Ken Terry | March 17, 2015 www.medscape.com
The US Drug Enforcement Agency (DEA) and the US Food and Drug Administration (FDA) should work together more closely to prevent shortages of prescription medications containing controlled substances, said a blistering new report from the General Accountability Office (GAO). The DEA should also improve its process for authorizing quotas of the controlled substances used in these drugs, the report recommends.
Shortages of prescription drugs containing controlled substances have increased in recent years, the report notes. Of the 168 shortages from January 2001 to June 2013, nearly 70% began after 2007. Shortages lasted nearly a year on average. Many shortages involved generic pain relievers and drugs with only one manufacturer.
Of the 168 shortages, 87 were identified as critical. More than half of those drug shortages involved analgesics. There were also shortages among this group of antianxiety drugs, sedative hypnotics, and stimulants, among others.
According to the FDA and organizations representing patients and providers, the GAO said, these shortages can lead to less effective care, no treatment, and/or medication errors. Providers spend time and resources mitigating the effects of drug shortages instead of taking care of patients.
One cause of these shortages, pharmaceutical companies charge, is the amount of time it takes the DEA to approve controlled substance quotas. The DEA has created these quotas for each class of controlled substances and for each manufacturer of drugs containing these agents to prevent their diversion to illegal uses.
According to the GAO report, the DEA did not respond to manufacturers’ quota applications within the time frames required by the agency’s own regulations for any year from 2001 to 2014. Even after the DEA implemented an electronic system to streamline this process in 2011, the report said, it took an average of 58 days to respond to quota applications in 2011 and 2012.
The DEA denied that its lack of adherence to its own quota application processing time frames has caused shortages of drugs, the report said. But the FDA data on the causes of 40 shortages of drugs containing controlled substances from January 2010 to 2013 showed that seven of these shortages “were caused by problems related to quota,” the report notes. Other shortages resulted from factors such as manufacturing delays, capacity issues, and product quality issues.
The GAO made several recommendations to improve the DEA’s management of the quota application process and to avoid future drug shortages. Among other things, the GAO advised the DEA and the FDA to update their existing memorandum of understanding, which has not been revised since the 1970s.
There is bipartisan interest on Capitol Hill in combatting the increasingly serious problem of medical drug shortages. Sen. Charles Grassley (RIA) and Sen. Sheldon Whitehouse (DRI) commissioned the GAO report in 2012, and next month, Grassley and Sen. Dianne Feinstein (DCA), the leaders of the Caucus on International Narcotics Control, are scheduled to hold a hearing on the report’s findings.
Negative Effect on Healthcare
Leaders of medical societies whose members are especially dependent on prescribing drugs containing controlled substances told Medscape Medical News that shortages of these medications have grown steadily worse in recent years.
“We are seeing regular and increasing shortages of these drugs,” said Beverly Philip, MD, vice president of scientific affairs for the American Society of Anesthesiologists. She cited a 2011 society survey of anesthesiologists showing that 90% of respondents reported they were currently experiencing a shortage of least one anesthesia drug, and that 98% had encountered a shortage within the past year.
As a result of these shortages, 49% of patients experienced a less optimal outcome (eg, postoperative nausea and vomiting), the survey found, and the same percentage of patients had longer operating room or recovery times than they otherwise would have had.
“When one of these drugs go on shortage, we have to look for alternatives,” Dr Philip noted. “That’s not easy, because there are drugs in the same class, but they’re just not the same. They have different strengths, different doses, they last different amounts of time. So we don’t have interchangeable drugs.”
The current shortage of midazolam, a drug commonly used to relax patients before they have surgery, shows how this problem affects patients, Dr Philip said. There are other drugs in the same category but they are much longer acting, which is not good for the patient, she noted.
Emergency department physicians have less of a problem finding substitutes for most controlled substance drugs, said Robert O’Connor, MD, a member of the board of the American College of Emergency Physicians. “If there’s a shortage of morphine, we can use something else to replace it. What has alarmed our members is where a particular drug is the only one in the class and there’s no real substitute for it.”
He cited etomidate, a sedation agent that is often used in emergency department procedures involving dislocated shoulders or fracture reductions. “There is no real substitute for it, and we’ve had to use less efficacious agents,” he said, adding that patients may suffer as a result. “You may not achieve the desired level of sedation when you’re putting somebody’s shoulder back in place because you don’t have the proper drug.”
The shortages of analgesics and sedatives also affect patients and physicians in ambulatory care, observed Lynn Webster, MD, past president of the American Academy of Pain Medicine.
“It compromises our ability to give the patients what they need,” he said. “You have to look for an alternative, and sometimes the alternative is not as effective and may also have side effects. It also takes a lot of time, and it adds to the level of frustration for physicians and patients.”
Moreover, he said, some shortages have led to patients not getting the medications they need. “We’ve seen a trend over the past 3 years of physicians not treating or trying to avoid treating patients with opioids. We’ve seen that with the upscheduling of hydrocodone. It’s a hassle factor, and physicians are just throwing up their hands, and patients are the ones who suffer.”
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Credit: GAO Report Claims DEA to Blame for Many Drug Shortages. Medscape. Mar 17, 2015.