In October, President Barack Obama signed an executive order aiming to reduce the current shortage of several critical medications, including a number of drugs used by anesthesiologists to sedate patients and control pain. The order enhances the Federal Drug Administration's oversight, calls for drug manufacturers to report manufacturing disruptions and expedites regulatory reviews.
Unprecedented shortages
The executive order came on the heels of a period of time with an unprecedented level of drug shortages, says Robert Farrar, MD, JD, vice president of medical affairs for Somnia Anesthesia and former director of cardiothoracic anesthesiology and vice chairman of the department of anesthesiology at Lower Bucks Hospital in Bristol, Pa. A December report by the Government Accountability Office, for example, found a record number of 196 drug shortages were reported in 2010; that number reached 267 in 2011, according to the University of Utah Drug Information Service, which tracks national drug shortages. Additionally, a survey by the American Hospital Association last summer found 99.5 percent of hospitals reported a shortage of at least one drug over a six month period.
Although shortages of certain chemotherapy drugs have gained the most attention from mainstream media, several different types of drugs ranging from antibiotics to pain medications have also been affected by shortages, including some of the medications most preferred by anesthesiologists. Dr. Farrar reports this can have a negative effect on patient care and hospital ratings, since pain control plays a large role in patient satisfaction.
Several classes of drugs frequently administered by anesthesiologists are affected, including narcotics, sedatives, muscle relaxants and adjunctive agents, says Dr. Farrar. For example, fentanyl, a "staple" narcotic, is currently experiencing a severe shortage, and many centers only have a few months supply of the drug on hand, he says. Additionally, the shortage has caused the cost of fentanyl to skyrocket, up from around 40 cents to $8 dollars a vial. Other narcotics, including morphine and Demerol (meperidine), are also increasingly more difficult to come by, meaning both preferred and alternative drugs are affected.
Midazolam (or Versed), a sedative widely used by many anesthesiologists, and popular alternatives Lorazepam and Diazepam are also affected by shortages. As are succinylcholine and pancuronuim, both muscle relaxants, and the adjunctive agents such as Lidocaine. Epinephrine (or adrenaline), crucial in patient resuscitation, and hypnotic agent Diprivan (propofol) are also in short supply.
How did theses shortages become so pervasive? The causes of the shortages are "multifactorial," including any combination of the following problems: manufacturing delays, production stoppages, shortages of raw materials, quality concerns and/or surging demand, says Dr. Farrar.
Dealing with drug shortages
Hospitals and anesthesia groups have no choice but to deal with these shortages and to ensure, to the greatest extent possible, optimal outcomes. "Anesthesiologists are trained to know the best drugs for the most appropriate cases and patients. When less optimal drugs are used, outcomes may include longer recovery stays, post-anesthesia nausea and vomiting, longer wake-up times and a decrease in patient satisfaction," says Dr. Farrar. He also notes all of these consequences can drive up costs.
To mitigate these issues, Dr. Farrar recommends hospitals and managers of anesthesia programs educate anesthesiologists about potential shortages and instruct clinicians to be very judicious with medications, using alternatives when necessarily. "Doctors are used to reaching for a drug and having it be there," he says. "Practitioners at the boots-on-the-ground level need to be more aware of these shortages."
He also encourages providers to work together to address shortages, as this is the best way to impact care. "It must be a shared burden; no one hospital or surgery center can address drug shortages alone," he says. "Providers must work together to reallocate resources." He points to how healthcare facilities stock Dantrolene, the only available treatment for malignant hypothermia, as a great example of "shared burden." Because Dantrolene is so expensive, many hospitals and surgery centers only have the first course of treatment available at each location. Because the condition is rare, if a case does present, a nearby facility with additional courses of the medication in stock shares its supply with the facility in need.
Finally, Dr. Farrar encourages anesthesiologists and other healthcare workers to take action at the grassroots level by contacting their lawmakers and explaining the need for government action regarding drug shortages. The American Society of Anesthesiologists has done a great job of garnering support for the issue, he says, but every individual familiar with the issue should also get involved.
"This is an unprecedented time for us in healthcare in general, and we're faced with a number of challenges, including drug shortages; however, challenges always present opportunities, and this is a time for us to proactively deal with a negative issue by enacting legislation and taking steps to ensure our supply of critical and anesthesia medications are subjected to a more transparent processes," he says.
