Monday, December 23, 2013

Drug shortage list climbs to 300+. What are hospitals, politicians, manufacturers doing about it?

The prescription drug Dopamine is so valuable to Dayton Children's Hospital that what is left of its dwindling supply is kept in a vault, accessible only by the medical center's pharmacists.
The drug isn't the only one proving difficult to keep in stock; it is one of hundreds in short supply nationwide.

"When you start hearing about life-saving medications not being available, that gets really scary," said Nancy Severt, pharmacy operations manager at Dayton Children's.

Drug shortages have been commonplace for years, but the problem has grown more serious at hospitals and Emergency Medical Service agencies. According to the U.S. Food and Drug Administration, 56 drug shortages were reported in 2006; by 2011, the number had climbed to 251. The FDA's list includes drugs that have "the greatest impact on public health."

Reasons for increased shortages include fewer manufacturers as some exit the market; quality-control issues and scrutiny by the FDA, which can shut down production; product recalls; increased demand; and a lack of raw materials.

The vast majority of drugs deemed to be in short supply are produced by generic drug companies. For example, 64 entries were logged on the American Society of Health-System Pharmacists web site the week of Dec. 9. Thirty of the hard-to-get drugs were made by drug giant Hospira, a suburban Chicago company that recently pledged to invest $1 billion in its operation.

The ASHP site currently has more than 300 entries listed under "current shortages." Updated daily, the list includes recognizable names such as heparin, DTaP vaccine, dextrose and caffeine. It also includes exotics such as the black widow anti-venom.

"Do we have a shortage of stuff that matters? Yes, we do. There's some stuff (on the list) that scares the hell out of me," said Ernest Boyd, executive director of the Ohio Pharmacists Association.
Dan Gueth, director of pharmacy at Miami Valley Hospital, said he grapples with drug shortages virtually every day.

"It's been a nightmare over the last two years," said Gueth, who has been on the job since 1985. "I might have 10 products on my list, but it's likely I'm going to be told about another back order and we have to scramble."

Scramble mode
Hospitals have buyers who search for additional supplies from drug manufacturers, wholesalers and other medical centers when shortages persist.

But sometimes, as with the dwindling supply of Dopamine at Dayton Children's, extreme measures are put in place.

"We have vials of it and make up drips specifically for that patient," Servert said of the drug which sustains blood pressure in critically ill patients. "We're down to probably five vials of Dopomine. We were able to get the adult version of premix bags, so just to make sure it doesn't get intermixed with anything else I've got it locked up in a vault that only the pharmacists can access."

The hospital also worries about electrolytes and other injectables used to make formula to feed babies. It also faces decisions on what patients get certain pain medications when they are not in abundant supply.

Sometimes, care-givers have to pivot when a drug is discontinued. That was the case in the spring when the supply of the popular sedative chloral hydrate ran out after two drug companies stopped making it in the past five years.

"The doctors liked the way it acted, they liked the way it didn't linger for hours and hours," Severt said. "The drug companies were making it, but the demand wasn't very high so they decided, 'We're not selling enough to make any money.' Our institution was very reliant on it.

"We had to start ordering it as a raw powder, so our doctors had to find alternatives. Now ... we do our own testing, compounding and make sure we have a viable shelf life for it."

Propofol, the anesthetic made famous in the investigation of the death of pop icon Michael Jackson, currently is produced by a single company. It is a drug Severt says is in "critical shortage" nationwide and at Dayton Children's, which has to administer the drug in smaller doses required for kids.
"We might use 5-to-10 milliliters out of a 20-milliliter vial. So we'd have a vial that we'd barely use and we'd have to remind our anesthesiologists to throw it out. We can't reuse it.

"(The shortage) has been going on so long it seems like common practice now."

At Miami Valley, Gueth can rattle off a handful of drugs whose availability concern him, despite his pharmacy's buying power as part of Premier Health. For hospitals, shortages can mean extra cost.
"We have a national contract with our GPO (group purchasing organization) to keep our costs low, but when a product becomes unavailable I might have to pay a higher cost," he said.

Dayton Children's is part of a network of more than 30 hospitals that work together to monitor shortages and make timely purchases.

"As soon as I know it's short in Dallas, I start shopping for that product," said Kevin Myers, the hospital's pharmacy purchasing manager.

Experts say the so-called "gray market" is one of the factors that is driving up prices. Manufacturers generally sell their products to wholesalers, which then sell to hospitals. But secondary wholesalers also buy drugs and charge higher prices 0n the drugs they buy.

"The gray market, in which companies are charging up to 1,704 percent more for a product than what a facility would have to pay, definitely needs to be monitored and price-gouging eliminated," said Donna Smith of Arizona-based Avella Specialty Pharmacy.

