but that's not safe either," she said. "You wouldn't want to take a chance unless someone was in the late stages."
Bakersfield patient Joan Goertzen, 63, has also struggled with similar issues for her multiple myeloma. She was able to go into remission for nearly five years. But, in November, disappointing test results spurred her doctor to recommend Doxil.
Like with the Smiths, though, that suggestion came when Doxil was no longer available in the United States. Her daughters located supplies in Canada, which ultimately wasn't feasible given medical regulations.
"It was very frustrating to me and my daughters," she said. "It was a real scary time."
Last month, Goertzen's doctor put her on the same chemotherapy regime she'd had before and it appears to be working --for now.
"My prayer is I won't need Doxil until a much later date when it will hopefully be back on the market," she said.
Even when alternatives do work, though, there can be undesirable side effects, said Patel of the CBCC. He's seen alternative drugs cause problems with bowels, hair loss or the nervous system.
In the midst of the shortages, he's frequently had to substitute drugs or simply remove one component from a patient's program -- the effects of which may not be known for some time.
Repercussions on patient care are more immediate for Hall Ambulance's drug supplies, Surface said.
The shortage first hit home last fall when he couldn't get magnesium sulfate, which is used for asthmatics, muscle relaxation or to stop pre-labor. Hall is currently running low on supplies of Fentanyl, a strong painkiller that nurses administer in airlifts and critical care ambulances. Morphine is a possible substitute, but now there's an alert on that, too.
"Running out of substitutes -- that's where we're headed," Surface said. "It's made us nervous for awhile."
Surface's most pressing concern centers on the medications that can be used to treat seizures, which can be a daily occurrence. Valium is out, Versed's supply is dwindling and the paramedics aren't approved to administer the next best alternative: Ativan.
Dr. Robert Barnes, the county's Emergency Medical Services' medical director, will be writing a letter to the state this month requesting expedited permission for paramedics to use that drug in ambulances.
"We're saying, 'We have a problem,'" said Ross Elliott, the county's EMS director. "Waive your normal procedures and let us have it right away."
Otherwise, the procedures for expanding what drugs paramedics can administer could take months.
"In most cases, it would end up being a hardship on patients," Elliott said. "If a paramedic isn't able to secure an airway for a patient who is seizing, it could be life-threatening."
At Kern Medical Center, senior clinical pharmacist Ryan Gates meets with the hospital's pharmacy buyer every day to discuss which drugs are low, and concoct a plan for substitutions. They study a "gigantic" list coded in green, yellow and red based on availability.
While the shortage has existed for the past couple of years, it's intensified in recent months -- especially for a trauma center that relies on painkillers that may be coded red.
"Healthcare is under strain, and adding another layer of complexity to patient care is challenging," Gates said.
To cope, local hospitals have turned to cooperation, calling around to obtain and offer up necessary drugs to keep each other afloat.
"If they're calling for Fentanyl, and we have four bags, we can't," Gates said. "But if we're sitting on a stockpile, we have an ethical obligation to share."
Patients in the hospital aren't aware of the behind-the-scenes jockeying, and don't play a role in the decisions, Gates said.
Tina Martin, KMC's pharmacy buyer, checks four different drug reports daily. Since the shortages hit, she's been spending four to six hours a day keeping up relationships with vendors, checking online and making phone calls.
She also gets emails from about two dozen "secondaries," distributors that sell back-ordered drugs often at dramatically raised prices. Last week, she saw a medication for hypertension that normally goes for $3.50 marked up to $34 for one injection.
With a tight county budget, though, Martin said she is "very frugal" and has only rarely purchased from secondary distributors.
Along with hefty price increases, drug expiration is also an issue when buying on the so-called gray market, said Brian Hartley, an account manager for Bound Tree Medical, a licensed wholesale distributor.
Hartley's company buys prescription drugs directly from the manufacturer and sells to places such as Hall Ambulance. Adding additional players to the supply chain means the patient's prescription may have a shorter shelf life.
"There's so much compromise currently going on, which has led to some shortages, inflation in prices, and, most importantly, delivery of products with short expiration dates," he said. "There will be a day of reckoning."
Over at Bakersfield Memorial Hospital, staff also receives emails from secondary distributors, but tries to avoid their inflated offers, said pharmacy director David Lozano.
"We have in the past but we really try not to," he said. "The hospital works on a small margin so we have to try and keep costs down."
Lozano attributes the hospital's stocking success so far to a buyer who is "ahead of the curve."
"I walked into her office yesterday and told her how much I loved her," Lozano said, laughing. "We were in desperate mode: Are we going to get them or not?"
When there's a limited amount of a certain drug, Lozano meets with physicians to discuss which patients should receive it, and who can handle an alterative. Those conversations are hard, though he imagines the most difficult might be for cancer patients -- the ones everyone agrees are shouldering the worst of the crisis.
Jim Smith, the Bakersfield multiple myeloma patient, will find out this week if his current drug regime was enough to push his body into remission. If it wasn't, he said he won't be able to avoid thinking: What if he had been on Doxil?
"It will just take longer, which is sad," Smith said. "But what can you do?"