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Unprecedented shortages
The executive order came on the heels of a period of time with an unprecedented level of drug shortages, says Robert Farrar, MD, JD, vice president of medical affairs for Somnia Anesthesia and former director of cardiothoracic anesthesiology and vice chairman of the department of anesthesiology at Lower Bucks Hospital in Bristol, Pa. A December report by the Government Accountability Office, for example, found a record number of 196 drug shortages were reported in 2010; that number reached 267 in 2011, according to the University of Utah Drug Information Service, which tracks national drug shortages. Additionally, a survey by the American Hospital Association last summer found 99.5 percent of hospitals reported a shortage of at least one drug over a six month period.
Although shortages of certain chemotherapy drugs have gained the most attention from mainstream media, several different types of drugs ranging from antibiotics to pain medications have also been affected by shortages, including some of the medications most preferred by anesthesiologists. Dr. Farrar reports this can have a negative effect on patient care and hospital ratings, since pain control plays a large role in patient satisfaction.
Several classes of drugs frequently administered by anesthesiologists are affected, including narcotics, sedatives, muscle relaxants and adjunctive agents, says Dr. Farrar. For example, fentanyl, a "staple" narcotic, is currently experiencing a severe shortage, and many centers only have a few months supply of the drug on hand, he says. Additionally, the shortage has caused the cost of fentanyl to skyrocket, up from around 40 cents to $8 dollars a vial. Other narcotics, including morphine and Demerol (meperidine), are also increasingly more difficult to come by, meaning both preferred and alternative drugs are affected.
Midazolam (or Versed), a sedative widely used by many anesthesiologists, and popular alternatives Lorazepam and Diazepam are also affected by shortages. As are succinylcholine and pancuronuim, both muscle relaxants, and the adjunctive agents such as Lidocaine. Epinephrine (or adrenaline), crucial in patient resuscitation, and hypnotic agent Diprivan (propofol) are also in short supply.
How did theses shortages become so pervasive? The causes of the shortages are "multifactorial," including any combination of the following problems: manufacturing delays, production stoppages, shortages of raw materials, quality concerns and/or surging demand, says Dr. Farrar.
Dealing with drug shortages
Hospitals and anesthesia groups have no choice but to deal with these shortages and to ensure, to the greatest extent possible, optimal outcomes. "Anesthesiologists are trained to know the best drugs for the most appropriate cases and patients. When less optimal drugs are used, outcomes may include longer recovery stays, post-anesthesia nausea and vomiting, longer wake-up times and a decrease in patient satisfaction," says Dr. Farrar. He also notes all of these consequences can drive up costs.
To mitigate these issues, Dr. Farrar recommends hospitals and managers of anesthesia programs educate anesthesiologists about potential shortages and instruct clinicians to be very judicious with medications, using alternatives when necessarily. "Doctors are used to reaching for a drug and having it be there," he says. "Practitioners at the boots-on-the-ground level need to be more aware of these shortages."
He also encourages providers to work together to address shortages, as this is the best way to impact care. "It must be a shared burden; no one hospital or surgery center can address drug shortages alone," he says. "Providers must work together to reallocate resources." He points to how healthcare facilities stock Dantrolene, the only available treatment for malignant hypothermia, as a great example of "shared burden." Because Dantrolene is so expensive, many hospitals and surgery centers only have the first course of treatment available at each location. Because the condition is rare, if a case does present, a nearby facility with additional courses of the medication in stock shares its supply with the facility in need.
Finally, Dr. Farrar encourages anesthesiologists and other healthcare workers to take action at the grassroots level by contacting their lawmakers and explaining the need for government action regarding drug shortages. The American Society of Anesthesiologists has done a great job of garnering support for the issue, he says, but every individual familiar with the issue should also get involved.
"This is an unprecedented time for us in healthcare in general, and we're faced with a number of challenges, including drug shortages; however, challenges always present opportunities, and this is a time for us to proactively deal with a negative issue by enacting legislation and taking steps to ensure our supply of critical and anesthesia medications are subjected to a more transparent processes," he says.
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