Pharmacies facing critical drug shortages

Pharmacies facing critical drug shortages

March 6th, 2011 by Emily Bregel in News

POLL: Have you been affected by the pharmaceutical drug shortage?

Local pharmacists are coping with the worst drug shortage in their memories, affecting medicines that range from antibiotics and pain medications to anesthetics and life-saving chemotherapy drugs.

"It's almost like, what drugs haven't been affected?" said Dustin Smith, pharmacy operations manager at Erlanger Health System.

The national shortage is the largest in decades, forcing hospitals to seek out alternatives to the drugs to which they are accustomed. Pharmacies are scrambling to track down those replacements, advise their doctors about the new availability and train medical staff on new dosage requirements for alternative drugs.

"It's the worst [shortage] we have encountered, at least in my experience," said Frank Bradford, pharmacy director at Parkridge Health System who has been in the business for three decades.

Pharmacists say the problem has grown more acute over the past year, and there's no easy fix.

In 2004, the American Society of Health-System Pharmacists recorded 58 reported drug shortages. In 2010, the total was 211, said Bona Benjamin, director of medication use quality improvement for the American Society of Health-System Pharmacists.

The shortages are rooted in complex factors including consolidation among drug companies, leaving fewer alternatives for a particular drug when one company exits the market, and quality issues throwing kinks into production of certain drugs.

Some drug companies also are opting out of the less-profitable generic drug market, leaving those cheaper drugs more vulnerable to shortages.

Thus far, local hospitals say the shortage hasn't affected patient care here, though errors involving replacement drugs and even some patient deaths have been reported nationally.

Looking ahead, though, some patient safety advocates have raised concerns that acute shortages of some critically needed drugs could lead to rationing and, ultimately, potential life-and-death decisions.

In recognition of the shortage, a bill has been introduced in Congress to require more notice from manufacturers when a drug shortfall is anticipated.

The U.S. Food and Drug Administration, which assures the safety of the nation's drugs, medical devices, food supply and other products, can't force manufacturers to continue making a drug or boost production.

And right now, oversight of shortages is decentralized at best.

"There really isn't anything set up officially in the U.S. to help manage these shortages," said Sandy Vredeveld, pharmacy director for Memorial Hospital.

Drug shortages are by no means unheard of, but the sheer number of drugs affected today means even second-line, backup drugs are sometimes also scarce, said Allen Vaida, executive vice president of the Institute for Safe Medicine Practices, a national nonprofit devoted to preventing medication errors.

"There's always going to be drug shortages for some reason or another. It's just right now, there are just a lot of them and a lot [involving] critical drugs," he said.


A national drug safety group also is also warning about the risk of medication errors resulting from clinicians using unfamiliar drugs in response to a shortage.

Errors and even four patient deaths resulting from shortages were reported in a national survey conducted in September by the Institute for Safe Medicine Practices.

About one in four surveyed reported actual errors resulting from the shortage. One in five reported adverse patient outcomes, according to the survey of 1,800 practitioners.

One reported death - (survey doesn't say location) resulted from an infection that couldn't be treated because the right antibiotic wasn't available. One patient died from a tenfold overdose of epinephrine when a nurse used a higher-concentration solution, assuming it was the hospital's typical low-concentration dose.

"People are having to use drugs they're not familiar with," said Benjamin. "Our pharmacists are very frustrated. We've heard about errors; we've heard about deaths; we've heard about parents upset because their kids can't get their chemotherapy."

Shortages of chemotherapy drugs could lead to ethical dilemmas, Vaida said.

"You have to start rationing. Who's going to get it, who's not going to get it?" he said.

Local hospitals say it hasn't come down to those kinds of choices here.

Like other hospitals, Parkridge has experienced a major shortage of the leukemia treatment cytarabine, a chemotherapy agent, but has been able to track down enough to fill patient needs thus far.

"We actually had to go to sources all over the country just to obtain enough for a single dose," Bradford said. "Actually, we have exhausted [he supply] at the moment," though the manufacturer has said the drug will be back in production next month.

Although doctors have expressed frustration with not being able to have their first-choice treatments, the shortages haven't harmed patient care, they said.

