GAO IDs 3 ways DEA can improve communications with pharmacists, manufacturers
WASHINGTON - The lack of effective communications between the Drug Enforcement Agency and both pharmaceutical distributors and chain pharmacy headquarters has impacted legitmate access to pain medicines, according to a report released by the United States Government Accountability Office on Monday. Both distributors and retail pharmacies still request improved guidance and a greater degree of interaction with the DEA, though the agency does not concur, the report noted.
"Without more registrant awareness of DEA resources and adequate guidance and communication from DEA, registrants may not fully understand or meet their CSA roles and responsibilities," the GAO noted.
GAO recommended the DEA take three actions to improve communication with and guidance for registrants about their CSA roles and responsibilities:
Identify and implement means of cost-effective, regular communication with distributor, pharmacy and practitioner registrants, such as through listservs or web-based training;
Solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting; and
Solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.
“GAO’s recommendations reaffirm HDMA’s long-standing position that enhanced communication, coordination and collaboration between the DEA and supply chain stakeholders is one of the keys to successfully mitigating prescription drug abuse and diversion," stated John Gray, president and CEO HDMA. "Further, GAO’s findings underscore the importance of the current federal legislation, the Ensuring Patient Access and Drug Enforcement Act of 2015 (H.R. 471/S. 483), which will help strengthen the relationship between supply chain stakeholders and the DEA, while encouraging productive dialogue between all parties. The House passed its version of the bill in April, and we urge the Senate to do the same."
Only 2-in-5 stakeholders interviewed believe the DEA is doing an effective job in combating prescription abuse. Aong those offering a perspective, between 31% and 38% of registrants GAO surveyed and 13 of 17 state agencies and national associations GAO interviewed believe that DEA enforcement actions have helped decrease prescription drug abuse and diversion.
GAO's survey results also showed that over half of DEA registrants have changed certain business practices as a result of DEA enforcement actions or the business climate these actions may have created. For example, GAO estimates that over half of distributors placed stricter limits on the quantities of controlled substances that their customers (e.g., pharmacies) could order, and that most of these distributors (84%) were influenced to a “great” or “moderate extent” by DEA's enforcement actions. Many individual pharmacies (52 of 84) and chain pharmacy corporate offices (18 of 29) reported that these stricter limits have limited, to a “great” or “moderate extent,” their ability to supply drugs to those with legitimate needs.
While DEA officials said they generally did not believe that enforcement actions have negatively affected access, better communication and guidance from DEA could help registrants make business decisions that balance ensuring access for patients with legitimate needs with controlling abuse and diversion, GAO concluded.