A bill designed to clamp down on the gray market is pending before a House subcommittee.

Hospitals aren't the only ones being squeezed by drug shortages. First-responders have fought shortages for years.

Pain-killers such as Morphine and Fentanyl are staples in ambulances and medical helicopters. But there's no guarantee the drugs will always be available.

"If you've got the biggest bone in your body, the femur, broken in a car crash, and we're taking you down the road and there are a couple of potholes, you want something for pain -- you deserve something for pain," said David Gerstner, president of the Greater Miami Valley Emergency Medical Services Council. "There have been times where we might not have it."

Gerstner said 23 hospitals supply drugs to 118 member agencies in the region through the Drug Bag Exchange Program. After first-responders administer a drug, they take their bags to a hospital for refills.

But sometimes they can't get there fast enough.

"We had some drug bags with no drug to treat seizures," Gerstner said. "So the saying became that the only drug we could use to treat seizures was diesel fuel. Put them in the back of the medic and run like hell to the hospital."

Dr. Carol Cunningham has served for nearly 10 years as state medical director for the Ohio Department of Public Safety Division -- EMS. She constantly worries about running out of injectables used to care for cardiac resuscitation, pain control and the management of seizures.

"It happens every week, there is something short," she said.

Closing down
Manufacturers leaving the business reduces the supply of some drugs. The Ben Venue Laboratory in suburban Cleveland ceased production and is shutting down due to quality-control issues. Its closing will not only cost the small town of Bedford more than 1,000 jobs, it will mean one fewer big player in the drug business.

One of the drugs previously made at Ben Venue was Doxil, a popular cancer-fighting injectable. Ben Venue was the only plant in the U.S. that made the drug, but an ongoing shortage was softened when a company in India gained FDA approval earlier this year to produce a brand-name substitute and a generic version of the drug.

"For a while, (Doxil) was restricted by the manufacturer," Miami Valley's Gueth said. "The company would only ship it if you had a patient that had already been started on the product. Oncologists in the area that may have wanted to start a patient on Doxil but couldn't had to use alternative chemotherapy agents."

Quality-control issues are the most prevalent reason for drug shortages. According to the FDA, manufacturing issues and delays or capacity issues accounted for 77 percent of sterile injectable shortages in 2012. Increased demand triggered 7 percent of shortages, as did discontinuation of products.

"The economic downturn in 2008 precipitated the issue. Manufacturers cut back on spending and some drugs that didn't make money were discontinued, and as a result the production shortages became exaggerated," said Robert Weber, Administrator for Pharmacy Services at the Ohio State

University Wexner Medical Center and Assistant Dean in the College of Pharmacy.

Generics and savings
Generic drugs save consumers big money -- $1.3 trillion in the past decade according to the Generic Pharmaceutical Association. But they also undercut brand-name drugs, which can lead to shortages if the brand-name drug companies cut production.

Drug patents expire after 20 years, but exclusive marketing rights can expire much sooner, leaving a small window for brand-name products to reap big profits to fund research and development.

Exclusivity, according to the FDA, was "designed to promote a balance between new drug innovation and generic drug competition."

"Generic companies -- Bedford, American Regent -- jump in and start making a product when it comes off patent," Dayton Children's Myers said. "That reduces the price, and all the sudden they have problems manufacturing it. It just disappears."

Generic companies also undercut each other, which leads to lower profit margins. Still, some think they should see past the bottom line.

"I believe that manufacturers have a moral and ethical responsibility to continue making lifesaving drugs or drugs that can medically alleviate a severe disease, and to make them affordable for patients and payers when possible," Smith said. "However, many times the shortage is out of their control, and any negative economic impacts cannot be dismissed."

Generic drug-makers contacted for this story would not make executives available to answer questions. A Hospira spokesman said the company is "investing hundreds of millions of dollars to help prevent future shortages," and is working to increase capacity at existing facilities, build additional capacity (Hospira is adding a plant in India), and strengthen its supply chain.

More production would be good news for Myers, who used to see a couple drug reps every day. Now he sees that many in a week.

"I had a Bedford sales rep that came in every week and she's gone. American Regent, she's gone. They have nothing to sell," he said. "They're keeping a low profile because they don't like to get pounded. When they come in here, we're all over them because we need the product."

Expiration dates
One solution that could ease the drug shortage problem is more lenient expiration dates. The dates are set by the drug companies, but some health districts around the country have extended them on some products. That could only happen in Ohio if all medical agencies agreed.

Proponents of such a policy say there is no harm in using drugs that are nearly full strength.