"We have not had any errors here attributed to the shortage, but we have tried to be proactive with education," said Vredeveld.


Currently, drugs including the blood-thinner heparin, various chemotherapy treatments, antibiotics for drug-resistant bugs and the pain medicine morphine are among the shortages.

"It's made our jobs more creative. You've got to be able to think on your feet and be able to figure out what to do," said Joy Longley, clinical coordinator for Erlanger's pharmacy. "You can't very well say, 'Sorry, we're out.'"

Critical shortages

Among the more than 200 drug shortages identified nationally that are being felt locally are:

• Heparin, blood thinner

• Chemotherapy agents, including cytarabine, doxorubicin and etoposide

• Antibiotic sulfamethoxazole (brand name Bactrim)

• Amikacin, antibiotic for highly drug-resistant bugs

• Anesthetics Propofol and succinylcholine

• Levophed for patients with critically low blood pressure

Source: Local pharmacists, American Society of Health-System

Typically, hospitals get their drugs from a wholesaler, but if the wholesaler is out, hospital leaders go directly to the manufacturer or find a secondary supplier that sells hard-to-find medicines - at an expensive premium, pharmacists said.

A few years ago, a penicillin shortage, now resolved, took Erlanger by surprise, Smith said. High demand met with sudden short supply and resulted in the price skyrocketing, he said.

"Penicillin went all the sudden from $2 a vial to $20 a vial," he said. "Penicillin's been around since World War II, and all of a sudden you can't get it."

A surprising shortage of a basic component in IV solutions, a concentrated form of sodium chloride, has compelled pharmacists to mix solutions on their own or contact local compound pharmacies to mix the solutions on an as-needed basis.

Tim Glascock, president of Surgery Pharmacy Services in St. Elmo, said he's seen increased demand from hospitals asking him to mix up emergency doses of IV solutions they usually buy in bulk from a wholesaler.

Glascock also has had to be careful with his supply in the face of shortages.

"I've never had to scramble and always know my inventory as much as I have this past year," he said.

Local hospitals also have turned to one another in times of desperation.

"When there's emergent need, we help each other out," said Rodney Elliott, purchasing agent for Memorial Hospital's pharmacy.


Greater scrutiny of quality from the FDA and drug companies' internal quality inspections have led to manufacturing disruptions when contaminants are found on the production line.

Consolidation among drug companies has heightened the problem.

"It's just like the airline industry. There are lots and lots of mergers now. They're bigger, and there are fewer of them," Vredeveld said.

For some drugs, only one or two companies are responsible for their manufacture, and if one of those exits the market or has production problems, the other company can struggle to meet demand alone, Benjamin said.

Canada and some European countries are facing shortages for many of the same reasons, she said.

Critical shortages of Propofol, a fast-acting sedative used during surgeries - and the drug implicated in Michael Jackson's death - began in late 2009, when two of the three companies that manufacture the drug had to halt production because of quality issues, according to the FDA. The third company has been unable to keep up with demand on its own.

"The top issue is quality problems in the manufacturing process," Benjamin said. "The good part of it is that [drug manufacturing] firms have internal quality programs that are detecting these issues before the drug gets out to the market."

In the meantime, the FDA temporarily has approved the use of an equivalent - but unapproved - drug from Germany to help fill demand from hospitals, Benjamin said.

The FDA can't force manufacturers to continue making a drug or boost production, but patient-safety experts say if drug companies would at least give hospitals and pharmacists as much warning as possible about impending shortages, that would allow for better planning to find alternatives and train staff.

Legislation called "The Preserving Access to Life Saving Medications Act," introduced last month in the U.S. Senate, would compel drug companies to give the FDA early warning when there could be a shortage on the horizon. They would have to give the FDA six months' notice of intent to discontinue a drug.

Benjamin said she doesn't see shortage issues relenting anytime soon, but advance notice will at least help pharmacists cope.

But Bradford of Parkridge worried that early warning of an impending shortage could become a self-fulfilling prophecy.

"I honestly think what would happen is it would cause everyone to try to stockpile and make the shortage even worse," he said.