Dec. 22--For at least two years, emergency responders working in the Middletown Division of Fire, have worried what drug they could run out of next.
Because of drug shortages that have plagued pharmacies nationwide, departments like Middletown have had trouble at times buying drugs such as dextrose, a sugar water used to treat diabetic patients, or Narcan, a life-saving antidote that reverses a drug overdose.
This week, it was morphine, the drug used to soothe injured patients while an ambulance carts them to the hospital, that's on the short list. All six bags that Middletown's EMS crews carry contain a dose of morphine and Todd Day, who oversees Middletown's EMS crews, has one vial for back-up.
But if the department uses it all anytime soon, Day isn't sure how quickly he could stock up again.
"If we're out, we just can't get it," Day said. "It's typically not a drug that's going to be a life or death drug. That just means there will be a little more pain and suffering until they get to the hospital."
Drug shortages have been commonplace for years, but the problem has grown more serious at hospitals and Emergency Medical Service agencies.
There were 56 drug shortages in 2006 on the U.S. Food and Drug Administration's list. That number climbed to 251 by 2011. The FDA's list includes drugs that have "the greatest impact on public health." Two forms of morphine are currently on the list.
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 American Society of Health-System Pharmacists' website has more than 300 entries listed under "current shortages." Updated daily, the list includes recognizable names such as DTaP vaccine, dextrose and caffeine. It also includes exotics such as the black widow antivenom.
"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.
Hospital patients generally are unaware of the behind-the-scenes moves and manhours required to keep critical drugs in supply, but the problem stresses pharmacists and drug buyers on a daily basis.
Dan Gueth knows what awaits him every day when he reports to work at Miami Valley Hospital, which is part of the network that owns Atrium Medical Center in Middletown. As the Director of Pharmacy, he's guaranteed to be dealing with drug shortages.
"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 supply from drug manufacturers, wholesalers and other medical centers. But shortages persist.
Care-givers sometimes have to pivot when a drug is on hold for production. That was the case this fall when a drug commonly used after surgeries called glycopyrrolate wasn't being made, said Bob Roberts, director of pharmacy for Fort Hamilton Hospital. Doctors had to use a second-choice alternative drug. In some drug shortage cases, doctors even consider rescheduling surgeries until a drug is back on the shelf, just to be safe.
"The last three to four years have been the worst I've ever seen it," Roberts, who has been in the field for more than two decades, said of the shortage. "A lot of us are scratching our heads. We're practicing medicine like we're in a third-world country at times. It's kind of like having milk in the fridge, you expect it to be in there every day."
Propofol, the anesthetic made famous in the investigation of the death of pop icon Michael Jackson, currently is produced by only one company. It is a drug that's in a "critical shortage" nationwide and at Dayton Children's Hospital, in part because it is packaged for adults and doesn't come in the small doses required for kids, said Nancy Severt, the Pharmacy Operations Manager at Dayton Children's Hospital.
"(The shortage) has been going on so long it seems like common practice now," she said.
At Miami Valley, Gueth can rattle off a handful of drugs that 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.
Experts say the "gray market" drives up prices for some drugs. Manufacturers generally sell their products to wholesalers, who sell to hospitals. But secondary wholesalers also buy drugs and charge much higher prices.
"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 Avella Specialty Pharmacy, which is based in Arizona.
Politicians in Washington have taken notice -- a House bill introduced in May was designed to clamp down on the "gray market." It currently is in the Subcommittee on Health.
'We might not have it'
First-responders, who start out with limited supplies, have fought low drug supply for years, only to find they've been worsened by a rash of recent shortages.
David Gerstner, president of the Greater Miami Valley Emergency Medical Services Council, 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 that doesn't mean they might not run out of a drug in the middle of the night.
"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. But if you're continuing to seize, that has tremendous detrimental long-term effects on the brain."
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," he said. "There have been times where we might not have it."
Emergency responders, like hospitals, have to seek out alternatives for medications that aren't available. When dextrose was on the drug shortage list, Day his crews in Middletown were forced to carry a glass vial, needle and a syringe to administer the drugs. For years, the crews have used a pre-filled syringe, but that form wasn't available.
"Even (Dextrose), which is sugar water, you wouldn't think that would be a problem," Day said. "That's critical for a diabetic patient."
Closing down
Shuttered manufacturers means less drugs in supply. The Ben Venue Laboratory in suburban Cleveland recently ceased production and is in the process of 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 that was 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."
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
The rise of generic drug-makers has had an unmistakable impact on medicine. Generics save consumers big money -- $1.3 trillion in the past decade according to the Generic Pharmaceutical Association.
They also undercut brand-name drugs, which can lead to shortages. 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 their research and development departments.
"Generic companies -- Bedford, American Regent -- jump in and start making a product when it comes off patent," Dayton Children's Kevin Myers, the purchasing manager for the hospital's pharmacy, said. "That reduces the price and all the sudden they have problems manufacturing it. All of the sudden, it just disappears.
"You always wonder how did Company A on the brand product supply the whole country, but these (generic) companies can't supply. Insurance companies drive you to the cheapest product."
Generic companies also undercut each other, which leads to lower profit margins.
Generic drug-makers contacted for this story would not make executives available to answer questions. A spokesman for Hospira, a suburban Chicago drug giant that produces 30 of the hard-to-get drugs currently listed on shortages, said the company is "investing hundreds of millions of dollars to help prevent future shortages," and working to build space at new and existing facilities.
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.
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.
Dr. Carol Cunningham, the state medical director for the Ohio Department of Public Safety Division -- EMS, is not giving up on pushing back expiration dates. The Ohio Department of Health distributed a survey this fall to all EMS agencies asking for a list of drugs that are critical for medical care, with an eye on pushing the discussion forward.
"The frustrating thing for us as physicians is the manufacturers determine the expiration date, not the FDA," Cunningham said. "If you were to test certain drugs, as long as they're stored properly, and you test it past the expiration date, the majority are therapeutically effective.
"Even if they're effective 95 percent, 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?"
Drugs that might remain useful are taken off shelves when they hit their expiration date. That comes at a cost to medical centers.
"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 policies
The FDA doesn't have the power to order companies to make drugs but it does want the 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.
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. "It's nothing I'd be scared of, asking your hospital in advance if they have the meds you need."
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