"I've always felt the expiration dates are for the benefit of the companies," Boyd said. "Does sugar become cheese after three years? If it's packaged properly, it's not going to deteriorate. I wouldn't do it with insulin or anything that has to be refrigerated, but the majority of the stuff we put in tablets is not."

There is a program already in place that allows for the use of expired drugs. The U.S. Department of Defense's Shelf Life Extension Program, launched in 1986, extends the dates on some drugs in the federal stockpile. Those drugs must be tested periodically by the FDA, a cost most public agencies could not stomach.

The Ohio Department of Health distributed a survey this fall to all EMS agencies asking for a list of drugs critical for medical care, with an eye on pushing for more flexible expiration dates.

"The frustrating thing for us as physicians is the manufacturers determine the expiration date, not the FDA," Cunningham said.

"Even if they're 95 percent effective, if that's the only thing out there and if you have one of those conditions -- you're in cardiac arrest or you're having a seizure or real pain -- do you really care if it's 95 percent, as long as it's not contaminated?"

Effective drugs taken off shelves when they hit their expiration dateraise medical center costs.
"You can't flush them down the toilet or throw them in the trash, so we're paying to get rid of something we'd like to keep that's still good and useful, and in some places we don't have a replacement for it," Gerstner said. "This makes sense how?"
FDA policy
The FDA wants d
rug companies to give earlier notice when production lags. The Food and Drug Administration Safety and Innovation Act, signed into law in July 2012, requires manufacturers to report drug stoppages or delays at least six months in advance of the action.

The agency is taking comments until Jan. 4 on a rule that would expand the list of drugs that fall under that reporting law.

The FDA does not have the power to order companies to make drugs, but it says it works with firms that manufacture similar drugs, asking them to increase production to prevent or reduce the impact of shortages.

Meanwhile, hospitals and first-responders search for alternatives if their first choice is not an option, at times putting patients in harm's way.

"I've heard in the past few years of surgeries being postponed or cancelled because of certain meds not being available," Boyd said. "I wouldn't be scared to ask your hospital in advance if they have the meds you need."

Drugs that stop bleeding, check cancer and sedate patients are not the only products pharmacists worry about. Basic formulas are in short supply, too.

"Sodium bicarbonate was a huge one," Dayton Children's Severt said. "That's baking soda. We just can't get it in a sterile injectable form because the company decided to stop making it."

-- Drugs in short supply
The American Society of Health-System Pharmacists lists more than 300 drugs on its drug shortage bulletin. Here are some of the drugs on the list, with their uses and comments from Miami Valley Hospital Director of Pharmacy Dan Gueth:

Atropine: Used to stabilize heart rate after heart attack or during surgery.
Status: Currently an anticipated shortage through 2015; getting allocations, repackage multi-dose vials into single-dose syringes to preserve supply at times.

Caffeine & Ergotamine Tartrate: Caffeine injectable formulation for headache.
Status: Has been unavailable for two years; have been using alternative agents.

Epinephrine injection: Emergency treatment for severe allergic reactions.
Status: Very limited supply; constantly scrambling to find product to meet our needs; MVH has never run out.

Dextrose 50% injection: Pure form of sugar often used to help diabetics.
Status: Currently available again; previously, shortage required MVH to repackage from large-volume solutions to smaller 50-ml syringe.

Glycopyrrolate: Treats peptic ulcers, dries mouth for surgery.
Status: Currently an anticipated shortage through 1st quarter 2014; atropine being used as alternative agent although it is in short supply, also.

Heparin infusion bags: Blood thinner that prevents clots in blood vessels.
Status: MVH has switched vendors and formulation multiple times to address shortages over the past two years.

Methylergonovine: Used to stop hemorrhaging post-delivery.
Status: Getting limited supply; will utilize oxytocin if supplies exhausted.

Nicardipine: Used for hypertension and for neuro-critical care patients.
Status: Supply issues have forced us to bounce back and forth between premix bag and vials that require mixing components; requires more staff time when we mix the components.

Prochlorperazine: Used for severe headache in ER, although caffeine was original agent of choice.
Status: Unavailable for a long period of time; recently available again but very limited supply.

Propofol: Sedative for surgery and other procedures.
Status: Currently only manufactured by one company; Hospira's inability to supply (plant shutdown) creating pressure on one vendor to meet demand; currently meeting our demand with allocations.
Watch our exclusive video of how staff at Miami Valley Hospital uses technology to better monitor drug supplies at

"It's been a nightmare over the last two years. I might have 10 products on my list, but it's likely I'm going to be told about another back order and we have to scramble."

Dan Gueth, director of pharmacy, Miami Valley Hospital

"It's been a nightmare over the last two years. I might have 10 products on my list, but it's likely I'm going to be told about another back order and we have to scramble."

Read more:

No comments:

Post a Comment