Pharmaceutical shortages due in part to Drug Enforcement Agency inefficiency jeopardize the treatment of millions of patients every year.
The agency missed annual deadlines from 2001 to 2014 for it to respond to drug manufacturers’ requests for permissible production quotas for controlled substances necessary for many of their products, especially generic prescription painkillers, according to a Government Accountability Office report. The DEA limits the amount of such substances manufacturers can make in any given year in order to control illegal distribution.
“In the last decade, shortages of prescription drugs containing controlled substances, such as narcotics and stimulants, have increased nationwide, preventing providers and patients from accessing essential medications for treatment,” the accountability report said. The DEA “has not effectively administered the quota process that limits the amount of controlled substances available for use in the United States.”
Regulated painkillers alone accounted for more 259 million prescriptions in 2012, according to the CDC. During shortages of drugs containing controlled substances “patients may receive less effective care, experience medication errors or not receive treatment at all,” the accountability office report said.
For example, if a shortage requires an alternative anesthesia medication, “patients can experience longer recovery times, delayed awakening, or postoperative nausea or vomiting,” the report said. People have also died in cases where morphine substitutes were needed.
Additionally, the shortages are extremely expensive, requiring additional or diverted staff for management. Shortages cost hospitals $216 million annually, according to a University of Michigan study.
The DEA allowed several deficiencies that may have contributed to drug shortages, including the agency’s failure to provide drug manufacturers with their annual quotas for controlled substances by the required deadlines.
The DEA’s tardiness “does not provide manufacturers with enough time to plan for production and order the raw material,” the accountability report said.
Also, when manufacturers requested more of a controlled substance midyear to prevent or mitigate a shortage, it took the DEA an average of 58 days to respond. The agency’s lengthiest such delay was five months.
The agency blamed its failure to meet deadlines on inadequate staffing due to being unable to hire qualified staff able to pass employment background checks.
Another issue was the inability of the DEA to collaborate with the Food and Drug Administration, which reports drug shortages.
The DEA assumes the FDA doesn’t properly investigate the legitimacy of manufacturer-reported drug shortages due to a “lack of trust,” the accountability report said, though the FDA provided the accountability office with its in-depth vetting process.
“Given such barriers to coordination, DEA and FDA cannot effectively act to prevent or alleviate shortages,” the report said.
The two agencies have a memorandum of understanding, but it remains unrevised since the 1970s. Executives from the agencies have been discussing an update for more than two years.
The agencies do have a memorandum of understanding intended to prevent such issues, but it hasn’t been updated since the 1970s. A revision was started more than two years ago and has yet to be finalized.
Also, the two agencies disagreed over what defined a drug shortage. Contrary to the FDA, the DEA only counts a deficit if there’s an inadequate supply of a controlled substance, rather than a specific pharmaceutical.
The DEA views drugs with the same substances as “viable substitutes for one another, even when the drugs are different strengths,” the report said, a perspective disputed by providers, manufacturers, and the FDA.
In fact, the DEA renounced any responsibility of shortages, claiming that the agency plays no role in the business decisions manufacturers make regarding the type, amount and strength of drugs it chooses that could help lead to a deficit.
However, accountability office director of health care Marcia Crosse said DEA’s data collection on quotas and shortages was unusable to determine the agency’s role in a deficit.
“We obtained data from the DEA that we were hopeful would let us see what role the quota might have played, but the data weren’t reliable,” she said. “We weren’t going to report on data that we couldn’t trust.”
The DEA offered objections to the accountability office’s conclusions, but was unclear if it would follow the recommendations made in the report.
“We do not know what actions they’re going to take or not take,” she said.
Also, the audit’s completion “was delayed significantly because of DEA’s refusal to comply with our requests for information,” the accountability report said.
