Across the country, paramedics and emergency room workers are reaching into their little black bags and drug cupboards and finding them nearly bare. Shortages of critical drugs are occurring so often that the U.S. Food and Drug Administration has created a website with a long list of reasons why drug makers cannot deliver the lifesaving medicines that used to be readily available.



"I would call it an impending crisis," said James J. Augustine, director of clinical operations for Emergency Medical Physicians, a national group that helps hospitals find ER physicians and services. Pediatric epi pens, the convenient epinephrine delivery device that parents reach for when children have allergic reactions, are in short supply,Augustine said. Versed, an anti-seizure medicine, is in critical back order nationwide, and production is suspended. Back orders for several types of Fentanyl, a common pain medicine, won't be filled until at least April, according to Boundtree Medical, which produces a pharmaceutical back-order list.



So far, emergency medical professionals have not documented any cases of patients harmed because of the shortages. But many believe it is only a matter of time. Emergency medical crews work in a structured environment so as to work fast, and they have places in their bags for frequently used medications of certain strengths and concentrations, Augustine said. When a paramedic has to find a drug different from the one that used to be stored in the right-hand bottom compartment of his bag, and it's a dark room and someone is dying in front of him, it's a miracle that someone has not already been badly hurt, Augustine said. "No doubt that people have been hurt, but we've not been able to document it," Augustine said.



Augustine said he planned to speak about the issue at a conference of emergency medical directors in Dallas this weekend."I've been tracking this for a couple of years, and it's become very critical this last year," he said. "In 1997, we had a list of five medicines that we regularly used in emergency medicine that were in short supply. In 2002, that list grew to 20 medicines. In 2011, the list was one page long. "The last list I printed out was four pages long with 250 medicines on it."







Searching for solutions "We really don't know what the cause is," said Jeff Beeson, MedStar medical director. "We're trying to find solutions day to day. "One possibility would be for manufacturers to make fewer concentrations of  the same drug to shorten production runs. Another solution emergency medical providers have explored is getting local pharmacists to compound medications, Beeson said. But such medicines have a much shorter shelf life than mass-produced drugs, Beeson said.



"And that's more expensive by orders of magnitude," said Sabina Braithewaite, medical director at Sedgwick County Emergency Medical Services in Wichita, Kan.  And there is the question of profit. Many drugs in short supply are generics that have been available for decades, cost relatively little to make and aren't very profitable to sell.



Craig Manifold, medical director of the San Antonio Fire Department and assistant professor at the University of Texas Health Science Center at San Antonio, suggested that the most direct solution might be to pay drug makers more to produce certain drugs and so to subsidize production. "I'm sure an economic solution can be arranged," Manifold said. "The public has to have confidence that our primary goal is to ensure patient safety."



His counterparts in other countries are not having the same problems acquiring drugs, he said. Other options include using expired medications that have maintained potency, Manifold said, as well as more resource-sharing among hospitals, ambulance services and other healthcare providers, Manifold said.  Also, first responders are looking to lawmakers, regulators and drug makers to solve the problem for the long term.







But Augustine said he has yet to meet the agency with the power to tell Big Pharma what drugs are needed and when they should be made. "The regulators oversee manufacturing, but drug manufacturing in this country is a very large and complex business," Augustine said.



FDA action



On Tuesday, the FDA announced steps to increase the supply of critically needed cancer drugs and build on President Barack Obama's executive order to help prevent drug shortages. "A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration," FDA Commissioner Margaret A. Hamburg said in a statement. "Through the collaborative work of the FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," she said.



Bob Simonson, CareFlite medical director, said he is living a different reality. "We're feeling the crunch on a daily basis," Simonson said. "What our suppliers can provide us with changes daily. I think this is a public-health issue. We're going to harm someone if this keeps up."



Article by Mitch Mitchell

mitchmitchell@star-telegram.com



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