By Pat Anson, Editor
Millions of dollars in fines and thousands of investigations by the U.S. Drug Enforcement Agency have had a chilling effect on the nation’s drug supply chain, leading to quotas, shortages and legitimate prescriptions going unfilled, according to a new government report.
Pain patients have complained for years that it was becoming difficult to get opioid prescriptions filled, but the DEA called the evidence of that “anecdotal” and said it was not responsibility for any shortages.
In a survey of hundreds of pharmacies, drug wholesalers and physicians by the General Accounting Office (GAO), over half said DEA enforcement actions had limited their ability to supply drugs to patients. Many said they were fearful of being fined or having their licenses revoked by the DEA. Others blamed the agency for poor communication and unclear rules.
“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report states.
In recent years the DEA has fined distributors, pharmacies and practitioners over $94 million for violations of the Controlled Substances Act. Over 4,500 criminal investigations were also launched.
The crackdown helped lead to a reduction in prescription drug abuse and diversion, but it has also disrupted the drug supply chain. The GOA estimates that over half the distributors have placed a strict quota system on the amount of controlled substances that pharmacists and physicians can order.
“A distributor reported it refuses to distribute large volumes of controlled substances to prescribers or pharmacies that specialize in pain management, even if it has no evidence that the prescribers or pharmacies are engaged in diversion,” the GAO said.
One pharmacy chain told the GAO they were “afraid of being the target of DEA enforcement action even if they fill a prescription in good faith.”
Another small pharmacy chain said “we take things to the extreme to the point where we have received complaints from providers for turning away legitimate patients.”
“The DEA has NO communication out to pharmacies at all. The DEA is not preventative, it is all reactive,” one pharmacist complained. “The only experience we get with the DEA is hearing when they investigate and levy fines against a pharmacy for common pharmacy practices.”
The GAO recommended that the DEA improve its communication with distributors, pharmacists and practitioners so they would have a better understanding of what’s expected of them.
In response to the GAO report, a top DEA administrator wrote a letter stating there was only “anecdotal data that patient care is being compromised.”
“The DEA would like to emphasize that it has no authority to control otherwise legitimate business decisions of registrants,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control. “DEA and state partners have repeatedly and emphatically informed distributors that arbitrary thresholds are inappropriate, negatively impact legitimate patients, and are an inadequate substitute for fulfilling their obligations under the CSA (Controlled Substances ACT).”
The GAO report is the second this year to criticize the DEA for its management and policies. In March, we reported the GAO had faulted the DEA for "weak internal controls" and poor management of the system under which controlled substances are produced and distributed. The GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers.
The shortages have grown worse in recent years, according to many pain patients, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.
Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA, while the Food and Drug Administration regulates what conditions the medications can be taken for. The two agencies are supposed to work together when shortages develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”