By Pat Anson, Editor
Poor oversight by the U.S. Drug Enforcement Agency has led to a sharp increase in shortages of some prescription drugs – including many opioid painkillers – according to a new government study that calls the shortages “a risk to public health.”
The lengthy report by U.S. Government Accountability Office (GAO) faults the DEA for “weak internal controls” and poor management of the quota system under which controlled substances are produced and distributed.
Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants. All of the drugs belong to a class of medications that affect the central nervous system and are used to treat seizures, manage anxiety, and relieve pain.
The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was in short supply over the course of four different shortages, with a combined duration of over eight and a half years.
“While we cannot establish a causal relationship between shortages of drugs containing controlled substances and DEA’s management of the quota setting process, the shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.
The shortages have only grown worse in recent years, according to many pain patients, physicians and pharmacists, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.
The DEA has blamed major pharmacy chains such as CVS and Walgreens for some of the shortages, claiming the companies made a “business decision” not to fill as many prescriptions for opioids, after they were fined tens of millions of dollars for violating rules for dispensing controlled substances.
But even small, independent pharmacies have complained that controlled substances are harder to obtain. In a 2013 survey of over 1,000 pharmacists, the National Community Pharmacists Association (NCPA) found that most had experienced delays of at least one week in obtaining shipments of painkillers and other controlled substances.
“Community pharmacists repeatedly cited having their supplies or shipments of controlled substances abruptly shut off by their wholesalers, which may have done so due to perceived pressure, intimidation or a lack of clear guidance from law enforcement officials, such as the Drug Enforcement Administration,” said B. Douglas Hoey, CEO of NCPA, which represents over 23,000 independent pharmacies.
Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA under a quota system to discourage diversion, while the Food and Drug Administration regulates what conditions the medications can be taken for. Drug manufacturers are required every year to apply to the DEA for quotas to make their drugs, but according to the GAO the DEA rarely responds in timely manner.
“Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs,” the GAO said.
The DEA and FDA are supposed to work together when shortages of controlled substances develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”
The inter-agency rivalry has at times led to finger pointing.
“DEA officials also said that they do not believe FDA appropriately validates or investigates the shortage information it posts on its website and that posting this information encourages manufacturers to falsely report shortages to obtain additional quota. However, FDA reports that it takes steps to investigate and confirm the shortages on its website,” the GAO report states.
The GAO recommended the DEA perform periodic data checks to better manage the quota process, improve the processing of quota applications, and do a better job coordinating with the FDA on how to handle drug shortages when they develop.