While prescription drugs have legitimate purposes and are safe when taken as directed, they also pose a risk for abuse and addiction, as well as diversion for illicit use, a director with the U.S. Government Accountability Office (GAO) said.
The situation creates a difficult journey ahead for the U.S. Department of Justice’s Drug Enforcement Administration (DEA), which plays a key role in carrying out the Controlled Substances Act (CSA).
“DEA faces a significant challenge in simultaneously ensuring the availability of controlled substances for legitimate use while limiting their availability for diversion and abuse,” Linda Kohn, director of Health Care at the GAO, told American Pharmacy News.
Nationally, in fact, the Centers for Disease Control and Prevention has declared that the United States is in the midst of an epidemic of prescription drug overdose deaths, with most deaths attributable to prescription opioid pain relievers. The ongoing abuse is costing health insurers more than $72 billion a year, according to various studies.
At the federal level, Kohn said, multiple agencies have responsibility for addressing aspects of this problem through prevention, treatment and enforcement activities, in particular the DEA, which must enforce the statute.
Thus, GAO was asked to review how DEA registrants – distributors, pharmacies and practitioners – interact with DEA and if DEA enforcement actions “have struck the right balance between reducing diversion and ensuring access to prescription opioids for legitimate medical needs,” she said.
In a report released in June, the GAO says that DEA must strengthen its interaction with the pharmacy industry to better manage the availability of controlled substances, Kohn said.
“Adequate DEA communication and guidance for its registrants is essential to help ensure that registrants are able to take actions that prevent abuse and diversion, but do not unnecessarily diminish patients’ access to controlled substances because of their uncertainty about how to appropriately meet their CSA roles and responsibilities,” she said.
Through four nationally representative surveys of DEA-registered distributors, individual pharmacies, chain pharmacy corporate offices, and practitioners, the GAO found that more information from DEA could help registrants improve how they carry out their roles and responsibilities under the CSA, Kohn said.
“Our surveys showed that registrants who interacted with DEA were generally satisfied with those interactions, but many registrants were not aware of various DEA resources,” she said.
Kohn pointed out several examples, including:
• While most pharmacies knew about DEA’s Pharmacist Manual, the document was last updated in 2010 and doesn’t reflect more recent changes in DEA enforcement practices or regulations, such as the rescheduling of hydrocodone.
• Chain pharmacy corporate offices reported getting inconsistent responses from DEA field office staff, such as widely varying interpretations of DEA requirements.
• Most distributors surveyed -- 36 of 55 -- said they needed more communication and information from DEA, such as more training related to their regulatory roles and responsibilities.
• An estimated 70 percent of practitioners said they were not aware of DEA’s Practitioner Manual.
And while the GAO found that survey respondents think that DEA enforcement actions have helped decrease prescription drug abuse and diversion, such as pharmacies checking more on the legitimacy of a prescription or practitioners asking patients more questions, registrants also said they have changed certain business practices as a result of DEA enforcement actions or the business climate these actions subsequently created, Kohn told American Pharmacy News.
For instance, she said that more than half of distributors placed stricter limits on the quantities of controlled substances that pharmacies could order and these limits ultimately affected the pharmacies’ ability to supply drugs to those with legitimate needs.
In its report, the GAO has recommended that DEA implement a means of regular communication with registrants; to solicit input from various registrant groups on their information needs; and to develop additional guidance. Additionally, the GAO will follow up “at least annually” with the agency to assess whether action has been taken to implement the recommendations, Kohn said.
“This particular report is unique in its focus on getting the perspectives and input directly from the registrant groups,” she said. “Our nationally representative surveys permit results to be generalized for a national picture of how the key players interact with one federal office. So this report provides one more piece of information to a very large and complex problem.”
The full GAO report is available online at: http://www.gao.gov/products/GAO-15-471.
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